Document YrjQ0v8jBYK9JJ6YQ9LpdrnZO

Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 1 of 151 PAGEID #: 42154 EXHIBIT A IN THE UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF OHIO EASTERN DIVISION IN RE: E. I. DU PONT DE NEMOURS AND COMPANY C-8 PERSONAL INJURY LITIGATION CASE NO. 2:13-MD-2433 JUDGE EDMUND A. SARGUS, JR. This document relates to: ALL ACTIONS. MAGISTRATE JUDGE ELIZABETH P. DEAVERS DECLARATION OF SAMUEL M. COHEN, M.D., Ph.D. I, Samuel M. Cohen, declare and state as follows: 1. I prepared the Expert Report of Samuel M. Cohen, dated January 28, 2015 ("Expert Report"), and a true and accurate copy is attached as Exhibit 1. 2. Each of the opinions in the Expert Report is stated to a reasonable degree of scientific certainty, and was arrived at using reliable methods. 3. If called as a witness, I would testify competently to the matters stated in the Expert Report. 4. I declare under penalty of perjury under the laws of the United States of America that the foregoing is true and correct. Dated: March S , 2015 Samuel M. Cohen Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 2 of 151 PAGEID #: 42155 EXHIBIT 1 Confidential Subject to Protective Order Expert Report of Samuel M. Cohen, M.D., Ph.D. Carla Marie Bartlett v. E. I. du Pont de Nemours and Company Civil Action No. 2:13-CV-170 (S.D. Ohio) January 28, 2015 1 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 3 of 151 PAGEID #: 42156 EXHIBIT 1 Confidential Subject to Protective Order I. Personal background I am a professor in the Department of Pathology and Microbiology and the Eppley Cancer Center at the University of Nebraska Medical Center in Omaha, Nebraska, and I am the HavlikWall Professor of Oncology. In 1972 I received my M.D. and Ph.D. degrees from the University of Wisconsin-Madison. My Ph.D. was in experimental oncology from the McArdle Laboratories and my major professor was Dr. George T. Bryan. My graduate research focused on investigations on chemical carcinogenesis, which I have continued for my career, focusing on mechanisms of carcinogenesis in a variety of animal models and the evaluation of when and under what circumstances it is proper to extrapolate these findings to humans. I completed a residency in pathology at St. Vincent Hospital, Worcester, Massachusetts, with board certification in anatomic and clinical pathology in 1976. I have been a practicing pathologist, subspecializing in surgical pathology, since 1975, in addition to my teaching, research and administrative activities. I have been a professor at the University of Nebraska Medical Center in Omaha, Nebraska, since 1981. My research has focused on mechanisms of carcinogenesis, involving investigations on toxicology, pathology, biochemistry and molecular biology, computer modeling and clinical investigations, and I have also been involved with the design and interpretation of epidemiology investigations. I have authored more than 350 articles published in peer reviewed scientific journals and nearly 50 chapters in various books. I have served on multiple editorial boards or associate editorships for various scientific journals, including five at the present time. I have also served as a reviewer for manuscripts for more than 90 scientific journals and as an invited reviewer for evaluation of research grants for more than 20 funding agencies from the United States and from all over the world. I have served on numerous national and international committees and panels for several government and non-governmental agencies, including the US Environmental Protection Agency (EPA), US Food and Drug Administration (FDA), National Institutes of Health (NIH), National Toxicology Program (NTP), World Health Organization (WHO) International Agency for Research on Cancer (IARC), and WHO International Programme on Chemical Safety (IPCS). I have served on the NTP Scientific Board of Counselors and the NIH National Institute of Environmental Health Sciences (NIEHS) Scientific Board of Counselors I have served on the Board of Trustees of the International Life Sciences Institute (ILSI), including as chairman (2012-2015), and the Board of Trustees of the ILSI Health and Environmental Sciences Institute (HESI), including as Chairman (2006-2008). My involvement with these institutes and with the WHO/IPCS has included participation on committees (mainly sponsored by EPA and Health Canada) that developed a framework for the evaluation of the mode of action of toxicologic events in animal models (Sonich-Mullin et al., 2001), and Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 4 of 151 PAGEID #: 42157 EXHIBIT 1 Confidential Subject to Protective Order importantly, an evaluation of when and how to properly extrapolate the findings from these animal models to possible human relevance (Meek et al., 2003; Cohen et al., 2003; Cohen et al., 2004; Seed et al., 2005; Boobis et al., 2006; 2008). This framework has evolved and continues to evolve (Pastoor et al., 2014; Embry et al., 2014; Simon et al., 2014), and is widely used by the EPA, Health Canada and other regulatory agencies around the world. In addition, I have been extensively involved in efforts by FDA, EPA and others to develop new and better testing methods for screening for carcinogenesis. My participation on these committees is based on my extensive experience and expertise in the use of animal models, and because of my continued participation in and knowledge of human medicine. Since 2002, I have been a member of the FEMA Expert Panel that is responsible for evaluation of flavor ingredients in foods, with a determination of their acceptability and determination of their "Generally Regarded as Safe (GRAS)" status. I currently serve as chairman of the panel. For my accomplishments in research, I have received several awards, including the Arnold J. Lehman Award from the Society of Toxicology, the George H. Scott Award from the Toxicology Forum, the Lifetime Achievement Award from the Association for Environmental Health and Sciences, and the Distinguished Scientist Award in Cancer Research from the Japanese Foundation for Cancer Research, the Japanese National Cancer Center and the Japan Academy. Based on my expertise and experience in toxicology, carcinogenesis research, pathology and clinical medicine, I have served on numerous national and international committees, as described above, and also have been asked to serve on several expert panels and consultations for numerous private companies regarding chemicals, food ingredients and pharmaceuticals. My research has been supported by grants and contracts from the State of Nebraska, NIH, and private industry, and I have an endowed professorship at the University of Nebraska Medical Center. Additional details regarding my career, participation in various activities, and listing of publications are provided in the attached curriculum vita. All of my opinions are stated to a reasonable degree of medical and scientific certainty. Also, I reserve the right to revise or supplement these opinions if additional information becomes available. A listing of the cases in which I have given testimony in the past 4 years is attached as Exhibit B. For my services on this case, I am being compensated at the rate of $600 per hour. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 5 of 151 PAGEID #: 42158 EXHIBIT 1 Confidential Subject to Protective Order II. Summary of Opinions I have been requested to opine, based on a reasonable degree of medical and scientific certainty, whether Mrs. Carla Bartlett's kidney tumor was caused by her claimed exposure to perfluorooctanoic acid (PFOA). I have also been requested to opine on the development over time of the evidence on PFOA's ability to cause cancer in humans. I am aware that DuPont has agreed not to contest general causation (defined as whether "it is probable that exposure to C8 is capable of causing a particular Human Disease") for class members with kidney cancer, that Mrs. Bartlett claims to be a class member, and that DuPont has reserved the right to contest specific causation (defined as whether "it is probable that exposure to C-8 caused a particular Human Disease in a specific individual"). I am also aware that the Science Panel made Probable Link determinations in 2012, "that based upon the weight of the available scientific evidence, it is more likely than not that there is a link between exposure to C-8 and a particular Human Disease among Class Members," and I have reviewed the Probable Link finding related to cancer. Mrs. Bartlett developed a kidney renal cell carcinoma that was surgically excised in 1997. It was grade 1, stage 1 and she has had no evidence of recurrence in the ensuing 17 years since the surgery. She has no family history of renal cell carcinoma, has no history of cigarette smoking and was not hypertensive at the time of her surgery in 1997. At the time of her kidney cancer surgery she weighed 250 pounds, which puts her in a category of morbidly obese. Obesity is a major risk factor for kidney renal cell cancer, especially in women. Some studies estimate the general attributable risk of obesity to kidney cancer is 40%, and other estimates are as high as 80-90% for someone with a BMI as high as Mrs. Bartlett. Attributable risk is the estimate of the percentage of the total number of cases of a given disease (in this case, renal cell carcinoma) that are likely to be caused by a particular factor (in this case, obesity). Her exposure to PFOA in the drinking water was relatively low, and she did not work in any position involving PFOA manufacture or direct handling. Animal studies indicate that the only tumors associated with chronic high exposures of the nongenotoxic chemical PFOA are liver cell tumors, pancreatic acinar cell tumors, and testicular Leydig cell tumors. Subsequent studies have found that the modes of action by which these tumors are induced in rats are not relevant to human cancer risk. No increased risk of kidney tumors has been observed in any animal studies. Epidemiology studies in workers involved with PFOA in various occupational settings have suggested only a few effects, which are not consistently observed between industrial sites. Only one study has found a suggestion of an association with kidney cancer, but only at the very highest exposures. These studies did not control for kidney tumor type or the known Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 6 of 151 PAGEID #: 42159 EXHIBIT 1 Confidential Subject to Protective Order confounding factors associated with kidney cancer, such as obesity and hypertension. Similarly, community studies have found few consistent associations with increased risk. The only relationship with kidney cancer in these community studies have not been statistically significant, are based on a trend analysis, and have the same limitations regarding tumor type ascertainment and lack of control of confounding factors as the occupational studies. In light of Mrs. Bartlett's history and clinical presentation, her relatively low claimed exposure to PFOA, my understanding of carcinogenesis and the toxicology of PFOA, and the wellestablished scientific literature concerning the relationship between renal cell carcinoma risk and obesity, I conclude, to a reasonable degree of scientific and medical certainty, that Mrs. Bartlett's kidney tumor was most likely the result of her history of morbid obesity and not related to her claimed exposure to PFOA. Her cancer would have likely occurred even without any exposure to PFOA. She was successfully treated with surgery, and is not likely to have any further issues as a result of her prior kidney cancer. III. Materials reviewed To reach my conclusions in this matter, I have reviewed an extensive amount of material. Various specific references and materials are listed at the end of this report, but my general knowledge of the fields of pathology, toxicology and carcinogenesis have been utilized in this evaluation, including all of the articles and chapters listed in my CV and the articles cited in those publications. In addition, I have considered: the depositions of Carla Marie Bartlett (and exhibits), Dr. Robert R. Bahnson (and exhibits), Dr. Robert Rickard, Dr. Gerald Kennedy, Dr. John Whysner, and Dr. Dee Ann Staats; Mrs. Bartlett's available medical records; the profile for participant ID#63254 (Mrs. Bartlett), Mrs. Bartlett's Plaintiff Fact Sheet and its recently updated version; various documents concerning the medical surveillance programs at the Washington Works Plant, and the expert opinion reports of David L. MacIntosh, Barry R. DeYoung, Robert R. Bahnson, Vitaly Margulis, Cy A. Stein, Robert Rickard, Douglas Weed and Steve Washburn. I will first review some aspects of kidney cancer, including some of the well-recognized causes of kidney cancer, then discuss basic principles of chemical carcinogenesis, followed by an overview of toxicological and epidemiological evidence concerning PFOA exposure and kidney cancer, and then a specific discussion of my analysis of specific causation for Mrs. Bartlett. IV. Kidney cancer - clinical aspects The term "kidney cancer" is often loosely used to refer to multiple diseases with different risk factors and different prognosis (Murphy et al., 2004). For example, tumors of the kidney pelvis are pathologically and etiologically similar to the urothelial (lining) tumors of the urinary bladder (Murphy et al., 2004; Johansson and Cohen, 1997; Cohen et al., 2000). Tumors of the renal parenchyma of epithelial origin predominantly arise from the renal tubules and are 5 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 7 of 151 PAGEID #: 42160 EXHIBIT 1 Confidential Subject to Protective Order classified as renal cell carcinomas (Murphy et al., 2004). Other renal tubular and collecting duct tumors have been identified over the years, some in the last decade, and these have very different histopathologic appearances, molecular biologic alterations, and causative factors, when known, from the more usual renal cell carcinomas. Renal cell carcinomas commonly occur in the general United Stated population, and account for approximately 2-3% of adult malignancies. They comprise the vast majority of kidney tumors in adults, estimated at 80-85% of all kidney tumors (Murphy et al., 2004; Hakimi et al., 2013). In the United States it is estimated that there are about 35,000 new cases of renal cell carcinoma per year and approximately 12,500 deaths each year. Men are generally affected more commonly than women, approximately in a ratio of 3 to 2. These tumors can occur at any age, but the incidence increases with age, and they are usually detected after the age of 40. With modern day typical medical examinations, routine screening procedures, and various imaging procedures, kidney cancer is frequently detected early and treated with good success. There are several types of renal cell carcinoma, but the most common is classified as clear cell renal cell carcinoma based on the clear appearance of the tumor cells in histopathologic sections (Murphy et al., 2004). This sub-type is the most common form of kidney cancer, and accounts for approximately 70% of renal cell carcinomas. This is the type of tumor that Mrs. Bartlett had, and there was nothing atypical in her presentation. For clinical management purposes and for prognosis, clear cell renal cell carcinomas are also evaluated on the basis of grade and stage at the time the patient is diagnosed (Murphy et al., 2004; Chin et al., 2006). Grade refers to the degree of differentiation of the tumor (how closely it resembles normal), with a 4 grade system most commonly used (referred to as the Fuhrman grade). Grade 1, the grade of Mrs. Bartlett's tumor, is the most well differentiated and the least aggressive grade. It is associated with an excellent prognosis, is frequently in relatively small tumors (<4 cm.), and is usually treated only with surgery, especially if the tumor is confined within the kidney. Stage refers to the extent of the disease. Stage I includes tumors that are 7 cm. in greatest dimension or less and are confined to the kidney. Stage II includes tumors that are more than 7 cm. in greatest dimension but are still confined to the kidney. Stage III refers to tumors that have spread outside the kidney locally or have spread to lymph nodes. Stage IV includes tumors that have spread to distant tissues such as lung, bone, or elsewhere. Mrs. Bartlett's kidney tumor was Stage I. Renal cell carcinomas of grade 1 and stage 1 tend to be slow growing. These low grade, low stage renal cell carcinomas are usually treated by surgical resection, either total or partial nephrectomy, and the patient is followed with imaging studies (CT, MRI or ultrasound) yearly for 5-10 years, depending on the urologist, and less frequently after that. 6 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 8 of 151 PAGEID #: 42161 EXHIBIT 1 Confidential Subject to Protective Order V. Kidney cancer - epidemiology and etiology The reported incidence of renal cell carcinomas has been increasing in the United States over the past two decades, and this has been primarily due to the increased detection of small, low grade tumors (Hollingsworth et al., 2006; Murphy et al., 2004). Such tumors are frequently detected incidentally during imaging studies in patients being evaluated for some other disease. The newer imaging technologies, especially CT and MRI scans, are able to detect small kidney masses that could not be easily detected with standard x-rays (Jayson and Sanders, 1998; Hollingsworth et al., 2006). This is the scenario that occurred with Mrs. Bartlett. The established causes of kidney cancer are dependent on the tumor type (Jonasch et al., 2012; Murphy et al., 2004). For renal cell carcinoma there are genetic factors and environmental factors that contribute to their causation (Murphy et al., 2004, Jonasch et al., 2012; Hakimi et al., 2013). Several rare genetic disorders, such as von Hippel-Lindau disease, are associated with the development of renal cell carcinomas. Through these rare genetic disorders, several genes have been identified that appear to be associated with the development of renal cell carcinoma, with different genes related to the different subtypes of renal cell carcinoma (Jonasch et al., 2012). Various environmental factors have also been associated with an increased risk of renal cell carcinoma, including obesity (especially in women), hypertension and cigarette smoking (Murphy et al., 2004; Hakimi et al., 2013; Adams et al., 2008; Macleod et al., 2013; Chow et al., 2010; Dobbins et al., 2013; Calle and Kaaks, 2004; Roberts et al., 2010). Some studies have suggested a relationship with diabetes mellitus, but more specific investigations indicate that this is related to the commonly associated factors of obesity and hypertension (Macleod et al., 2013; Murphy et al., 2014). Obesity is well established as a major risk factor for the development of renal cell carcinoma. Some studies indicate that overall, approximately 40% of renal cell carcinomas can be attributed to obesity (Hakimi et al., 2013; Renehan et al., 2008; Adams et al., 2008; Chow et al., 2010; MacLeod et al., 2013; Pischon et al., 2006). Some studies estimate that the risk increases with the severity of the obesity, with those in the highest 5% by body mass index (BMI) having a five-fold higher risk than an individual with a normal BMI (Murphy et al., 2004). Some studies have reported that individuals with morbid obesity (BMI > 40), such as Mrs. Bartlett, have an attributable risk for developing renal cell carcinoma of 60 90%, with risk increasing by about 30% per 5 BMI units above normal (normal is usually defined as BMI <25, so Mrs. Bartlett is three sets of 5 BMI units greater than normal)(Hakimi et al., 2013; Renehan et al., 2008; Chow et al., 2010) Other than cigarette smoking, there are no well-established, definitive relationships between specific chemicals and renal cell carcinoma (Murphy et al., 2004; MacLeod et al., 2013; Hakimi et al., 2013; Chow et al., 2010). However, there is some evidence relating trichloroethylene to 7 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 9 of 151 PAGEID #: 42162 EXHIBIT 1 Confidential Subject to Protective Order the development of renal cell carcinoma (IARC, 2014; Lock and Hard, 2004). Various occupations have also been observed to have an increased risk of renal cell carcinoma, but more specific studies have not been able to support the association suggested by these initial observations. Sometimes this is due to lack of control in the studies for confounding factors, such as obesity, hypertension, and cigarette smoking, or due to lack of specifying what kind of kidney cancer the patients had. For example, inorganic arsenic was initially shown to be related to an increased risk of kidney cancer, but when tumor type was specified the only tumor type related to arsenic exposure was kidney pelvis urothelial carcinomas, not renal cell carcinomas (Ferreccio et al., 2013). Although several chemicals have been associated with the development of renal cell tumors in animal models (e.g. Lock and Hard, 2004), including various nitrosamines, polycyclic aromatic hydrocarbons, estrogens, lead, and certain food ingredients such as d-limonene, none have been shown to be associated with an increase in renal cell carcinomas in humans. Certain viruses have also been associated with kidney tumors in animal models, such as polyoma virus, but these also do not appear to be related to human renal cell carcinomas (Murphy et al., 2004). Similarly, radiation has produced kidney tumors in animal models but has not been demonstrated in humans (Murphy et al., 2004). Some kidney cancer also arises spontaneously or is the result of idiopathic causes. VI. Principles of carcinogenesis To address the issue of specific causation of Mrs. Bartlett's kidney cancer, some basic principles of carcinogenesis need to be considered (Cohen and Arnold, 2011). The cause of many cancers are unknown, however, a variety of agents have been identified as etiologic factors for cancer, including but not limited to radiation, nutrition, infectious organisms, cigarette smoking and some chemicals. Extensive investigations during the past several decades have clearly demonstrated that cancer arises from multiple genetic errors occurring in a single tissue stem cell, which then multiplies into a malignant tumor. It is also well known that mistakes can occur spontaneously during DNA replication (the duplication of DNA during the process of a cell undergoing division into two daughter cells). Accordingly, it is well accepted that cancer can and does occur in some individuals without any external stimulus. Although numerous alterations to cellular DNA occur daily in virtually every cell, including oxidative damage, deamination, depurination, exocyclic adduct formation, and a variety of other modifications, only a few of these result in permanent damage to the DNA because of an extensive and exquisite system of DNA repair mechanisms present in cells. Nevertheless, although DNA replication is extraordinarily precise, permanent mistakes occur each time DNA replicates. If the mistake happens to be in one of the genes that are necessary for the development of cancer, then the cell takes a step towards the process of becoming a malignancy. For most tumors, we do not know the number or specific genetic alterations that are required for cancer development, but the basic principle of multiple genetic errors leading to cancer is well 8 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 10 of 151 PAGEID #: 42163 EXHIBIT 1 Confidential Subject to Protective Order established. Based on these principles, a tumor can arise spontaneously, unassociated with any external exposure, or the tumor can arise secondary to certain chemical, infectious, or radiation causes (Greenfield et al., 1984; Moolgavkar and Knudson, 1981; Knudson, 1971; Tomasetti and Vogelstein, 2015). There are fundamentally only two ways that an external agent can increase the risk of cancer: 1) the agent directly damages the DNA, increasing the probability that a mistake will occur in one of the critical genes necessary for cancer to develop every time the DNA replicates; or 2) the agent can increase the number of cells that are replicating, increasing the opportunity for spontaneous mistakes to occur in the DNA (Knudson, 1971; Moolgavkar and Knudson, 1981; Greenfield et al., 1984; Cohen and Ellwein, 1990; 1991; Cohen and Arnold, 2011; Tomasetti and Vogelstein, 2015). Agents that act by damaging DNA are referred to as genotoxic (or DNA reactive) and those that act by increasing DNA replication are referred to as non-genotoxic (Cohen and Arnold, 2011; Cohen and Ellwein, 1991). Genotoxic chemicals include several well known classes of human carcinogens, including polycyclic aromatic hydrocarbons, aromatic amines, N-nitrosamines, and aflatoxins. Numerous assays have been developed to assess the potential genotoxicity of a given agent, most notably the Ames mutagenicity assay in Salmonella bacteria. Pharmaceuticals, consumer chemicals, and agrichemicals that are developed undergo an extensive battery of tests to evaluate genotoxicity. Such an evaluation has been performed for PFOA, and the results show that it is not genotoxic (e.g. Lawlor, 1995; Sadhu, 2002; Murli, 1996; Eriksen et al., 2010; Klaunig et al., 2012). If an agent that causes cancer does not increase the risk of cancer by directly damaging DNA, then it does so by increasing cell proliferation (Cohen and Arnold, 2011; Cohen and Ellwein, 1991). The agent can do this by acting directly on the target cell, or it can do so indirectly by affecting one or more of a variety of basic cellular processes. Increasing cell proliferation can occur either by increasing cell births or decreasing cell deaths (which would lead to an accumulation of cells). Cell births can be increased either by direct stimulation of cell proliferation, referred to as mitogenesis, or by damaging cells in the tissue (cytotoxicity) with consequent regeneration of the damaged tissue, such as occurs with a wound. Mitogenesis involves alterations in growth factors or endocrine functions, often through an effect on cellular receptors. For example, estrogen has been associated with endometrial cancer by interacting with the estrogen receptors, stimulating the endometrial cells to proliferate. Cytotoxicity is frequently involved as a carcinogenic mechanism, such as damage to the liver by ethanol or by hepatitis B virus (HBV), with extensive regeneration such as occurs in chronic liver disease (Cohen, 2010; Holsapple et al., 2006). 9 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 11 of 151 PAGEID #: 42164 EXHIBIT 1 Confidential Subject to Protective Order A key factor in addressing specific causation or the risk assessment of specific chemicals involves establishing whether they are genotoxic or not, since the dose response is usually quite different between genotoxic and non-genotoxic chemicals (Meek et al., 2003; Seed et al., 2005; Boobis et al., 2008). Non-genotoxic chemicals usually have a non-linear dose response, and it is well established that they have a threshold for the response (Boobis et al., 2006; 2008; Simon et al., 2014; Cohen and Arnold, 2011). The non-linearity and threshold are due to these chemicals affecting basic cellular processes, besides DNA, that are related with toxic effects, not damaging DNA directly or inducing cancer directly. It is the toxic reaction which leads to an increase in cell proliferation that ultimately leads to a cancer, and the toxic reaction only occurs once a threshold dose is reached. It has long been assumed that genotoxic chemicals have no threshold and the dose response is approximately linear. However, this paradigm has recently been challenged, at least for certain types of genotoxic chemicals, due to metabolic and kinetic factors (Kirsch-Volders et al., 2009). Non-linearity is actually relatively commonplace for genotoxic chemicals, but the possibility of a threshold remains controversial for these chemicals. The standard screening process for chemicals regarding carcinogenic potential that is used by regulatory agencies, and involves long-term assays in rodents, usually rats and mice and usually for a period of 2 years (Cohen and Arnold, 2011). These assays are for screening purposes; they don't prove that the chemical causes cancer in humans but raise the possibility, so that more extensive investigations can take place to further evaluate the true risk, if any, for humans, and at what doses. With all of these animal studies, there are two basic assumptions: (1) the response in the model system also can occur in humans (interspecies extrapolation); and (2) the doses used in the animal assays will produce the same effects at the exposure levels of humans (dose extrapolation). If no data are available addressing these assumptions, the default assumption made by the regulatory agencies is that they are correct. However, during the past six decades, extraordinary progress has been made in our understanding of the carcinogenic process in animal models and in humans, so that we can now better evaluate the interspecies and the dose extrapolation assumptions. This produces a more rational risk assessment for humans based on the findings in animals (Meek et al., 2003; Seed et al., 2005; Boobis et al., 2006; 2008). These scientific developments have been incorporated into a framework to evaluate mode of action of a chemical-induced toxicologic effect, including cancer, and an evaluation of its human relevance. This framework has been developed over the past 18 years by committees of the IPCS and ILSI, sponsored primarily by EPA and Health Canada. I have had the good fortune to be on several of these committees developing this framework, which continues to evolve (Sonich-Mullin et al., 2001; Meek et al., 2003; Seed et al., 2005; Boobis et al., 2006; 2008; Simon 10 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 12 of 151 PAGEID #: 42165 EXHIBIT 1 Confidential Subject to Protective Order et al., 2014). This framework is widely used by regulatory agencies in their evaluation of the risk assessment of chemicals, whether agrichemicals, industrial chemicals, consumer products, food ingredients or pharmaceuticals. By understanding the means by which a chemical produces a toxic effect in an animal model, one can develop a better understanding of the dose response in the animal model and the relevance of the mode of action and dose response to humans and specific exposures in humans. For some chemicals, such as aromatic amines and estrogen, the findings in the animal models are predictive of the human response, mechanistically and with respect to the dose response. However, for a large number of chemicals, especially those that are non-genotoxic (like PFOA), research has demonstrated that the findings in the animal models are not relevant to humans, or the dosages used to produce an effect in the animal do not apply at human exposure levels (Cohen and Arnold, 2011; Meek et al., 2003; IARC, 1999). For example, more than half of the drugs listed in the Physicians' Desk Reference have positive carcinogenicity tests in rats and/or mice, and yet they have been approved for human use by the FDA (Brambilla et al., 2012). One such drug (Betton et al., 1988; Hakanson and Sundler, 1990) that produces cancer in rodents (neuroendocrine tumors of the stomach) is omeprazole, which Mrs. Bartlett is currently taking for her gastrointestinal reflux disease. A critical factor evaluating specific causation and in estimating risk of cancer for any chemical is dose (Simon et al., 2014). As described above, for some genotoxic substances risk is estimated based on a linear, non-threshold dose response. To estimate a safe dose for genotoxic substances, a calculation is made as to the dose that would be required to produce 1 new cancer case in one million people over a lifetime of exposure. For example, aflatoxins, the most potent genotoxic carcinogens known, are present in all peanut products, but the FDA has set a limit of 20 micrograms per kilogram (ppb)(US FDA Guidelines for Aflatoxin Levels) to be a safe level for human consumption. For non-genotoxic agents (like PFOA), the dose response is non-linear and involves a threshold (Meek et al., 2003; Andersen et al., 2000). Thus, a certain level of exposure has to occur and be sustained for a long period of time for there to be an increased risk of cancer. The example of chloroform described below is a well-known example of a threshold, non-genotoxic carcinogen. There are many natural and synthetic substances in drinking water and in food that are known to cause cancer in animal models at high doses (Ames et al., 1990a; 1990b; Ames and Gold, 1990). However, safe levels are estimated by various regulatory agencies, such as EPA and FDA, based on our understanding of the dose response and mode of action for a given chemical. For genotoxic chemicals such as aflatoxin, a linear extrapolation is made for an estimate of anticipated risk of 1 new case in 1 million individuals over a lifetime of exposure. For non- 11 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 13 of 151 PAGEID #: 42166 EXHIBIT 1 Confidential Subject to Protective Order genotoxic chemicals such as chloroform, safety factors, usually 100 or 1000, are applied to the lowest dose causing an effect in the animal models. I will next provide some examples illustrating the application of this framework, and then show its application to specific causation analysis of whether Mrs. Bartlett's cancer was caused by PFOA. VII. Chemical carcinogens - examples of modes of action and human relevance 2-Acetylaminofluorene is a genotoxic chemical in the aromatic amine class of chemicals (Cohen and Ellwein, 1990a; Cohen et al., 2006). It was shown to produce liver and urinary bladder tumors in mice in long term studies. The proposed mode of action involves metabolic activation, formation of a reactive metabolite, which then bind to DNA forming DNA adducts that are mutagenic, ultimately leading to permanent damage to the DNA and cancer. The same precursor steps were demonstrated in humans, including the same metabolic activation, formation of DNA adducts and mutations. Based on the mode of action analysis and examination of each of the key events, it would be predicted that 2-acetylaminoflourene would be carcinogenic to humans, similar to other aromatic amines and amides. Epidemiology of occupations involving various aromatic amines in the 1930s to 1950s (long before routine protective gear and precautions were part of the workplace) showed a marked increase in the risk of developing urinary bladder cancer (Clayson and Cooper, 1970). Cigarette smoke also generates substantial amounts of aromatic amines, and cigarette smokers are associated with a 3 to 4 fold increased risk of urinary bladder cancer. The framework showed the qualitative similarity between mice and humans with respect to urinary bladder cancer. The framework, however, can also be useful in analyzing the quantitative aspects of carcinogenic risk (Cohen et al., 2006). At high doses there is both a genotoxic effect and increased proliferation secondary to toxicity. At lower doses, such as in cigarette smoking, it produces only the genotoxic effect while other substances in the smoke produce the proliferative response. The result is the same whether the genotoxic and proliferative effect are caused by one agent or a combination of agents. For non-genotoxic chemicals, the framework also is useful both qualitatively and quantitatively. For example, chloroform has been shown to produce liver and kidney tumors in rats and mice, but it is non-genotoxic (Andersen et al., 2000; Meek et al., 2003). The mode of action for chloroform-induced cancer involves metabolism which forms a cytotoxic metabolite, leading to regenerative proliferation, which when sustained can lead to the development of cancer. Based on this mode of action, if the dose is not sufficient to produce the cytotoxicity, there is no increased cancer risk. A clear threshold is present for the toxic and carcinogenic effects. In humans, chloroform is metabolized the same way as in rodents, so that a potentially cytotoxic 12 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 14 of 151 PAGEID #: 42167 EXHIBIT 1 Confidential Subject to Protective Order metabolite is formed. Chloroform at high doses also produces liver toxicity (and possibly kidney toxicity) in humans, which goes away once the exposure to the chloroform stops. High doses of chloroform were used as an anesthetic in the 1930s to 1950s. Occasionally patients were given a high dose (exposure was not easily controlled) and developed liver toxicity, but it gradually resolved over time. Based on the animal model, if the high dose had persisted and the toxicity persisted, these patients would have had an increased risk of liver cancer. Today, humans are exposed to extremely low doses in our drinking water since chloroform is a by-product of the chlorination of water. The framework indicates that these low doses would not be sufficient to produce a toxic effect in the liver (or kidney or other tissues) so the chloroform does not produce an increased cancer risk to humans. In short, a threshold is present for the toxic and carcinogenic effect. Cytotoxicity with consequent regenerative proliferation is a well-known mode of action for many carcinogenic agents, not only chemicals such as chloroform for liver and kidney cancer, but also for certain infectious organisms, such as hepatitis B virus and liver cancer (Cohen and Arnold, 2011). These agents involve a threshold, a concept well established in toxicology, and this mode of action and threshold was also substantiated legally, specifically for the example of chloroform in the drinking water (Chlorine Chemical Council v. EPA, 2000). Numerous examples have been identified of chemicals that produce cancer in animals but by a mode of action that is not applicable to humans, either qualitatively or quantitatively. Humans would not have an increased risk of cancer from such chemicals, no matter how much we were exposed to. D-Limonene is a natural chemical that is present in many plants, but particularly in citrus fruits. There is epidemiologic evidence that ingestion of such fruits actually decreases the risk of certain cancers. However, in male rats high doses of d-limonene produce a small increase in the incidence of kidney cancer (Meek et al., 2003), but not in female rats or in male or female mice. D-Limonene is non-genotoxic, but in male rats it produces toxicity in the kidney with consequent increased cell proliferation. The mode of action for the d-limonene-induced toxicity and carcinogenicity involves metabolism to a form that can bind to a specific protein called alpha-2u-globulin. In the normal male rat, alpha-2u-globulin is produced in the liver, filtered in the kidney glomerulus but reabsorbed in the kidney tubule and then degraded and reused by the rat. However, when this protein is bound to the metabolite of d-limonene it is filtered through the glomerulus and reabsorbed by the tubules, but it cannot be degraded. Thus, it accumulates in the cell, eventually killing the tubular cell. If exposure continues for the 2 years of the male rat's lifetime, this chronic toxicity leads to sustained increased cell proliferation and eventually can lead to an increase in kidney tumors. 13 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 15 of 151 PAGEID #: 42168 EXHIBIT 1 Confidential Subject to Protective Order Female rats and male and female mice do not have alpha-2u-globulin, so there is no toxicity or regenerative cell proliferation, and no increase in the incidence of kidney cancer when treated with d-limonene. Humans also metabolize d-limonene the same way as the male rat, but we do not have alpha-2u-globulin (or a comparable protein that binds the d-limonene metabolite), so we, like the female rat and the male and female mouse, do not have a cancer risk from the ingestion of d-limonene, no matter how much we ingest. Another example of a non-genotoxic group of chemicals that produce cancer in rodents but not in humans are the statins, widely used drugs that lower blood cholesterol, reduce cardiovascular risks and consequently reduce the risk of death. The statins produce a high incidence of liver cancer in male and female rats and in male and female mice (MacDonald and Halleck, 2004). The mode of action in rodents involves blocking cellular metabolism, which in the rodent at high doses leads to increased liver cell proliferation. The same initial block in metabolism, inhibiting a critical enzyme involved with cholesterol synthesis, HMG-CoA reductase, also occurs in humans. However, in humans this does not lead to an increase in cell proliferation so it would not be expected to lead to an increase in liver cancer. There is a fundamental difference in the way rodents respond to statins inhibiting HMG-CoA reductase and how humans respond. In rodents, there is an increase in liver cell proliferation but no decrease in blood cholesterol. In humans there is an opposite response, a decrease in blood cholesterol and no increase in liver cell proliferation. Extensive epidemiology studies involving several hundreds of thousands of patients have clearly shown no increased risk of liver cell cancer in people taking long term statins (Chiu et al., 2011), and for that matter, no increased risk of any other cancer or in cancer overall (Nielsen et al., 2012). A common concern in extrapolating from animal models to humans regarding cancer risk has to do with organ specificity: could the cancer effect occur in one tissue in the animal models and in some other tissue in humans. For genotoxic chemicals, there sometimes is a difference in the tissue that has a cancer effect in the animal model compared to the cancer that is produced in humans. For example, many aromatic amines, such as 2-acetylaminofluorene described above, produce liver and urinary bladder cancer, and sometimes other cancers, in the rodent models but only urinary bladder cancer in humans (Cohen et al., 2006; Cohen and Arnold, 2011). These differences occur due to differences in the metabolism between species so that the DNA adduct formation and subsequent cancers occur in different tissues. However, the basic mode of action, metabolism to a reactive metabolite that binds to DNA and produces mutations, is the same for all of the tissues involved and the different species. One issue in considering animal studies is organ specificity of a compound's effects. For nongenotoxic chemicals, like PFOA, the mode of action is tissue specific, or at least target tissue type specific. Thus, chloroform produces toxicity in the liver and kidney and produces cancer in 14 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 16 of 151 PAGEID #: 42169 EXHIBIT 1 Confidential Subject to Protective Order these same tissues, not in other tissues. d-Limonene produces a toxicity that can only occur in the male rat kidney, and that is where the tumors occur. No other toxicity is produced and no other cancers are produced (Meek et al., 2003). The recent extensive research on statins provides the strongest evidence for tissue specificity in extrapolating between species (MacDonald and Halleck, 2004; Chiu et al., 2011; Nielsen et al., 2012). Statins produce liver toxicity and liver cancer in rodents, but not cytotoxicity or cancer in other tissues. The toxicity and carcinogenicity is specific to the liver. This sustained toxicity and proliferation does not occur in humans and there is no increased risk of liver cancer. However, there is no sustained cytotoxicity in humans in other tissues and there is no increased risk of cancer in any other tissue, as well. VIII. Brief comments regarding PFOA toxicology and epidemiology studies I have reviewed the expert reports of Dr. Robert Rickard and Dr. Douglas Weed, and they have confirmed my understanding of the historical toxicology and epidemiology studies that have been performed on PFOA. I mention only a few of those studies below, although I have reviewed several others. PFOA has been studied toxicologically in a number of species in a variety of short and long term studies by several routes of administration, including inhalation, dermal, and oral (drinking water and diet). It is only weakly to moderately acutely toxic, with an LD50 of 470 mg/kg in rats. A chronic carcinogenicity study was initially performed by the primary manufacturer of PFOA in the United States, 3M, in the 1980s in male and female Sprague-Dawley rats at concentrations of 0, 30, or 300 ppm of the diet for 2 years (Sibinski, 1987; Butenhoff et al., 2012). Only at the high dose there was an increased incidence of Leydig cell tumors of the testis. There were no reports of kidney tumors related to this study. Subsequent animal toxicology studies have been performed over the years on a variety of different animals and at different dose levels, as referenced in the expert report of Dr. Rickard. None of these studies have shown any form of cancer being caused by PFOA at the relatively low dose level being claimed by Mrs. Bartlett. Indeed, none of these animal studies have shown kidney cancer being caused at any dose. A subsequent study by DuPont completed in the early 1990s, only in male CD rats, at 300 ppm of the diet by DuPont showed an increased incidence of the Leydig cell tumors as well as an increase in pancreatic acinar cell tumors and liver cell tumors (Cook et al., 1992). Differences between the 2 studies are likely related to differences in the diets that were used. During the 1990s and later, a variety of specific investigations in animal models were performed to determine the mode of action for these tumors in rats (reviewed in Klaunig et al., 2003; 2012). 15 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 17 of 151 PAGEID #: 42170 EXHIBIT 1 Confidential Subject to Protective Order Epidemiologically there have been studies of various worker populations and of the general community around the Washington Works plant (which included workers and a very wide range of exposures), as described more fully in the expert report of Dr. Weed. Epidemiology studies are studies of groups or populations, and cannot prove specific causation in an individual. However, they are part of the body of evidence that should be considered in evaluating specific causation in a particular individual. Ubel et al. (1980) were the first to report an evaluation of the health effects of PFOA in workers based on the 3M facility in Minnesota. They found no increased cancer or other health risks. A further analysis of workers at this plant was reported by Gilliland and Mandel (1993), again with no increased risks related to PFOA except for a slight increase in prostate cancer. However, the potential association with prostate cancer was based on only 4 cases and this finding has not been replicated at other work sites where PFOA has been manufactured or used. On further review, it turned out that only 1 of the 4 men with prostate cancer had actually worked with PFOA (Olsen et al., 1998). This cohort was further evaluated by Lundin et al. (2009), who again determined no overall increased cancer risk. They found a slightly higher rate of prostate cancer in highly exposed workers compared to controls, but it appears that the incidence in the controls was considerably lower than in the general Minnesota population. No increased risk of kidney cancer was detected in any of these studies. A recent follow up of the employees at the various 3M facilities in Minnesota again showed no evidence of an increase in kidney tumors (Raleigh et al., 2014). Leonard et al. (2008) studied a cohort made up of employees at DuPont's Washington Works Plant. Leonard reported no increase in tumors except for thyroid, and actually found a decreased incidence of prostate cancer in the workers exposed to PFOA. This cohort was further evaluated by Steenland and Woksie (2012) who observed a slightly increased rate of kidney cancer, but only at the highest quartile of worker exposure. A more recent evaluation of this cohort by Steenland et al. (2015) found no evidence of an increase in kidney tumors nor any other tumor type. They did detect a decreased incidence of urinary bladder tumors. I have also reviewed the earlier surveillance data gathered on the entire Washington Works plant, and the follow up that was done to investigate work histories for persons with incidence of disease, and medical records for those workers with higher PFOA blood levels. An overall evaluation of workers at US and European sites was conducted by Consonni et al. (2013) and found no overall increased risk of any cancer (actually observed an overall decreased cancer risk). This study had several limitations compared to the site specific studies. Epidemiological investigations including more than occupationally exposed persons have primarily involved the Mid-Ohio Valley community studied by the C-8 Science Panel and Dr. Emmett, which included more highly exposed workers as well as lower exposed non-workers 16 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 18 of 151 PAGEID #: 42171 EXHIBIT 1 Confidential Subject to Protective Order with wide ranges of exposures and blood levels. Mr. Washburn and Dr. Weed describe more about the range of blood levels of PFOA and other details about these studies in their reports. The Emmett study was published in 2006, and did not involve cancer. The Science Panel probable link findings came out in 2011 and 2012, and in publications in the scientific literature since then. In these investigations, the only tumor for which they found statistically significant associations for cancer risk was germ cell tumors of the testis. Based on the Science Panel's work, Barry et al. (2013) reported a weak association with kidney cancer (i.e. adjusted odds ratio 1.58) at the highest quartile of exposure. The AORs were lower in the lower-exposed quartiles (i.e., AOR 1.23 and 1.48 for quartiles 2 and 3 respectively). These weak associations were not statistically significant. In Barry et al. (2013), a very complex set of models involving environmental fate, transport and kinetics and numerous general, group assumptions for evaluation of exposure is used. They did not verify type of kidney cancer, did not have available data to evaluate confounding factors such as obesity and hypertension, and did only a very limited evaluation for cigarette smoking. The report also does not indicate that they have dealt with the issue of chance findings, even though they are statistically evaluating a large number of comparisons. Vieira et al. (2013) reported inconsistent associations with kidney cancer in an ecologic epidemiology study. Overall, it found non-statistically significant and very weak association (i.e., RR 1.1) between residence in one of six water districts studied by the C-8 Health Project and kidney cancer. This study looked only at residence at the time of cancer diagnosis. It did not control for confounding factors, and does not control for an estimated dose of PFOA. In certain sub-analyses Vieira et al. (2013) claim to have identified associations between kidney cancer and PFOA exposure, but only for those in the highest exposure categories. Vieira et al. (2013), however, relies on an even less precise geographic model to assess exposure than in Barry et al. (2013). Vieira et al. assumes that individuals identified by cancer registry data lived at the same site for 10 years. Mrs. Bartlett illustrates the problem with this assumption, since she did not live in the same place for the 10 years prior to her kidney tumor diagnosis, and not even in the assessed area for part of the time. Nor does Vierra et al. control for confounding factors such as obesity or hypertension. IX. Animal models of PFOA carcinogenesis PFOA produces tumors when administered to rats in high doses, and it produces liver, pancreatic and Leydig cell testicular tumors (Cook et al., 1992; Sibinski, 1987: Butenhoff et al., 2012; Klaunig et al., 2003; 2012). The liver tumors are hepatocellular tumors (benign and malignant). The pancreatic tumors are classified as acinar cell tumors (mostly benign), and the testicular tumors are Leydig cell tumors (benign). This is the typical spectrum of tumors that are produced by chemicals classified as peroxisome proliferators, because of their ability to 17 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 19 of 151 PAGEID #: 42172 EXHIBIT 1 Confidential Subject to Protective Order increase peroxisomes in the liver (Klaunig et al, 2003). Peroxisomes are a subcellular organelle involved in processing degraded and foreign material to maintain cellular homeostasis. Chemicals that have these effects in rodent models are quite diverse and include such chemicals as phthalates (used in plastics) and fibrates (drugs used to lower blood lipids). The primary mode of action for these chemicals has been shown to involve their interaction with a cellular nuclear receptor called peroxisome proliferator-activated receptor alpha, or PPAR alpha (Klaunig et al., 2003; 2012; Corton et al., 2014). Since this leads to activation of the receptor, the chemicals are referred to as PPAR alpha agonists. In rodents, the chemicals interact with the receptor in the liver cells (hepatocytes) which leads to effects on lipid metabolism and also leads to proliferation of the hepatocytes. If exposure continues for long periods of time, the sustained increased proliferation can lead to the development of benign and malignant hepatocellular tumors. In humans, there are significantly fewer PPAR alpha receptors, but the metabolic effects on the hepatocytes regarding lipid metabolism is qualitatively similar to that observed in rodents. However, in humans, in contrast to rats and mice, these chemicals do not increase hepatocyte proliferation (Tateno et al., 2014; Corton et al., 2014). Beginning in the early 1990s, considerable evidence supporting a lack of human relevance of the rodent tumor findings was developed, and by 2003 an international panel concluded that the rodent tumors were not predictive of a human cancer risk. Furthermore, lack of cancer risk extrapolation to humans was recently convincingly demonstrated in a model in which human liver cells were incorporated into the liver of mice, so called chimeric mice (Tateno et al., 2014). When administered the PPAR alpha agonist, the effects on lipid metabolism occur in both the mouse and human hepatocytes. However, increased proliferation only occurs in the mouse hepatocytes but not in the human hepatocytes. Without this increased cell proliferation there is no increased risk for the development of liver tumors in humans. Also, recently it has been demonstrated that many of these chemicals that are PPAR alpha agonists also can interact with another liver cell receptor named constitutive androstane receptor (CAR)(Rosen et al., 2008a; 2008b; Cheng and Klaassen, 2008;Corton et al., 2014; Elcombe et al., 2012; 2014). This interaction is weaker than with PPAR alpha, so the effect is considerably less. However, if the PPAR alpha receptor is eliminated from the mouse, using sophisticated molecular biologic techniques, the interaction with CAR becomes significant. The interaction with CAR also produces cellular effects in hepatocytes, primarily with the metabolism of foreign substances to which the animal is exposed. In rodents, activation of CAR also leads to hepatocellular proliferation, the same as seen with PPAR alpha agonists (Elcombe et al., 2014). Like the PPAR alpha agonists, the metabolic effects also occur in humans, but the proliferative effects that occur in rodents do not occur in humans (Elcombe et al., 2014; 18 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 20 of 151 PAGEID #: 42173 EXHIBIT 1 Confidential Subject to Protective Order Yamada et al., 2014). Thus, an effect on CAR or PPAR alpha in humans would not lead to increased hepatocellular proliferation and there would be no increased risk of cancer. Supporting the conclusion of no risk to humans regarding liver cancer for PPAR alpha (IARC, 1996) and CAR (IARC, 2001) agonists are several epidemiology studies that have shown that they are not associated with an increase in liver tumors. Such epidemiology studies have primarily been performed in patients treated with the fibrates (PPAR alpha agonists used to lower blood lipids) and with phenobarbital (CAR agonist used for the treatment of seizures)(IARC, 2001), but have also been examined for other pharmaceuticals and chemicals, such as pyrethroids (CAR agonist) that are used as environmental pesticides (Rusiecki et al., 2009). The pancreatic tumors produced in rats administered PPAR alpha agonists are acinar cell tumors. Like the kidney, the pancreas can give rise to several types of tumors. In rats, they most often are acinar cell tumors, which are relatively common in rats (Rao and Haseman, 1993; Obourn et al., 1997). In humans, acinar cell tumors are rare. In mice they are also rare. The reason for the rat's sensitivity to the development of pancreatic acinar cell tumors is due to their reaction to a hormone produced primarily in the liver that is called cholecystokinin (CCK). In rats, this hormone stimulates secretion by the acinar cells in the pancreas, but it also stimulates them to proliferate. If the increased acinar cell proliferation continues for long periods of time, it can lead to the development of tumors. CCK is produced in response to lipids in the diet, stimulation of lipid metabolism or cholestasis such as occurs with activation of PPAR alpha (Obourn et al., 1997). Thus, administration of high fat diets or PPAR alpha agonists to rats leads to acinar cell tumors in the rat. CCK also is produced in mice and humans (most mammals) in response to dietary fat. However, pancreatic acinar cells respond to CCK by stimulating secretions but it does not stimulate the acinar cells to proliferate. Thus, this mode of action does not result in an increased risk of pancreatic acinar cell tumors (or other pancreatic tumors) in humans. Leydig cell testicular tumors are also very common in rats, with incidences in controls of nearly 100% in some laboratory strains (Cook et al., 1999). Leydig cells in the testis are the interstitial cells that are present between the seminiferous tubules which contain the germ cells. The Leydig cells are endocrine cells that produce hormones, mainly androgens such as testosterone. In rats, many treatments that affect testosterone levels and associated hormones from the pituitary lead to increased Leydig cell proliferation (Cook et al., 1992; 1999). Again, if cell proliferation is prolonged in the rat, there can be an increase in tumors, nearly always benign. PPAR alpha agonists are amongst the chemicals that can cause this effect (Cook et al., 1999; Klaunig et al., 2003). Like the hepatocytes in the liver and pancreatic acinar cells, humans do not have this same proliferative response so there is no increased risk of Leydig cell tumors in 19 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 21 of 151 PAGEID #: 42174 EXHIBIT 1 Confidential Subject to Protective Order humans. The PPAR alpha agonists have no proliferative or tumorigenic effects on the germ cells in the testis in rats or mice. In animal models, long term administration of PPAR alpha agonists, such as PFOA, do not produce tumors of the kidney or tumors of other tissues other than the ones described above (Klaunig et al., 2012). X. Carla Bartlett Mrs. Carla Bartlett had a renal cell carcinoma that was initially detected by CT scan during a work-up for abdominal pain and gall bladder disease. A mass was initially visualized in 1996 and observed by scans until it was resected in 1997, when she was 41 years old. There was nothing atypical in her presentation or treatment for renal cell carcinoma. She has had no recurrence of her kidney tumor nor development of new kidney cancers or other malignancies. The kidney tumor was diagnosed as a clear cell renal cell carcinoma, grade 1 and stage 1. Grade 1, stage 1 renal cell carcinoma has an excellent prognosis. Indeed, she has been free of recurrence for 17 years, and her risk for recurrence or progression is negligible, although her continued obesity places her at continued increased risk for development of another renal cell carcinoma as well as being at increased risk of other malignancies and health issues. I have considered the established risk factors for renal cell cancer in Mrs. Bartlett's case. There is no evidence of Mrs. Bartlett ever being a cigarette smoker and she was not hypertensive at the time of her original diagnosis. She has subsequently become hypertensive, and has also developed several other manifestations associated with obesity including gastroesophageal reflux disease (GERD), diabetes and hypercholesterolemia. Her father had a kidney cancer, but according to his death certificate this was a transitional cell carcinoma, indicating that it arose from the kidney pelvis, not the kidney tubules, and would not pertain to a family history of renal cell carcinoma. Also, I did not find other documents indicating that Mrs. Bartlett had any family history of renal cell carcinoma. According to her medical records at the time of diagnosis, she was 250 pounds (morbidly obese), and in the reports of the plaintiff's experts she is listed as being 265 pounds in 2014, a net gain of 15 pounds in 17 years. She listed her weight as 230 pounds at the time of the collection of her demographic and other data for evaluation for inclusion in the C8 Health Project. Thus, she has a history of some variability in her weight over the past 17 years, ranging from 230 to 265 pounds in the data I currently have available. She has had, or continues to have, several other medical problems including the gall bladder disease for which she had her gall bladder removed, irritable bowel syndrome, removal of uterine fibroids (leiomyomas) during pregnancy, a subsequent hysterectomy for fibroids, a vesicovaginal fistula, back surgery, 20 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 22 of 151 PAGEID #: 42175 EXHIBIT 1 Confidential Subject to Protective Order diabetes mellitus, GERD, hypertension, hypercholesterolemia, depression and anxiety. Although she has had a number of medical issues, she has been a regular member of the workforce, and is not a member of any sensitive subpopulations. Of the well-established risk factors for renal cell carcinoma, the only one that was pertinent at the time of her diagnosis and surgery in 1997 was obesity. As noted above, obesity is a major risk factor for the development of renal cell kidney cancer in humans, especially women. At the time of her kidney cancer diagnosis, Mrs. Bartlett weighed approximately 250 pounds and had a BMI of approximately 40. As I explained above, as a result of her obesity, Mrs. Bartlett was at significant increased risk of developing renal cell carcinoma. I have considered the claim made by Mrs. Bartlett's experts that PFOA was a substantial factor in the development of her specific kidney cancer. As mentioned above, dose is a significant factor in evaluating the potential carcinogenicity of any substance, especially for a non-genotoxic chemical like PFOA. There are a number of epidemiological studies that have attempted to estimate the risk of developing cancer as a result of PFOA exposure. To understand Mrs. Bartlett's risk, her exposure needs to be understood in the context of these various studies. Mrs. Bartlett appears to have had very low exposures to PFOA compared to the animal studies and the human populations in the studies referenced above. She lived in Coolville, Ohio from I9 60 to 1989 based on the assessment reported by Dr. David L. Macintosh, and she has lived in Guysville, Ohio since 1993. Mrs. Bartlett's water supply (according to Dr. Macintosh) was estimated to contain PFOA at a level of 0.17-0.24 ppb in 1983 when her water supply was connected to the Tuppers Plains Water District. While in Guysville, her water was estimated to contain PFOA at levels of 0.29-0.47 ppb prior to 1997. These claimed levels of drinking water exposure are below the EPA's current provisional health advisory level (0.4 ppb) in all but one year considered by Dr. Macintosh. This strongly suggests that she was at very low risk for PFOA-related health effects. Even amongst those exposed to PFOA in these water districts, her blood level of PFOA was low; her blood level measured in 2005 was 19.5 ng/mL (ppb). Blood level is a better measure of actual exposure than drinking water levels as it accounts for the way the person is handling the substance, and for substances like PFOA is a better indicator over time. For the C8 Health Project the average blood PFOA level for women 40-59 years of age was 80.2 ng/mL(median 25.7), but there was very wide variability as indicated by a standard deviation of 260.7 ng/mL The average for women of all ages was 68.8 ng/mL (median 23.6), again with very large variability (standard deviation of 190.6) (Frisbee, 2009). Her levels are also low compared to other residents of Tuppers Plains (Washburn) 21 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 23 of 151 PAGEID #: 42176 EXHIBIT 1 Confidential Subject to Protective Order In the ecologic analysis by Vieira et al. (2013), they classified the participants into low, medium, high and very high groupings. Based on their analysis, Mrs. Bartlett would have been included in the lower half of the medium group (blood levels 12.9-30.8 ng/mL). According to their analysis, however, there was an association with increased kidney cancer risk only at the high and very high blood levels. The problems with the dose assumptions used in Vieira et al. (2013) are also discussed above. I note that Vieira et al. also report a potential increased risk of kidney cancer for residents of Tuppers Plains, but that study is based on residence at the time of diagnosis, not estimated PFOA dose. Note that in the overall C8 Health Project (Barry et al., 2013), the increase in kidney cancer risk was not statistically significantly increased (p>0.05). Furthermore, a recent publication evaluating the worker cohort at the DuPont West Virginia plant shows no increased risk of any tumor type, with a decreased cancer risk for urinary bladder cancer (Steenland et al., 2015) In addition, Mrs. Bartlett's claimed exposures are significantly lower than the PFOA levels in the blood of definitely exposed workers that worked in the industries involved with the production and use of PFOA. In studies of the workers at the West Virginia plant (Steenland and Woksie, 2012), measured blood levels ranged from 160 to 2,880 ng/mL. An association with kidney cancer was observed only at the highest quartile estimated cumulative exposure group (i.e. >2,700 ppm-years). This was not corroborated in their most recent evaluation of this worker cohort (Steenland et al., 2015). In workers in various other studies, no relationship between kidney cancer and PFOA exposures even at much higher occupational levels were consistently found (Lundin et al., 2009; Chang et al., 2014; Steenland et al., 2015). In the animal studies, no kidney tumors were found at any dose, and the concentration required to produce other tumors was 300 ppm of the diet, whereas the dose of 30 ppm did not significantly increase the incidence of tumors. No animal studies support the claim that any cancer tumor could be caused at the low dose of PFOA claimed by Ms. Bartlett. Likewise, in all of the epidemiology studies, including the Science Panel studies, a possible relationship between PFOA and kidney cancer was only observed at much higher exposures than Mrs. Bartlett likely experienced. The exposure that Mrs. Bartlett claims was not associated with an increased risk of kidney cancer. In sum, it is my opinion, based on a reasonable degree of medical and scientific certainty, that the renal cell carcinoma of Mrs. Bartlett resulted from her history of morbid obesity, and was not caused by or related to her low exposure to PFOA. XI. Additional Opinions Concerning Reports Submitted By Mrs. Bartlett's Experts 22 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 24 of 151 PAGEID #: 42177 EXHIBIT 1 Confidential Subject to Protective Order I have reviewed the expert reports of Drs. Stein, Margulis and Bahnson. Obviously, I disagree with them to the extent that they make statements different from what I have said above. I also note the following: The written reports of the plaintiff's experts are incorrect when they indicate that they can dismiss Mrs. Bartlett's obesity. As explained above, obesity is a very well-established risk factor of the development of renal cell kidney cancer. Although some of the expert opinion reports for the plaintiff list many potential risk factors for kidney cancer, in fact many of the substances on their lists refer to risks associated with kidney pelvis urothelial tumors, not for renal cell carcinomas. For example, phenacetin is listed by them as a cause of renal cell carcinoma. Although it is associated with kidney damage (to the renal papilla), it is only associated with urothelial tumors, most commonly of the kidney pelvis but also of the ureters and urinary bladder (IARC, 2012). Based on the CV's provided of the plaintiff's experts, it does not appear that they have experience with investigations concerning animal carcinogenesis or human cancer epidemiology, nor do they appear to have experience on committees or panels related to an evaluation of cancer etiology or extrapolation from animal models to humans. They appear to be relying on published reports without a background to critically analyze them. In the reports of Dr. Margulis and Dr. Stein, they claim that PFOA could be acting synergistically with obesity to produce her kidney cancer. There is nothing in the scientific literature to support any claim of a synergistic effect between PFOA and obesity as it relates to kidney cancer. Indeed, there is no theoretical basis to consider a synergy between obesity and PFOA. Neither acts as a genotoxic agent, and for a non-genotoxic agent there will be a threshold dose that needs to be attained before there is any effect, whether by itself or in synergy with other agents. As indicated above, there has been a suggestion of a possible relationship in some studies between PFOA and kidney cancer. However, this only occurs at exposures considerably higher than Mrs. Bartlett's exposure. There is no scientific evidence that the low exposures that Mrs. Bartlett claims would act synergistically with other risk factors to increase kidney cancer risk. In the reports of Dr. Stein and Dr. Margulis, they refer to her kidney tumor as stage 2. That is incorrect as the tumor would have had to have been >7 cm. in greatest diameter for such a classification, and Mrs. Bartlett's tumor was up to 3.2 cm. in diameter according to the pathology report and was never measured greater than 5 cm. in diameter in imaging studies. 23 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 25 of 151 PAGEID #: 42178 EXHIBIT 1 Confidential Subject to Protective Order Samuel M. Cohen, M.D., Ph.D. January 28, 2015 24 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 26 of 151 PAGEID #: 42179 EXHIBIT 1 Confidential Subject to Protective Order References Adams et al., Am. J. Epidemiol., 168: 268-277, 2008 American Joint Committee on Cancer (AJCC). AJCC Cancer Staging Manual, Seventh Edition. Springer, New York, 2010. P. 479-489. 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Health Persp., 122:1299-1305, 2014 28 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 30 of 151 PAGEID #: 42183 EXHIBIT 1 Confidential Subject to Protective Order Winquist et al., Env. Health Persp., 121: 893-899, 2013 Yamada et al., Toxicol. Sci., 142:137-157, 2014 29 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 31 of 151 PAGEID #: 42184 EXHIBIT 1 Name: Address: Personal: Education: Post-degree training: Curriculum Vitae Samuel Monroe Cohen, M.D., Ph.D. University of Nebraska Medical Center 983135 Nebraska Medical Center Omaha, Nebraska 68198-3135 (402)559-6388 (402) 559-8330 (F) E-mail: scohen@unmc.edu Place of birth: Milwaukee, Wisconsin Date of birth: September 24, 1946 Citizenship: United States citizen by birth Marital Status: Married to Janet Lu Olson, January 27, 1968 (Died December 22, 2011) Children: Sheri Lyn: July 20, 1971 Benjamin Aaron: November 15, 1972 Daniel Eric: February 15, 1974 Erica Ann: November 18, 1975 1963-1967-B.S. University of Wisconsin, Madison Major: Medical Science (Honors) 1966-1972 - M.D. University of Wisconsin, Madison 1968-1972 - Ph.D. University of Wisconsin, Madison Major: Oncology Theses: Cohen, S.M. Studies on N-[4-(5-nitro-2-furyl)-2-thiazolyl] formamide, a potent bladder carcinogen. B.S. Thesis, University of Wisconsin, 1967 Cohen, S.M. Carcinogenicity of 5-nitrofurans: Formic acid 2-[4(5-nitro-2-furyl-2-thiazolyl]hydrazide and N-[4-5-nitro-2-furyl)2-thiazolyl]acetamide. Ph.D. Thesis, University of Wisconsin, 1972 Internship: St. Vincent Hospital, Worcester, Massachusetts, July 1, 1972-June 30, 1973 (Straight Pathology) Residency: St. Vincent Hospital, Worcester, Massachusetts, July 1, 1973-October 31, 1975 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 32 of 151 PAGEID #: 42185 EXHIBIT 1 Curriculum Vitae Page 2 Samuel M. Cohen, M.D. Ph.D. Academic and staff appointments: 2010- Adjunct Professor, Program on Toxicologic Pathology, Sao Paulo State University Medical School, Botucatu, Brazil 2010- Staff pathologist, Nebraska Orthopaedic Hospital, Omaha, Nebraska, and Bellevue Medical Center, Bellevue, Nebraska 1992-2007 Chairman, Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha, Nebraska 1988, 1992 Acting Chairman (during Chairman's sabbaticals), Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha, Nebraska 1981- Professor, Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha, Nebraska 1981- Professor, Eppley Institute for Research in Cancer, University of Nebraska Medical Center, Omaha, Nebraska 1981-1992 Vice Chairman (Acting Chairman during Dr. David Purtilo's absences), Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha, Nebraska 1977-1981 Associate Professor, Department of Pathology, University of Massachusetts Medical School, Worcester, Massachusetts 1977-1981 Staff Pathologist, St. Vincent Hospital, Worcester, Massachusetts 1976-1977 Visiting Professor, First Department of Pathology, Nagoya City University Medical School, Nagoya, Japan (sponsored by the United States-Japan Co operative Cancer Research Program) 1975-1976 Staff Pathologist, St. Vincent Hospital, Worcester, Massachusetts 1974-1977 Instructor, Department of Pathology, University of Massachusetts Medical School, Worcester, Massachusetts 1974-1976 Physician, Massachusetts Rehabilitation Hospital, Boston, Massachusetts Certifications and licenses: Board Certified in Anatomic and Clinical Pathology, American Board of Pathology, 1976 Massachusetts, by examination, 1973-2013 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 33 of 151 PAGEID #: 42186 EXHIBIT 1 Curriculum Vitae Page 3 Samuel M. Cohen, M.D. Ph.D. Maine, by reciprocity, 1975 - 1976 Nebraska, by reciprocity, 1981-(active) Grant Support (active): 1. NIH (R21NS084391). Therapeutic Targeting of Aberrant Glial Function During Juvenile Batten Disease. 2% effort, Co-Investigator, 9/01/14 - 12/31/15, $250,000 (annual direct cost). 2. NIH (2P20GM103480) COBRE Nebraska Center for Nanomedicine, 3% effort, Co Investigator, 9/15/13 - 5/31/18. 3. Sumitomo Chemical Company, Principal Investigator, 2013-2015, $30,000 (total costs). 4. Inorganic Arsenic Task Force, Principal Investigator, Investigations on the Mode of Action of Inorganic Arsenic Carcinogenesis and Toxicity, 2013-2015, $105,000 (total costs). 5. ILSI North America, Principal Investigator, Inorganic Arsenic Investigations, $28,000 (total costs). 6. Laboratoire Pareva, Evaluation of the Proliferative Effects of Chronic Treatment with PHMB in the Liver Tissue of Male Sprague Dawley Rats, Principal Investigator, 1/01/2015 - 7/31/2015, $47,840 (total costs). 7. Laboratoire Pareva, Early Proliferative Effects of PHMB on the Liver Tissue of Male Wistar Han Rats, Principal Investigator, 2/01/2015 - 9/30/2015, $181,057 (total costs). 8. Electric Power Research Institute (EPRI), Low-Dose Dose-Response Relationship for Cell Death Induced by Exposure to Inorganic Arsenite, Principal Investigator, 2/01/157/31/15, $114,669 (total costs). Grant Support (completed): 1. Pareva, Principal Investigator. Assessment of Bioavailability and Distribution of PHMB in the Rat and Its Effects on Oxidative Stress, Cytotoxicity, Mitogenicity, and Histologic Alterations. $163,434 (total costs), 2013-2014. 2. Inorganic Arsenic Task Force, Principal Investigator, Investigations on the Mode of Action of Inorganic Arsenic Carcinogenesis, 2012-2013, $150,000 (total costs). 3. NIH COBRE: Nebraska Center for Nanomedicine, Core B, Collaborator, 9/08-6/13, $36,500/yr. (total costs). Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 34 of 151 PAGEID #: 42187 EXHIBIT 1 Curriculum Vitae Page 4 Samuel M. Cohen, M.D. Ph.D. 4. H. Lundbeck A/S, Principal Investigator, Cytotoxicity, proliferation and apoptosis in mouse and human endothelial cells, 2012, $107,420 (total costs). 5. Dainippon Sumitomo Pharma, Principal Investigator, Mechanistic Study for Carcinogenicity of DSP-8658 in Male Rats. Follow-up Urinalysis Evaluation in Rats, 7/2012-7/2013, $32,618 (total costs). 6. Pfizer, Principal Investigator, Immunohistochemical Markers of Human Vascular Tumors, 2012, $17,203 (total costs). 7. Minnesota Mining and Manufacturing, Principal Investigator, Effects of Administration of MTDID 25575 by Oral Gavage on the Urinary Bladder of Male Rats, 2012, $96,108 (total costs). 8. NIH R01 CA 143460. NOC in processed meat as a likely cause of colon cancer. Co investigator (4% effort). (Dr. S. Mirvish, P.I.). 2010-2013, $145,250 (total direct costs for first year). 9. DuPont, Principal Investigator, Time Course of Early Effects of Treatment with Diuron (DPX-14740) Technical in the Diet on the Bladder Epithelium of Male Wistar Rats, 2011-2012, $64,512 (total costs). 10. Inorganic Arsenic Task Force, Principal Investigator, Investigations on the Mode of Action of Inorganic Arsenic Carcinogenesis, 2011-2012, $75,000 (total costs). 11. Sumitomo Chemical Company, Principal Investigator, 2010-2012, $20,000 (total costs). 12. Makhteshim Agan of North America, Principal Investigator, 2012, $10,000 (total costs). 13. Organic Arsenical Products Task Force, Principal Investigator, 2011-2012, $30,000 (total costs). 14. Electric Power Research Institute, Collection of Epithelial Cells from Human Ureters, Principal investigator, 4/08-6/12, $17,236 (total costs). 15. FEMA, Principal Investigator, The Effects of Oral Administration of Pulegone on the Urinary Bladder of Female F344/N Rats, $62,815 (total costs). 16. Teva Pharmaceutical Industries Ltd., The Effects of Materials on Rodent and Human Urothelial and Keratinocyte Cell Lines, Principal Investigator, 7/8/10-2/28/11, ($27,971 total costs). 17. Takeda Pharmaceutical Co., PPARy-induced endothelial cell proliferation, Principal Investigator, 2007-2010, $50,000 (total costs). Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 35 of 151 PAGEID #: 42188 EXHIBIT 1 Curriculum Vitae Page 5 Samuel M. Cohen, M.D. Ph.D. 18. Sumitomo Chemical Company, 2008-2010, Principal Investigator, $10,000/yr. 19. Landis International, The Effects of Dietary Administration of Pyroxasulfone on the Urinary Bladder of Male Rats, Principal Investigator, 7/27/10-11/26/10, ($51,321 total costs). 20. Lexicon, The Effects of Oral Gavage Administration of LX3305 for 4 weeks in Female Rats. 2009-2010, $78,382 (total costs). 21. Bayer Crop Science, The Effects of Transfluthrin on the Urinary Bladder of Rats and Mice (In Vivo). 2009-2010, $78,382 (total costs). 22. Bayer Crop Science, The Effect of Transfluthrin on the Urinary Bladder of Rats and Mice (In Vitro) 2009-2010, $23,475 (total costs). 23. Dainippon Sumitomo Pharma Co., Ltd. 26-Week Oral Gavage Chronic Toxicity and Toxicokinetic Study with DSP-8658 in Rats with a 13-Week Recovery Period. Follow-up Urine Examination in Rats, Principal Investigator, 04/09-04/10, $54,132 (total costs). 24. Merck & Co., Inc., Investigation of potential mechanisms of rat bladder tumorigenesis and carcinogenicity, Principal Investigator, 2006-2007, $30,900 (total costs). 25. Covance Laboratories, Inc. Urinary precipitate and urine chemistry evaluations for a carcinogenicity study with CS-011 in rats, Principal Investigator, 2006-2007, $27,544 (total costs). 26. Theravance, TD: 5108: 28-day oral study in male rats with 28-day recovery period, 2006 2007, Principal Investigator, $47,075 (total costs). 27. Bristol-Myers Squibb, Three month oral investigative study of urine composition in Winstar and Sprague Dawley male rats, Principal Investigator, 2006-2007, $71,825 (total costs). 28. Bristol-Myers Squibb, Three-month oral investigative study of urine composition in male rats years, Principal Investigator, 2005-2006, $80,847 (total costs). 29. Bristol-Myers Squibb, Six-month oral investigative urinary bladder reversibility study in male rats years, Principal Investigator, 2005-2006, $175,292 (total costs). 30. Sumitomo Chemical Company, 2004-2007, Principal Investigator ($10,000 per year). 31. Covance Labs, Urinary precipitate and urine chemistry evaluations for carcinogenicity study with CS-011 in rats, 2161-001, 3/6/06-9/30/06, $27,833. 32. Bristol-Myers, One month oral investigative study of urinary bladder effects in male rats, 2183-001, 2005-2006, $76,944. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 36 of 151 PAGEID #: 42189 EXHIBIT 1 Curriculum Vitae Page 6 Samuel M. Cohen, M.D. Ph.D. 33. Bristol-Myers Squibb, Three-month oral investigative urinary bladder and metabonomics study in young versus aged male and female rats, 2004-2005, Principal Investigator, $40,761 (total costs). 34. Bristol-Myers Squibb, Twenty-one month investigative urinary bladder study of urinary bladder effects in male rats, 2003-2006, Principal Investigator, $292,420 (total costs). 35. Aventis, Exploratory 28-Day oral Gavage Toxicity in Male Rats, 2004-2005, Principal Investigator, $44,204 (total costs). 36. Wrigley, The Effects of Oral Gavage Administration of Two Bioglass Substances for 13 Weeks in Male Rats, 2004, Principal Investigator, $28,100 (total costs). 37. Bristol-Myers Squibb, Three-month oral investigative urinary bladder study in young versus aged male and female rats, 2003-2004, Principal Investigator, $201,531 (total costs). 38. Merck, Potential role of urinary physiologic changes in urinary bladder tumorigenesis by a Merck compound, 2002-2003, Principal Investigator, $88,194 (total costs). 39. Sumitomo Chemical Co., 2000-2003, Principal Investigator, $10,000 per annum. 40. Monsanto, The Effect of Sulfosulfuron on Urinary Parameters and Bladder Epithelium in Male Sprague-Dawley Rats, 2000, Principal Investigator, $86,768 (total costs). 41. Sumitomo Chemical Co., 1996-2000, Principal Investigator, $10,000 (total costs per annum). 42. National Cancer Institute, CA32513, Studies on Experimental Bladder Tumors, 1993 1999, Principal Investigator, 20% effort. 43. Luxembourg (Pamol), Ltd., Effects of Cacodylic Acid on the Rat Urinary Bladder, 1998, Principal Investigator, 10% effort, $123,174 (total costs). 44. International Life Sciences Institute-NA, Mechanistic Research on Bladder Carcinogenesis, 1997-1998, Principal Investigator, 10% effort, $125,000 (total costs). 45. Bayer Corp., YRC 2388, 1997, Principal Investigator, $8,500 (total costs). 46. International Life Sciences Institute-NA, Mechanistic Research on Bladder Carcinogenesis, 1994-1997, Principal Investigator, 30% effort, $1,055,000 (total costs). 47. Bayer Corp., Ortho-phenylphenol, 1996, Principal Investigator, $66,800 (total costs). Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 37 of 151 PAGEID #: 42190 EXHIBIT 1 Curriculum Vitae Page 7 Samuel M. Cohen, M.D. Ph.D. 48. American Cancer Society, Auger Electron Emitters for Treating Bladder Cancer, 1995 1996, Co-investigator, 5% effort, $75,000 (total costs). 49. Synthetic Organic Chemical Manufacturers Association (SOCMA), Tributyl Phosphate, 1995, Principal Investigator, $56,450 (total costs). 50. Sumitomo Chemical Co., 1992-1995, Principal Investigator, $30,000 (total costs). 51. International Life Sciences Institute-NA, Mechanistic Research on Bladder Carcinogenesis, 1993-1994, Principal Investigator, 30% effort, $480,000 (total cost). 52. E. I. DuPont de Nemours & Co., Scanning Electron Microscopy Studies, 1992, Principal Investigator, $35,000 (total costs). 53. Miles, Inc., Ortho-phenylphenol, 1992-1994, Principal Investigator $70,000 (total costs). 54. Miles, Inc., Propoxur, 1992, Principal Investigator, $9,324 (total costs). 55. National Cancer Institute, CA32513, Studies on Experimental Bladder Tumors, 1990 1992, Principal Investigator, 20% effort, $241,686 (total direct costs). 56. International Life Sciences Institute-Nutrition Foundation, Mechanistic Research on Bladder Carcinogenesis, 1990-1993, Principal Investigator, 30% effort, $1,450,000 (total cost). 57. Norden-SmithKline Beecham, Scanning Electron Microscopic Evaluation of a New Product, 1988-1992, Principal Investigator, $8,559 (total costs). 58. National Cancer Institute, CA44886, Acrolein and Urinary Bladder Carcinogenesis, 1987-1992, Principal Investigator, 10% effort, $481,850 (total direct costs). 59. National Cancer Institute, CA36727, Laboratory Cancer Research Center Support (CORE) Grant, 1987-1990, Co-Investigator, 2.5% effort. 60. Summit Corp., Scanning Electron Microscopy of new product, Principal Investigator, 1989-1990, $3,620 (total costs). 61. International Life Sciences Institute-Nutrition Foundation, Saccharin Initiation Promotion Bioassay, 1988-1990, Principal Investigator, 5% effort, $260,656 (total costs). 62. International Life Sciences Institute-Nutrition Foundation, Mechanistic Research on Bladder Carcinogenesis, 1987-1990, Principal Investigator, 25% Effort, $900,000 (total costs). Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 38 of 151 PAGEID #: 42191 EXHIBIT 1 Curriculum Vitae Page 8 Samuel M. Cohen, M.D. Ph.D. 63. International Life Sciences Institute-Nutrition Foundation, Effect of Sodium Saccharin Administration on Lipid Levels in the Rat: Dose Response and Reversibility, 1989, Co Investigator, 5% effort, $128,301 (total costs). 64. Hoechst Co., The Evaluation of the Protective Effects of Chitosan in Preventing the Hemorrhagic Cystitis Secondary to Cyclophosphamide Administration, 1988, Secondary Investigator, $5,600 (total costs). 65. National Cancer Institute, CA32513, Studies on Experimental Bladder Tumors, 1987 1990, Principal Investigator, 20% effort, $301,043 (total direct costs). 66. National Cancer Institute, CA28015, Bladder Cancer: Metabolism of Carcinogens and Prevention, consortium grant between Dr. Terry Zenser, St. Louis University, and Dr. Samuel M. Cohen, University of Nebraska Medical Center, 1986-1989, Co-Principal Investigator, 10% effort, $149,905 (total costs). 67. International Life Sciences Institute Nutrition Foundation, Effects of High Doses of Sodium Saccharin on the Neonatal Rat Bladder, 1986-1987, Principal Investigator, 5% effort, $33,840 (total direct costs). 68. Norden Laboratories, Scanning Electron Microscopic Evaluation of a New Product, 1987, Principal Investigator, $1,500 (total costs). 69. International Life Sciences Institute Nutrition Foundation, Relationship Between High Doses of Sodium Saccharin to the Maternal Rat and Pup Metabolic/Nutritional Status, 1986-1987, Principal Investigator, 5% effort, $63,407 (total direct costs). 70. National Cancer Institute, CA36727, Laboratory Cancer Research Center Support (CORE) Grant, 1984-1987, Co-Investigator, 2.5% effort, $891,043 (total direct costs). 71. State of Nebraska, Relationship of Acrolein to Cigarette Smoking-Induced Bladder Cancer, 1986-1987, Principal Investigator, 5% effort, $38,988 (total direct costs). 72. State of Nebraska, Male/Female Differences in Neonatal Cell Proliferation in Experimental Urinary Bladder Carcinogenesis, 1986-1987, Co-Investigator, 5% effort, $33,939 (total direct costs). 73. International Life Sciences Institute, Mechanistic Research on Bladder Carcinogenesis, 1985-1987, Principal Investigator, 25% effort, $787,584 (total direct costs). 74. State of Nebraska, Relationship of Acrolein to Cigarette Smoking-Induced Bladder Cancer, 1985-1986, Principal Investigator, 5% effort, $36,634 (total direct costs). 75. National Cancer Institute, CA28015, Bladder Cancer: Metabolism of Carcinogens and Prevention, consortium grant between Dr. Terry Zenser, St. Louis University, and Dr. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 39 of 151 PAGEID #: 42192 EXHIBIT 1 Curriculum Vitae Page 9 Samuel M. Cohen, M.D. Ph.D. Samuel M. Cohen, University of Nebraska Medical Center, 1983-1986, Co-Principal Investigator, 10% effort, $270,520 (total direct costs). 76. National Cancer Institute, CA33368, Urinary Bladder Cancer Promotion by Dietary LTryptophan, 1983-1986, Co-Investigator, 5% effort, $173,591 (total direct costs). 77. State of Nebraska, Analysis of Neonatal Cell Kinetics and Experimental Urinary Bladder Carcinogenesis, 1985-1986, Co-Principal Investigator, 5% Effort, $32,807 (total direct costs). 78. National Cancer Institute, CA38150, Cruciferae and Carcinogenesis, Co-Investigator, 5% effort, $429,430 (total direct costs). 79. State of Nebraska, Experimental and Computer Modeling of 2-Stage Carcinogenesis, 1984-1985, Co-Investigator, 5% effort, $28,032 (total direct cost). 80. State of Nebraska, Scanning Electron Microscopic Urinary Cytology, 1984-1985, Principal Investigator, 5% effort, $24,330 (total direct costs). 81. National Cancer Institute, CA32313, Non-mutational Multistage Urinary Bladder Carcinogenesis, 1982-1985, Principal Investigator, 10% effort, $214,904 (total direct costs). 82. International Life Sciences Institute, Contract with ILSI for Study with Intox, 1985, $3,397.50 (total direct costs). 83. State of Nebraska, Scanning Electron Microscopic Urinary Cytology, 1983-1984, Principal Investigator, 10% effort, $32,164 (total direct costs). 84. National Cancer Institute, CA32513, Studies on Experimental Bladder Tumors, 1982 1985, Principal Investigator, 20% effort, $243,094 (total direct costs). 85. National Cancer Institute, CA32513, Studies on Experimental Bladder Tumors, 1981 1982, Principal Investigator, 30% effort, $181,223 (total direct costs). 86. University of Nebraska Foundation, Automatic Image/X-ray Analysis System for scanning electron microscope, $76,365 (total award). 87. National Cancer Institute, CA28015, Bladder Cancer: Metabolism of Carcinogens and Prevention; consortium grant between Dr. Terry Zenser, St. Louis University, and Dr. Samuel M. Cohen, St. Vincent Hospital and University of Nebraska Medical Center, 1980-1982, Co-principal Investigator, 10% effort, $81,247 (total Direct costs to Dr. Cohen's institution). 88. RR05660, Subgrant #31; Biomedical Research Support Grant, St. Vincent Hospital; 1980-1981; Principal Investigator, 5% effort, $3,600 (total award). Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 40 of 151 PAGEID #: 42193 EXHIBIT 1 Curriculum Vitae Page 10 Samuel M. Cohen, M.D. Ph.D. 89. National Cancer Institute, CA21612, Cyclic AMP Metabolism in Transitional Epithelium, 1980-1983, Co-Investigator, 5% effort, $252,402 (total direct costs). 90. RR05660, Subgrant #21; Biomedical Research Support Grant, St. Vincent Hospital; 1979-1980; Principal Investigator, 5% effort, $5,875 (total award). 91. National Cancer Institute, CA15945, Studies on Experimental Bladder Tumors, 1979 1981, Principal Investigator, 30% effort, $233,622 (total direct costs). 92. National Cancer Institute, CA15945, Studies on Experimental Bladder Tumors, 1976 1979, Principal Investigator, 30% effort, $233,584 (total direct costs). 93. National Cancer Institute, CA15945, Studies on Experimental Bladder Tumors, 1973 1976, Co-Investigator, 20% effort, $155,475 (total direct costs). Grant Support (pending): None Study Sections: NIH Chemical Pathology, 1982-6 NAS/NRC Associateship Program, 1987-8 NIH Immunology, Virology, Pathology, 1989-93 (Chair, 1991-93) NIH Special Study Section, Outstanding Investigator Grants, 1993 NIH Special Study Section, Chemoprevention, 2002 NTP National Toxicology Program Board of Scientific Counselors, 2002-4 NIEHS Superfund Review, 2006 FDA Review Panel on Melamine, 2007 NIEHS Board of Scientific Counselors, 2008 - 2013 Site Visits: 1978 1980 1983 1984 1985 1988 1988 1998 2000 2001 2002 2004 2004 2004 Eppley Cancer Institute New York University McArdle Laboratory Memorial Sloan Kettering Institute University of Idaho Los Alamos, New Mexico Sloan Kettering Institute National Center for Toxicologic Research Memorial Sloan Kettering Institute National Cancer Institute, Intramural Program New York University National Toxicology Program, Intramural Program National Institute of Environmental Health Sciences, Intramural Program Environmental Protection Agency, Intramural Program Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 41 of 151 PAGEID #: 42194 EXHIBIT 1 Curriculum Vitae Page 11 Samuel M. Cohen, M.D. Ph.D. 2006 2007 National Cancer Institute, Intramural Program Environmental Protection Agency, Intramural Program Patents: None Other appointments: None Consulting positions: Numerous Grant Reviews: American Association for Cancer Research, Henry Shepard Trust Grants for Bladder Cancer Research Austrian Science Fund Czech Science Foundation Dutch Cancer Society Environmental Protection Agency (grants; intramural research programs) Food and Drug Administration Hong Kong Food and Health Bureau International Programme on Chemical Safety International Research Program on Tea Israel Research Foundation Kentucky Science and Engineering Foundation Medical Research Council (MRC), United Kingdom National Academy of Sciences (fellowships and grants) National Center for Toxicological Research National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), Great Britain National Institutes of Health (extramural grants and contracts; intramural research programs) Netherlands Organization for Health Research and Development Office of Technology Assessment, United States Congress U.S. Army (breast cancer grants) University of North Carolina Center for Environmental Health and Susceptibility Veterans Administration (grants) Wellcome Trust Yorkshire Cancer Research Center Journal Reviews: Acta Anatomica American Journal of Clinical Nutrition American Journal of Pathology Annals of Surgical Oncology Archives of Environmental Contamination & Toxicology Belgian Journal of Zoology Biochemica Biophysica Acta Biochemical Pharmacology BJU International Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 42 of 151 PAGEID #: 42195 EXHIBIT 1 Curriculum Vitae Page 12 Samuel M. Cohen, M.D. Ph.D. Bulletin of Mathematical Biology Cancer Cancer Causes and Control Cancer Chemotherapy Reports Cancer Detection and Prevention Cancer Epidemiology, Biomarkers and Prevention Cancer Journal Cancer Letters Cancer Research (Associate Editor, 1982-1990) Cancer Science Carcinogenesis Cell Biochemistry and Function Cell Biology and Toxicology Cell and Molecular Biology Letters Chemico-Biological Interactions Clinical Cancer Research Critical Reviews in Toxicology (Editorial Board, 2009 - ) Current Pharmaceutical Design Electrophoresis Environment International Environmental and Molecular Mutagenesis Environmental Health Perspectives Environmental Research Environmental Toxicology Environmental Toxicology and Pharmacology Expert Opinion on Drug Safety Food Additives and Contaminants Food and Chemical Toxicology (Editorial Board, 1990-2009; Associate Editor, 2009 2010; Editorial Board, 2011-) Fundamental and Applied Toxicology (Editorial Board, 1992-1997) Genes and Environment Hepatology Histochemical Journal Human and Experimental Toxicology Industrial Health International Journal of Cancer International Journal of Environmental Research and Public Health International Journal of Oncology (Editorial Board, 1996-2010) International Journal of Radiation Biology Journal of Agricultural and Food Chemistry Journal of Biological Chemistry Journal of Environmental Sciences Journal of Luminescence Journal of Pathology Journal of Pharmacology and Experimental Therapeutics Journal of the American Association for Laboratory Animal Science Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 43 of 151 PAGEID #: 42196 EXHIBIT 1 Curriculum Vitae Page 13 Samuel M. Cohen, M.D. Ph.D. Journal of the American Medical Association Journal of the National Cancer Institute Journal of Toxicology (Editorial Board, 2008-2011) Journal of Toxicology-Clinical Toxicology Journal of Translational Medicine Research Journal of Urology Kidney International Laboratory Investigation (Editorial Board, 1993-2008) Liver International Molecular Biology of Cancer Molecular Cancer Therapeutics Molecular Carcinogenesis Mutation Research Nature Reviews Drug Discovery Nutrition Journal Nutrition Research Oncology Oxford University Press Pathology International (Editorial Board, 2001- 2013) PLoS ONE PPAR Research Proceedings of the Japan Academy, Series B Proceedings of the National Academy of Sciences Proteomics Regulatory Toxicology and Pharmacology (Editorial Board, 2014 - ) Research in Health Risk Assessment Risk Analysis Scanning Microscopy Science Teratogenesis, Carcinogenesis, Mutagenesis Toxicologic Pathology (Associate Editor, 2005-) Toxicological Sciences (Editorial Board, 1998-2003) Toxicology (Editorial Board, 2003- ) Toxicology and Applied Pharmacology Toxicology In Vitro Toxicology Letters Urologic Oncology (Editorial Board, 1995-2010) Veterinary Pathology Abstract Reviews: American Association for Cancer Research American Urological Association Military service: None Honors and Awards: Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 44 of 151 PAGEID #: 42197 EXHIBIT 1 Curriculum Vitae Page 14 Samuel M. Cohen, M.D. Ph.D. 1964 1966 1967 1968 1969 1968-1972 1982 1982-1990 1985 1988 1990 1990-2009 1990 1991 1991 1992 1992- 1997 1993- 2008 1993-1996 1993-1996 1994 1995-2010 1995- 1996 1996-2013 1996-2013 1996- 2010 1996 1997- 2003 1998 1998-2003 1999 2000 2001 2001- 2013 2002- 2002-2004 Phi Eta Sigma Phi Kappa Phi Phi Beta Kappa Sigma Sigma James M. Price Cancer Research Award, University of Wisconsin College of Medicine NIH Medical Scientist Trainee (GM01932) Who's Who in Frontiers of Science and Technology Associate Editor, Cancer Research Havlik-Wall Professor of Oncology, Endowed Chair Alpha Omega Alpha University of Nebraska Outstanding Research and Creative Activity Award Editorial Board, Food and Chemical Toxicology Who's Who in the Midwest Who's Who in Health and Medical Services Who's Who in Science and Engineering Fuji-Otsuka Lectureship at the University of Tokushima School of Medicine, Tokushima, Japan Editorial Board, Fundamental and Applied Toxicology Editorial Board, Laboratory Investigation Chloroform Scientific Advisory Board, Chemical Industry Institute of Toxicology National Research Council Committee on Comparative Toxicity of Naturally Occurring Carcinogens American Men and Women of Science Editorial Board, Urologic Oncology Elected fellow, The Academy of Toxicological Sciences (Board of Directors, 2014-2016) Dean's Award for Outstanding Service to the College of Medicine, University of Nebraska Best Doctors in America: Central Region Best Doctors in Omaha, Nebraska Editorial Board, International Journal of Oncology John Doull Medal, Central States Chapter, Society of Toxicology Science Advisory Committee, Chemical Industry Institute of Toxicology (CIIT) Pathology/Microbiology/Molecular Biology-Genetics/Health Risk Assess ment, Environmental Protection Agency Peer Review Panel Editorial Board, Toxicological Sciences Distinguished Alumnus Citation, University of Wisconsin Medical School Biographical Candidate, Lexington Who's Who Arnold J. Lehman Award, Society of Toxicology Editorial Board, Pathology International Flavor and Extracts Manufacturers Association Expert Panel (Vice Chairman, 2011-2013; Chairman, 2014-2016) Board of Scientific Counselors, National Toxicology Program Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 45 of 151 PAGEID #: 42198 EXHIBIT 1 Curriculum Vitae Page 15 Samuel M. Cohen, M.D. Ph.D. 2002-2003 2003 2003 2004 2005 2008-2011 2008-2013 2009 2009-2010 2010 2010 2012 2012 2014 2014- National Research Council Subcommittee on Dietary Supplements Editorial Board, Toxicology Elected Fellow, International Academy of Toxicologic Pathology Distinguished Scientist in Cancer Research, Japanese Foundation for Cancer Research, Japanese National Cancer Center and Japan Academy Associate Editor, Toxicologic Pathology Journal of Toxicology, Editorial Board Board of Scientific Counselors, National Institute of Environmental Health Sciences Editorial Board, Critical Reviews in Toxicology Associate Editor, Food and Chemical Toxicology Editorial Board, Food and Chemical Toxicology Distinguished Scientist Award, University of Nebraska Medical Center George H. Scott Award, Toxicology Forum Lifetime Achievement Award, Association for Environmental Health and Sciences One of the Best Papers Demonstrating Application of Risk Assessment, in 2013, SOT Risk Assessment Specialty Section (for Cohen et al., Crit. Rev. Toxicol., 43:711-752, 2013). Editorial Board, Regulatory Toxicology and Pharmacology Memberships and offices in professional societies: Academy of Toxicological Sciences (fellow) (Board of Directors, 2014-2016), 1995American Association for Advancement of Science, 1980-2006 American Association for Cancer Research, 1975American Association of Pathology, 1975-1992 American Medical Association, 1988-2007 American Society of Clinical Pathology, 1989-2012 American Society for Investigative Pathology, 1993-2013 Association of Medical School Microbiology and Immunology Chairs, 1992-2007 Association of Pathology Chairs, 1992-2007 Central States Chapter, Society of Toxicology (President 2004-2005), 1994College of American Pathologists (diplomate), 1994-2011 Gann, The Japanese Cancer Association, 1976International Academy of Pathology, United States and Canadian Academy of Pathology, 1986-2012 International Academy of Toxicologic Pathology (fellow), 2003 International Life Sciences Institute Board of Trustees (Vice Chairman, 2010 -2012; Chairman, 2012-2015), 2007International Life Sciences Institute-Health and Environmental Sciences Institute Board of Trustees (Vice Chairman, 2004-2006; Chairman, 2006-2008), 2001International Society of Urologic Pathology, 1993-2012 Nebraska Association of Pathologists, 1982Nebraska Medical Association, 1986-2007 Omaha Medical Society, 1986-2007 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 46 of 151 PAGEID #: 42199 EXHIBIT 1 Curriculum Vitae Page 16 Samuel M. Cohen, M.D. Ph.D. Society for Environmental Geochemistry and Health, 1998-2006 Society of Toxicologic Pathologists, 1990Society of Toxicology, 1986Society of Toxicology, Carcinogenesis Specialty Section, Vice President-Elect (2000), Vice President (2001), and President (2002), 1998- Committee assignments: Local (completed): Hospital Infections Committee, St. Vincent Hospital Medical Staff, 1978-1981 Animal Care Committee (Chairman), St. Vincent Hospital, 1978-1981 Laboratory Committee, St. Vincent Hospital Medical Staff, 1980-1981 Cancer Education Committee, University of Massachusetts Medical School, 1978-1981 Chemical Hazards Committee, University of Massachusetts Medical School, 1978-1981 Research Council, St. Vincent Hospital, 1980-1981 Academic Computing Advisory Committee, University of Nebraska Medical Center, 1981 1983 Safety Committee, Eppley Institute, University of Nebraska Medical Center, 1981-1983 Research and Development Committee, University of Nebraska College of Medicine, 1981 1984 Seed Grant Review Committee (Chairman, Basic Sciences Section), University of Nebraska Medical Center, 1982 Cancer Research Grant Review Committee, University of Nebraska Medical Center, 1982 Seed Grant Review Committee (Chairman, Clinical and Behavioral Sciences Section), University of Nebraska Medical Center, 1983 Cancer Research Grant Review Committee (Chairman), University of Nebraska Medical Center, 1983 Tissue and Transfusion Review Committee (Chairman), University of Nebraska Hospital Medical Staff, 1983-1984 Search Committee for Chairman of the Department of Surgery, University of Nebraska Medical Center, 1983-1984 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 47 of 151 PAGEID #: 42200 EXHIBIT 1 Curriculum Vitae Page 17 Samuel M. Cohen, M.D. Ph.D. Quality Assurance Committee, University of Nebraska Medical Center, 1983-1984 Toxicology Task Force, University of Nebraska Medical Center, 1983-1984 Biannual Continuing Medical Education Program Committee, Nebraska Association of Pathologists, 1983-1984 Cancer Research Grant Review Committee, University of Nebraska Medical Center, 1984 Advisory Committee, Dean Selection, College of Medicine (Chairman), University of Nebraska Medical Center, 1984-1985 Graduate Committee, Department of Pathology and Laboratory Medicine (Chairman), University of Nebraska Medical Center, 1981-1985 Medical Sciences Interdepartmental Area Graduate Committee, University of Nebraska Medical Center, 1982-1985 Diagnostically-Related Group Committee, University of Nebraska Medical Center, 1983 1985 Tenure and Promotion Committee, Eppley Institute (Chairman, 1984), University of Nebraska Medical Center, 1983-1986 Director's Advisory Committee, Eppley Institute, University of Nebraska Medical Center, 1983- 1992 NMR Committee, University of Nebraska Medical Center, 1984-1992 Outpatient Diagnostic and Treatment Programs Task Force, University of Nebraska Medical Center, 1984-1986 Nebraska Association of Pathologists - Continuing Medical Education, State of Nebraska, 1984- 1986 Advisory Committee, Biochemistry Chairman Search Committee, College of Medicine, University of Nebraska Medical Center, 1985-1986 Advisory Committee, Pediatric Chairman Search Committee, College of Medicine, University of Nebraska Medical Center, 1985-1986 Advisory Committee, Pediatric Chairman Search Committee, College of Medicine, University of Nebraska Medical Center, 1985-1986 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 48 of 151 PAGEID #: 42201 EXHIBIT 1 Curriculum Vitae Page 18 Samuel M. Cohen, M.D. Ph.D. University of Nebraska Medical Center/Share Liaison Committee - Information System, Sub-Committee of Clinical Practice Board, University of Nebraska Medical Center, 1986 Advisory Committee to President Roskens, Foundation Awards, University of Nebraska, 1986 Outstanding Research and Creativity Award Committee (Chairman, 1986-1987), University of Nebraska, 1985-1987 Clinical Practice Board, University of Nebraska Medical Center, 1988 Clinical Practice Board Executive Committee, University of Nebraska Medical Center, 1988 Eppley Institute Promotion and Tenure Committee, University of Nebraska Medical Center, 1987-1988 Board of Directors, Nebraska Clinicians Group, University of Nebraska Medical Center, 1983-1989 Audit Committee, Nebraska Clinicians Group (Chairman, 1987-1989), University of Nebraska Medical Center, 1986-1989 Cancer Education Committee, University of Nebraska College of Medicine, 1981-1990 Carcinogenesis/Nutrition Group, Eppley Institute (Chairman, 1989-1991), University of Nebraska Medical Center, 1983-1990 College of Medicine Tenure and Promotion Committee (Chairman, 1989-1991), University of Nebraska Medical Center, 1985-1991 Committee on Selection of Student Nominees, Alpha Omega Alpha, University of Nebraska Medical Center, 1988-1990 College of Medicine Blue Ribbon Committee on the Curriculum, University of Nebraska Medical Center, 1988-1990 Hospital Executive Planning Council, University of Nebraska Medical Center, 1986-1992 Department of Pathology and Microbiology Promotion and Tenure Committee (Chairman, 1988), University of Nebraska Medical Center, 1988-1992 M.D.,-Ph.D. Committee, University of Nebraska Medical Center, 1988-1992 Committee to Recommend Cancer Activities Strategies, University of Nebraska Medical Center, 1990-1993 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 49 of 151 PAGEID #: 42202 EXHIBIT 1 Curriculum Vitae Page 19 Samuel M. Cohen, M.D. Ph.D. Dean of the College of Medicine Search Committee (Chairman), University of Nebraska Medical Center, 1992-1993 Curriculum Oversight Group, University of Nebraska Medical Center, 1992-1993 Toxicology Program, University of Nebraska Medical Center, 1985-1992 Nebraska Medical Association Coordinating Committee, 1993-1994 Search Committee for Deputy Director of University of Nebraska Comprehensive Cancer Center (Chairman), 1994-1995 College of Medicine Strategic Planning Oversight Committee, 1994-1995 University of Nebraska Medical Staff Executive Committee, 1994-1996 College of Medicine Howard Hughes Institute Grant Committee, 1995 University of Nebraska Medical Center Redesign Executive Team, 1995-1996 University of Nebraska Medical Center Redesign Research and Education Steering Team (Director), 1995-1996 Chancellor's and President's Advisory Committee for Research and Education, 1996 University of Nebraska Medical Center Partnership Internal Assessment Committee, 1996 Howard Hughes Candidates Nominating Committee, 1996 Graduate Committee, Department of Pathology and Microbiology (Chairman, 1985-1992), University of Nebraska Medical Center, 1985-1997 Search Committee for the Director of University of Nebraska Medical Center/Eppley Cancer Center, University of Nebraska Medical Center, 1997 University Hospital Board of Governors, 1995-1997 Outcomes Management Pre-Merger Transition Team, University of Nebraska Medical Center, 1997 Genetics Research Space Executive Committee (Chairman), 1994-1998 Environmental and Occupational Medicine Coordinating Council, 1994-1999 University of Nebraska Medical Center and University of Nebraska Marshall Professorship in Biotechnology Selection Committee, 1998 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 50 of 151 PAGEID #: 42203 EXHIBIT 1 Curriculum Vitae Page 20 Samuel M. Cohen, M.D. Ph.D. College of Medicine Genetics Strategic Planning and Implementation Committee (Chairman), 1994-1998 College of Medicine Definition of Productive Space Committee, 1998 University Medical Associates Executive Committee, 1994-1998 Chancellor's Research and Education Advisory Panel, 1996-1998 University of Nebraska Medical Center/Molecular Genetics Director Search Committee, 1997-1999 Education Planning Work Group Committee, 1999 University of Nebraska Medical Center/Research Planning Work Group Committee, 1999 Chancellor's Investiture Committee (Co-Chair), 1999 Interactions Between Centers and Departments at University of Nebraska Medical Center (Chairman), 1999-2000 Review of the Department of Internal Medicine, 1999-2000 Research Centers of Excellence Steering Committee (Chair of Laboratory Support Subcommittee), 1999-2000 University of Nebraska Medical Center/Ad Hoc Committee on Volunteer Faculty, 2000 University of Nebraska Medical Center/Seed Grant Subcommittee, 2000 Breast Cancer Research Program Internal Advisory Committee, 1994-2000 Pancreas Cancer Research, Internal Advisory Committee, 1995-2000 Search Committee for Chair of Internal Medicine, 1999-2001 University of Nebraska Minority Faculty Symposium, 2000-2001 Biotechnology Program on Infectious Diseases, University of Nebraska Medical Center (Director), 1988-2001 Technology Evaluation and Protection Committee, University of Nebraska Medical Center, 1992-2001 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 51 of 151 PAGEID #: 42204 EXHIBIT 1 Curriculum Vitae Page 21 Samuel M. Cohen, M.D. Ph.D. Animal Care Committee, Eppley Institute, University of Nebraska Medical Center, 1981 2001 University of Nebraska Medical Center Research Council, 1993-2002 Search Committee, Chair of the Department of Cell Biology, Anatomy and Genetics, 2002 2003 Radiolabelled Antibody Advisory Committee, University of Nebraska Medical Center, 1991 2003 University of Nebraska Medical Center/Eppley Center for Cancer Research and Care, Internal Advisory Committee, 1993-2003 University of Nebraska Medical Center/Eppley Cancer Center, Leadership Council, 1996 2003 Strategic Planning Committee, UNMC, 2002-2004 University Medical Associates, Executive Committee, 2000-2004 Latta Lectureship Committee, University of Nebraska Medical Center, 1988-2004 University of Nebraska Medical Center, Strategic Recruitment Proposal Review Committee, 1998-2005. University of Nebraska Medical Center, Strategic Recruitment Proposal Review Committee, 1998- 2005. Core Facility Advisory Council, UNMC, 2002-2005. Clinical Oncology Planning Committee, UNMC, 2004-2005 University of Nebraska Medical Center/Research Development Board, 1999- 2005 Dean's Committee, Veterans Administration Hospital, Omaha, Nebraska, 1992-2007 University Medical Associates Benefits Committee (Chairman), 1995-2007 University Medical Associates Board of Directors (Vice President, 1996-1999), 1995-2007 University of Nebraska Federal Relations Team, 2000-2007 Durham Research Center Management Council, UNMC, 2003-2007 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 52 of 151 PAGEID #: 42205 EXHIBIT 1 Curriculum Vitae Page 22 Samuel M. Cohen, M.D. Ph.D. University of Nebraska Medical Center/Eppley Cancer Center, Scientific Advisory Council (Vice-Chair, 1996-2000), 1996-2007 Pathology Residency Program (Director) 2009-2013 Graduate Medical Education Committee, 2009-2013 Local (Active): University of Nebraska College of Medicine Grievance Committee (Chair 2011-2016), 2010 2016 University of Nebraska Medical Center Subcommittee of Equity Office Working Group on Under Represented Minorities Faculty, 2014- National and International (completed): Special Study Section, NIH, 1980 Chemical Pathology Study Section, NIH, 1982-1986 Program and Organizing Committee, International Symposium on the Role of Co Carcinogens and Promoters in Human and Experimental Carcinogenesis; Budapest, Hungary, May 16-18, 1983 Membership Committee, American Association for Cancer Research, Inc., 1985-1986 U.S.-Japan Co-Operative Cancer Research Program, Recent Advances In Bladder Cancer Research, Organizing Committee (Co-Chair), 1985-1986 Chemical Pathology B Study Section Special Review (Chairman), 1988 Program Committee, The Fourth International Symposium, Foundation for Promotion of Cancer Research, Japan, March 26-28, 1991 Mini-Symposium on Chemical and Viral Carcinogenesis, Federation of American Societies of Experimental Biology, (Organizer and Chairman), Anaheim, California, April 8, 1992 Immunology, Virology, Pathology Study Section, NIH (Chairman, 1991-1993), 1989-1993 Special Study Section, NIH, Outstanding Investigator Grants, 1993 Finance Committee, American Association for Cancer Research, 1991-1994 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 53 of 151 PAGEID #: 42206 EXHIBIT 1 Curriculum Vitae Page 23 Samuel M. Cohen, M.D. Ph.D. Forestomach Subgroup of the Carcinogenicity Working Group, International Life Sciences Institute, Washington, D.C., 1988-1994 Cell and Tissue Biology 3 (CTB3) Review Committee, United States Army Research and Development Command Breast Cancer Research Program (Chairman), 1994 Nomenclature Committee, Society of Toxicologic Pathologists, 1992-1995 Working Group on Bladder Cancer, International Life Science Institute, Risk Science Institute and Environmental Protection Agency, 1992-1995 American Association of Cancer Research, Program Committee, 1993-1995; International Cancer Congress, "Novel Mechanisms Chemical Carcinogenesis (Organizer and Co Chairman), New Delhi, India, 1994 American Association for Cancer Research, Program Committee, Genitourinary Tract Cancers (Chairman), 1994-1995 Special Study Section, NIH (Chairman), 1995 International Life Sciences Histopathology Workshop-Urinary Tract (Organizer), Hannover, Germany, 1995 National Research Council Committee on Comparative Toxicity of Naturally Occurring Carcinogens, 1993-1996 Scientific Advisory Panel on Chloroform, Chemical Industry Institute of Toxicology, 1992 1996 International Life Sciences Institute-Environmental Protection Agency Working Group on Cancer Bioassay Dose-Selection Modeling, 1990-1996 Environmental Protection Agency/FIFRA Scientific Advisory Panel, 1996-1997 Expert Panel on Arsenic Carcinogenicity, U.S. Environmental Protection Agency, 1997 International Life Sciences Institute/Environmental Protection Agency Expert Panel to Evaluate EPA's Proposed Guidelines for Carcinogenic Risk Assessment, 1996-1998 Environmental Protection Agency/FIFRA Scientific Advisory Panel, 1997 Editorial Board of Fundamental and Applied Toxicology, 1992-1997 International Agency for Research on Cancer, Working Group, 1997 Scientific Advisory Group on Cellular Telephone Research, 1995-1998 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 54 of 151 PAGEID #: 42207 EXHIBIT 1 Curriculum Vitae Page 24 Samuel M. Cohen, M.D. Ph.D. Pathology/Microbiology/Molecular Biology-Genetics/Health Risk Assessment, Environmental Protection Agency Peer Review Panel, 1998 Electric Power Research Institute; Scientific Advisory Panel, 1994-1998 Scientific Advisory Committee (SAC), Chemical Industry Institute of Toxicology (CIIT), 1997-1998 International Agency for Research on Cancer, Working Group, 1998 Cell Death Nomenclature Committee, Society of Toxicology Pathology, 1997-1999 Program Committee, Carcinogenesis Specialty Section, Society of Toxicology, 1997-1999 Princess Takamatsu Cancer Research Symposium Organizing Committee (Co-Chair), 1998 1999 International Academy of Pathology Symposium Organizing Committee (Co-Chair), 1999 2000 Arsenic Expert Panel, U.S. Environmental Protection Agency, 2000 International Life Sciences Institute/Risk Sciences Institute Annual Meeting Scientific Session (Organizer and Chair), 2000-2001 International Life Sciences Institute/N.A. Apoptosis Joint Subcommittee of the Committees on Proposition 65 and the Technical Committee on Food Toxicology and Safety Assessment (Chairman), 1998-2001 Society of Toxicology Workshop Organizing Committee for 2001 Annual Meeting (Co Chair), 2000-2001 National Cancer Institute, Intramural Program Site Visit and Review, 2001 International Life Sciences Institute/Alternatives to Carcinogenicity Testing Committee (ACT), 1997-2002 International Life Sciences Institute/AFIP, Working Group on Mesenchymal Tumors of the Mouse Urinary Bladder, 1997-2001 Society of Toxicology Task Force to improve the scientific basis of Risk Assessment (RATF), 1999-2001 International Programme on Chemical Safety Panel, London, 2000-2001 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 55 of 151 PAGEID #: 42208 EXHIBIT 1 Curriculum Vitae Page 25 Samuel M. Cohen, M.D. Ph.D. International Life Sciences Institute/Health and Environmental Sciences Institute, Mechanisms and Risk Assessment Committee (Vice Chair), 2001-2002 Search Committee for Director of International Life Sciences Institute/Health and Environmental Sciences Institute, 2002 Society of Toxicology Workshop Organizing Committee for 2003 Annual Meeting (Co Chair), 2002-2003 Editorial Board of Toxicological Sciences, 1998-2003 International Life Sciences Institute/RSI Peroxisome Proliferator and Human Relevance Committee, Chair, 2001-2003 National Research Council Working Group of the Committee on the Framework for Evaluating the Safety of Dietary Supplements, 2002-2003 Schering-Plough Research Institute Consultants Panel, 2001-2004 National Toxicology Program Board of Scientific Counselors of the Office of the Assistant Secretary for Health, 2002-2004 International Life Sciences Institute/Risk Science Institute Board of Scientific Advisors, 1998-2005 Pfizer Carcinogenesis Advisory Board, 2000-2005 International Life Sciences Institute/RSI Dose Response II Committee, 2001-2005 Astra Zeneca Science Advisory Board (Chair), 2002-2005 International Life Sciences Institute/RSI Human Relevance II Committee, 2003-2005 Environmental Protection Agency, Intramural Research Program Site Visit and Review, 2004 International Life Sciences Institute/Health and Environmental Sciences Institute, Editorial Review Committee (Chair), 2002-2006 International Programme on Chemical Safety (IPCS), World Health Organization, Cancer Working Group, 2003-2006 National Cancer Institute, Intramural Program Site Visit and Review, 2006 International Life Sciences Institute/Health and Environmental Sciences Institute, Emerging Issues Committee, 2000-2006 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 56 of 151 PAGEID #: 42209 EXHIBIT 1 Curriculum Vitae Page 26 Samuel M. Cohen, M.D. Ph.D. International Life Sciences Institute/Health and Environmental Sciences Institute, Liver Tumor Working Group, 2004-2006 International Life Sciences Institute/Health and Environmental Services Institute, Search Committee, 2006-2007 National Comprehensive Cancer Network, Bladder Cancer Working Group, 1996-2007 Research Committee, Association of Pathology Chairs, 1997-2007 International Life Sciences Institute/Health and Environmental Sciences Institute, Nominating Committee, 2002-2007 International Life Sciences Institute/Health and Environmental Sciences Institute, Cancer Hazard Identification Strategies Committee, 2004-2007 Organizing Committee, International Federation of Societies of Toxicologic Pathology, 2007 symposium (Sept), Board, Basel Switzerland, 2006-2007 Society of Toxicologic Pathology, Membership Committee, 2007-2008 Editorial Board of L aboratory Investigation, 1993-2008 Society of Toxicologic Pathology, 2008 Annual Meeting, Symposium Organizing Committee (Co-Chair), 2007-2008 International Life Sciences Institute/Health and Environmental Sciences Institute, PPAR Working Group, 2005-2009 Society of Toxicologic Pathology, Awards Committee, 2008-2009 Society of Toxicologic Pathology, Nominations Committee, 2008-2009 Society of Toxicology/Health and Environmental Sciences Institute, Current Concepts in Toxicology (CCT) Workshop, "Hemangiosarcomas in Rodents: Understanding Modes of Action and Human Relevance", Organizing Committee (Co-Chair), 2008- 2009 Scientific Review Committee, American Association for Cancer Research, Henry Sheperd Trust grants for bladder cancer research, 2008 - 2009 Schering-Plough Science Advisory Board, 2009 Editorial Board of F o o d a n d C hem ical Toxicology, 1990-2009 Sanofi-Aventis Science Advisory Board, 2006-2009 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 57 of 151 PAGEID #: 42210 EXHIBIT 1 Curriculum Vitae Page 27 Samuel M. Cohen, M.D. Ph.D. Editorial Board of Journal of Toxicology, 2008-2011 Society of Toxicologic Pathology, 2009 Annual Meeting Organizing Committee, 2008-2009 American Urological Association Abstract Review Team, 2009 International Life Sciences Institute, Risk Science Institute and Health and Environmental Sciences Institute, and ECETOC Mode of Action, Conference Organizing Committee, 2009 Associate Editor, F o o d a n d C hem ical Toxicology, 2009-2010 International Life Sciences Institute/Health and Environmental Sciences Institute, Executive Committee (Member at Large, 2002-2004, 2008-2010; Vice Chairman of the Board, 2004 2006; Chairman of the Board, 2006-2008) Society of Toxicology Current Concepts in Toxicology, Workshop on New Approaches to Carcinogenicity Testing, Organizing Committee, 2010 Editorial Board of U rologic O ncology, 1995-2010 Editorial Board of In tern a tio n a l Jo u rn a l o f O ncology, 1996-2010 EPRI Arsenic Scientific Review Panel, 2008-2012 International Life Sciences Institute, Nominations Committee, 2010-2012 Society of Toxicologic Pathology, Editor Search Committee, 2012-2013 Board of Scientific Counselors, National Institute of Environmental Health Sciences, 2008 2013 International Life Sciences Institute/Health and Environmental Sciences Institute, Executive Committee, 2011-2012 International Life Sciences Institute, Board of Trustees, Scientific Issues Committee, 2007 2014 International Life Sciences Institute, Board of Trustees, Tripartite Committee, 2007-2014 Society of Toxicology, Awards Committee (elected), 2012-2014 Editorial Board of P athology International, 2001-2013 International Academy of Toxicologic Pathology, Membership committee, 2007-2013 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 58 of 151 PAGEID #: 42211 EXHIBIT 1 Curriculum Vitae Page 28 Samuel M. Cohen, M.D. Ph.D. Health and Environmental Sciences Institute, Risk Assessment for the 21st Century Committee (Co-Chair of Dose Response Team), 2009-2014 International Life Sciences Institute Board of Trustees, Executive Committee, 2010-2015 Society of Toxicologic Pathology Working Group on Cell Proliferation and Apoptosis, 2013 2015 National and International (current): International Life Sciences Institute/Health and Environmental Sciences Institute Board of Trustees (Vice Chairman, 2004-2006; Chairman, 2006-2008), 2001-2016 International Life Sciences Institute/Health and Environmental Sciences Institute Program Strategy and Stewardship Committee (Vice Chair, 2001-2004; Chair, 2004-2006), 2001-2016 Flavor and Extract Manufacturers Association of the United States, Expert Panel, 2002(Vice Chairman, 2011-2013; Chairman, 2014-2016) Editorial Board of Toxicology, 2003- Associate Editor of Toxicologic P athology, 2005- Editorial Board of C ritical R eview s in Toxicology, 2009- International Life Sciences Institute, Board of Trustees, 2007-2016 (Vice Chairman, 2010 2012; Chairman, 2012-2015) International Life Sciences Institute/Health and Environmental Sciences Institute Global Platform Initiative Steering Team, 2014- International Life Sciences Institute Malaspina Intenational Scholars Travel Award Selection Committee, 2014- Editorial Board of Regulatory Toxicology and Pharmacology, 2014- Michigan State University's Center for Research on Ingredient Safety (CRIS) Emerging Issues Committee, 2014- Service Pathology: Current: Surgicals (approximately 1,700/year) Teaching: Current: Small groups and laboratories in second year medical school courses Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 59 of 151 PAGEID #: 42212 EXHIBIT 1 Curriculum Vitae Page 29 Samuel M. Cohen, M.D. Ph.D. Pathology residents Interdepartmental and intradepartmental conferences Graduate Students: Thesis Advisor to: Daniel Williamson (M.D., Ph.D.) Irene A. Sysel (M.D.) Susan Speaks (M.D., Ph.D.) Theodore D. Miller (M.D.) Maria Louisa de Oliveira (Ph.D.) (Sao Paulo State University, Botucatu, Brazil) Merielen Nascimento (Ph.D.) (Sao Paulo State University, Botucatu, Brazil) Satako Kiyota (Ph.D.) Mitscheli Sanches da Rocha (Ph.D.) (Sao Paulo State University, Botucatu, Brazil) Ana Paula Cardoso (Ph.D.) (Sao Paulo State University, Botucatu, Brazil) Lora Arnold (M.S.) Margaret St. John (M.S.) Maria Jackson (B.S.) Amy Salem (B.S.) Denise Demers (B.S.) Donald Headley (B.S.) John Wittenberg (B.S.) Eric Boyd (B.S.) Supervisory Committee for: Christine Eccleston (Ph.D.) Thomas Gross (M.D., Ph.D.) Susan Speaks (M.D., Ph.D.) Julie Gulizia (M.D., Ph.D.) Shadia M. Ihlaseh (Ph.D.) Aniruddha Chatterjee (Ph.D.) (University of Calcutta, External Reviewer) Hang Su (Ph.D.) Matthew T. McLeay (M.D., M.S.) Terry N. Wooldridge (M.D., M.S.) Michael W. Davis (M.S.) Deborah L. Hassler (M.S.) Sally G. Johnson (M.S.) Krysten Knott (M.S.) James Burgart (M.S.) Denise Kolbet (M.S.) James H. Lichty (M.S.) Nancy A. Riesberg (M.S.) James D. Sargeant (M.S.) Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 60 of 151 PAGEID #: 42213 EXHIBIT 1 Curriculum Vitae Page 30 Samuel M. Cohen, M.D. Ph.D. Alice M. Schumaker (M.S.) Shirley Shepherd (M.S.) Justin Hobbs (M.S.) Post-Doctoral Fellows (present positions): Masayuki Arai, M.D. (Professor and Chairman, Department of Pathology, and Dean, School of Medical Technology and Nursing, Fujita-Gakuen University, Toyoake, Japan) (Deceased) Shoji Fukushima, M.D., Ph.D. (Professor and Chairman, Department of Pathology, Osaka City University Medical School, Osaka, Japan, retired; Director, Japan Bioassay Research Center, Japan Industrial Safety and Health Association) Gen'i Murasaki, M.D. (Director of Shutoken JP Health Care Center, Tokyo, Japan) Toru Suzuki, M.D. (Associate Professor, Department of Urology, Dokkyo University School of Medicine, Mibu, Japan) Michael J. Becich, M.D., Ph.D. (Professor, Department of Pathology; Chairman, Department of Biomedical Informatics, University of Pittsburgh, Pittsburgh, Pennsylvania) Ryohei Hasegawa, M.D. (Chiba, Japan) Raymond A. Smith, Ph.D. (Pharmacist, Marinette, Wisconsin) Takao Sakata, M.D. (Department of Urology, Nagoya University Medical School, Nagoya, Japan) Angela Mann, Ph.D. (Assistant Professor, University of Massachusetts Medical Center, Worcester, Massachusetts) Tsuneo Masui, M.D., Ph.D. (General Director, Aichi Prefectural Government, Public Health Science, Aichi, Japan) Emily Garland, Ph.D. (Research Associate, Vanderbilt University) Takehiko Okamura, M.D. (Assistant Professor, Department of Urology, Nagoya City University Medical School, and Chief of Urology, Meijo Hospital, Nagoya, Japan) Makoto Asamoto, M.D., Ph.D. (Associate Professor, First Department of Pathology, Nagoya City University Medical School, Nagoya, Japan) (Deceased) Kumiko Ogawa, M.D., Ph.D. (Head, Division of Pathology, National Institute of Health Sciences, Tokyo, Japan) Masahiro Ito, M.D. (Associate Professor, Department of Surgery, Fujita-Gakuen University, Toyoake, Japan) Shinji Yamamoto, M.D. (Physician, Osaka, Japan) Min Wei,, M.D., Ph.D. (Associate Professor, Department of Pathology, Osaka City University, Osaka, Japan) Mitsuru Futakuchi, M.D., Ph.D. (Associate Professor, Dept. of Molecular Toxicology, Nagoya City University Medical School, Nagoya, Japan) Takamasa Ohnishi, M.D., Ph.D. (Professor and Chairman, Nutrition Division, Department of Health and Science, Hyogo University, Hyogo, Japan) Shugo Suzuki, M.D., Ph.D., (Assistant Professor, First Department of Pathology, Nagoya City University Medical School, Nagoya, Japan) Masanao Yokohira, M.D., Ph.D., (Assistant Professor, Department of Pathology, Kagawa Medical School, Kagawa, Japan) Satoko Kakiuchi-Kiyota, Ph.D. (Scientist, Pfizer, Groton, CT) Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 61 of 151 PAGEID #: 42214 EXHIBIT 1 Curriculum Vitae Page 31 Samuel M. Cohen, M.D. Ph.D. Puttappa Dodmane, Ph.D. (Present fellow) Presentations: 07/05/72 "Carcinogenesis caused by nitrofuran derivatives," Fifth International Congress of Pharmacology, San Francisco, California 10/21 10/25/75 "Early lesions in experimental bladder cancer: Experimental design and light microscopic findings," International Symposium on Early Lesions and the Development of Epithelial Cancer, Bethesda, Maryland 07/21 07/22/76 "Tissue culture characteristics of bladder carcinoma cells," Annual Meeting of the Japanese Bladder Cancer Group, Unuma, Japan 09/16/76 "Bladder cancer," Osaka University, Osaka, Japan 09/26 09/28/76 Etiology of Bladder Cancer, U.S.-Japan Cancer Research Program, Kyoto, Japan 10/0810/09/76 Conference on Analytical Epidemiology, U.S.-Japan Cancer Research Program, Tokyo, Japan 10/29/76 "Scanning electron microscopy of bladder carcinogenesis," Tukushima University, Tokushima, Japan 12/12/76 "Use of scanning electron microscopy in the diagnosis of urinary bladder cancer," 150th Meeting of the Okayama Urological Association, Okayama, Japan 01/22/77 "Neovascularization in bladder carcinogenesis," Japanese Study Group on Epithelial-Mesenchymal Interactions, Tokyo, Japan 01/2801/29/77 "Bladder carcinogenesis," Annual Meeting of the Japanese Bladder Cancer Group, Unuma, Japan 02/07 02/08/77 "Nitrofuran carcinogenesis," Tohoku University, Sendai, Japan 02/15/77 "Effects of nitrofurans on the immune system," Radiation Effects Research Foundation, Hiroshima, Japan 02/16/77 "Urinary bladder carcinogenesis," Hiroshima University, Hiroshima, Japan Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 62 of 151 PAGEID #: 42215 EXHIBIT 1 Curriculum Vitae Page 32 Samuel M. Cohen, M.D. Ph.D. 02/23/77 "Bladder cancer," Kyoto University, Kyoto, Japan 03/08/77 "Ultrastructural aspects of bladder cancer," Aichi Cancer Center, Nagoya, Japan 03/14/77 "Bladder cancer," Gifu University, Gifu, Japan 03/22/77 "Nitrofuran carcinogenesis," Cancer Institute, Tokyo, Japan 03/23/77 "FANFT metabolism and bladder carcinogenesis," Biochemical Research Institute, Tokyo, Japan 04/21/77 "Nitrofuran carcinogenesis," Nara Medical University, Nara, Japan 04/23/77 "Experimental bladder cancer research," Masuko Hospital, Nagoya, Japan 05/10/77 "Nitrofuran carcinogenesis," National Institute of Hygienic Sciences, Tokyo, Japan 05/16/77 "Nitrofuran carcinogenesis," Kyoto University, Kyoto, Japan 11/07 11/11/78 "Urinary cytology as examined by scanning electron microscopy," Symposium on Tumors of the Urothelium, American Society of Cytology, Miami, Florida 11/07 11/11/78 "Experimental urinary bladder carcinogenesis," Symposium on Tumors of the Urothelium, American Society of Cytology, Miami, Florida 07/11/79 "Morphological and biochemical markers of bladder cancer in man and animals," Department of Human Oncology Grand Rounds, Clinical Science Center, University of Wisconsin, Madison, Wisconsin 11/02/79 "Initiation and promotion of cancer," New England Cancer Society, Boston, Massachusetts 11/07 11/09/79 "Urinary bladder carcinogenesis with N-substituted aryl compounds: Initiation and promotion," International Conference on Carcinogenic and Mutagenic NSubstituted Aryl Compounds, Rockville, Maryland 12/10/79 "Urinary bladder cancer," Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois 12/11/79 "Urinary bladder carcinogenesis," Northwestern University Medical School, Chicago, Illinois Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 63 of 151 PAGEID #: 42216 EXHIBIT 1 Curriculum Vitae Page 33 Samuel M. Cohen, M.D. Ph.D. 03/12 -- 03/15/81 "Promotion in urinary bladder carcinogenesis," International Symposium on Health Effects of Tumor Promotion, Cincinnati, Ohio 03/00/81 "Promotion of urinary bladder carcinogenesis," International Symposium on Organ and Species Specificity in Chemical Carcinogenesis, Raleigh, North Carolina 11/04/81 "Urinary bladder cancer," University of Baroda Medical School, Baroda, India 11/11 -- 11/12/81 "Promotion in urinary bladder carcinogenesis," Symposium on Tumor Promotion, Nagoya, Japan 03/30 04/01/82 "Multistage carcinogenesis in the urinary bladder," Second International Conference on Carcinogenic and Mutagenic N-Substituted Aryl Compounds, Hot Springs, Arkansas 12/09 -- 12/10/82 "A probabilistic model of carcinogenesis," Rush-Presbyterian-St. Luke's, Chicago, Illinois 01/05 -- 01/08/83 "Diagnostic electron microscopy," Second National Bladder Cancer Conference, Sarasota, Florida 05/16 -- 05/18/83 "Urinary bladder carcinogenesis," International Symposium on Role of Co Carcinogens and Promoters in the Human and Experimental Carcinogenesis," Budapest, Hungary 05/05/83 "Multi-stage carcinogenesis in the urinary bladder," Scientific Review Panel on Saccharin: An Update, Duke University Medical Center, Durham, North Carolina 11/01 -- 11/02/83 "Promotion in urinary bladder carcinogenesis," Environmental Health Seminar Series, University of Cincinnati, Cincinnati, Ohio 01/04 01/07/84 "Unmet needs and available models," Session Co-Chairman, Tenth National Bladder Cancer Project Investigators' Workshop, Sarasota, Florida 01/04 Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 64 of 151 PAGEID #: 42217 EXHIBIT 1 Curriculum Vitae Page 34 Samuel M. Cohen, M.D. Ph.D. 01/07/84 "Tumor dissemination," Session Chairman, Tenth National Bladder Cancer Project Investigators' Workshop, Sarasota, Florida 01/04 -- 01/07/84 "Growth factors and membrane receptors in tumor growth and progression," Session Chairman, Tenth National Bladder Cancer Project Investigators' Workshop, Sarasota, Florida 05/03 05/04/84 "Aspirin inhibition of N-[4-(-nitro-2-furyl)-2-thiazolyl]formamide (FANFT) in urinary bladder carcinogenesis," Development of Cancer Chemopreventive Agents, National Cancer Institute, Gaithersburg, Maryland 10/15 -- 10/18/84 "Saccharin: Past, present and future," 67th Annual Meeting of the American Dietetic Association, Washington, D.C. 01/08/86 "Effects of Different Salt Forms of Saccharin on the Rat Urinary Bladder," Meeting of the Saccharin Technical Committee, International Life Sciences Institute - Nutrition Foundation, Omaha, Nebraska 01/21/86 "Saccharin," International Life Sciences Institute - Nutrition Foundation, Annual Meeting of the Food, Nutrition and Safety Committee, meeting Dates: 01/20-01/23/86, Naples, Florida 03/20/86 "Urinary Bladder Carcinogenesis," National Institute of Hygienic Sciences, Tokyo, Japan 03/20/86 "Importance of cell proliferation in urinary bladder carcinogenesis," Urology and Biochemistry Divisions, National Cancer Center Research Institute, Tokyo, Japan 03/25/86 "Modifiers of carcinogenesis," U.S.-Japan Cooperative Cancer Research Program Seminar; Recent Advances in Bladder Cancer Research, meeting Dates: 03/24-03/25/86, Nagoya, Japan 03/26 -- 03/29/86 "Effects of Urinary Parameters on Bladder Carcinogenesis," International Symposium and International Life Sciences Institute Histopathology Seminar on the Urinary System of Laboratory Animals, Nara, Japan 04/13 -- 04/16/86 "Bladder Tumor Promotion," Non-genotoxic Mechanisms in Carcinogenesis, Banbury Center, Cold Spring Harbor Laboratory. 05/21/86 "Multi-stage Carcinogenesis in the Urinary Bladder: Rats, Humans and Computer Models," Northwestern University Cancer Center, Chicago, Illinois Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 65 of 151 PAGEID #: 42218 EXHIBIT 1 Curriculum Vitae Page 35 Samuel M. Cohen, M.D. Ph.D. 05/21/86 "Importance of Cell Proliferation in Carcinogenesis," Department of Pathology, Northwestern University Medical School, Chicago, Illinois 06/09/86 "Bladder cancer in rats, humans and computers," Wisconsin Clinical Cancer Center, Department of Human Oncology, University of Wisconsin Medical School, Madison, Wisconsin 10/30/86 "Multi-Stage Carcinogenesis," Chemical Carcinogenesis/Molecular Biology Interface Working Session, sponsored by the Bladder Cancer Working Group of the Organ Systems Program, National Cancer Institute, Michigan Cancer Foundation, Detroit, Michigan 12/17/86 "Saccharin," Food and Drug Administration, Washington, D.C. 01/14/87 "Role of saccharin in bladder cancer research," Optimist Club Luncheon, Omaha, Nebraska 01/17/87 "Computer modeling in cancer research," Board of Regents, Lincoln, Nebraska 01/22/87 "Computer modeling in cancer research," University of Nebraska Medical Center Chancellor's Board of Counselors, Omaha, Nebraska 02/02/87 "Cancer: Cause and Prevention," Sertoma Club, Kearney, Nebraska 04/03/87 "Saccharin," Food and Drug Administration, Washington, D.C. 04/13/87 "Mechanistic Research on Bladder Carcinogenesis," International Life Sciences Institute-Nutrition Foundation, Washington, D.C. 09/21 09/22/87 "Cancer: Etiology and Pathogenesis," University of Massachusetts Medical School, Worcester, Massachusetts 09/24/87 "Saccharin Mechanistic Research," Sweetener Safety/Regulatory Symposium, Pepsi Somers Conference Center, Valhalla, New York 09/28/87 "Basic Research Directions," Moderator Chairman, Second International Consensus Development Conference on Guidelines for Clinical Research in Bladder Cancer, Hakone, Japan 09/28/87 "Carinoma in Situ," Second International Consensus Development Conference on Guidelines for Clinical Research in Bladder Cancer, Hakone, Japan Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 66 of 151 PAGEID #: 42219 EXHIBIT 1 Curriculum Vitae Page 36 Samuel M. Cohen, M.D. Ph.D. 09/28/87 "Evaluation and Clinical Follow-Up," Second International Consensus Development Conference on Guidelines for Clinical Research in Bladder Cancer, Hakone, Japan 09/30/87 "Basic Research Directions," Moderator Chairman, Second International Consensus Development Conference on Guidelines for Clinical Research in Bladder Cancer, Hakone, Japan 10/02/87 "Genotoxic versus Non-Genotoxic Mechanisms of Carcinogenesis," National Cancer Institute, Tokyo, Japan 10/05/87 "Initiation and Promotion in Urinary Bladder Carcinogenesis," Nagoya City University Medical School, Nagoya, Japan 11/04/87 "Cell Growth in Long-Term Bladder Carcinogenesis," 17th Conference on Toxicology, Fairborn, Ohio 12/08/87 "Restructuring the Department of Pathology's Charge Capture System," RushPresbyterian-St. Luke's Medical Center, Chicago, Illinois 02/10/88 "Cell Growth Dynamics in Bladder Carcinogenesis: Implications for Risk Assessment," Brookings Institute, Washington, D.C. 05/03/88 "Saccharin," Symposium on Human Cancer Risk Assessment Based on Experimental Data, Wrightsville Beach, North Carolina 06/15/88 Forestomach Subgroup of the Carcinogenicity Working Group, International Life Sciences Institute, Risk Science Institute, Washington, D.C. 09/26 09/27/88 "Cancer: Etiology and Pathogenesis," University of Massachusetts Medical School, Worcester, Massachusetts 10/06/88 "The Role of Cell Dynamics in Multi-stage Carcinogenesis: Implications for Risk Assessment," Japanese Cancer Association Symposium, Contributions of Rodent Carcinogenesis Studies to Human Health, Nagoya, Japan 02/01/89 "Bladder Carcinogenesis: Non-genotoxic and Genotoxic Agents," University of Wisconsin Clinical Cancer Center, Department of Human Oncology, Madison, Wisconsin 02/28/89 "Toxic and Nontoxic Changes Induced in the Urothelium by Xenobiotics," Symposium II. Correlation Between Morphologic and Functional Changes Induced by Xenobiotics: "Is Every Change a Sign of Toxicity?," Society of Toxicology Meeting, Atlanta, Georgia Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 67 of 151 PAGEID #: 42220 EXHIBIT 1 Curriculum Vitae Page 37 Samuel M. Cohen, M.D. Ph.D. 02/28/89 "The Relationship of Androgens/Estrogens to Proliferative Changes in the Prostate," Symposium II. Correlation Between Morphologic and Functional Changes Induced by Xenobiotics: "Is Every Change a Sign of Toxicity?," Society of Toxicology Meeting, Atlanta, Georgia 03/08/89 "Cell Proliferation and Its Implications for Risk Assessment," Mobay Corp., Kansas City, Missouri 03/22/89 "Overview of Initiation and Promotion; Genotoxic and Non-genotoxic Mechanisms of Carcinogenesis," The Biology of Bladder Cancer: The Potential Clinical Implications, Organ Systems Coordinating Center, Organ Systems Program, NCI, Bethesda, Maryland 03/31/89 "Morphologic Changes During Urinary Bladder and Kidney Carcinogenesis," Great Lakes Regional Discussion Group, Society of Toxicologic Pathologists, Spring Meeting, Madison, Wisconsin 06/1706/22/89 "Cell Growth Dynamics and DNA Alterations in Carcinogenesis," Scientific Issues in Quantitative Cancer Risk Assessment, Societal Institute of the Mathematical Sciences, Snowbird, Utah 09/11 09/12/89 "Bladder Cancer," Immunology of Solid Tumors: Animal Models, Cancer Immunology Branch, Division of Cancer Biology and Diagnosis, NCI, Rockville, Maryland 09/1809/22/89 "Update on Sweeteners - Saccharin," Toxicology Forum, Toulouse, France. 09/27 09/28/89 "Cancer: Etiology and Pathogenesis," University of Massachusetts Medical School, Worcester, Massachusetts 10/10 10/11/89 "Saccharin," International Life Sciences Institute, Washington, D.C. 11/01/89 "Role of cell proliferation and genotoxicity in bladder carcinogenesis: Implications for Risk Assessment," E. I. DuPont de Nemours and Co., Neward, Delaware 11/29 12/02/89 "Chemically Induced Cell Proliferation: Implications for Risk Assessment," Austin, Texas Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 68 of 151 PAGEID #: 42221 EXHIBIT 1 Curriculum Vitae Page 38 Samuel M. Cohen, M.D. Ph.D. 04/09/90 "Sweet Daggers, Chemicals, Cells, and Cancer," University of Nebraska Medical Center, Omaha, Nebraska 05/23/90 "New Technology, Your Pathologist, and You," Workshop, American Association for Cancer Research, Washington, D.C. 09/20 09/21/90 "Cancer: Etiology and Pathogenesis," University of Massachusetts Medical School, Worcester, Massachusetts 10/01/90 "Bladder Cancer," Noble-Foundation, Inc., Fifth Annual Mid-America Molecular and Cellular Biology Colloquium, Ardmore, Oklahoma 10/15/90 "Saccharin," International Life Sciences Institute, Washington, D.C. 10/22/90 "Role of Cell Proliferation on the Dose Response of Genotoxic and Nongenotoxic Carcinogens," 1990 Drug Safety Meeting, Pharmaceutical Manufacturers Association, Tampa, Florida 11/08/90 "Two-stage Models of Carcinogenesis: Applications and Implications in Risk Assessment," National Research Council, Committee on Risk Assessment Methodology (CRAM), Washington, D.C., 1990 12/07/90 "Relevance of Animal Studies to Evaluate Human Cancer Risk," University of Texas, M.D. Anderson Cancer Center-Science Park. Barton Creek Conference Resort, Austin, Texas 12/12/90 "Saccharin," International Life Sciences Institute, Washington, D.C. 12/13/90 "Saccharin," Federal Drug Administration, Washington, D.C. 12/13/90 "Biological Models and Risk Assessment," Federal Drug Administration, Washington, D.C. 12/18/90 "Cell Proliferation in Carcinogenesis," First Department of Pathology, Nagoya City University Medical School, Nagoya, Japan 12/18/90 "Cell Proliferation in Carcinogenesis," First Department of Pathology, Osaka City University Medical School, Osaka, Japan 12/19/90 "Cell Proliferation in Carcinogenesis: Implications for Risk Assessment," Food and Drug Administration, Rockville, Maryland 02/06/91 "Cell Proliferation in Carcinogenesis: Implications for Risk Assessment," Food and Drug Administration, Rockville, Maryland Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 69 of 151 PAGEID #: 42222 EXHIBIT 1 Curriculum Vitae Page 39 Samuel M. Cohen, M.D. Ph.D. 02/26/91 "Simvastatin: Risk Evaluation," Merck Sharp and Dohme Research Laboratories, West Point, Pennsylvania 03/08/91 "Simvastatin," Food and Drug Administration, Rockville, Maryland 03/26 03/28/91 "Cell Proliferation, Genotoxicity, and Carcinogenesis," Fourth International Symposium, Fundamental and Clinical Research in Urogenital Cancer, Foundation for Promotion of Cancer Research, Tokyo, Japan 04/24/91 "Solid Wastes and Toxics," Nebraska Wesleyan University, Lincoln, Nebraska 06/11 06/14/91 "Cell Proliferation in Mutagenesis and Carcinogenesis," Gordon Conference Genetic Toxicology, Colby-Sawyer College, New London, New Hampshire 08/26/91 "Of Mice and Men: Carcinogenesis and Risk Assessment," NIEHS, Research Triangle Park, North Carolina 09/05/91 "Cancer Modeling," Harvard University, Boston, Massachusetts 09/19 09/20/91 "Cancer: Etiology and Pathogenesis," University of Massachusetts Medical School, Worcester, Massachusetts 09/22 09/23/91 "Classification of 3,4'methylene A(2-chloraniline) (MOCA)," American Conference of Governmental Industrial Hygienists Threshold Limit Values Committee, Cincinnati, Ohio 10/10/91 "Chemicals, Biology and Potential Cancer Risk," American Chemical Society, Anaheim, California 11/11/91 "Genetic Alterations and Cell Proliferation in Chemical Carcinogenesis," National Cancer Institute-Frederick, Frederick, Maryland 11/20/91 "Cell Proliferation and Carcinogenesis: Implications for Risk Assessment," Merck Sharp and Dohme Research Laboratories, West Point, Pennsylvania 12/05 12/06/91 "Biological Theory of Carcinogenesis and Characteristics of Bladder Tumors from Mutagenic and Nonmutagenic Compounds," International Life Sciences Institute Risk Science Institute Cancer Dose-Response Working Group, Herndon, Virginia Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 70 of 151 PAGEID #: 42223 EXHIBIT 1 Curriculum Vitae Page 40 Samuel M. Cohen, M.D. Ph.D. 01/13 01/16/92 "Modeling Urinary Bladder Carcinogenesis Using Cell Proliferation Data," NIEHS Symposium on Cell Proliferation and Carcinogenesis, Research Triangle Park, Raleigh-Durham, North Carolina 03/10/92 Seminar, "Of Mice and Men: A Biological Basis for Carcinogenesis Risk Assessment," Kansas University Medical Center, Kansas City, Kansas 03/24/92 Nagoya City Seminar, "Genetic Errors, Cell Proliferation and Carcinogenesis," Nagoya, Japan 03/27/92 Tokushima Lectureship, "Saccharin: A Rat Bladder Carcinogen," Fuji-Otsuka Lecture at University of Tokushima, College of Medicine, Tokushima, Japan 04/07 04/08/92 FASEB Meeting, "Saccharin and urothelial proliferation: A threshold phenomenon," Anaheim, California 04/15/92 "Saccharin," International Life Sciences Institute-North America, Saccharin Committee Meeting, Washington, D.C. 04/16/92 "Saccharin is a rat carcinogen," Food and Drug Administration, Beltsville, Maryland 04/21/92 "Is saccharin a human carcinogen?," Osaka City University Medical School, Osaka, Japan 04/22 04/24/92 "Bladder calculi and proliferative effects on bladder carcinogenesis," First International Federation of Societies of Toxicologic Pathologists, Nagoya, Japan 05/05/92 "Propoxur," U.S. Environmental Protection Agency, Arlington, Virginia 07/02 07/09/92 "Cell Division in Dose-Response Models," ETH and University of Zurich, Zurich, Switzerland 08/26/92 "Urine physiology and chemistry," Rodent Bladder Carcinogenesis Working Group, International Life Sciences Institute/Environmental Protection Agency, Washington, D.C. 09/10/92 "Cancer Modeling," Harvard University, Boston, Massachusetts 09/22/92 "The Interpretation of Rodent Bioassays," International Life Sciences Institute, Brookings Institute, Washington, D.C. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 71 of 151 PAGEID #: 42224 EXHIBIT 1 Curriculum Vitae Page 41 Samuel M. Cohen, M.D. Ph.D. 09/24 09/25/92 "Cancer Etiology and Pathogenesis," University of Massachusetts School of Medicine, Worcester, Massachusetts 11/06 11/07/92 "Role of Cell Proliferation in Carcinogenesis," Fred Hutchinson Cancer Research Center, Seattle, Washington 11/09/92 "Current Trends in Food Safety Evaluation," Calorie Control Council Annual Meeting, LaJolla, California 02/10/93 "Role of Toxicologic Pathology in Safety Assessment," National Research Council Environmental Studies and Toxicology, Washington, D.C. 03/16/93 "Recent Results of Research Concerning the Carcinogenicity of Saccharin," Environmental Protection Agency, Washington, D.C. 04/16/93 "Risk Assessment Based on High Dose Animal Exposure Experiments," Central States Chapter Society of Toxicology, Creighton University, Omaha, Nebraska 04/1904/20/93 "Importance of Toxicologic Pathology in Determining Mechanisms for Risk Assessment Extrapolations," International Life Sciences-Japan, Symposium, Tokyo, Japan 04/21/93 "Applications of Pathology to Risk Assessment: The Sodium Saccharin Case," Sumitomo Chemical Co., Osaka, Japan 04/27/93 "Chemical Carcinogenesis," University of Kansas Medical Center Mid-America Toxicology Course, Kansas City, Missouri 04/29/93 "Mechanistic Research on Bladder Cancer," International Life Sciences Saccharin Committee Meeting, Washington, D.C. 05/03/93 "Cell Proliferation, Genetics and Carcinogenesis," Northwestern University Medical School, Chicago, Illinois 05/24/93 University of Nebraska Medical Center Overview Presentation, Rotary Club, Ashland, Nebraska 06/24/93 University of Nebraska Medical Center Overview Presentation, Rockbrook Rotary Club, Omaha, Nebraska 06/29 06/30/93 "Mechanistic Studies of Bladder Tumors Associated with Sodium Saccharin in the Rat," Ottawa, Canada Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 72 of 151 PAGEID #: 42225 EXHIBIT 1 Curriculum Vitae Page 42 Samuel M. Cohen, M.D. Ph.D. 09/07/93 "Replication Errors and Cancer," Genetics Interest Group, University of Nebraska Medical Center, Omaha, Nebraska 09/14/93 "Biological Models for Carcinogenesis Risk Assessment," Toxicology Round Table Meeting, Washington, D.C. 09/20/93 "Cell Kinetics and Carcinogenesis," Department of Anatomy and Cell Biology, University of Nebraska Medical Center, Omaha, Nebraska 09/27/93 "Cancer Etiology and Pathogenesis," University of Massachusetts School of Medicine, Worcester, Massachusetts 09/29/93 "Advances in Cancer Modeling," Harvard University, Boston, Massachusetts 10/2210/24/93 "Bladder Cancer: New Concepts in Biology and Therapy," NIH-sponsored Bladder Cancer Conference, Prout's Neck, Maine 11/02 11/04/93 "Cell Proliferation in the Bladder and Implications for Cancer Risk Assessment," Health Effects Research Laboratory (HERL) Symposium on Biological Mechanisms in Quantitative Risk Assessment, Research Triangle Park, North Carolina 01/18/94 "Genetic Errors, Cell Proliferation, and Carcinogenesis Risk Extrapolation," Risk Assessment in Environmental Carcinogenesis, American Association for Cancer Research, Whistler, British Columbia, Canada 01/24/94 "Saccharin: Rodent Bioassays and Human Risk," Washington State University, Pullman, Washington 02/18/94 "Advances in Cancer Modeling," National Institute for Occupational Safety and Health (NIOSH), sponsored by the Cincinnati Carcinogenesis and Mutagenesis Consortium, Cincinnati, Ohio 03/23 03/24/94 "Human Relevance of Animal Carcinogenicity Studies," Symposium on Design and Interpretation of Animal Carcinogenicity Studies, Great Lakes Region Discussion Group Meeting of the Society of Toxicologic Pathologists, Cincinnati, Ohio 04/06/94 "Biological Mechanisms in Carcinogenesis Risk Assessment," Department of Pathology, Osaka City University, Osaka, Japan Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 73 of 151 PAGEID #: 42226 EXHIBIT 1 Curriculum Vitae Page 43 Samuel M. Cohen, M.D. Ph.D. 04/13 04/15/94 "A non-DNA reactive mechanism involving urothelial proliferation," U.S.Environmental Protection Agency and California-Environmental Protection Agency, San Francisco, California 04/26/94 "Chemical Carcinogenesis," University of Kansas Medical Center Mid-America Toxicology Course, Kansas City, Missouri 05/24/94 "Saccharin, Vitamin C and Bladder Cancer," Veterans Administration Medical Center, Omaha, Nebraska 06/06/94 "Relationship of DNA Adducts Derived from 2-AAF to Cell Proliferation and the Induction of Rodent Liver and Bladder Tumors," 13th International Symposium, Role of Drug Metabolism and Pharmacokinetics in Toxicologic Pathology, Society of Toxicologic Pathologists, Charleston, South Carolina 09/07/94 "Biologic Approaches to Bioassay Interpretation," Pharmaceutical Research and Manufacturers of America (PhRMA), Washington, D.C. 09/28/94 "Cancer Etiology and Pathogenesis," University of Massachusetts School of Medicine, Worcester, Massachusetts 09/29 09/30/94 "Advances in Cancer Modeling," Harvard University, Boston, Massachusetts 10/24/94 "Biological Basis for Risk Assessment," American College of Toxicology, Willliamsburg, Virginia 01/20/95 "DNA Replication, DNA Damage and Carcinogenesis," Vanderbilt University School of Medicine, Nashville, Tennessee 04/09/95 "Urinary Bladder Carcinogenesis and Cancer Prevention," Experimental Biology (FASEB), Atlanta, Georgia 04/25/95 "Chemical Carcinogenesis," University of Kansas Medical Center Mid-American Toxicology Course, Kansas City, Missouri 07/03/95 "Role of Cell Proliferation in Regenerative and Neoplastic Disease," International Congress on Toxicology VII, Symposium on "Cell Proliferation: Biological Effects and Carcinogenic Risk Assessment," Seattle, Washington 09/13/95 "The role of urinary physiology and chemistry in urothelial toxicity and carcinogenicity," Histopathology Seminar, International Life Sciences Institute, Hannover, Germany Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 74 of 151 PAGEID #: 42227 EXHIBIT 1 Curriculum Vitae Page 44 Samuel M. Cohen, M.D. Ph.D. 09/14/95 "Urinary calculi, crystals, and precipitate and the role of increased cell proliferation in carcinogenesis," Histopathology Seminar, International Life Sciences Institute, Hannover, Germany 09/25 09/26/95 "Cancer Etiology and Pathogenesis," University of Massachusetts School of Medicine, Worcester, Massachusetts 09/27/95 "Advances in Cancer Modeling," Harvard University, Boston, Massachusetts 10/06/95 "Saccharin - A case study," Federal Focus, Inc., London, England 12/04/95 "Laboratory Investigations of Dietary Carcinogens," Netherlands Food Council, Leiden, The Netherlands 12/05/95 "Conclusions and Recommendations Reached by the NRC/NAS Committee," Netherlands Food Council, Leiden, The Netherlands 02 15 96 "Carcinogens and Anticarcinogens in the Human Diet," United States Congress, Washington, D.C. 02/15/96 "Carcinogens and Anticarcinogens in the Human Diet," National Academy of Sciences, Washington, D.C. 02/19/96 "Cell Proliferation and Carcinogenesis: Implications for Risk Assessment," University of Arizona, Southwest Environmental Health Science Center, Tucson, Arizona 04/23/96 "Chemical Carcinogenesis," University of Kansas Medical Center Mid-America Toxicology Course, Kansas City, Missouri 05/06/96 "Comments on Proposed EPA Cancer Risk Assessment Guidelines," Environmental Protection Agency, Washington, D.C. 06/25/96 "Cell Proliferation and Carcinogenesis," University of Pittsburgh, Pittsburgh, Pennsylvania 08/06/96 "Chemical Carcinogenesis: Implications for Dose and Species Extrapolations," American Industrial Hygiene Association (AIHA). 09/23 09/24/96 "Cancer Etiology and Pathogenesis," University of Massachusetts School of Medicine, Worcester, Massachusetts 09/30/96 "Tributylphosphate," United States Environmental Protection Agency, Tributylphosphate Task Force, EPA, Washington, D.C. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 75 of 151 PAGEID #: 42228 EXHIBIT 1 Curriculum Vitae Page 45 Samuel M. Cohen, M.D. Ph.D. 01/10/96 "Cell Proliferation and Carcinogenesis":, Arkansas Symposium, Understanding the Causes of Aging and Cancer, Little Rock, Arkansas 11/08/96 "Mechanisms of Carcinogenesis," 13th Annual Meeting, Central States Chapter Society of Toxicology (SOT), Kansas City, Kansas 02/05 02/06/97 "Update on Saccharin Safety," ISA/CIFTI Seminar on Low-Calorie Sweeteners, New Delhi, India 04/22/97 "Recent investigations on bladder cytotoxicants and mitogens and their relationship to carcinogenesis," Osaka City University Medical School, Osaka City, Japan 04/24/97 "The role of urinary physiology and chemistry in urothelial toxicity and carcinogenicity," International Life Sciences Institute Nara International Symposium and Histopathology Seminar on the Urinary System of Laboratory Animals, Nara, Japan 04/25/97 "Urinary calculi, crystals, and precipitate and the role of increased cell proliferation in carcinogenesis," International Life Sciences Institute Nara International Symposium and Histopathology Seminar on the Urinary System of Laboratory Animals, Nara, Japan 05/01/97 "Experimental models for the study of mechanisms of chemical carcinogenesis," 21st Brazilian Congress of Pathology, Brasilia, Brazil. 05/02/97 "Mechanisms of chemical carcinogenesis," 21st Brazilian Congress of Pathology, Brasilia, Brazil 05/05/97 "Chemical carcinogenesis," State University of Sao Paulo, Botucatu, Brazil 05/06/97 "Risk Factors for Human Cancer," State University of Sao Paulo, Botucatu, Brazil 05/19/97 "Saccharin," Food and Drug Administration, Washington, D.C. 05/21/97 "Fundamentals of Carcinogenesis," Expert Panel on Arsenic Carcinogenicity, Environmental Protection Agency, Washington, D.C. 06/25/97 "Urinary Bladder Carcinogenesis," 16th Annual Symposium, Society of Toxicologic Pathologists, Beaver Creek, Colorado 07/28/97 "Chemical Carcinogenesis: Implications for Dose and Species Extrapolations," AIHA Toxicology Symposium, Seattle, Washington Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 76 of 151 PAGEID #: 42229 EXHIBIT 1 Curriculum Vitae Page 46 Samuel M. Cohen, M.D. Ph.D. 09/09/97 Environmental Protection Agency-FIFRA-Scientific Advisory Panel, Arsenic Presentation, Arlington, Virginia 04/21/98 "Chemical Carcinogenesis," University of Kansas Medical Center Mid America Toxicology Course, Kansas City, Missouri 07/06/98 "Cell Proliferation and Carcinogenesis," International Union of Toxicology (IUTOX) Continuing Education Course, Paris, France 07/14/98 "Evaluation of cell proliferative activity in the rat urinary bladder after feeding high doses of cacodylic acid," Society of Environmental Geochemistry and Health (SEGH), Arsenic Conference, San Diego, California 08/19/98 "Saccharin," International Life Sciences Institute, Saccharin Technical Committee, Washington, D.C. 11/09/98 "Carcinogenesis," Osaka City University Medical School, Osaka, Japan 11/09/98 "Bladder Carcinogenesis," Osaka City University Medical School, Osaka, Japan 11/17/98 "Cell Proliferation as the Basis for Carcinogenesis of Non-Genotoxic Chemicals," Alternative Bioassays for Carcinogen Detection, 5th Congresso Latino-Americano De Mutagenese, Carcinogenese E Teratogenese Ambiental, Curitiba, Parana, Brazil 11/19/98 "Methods for Evaluating Cell Proliferation," 5th Alexander Hollaender Training Course in Genetic Toxicology, Curitiba, Parana, Brazil 12/02/98 "Saccharin," Health Protection Branch, Ottawa, Canada 01/25/99 "The Use of Animal Data in Risk Assessment," International Life Sciences Institute Risk Science Institute Advisors' Forum, Nassau, Bahamas 01/26/99 "Saccharin," International Life Sciences Institute Food, Nutrition and Safety Committee, Nassau, Bahamas 02/10/99 "Relationship of Apoptosis and Necrosis to Carcinogenesis," Apoptosis Working Group, International Life Sciences Institute-North America Technical Committee on Food Toxicology and Safety Assessment and the Proposition 65 Technical Committees' Joint Subcommittee on Apoptosis, Washington, D.C. 03/16/99 "SOT/EUROTOX Debate: The Results of Mechanistic Toxicity Studies Should Supercede Ambiguous Epidemiological Data," Society of Toxicology, New Orleans, Louisiana 04/27/99 "Chemical Carcinogenesis," Midwest Toxicology Course, Kansas City, Missouri Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 77 of 151 PAGEID #: 42230 EXHIBIT 1 Curriculum Vitae Page 47 Samuel M. Cohen, M.D. Ph.D. 04/28/99 "Cell Proliferation and Carcinogenesis: Implications for Risk Assessment," Michigan Society of Toxicology, Lansing, Michigan 06/29/99 "SOT/EUROTOX Debate: The Results of Mechanistic Toxicity Studies Should Supercede Ambiguous Epidemiological Data," EUROTOX Meeting, Oslo, Norway 08/12/99 "Carcinogenesis: Of Mice and Men," American Industrial Hygiene Association, 14th Annual Toxicology Symposium, Williamsburg, Virginia 12/16 -- 12/18/99 "Lesions of the Bladder I - Structure/Spontaneous/Induced Changes; Lesions of the Bladder II - Proliferative/Dysplastic Changes; Lower Urinary Tract Conditions - Practical; Human LUT Pathology," British Society of Toxicological Pathologists, Cambridge, England 01/10/00 "Apoptosis and its implications for toxicity, carcinogenicity and risk: Fumonisin B1 as an example," Fumonisins Risk Assessment Workshop, Food and Drug Administration, Washington, D.C. 01/19/00 "Fetal Cell Research: Science and Politics," University of Nebraska Medical Center, Board of Counselors Annual Meeting, Omaha, Nebraska 02/23/00 "Fetal Tissue Research," Judiciary Committee Testimony, Lincoln, Nebraska 03/09/00 "Fetal Tissue Research," Testimony to the Health and Environment Subcommittee of the Commerce Committee, United States House of Representatives, Washington, D.C. 03/21/00 "Saccharin: Overview and History," Society of Toxicology, Philadelphia, Pennsylvania 03/21/00 "Saccharin: Epidemiology," Society of Toxicology, Philadelphia, Pennsylvania 03/22/00 "Apoptosis and its implications for toxicity, carcinogenicity and risk: Fumonisin B1as an example," Society of Toxicology, Philadelphia, Pennsylvania 04/20/00 "Isocyanuric acid," U.S. Environmental Protection Agency, Washington, D.C. 05/02/00 "Chemical carcinogenicity," Mid-America Toxicology Course, Kansas City, Missouri 06/20/00 "The carcinogenicity of dimethylarsinic acid (DMA) in rats," Fourth International Conference on Arsenic Exposure and Health Effects, San Diego, California Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 78 of 151 PAGEID #: 42231 EXHIBIT 1 Curriculum Vitae Page 48 Samuel M. Cohen, M.D. Ph.D. 06/22/00 "Research needs to refine MCL," Fourth International Conference on Arsenic Exposure and Health Effects, San Diego, California 06/24/00 "Comparative pathology of proliferative lesions of the urinary bladder in man, rat and mouse," National Toxicology Program Satellite Symposium to annual meeting of Society of Toxicologic Pathologists, Phoenix, Arizona 07/18/00 Bioethics Panel, University of Nebraska Medical Center, Omaha, Nebraska 07/28/00 "Difficult ethical and political issues facing tissue brokers," Association of Pathology Chairs, Boulder, Colorado 10/12/00 Mentoring Institute, University of Nebraska Medical Center, Omaha, Nebraska 10/17/00 Introduction, Comparative Pathology of Carcinogenesis Symposium, International Academy of Pathology, Nagoya, Japan 10/17/00 "The two diseases of bladder cancer in rodents and humans," Comparative Pathology of Carcinogenesis Symposium, International Academy of Pathology, Nagoya, Japan 10/23/00 "Recent advances in urinary bladder carcinogenesis research," Takeda Chemical Industries, Ltd., Osaka, Japan 10/24/00 "Carcinogenicity of dimethylarsinic acid," Osaka City University, Osaka, Japan 11/03/00 "Weight of evidence evaluation across models," International Life Sciences Institute Alternatives to Carcinogenicity Testing Workshop, Leesburg, Virginia 11/09/00 "Human relevance case studies: What have we learned?" International Programme on Chemical Safety/International Life Sciences Institute, London, England 01/22/01 "The dose makes the poison: Did Paracelsus throw us a curve?," International Life Sciences Institute 2001 Annual Meeting, Montego Bay, Jamaica 01/22/01 "What do the data tell us?," International Life Sciences Institute 2001 Annual Meeting, Montego Bay, Jamaica 01/22/01 "Alternatives to Carcinogenicity Testing: Why Bother?," International Life Sciences Institute 2001 Annual Meeting, Montego Bay, Jamaica 01/29/01 "Use of Pathology in Risk Assessment," Expert Panel of the Flavor and Extract Manufacturers Association (FEMA), Miami, Florida Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 79 of 151 PAGEID #: 42232 EXHIBIT 1 Curriculum Vitae Page 49 Samuel M. Cohen, M.D. Ph.D. 02/09/01 "Fetal Cell Research," Testimony to State of Nebraska Legislative Judiciary Committee, Lincoln, Nebraska 03/29/01 "Summary of findings across the models examined in the ILSI-HESI evaluation of alternatives for carcinogenicity testing," Workshop on Use of Transgenic Models for Carcinogenicity Testing--A Data-Based Evaluation. Society of Toxicology, San Francisco, California 03/29/01 "Introduction," Workshop on Risk Assessment: Science, Regulation and Legislation. Society of Toxicology, San Francisco, California 04/17/01 "Fetal Cell Research," Testimony to Omaha City Council, Omaha, Nebraska 04/24/01 "Chemical Carcinogenesis," Mid-America Toxicology Course, Kansas City, Missouri 12/04/01 "UNMC Rapid Autopsy Program," State Legislature, Lincoln, Nebraska 04 23 02 "Chemical Carcinogenesis," Mid-America Toxicology Course, Kansas City, Missouri 07/17/02 "Carcinogenicity of dimethylarsinic acid in rats," Fifth International Conference on Arsenic Exposure and Health Effects, San Diego, California 09/25/02 "All models are wrong; some are useful," Aventis Pharmaceuticals, Bridgewater, New Jersey 10/14/02 "Ethics of Stem Cell Research - The Pathologists' Perspective," College of American Pathologists Annual Meeting, Washington, D.C. 10/18/02 "Alternatives to carcinogenicity testing," Schering-Plough Corporation, Morristown, New Jersey 12/10/02 "Analysis of mode of action of carcinogenesis in animal models," International Life Sciences Institute Society for Risk Analysis Symposium, New Orleans, Louisiana 01/20/03 "Cancer causation," International Life Sciences Institute Annual Meeting, Miami, Florida 01/28/03 "Cancer causation: Of mice (and rats) and men," Fujita-Gakuen University, Nagoya, Japan 01/30/03 "Transgenic mice as alternative models for carcinogenicity testing," Daiyu-Kai Symposium, Nagoya, Japan Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 80 of 151 PAGEID #: 42233 EXHIBIT 1 Curriculum Vitae Page 50 Samuel M. Cohen, M.D. Ph.D. 03/11/03 "Mode of action in assessing human relevance of animal tumors," Society of Toxicology Symposium, Salt Lake City, Utah 04/23/03 "Special study to characterize the changes in the lower urinary tract of rats associated with chronic administration of LY519818," Eli Lilly and Company, Greenfield, Indiana 04/29/03 "Chemical Carcinogenesis," Mid-America Toxicology Course, Kansas City, Missouri 06/16/03 "Risk assessment in the genomic era," Society of Toxicologic Pathology, Savannah, Georgia 09/23/03 "Carcinogenesis: of mice and men," New York Medical College, Valhalla, New York 12/11/03 "Lesions of the Bladder I - structure/spontaneous/induced changes," British Society of Toxicologic Pathology, Cambridge, England 12/11/03 "Lesions of the Bladder II - proliferative/dysplastic changes," British Society of Toxicologic Pathology, Cambridge, England 12/11/03 "Lesions of the Bladder - Practical," British Society of Toxicologic Pathology, Cambridge, England 12/11/03 "Human urinary tract pathology and drug development," British Society of Toxicologic Pathology, Cambridge, England 01 14 04 "Carcinogenicity of methylated arsenicals," U.S. Environmental Protection Agency, Alexandria, Virginia 01/23/04 "Urinary bladder carcinogenicity of pioglitazone in rats," French Drug Agency (AFSSAPS), Paris, France 02/09/04 "Human risk of environmental chemicals: Man is not a rat or a mouse," National Cancer Center, Tokyo, Japan 02/12/04 "Urinary bladder carcinogenesis: Aromatic amines to arsenic," Nagoya City University, Nagoya, Japan 02/17/04 "Human relevance of carcinogenesis in rodents," Plenary Lecture, International Society of Toxicologic Pathology, Kobe, Japan 02/20/04 "Urinary bladder carcinogenesis," Takeda Chemical Company, Osaka, Japan Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 81 of 151 PAGEID #: 42234 EXHIBIT 1 Curriculum Vitae Page 51 Samuel M. Cohen, M.D. Ph.D. 07/22/04 "Alternatives to the 2-year bioassay in detecting potential risk of chemical carcinogens," Toxicology Forum, Aspen, Colorado. 07/27/04 "Flonicamid," Environmental Protection Agency, Washington, D.C. 07/28/04 "Arsenic," Environmental Protection Agency, Washington, D.C. 09/15/04 "Bladder carcinogenesis -- a 40-year sojourn," Pathology/Microbiology Grand Rounds, University of Nebraska Medical Center, Omaha, Nebraska 09/17/04 "Toxicological testing versus science," Central States Chapter, Society of Toxicology, Kansas City, Kansas 09/24/04 "Urinary bladder carcinogenesis: Rodents and humans," Roche Pharmaceutical Company, Basel, Switzerland 10/12/04 "Pioglitazone," CHMP Science Working Party, London, England 03/03/05 "Flonicamid: Evaluation of the relevance of mouse lung tumors to humans," Brazilian Ministry of Health, Brasilia, Brazil. 03/08/05 "Framework for Evaluating the Human Relevance of Carcinogenetic Modes of Action in Animals," Society of Toxicology, New Orleans, Louisiana 03/19/05 "Bladder Urothelial Tumors," National Comprehensive Cancer Network, Hollywood, Florida 04/21/05 "Human Relevance Framework," International Programme on Chemical Safety (WHO), Bradford, England 04/26/05 "Chemical Carcinogenesis," Mid-American Toxicology Course, Kansas City, Missouri 05/11/05 "Mechanisms of Bladder Carcinogenicity," American College of Toxicology, Lincolnshire, Illinois 05/20/05 "Bladder Carcinogenesis: From Rodents to Humans," C.L. Davis Seminar, Bridgewater, New Jersey 09/09/05 "Bladder Carcinogenesis: from Rodents to Humans," for Glaxo-Smith Kline (by video) 09/12/05 "Arsenic Carcinogenesis," U.S. EPA Science Advisory Board, Washington, D.C. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 82 of 151 PAGEID #: 42235 EXHIBIT 1 Curriculum Vitae Page 52 Samuel M. Cohen, M.D. Ph.D. 09/30/05 "PPAR Agonists and Bladder Cancer," International Life Sciences Institute/Health and Environmental Sciences Institute Committee on PPAR Agonists, Washington, D.C. 10/11/05 "Cancer: Recent Aspects in Human Risk Assessment," XIV Brazilian Congress of Toxicology, Recife, Brazil 10/12/05 "An Alternative to the 2-Year Rodent Bioassay," XIV Brazilian Congress of Toxicology, Recife, Brazil 10/28/05 "Bladder Carcinogenesis in Animals and Humans: It's All in the Details," Merck Seminar Series Co-Sponsored with the Toxicology Seminar Series, University of Illinois at Urbana-Champaign, Urbana, Illinois 11/15/05 "Framework for Evaluating the Human Relevance of Carcinogenic Modes of Action in Animals," International Life Sciences Institute/Health and Environmental Sciences Institute, Rodent Liver Tumor Session, Nice, France 11/15/05 "Liver Cytotoxicity as a Mode of Action," International Life Sciences Institute/Health and Environmental Sciences Institute, Rodent Liver Tumor Session, Nice, France 02/09/06 "Carcinogenesis: Human Relevance of Animal-derived Data," Roche, Palo Alto, California 03/07/06 "Carcinogenicity of Arsenicals in Human and Animal Models," Workshop on Arsenic Toxicology, Society of Toxicology, San Diego, California 04/25/06 "Chemical Carcinogenesis," Mid-America Toxicology Course, Kansas City, Missouri 05/31/06 "Arsenic-induced Bladder Cancer in an Animal Model," U.S. EPA Workshop on Arsenic Research and Risk Assessment, Shepherdstown, Pennsylvania 06/17/06 "Urinary Bladder Lesions," NTP Symposium, Vancouver, British Columbia 06/18/06 "The Human Relevance of Urothelial Tumors in Rodents," Society of Toxicologic Pathology, Vancouver, British Columbia 07/04/06 "Carcinogenic Modes of Action of PPAR Agonists: the HESI Initiative," Japanese Society of Toxicology, Nagoya, Japan 07/05/06 "PPAR Agonists and Carcinogenesis," Nagoya City University, Nagoya, Japan 07/06/06 "PPAR Agonists and Carcinogenesis," Eisai Pharmaceuticals, Gifu, Japan Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 83 of 151 PAGEID #: 42236 EXHIBIT 1 Curriculum Vitae Page 53 Samuel M. Cohen, M.D. Ph.D. 08/01/06 "PPAR Agonists and Carcinogenesis," Sanofi-Aventis, Great Valley, Pennsylvania 10/23/06 "Urothelial Carcinoma: Two Diseases," Cancer Molecular Diagnosis and Gene Therapy: 2006 International Symposium, Xi'an Jiaotang Medical University, Xi'an, China 10/27/06 "Urothelial Carcinoma: Two Diseases," Fourth Chinese Conference on Oncology, Tianjin, China 10/30/06 "Urinary Bladder Cancer Pathology," Beijing Association of Pathologists, Beijing, China 11/30/06 "Carcinogenicity of Arsenicals," U.S. EPA, Washington, D.C. 12/13/06 "Hyperplasia and Carcinogenesis," Proctor & Gamble Pharmaceuticals, Inc., Cincinnati, Ohio 02/15/07 "Mechanism-Based Cancer Risk Assessment," Society of Toxicology Current Concepts in Toxicology, Arlington, Virginia 04/24/07 "Chemical Carcinogenesis," Mid-America Toxicology Course, Kansas City, Missouri 05/14/07 "Of Mice and Men: Extrapolating from Animal Models to Humans for Cancer Risk Assessment". Alfred I. duPont, Hospital for Children, Wilmington Delaware 07/12/07 "Inorganic and Organic Arsenics and Bladder Carcinogenesis," Toxicology Forum, 33rd Annual Meeting, Aspen, Colorado 08/29/07 "Carcinogenicity Data in Mice", HESI PPAR Agonist Project Committee, Sarcomas Data Sharing Meeting, Washington, DC 9/16/07 "The Human Relevance of Urothelial Tumors in Rodents", International Academy of Toxicologic Pathology Satellite Symposium, Basel, Switzerland 9/18/07 "An Enhanced 13 Week Bioassay: An Alternative to the Two-Year Bioassay to Screen for Human Carcinogenesis," European Society of Toxicologic Pathology/ International Federation of Toxicologic Pathology Congress of Toxicologic Pathology 2007, Basel, Switzerland 10/05/07 "Chemical Carcinogenesis", International Workshop on Toxicology Towards Diplomate of American Board of Toxicology, Bangalore, India 11/08/07 "Mouse Liver Tumors: Benefits and Constraints on Use in Human Health Risk Assessment, Qualitative and Quantitative Aspects," Third Workshop of the Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 84 of 151 PAGEID #: 42237 EXHIBIT 1 Curriculum Vitae Page 54 Samuel M. Cohen, M.D. Ph.D. Standing Committee on Risk Analysis Issues and Reviews. National Academy of Sciences, Washington DC 11/22/07 "An Enhanced Thirteen Week Bioassay: An Alternative for Screening for Carcinogenesis Factors," DIMS 30th Anniversary Symposium, Nagoya, Japan 11/26/07 "The Human Relevance of Urothelial Tumors in Rodents," Japan Bioassay Research Center, Hadano, Japan 11/27/07 "Liver Carcinogenesis: Human Relevance of Animal Tumors," Sumitomo Chemical Co., Osaka, Japan 02/06/08 "A Framework of Human Relevance Analysis of Information of Carcinogenic Modes of Action in Animals," Japanese Society of Toxicologic Pathology, Nagoya, Japan 02/08/08 "PPAR Agonists and Bladder Carcinogenesis," Dainippon Sumitomo Pharma, Osaka, Japan 04/22/08 "Chemical Carcinogenesis", Mid-America Toxicology Course, Kansas City, Missouri 6/19/08 "Carcinogenicity of Arsenic," Institute of Medicines Committee on Review of the Health Effects in Vietnam Veterans of Exposure to Herbicides, San Antonio, Texas 7/23/08 "Thresholds in Genotoxicity and Carcinogenicity: Urniary Bladder Carcinogenesis", International Symposium on Genotoxic and Carcinogenic Thresholds, Tokyo, Japan 7/24/08 "Evaluation of the Human Relevance of Animal Studies for Cancer Risk Assessment", Food Safety Commission of Japan, Tokyo, Japan 7/25/08 "Rats and Mice are not Small Humans; Human Risk Assessment Based on Animal Studies", Food Safety Commission of Japan, Public Session, Tokyo, Japan 8/18/08 "Current Concepts in Carcinogenesis and Susceptibility: What do we know about Bladder Cancer", BCAN's Bladder Cancer Research Network Think Tank, Quebec, Canada 8/18/08 "What Can Animal Models Teach Us About Human Bladder Cancer", BCAN's Bladder Cancer Research Network Think Tank, Quebec, Canada 12/04/08 "Troglitazone Effects on Endothelial Cells In Vivo and In Vitro: Differences Between Mice and Humans", SOT Contemporary Concepts in Toxicology Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 85 of 151 PAGEID #: 42238 EXHIBIT 1 Curriculum Vitae Page 55 Samuel M. Cohen, M.D. Ph.D. Workshop, Hemangiosarcoma in Rodents: Mode of Action Evaluation and Human Relevance, Arlington, VA. 1/28/09 "Carcinogenicity of PPARy and Dual a/y Agonists: Mode of Action and Human Relevance." Planary Lecture, Japanese Society of Toxicologic Pathology. Hamamatsu, Japan. 1/30/09 "Carcinogenicity of PPAR Agonists: Are They Rodent Specific Carcinogens?" Nagoya City University Medical School. Nagoya, Japan. 3/15/09 "The Development and Significance of Mode of Action/Human Relevance Analysis. Characterizing Modes of Action and Their Relevance in Assessing Human Health Risks". Society of Toxicology Continuing Education Course, Baltimore, Maryland. 3/23/09 "How Predictive Are 3M, 6M, and Transgenic Studies for Carcinogenic Risk". British Toxicology Society, University of Warwick, Warwick, England. 3/23/09 "Relevance of Rodent Bladder Carcinogens to Man". British Toxicology Society, University or Warwick, Warwick, England. 4/02/09 "Bladder Practical". Modular Education Programme in Toxicological Pathology., Module 14: Urinary System, Cambridge University, Cambridge England. 4/02/09 "Lesions of the Bladder Proliferative/Dysplastic Changes". Modular Education Programme in Toxicological Pathology., Module 14: Urinary System, Cambridge University, Cambridge England. 4/02/09 "Lesions of the Bladder. Structure/Spontaneous/Induced Changes". Modular Education Programme in Toxicological Pathology., Module 14: Urinary System, Cambridge University, Cambridge England. 4/02/09 "Human Urinary Tract Pathology and Drug Development". Modular Education Programme in Toxicological Pathology., Module 14: Urinary System, Cambridge University, Cambridge England. 4/21/09 "Chemical Carcinogenesis". Mid-America Toxicology Course, Kansas City, Missouri. 4/28/09 "Urothelial Carcinogenesis in Experimental Models and Humans". State University of San Paulo, Botucatu, Brazil. 4/30/09 "Human Relevance of Experimentally Induced Rodent Tumors". State University of San Paulo, Botucatu, Brazil. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 86 of 151 PAGEID #: 42239 EXHIBIT 1 Curriculum Vitae Page 56 Samuel M. Cohen, M.D. Ph.D. 1/26/10 "Mode of Action Human Relevance Framework". International Life Sciences Institute Annual Meeting, Rio Grande, Puerto Rico. 1/28/10 "Relevance of Arsenic Mode of Action for Human Carcinogenicity". Arsenic Workshop and EPRI Scientific Review Panel, Hamner Institute for Health Sciences, Research Triangle Park, North Carolina. 2/26/10 "Inorganic Arsenic". US EPA, Washington, DC. 4/06/10 "Inorganic Arsenic Carcinogenesis, Mode of Action". US EPA Sciences Advisory Board Special Panel, Washington, DC. 4/27/10 "Chemical Carcinogenesis". Mid-America Toxicology Course, Kansas City, Missouri. 8/18/10 "Liver Tumorigenesis Modes of Action". Liver Tumorigenesis & PPAR Workshop, Research Triangle Park, North Carolina. 10/12/10 "Evaluation of the Relevance to Humans of Animal Models of Environmental Toxicants". Environmental Pathology Symposium, 28th International Congress of the International Academy of Pathology, Sao Paulo, Brazil. 10/18/10 "Carcinogenicity Testing - Where to Go?" First Meeting of the Latin American Association of Toxicologic Pathology, Botucatu, Brazil. 10/19/10 "Bladder Carcinogenesis". Program in Toxicology, Sao Paulo State University Medical School, Botucatu, Brazil. 4/6/11 "Mode of Action and Toxicological Studies". ILSI - Brazil, Pre-Congress, Sao Pedro, Brazil. 4/7/11 "Risk Assessment for the 21st Century (Risk 21)". 21st Annual Congress of ILSI Brazil, Sao Pedro, Brazil. 5/3/11 "Chemical Carcinogenesis". Mid-America Toxicology Course, Kansas City, Missouri. 5/4/11 "Arsenic, A Natural Carcinogen: What Is Safe?". Grand Rounds, Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha, Nebraska. 5/18/11 "Mode of Action and Human Relevance: Risk Assessment for the 21st Century." HESI Asia Webinar Series. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 87 of 151 PAGEID #: 42240 EXHIBIT 1 Curriculum Vitae Page 57 Samuel M. Cohen, M.D. Ph.D. 6/13/11 "Mode of Action and Weight-of-Evidence Approach Into Toxicological Evaluation". ILSI-Brasil Workshop, Scientific Basis to Pesticides Toxicological Evaluation, Risk Assessment and Risk Management, Brasilia, Brazil. 7/14/11 "Liver Cancer Etiology". 66th Meeting of Japanese Society of Gastroenterological Surgery, Nagoya, Japan. 7/19/11 "Mode of Action and Human Relevance: Risk Assessment for the 21st Century". Ministry of Environment, Tokyo, Japan. 7/19/11 "Mode of Action and Human Relevance: Risk Assessment for the 21st Century". Food Science Commission, Tokyo, Japan. 10/24/11 "Mode of Action and Human Relevance". Pathology Graduate Program, State University of Sao Paul, Botucatu, Brazil. 10/26/11 "Research and Graduate Education in the United States". Pathology Graduate Program, State University of Sao Paulo, Botucatu, Brazil. 11/22/11 "Mode of Action and Human Relevance Framework: Some Recent Examples of Pharmaceuticals, Pesticides and Food Additives". National Institute of Health Sciences, Tokyo, Japan. 11/23/11 "Urinary Bladder Carcinogenesis by DNA Reactive and Non-Reactive Chemicals: Non-linearities and Thresholds." Symposium on Genotoxic and Carcinogenic Threshold, Tokyo, Japan. 12/1/11 "Evaluation of the Carcinogenecity of Monomethylarsonic Acid". US EPA, Washington, DC. 3/13/12 "Inorganic Arsenic". US EPA, San Francisco, CA. 4/23/12 "New Angle to Screen Carcinogenesis Factors". Workshop on Selected Topics in Carcinogenicity, US FDA, Silver Spring, MD. 4/24/12 "Chemical Carcinogenesis". Mid-America Toxicology Course, Kansas City, MO. 4/27/12 "Evaluation of the Potential Carcinogenicity Due to Exposure to Inorganic Arsenic". US EPA, Washington, DC. 6/27/12 "The Two-Year Bioassay as a Carcinogenesis Screen: A Useless and Often Misleading Waste of Resources". Drug Information Association Annual Meeting, Philadelphia, PA. 7/11/12 "Comparing Rat CPN to Human Kidney Disease". Toxicology Forum, Aspen, CO. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 88 of 151 PAGEID #: 42241 EXHIBIT 1 Curriculum Vitae Page 58 Samuel M. Cohen, M.D. Ph.D. 8/17/12 "Relevance of Rodent Renal Tumors for Human Health Risk Assessment". Charles Louis Davis Foundation Seminar on Renal Carcinogenesis, Raritan, NJ. 9/11/12 "Risk 21". 8th Congress of Toxicology in Developing Countries, Bangkok, Thailand. 9/16/12 "Lower Urinary Tract: Normal Structure, Toxicity, and Carcinogenesis". Sixth RTP Rodent Pathology Course, Urinary Pathology, NC. 10/22/12 "Mode of Action and Human Relevance Framework". Pathology Graduate Program, State University of Sao Paulo, Botucatu, Brazil. 10/26/12 "Arsenic Carcinogenesis: How to Critically Read the Scientific Literature". Pathology Graduate Program, State University of Sao Paulo, Botucatu, Brazil. 11/23/12 1/8/13 "Mode of Action as the Scientific Basis for Human Risk Assessment for Bladder Carcinogens: Pioglitazone as a Case Study". Swiss Society of Toxicology, Basel, Switzerland. "Mode of Action of Arsenic Carcinogenesis". US EPA Workshop on Arsenic Risk Assessment, Research Triangle Park, NC. 1/22/13 "Arsenic in Food". ILSI North America Food and Chemical Safety Committee, Miami, FL. 1/23/13 "Key Events Dose Response Framework (KEDRF)". Weight of Evidence Workshop, ILSI North America, Miami, FL. 4/3/13 "Inorganic Arsenic Toxicity and Carcinogenicity." US FDA, College Park, MD. 4/4/13 "Mode of Action and Mechanism Identification and Implications for Low Dose Assessments." Workshop on Inorganic Arsenic: Scientific Considerations for Hazard Identification and Dose-Response Analysis; National Academy of Sciences, Washington, DC. 4/25/13 "Chemical Carcinogenesis". Mid-America Toxicology Course, Kansas City, MO. 5/8/13 "Mode of Action of Arsenical Carcinogenesis". US EPA Webinar. 6/27/13 "Safety Assessment of Sugar Alternatives: Case of Saccharin Safety Assessment and Perspectives for Industrial Uses." International Symposium on Understanding Carbohydrates: Controversies, Regulation and Future Direction. ILSI KoreaKorean Nutrition Society, Seoul Korea. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 89 of 151 PAGEID #: 42242 EXHIBIT 1 Curriculum Vitae Page 59 Samuel M. Cohen, M.D. Ph.D. 6/30/13 "Trends in Chemical Carcinogenesis." Continuing Education Course in Genotoxicology and Carcinogenesis, XIII International Congress of Toxicology, Seoul, Korea. 7/4/13 "Lesions of the Bladder - Structure/Spontaneous/Induced Changes - Lecture I". Modular Education Programme in Toxicological Pathology, Module 12, Urinary System. British Society of Toxicologic pathology, Cambridge University, England. 7/4/13 "Lesions of the Bladder - Structure/Spontaneous/Induced Changes - Lecture II". Modular Education Programme in Toxicological Pathology, Module 12, Urinary System. British Society of Toxicologic pathology, Cambridge University, England. 7/4/13 "Lesions of the Bladder - Practical". Modular Education Programme in Toxicological Pathology, Module 12, Urinary System. British Society of Toxicologic pathology, Cambridge University, England. 7/4/13 "Human Urinary Tract Pathology and Drug Development". Modular Education Programme in Toxicological Pathology, Module 12, Urinary System. British Society of Toxicologic pathology, Cambridge University, England. 8/14/13 "Mode of Action for Arsenic Toxicity and Carcinogenesis". 10th International Symposium on Persistent Toxic Substances. Edmonton, Alberta, Canada. 11/3/13 "Using Mode of Action in Determining Relevance in Human Carcinogenesis Risk Assessment." Continuing Education Course, American College of Toxicology. 34th Annual Meeting, San Antonio, Texas. 11/7/13 "Urinary Bladder Carcinogenesis in Animals and Humans". Pathology Graduate Program, State University of Sao Paulo, Botucatu, Brazil. 11/9/13 "Medicine and Science: Where Have We Been, Where Are We Going". 50th Anniversary Celebration of Faculdade de Medicina de Botucatu, Botucatu, Brazil. 12/4/13 "Chemical Carcinogenesis, Toxicology and Risk Assessment." Symposium on Mechanistic Paradigms for Toxicological Regulation, Society of Toxicology of Canada, Ottawa, Canada. 12/9/13 "A Common Mode of Action for Arsenical Toxicity." Symposium on Understanding Human Health Risks from Dietary Arsenic Exposure, Society for Risk Analysis, Baltimore, Maryland. 1/21/14 "Arsenic in Food: Sources and Issues in Assessment of Its Risk." Symposium, Food Safety Case Study: Arsenic, ILSI North America, Bermuda. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 90 of 151 PAGEID #: 42243 EXHIBIT 1 Curriculum Vitae Page 60 Samuel M. Cohen, M.D. Ph.D. 3/26/14 "A mutagen is a carcinogen b3ecause it is a mutagen." Debate, Regulatory and Safety Evaluation Specialty Section, Society of Toxicology, Phoenix, Arizona. 4/9/14 "The FEMA GRAS Program and the FEMA Expert Panel." IOFI Meeting with Japanese Scientists, Tokyo, Japan. 525/14 "FEMA GRAS: The Safety Evaluation of Flavoring Ingredients in the United States." International Symposium on Safety, Regulation of Food Flavorings and Their Best Practices. Food and Drug Administration of Taiwan Workshop on Flavoring Safety Evaluation, Taipei, Taiwan. 5/30/14 "Arsenic in Rice: Toxicological Issues and Implications for Human Health Risk Assessment." ILSI Southeast Asia and Agri-Food & Veterinary Authority of Singapore Symposium on Arsenic in Rice - Risk Assessment and Standards, Singapore. 6/4/14 "The FEMA GRAS Program and FEMA Expert Panel." ConAgra Food Safety Committee, Omaha, Nebraska. 6/25/14 "Rodent vs. Human Lung Cancer: The Good, the Bad, and the Ugly." Symposium on Environmental Toxicologic Pathology and Prediction of Human Health Risks, 33rdAnnual Meeting of Society of Toxicologic Pathology, Washington, DC. 10/16/14 "Two-year Rodent Cancer Bioassay: Human Relevance?" Annual Meeting of the Southern California Chapter of the Society of Toxicology, La Jolla, California. 10/28/14 "Chemical Carcinogenesis." Food and Drug Administration, College Park, Maryland. 11/12/14 "In Vitro to In Vivo Extrapolation." Pathology Graduate Program, State University of Sao Paulo, Botucatu, Brazil. 11/13/14 "Arsenic Carcinogenesis." Pathology Graduate Program, State University of Sao Paulo, Botucatu, Brazil. Community service: Numerous (Venerini Academy, Marian High School, Creighton Preparatory School, University Hospital Auxiliary, Mary Our Queen Parish, Sacred Heart Ministry) Publications: a. Articles published in scholarly journals 1. Erturk, E., Price, J.M., Morris, J.E., Cohen, S., Leith, R.S., Von Esch, A.M. and Crovetti, A.J. The production of carcinoma of the urinary bladder in rats by feeding N[4-(5-nitro-2-furyl)-2-thiazolyl]foramide. Cancer Res., 27: 1998-2002, 1967. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 91 of 151 PAGEID #: 42244 EXHIBIT 1 Curriculum Vitae Page 61 Samuel M. Cohen, M.D. Ph.D. 2. Erturk, E., Cohen, S.M., Price, J.M., Von Esch, A.M., Crovetti, A.J. and Bryan, G.T. The production of hemangioendothelialsarcoma in rats by feeding 5-acetamido-3-(5nitro-2-furyl)-6H-1,2,4-oxadiazine. Cancer Res., 29: 2212-2218, 1969. 3. Erturk, E., Cohen, S.M., Price, J.M. and Bryan, G.T. Pathogenesis, histology, and transplantability of urinary bladder carcinomas induced in albino rats by oral administration of N-[4-(5-nitro-2-furyl)-2-thiazolyl] formamide. Cancer Res., 29: 2219-2228, 1969. 4. Cohen, S.M., Erturk, E., Price, J.M. and Bryan, G.T. Comparative carcinogenicity in the rat of 2-hydrazinothiazoles with nitrofuryl, nitrophenyl, or aminophenyl substituents in the 4-position. Cancer Res., 30: 897-901, 1970. 5. Cohen, S.M., Erturk, E. and Bryan, G.T. Carcinogenicity of formic acid 2-[4-(5-nitro2-furyl)-2-thiazolyl] hydrazide in Swiss mice. Cancer Res., 30: 906-912, 1970. 6. Erturk, E., Cohen, S.M. and Bryan, G.T. Carcinogenicity of N-[4-(5nitro-2-furyl)-2thiazolyl] acetamide in female rats. Cancer Res., 30: 936-941, 1970. 7. Erturk, E., Cohen, S.M. and Bryan, G.T. Urinary bladder carcinogenicity of N-[4(50nitro-2-furyl)-2-thiazolyl] formamide in female Swiss mice. Cancer Res., 30: 1309 1311, 1970. 8. Erturk, E., Morris, J.E., Cohen, S.M., Price, J.M. and Bryan, G.T. Transplantable rat mammary tumors induced by 5-nitro-2-furaldehyde semicarbazone and by formic acid 2[4-(50nitro-2-furyl)-2-thiazolyl]-hydrazide. Cancer Res., 30: 1409-1412, 1970. 9. Erturk, E., Cohen, S.M. and Bryan, G.T. Induction, histogenesis, and isotransplantability of renal tumors induced by formic acid 2[4-(5-nitro-2-furyl)-2thiazolyl] hydrazide in rats. Cancer Res., 30: 2098-2106, 1970. 10. Cohen, S.M., Erturk, E. and Bryan, G.T. Production of leukemia and stomach neoplasms in Swiss, RF, BALB/c, and C3H female mice by feeding N-[4-(5-nitro-2furyl)-2-thiazolyl] acetamide. Cancer Res., 30: 2320-2325, 1970. 11. Erturk, E., Atassi, S.A., Yoshida, O., Cohen, S.M., Price, J.M. and Bryan, G.T. Comparative urinary and gallbladder carcinogenicity of N-[4(5-nitro-2-furyl)-2thiazolyl] formamide and N-[4-(5-nitro-2-furyl)-2-thiazolyl]-acetamide in the dog. J. Natl. Cancer Inst., 45: 535-542, 1970. 12. Erturk, E., Morris, J.E., Cohen, S.M., Von Esch, A.M., Crovetti, A.J., Price, J.M. and Bryan, G.T. Comparative carcinogenicity of formic acid 2-[4-(5-nitro-2-furyl)-2thiazolyl] hydrazide and related chemicals in the rat. J. Natl. Cancer Inst., 47: 437-445, 1971. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 92 of 151 PAGEID #: 42245 EXHIBIT 1 Curriculum Vitae Page 62 Samuel M. Cohen, M.D. Ph.D. 13. Cohen, S.M., Headley, D.B. and Bryan, G.T. The effect of adult thymectomy and adult splenectomy on the production of leukemia and stomach neoplasms in mice by N-[4-(5nitro-2-furyl)-2-thiazolyl] acetamide. Cancer Res., 33: 637-640, 1973. 14. Cohen, S.M., Lower, G.M., Jr., Erturk, E. and Bryan, G.T. Comparative carcinogenicity in Swiss mice of N-[4-(5-nitro-2-furyl)-2-thiazolyl] acetamide and structurally related 5-nitrofurans and 4-nitrobenzenes. Cancer Res., 33: 1593-1597, 1973. 15. Cohen, S.M., Erturk, E., Von Esch, A.M., Crovetti, A.J. and Bryan, G.T. Carcinogenicity of 5-nitrofurans, 5-nitroimidazoles, 4-nitrobenzenes and related compounds. J. Natl. Cancer Inst., 51: 403-417, 1973. 16. Cohen, S.M., Alter, A. and Bryan, G.T. Distribution of radioactivity and metabolism of formic acid 2-[4-(5-nitro-2-furyl)-2-14C-2-thiazolyl]-hydrazide following oral administration to rats and mice. Cancer Res., 33: 2802-2809, 1973. 17. Cohen, S.M. and Bryan, G.T. Carcinogenesis caused by nitrofuran derivatives. In: Pharmacology and the Future of Man, Proc. Fifth Intl. Congr. Pharmacology, San Francisco, 1972, Vol. 2, pp. 164-170, 1973. 18. Cohen, S.M., Erturk, E., Von Esch, A.M., Crovetti, A.J. and Bryan, G.T. Carcinogenicity of 5-nitrofurans and related compounds with aminoheterocyclic substituents. J. Natl. Cancer Inst., 54: 841-850, 1975. 19. Beal, D.D., Skibba, J.L., Croft, W.A., Cohen, S.M. and Bryan, G.T. Carcinogenicity of the antineoplastic agent, 5-(3,3-dimethyl-1-triazeno) imidazole-4-carboxamide, and its metabolites in rats. J. Natl. Cancer Inst., 54: 951-957, 1975. 20. Soloway, M.S., Cohen, S.M., deKernion, J.B. and Persky, L. Failure of ascorbic acid to inhibit FANFT-induced bladder cancer. J. Urol., 113: 483-486, 1975. 21. Cohen, S.M., Wittenberg, J.F. and Bryan, G.T. Effect of avitaminosis A and hypervitaminosis A on urinary bladder carcinogenicity of N-[4-(5-nitro-2-furyl)-2thiazolyl]foramide. Cancer Res., 36: 2334-2339, 1976. 22. Jacobs, J.B., Cohen, S.M., Arai, M., Friedell, G.H., Bulay, O. and Urman, H.K. Chemically induced smooth muscle tumors of the mouse urinary bladder. Cancer Res., 36: 2396-2398, 1976. 23. Cohen, S.M., Jacobs, J.B., Arai, M., Johansson, S. and Friedell, G.H. Early lesions in experimental bladder cancer: Experimental design and light microscopic findings. Cancer Res., 36: 2508-2511, 1976. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 93 of 151 PAGEID #: 42246 EXHIBIT 1 Curriculum Vitae Page 63 Samuel M. Cohen, M.D. Ph.D. 24. Jacobs, J.B., Arai, M., Cohen, S.M. and Friedell, G.H. Early lesions in experimental bladder cancer: Scanning electron microscopy of cell surface markers. Cancer Res., 36: 2512-2517, 1976. 25. Jacobs, J.B., Arai, M., Cohen, S.M. and Friedell, G.H. Light and scanning electron microscopy of exfoliated bladder epithelial cells in rats fed N-[4-(5-nitro-2-furyl)-2thiazolyl]foramide. J. Natl. Cancer Inst., 57: 63-66, 1976. 26. Cohen, S.M., Erturk, E. and Bryan, G.T. Comparative carcinogenicity of 5nitrothiophenes and 5-nitrofurans in rats. J. Natl. Cancer Inst., 57: 277-282, 1976. 27. Jacobs, J.B., Cohen, S.M., Arai, M. and Friedell, G.H. SEM on bladder cells. Acta Cytol., 21: 3-4, 1977. 28. Tatematsu, M., Cohen, S.M., Fukushima, S., Shinohara, Y. and Ito, N. Vascular changes during rat urinary bladder carcinogenesis induced by N-butyl-N-(4hydroxybutyl) nitrosamine. Gann, 68: 127-128, 1977. 29. Headley, D.B., Cohen, S.M. and Bryan, G.T. Suppression of antibody-mediated and cell-mediated murine immunity by the carcinogen N-[4-(5-nitro-2-furyl)-2-thiazolyl] acetamide. Cancer Res., 37: 974-979, 1977. 30. Cohen, S.M., Ichikawa, M. and Bryan, G.T. Carcinogenicity of 2-(2-0furyl)-3-(5-nitro2-furyl) acrylamide (AF-2) fed to female Sprague-Dawley rats. Gann, 68: 473-476, 1977. 31. Shirai, T., Cohen, S.M., Fukushima, S. and Ito, N. Production of reversible papillary proliferation of the urinary bladder in rats. Gann, 68: 521-522, 1977. 32. Jacobs, J.B., Arai, M., Cohen, S.M. and Friedell, G.H. A long-term study of reversible and progressive urinary bladder cancer lesions in rats fed N-[4-(5-nitro-furyl)-2thiazolyl] formamide. Cancer Res., 37: 2817-2821, 1977. 33. Friedell, G.H., Jacobs, J.B., Nagy, G.K. and Cohen, S.M. The pathogenesis of bladder cancer. Am. J. Pathol., 89: 431-442, 1977. 34. Johansson, S., Cohen, S.M., Yang, J.P.S., Arai, M. and Friedell, G.H. The influence of N-[4-(5-nitro-2-furyl)-2-thiazolyl] formamide and phenacetin on the immune status in male Fischer rats. Invest. Urol., 15: 308-311, 1978. 35. Cohen, S.M. and Bryan, G.T. Effect of p-hydroxyacetanilide, sodium sulfate, and Lmethionine on the leukemogenicity of N-[4-(5-nitro-2-furyl)-2-thiazolyl] acetamide. CancerRes., 38: 1398-1405, 1978. 36. Shirai, T., Cohen, S.M., Fukushima, S., Hananouchi, M. and Ito, N. Reversible papillary hyperplasia of the rat urinary bladder. Am. J. Pathol., 91: 33-48, 1978. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 94 of 151 PAGEID #: 42247 EXHIBIT 1 Curriculum Vitae Page 64 Samuel M. Cohen, M.D. Ph.D. 37. Tatematsu, M., Cohen, S.M., Fukushima, S., Shirai, T., Shinohara, Y. and Ito, N. Neovascularization in benign and malignant urinary bladder epithelial proliferative lesions of the rat observed in situ by scanning electron microscopy and autoradiography. Cancer Res., 38:1792-1800, 1978. 38. Pauli, B.U., Cohen, S.M., Alroy, J. and Weinstein, R.S. Desmosome ultrastructure and the biological behavior of chemical carcinogen-induced urinary bladder carcinomas. Cancer Res., 38: 3276-3285, 1978. 39. Cohen, S.M., Fukushima, S., Tsuda, H., Murasakki, G. and Ito, N. Effect of azathiopurine and OK-432 on urinary bladder carcinogenesis in rats. Gann, 69: 773 779, 1978. 40. Cohen, S.M., Jacobs, J.B., Arai, M. and Friedell, G.H. Co-carcinogenicity testing of saccharin and DL-tryptophan following oral initiation with N-[4-(5-nitro-2-furyl)-2thiazolyl] formamide. Health and Sugar Substitutes, Proc. European Res. Grp. Oral Biol. (ERGOB) Conf., S. Karger, Basel, pp. 70-75, 1978. 41. Friedell, G.H., Greenfield, R.E. and Cohen, S.M. Nutritional factors that may be involved in cancer of the bladder. Nutr. Cancer, 1: 80-89, 1979. 42. Cohen, S.M., Arai, M., Jacobs, J.B. and Friedell, G.H. Promoting effect of saccharin and DL-tryptophan in urinary bladder carcinogenesis. Cancer Res., 39: 1207-1217, 1979. 43. Arai, M., Cohen, S.M., Jacobs, J.B. and Friedell, G.H. Effect of dose on urinary bladder carcinogenesis induced in F344 rats by N-[4-(5-nitro-2-furyl)-2-thiazolyl] formamide. J. Natl. Cancer Inst., 62: 1013-1016, 1979. 44. Friedell, G.H. and Cohen, S.M. Experimental models of cancer of the urinary bladder. Adv. Med. Oncol. Res. Educ., 11: 233-240, 1979. 45. Cohen, S.M. and Friedell, G.H. Carcinoma of the urinary bladder, induced in Fischer rats by N-[4-(5-nitro-2-furyl)-2-thiazolyl] formamide. Am. J. Pathol., 95: 849-852, 1979. 46. Cohen, S.M. Urinary bladder carcinogenesis: Initiation-promotion. Sem. Oncology, 6: 157-160, 1979. 47. Fukushima, S. and Cohen, S.M. Saccharin-induced hyperplasia of the rat urinary bladder. Cancer Res., 40: 734-736, 1980. 48. Cohen, S.M., Tatematsu, M., Shinohara, Y., Nakanishi, K. and Ito, N. Neo vascularization in rats during urinary bladder carcinogenesis induced by N-[4-(5-nitro2-furyl)-2-thiazolyl] formamide. J. Natl. Cancer. Inst., 65: 145-148, 1980. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 95 of 151 PAGEID #: 42248 EXHIBIT 1 Curriculum Vitae Page 65 Samuel M. Cohen, M.D. Ph.D. 49. Plotkin, G.M., Gilbert, S.L., Wides, R.J., Wolf, G., Cohen, S.M. and Fukushima, S. Galactosyl transferase activity in rat bladder transitional cell carcinoma lines and in exfoliated cells in urine during carcinogenesis and reversible hyperplasia. Cancer Biochem. Biophys., 4: 251-256, 1980. 50. Demers, D.M., Fukushima, S. and Cohen, S.M. Effect of sodium saccharin and Ltryptophan on rat urine during bladder carcinogenesis. Cancer Res., 41: 108-112, 1981. 51. Fukushima, S., Arai, M., Cohen, S.M., Jacobs, J.B. and Friedell, G.H. Scanning electron microscopy of cyclophosphamide-induced hyperplasia of the rat urinary bladder. Lab. Invest., 44: 89-96, 1981. 52. Murasaki, G. and Cohen, S.M. Effect of dose of sodium saccharin on the induction of rat urinary bladder proliferation. Cancer Res., 41: 942-944, 1981. 53. Fukushima, S., Cohen, S.M., Arai, M., Jacobs, J.B. and Friedell, G.H. Scanning electron microscopic examination of reversible hyperplasia of the rat urinary bladder. Am. J. Pathol., 102: 373-380, 1981. 54. Fukushima, S., Friedell, G.H., Jacobs, J.B. and Cohen, S.M. Effect of L-tryptophan and sodium saccharin on urinary tract carcinogenesis initiated by N-[4-(5-nitro-2furyl)-2-thiazolyl] formamide. Cancer Res., 41: 3100-3103, 1981. 55. Cohen, S.M., Zenser, T.V., Murasaki, G., Fukushima, S., Mattammal, M.B., Rapp, N.S. and Davis, B.B. Aspirin inhibition of N-[4-(5-nitro-2-furyl)-2-thiazolyl] foramideinduced lesions of the urinary bladder correlated with inhibition of metabolism by bladder prostaglandin endoperoxide synthetase. Cancer Res., 41: 3355-3359, 1981. 56. Jacobs, J.B., Cohen, S.M., Farrow, G.M. and Friedell, G.H. Scanning electron microscopic features of human urinary bladder cancer. Cancer, 48: 1399-1409, 1981. 57. Cohen, S.M., Brown, L., Janower, M.L. and McCready, F.J. Multiple metaplastic (hyperplastic) polyposis of the colon. Gastrointest. Radiol., 6: 333-335, 1981. 58. Cohen, S.M., Yang, J.P.S., Jacobs, J.B., Arai, M., Fukushima, S. and Friedell, G.H. Transplantation and cell culture of rat urinary bladder carcinoma. Invest. Urol., 19: 136-141, 1981. 59. Cohen, S.M. Urinary bladder carcinogenesis with N-substituted aryl compounds: Initiation and promotion. Natl. Cancer Inst. Monogr., 58: 63-67, 1981. 60. Cohen, S.M., Murasaki, G., Fukushima, S. and Greenfield, R.E. Effect of regenerative hyperplasia on the urinary bladder: carcinogenicity of sodium saccharin and N-4-(5nitro-2-furyl)-2-thiazolyl]formamide. Cancer Res., 42: 65-71, 1982. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 96 of 151 PAGEID #: 42249 EXHIBIT 1 Curriculum Vitae Page 66 Samuel M. Cohen, M.D. Ph.D. 61. Grazer, R., Cohen, S.M., Jacobs, J.B. and Lucas, P. Melanin-containing peripheral carcinoid of the lung. Am. J. Surg. Pathol., 6: 73-78, 1982. 62. Murasaki, G., Greenfield, R.E. and Cohen, S.M. Alterations in the rat kidney associated with sodium saccharin feeding. Toxicol. Lett., 12: 251-258, 1982. 63. Ansell, J., Bhawan, J., Cohen, S.M., Sullivan, J. and Sherman, D. Histiocytic lymphoma and malignant angioendotheliomatosis: One disease or two? Cancer, 50: 1506-1512, 1982. 64. Cohen, S.M. Promotion in urinary bladder carcinogenesis. Saishin-Igaku, 37: 1776 1780, 1982. 65. Murasaki, G. and Cohen, S.M. Effect of sodium saccharin on urinary bladder epithelial regenerative hyperplasia following freeze ulceration. Cancer Res., 43: 182-187, 1983. 66. Murasaki, G. and Cohen, S.M. Co-carcinogenicity of sodium saccharin and N-[4-(5nitro-2-furyl)-2-thiazolyl] formamide for the urinary bladder. Carcinogenesis, 4: 97-99, 1983. 67. Zenser, T.V., Cohen, S.M., Mattammal, M.B., Wise, R. and Davis, B.B. Prostaglandin hydroperoxidase-catalyzed activation of certain N-substituted aryl renal and bladder carcinogens. Environ. Hlth. Perspect., 49: 33-41, 1983. 68. Cohen, S.M., Greenfield, R.E. and Ellwein, L.B. Multi-stage carcinogenesis in the urinary bladder. Environ. Hlth. Perspect., 49: 209-215, 1983. 69. Arai, M., St. John, M., Fukushima, S., Friedell, G.H. and Cohen, S.M. Long term dose response study of N-[4-(5-nitro-2-furyl)-2-thiazolyl]formamide-induced urinary bladder carcinogenesis. Cancer Lett., 18:261-269, 1983. 70. Alroy, J., Goyal, V., Ucci, A.A., Klauber, G.T., Heaney, J.A. and Cohen, S.M. Cell surface coat of human and rat bladder urothelium. I. Ruthenium-red studies in non neoplastic and neoplastic cells. Virch. Arch., 42: 251-262, 1983. 71. Pauli, B.U., Cohen, S.M. and Weinstein, R.S. Cellular changes in rat urinary bladder carcinomas induced by N-[4-(5-nitro-2-furyl)-2-thiazolyl]-formamide: A quantitative electron microscopic analysis. J. Urol., 129: 646-652, 1983. 72. Cohen, S.M., Erturk, E., Skibba, J.L. and Bryan, G.T. Azathioprine induction of lymphomas and squamous cell carcinomas in rats. Cancer Res., 43: 2768-2772, 1983. 73. Cohen, S.M. Promotion in urinary bladder carcinogenesis. Environ. Hlth. Perspect., 50: 51-59, 1983. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 97 of 151 PAGEID #: 42250 EXHIBIT 1 Curriculum Vitae Page 67 Samuel M. Cohen, M.D. Ph.D. 74. Mirvish, S.S., Salmasi, S., Cohen, S.M., Patil, K. and Mahboubi, E. Liver and forestomach tumors and other forestomach lesions in rats treated with morpholine and sodium nitrite, with and without sodium ascorbate. J. Natl. Cancer Inst., 71: 81-85, 1983. 75. Suzuki, T., St. John, M., Cohen, S.M. and Friedell, G.H. Benign squamous cells with pleomorphic microvilli in urine or bladder washings. Acta Cytol., 27: 497-499, 1983. 76. Chlapowski, F.J., Minsky, B.D., Jacobs, J.B. and Cohen, S.M. Effect of a collagen substrate on the growth and development of normal and tumorigenic rat urothelial cells. J. Urol., 130: 1211-1216, 1983. 77. Miller, T.D. and Cohen, S.M. Alterations in the rat kidney associated with sodium saccharin feeding: A scanning electron microscopic study. Toxicol. Lett., 20: 177-181, 1983. 78. Murasaki, G., Zenser, T.V., Davis, B.B. and Cohen, S.M. Inhibition by aspirin of N-[4(5-nitro-2-furyl)-2-thiazolyl]formamide-induced bladder carcinogenesis and enhancement of forestomach carcinogenesis. Carcinogenesis, 5: 53-55, 1984. 79. Suzuki, T., Hasegawa, R., Murasaki, G. and Cohen, S.M. Distinction by concanavalin A agglutination between ulceration and repair of rat bladder epithelium induced by freezing or cyclophosphamide and the effect of sodium saccharin. Cancer Res., 44: 74 77, 1984. 80. Hasegawa, R., St. John, M., Murasaki, G., Fukushima, S. and Cohen, S.M. Effect of aspirin on N-[4-(5-nitro-2-furyl)-2-thiazolyl]formamide-induced epithelial proliferation in the urinary bladder and forestomach of the rat. Cancer Lett., 21: 269-275, 1984. 81. Koerber, R. K., Haven, G.T., Cohen, S.M. and Hofschire, P. Peripheral gangrene associated with dopamine infusion in a child. Clin. Pediat., 23: 106-107, 1984. 82. Greenfield, R.E., Ellwein, L.B. and Cohen, S.M. A general probabilistic model of carcinogenesis: Analysis of experimental urinary bladder cancer. Carcinogenesis, 5: 437-445, 1984. 83. Hasegawa, R., St. John, M.K., Cano, M., Issenberg, P., Klein, D.A., Walker, B.A., Jones, J.W., Schnell, R.C., Merrick, B.A., Davies, M.H., McMillan, D.T. and Cohen, S.M. Bladder freeze ulceration and sodium saccharin feeding in the rat: Examination for urinary nitrosamines, mutagens and bacteria, and effects on hepatic microsomal enzymes. Fd. Chem. Toxicol., 22: 935-942, 1984. 84. Koerber, R.K., Torkelson, R., Haven, G., Donaldson, J., Cohen, S.M. and Case, M. Increased cerebral spinal fluid 5-hydroxytryptamine and 5-hydroxyindoleacetic acid in a patient with Kleine-Levin syndrome. Neurology, 34: 1597-1600, 1984. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 98 of 151 PAGEID #: 42251 EXHIBIT 1 Curriculum Vitae Page 68 Samuel M. Cohen, M.D. Ph.D. 85. Hasegawa, R., Greenfield, R.E., Murasaki, G., Suzuki, T. and Cohen, S.M. Initiation of urinary bladder carcinogenesis in rats by freeze ulceration with sodium saccharin promotion. Cancer Res., 45: 1469-1473, 1985. 86. Hasegawa, R. and Cohen, S.M. Immunohistochemical study of keratin in proliferative bladder epithelium induced by freezing, cyclophosphamide or N-[4-(5-nitro-2-furyl)-2thiazolyl]formamide in the rat. Carcinogenesis, 6: 409-414, 1985. 87. Purtilo, D.T. and Cohen, S.M. Diet, nutrition, and cancer. Postgraduate Medicine, 78: 193-203, 1985. 88. Cohen, S.M. Multi-stage carcinogenesis in the urinary bladder. Fd. Chem. Toxicol., 23: 521-528, 1985. 89. Spry, L.A., Zenser, T.V., Cohen, S.M. and Davis, B.B. Role of renal metabolism and excretion in 5-nitrofuran induced uroepithelial cancer in the rat. J. Clin. Invest., 76: 1025-1031, 1985. 90. Macke, R.A., Hussain, M.B., Imray, T.J., Wilson, R.B. and Cohen, S.M. Osteogenic and sarcomatoid differentiation of a renal cell carcinoma. Cancer, 56: 2452-2457, 1985. 91. Cano, M., Wilson, R.B. and Cohen, S.M. Quantitation of scanning electron microscopic urinary cytology. SEM/1985, III: 1273-1278, 1985. 92. Hasegawa, R., Cohen, S.M., St. John, M., Cano, M. and Ellwein, L.B. Effect of dose on the induction of urothelial proliferation by N-[4-(5-nitro-2-furyl)-2thiazolyl]formamide and its relationship to bladder carcinogenesis in the rat. Carcinogenesis, 7: 633-636, 1986. 93. Hasegawa, R. and Cohen, S.M. The effect of different salts of saccharin on the rat urinary bladder. Cancer Lett., 30: 261-268, 1986. 94. Merrick, B.A., Davies, M.H., Hasegawa, R., St. John, M.K., Cohen, S.M. and Schnell, R.C. Effect of sodium selenite upon bromobenzene toxicity in rats. Toxicol. Appl. Pharmacol., 83: 271-278, 1986. 95. Cohen, S.M. Saccharin: Past, present and future. J. Am. Diet. Assn., 86: 929-931, 1986. 96. Suzuki, T., Cano, M. and Cohen, S.M. Scanning electron microscopic exfoliative urinary cytology in patients with malignant and non-malignant diseases of the lower urinary tract. Urology, 28: 62-66, 1986. 97. Sakata, T., Hasegawa, R., Johansson, S.L., Zenser, T.V. and Cohen, S.M. Inhibition by aspirin of N-[4-(5-nitro-2-furyl)-2-thiazolyl] formamide initiation and sodium saccharin Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 99 of 151 PAGEID #: 42252 EXHIBIT 1 Curriculum Vitae Page 69 Samuel M. Cohen, M.D. Ph.D. promotion of urinary bladder carcinogenesis in male F344 rats. Cancer Res., 46: 3903 3906, 1986. 98. Johansson, S.L., Sakata, T., Hasegawa, R., Zenser, T.V., Davis, B.B. and Cohen, S.M. The effect of long-term administration of aspirin and sodium saccharin on the rat kidney. Toxicol. Appl. Pharmacol., 86: 80-92, 1986. 99. Williamson, D.S., Cremonesi, P., Cavalieri, E., Nagel, D.L., Markin, R.S. and Cohen, S.M. Assignment of 1H NMR spectra of polycyclic aromatic hydrocarbons by multiple quantum filtration. J. Organ. Chem., 51: 5210-5213, 1986. 100. Cano, M., Johansson, S.L., Wilson, R.B., Ellwein, L.B., Sakata, T. and Cohen, S.M. Preparation methods for light microscopic and ultrastructural studies of fetal rat bladder. SEM/1986, IV: 1357-1362, 1986. 101. Williamson, D.S., Nagel, D.L., Markin, R.S. and Cohen, S.M. (N-1)-Spin filtration as a more sensitive assignment technique than N-quantum filtration. J. Magn. Reson., 71: 163-167, 1987. 102. Birt, D.F., Julius, A.D., Hasegawa, R., St. John, M. and Cohen, S.M. Effect of Ltryptophan excess and vitamin B6 deficiency on urinary bladder cancer promotion. Cancer Res., 47: 1244-1250, 1987. 103. Williamson, D.S., Nagel, D.L., Markin, R.S. and Cohen, S.M. Effect of pH and ions on the chemical structure of saccharin. Fd. Chem. Toxicol., 25: 211-218, 1987. 104. Hasegawa, R., St. John, M., Tibbels, T.S. and Cohen, S.M. Evaluation of epidermal cell kinetics following freezing or wounding of mouse skin and their potential as initiators of carcinogenesis. J. Invest. Derm., 88: 652-656, 1987. 105. Smith, R.A., Sysel, I.A., Tibbels, T.S. and Cohen, S.M. Implications for the formation of abasic sites following modification of polydeoxycytidylic acid by acrolein in vitro. Cancer Lett., 40: 103-109, 1988. 106. Ellwein, L.B. and Cohen, S.M. A cellular dynamics model of experimental bladder cancer: Analysis of sodium saccharin in the rat. Risk Analysis, 8: 215-221, 1988. 107. Tibbels, T.S., Smith, R.A. and Cohen, S.M. Determination of saccharin in diet and biological materials. J. Chromatogr., 441: 448-453, 1988. 108. Sakata, T., Masui, T., St. John, M. and Cohen, S.M. Uracil-induced calculi and proliferative lesions of the mouse urinary bladder. Carcinogenesis, 9: 1271-1276, 1988. 109. Cohen, S.M. and Ellwein, L.B. Cell growth dynamics in long-term bladder carcinogenesis. Toxicol. Lett., 43: 151-173, 1988. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-125F3iled: 04/06/15 Page: 100 of 151 PAGEID #: EXHIBIT 1 Curriculum Vitae Page 70 Samuel M. Cohen, M.D. Ph.D. 110. Cohen, S.M., Cano, M., Sakata, T. and Johansson, S.L. Ultrastructural characteristics of the fetal and neonatal rat urinary bladder. Scanning Microsc., 2: 2091-2104, 1988. 111. Cohen, S.M., Hasegawa, R., Sakata, T. and Johansson, S.L. Effect of aspirin on urinary bladder carcinogenesis initiated with N-[4-(5-nitro-2-furyl)-2-thiazolyl] formamide in rats. Cancer Res., 49: 372-377, 1989. 112. Fisher, M.J., Sakata, T., Tibbels, T.S., Smith, R.A., Patil, K. Khachab, M., Johansson, S.L. and Cohen, S.M. Effect of sodium saccharin and calcium saccharin on urinary parameters in rats fed Prolab 3200 or AIN-76 diet. Fd. Chem. Toxicol., 27: 1-9, 1989. 113. Smith, R.A., Tibbels, T.S. and Cohen, S.M. Quantitation of N-[4-(5-nitro-2-furyl)-2thiazolyl]formamide and 2-amino-4-(5-nitro-2-furyl)thiazole in rodent diet. J. Chromatography, 465: 442-447, 1989. 114. Williamson, D.S., Smith, R.A., Nagel, D.L. and Cohen, S.M. Phase-sensitive heteronuclear multiple-bond correlation in the presence of modest homonuclear coupling. Application to distamycin A. J. Mag. Res., 82: 605-612, 1989. 115. Smith, R.A., Williamson, D.S. and Cohen, S.M. Identification of 3,N4-propanodeoxycytidine-5'-monophosphate formed by the reaction of acrolein with deoxycytidine 5'-monophosphate. Chem. Res. Toxicol., 2: 267-271, 1989. 116. Sakata, T., Smith, R.A., Garland, E.M. and Cohen, S.M. Rat urinary bladder epithelial lesions induced by acrolein. J. Environm. Pathol. Toxicol. Oncol., 9: 159-170, 1989. 117. Ellwein, L.B. and Cohen, S.M. Comparative analyses of the timing and magnitude of genotoxic and non-genotoxic cellular effects in urinary bladder carcinogenesis. In: Biologically Based Methods for Cancer Risk Assessment. Plenum Publishing Corp., 181-192, 1989. 118. Garland, E.M., Sakata, T., Fisher, M.J., Masui, T. and Cohen, S.M. Influences of diet and strain on the proliferative effect on the rat urinary bladder induced by sodium saccharin. Cancer Res., 49: 3789-3794, 1989. 119. Masui, T., Mann, A.M., Garland, E.M. and Cohen, S.M. Strong promoting activity by uracil on urinary bladder carcinogenesis and a possible inhibitory effect on thyroid tumorigenesis in rats initiated by N-methyl-N-nitrosourea. Carcinogenesis, 10: 1471 1474, 1989. 120. Cohen, S.M. and Ellwein, L.B. Cell growth dynamics in bladder carcinogenesis: Implications for risk assessment. J. Am. Coll. Toxicol., 8: 1103-1113, 1989. 121. Cohen, S.M. Toxic and non-toxic changes induced in the urothelium by xenobiotics. Toxicol. Appl. Pharmacol., 101: 484-498, 1989. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-125F4iled: 04/06/15 Page: 101 of 151 EPXAHGIBEITID1 #: Curriculum Vitae Page 71 Samuel M. Cohen, M.D. Ph.D. 122. Pour, P.M., Lawson, T.A. and Cohen, S.M. Proliferative changes in the prostate. Toxicol. Appl. Pharmacol., 101: 499-509, 1989. 123. Cohen, S.M. Update on sweeteners - saccharin. Toxicol. Forum, Toulouse, France. 328-334, 1989. 124. Cohen, S.M., Fisher, M.J., Sakata, T., Cano, M., Schoenig, G.P., Chappel, C.I. and Garland, E.M. Comparative analysis of the proliferative response of the rat urinary bladder to sodium saccharin by light and scanning electron microscopy and autoradiography. Scanning Microscopy, 4: 135-142, 1990. 125. Smith, R.A., Cohen, S.M. and Lawson, T.A. Acrolein mutagenicity in the V79 assay. Carcinogenesis, 11: 497-498, 1990. 126. Smith, R.A., Williamson, D.S., Cerny, R.L. and Cohen, S.M. Detection of 1,N6propano-deoxyadenosine in acrolein-modified polydeoxyadenylic acid and DNA by 32P post-labeling. Cancer Res., 50: 3005-3012, 1990. 127. Ellwein, L.B. and Cohen, S.M. The health risks of saccharin revisited. Crit. Rev. Toxicol., 20: 311-326, 1990. 128. Cohen, S.M. and Ellwein, L.B. Proliferative and genotoxic cellular effects in 2acetylaminofluorene bladder and liver carcinogenesis: Biological modeling of the ED01 study. Toxicol. Appl. Pharmacol., 104: 79-93, 1990. 129. Hasegawa, R., Murasaki, G., St. John, M.K., Zenser, T.V. and Cohen, S.M. Evaluation of nitrofurantoin on the two stages of urinary bladder carcinogenesis in the rat. Toxicol., 62: 333-347, 1990. 130. Cohen, S.M. and Ellwein, L.B. Cell proliferation in carcinogenesis. Science, 249: 1007-1011, 1990. 131. Masui, T., Mann, A.M., Garland, E.M., Okamura, T., Johansson, P.L. and Cohen, S.M. Point mutation of codons 12 and 61 of the H -ras gene in rat urinary bladder carcinomas induced by N-[4-(n5-nitro-2-furyl)-2-thiazolyl]formamide. Molecular Carcinogenesis, 3: 210-215, 1990. 132. Masui, T., Garland, E.M., Wang, C.Y. and Cohen, S.M. Effects of different types of diet and sodium saccharin on proliferation at the limiting ridge of the rat forestomach. Fd. Chem. Toxicol., 28: 497-505, 1990. 133. Cohen, S.M. Carcinogenicity of antioxidants. Jpn. J. Cancer Res., 82: 1454-1455, 1991. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 102 of 151 PAGEID #: 42255 EXHIBIT 1 Curriculum Vitae Page 72 Samuel M. Cohen, M.D. Ph.D. 134. Mann, A.M., Stevenson, M., Masui, T., Borgeson, C.D. and Cohen, S.M. Transformation of rat bladder epithelial cells by introduction of a single oncogene. Oncogene Res., 6: 65-72, 1991. 135. Cohen, S.M., Ellwein, L.B., Okamura, T., Masui, T., Johansson, S.L., Smith, R.A., Wehner, J.M., Khachab, M., Chappel, C.I., Schoenig, G.P., Emerson, J.L. and Garland, E.M. Comparative bladder tumor promoting activity of sodium saccharin, sodium ascorbate and related acids and calcium salts in rats. Cancer Res., 51: 1766-1777, 1991. 136. Okamura, T., Garland, E.M., Masui, T., Sakata, T., St. John, M. and Cohen, S.M. Lack of bladder tumor promoting activity in rats fed sodium saccharin in AIN-76A diet. Cancer Res., 51: 1778-1782, 1991. 137. Mann, A.M., Masui, T., Chlapowski, F.J., Okamura, T., Borgeson, C.D. and Cohen, S.M. In vitro transformation of rat bladder epithelium by 2-amino-4-(5-nitro-2furyl)thiazole. Carcinogenesis, 12: 417-422, 1991. 138. Cohen, S.M. and Ellwein, L.B. Carcinogenesis models. Science, 251: 143-144, 1991 (Letter). 139. Cohen, S.M., Purtilo, D.T. and Ellwein, L.B. Pivotal role of increased cell proliferation in human carcinogenesis. Modern Pathol., 4: 371-382, 1991. 140. Masui, T., Mann, A.M., Macatee, T.L., Okamura, T., Garland, E.M., Fujii, H., Pelling, J.C. and Cohen, S.M. H-ras mutation in rat urinary bladder carcinomas induced by N[4-(5-nitro-2-furyl)-2-thiazolyl]formamide (FANFT) and sodium saccharin, sodium ascorbate, or related salts. Cancer Res., 51: 3471-3475, 1991. 141. Cohen, S.M. and Ellwein, L.B. Carcinogenesis mechanisms: The debate continues. Science, 252: 902-903, 1991 (Letter). 142. Cohen, S.M. and Ellwein, L.B. Carcinogens. Lancet, 337: 973, 1991 (Letter). 143. Smith, R.A., Tibbels, T.S., Smith, T.E. and Cohen, S.M. Quantitation of uracil in rodent diet. Anal. Biochem., 195: 375-377, 1991. 144. Masui, T., Ward, J.M. and Cohen, S.M. Enhanced immunoreactivity of ras oncogene p21 protein in urinary bladder epithelium of rats treated with N-[4-(5-nitro-2-furyl)-2thiazolyl]formamide (FANFT). Cancer Lett., 59: 95-102, 1991. 145. Cohen, S.M., Cano, M., Garland, E.M., Earl, R.A. and Carson, S. A proposed role for silicates and protein in the proliferative effects of saccharin on the male rat urothelium. Carcinogenesis, 12: 1551-1555, 1991. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-125F6iled: 04/06/15 Page: 103 of 151 PAGEID #: EXHIBIT 1 Curriculum Vitae Page 73 Samuel M. Cohen, M.D. Ph.D. 146. Cohen, S.M. and Ellwein, L.B. Genetic errors, cell proliferation, and carcinogenesis. Cancer Res., 51: 6493-6505, 1991. 147. Garland, E.M., Shapiro, R., Kraft, P.L., Khachab, M., Patil, K., Ellwein, L.B. and Cohen, S.M. Effects of in utero and postnatal sodium saccharin exposure on the nutritional status of the young rat. I. Effects at 30 days postbirth. Fd. Chem. Toxicol., 29: 657-667, 1991. 148. Garland, E.M., Shapiro, R., Kraft, P.L., Mattson, B.J., Parr, J.M. and Cohen, S.M. Effects of in utero and postnatal sodium saccharin exposure on the nutritional status of the young rat. II. Dose response and reversibility. Fd. Chem. Toxicol., 29: 669-679, 1991. 149. Masui, T., Mann, A.M., Macatee, T.L., Garland, E.M., Okamura, T., Smith, R.A. and Cohen, S.M. Direct DNA sequencing of the rat neu oncogene transmembrane domain in urinary bladder carcinomas induced in rats by N-butyl-N-(4-hydroxybutyl) nitrosamine (BBN), N-[4-(5-nitro-2-furyl)-2-thiazolyl]formamide (FANFT) or Nmethyl-N-nitrosourea (MNU). Carcinogenesis, 12: 1975-1978, 1991. 150. Okamura, T., Garland, E.M., Johnson, L.S., Cano, Johansson, S.L. and Cohen, S.M. Acute urinary tract toxicity of tetraethylorthosilicate (TES) in rats. Fund. Appl. Toxicol., 18: 425-441, 1992. 151. Ellwein, L.B. and Cohen, S.M. Simulation modeling of carcinogenesis. Toxicol. Appl. Pharmacol., 113: 98-108, 1992. 152. Cohen, S.M., Garland, E.M., St. John, M., Okamura, T. and Smith, R.A. Acrolein initiates rat urinary bladder carcinogenesis. Cancer Res., 52: 3577-3581, 1992. 153. Mann, A.M., Asamoto, M., Chlapowski, F.J., Masui, T., Macatee, T.L. and Cohen, S.M. R as involvement in cells transformed with 2-amino-4-(5-nitro-2-furyl)thiazole (ANFT) in vitro and with N-[4-(5-nitro-2-furyl)-2-thiazolyl] formamide (FANFT) in vivo. Carcinogenesis, 13: 1651-1655, 1992. 154. Okamura, T., Garland, E.M., Taylor, R.J., Johansson, S.L. and Cohen, S.M. The effect of cyclophosphamide administration on the kidney of the rat. Toxicol. Lett., 63: 261 276, 1992. 155. Cohen, S.M. and Ellwein, L.B. Risk assessment based on high-dose animal exposure experiments. Chem. Res. Toxicol., 5: 742-748, 1992. 156. Masui, T., Mann, A.M., Macatee, T.L., Okamura, T., Garland, E.M., Smith, R.A. and Cohen, S.M. Absence of ras oncogene activation in rat urinary bladder carcinomas induced by N-methyl-N-nitrosourea (MNU) or N-butyl-N-(4-hydroxybutyl)nitrosamine (BBN). Carcinogenesis, 13: 2281-2285, 1992. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-125F7iled: 04/06/15 Page: 104 of 151 PAGEID #: EXHIBIT 1 Curriculum Vitae Page 74 Samuel M. Cohen, M.D. Ph.D. 157. Masui, T., Mann, A.M., Borgeson, C.D., Garland, E.M., Okamura, T., Fujii, H., Pelling, J.C. and Cohen, S.M. Sequencing analysis of Ha-, Ki-, and N-ras genes in rat urinary bladder tumors induced by N-[4-(5-nitro-2-furyl)-2-thiazolyl]formamide (FANFT) and sodium saccharin. Teratogenesis, Carcinogenesis, Mutagenesis, 13: 225 233, 1993. 158. Cano, M., Suzuki, T. and Cohen, S.M. Application of scanning electron microscopy and x-ray analysis to urinary tract cancer in animals and humans. Scanning Microscopy, 7: 363-370, 1993. 159. Garland, E.M., Shapiro, R., Wehner, J.M., Johnson, L.S., Mattson, B.J., Khachab, M., Asamoto, M. and Cohen, S.M. The effects of dietary iron and folate supplementation on the physiological changes produced in weanling rats by sodium saccharin exposure. Fd. Chem. Toxicol., 31: 689-699, 1993. 160. Cohen, S.M. and Ellwein, L.B. The use of cell proliferation data in modeling urinary bladder carcinogenesis. Environ. Health Persp., 101: 111-114, 1993. 161. Asamoto, M., Mann, A.M. and Cohen, S.M. p53 mutation is infrequent and might not give a growth advantage in rat bladder carcinogenesis in vivo. Carcinogenesis, 15: 455 458, 1994. 162. Asamoto, M., Mann, A.M., Macatee, T.L. and Cohen, S.M. Mutations and expression of p53 gene in rat bladder carcinoma and cell lines. Molecular Carcinogenesis, 9: 236 244, 1994. 163. Garland, E.M., St. John, M., Asamoto, M., Eklund, S.H., Mattson, B.J., Johnson, L.S., Cano, M. and Cohen, S.M. A comparison of the effects of sodium saccharin in NBR rats and in intact and castrated male F344 rats. Cancer Lett., 78: 99-107, 1994. 164. Asamoto, M. and Cohen, S.M. Prohibitin gene is overexpressed but not mutated in rat bladder carcinomas and cell lines. Cancer Lett., 83: 201-207, 1994. 165. Mann, A.M., Asamoto, M., Masui, T., Macatee, T., Eklund, S.H. and Cohen, S.M. N eu is not involved in N-[4-(5-nitro-2-furyl)-2-thiazolyl]formamide-induced bladder carcinoma or 2-amino-4-(5-nitro-2-furyl)thiazole transformation of rat bladder epithelial cells. Cancer Lett., 84: 7-13, 1994. 166. Okamura, T., Garland, E.M. and Cohen, S.M. Glandular stomach hemorrhage induced by high dose saccharin in young rodents. Toxicol. Lett., 74: 129-140, 1994. 167. Cohen, S.M., Cano, M., Johnson, L.S., St. John, M.K., Asamoto, M., Garland, E.M., Thyssen, J.H., Sangha, G.K. and Van Goethem, D.L. Mitogenic effects of propoxur on male rat bladder urothelium. Carcinogenesis, 15: 2593-2597, 1994. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-125F8iled: 04/06/15 Page: 105 of 151 PAGEID #: EXHIBIT 1 Curriculum Vitae Page 75 Samuel M. Cohen, M.D. Ph.D. 168. Cohen, S.M. Human relevance of animal carcinogenicity studies. Regulatory Toxicol. Pharmacol., 21: 75-80, 1995. 169. Cohen, S.M., Cano, M., Garland, E.M., St. John, M.K. and Arnold, L. Urinary and urothelial effects of sodium salts in male rats. Carcinogenesis, 16: 343-348, 1995. 170. Cohen, S.M. and Ellwein, L.B. Relationship of DNA adducts derived from 2acetylaminofluorene to cell proliferation and the induction of rodent liver and bladder tumors. Toxicol. Pathol., 23: 136-142, 1995. 171. Okamura, T., Masui, T., St. John, M.K., Cohen, S.M., and Taylor, R.J. Evaluation of effects of chitosan in preventing hemorrhagic cystitis in rats induced by cyclophosphamide. Acta Urol. Jpn., 41: 289-296, 1995. 172. Cohen, S.M., Winter, C., Graham, J.D., Well, Jr., B.W., Kroger, M., Crawford, L.M., Avery, D., Scheuplen, R.J. and Weisberger, E. Delaney Reform. Science (Letter) 268: 1829-1830, 1995. 173. Cohen, S.M. and Lawson, T.A. Rodent bladder tumors do not always predict for humans. Cancer Lett., 93: 9-16, 1995. 174. Craft, R.M., Cohen, S.M. and Porreca, F. Long-lasting desensitization of bladder afferents following intravesical resiniferatoxin and capsaicin in the rat. Pain, 61: 317 323, 1995. 175. Cohen, S.M. The role of urinary physiology and chemistry in bladder carcinogenesis. Fd. Chem. Toxicol., 33:715-730, 1995. 176. Clayson, D.B., Fishbein, L. and Cohen, S.M. The effect of stones and other physical factors on the induction of rodent bladder cancer. Fd. Chem. Toxicol., 33: 771-784, 1995. 177. Rodent Bladder Carcinogenesis Working Group. Urinary bladder carcinogenesis: Implications for risk assessment. Fd. Chem. Toxicol., 33: 797-802, 1995. 178. Cohen, S.M., Cano, M., St. John, M.K., Garland, E.M., Khachab, M. and Ellwein, L.B. Effect of sodium saccharin in the neonatal rat bladder. Scanning Microscopy, 9: 137 148, 1995. 179. Cohen, S.M. Cell proliferation in the bladder and implications for cancer risk assessment. Toxicology, 102: 149-159, 1995. 180. Cohen, S.M., Garland, E.M., Cano, M., St. John, M.K., Khachab, M. and Arnold, L.L. Effects of sodium ascorbate, sodium saccharin and ammonium chloride on the male rat urinary bladder. Carcinogenesis, 16:2743-2750, 1995. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-125F9iled: 04/06/15 Page: 106 of 151 EPXAHGIBEITID1 #: Curriculum Vitae Page 76 Samuel M. Cohen, M.D. Ph.D. 181. Cohen, S.M. Role of cell proliferation in regenerative and neoplastic disease. Toxicol. Lett., 82/83, 15-21, 1995. 182. Cohen, S.M., Cano, M., Anderson, T. and Garland, E.M. Extensive handling of rats leads to mild urinary bladder hyperplasia. Toxicol. Pathol., 24: 251-257, 1996. 183. Ogawa, K., Sun, T-T. and Cohen, S.M. Analysis of differentiation associated proteins in rat bladder carcinogenesis. Carcinogenesis, 17: 961-965, 1996. 184. Cohen, S.M. and Ellwein, L.B. Cell proliferation as a major risk factor for cancer: A concept of doubtful validity; Reply Letter to the Editor. Cancer Res., 56: 4269-4270, 1996. 185. Harrison, K.S., Dalrymple, G.V., Baranowska-Kortylewicz, J., Holdeman, K.P., Schneiderman, M.H., Lieberman, R.P., Sharp, J.G., Cohen, S.M., Leichner, P.K., Augustine, S.C., Tempero, M.A., Taylor, R.J. and Chiou, R.K. Radiolabeled iododeoxyurieine: Safety evaluation. J. Nucl. Med., 37: 135-165, 1996. 186. Baranowska-Kortylewicz, J., Dalrymple, G.V., Harrison, K.A., Holeman, K.P., Sharp, J.G., Cohen, S.M., Schneiderman, M.H., Lieberman, R.P., Clausen, S.R., Hoffman, D., Lai, J. and Schneiderman, G.S. On the safety of 5-[125I]Iodo-2'-deoxyuridine. Pre Clinical Evaluation in Swine. Acta Oncol., 35(7): 925-933, 1996. 187. Foran, J. and ILSI Risk Science Institute Dose Selection Working Group. Principles for the selection of doses in chronic rodent bioassays. Environ. Health Perspec., 105: 18-20, 1997. 188. Cohen, S.M., Masui, T., Garland, E.M. and Arnold, L.L. Effects of diet on urinary bladder carcinogenesis and cancer prevention. J. Nutr., 127: 826S-829S, 1997. 189. Cohen, S.M. "Saccharin Safety Update". In: S.G. Liansky and A. Corti (eds). ISA/CIFTI Seminar on Low-Calorie Sweeteners, The International Sweeteners Association., pp. 92-100, 1997. 190. Butler, W.H., Cohen, S.M. and Squire, R.A. Mesenchymal tumors of the mouse urinary bladder with vascular and smooth muscle differentiation. Toxicol. Pathol., 25: 268-274, 1997. 191. Johansson, S.L. and Cohen, S.M. Epidemiology and etiology of bladder cancer. Sem. Surg. Oncol., 13: 291-298, 1997. 192. Arnold, L.L., Christenson, R., Cano, M., St. John, M.K., Wahl, B.S., and Cohen, S.M. Tributyl phosphate effects on urine and bladder epithelium in male Sprague-Dawley rats. Fund. Appl. Toxicol., 40: 247-255, 1997. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-126F0iled: 04/06/15 Page: 107 of 151 PAGEID #: EXHIBIT 1 Curriculum Vitae Page 77 Samuel M. Cohen, M.D. Ph.D. 193. Andersen, M., Brusick, D., Cohen, S., Dragan, Y., Frederick, C., Goodman, J.I., Hard, G., Meek, B., and O'Flaherty, E. J. U.S. Environmental Protection Agency's revised cancer guidelines for carcinogen risk assessment. Toxicol. Appl. Pharmacol. 153: 133 136, 1998. 194. Takayama, S., Sieber, S.M., Adamson, R.H., Thorgeirsson, U.P., Dalgard, D.W., Arnold, L.L., Cano, M., Eklund, S. and Cohen, S.M. Long-term feeding of sodium saccharin to nonhuman primates: Implications for urinary tract cancer. J. Natl. Cancer Inst., 90: 19-25, 1998. 195. Ogawa, K., Uzvolgyi, E., St. John, M.K., de Oliveria, M.L., Arnold, L.L. and Cohen, S.M. Frequent p53 mutations and occasional loss of chromosome 4 in invasive bladder carcinoma induced by N-butyl-N-(4-hydroxybutyl) nitrosamine in B6D2F1 mice. Molecular Carcinogenesis, 21: 270-279, 1998. 196. Cohen, S.M. Thresholds in Carcinogenesis. Newsletter/Carcinogenesis Specialty Section of Society of Toxicology, February, 1998. 197. Cohen, S.M. Urinary bladder carcinogenesis. Toxicol. Pathol., 26: 121-127, 1998. 198. Cohen, S.M. Cell proliferation and carcinogenesis. Drug Metabolism Rev., 30: 339 357, 1998. 199. Takayama, S., Sieber, S.M., Adamson, R.H., Thorgeirsson, U.P., Dalgard, D.W., Arnold, L.L., Cano, M., Eklund, S. and Cohen, S.M. Long-term feeding of sodium saccharin to nonhuman primates: Implications for urinary tract cancer. A Letter of Reply @ J. Natl. Cancer Inst., 90: 934-935, 1998. 200. Cohen, S.M., Anderson, T.A., de Oliveira, L.M. and Arnold, L.L. Tumorigenicity of sodium ascorbate in male rats. Cancer Res., 58: 2557-2561, 1998. 201. Smith, R.A., Christenson, W.R., Bartels, M.J., Arnold, L.L., St. John, M.K., Cano, M., Wahle, B.S., McNett, D.A. and Cohen, S.M. Urinary physiologic and chemical metabolic effects on the urothelial cytotoxicity and potential genotoxicity of ophenylphenol in male rats. Toxicol. Appl. Pharmacol., 150: 402-413, 1998. 202. Scher, H., Bahnson, R., Cohen, S., Eisenberger, M., Herr, H., Kozlowski, J., Lange, P., Montie, J., Pollack, A., Raghaven, D., Richie, J. and Shipley, W. NCCN urothelial cancer practice guidelines. Oncology, 12: 225-271, 1998. 203. Asamoto, M., Toriyama-Baba, H., Krutovskikh, V., Cohen, S.M. and Tsuda, H. Enhanced tumorigenicity of rat bladder squamous cell carcinoma cells after abrogation of gap junctional intercellular communication. Jpn. J. Can. Res., 89: 481-486, 1998. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-126F1iled: 04/06/15 Page: 108 of 151 PAGEID #: EXHIBIT 1 Curriculum Vitae Page 78 Samuel M. Cohen, M.D. Ph.D. 204. Andersen, M., Brusick, D., Cohen, S.M., Dragan, Y., Frederick, C., Goodman, J.I., Hard, G., Meek, B. and O'Flaherty, E.J. Letter to the Editor: Response to Melnick, et al., Toxicol. Appl. Pharmacol., 153: 133-140, 1998. 205. Cohen, S.M. Cell proliferation in the evaluation of carcinogenic risk and the inadequacies of the initiation-promotion model. Int. J. Toxicol., 17: 129-142, 1998. 206. Cohen, S.M. Calcium phosphate-containing urinary precipitate in rat urinary bladder carcinogenesis. International Agency for Research on Cancer, IARC Scientific Publications, 147: 175-189, 1999. 207. IARC Working Group. Consensus Report. International Agency for Research on Cancer, IARC Scientific Publications, 147: 1-32, 1999. 208. Levin, S., Bucci, T.J., Cohen, S.M., Fix, A.S., Hardistry, J.F., LeGrand,E.K., Maronpot, R.R. and Trump, B.F. The nomenclature of cell death: Recommendations of an ad hoc committee of the Society of Toxicologic Pathologists. Toxicol. Pathol., 27: 484-490, 1999. 209. Arnold, L.L., Cano, M., St. John, M., Eldan, M., van Gemert, M. and Cohen, S.M. Effects of dietary dimethylarsinic acid on the urine and urothelium of rats. Carcinogenesis, 20: 2171-2179, 1999. 210. Ogawa, K., Johansson, S.L. and Cohen, S.M. Immunohistochemical analysis of uroplakins, urothelial specific proteins, in ovarian Brenner tumors, normal tissues, and benign and neoplastic lesions of the female genital tract. Am. J. Pathol., 155: 1047 1050, 1999. 211. Ogawa, K., St. John, M., de Oliveira, M.L., Arnold, L.L., Shirai, T., Sun, T-T. and Cohen, S.M. Comparison of uroplakin expression during urothelial carcinogenesis induced by N-butyl-N-(4-hydroxybutyl)nitrosamine-treated in rats and mice. Toxicol. Pathol., 27: 645-651, 1999. 212. Andersen, M.E., Meek, E., Boorman, G.A., Brusick, D.J., Cohen, S.M., Dragan, Y.P., Frederick, C.B., Goodman, J.I., Hard, G.C., O'Flaherty, E.J. and Robinson, D.E. Lessons learned in applying the U.S. EPA's proposed cancer guidelines to specific compounds. Toxicol. Sci., 53: 159-172, 2000. 213. Cohen, S.M., Arnold, L.L., Cano, M., Ito, M., Garland, E.M. and Shaw, R.A. Calcium phosphate-containing precipitate and the carcinogenicity of sodium salts in rats. Carcinogenesis, 21: 783-792, 2000. 214. Goodman, J.I., Brusick, D.J., Busey, W.M., Cohen, S.M., Lamb, J.C. and Starr, T.B. Re-evaluation of the cancer potency factor of toxaphene: Recommendations from a peer review panel. Toxicol. Sci., 55: 3-16, 2000. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-126F2iled: 04/06/15 Page: 109 of 151 PAGEID #: EXHIBIT 1 Curriculum Vitae Page 79 Samuel M. Cohen, M.D. Ph.D. 215. Cohen, S.M., Shirai, T. and Steineck, G. Epidemiology and etiology of premalignant and malignant urothelial changes. Scand. J. Urol. Nephrol., 34(Suppl. 205): 105-115, 2000. 216. Wijkstrom, H., Cohen, S.M., Gardiner, R.A., Kakizoe, T., Schoenberg, M., Steineck, G. and Tobisu, K. Prevention and treatment of urothelial premalignant and malignant lesions. Scand. J. Urol. Nephrol. Suppl., 34(Suppl. 205): 116-135, 2000. 217. Cohen, S.M., Yamamoto, S., Cano, M. and Arnold, L.L. Urothelial cytotoxicity and regeneration induced by dimethylarsinic acid in rats. Toxicol. Sci., 59: 68-74, 2001. 218. St. John, M.K., Arnold, L.L., Anderson, T., Cano, M., Johansson, S.L. and Cohen, S.M. Dietary effect of ortho-phenylphenol and sodium ortho-phenylphenol on rat bladder urothelium. Toxicol. Sci., 59: 346-351, 2001. 219. Dragan, Y.P., Bidlack, W.R., Cohen, S.M., Goldsworthy, T.L., Hard, G.C., Howard, P.C., Riley, R.T. and Voss, K.A. Implications of apoptosis for toxicity, carcinogenicity and risk assessment: Fumonisin B1as an example. Toxicol. Sci., 61: 6-17, 2001. 220. Arnold, L.L., Cano, M., St. John, M.K., Healy, C. and Cohen, S.M. Effect of sulfosulfuron on the urine and urothelium of male rats. Toxicol. Pathol., 29: 344-352, 2001. 221. Cohen, S.M. What's the truth about the health risks of sugar substitutes such as saccharin and aspartame? Health News, 7(1):10, 2001. 222. Cohen, S.M. Alternative models for carcinogenicity testing: Weight of evidence evaluation across models. Toxicol. Pathol., 29(Suppl.): 183-190, 2001. 223. Cohen, S.M., Robinson, D., and MacDonald, J. Alternative models for carcinogenicity testing. Toxicol. Sci., 64: 14-19, 2001. 224. Cano, M., Arnold, L.L., and Cohen, S.M. Evaluation of diet and dimethylarsinic acid on the urothelium of Syrian golden hamsters. Toxicol. Pathol., 29: 600-606, 2001. 225. Cohen, S.M., Johansson, S.L., Arnold, L.L., Lawson, T.A. Urinary tract calculi and thresholds in carcinogenesis. Food Chem. Toxicol., 40: 793-799, 2002. 226. Herbel, M.J., Blum, J.S., Hoeft, S.E., Cohen, S.M., Arnold, L.L., Lisak, J., Stolz, J.F., and Oremland, R.S. Dissimilatory arsenate reductase activity and arsenate-respiring bacteria in bovine rumen fluid, hamster feces, and the termite hindgut. FEMS Microbiol. Ecol., 41: 59-67, 2002. 227. Cohen, S.M., Arnold, L.L., Uzvolgyi, E., Cano, M., St. John, M., Yamamoto, S., Lu, X., Le, X.C. Possible role of dimethylarsinous acid in dimethylarsinic acid-induced Case: 2:13-md-02433-EAS-EPD Doc #: 280472-126F3iled: 04/06/15 Page: 110 of 151 PAGEID #: EXHIBIT 1 Curriculum Vitae Page 80 Samuel M. Cohen, M.D. Ph.D. urothelial toxicity and regeneration in the rat. Chem. Res. Toxicol., 15: 1150-1157, 2002. 228. Cohen, S.M. Response to Syrian Hamster embryo assay working group letter to the editor. Toxicol. Pathol., 30: 292-293, 2002. 229. Cohen, S.M. Bioassay bashing as bad science. Envir. Hlth. Perspect., 110: A14, 2002. 230. Cohen, S.M., Meek, B., and Patton, D.E. A framework for mode of action/human relevance analysis. Risk Policy Report, pp. 41-44, 2002. 231. Cohen, S.M., and Ito, N. A critical review of the toxicological effects of carrageenan and processed Eucheuma seaweed on the gastrointestinal tract. Crit. Rev. Toxicol., 32: 413-444, 2002. 232. Cohen, S.M. "Bioassay bashing is bad science": Cohen's response. Environ. Health Perspect., 110: A737-A738, 2002. 233. Cohen, S.M. Comparative pathology of proliferative lesions of the urinary bladder. Envir. Health Perspect, 30: 663-671, 2002. 234. Smith, R.L., Cohen, S.M., Doull, J., Feron, V.J., Goodman, J.I., Marnett, L.J., Portoghese, P.S., Waddell, W.J., Wagner, B.M., and Adams, T.B. The 21st publication by the Expert Panel of the Flavor Extract Manufacturers Association on recent progress in the consideration of flavoring ingredients generally recognized as safe under the Food Additives Amendment. J. Food Tech., 57: 30-40, 2003. 235. Arnold, L.L., Eldan, M., van Gemert, M., Capen, C.C., and Cohen, S.M. Chronic studies evaluating the carcinogenicity of monomethylarsonic acid in rats and mice. Toxicology, 190: 197-219, 2003. 236. Lu, X., Arnold, L.L., Cohen, S.M., Cullen, W.R., and Le, C. Speciation of dimethylarsinous acid (DMA111) and trimethylarsine oxide in rats fed with dimethylarsinic acid (DMAV) in the diet. Anal. Chem., 75: 6463-6468, 2003. 237. Cohen, S.M., Klaunig, J., Meek, M.E., Hill, R.N., Pastoor, T., Lehman-McKeem, L., Bucher, J., Longfellow, D.G., Seed, J., Dellarco, V., Fenner-Crisp, P., Patton, D. The human relevance of information on carcinogenic modes of action: overview. Crit. Rev. Toxicol., 33: 581-590, 2003. 238. Meek, M.E. (Bette), Bucher, J.R., Cohen, S.M., Dellarco, V., Hill, R.N., LehmanMcKeeman, L.D., Longfellow, D.G., Pastoor, T., Seed, J., and Patton, D.E. A framework for human relevance analysis of information on carcinogenic modes of action. Crit. Rev. Toxicol., 33: 591-653, 2003. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-126F4iled: 04/06/15 Page: 111 of 151 PAGEID #: EXHIBIT 1 Curriculum Vitae Page 81 Samuel M. Cohen, M.D. Ph.D. 239. Cohen, S.M., Klaunig, J., Meek, M.E., Hill, R.N., Pastoor, T., Lehman-McKeeman, L., Bucher, J., Longfellow, D.G., Seed, J., Dellarco, V., Fenner-Crisp, P. Evaluating the human relevance of chemically-induced animal tumors. Toxicol. Sci., 78: 181-186, 2004. 240. Cohen, S.M. Risk assessment in the genomic era. Toxicol. Pathol., 32(Suppl. 1): 3-8, 2004. 241. Adams, T.B., Cohen, S., Doull, J., Feron, V.J., Goodman, J.I., Marnett, L.J., Munro, I.C., Portoghese, P.S., Smith, R.L., Waddell, W.J., and Wagner, B.M. The FEMA GRAS assessment of cinnamyl derivatives used as flavor ingredients. Food Chem. Toxicol., 42: 157-185, 2004. 242. Smith, R.L., Adams, T.B., Cohen, S.M., Doull, J., Feron, V.J., Goodman, J.I., Hall, R.L., Marnett, L.J., Portoghese, P.S., Waddell, W.J., and Wagner, B.M. Safety evaluation of natural flavour complexes. Toxicol. Lett., 149: 197-207, 2004. 243. Cohen, S.M. Human carcinogenic risk evaluation: An alternative approach to the twoyear rodent bioassay. Toxicol. Sci., 80: 225-229, 2004. 244. Mathews, K., Sasson, A., and Cohen, S.M. Pathologic quiz case: A woman with abdominal fullness. Arch. Pathol. Lab. Med., 128: 703-704, 2004. 245. Lu, M., Wang, H., Li, X-F., Lu, X., Cullen, W.R., Arnold, L.L., Cohen, S.M., and Le, X.C. Evidence of hemoglobin binding to arsenic as a basis for the accumulation of arsenic in rat blood. Chem. Res. Toxicol., 17: 1733-1742, 2004. 246. Wei, M., Arnold, L., Cano, M., and Cohen, S.M. Effects of co-administration of antioxidants and arsenicals on the rat urinary bladder epithelium. Toxicol. Sci., 83: 237-245, 2005. 247. Smith, R.L., Cohen, S.M., Doull, J., Feron, V.J., Goodman, J.I., Marnett, L.J., Portoghese, P.S., Waddell, W.J., Wagner, B.M., Hall, R.L., Higley, N.A., Lucas-Gavin, C. and Adams, T.B. A procedure for the safety evaluation of natural flavor complexes used as ingredients in food: essential oils. Food Chem. Toxicol., 43: 345-363, 2005. 248. Smith, R.L., Cohen, S.M, Doull, J., Feron, V.J., Goodman, J.I., Marnett, L.J., Munro, I.C., Portoghese, P.S., Waddell, W.J., Wagner, B.M., and Adams, T.B. Criteria for the safety evaluation of flavoring substances: The Expert Panel of the Flavor and Extract Manufacturers Association. Food Chem. Toxicol., 43: 1141-1177, 2005. 249. Adams, T.B., Cohen, S.M., Doull, J., Feron, V.J., Goodman, J.I., Marnett, L.J., Munro, I.C., Portoghese, P.S., Smith, R.L., Waddell, W.J., and Wagner, B.M. The FEMA GRAS assessment of phenethyl alcohol, aldehyde, acid, and related acetals and esters used as flavor ingredients. Food Chem. Toxicol., 43: 1179-1206, 2005. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-126F5iled: 04/06/15 Page: 112 of 151 PAGEID #: EXHIBIT 1 Curriculum Vitae Page 82 Samuel M. Cohen, M.D. Ph.D. 250. Adams, T.B., Cohen, S.M., Doull, J., Feron, V.J., Goodman, J.I., Marnett, L.J., Munro, I.C., Portoghese, P.S., Smith, R.L., Waddell, W.J., and Wagner, B.M. The FEMA GRAS assessment of benzyl derivatives used as flavor ingredients. Food Chem. Toxicol., 43: 1207-1240, 2005. 251. Adams, T.B., Cohen, S.M., Doull, J., Feron, V.J., Goodman, J.I., Marnett, L.J., Munro, I.C., Portoghese, P.S., Smith, R.L., Waddell, W.J. and Wagner, B.M. The FEMA GRAS assessment of hydroxy- and alkoxy-substituted benzyl derivatives used as flavor ingredients. Food Chem. Toxicol., 43: 1241-1271, 2005. 252. Smith, R.L., Cohen, S.M., Doull, J., Feron, V.J., Goodman, J.I., Marnett, L.J., Portoghese, P.S., Waddell, W.J., Wagner, B.M. and Adams, T.B. GRAS Flavoring Substances 22. Food Tech., 59: 1-34, 2005. 253. Cohen, S.M. Effects of PPARy and combined agonists on the urinary tract of rats and other species. Toxicol. Sci., 87: 322-327, 2005. 254. Holsapple, M.P., Pitot, H.C., Cohen, S.M., Boobis, A.R., Klaunig, J.E., Pastoor, T., Dellarco, V. and Dragan, Y.P. Mode of action in relevance of rodent liver tumors to human cancer risk. Toxicol. Sci., 89: 51-56, 2006. 255. Cohen, S.M., Arnold, L.L., Eldan, M., Schoen, A.S. and Beck, B.D. Methylated arsenicals: The implications of metabolism and carcinogenicity studies in rodents to human risk assessment. Crit. Rev. Toxicol., 36: 99-133, 2006. 256. Arnold, L.L., Nyska, A., Eldan, M., van Gemert, M. and Cohen, S.M. Dimethylarsinic acid: Results of chronic toxicity/oncogenicity studies in F344 rats and B6C3F1 mice. Toxicology, 223: 82-100, 2006. 257. Talmon, G.A. and Cohen, S.M. Mesenchymal hamartoma of the liver with an interstitial deletion involving chromosome band 19q134.4, A theory as to pathogenesis? Arch. Pathol. Lab. Med., 130: 1216-1218, 2006. 258. Cohen, S.M. and Johansson, S.L. Urothelial carcinoma: Two diseases. The 4th Chinese Conference on Oncology & 5th Cross-Strait Academic Conference on Oncology, 436 441, 2006. 259. Boobis, A.R., Cohen, S.M., Dellarco, V., McGregor, D., Meek, M.E., Vickers, C., Willcocks, D. and Farland, W. IPCS framework for analyzing the relevance of a cancer mode of action for humans. Crit. Rev. Toxicol., 36: 781-792, 2006. 260. Dellarco, V.L., McGregor, D., Berry, C., Cohen, S.M, and Boobis, A. Thiazopyr and thyroid disruption: case study within the context of the 2006 IPCS human relevance framework for analysis of a cancer mode of action. Crit. Rev. Toxicol., 36: 793-801, 2006. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-126F6iled: 04/06/15 Page: 113 of 151 PAGEID #: EXHIBIT 1 Curriculum Vitae Page 83 Samuel M. Cohen, M.D. Ph.D. 261. Cohen, S.M., Boobis, A.R., Meek, M.E., Preston, R.J., and McGregor, D.B. 4Aminobiphenyl and DNA reactivity: case study within the context of the 2006 IPCS human relevance framework for analysis of a cancer mode of action for humans. Crit. Rev. Toxicol., 36: 803-819, 2006. 262. Dominick, M.A., White, M.R., Sanderson, T.P., Van Vleet, T.R., Cohen, S.M., Arnold, L.L., Cano, M., Tannehill-Gregg, S., Moehlenkamp, J.D., Waites, C.R. and Schilling, B.E. Urothelial carcinogenesis in the urinary bladder of male rats treated with muraglitazar, a PPAR a/y agonist: Evidence for urolithiasis as the inciting event in the mode of action. Toxicol. Pathol., 34: 903-920, 2006. 263. Weiner, M.L., Nuber, D., Blakemore, W., Harriman, J.F., and Cohen, S.M. A 90-day dietary study on kappa carrageenan with emphasis on the gastrointestinal tract. Food Chem. Toxicol., 45: 98-106, 2007. 264. Van Vleet, T.R., White, M.R., Sanderson, T.P., Cohen, S.M., Cano, M., Arnold, L.L., Waites, C.R., Schilling, B.E., Mitroka, J. and Dominick, M.A. Subchronic urinary bladder effects of muraglitazar in male rats. Toxicol. Sci., 96(1): 58-71, 2007. 265. Adams, T.B., McGowen, M.M., Williams, M.C., Cohen, S.M., Feron, V.J., Goodman, J.I., Marnett, L.J., Munro, I.C., and Portoghese, P.S. The FEMA GRAS assessment of aromatic substituted secondary alcohols, ketones, and related esters used as flavor ingredients. Food Chem. Toxicol., 24: 171-201, 2007. 266. Lu, M., Wang, H., Li, X.F., Arnold, L.L., Cohen, S.M., and Le, X.C. Binding of dimethylarsinous acid to cys-13a of rat hemoglobin is responsible for retention of arsenic in rat blood. Chem. Res. Toxicol., 20: 27-37, 2007. 267. Cohen, S.M., Ohnishi, T., Clark, N.M., He, J., Arnold, L.L. Investigations of rodent urinary bladder carcinogens: collection, processing, and evaluation of urine and bladders. Toxicol. Pathol., 35: 337-347, 2007. 268. Tannehill-Gregg, S.H., Sanderson, T.P., Minnema, D., Voelker, R., Ulland, B., Cohen, S.M., Arnold, L.L., Schilling, B.E., Waites, C.R., and Dominick, M.A. Rodent carcinogenicity profile of the antidiabetic dual PPAR a and y agonist muraglitazar. Toxicol. Sci., 98: 258-270, 2007. 269. Cohen, S.M., Ohnishi, T., Arnold, L.L., Le, X.C. Arsenic-induced bladder cancer in an animal model. Toxicol. Appl. Pharmacol., 222: 258-263, 2007. 270. Waddell, W.J., Cohen, S.M., Feron, V.J., Goodman, J.I., Marnett, L.J., Portoghese, P.S., Rietjens, I.M.C.M., Smith, R.L., Adams, T.B., and Williams, M.C. Recent progress in the consideration of flavoring ingredients under the Food Additives Amendment 23. GRAS flavoring substances. Food Technol., 61: 22-48, 2007. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-126F7iled: 04/06/15 Page: 114 of 151 PAGEID #: EXHIBIT 1 Curriculum Vitae Page 84 Samuel M. Cohen, M.D. Ph.D. 271. Ohnishi, T., Arnold, L.L., He, J., Clark, N.M., Kawasaki, S., Rennard, S.I., Bioyer, C.W., and Cohen, S.M. Inhalation of tobacco smoke induces increased proliferation of urinary bladder epithelium and endothelium in female C57BL/6 mice. Toxicology, 241: 58-65, 2007. 272. Rhomberg, L., Baetcke, K., Blancato, J., Bus, J., Cogliano, V., Cohen, S., Conolly, R., Dixit, R., Doe, J., Ekelman, K., Fenner-Crisp, P., Harvey, P., Hattis, D., Jacobs, A., Jacobson-Kram, D., Liteplo, R., Pelkonen, O., Rice, J., Somers, D., Turturro, A., West, W., and Olin, S. Issues in the design and interpretation of chronic toxicity and carcinogenicity studies in rodents: approaches to dose selection. Crit. Rev. Toxicol., 37: 729-837, 2007. 273. Ohnishi, T., Arnold, L.L., Clark, N.M., Wisecarver, J.L., and Cohen, S.M. Comparison of endothelial cell proliferation in normal liver and adipose tissue in B6C3F1 mice, F344 rats, and humans. Toxicol. Pathol., 35: 904-909, 2007. 274. Cohen, S.M. Inorganic and organic arsenic and bladder carcinogenesis. Toxicology Forum, 2007. 275. Cohen, S.M., and Arnold, L.L. Cell proliferation and carcinogenesis. J. Toxicol. Pathol., 21:1-7, 2008. 276. Nascimento, M.G., Suzuki, S., Wei, M., Tiwari, A., Arnold, L.L., Lu, X., Le, S.C. and Cohen, S.M. Cytotoxicity of combinations of arsenicals on rat urinary bladder urothelial cells in vitro. Toxicology, 249: 69-74, 2008. 277. Adams, T.B. Lucas Gavin, C., Taylor, S.V., Waddell, W.J., Cohen, S.M., Feron, V.J., Goodman, J., Rietjens, I.M.C.M., Marnett, L.J., Munro, I.C., Portoghese, P.S., and Smith, R.L. The FEMA GRAS assessment of a,X-unsaturated aldehydes and related substances used as flavor ingredients. Food Chem. Toxicol., 46:2935-2967, 2008. 278. Meek, M.E. (Bette), Berry, Sir C., Boobis, A.R., Cohen, S.M., Hartley, M., Mann, S., Olin, S., Schlatter, J., and Vickers, C. Letter to the editor. Re: Mode of action frameworks: a critical analysis, by K.E. Grayton et al., J. Toxicol. Environ. Health, Part B, 11:681-685, 2008. 279. Suzuki, S., Arnold, L.L., Ohnishi, T., and Cohen, S.M. Effects of inorganic arsenic on the rat and mouse urinary bladder. Toxicol. Sci., 106:350-363, 2008. 280. Cohen, S.M. Thresholds in Genotoxicity and Carcinogenicity: Urinary Bladder Carcinogenesis. Genes and Environment, 30:132-138, 2008. 281. Cohen, S.M., Arnold, L.L., and Emerson, J.L. Safety of saccharin. Agro Food Industry Hi-Tech., 19: 26-29, 2008. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-126F8iled: 04/06/15 Page: 115 of 151 PAGEID #: EXHIBIT 1 Curriculum Vitae Page 85 Samuel M. Cohen, M.D. Ph.D. 282. Suzuki, S., Arnold, L.L., Muirhead, D., Lu, X., Le, X.C., Bjork, J.A. , Wallace, K.B., Ohnishi, T., Kakiuchi-Kiyota,S., Pennington, K.L., and Cohen S.M. Inorganic arsenic induced intramitochondrial granules in mouse urothelium. Toxicol. Pathol., 36: 999 1005, 2008. 283. Smith, L.L., Brent, R.L., Cohen, S.M., Doerrer, N.G., Goodman, J.I., Greim, H., Holsapple, M.P., and Lightfoot-Dunn, R. M. Predicting future human and environmental health challenges: the Health and Environmental Sciences Institute's scientific mapping exercise. Crit. Rev. Toxicol., 38:817-845, 2008. 284. Petito-Boyce, C., Lewis, A.S., Sax, S.N., Eldan, M., Cohen, S.M., and Beck, B.D. Probabilistic analysis of human health risks associated with background concentrations of inorganic arsenic: use of a margin of exposure approach. Human Ecol. Risk Assess., 14:1159-1201, 2008. 285. Yamada, T, Uwagawa, S., Okuno, Y., Cohen, S., Kaneko, H. Case Study: An evaluation of the human relevance of the synthetic pyrethroid metofluthrin-induced liver tumors in rats based on mode of action. Toxicol. Sci.,108:59-68, 2009. 286. Tannehill-Gregg, S.H., Dominick, M.A., Reisinger, A.J., Moehlenkamp, J.D., Waites, C.R., Stock, D.A., Sanderson, T.P., Cohen, S.M., Arnold, L.L., and Schilling, B.E. Strain-related differences in urine composition of male rats of potential relevance to urolithiasis. Toxicol. Pathol., 37: 293-305, 2009. 287. Suzuki, S., Arnold, L.L., Pennington, K.L., Chen, B., Le, C., and Cohen, S.M. Effects of an epidermal growth factor receptor inhibitor on arsenic associated toxicity in the rat bladder epithelium. Toxicol. Letters, 187: 124-129,2009. 288. Kakiuchi-Kiyota, S., Vetro, J., Suzuki, S., Varney, M., Han, H., Nascimento, M., Pennington, K., Arnold, L., Singh, R., Cohen, S.M. Effect of the PPARy agonist troglitazone on endothelial cells in vivo and in vitro: Differences between human and mice. Toxicol. Appl. Pharm., 237: 83-90, 2009. 289. Suzuki, S., Arnold L.L., Pennington, K., Kakiuchi-Kiyota, S., and Cohen, S.M. Effects of co-administration of dietary sodium arsenite and a NADPH oxidase inhibitor on the rat bladder epithelium. Toxicology, 261: 241-46, 2009. 290. Cohen, S.M., Storer, R.D., Criswell, K.A., Doerrer, n.g., Dellarco, V.L., Pegg, D., Wojcinski, Z., Malarkey, D.E., Jacobs, A.C., Klaunig, J.E., Swenberg, J.A., and Cook, J.C. Hemangiosarcoma in rodents: mode of action evaluation and human relevance. Toxicol Sci., 111: 4-18, 2009. 291. Hard, G.C., Johnson, K.J., and Cohen, S.M. A comparison of rat chronic progressive nephropathy (CPN) with human renal disease-implications of human risk assessment. Crit. Rev. Toxicol., 39: 332-346, 2009. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 116 of 151 PAGEID #: 42269 EXHIBIT 1 Curriculum Vitae Page 86 Samuel M. Cohen, M.D. Ph.D. 292. Boobis, A.R., Cohen, S.M., Doerrer, N.G., Galloway, S.M., Haley, P.J., Hard, G.C., Hess, MacDonald, J.S., Thibault, S., Wolf, D.C., and Wright, J. A data-based assessment of alternative strategies for identification of potential human cancer hazards. Toxicol. Pathol., 37:714-732, 2009. 293. Smith, R.L., Waddell, W.J., Cohen, S.M., Feron, V.J., Marnett, L.J., Portoghese, P.S., Rietjens, I.M.C.M., Adams, T.B., Lucas Gavin, C., McGowen, M.M., Taylor, S.V., and Williams, M.C.. GRAS flavoring substances 24. Food Technol., p.46-105, 2009. 294. Cohen, S.M. An enhanced thirteen-week bioassay as an alternative to screening for carcinogenesis factors. Asian Pac. J. Cancer Prev., 10 (DIMS Suppl.): 13-15, 2010. 295. Suzuki, S., Arnold, L.L., Pennington, K.L., Kakiuchi-Kiyota, S., Wei, M., Wanibuchi, H., and Cohen, S.M. Effect of pioglitazone, a peroxisome proliferator- activated receptor gamma agonist, on urine and urothelium of the rat. Toxicol. Sci., 113:349 357, 2010. 296. Suzuki, S., Arnold, L.L., Pennington, K.L., Chen,B., Naranmandura, H., Le, X.C., and Cohen, S.M. Dietary administration of sodium arsenite to rats: Relation between dose and urinary concentrations of methylated and thio-metabolites and effects on the rat urinary bladder epithelium. Toxicol. Appl. Pharm., 244:99-105, 2010. 297. Cohen, S.M. Evaluation of possible carcinogenic risk to humans based on liver tumors in rodent assays: The two year bioassay is no longer necessary. Toxicol. Pathol., 38:487-501, 2010. 298. Zlotta, A.R., Cohen, S.M., Dinney, C., Droller, M., van der Kwast., T.H., van Rhizjn, B.W.G., Bochner, B., Ameil, G., and Jewett, M.A.S. Overview of risks for and causes of bladder cancer. Urol. Oncol., 28:329-333, 2010, 299. Yokohira, M., Arnold, L.L., Pennington, K.L., Suzuki, S., Kakiuchi-Kiyota, S., Herbin Davis, K., Thomas, D.J., and Cohen, S.M. Severe systemic toxicity and urinary bladder cytotoxicity and regenerative hyperplasia induced by arsenite in arsenic (+3 oxidation state) methyltransferase knockout mice. A preliminary report. Toxicol. Appl. Pharm., 246:1-7, 2010. 300. Cohen, S.M. An enhanced 13-week bioassay: An alternative to the 2 year bioassay to screen for human carcinogenesis. Exp. Toxicol. Pathol., 11:15-17, 2010. 301. Cohen, S.M., Gordon, E.B., Singh, P., Arce, G.T., and Nyska, A. Carcinogenic mode of action of folpet in mice and evaluation of its relevance to humans. Crit. Rev. Toxicol., 40:531-545, 2010. 302. Arce, G.T., Gordon , E.B., Cohen, S.M., and Singh, P. Genetic toxicology of folpet and captan. Crit. Rev. 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Kakiuchi-Kiyota, S., Arnold, L.L., Yokohira, M., Suzuki, S., Pennington, K.L., and Cohen, S.M. Evaluation of PPARy agonists on rodent endothelial cell proliferation. Toxicology, 287:91-98, 2011. 311. Cohen, S.M., Ward, J.M., Camargo, J., Shirai, T., Tsuda, H., and Fukushima, S. Nobuyuki Ito, M.D., Ph.D. (Obituary). Toxicol. Pathol., 39:905-906, 2011. 312. Nukolova, N.V., Oberoi, H.S., Cohen, S.M., Kabanov, A.V., and Bronich, T.K. Folate decorated nanogels for targeted therapy of ovarian cancer. Biomaterials, 32:5417-5426, 2011. 313. Cohen, S.M. Letter to the Editor, Re: "Reversal and prevention of arsenic-induced human bronchial epithelial cell malignant transformation by microRNA-200b" by Wang et al., Toxicol. Sci., 122:606, 2011. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-127F1iled: 04/06/15 Page: 118 of 151 PAGEID #: EXHIBIT 1 Curriculum Vitae Page 88 Samuel M. Cohen, M.D. Ph.D. 314. Yokohira, M., Arnold, L.L., Pennington, K.L., Suzuki, S, Kakiuchi-Kiyota, S., Herbin Davis, K., Thomas, D.J., and Cohen, S.M. Effect of sodium arsenite dose administered in the drinking water on the urinary bladder epithelium of female arsenic (+3 oxidation state) methyltransferase knockout mice. Toxicol. Sci., 121:257-266, 2011. 315. Adams, T.B., Lucas-Gavin, C., McGowen, M.M., Waddell, W.J., Cohen, S.M. Feron, V.J., Goodman, J.I., Marnett, L.J., Munro, I.C., Portoghese, P.S., Rietjens, I.M.C.M., and Smith, R.L. The FEMA GRAS assessment of aliphatic and aromatic terpene hydrocarbons used as flavor ingredients. Food Chem. Toxicol., 49:2471-2494, 2011. 316. Smith, R.L., Waddell, W.J., Cohen, S.M., Fukushima, S., Gooderham, N.J., Hecht, S. S., Marnett, L.J., Portoghese, P.S., Rietjens, I.M.C.M., Adams, T.B., Lucas Gavin, C., McGowen, M.M., and Taylor, S.V. Recent progress in the consideration of flavoring ingredients under the food additives amendment. 25. GRAS flavoring substances, Food Technol., 65:44-75, 2011. 317. Gordon, E., Cohen, S.M., Arce, G., and Singh, P. Folpet-induced short term cytotoxic and proliferative changes in the mouse duodenum. Toxicol. Mechanisms Methods, 22:54-59, 2011. 318. Kakiuchi-Kiyota, S., Arnold, L.L., Yokohira, M., Koza-Taylor, P., Suzuki, S., Varney, M., Pennington, K.L., and Cohen, S.M. Evaluation of direct and indirect effects of the PPARy agonist troglitazone on mouse endothelial cell proliferation, Toxicol. Pathol., 39:1032-1045, 2011. 319. Chen, B., Arnold, L.L., Cohen, S.M., Thomas, D.J., and Le, X.C. Mouse arsenic (+3 oxidation state) methyltransferase genotype affects metabolism and tissue dosimetry of arsenicals after arsenite administration in drinking water. Toxicol. Sci., 124:320-326, 2011. 320. Ogawa, K., Mamiya, S., Sato, S., Naiki-Ito, A., Suzuki, S., Takahaski, S., Cohen, S.M., and Shirai, T. 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Relationship of metabolism and cell proliferation to the mode of action of fluensulfoneinduced mouse lung tumors: analysis of their human relevance using the IPCS framework. Toxicol. Sci., 128:284-294, 2012. 324. Oberoi, H.S., Nukolova, N.V., Zhao, Y., Cohen, S.M., Kabanov, A.V., and Bronich, T.K. Preparation and in vivo evaluation of dichloro(1,2-diaminocyclohexane) platinum(II) (DACHPt)-loaded core cross-linked polymer micelles. Chemother. Res. Pract., 2012:1-10, 2012. 325. Suzuki, S., Arnold, L.L., Pennington, K.L., Kakiuchi-Kiyota, S., Chen, B., Le, X.C., and Cohen, S.M. Effects of co-administration of dietary sodium arsenate and 2,3dimercaptopropane-1-sulfonic acid (DMPS) on the rat bladder epithelium. Toxicol., 299:155-159, 2012. 326. Roy, V., McMillan, J., Alnouti, Y., Gautum, N., Smith, N., Balkundi, S., Dash, P., Gorantia, S., Martinez-Skinner, A., Meza, J., Kanmogne, G., Swindells, S., Cohen, S.M., Mosley, R.L., Polucktova, L., and Gendelman, H. Pharmacodynamics and antiviral efficacy of combination nanoformulated antiretroviral therapy in HIV-1infected human PBL-reconstituted mice. J. Infect. Dis., 206:1577-1588, 2012. 327. Da Rocha, M.S., Arnold, L.L., Pennington, K.L., Muirhead, D., Dodmane, P.R., Anwar, M.M., Battallora, M., Camargo, J., and Cohen, S.M. Diuron-induced rat bladder epithelial cytotoxicity. Toxicol. Sci., 130:281-288, 2012. 328. Cohen, S.M. Urinary bladder carcinogenesis by DNA reactive and non-reactive chemicals: non-linearities and thresholds. Genes Environ., 34:165-170, 2012. 329. Bomhard, E.M., Gelbke, H.-P., Williams, G.M., and Cohen, S.M. Evaluation of the male reproductive toxicity of gallium arsenide. Reg. Toxicol. Pharmacol., 64:77-86, 2012. 330. Dodmane, P.R., Arnold, L.L., Pennington, K.L., Thomas, D.J., and Cohen, S.M. Effect of dietary treatment with dimethylarsinous acid (DMAIn) on the urinary bladder epithelium of arsenic (+3 oxidation state) methyltransferase (As3mt) knockout and C7BL/6 wild type female mice. Toxicology, 305:130-135, 2013. 331. Hard, G., Banton, M.I., Bretzlaff, R.S., Dekant, W., Fowles, J., Mallett, A.K., McGregor, D., Roberts, K.M., Sielken, R.L., Valdez-Flores, C., and Cohen, S.M. Consideration of rat chronic progressive nephropathy (CPN) in regulatory evaluations for carcinogenicity. Toxicol. Sci., 132:268-275, 2013. 332. Bomhard, E.M., Gelbke, H.-P., Schenk, H., Williams, G.M., and Cohen, S.M. Evaluation of the carcinogenicity of gallium arsenide. Crit. Rev. Toxicol., 43:436-466, 2013. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 120 of 151 PAGEID #: 42273 EXHIBIT 1 Curriculum Vitae Page 90 Samuel M. Cohen, M.D. Ph.D. 333. Kakiuchi-Kiyota, S., Crabbs, T.A., Arnold, L.L., Pennington, K.L., Cook, J.C., Malarkey, D.E., and Cohen, S.M. Evaluation of expression profiles of hematopoietic stem cell, endothelial cell, and myeloid cell antigens in spontaneous and chemically induced hemangiosarcomas and hemangiomas in mice. Toxicol. Pathol., 41:709-721, 2013. 334. Wedel, W.R., Muirhead, D.E., Arnold, L.L., Dodmane, P., Maness-Harris, L., Hoyt, R., and Cohen, S.M. Urothelial cell intracytoplasmic inclusions after treatment of promyelocytic leukemia with arsenic trioxide. Toxicol. Sci., 134:271-275,2013. 335. Cohen, S.M., Dodmane, P., and Arnold, L.L. Comments, RE: Banarjee et al., High arsenic in rice is associated with elevated genotoxic effects in humans. Nature Scientific Reports, 2013. 336. Chen, B., Lu, X., Shen, S., Arnold, L.L., Cohen, S.M., and Le, X.C. Arsenic speciation in the blood of arsenite-treated F344 rats. Chem. Res. Toxicol., 26:952-962, 2013. 337. Marnett, L.J., Cohen, S.M., Fukushima, S., Gooderham, N.J., Hecht, S.S., Rietjens, I. M.C.M., Smith, R.L., Adams, T.B., Hallagan, J.B., Harman, C., McGowen, M.M., and Taylor, S.V. GRAS Flavoring Substances 26. Food Toxicology, 67:38-56, 2013. 338. Cohen, S.M., Arnold, L.L., Beck, B.D., Lewis, A.S., and Eldan, M. Evaluation of the carcinogenicity of inorganic arsenic. Crit. Rev. Toxicol., 43:711-752, 2013. 339. Liu, L., Kakiuchi-Kiyota, S., Arnold, L.L., Johansson, S.L., Wert, D., and Cohen, S.M. Pathogenesis of human hemangiosarcomas and hemangiomas. Human Pathol., 44:2302-2311, 2013. 340. Desale, S.S., Cohen, S.M., Zhao, Y., Kabanov, A.V., and Bronich, T.K. Biodegradable hybrid polymer micelles for combination drug therapy in ovarian cancer. J. Controlled Release, 171:339-348, 2013. 341. Dodmane, P.R., Arnold, L.L., Kakiuchi-Kiyota, S., Qiu, F., Liu, X., Rennard, S.I., and Cohen, S.M. Cytotoxicity and gene expression changes induced by inorganic and organic trivalent arsenicals in human cells. Toxicology, 312:18-29, 2013. 342. DaRocha, M.S., Arnold, L.L., Dodmane, P.R., Pennington, K.L., Qui, F., de Camargo, J. L.V., and Cohen, S.M. Duiron metabolites and urothelial cytotoxicity: In vivo, in vitro and molecular approaches. Toxicology, 314:238-246, 2013. 343. Dodmane, P.R., Arnold, L.L., Muirhead, D. E., Suzuki, S., Yokohira, M., Pennington, K. L., Lu, X., Le, X.C., and Cohen, S.M. Characterization of intracellular inclusions in the urothelium of mice exposed to inorganic arsenic. Toxicol. Sci., 137:36-46, 2014. 344. Dodmane, P.R., Arnold, L.L., Pennington, K.L., and Cohen, S.M. Orally administered nicotine induces urothelial hyperplasia in rats and mice. Toxicology, 315:49-54, 2014. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-127F4iled: 04/06/15 Page: 121 of 151 PAGEID #: EXHIBIT 1 Curriculum Vitae Page 91 Samuel M. Cohen, M.D. Ph.D. 345. Dodmane, P.R., Arnold, L.L., and Cohen, S.M. Mode of action for inorganic arsenic toxicity and carcinogenesis. Chinese Cancer Bulletin, 59: 1078-1082, 2014. 346. DaRocha, M.S., Arnold, L.L., De Oliveira, M.L.C.S., Ihlasch, S.M., Cardoso, A.P.F., Pontes, M.G.N., Dodmane, P.R., Cohen, S.M., and de Camargo, J.L.V. Diuron-induced rat urinary bladder carcinogenesis: mode of action and human relevance evaluation using the International Programme on Chemical Safety framework. Crit. Rev. Toxicol., 44: 393-406, 2014. 347. Arnold, L.L., Suzuki, S., Yokohira, M. Kakiuchi-Kiyota, S., Pennington, K.L., and Cohen, S.M. Time course of urothelial changes in rats and mice orally administered arsenite. Toxicol. Pathol., 42: 855-862, 2014. 348. Pastoor, T., Bachman, A., Bell, D., Cohen, S.M., Dellarco, M., Dewhurst, I., Doe, J., Doerrer, N., Embry, M., Hines, R., Moretto, A., Phillips, R., Rowlands, J.C., Tanir, J.Y., and Wolf, D., and Boobis, A. A 21st century roadmap for human health risk assessment. Crit. Rev. Toxicol., 44(S3): 1-5, 2014. 349. Embry, M.R., Bachman, A., Bell, D., Boobis, A., Cohen, S.M., Dellarco, M., Dewhurst, I. , Doerrer, N., Hines, R., Moretto, A., Pastoor, T., Phillips, R., Rowlands, J.C., Tanir, J. Y., Wolf, D., and Doe, J. Risk assessment in the 21st century (Risk21): Roadmap and matrix. Crit. Rev. Toxicol., 44(S3): 6-16, 2014. 350. Simon, T., Simons, Jr., S.S., Preston, R.J., Boobis, A.R., Cohen, S.M., Doerrer, N.G., Fenner-Crisp, P.A., McMullin, T., McQueen, C.A., and Rowlands, J.C. The use of mode of action information in risk assessment: quantitative key events/dose-response framework (Q-KEDRF) for modeling the dose-response for key events. Crit. Rev. Toxicol., 44(S3): 17-43, 2014. 351. Cohen, S.M., Arnold, L.L., Klaunig, J.E., and Goodman, J.I. Letter to the Editor, Re: Lung tumors in mice induced by "whole-life" inorganic arsenic exposure at human relevant doses, by Waalkes et al. Arch. Toxicol., 88: 2061-2062, 2014. 352. Yamada, T., Okuda, Y., Kushida, M., Sumida, K., Takeuchi, H., Nagahori, H., Fukuda, T., Lake, B.G., Cohen, S.M., and Kawamura, S. Human hepatocytes support the hypertrophic but not the hyperplastic response to the murine nongenotoxic hepatocarcinogen sodium phenobarbital in an in vivo study using a chimeric mouse with humanized liver. Toxicol. Sci., 142: 137-157. 2014. b. Articles accepted for publication in scholarly journals: 1. Marnett, L.F., Cohen, S.M., Fukushima, S., Gooderham, N.J., Hecht, S.S., Rietjens, I.M.C.M., Smith, R.R., Adams, T.B., Bastaki, M., Harman, C.L., McGowan, M.M., and Taylor, S.V. GRASr2 evaluation of aliphatic acyclic and alicyclic terpenoid tertiary Case: 2:13-md-02433-EAS-EPD Doc #: 280472-127F5iled: 04/06/15 Page: 122 of 151 PAGEID #: EXHIBIT 1 Curriculum Vitae Page 92 Samuel M. Cohen, M.D. Ph.D. alcohols and structurally related substances used as flavoring ingredients. J. Food Sci., in press. 2. Rietjens, I.M.C.M., Cohen, S.M., Fukushima, S., Gooderham, N.J., Hecht, S., Marnett, L. J., Smith, R.L., Adams, T.B., Bastaki, M., Harman, C.L., and Taylor, S.V. The impact of structureal and metabolic variation on the toxicity and carcinogenicity of hydroxy- and alkoxy-substituted allyl- and propenylbenzenes. Chem. Res. Toxicol., in press. 3. Cohen, S.M., Arnold, L.L., Klaunig, J.E., and Goodman, J.I. Letter to the Editor, Re: Waalkes et al., Response to Cohen et al., Arch. Toxicol., in press. 4. Wood, C.E., Hukkanen, R.R., Sura, R., Boyce, R., Jacobson-Kram, D., Nolte, T., Odin, M. , and Cohen, S.M. Scientific and regulatory policy committee (SRPC) review: Interruption and use of cellular proliferation in cancer risk assessment, in press. c. Articles submitted for publication in scholarly journals: 1. Adams, T.B., Cohen, S.M., Fukushima, S., Gooderham, N.J., Hecht, S.S., Marnett, L.J., Portoghese, P.S., Rietjens, I.M.C.M., Smith, R.L., Waddell, W.J., and Taylor, S.V. The FEMA GRAS assessment of allyl esters used as flavor ingredients. Submitted. 2. Marnett, L.J., Cohen, S.M., Fukushima, S., Gooderham, N.J., Hecht, S.S., Rietjens, I.M.C.M., Smith, R.L., Adams, T.B., Bastaki, M., Harman, C.L., McGoven, M.M., and Taylor, S.V. GRASr evaluation of substituted thiophenes used as flavoring ingredients. Submitted. 3. Smith R.L., Cohen, S.M., Fukushima, S., Gooderham, N.J., Hecht, S.S., Marnett, L.J., Rietjens, I.M.C.M., Adams, T.B., Bastaki, M., Harman, C.L., McGowan, M.M., and Taylor, S.V. The Safety Evaluation of Food Flavoring Substances: The Role of Metabolic Studies. Submitted. 4. Dodmane, P.R., Arnold, L.L., Pennington, K.L., Cardoso, A.P.F., and Cohen, S.M. Effect of trivalent arsenicals on mouse and human microvascular endothelial cells. Submitted. 5. Ptaszynska, A., Cohen, S.M., Messing, E.M., Reilly, T., Johnsson, E., and Johnsson, K. Assessing bladder cancer risk in type 2 diabetes clinical trials: a case study from the dapagliflozin drug development program. Submitted. 6. Desale, S.S., Raja, S.M., Kim, J.O., Mohapatra, B., Soni, K.S., Luar, H., Williams, S.H., Storek, M., Band, V., Cohen, S.M., Band, H., and Bronich, T.K. Polypeptide-based nanogels co-encapsulating synergistic combination of doxorubicin with 17-AAG show potent anti-tumor activity in ErbB-2-driven breast cancer models. Submitted. d. Books published: None e. Chapters in books: Case: 2:13-md-02433-EAS-EPD Doc #: 280472-127F6iled: 04/06/15 Page: 123 of 151 PAGEID #: EXHIBIT 1 Curriculum Vitae Page 93 Samuel M. Cohen, M.D. Ph.D. 1. Cohen, S.M. Toxicity and carcinogenicity of nitrofurans. In: G.T. Bryan (ed.), Carcinogenesis, Vol. 4: Nitrofurans, Raven Press, New York, NY, 1978, pp. 171-231. 2. Cohen, S.M., and Friedell, G.H. Neoplasms of the urinary system. In: H.L. Foster, J.D. Small and J.G. Fox (eds.), The Mouse in Biomedical Research, Vol. IV, Experimental Biology and Oncology, Academic Press, New York, NY, 1982, pp. 439 463. 3. Cohen, S.M., Greenfield, R.E., and Friedell, G.H. Urinary bladder carcinogenesis. In: H.L. Loachim (ed.), Pathobiology Annual 1982, Vol. 12, Raven Press, New York, NY, 1982, pp. 267-280. 4. Zenser, T.V., Cohen, S.M., Mattammal, M.B., Murasaki, G., and Davis, B.B. Role of prostaglandin endoperoxide synthetase in benzidine and 5-nitro-furan-induced kidney and bladder carcinogenesis. In: Prostaglandin and Cancer, First Intl. Conf., Alan R. Liss, Inc., New York, NY, 1982, 123-141. 5. Friedell, G.H., Nagy, G.K., and Cohen, S.M. Pathology of human bladder and cancer and related lesions. In: S.M. Cohen and G.T. Bryan (eds.), The Pathology of Bladder Cancer, Vol. I, CRC Press, Boca Raton, FL, 1983, pp. 11-42. 6. Cohen, S.M. Pathology of experimental bladder cancer in rodents. In: S.M. Cohen and G.T. Bryan (eds.), The Pathology of Bladder Cancer, Vol. II, CRC Press, Boca Raton, FL, 1983, pp. 1-40. 7. Jacobs, J.B., Cohen, S.M., and Friedell, G.H. Scanning electron microscopy of the lower urinary tract. In: S.M. Cohen and G.T. Bryan (eds.), The Pathology of Bladder Cancer, Vol. II, CRC Press, Boca Raton, FL, 1983, pp. 141-181. 8. Cohen, S.M., Murasaki, G., Ellwein, L.B., and Greenfield, R.E. Tumor promotion in bladder carcinogenesis. In: T.J. Slaga (ed.), Mechanisms of Tumor Promotion, Vol. I, CRC Press, Boca Raton, FL, 1983, pp. 131-149. 9. Cohen, S.M. Promotion of urinary bladder carcinogenesis. In: Organ and species specificity in chemical carcinogenesis, R. Langenbach, S. Nesnow and J.M. Rice (eds.), Basic Life Sciences, Plenum Press, New York, NY, 1983, 24: pp. 253-272. 10. Cohen, S.M. Multi-stage carcinogenesis in urinary bladder. In: Scientific Review Panel, "Saccharin: An Update," May, 1983. 11. Cohen, S.M., Greenfield, R.E., Jacobs, J.B., and Friedell, G.H. Precancerous and non invasive lesions of the urinary bladder. In: R.L. Carter (ed.), Preneoplastic States, Oxford University Press, 1984, pp. 278-303. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-127F7iled: 04/06/15 Page: 124 of 151 PAGEID #: EXHIBIT 1 Curriculum Vitae Page 94 Samuel M. Cohen, M.D. Ph.D. 12. Zenser, T.V., Mattammal, M.B., Cohen, S.M., Palmier, M.O., Wise, R.W., and Davis, B.B. Molecular mechanism of chemically-induced transitional cell carcinoma: Co oxidation by prostaglandin H synthase. In: H. Thaler-Dao, et al. (eds.), Icosanoids and Cancer, Raven Press, New York, NY, 1984, pp. 71-78. 13. Cohen, S.M., Hasegawa, R., Greenfield, R.E., and Ellwein, L.B. Urinary bladder carcinogenesis. In: M. Borzsonyi, K. Lapis, N.E. Day and H. Yamasaki (eds.), IARC Scientific Publications, Models, Mechanisms and Etiology of Tumour Promotion, Lyon, International Agency for Research on Cancer, 1984, 56: pp. 93-108. 14. Zenser, T.V., Cohen, S.M., and Davis, B.B. On a mechanism for activation of nephrotoxins and urinary tract carcinogens. In: P. Bach (ed.), Renal Heterogeneity and Target Cell Toxicity: Proceedings of the Second International Symposium in Nephrotoxicity. International Symposium of Nephrotoxicity, 1984: University Surrey, UK. Wiley, Chicchester, England, pp. 175-178. 15. Cohen, S.M., Ellwein, L.B., and Johansson, S.L. Bladder tumor promotion. In: B.E. Butterworth and T.J. Slaga, (eds.), Banbury Report 25: Nongenotoxic Mechanisms in Carcinogenesis, Cold Spring Harbor Laboratory, New York, NY, 1987, 55-67. 16. Johansson, S.L., and Cohen, S.M. Premalignant and non-invasive lesions of the urinary bladder. In: E.K. Weisburger (ed.), Mechanisms of Carcinogenesis, H.E. Kaiser (series ed.), Cancer Growth and Progression, Vol. 2, Kluwer Academic Publishers, Dordrecht, Netherlands, 1989, pp. 43-50. 17. Cohen, S.M., and Ellwein, L.B. Cell growth dynamics and DNA alterations in carcinogenesis. In: S.H. Moolgavkar (ed.), Scientific Issues in Quantitative Cancer Risk Assessment. Societal Institute of the Mathematical Sciences, 1990, pp. 116-135. 18. Cohen, S.M. Analysis of modifying factors in chemical carcinogenesis. In: N. Ito (ed.), Modification of Tumor Development of Rodents, Progress in Experimental Tumor Research, Vol. 33, Karger and Basel, New York, NY, 1991, pp. 21-40. 19. Cohen, S.M., and Ellwein, L.B. Cell proliferation and bladder tumor promotion. In: B.E. Butterworth, T.J. Slaga, W. Farland, M. McClain (eds.), Chemically Induced Cell Proliferation, Vol. 369, Wiley-Liss Publishers, New York, NY, 1991, pp. 347-355. 20. Cohen, S.M., Garland, E.M., and Ellwein, L.B. Cancer enhancement by cell proliferation. In: R. D'Amato, T.J. Slaga, W. Farland and C. Henry (eds.), Relevance of Animal Studies to Evaluate Human Cancer Risk; Progress in Clinical and Biological Research Series, 1992, Vol. 374, pp. 213-229. 21. Cohen, S.M., and Ellwein, L.B. Cell proliferation in carcinogenesis. In: J.H. Lehr, (ed.), Rational Readings on Environmental Concerns, Van Nostrand Reinhold, NY, 1992, pp. 167-181. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-127F8iled: 04/06/15 Page: 125 of 151 PAGEID #: EXHIBIT 1 Curriculum Vitae Page 95 Samuel M. Cohen, M.D. Ph.D. 22. Cohen, S.M., and Johansson, S.L. Epidemiology and etiology of bladder cancer. In: Urologic Clinics of North America, W.B. Saunders Co., Philadelphia, PA, 1992, 19: 421-428. 23. Cohen, S.M., Okamura, T., Garland, E.M., and Johansson, S.L. Susceptibility of the urinary bladder and ureter to toxic substances. In: U. Mohr, D.L. Dungworth and C.C. Capen (eds.), Pathobiology of the Aging Rat, Vol. 1, Blood and Lymphoid, Respiratory, Urinary, Cardiovascular, and Reproductive Systems. International Life Sciences Institute (ILSI) Monograph Series, 1992, pp. 285-298. 24. Swenberg, J.A., Dietrich, D.R., McClain, R.M., and Cohen, S.M. Species-specific mechanisms of carcinogenesis. In: H. Vainio, P.N. Magee, D.B. McGregor and A.J. McMichael (eds.), Mechanisms of Carcinogenesis in Risk Identification, IARC, Lyon, 1992, pp. 477-500. 25. Frith, C.H., Greenman, D.L., and Cohen, S.M. Urinary bladder carcinogenesis in the rodent. In: M.P. Waalkes and J.M. Ward (eds.), Target Organ Toxicology Series, Carcinogenesis, Raven Press, Ltd., New York, NY, 1994, 161-197. 26. Frith, C.H., Eighmy, J.J., Fukushima, S., Cohen, S.M., Squire, R.A., and Chandra, M. Proliferative lesions of the lower urinary tract in rats. URG-2. In: Guides for Toxicologic Pathology, STP/ARP/AFIP, Washington, D.C., 1995, pp. 1-13. 27. Cohen, S.M., and Ellwein, L.B. Biological theory of carcinogenesis: Implications for risk assessment. In: S. Olin, W. Farland, C. Park, L. Rhomberg, R. Scheuplein, T. Starr and J. Wilson (eds.), Low-dose Extrapolation of Cancer Risks: Issues and Perspectives. International Life Sciences Institute (ILSI) Monograph Series, 1995, pp. 145-161. 28. Garland, E.M., and Cohen, S.M. Saccharin-induced bladder cancer in rats. In: R.M. McClain, T.J. Slaga, R. Le Boerf and H. Pitot (eds.), Growth Factors and Tumor Promotion, Prog. Clin. Biol. Res., Vol. 391, Wiley-Liss, NY, 1995, pp. 237-243. 29. Johannson, S.L., and Cohen, S.M. Lower urinary tract. In: I. Damjanov and J. Linder (eds.), Anderson's Pathology, Vol. 2, Mosby, New York, 1996, pp. 2143-2165. 30. Cohen, S.M. The role of cell proliferation in the etiology of neoplasia. In: G.T. Bowden and S.M. Fisher, (eds.), Chemical Carcinogens and Anticarcinogens, Vol. 12 of Comprehensive Toxicology, Sipes, I.G., Gandolfi, A.J., and McQueen, C.A. (series eds.), Pergamon (Elsevier), Amsterdam, 1997, pp. 401-424. 31. Foran, J.A., and ILSI Risk Science Institute Working Group on Dose Selection. Principles for the selection of doses in chronic rodent bioassays. ILSI Press, Washington, D.C., 1997. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-127F9iled: 04/06/15 Page: 126 of 151 PAGEID #: EXHIBIT 1 Curriculum Vitae Page 96 Samuel M. Cohen, M.D. Ph.D. 32. Johansson, S.L., and Cohen, S.M. Pathology of bladder cancer. In: D. Raghaven, H I. Scher, S.A. Leibel and P. Lang (eds). Principles and Practice of Genitourinary Oncology, J.B. Lippincott Co., 1997, pp. 207-213. 33. Cohen, S.M. Urinary system. In: T.C. Jones, U. Mohr and R.D. Hunt (eds.), Monographs on Pathology of Laboratory Animals, International Life Sciences Institute, Springer-Verlag, 1998, pp. 420-426. 34. Frith, C.H., Chandra, M., and Cohen, S.M. Urinary system. In: T.C. Jones, U. Mohr and R.D. Hunt (eds.), Monographs on Pathology of Laboratory Animals, International Life Sciences Institute, Springer-Verlag, 1998, pp. 427-430. 35. Cohen, S.M. Infection, cell proliferation, and malignancy. In: J. Parsonnet and S. Horning (eds.), Microbes and Malignancy: Infection as a Cause of Cancer. Oxford University Press, 1999, pp. 89-106. 36. Johansson, S.L., and Cohen, S.M. The pathology of bladder cancer. In: K.N. Syrigos and D.G. Skinner (eds.), Bladder Cancer: Biology, Diagnosis and Management. Oxford University Press, Oxford, Great Britain, 1999, pp. 97-123. 37. Cohen, S.M., Arnold, L.L., St. John, M.K., and Cano, M. Evaluation of cell proliferative activity in the rat urinary bladder after feeding high doses of cacodylic acid. In: W.R. Chappell, C.O. Abernathy and R.L. Calderon (eds.), Arsenic Exposure and Health Effects. Elsevier Science Ltd., Oxford, UK, 1999, pp. 253-262. 38. International Agency for Research on Cancer. Saccharin and its salts. Some Chemicals That Cause Tumours of the Kidney or Urinary Bladder in Rodents and Some Other Substances. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, 1999, Vol. 73, pp. 517-624. 39. Cohen, S.M. Cell proliferation as a basis for genetic errors in carcinogenesis. In: S.M. Cohen, O. Hino, T. Ishikawa, H. Nakagama, T. Shirai, and T. Sugimura (eds.). New Frontiers in Mechanistic Cancer Research in Animal Models. Extended Abstracts for the 30th International Symposium of the Princess Takamatsu Cancer Research Fund, Tokyo, 1999, pp. 72-76. 40. Cohen, S.M., and Johansson, S.L. Etiology and prevention of bladder neoplasia. In: J.C. Angulo, and J.I. Lopez (eds.), Management of High Risk Superficial Urothelial Carcinoma. Urologia Integrada y de Investigacion, Barcelona, 2001, pp. 3-11. 41. Cohen, S.M., Cano, M., St. John, M.K., Ryder, P.C., Uzvolgyi, E., and Arnold, L.L. The carcinogenicity of dimethylarsinic acid (DMA) in rats. Arsenic Exposure and Health Effects. Elsevier Science Ltd., Oxford, UK, 2001, pp. 277-283. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-128F0iled: 04/06/15 Page: 127 of 151 PAGEID #: EXHIBIT 1 Curriculum Vitae Page 97 Samuel M. Cohen, M.D. Ph.D. 42. Cohen, S.M., Wanibuchi, H., and Fukushima, S. Lower urinary tract. In: W.M. Haschek, C.G. Rousseaux, and M.A. Wallig (eds.), Handbook of Toxicologic Pathology, 2ndEd., Vol. 2, Academic Press, San Diego, 2002, pp. 337-361. 43. Cohen, S.M., Le, C., Lu, X., Cano, M., and Arnold, L.L. Carcinogenicity of dimethylarsinic acid (DMAV). In: W.R. Chappell, C.O. Abernathy, R.L. Calderon, D.J. Thomas (eds.), Arsenic Exposure and Health Effects V, Elsevier Press, San Diego, 2003, pp.321-335. 44. Cohen, S.M., and Johansson, S.L. Prevencin de las neoplasias vesicales. In: Angulo, J. and Berenguer, A. (eds.), Cncer De Vejiga. Historia Natural Biologa Teraputica, Schering Espaa, S.A., Madrid, 2004. 45. Abrahams, N.A., Cohen, S.M., and Johansson, S.L. Premalignant and non-invasive lesions of the urinary bladder. In: Coppola, D., and Weisburger, E.K. (eds.), Cancer Growth and Progression, Volume II. Mechanisms of Carcinogenesis. Kluwer Academic Publishers. Vol. 2, pp. 1-17, 2007. 46. Cohen, S.M., Arnold, L.L., and Suzuki, S. Urinary tract calculi and bladder tumors. In: Hsu, C.-H. and Stedeford, T. (Eds), Cancer Risk Assessment. John Wiley & Sons, Inc., Hoboken, NJ, p. 501-514, 2010. 47. Cohen, S.M. The role of cell proliferation in the etiology of neoplasia. In: Roberts, R. (Ed.), Chemical Carcinogenesis. In: McQueen, C. (Editor-in-Chief), Comprehensive Toxicology, 2nd Edition, Elsevier, Oxford, United Kingdom, Vol. 14., p. 229-253, 2010. 48. Cohen, S.M. Lower urinary tract. In: Hascheck-Hock, W.M., Rousseaux, C.G., and Wallig, M.A. (Eds). Haschek and Rousseaux's Handbook of Toxicologic Pathology. Edition 3. Elsevier, Inc., Academic Press, p. 1775-1793, 2013. 49. Singh, P., Cohen, S.M., and Gordon, E. Folpet. In: Wexler, P. (Ed.), Encyclopedia of Toxicology, 3rdEdition, Vol. 2, Elsevier, Inc., Academic Press, p. 619-621. f. Books edited: 1. Bryan, G.T., and Cohen, S.M. (eds.). The Pathology of Bladder Cancer. Vol. I and II. CRC Press, Boca Raton, FL, 1983. 2. Cohen, S.M., Hino, O., Ishikawa, T., Nakagama, H., Shirai, T., and Sugimura, T. (eds.). New Frontiers in Mechanistic Cancer Research in Animal Models. Extended Abstracts for the 30th International Symposium of the Princess Takamatsu Cancer Research Fund, Tokyo, 1999. 3. International Task Force for the Development of PPARS. White Paper on the Development of PPAR Agonists. International Atherosclerosis Society, 2005. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-128F1iled: 04/06/15 Page: 128 of 151 PAGEID #: EXHIBIT 1 Curriculum Vitae Page 98 Samuel M. Cohen, M.D. Ph.D. g. Abstracts: 1. Cohen, S.M., Price, J.M., Ansfield, F.J., and Bryan, G.T. Carcinogenicity of 2-(2formylhydrazino)-2-(5-nitro-2-furyl)-thiazole (FNT) and structurally related compounds. Proc. Amer. Assoc. Cancer Res., 10: 15, 1969. 2. Erturk, E., Cohen, S.M., and Bryan, G.T. Comparative carcinogenicity of amino and N-acetylamino-5-nitrofuran compounds in the rat. Fed. Proc., 29: 817, 1970. 3. Cohen, S.M., Erturk, E., and Bryan, G.T. Carcinogenicity of 5-nitrofuryl pyrimidine and-triazine compounds. Proc. Amer. Assoc. Cancer Res., 11: 17, 1970. 4. Cohen, S.M., Erturk, E., and Bryan, G.T. Leukemogenicity of N-[4-(5-nitro-2-furyl)-2thiazolyl] acetamide (NFTA) in mice. Tenth Intl. Cancer Congress, p. 21, 1970. 5. Erturk, E., Cohen, S.M., Yoshida, O., Price, J.M., and Bryan, G.T. Urinary bladder carcinogenicity of N-[r-(5-nitro-2-furyl)-2-thiazolyl] formamide (FANFT) in the rat, mouse, and dog. Tenth Intl. Cancer Congress, pp. 21-22, 1970. 6. Cohen, S.M., Price, J.M., and Bryan, G.T. Tissue distribution of formic acid 2-[4-(5nitro-2-furyl)-2-14C-thiazolyl] hydrazide (FNT) in rats and mice. Proc. Amer. Assoc. Cancer Res., 12: 20, 1971. 7. Cohen, S.M., Ansfield, F.J., and Bryan, G.T. Effect of p-hydroxyacetanilide (PHAA) and sodium sulfate (SS) on the murine leukemogenicity of N-[4-(5-nitro-2-furyl)-2thiazolyl] acetamide (NFTA). Proc. Amer. Assoc. Cancer Res., 13: 35, 1972. 8. Cohen, S.M., and Bryan, G.T. Carcinogenesis caused by nitrofuran derivatives. Proc. Fifth Intl. Congress Pharmacol., pp. 210-211, 1972. 9. Cohen, S.M., and Bryan, G.T. Carcinogenicity of 5-nitrothiophene chemicals in rats. Fed. Proc., 32: 825, 1973. 10. Leklem, J.E., Arend, R.A., Cohen, S.M., and Brown, R.R. Altered tryptophan pyrolase (TP) and tryptophan metabolism in rats fed the bladder carcinogen (N-[4-(5-nitro-2furyl)-2-thiazolyl] formamide (FANFT). Proc. Amer. Assoc. Cancer Res., 11: 48, 1973. 11. Cohen, S.M., Wittenberg, J.F., and Bryan, G.T. Effect of hyper (HA) and avitaminosis A (AA) on urinary bladder carcinogenicity of N-[4-(5-nitro-2-furyl)-2-thiazolyl] formamide (FANFT). Fed. Proc., 33: 602, 1974. 12. Headley, D.B., Cohen, S.M., Pamukcu, A.M., and Bryan, G.T. Effect of N-[4-(5-nitro2-furyl)-2-thiazolyl] acetamide (NFTA) on antibody mediated immunity (AMI) and cell mediated immunity (CMI) of mice. Proc. Amer. Assoc. Cancer Res., 15: 55, 1974. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-128F2iled: 04/06/15 Page: 129 of 151 EPXAHGIBEITID1#: Curriculum Vitae Page 99 Samuel M. Cohen, M.D. Ph.D. 13. Cohen, S.M., Headley, D.B., and Bryan, G.T. Carcinogenesis and immunosuppression of N-[4-(5-nitro-2-furyl)-2-thiazolyl] acetamide (NFTA) and related 5-nitrofurans in BALB/c mice. Eleventh Intl. Cancer Congress, 2: 40-41, 1974. 14. Cohen, S.M., Jacobs, J.B., Friedell, G.H., and Russfield, A.B. Urinary bladder epithelial changes induced by N-[4-(5-nitro-2-furyl)-2-thiazolyl] formamide (FANFT) as observed by the scanning electron microscope (SEM). Fed. Proc., 34: 828, 1975. 15. Jacobs, J.B., Cohen, S.M., Arai, M., and Friedell, G.H. Scanning electron microscopy (SEM) observations of urinary cytology from rats fed N-[4-(5-nitro-2-furyl)-2thiazolyl] formamide (FANFT). Proc. Amer. Assoc. Cancer Res., 16: 49, 1975. 16. Arai, M., Johansson, S., Cohen, S.M., and Friedell, G.H. The influence of N-[4-(5nitro-2-furyl)-2-thiazolyl] formamide (FANFT) on the immune status of rats. Fed. Proc., 35: 330, 1976. 17. Pauli, B.U., Weinstein, R.S., Alroy, J., and Cohen, S.M. Gap junctions in chemical carcinogen (FANFT)-induced transitional cell carcinomas in rat urinary bladder. Fed. Proc., 35: 476, 1976. 18. Jacobs, J.B., Cohen, S.M., Arai, M., Yang, J.P.S., and Friedell, G.H. Electron microscopic features of transplanted and tissue cultured rat urinary bladder carcinoma. Proc. Amer. Assoc. Cancer Res., 17: 136, 1976. 19. Cohen, S.M., Arai, M., Jacobs, J.B., Friedell, G.H., and Ito, N. Transplantation and tissue culture of rat urinary bladder transitional cell carcinoma. Proc. Jpn. Cancer Assoc., 35: 209, 1976. 20. Friedell, G.H., and Cohen, S.M. Studies on experimental bladder tumors. Natl. Bladder Cancer Project Investigators' Workshop, p. 11, 1976. 21. Ito, N., Tatematsu, M., Shirai, T., Cohen, S.M., Arai, M., and Fukushima, S. Vascular changes in neoplasia and hyperplasia of the urinary bladder. Proc. Amer. Assoc. Cancer Res., 18: 39, 1977. 22. Arai, M., Jacobs, J.B., Cohen, S.M., and Friedell, G.H. Patterns of invasive carcinoma of rat urinary bladders induced by lifetime feeding of N-[4-(5-nitro-2-furyl)-2-thiazolyl] formamide (FANFT). Proc. Amer. Assoc. Cancer Res., 18: 192, 1977. 23. Tatematsu, M., Cohen, S.M., Murasaki, G., Ito, N., and Fukushima, S. Vascular changes during rat urinary bladder carcinogenesis induced by BBN. Trans. Soc. Path. Jpn., 66: 70, 1977. 24. Ito, N., Takahashi, M., Cohen, S.M., Shirai, T., Tatematsu, M., Miyata, Y., and Shinohara, Y. Rapid induction of pre-neoplastic lesions in rats with chemical carcinogens. Proc. Jpn. Cancer Assoc., 36: 21, 1977. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 42283 04/06/15 Page: 130 of 151 EPXAHGIBEITID1#: Curriculum Vitae Page 100 Samuel M. Cohen, M.D. Ph.D. 25. Arai, M., Cohen, S.M., and Friedell, G.H. Promoting effect of cyclophosphamide (CP) on rat urinary bladder carcinogenesis following initiation by N-[4-(5-nitro-2-furyl)-2thiazolyl] formamide (FANFT). Proc. Jpn. Cancer Assoc., 36: 39, 1977. 26. Tatematsu, M., Cohen, S.M., Shinohara, Y., Nakanishi, K., Yoshimura, T., and Ito, N. Experimental study on neovascularization in benign and malignant rat urinary bladder epithelial proliferations observed by scanning electron microscopy and autoradiography. Proc. Jpn. Cancer Assoc., 36: 59, 1977. 27. Fukushima, S., Murasaki, G., Shibata, M., Cohen, S.M., Tatematsu, M., Mizutani, M., and Ito, N. Histopathological studies of preneoplastic and neoplastic changes in rat urinary bladders induced by N-butyl-N-(4-hydroxybutyl) nitrosamine. Proc. Jpn. Cancer Assoc., 36: 59, 1977. 28. Murasaki, G., Hananouchi, M., Shinohara, Y., Hirose, M., Cohen, S.M., Yoshioka, Y., and Tatematsu, M. Early changes caused by N-butyl-N-(4-hydroxybutyl) nitrosamine in bladder epithelium of different animal species. Proc. Jpn. Cancer Assoc., 36: 203, 1977. 29. Cohen, S.M., Tatematsu, M., Arai, M., Fukushima, S., Ogiso, T., Tsuda, H., and Ito, N. Neovascularization during urinary bladder carcinogenesis induced by N-[4-(5-nitro-2furyl)-2-thiazolyl] formamide (FANFT). Proc. Jpn. Cancer Assoc., 36: 241, 1977. 30. Shirai, T., Cohen, S.M., Fukushima, S., and Ito, N. Reversible papillary hyperplasia in rat urinary bladder induced by means of serosal freezing. Proc. Jpn. Cancer Assoc., 36: 240, 1977. 31. Cohen, S.M., Arai, M., and Friedell, G.H. Promoting effect of DL-tryptophan and saccharin in urinary bladder carcinogenesis in the rat. Proc. Amer. Assoc. Cancer Res., 19: 4, 1978. 32. Jacobs, J.B., Cohen, S.M., and Friedell, G.H. Effect of dose on N-[4-(5-nitro-2-furyl)2-thiazolyl] formamide (FANFT) induced urinary bladder carcinogenesis in rats. Proc. Amer. Assoc. Cancer Res., 19: 4, 1978. 33. Shibata, M., Fukushima, S., Cohen, S.M., Nakanishi, K., Arai, M., and Ito, N. Effect of asothiopurine or OK-432 on urinary bladder carcinogenesis in rats treated with BBN or FANFT. Proc. Jpn. Cancer Assoc., 37: 157, 1978. 34. Friedell, G.H., and Cohen, S.M. Experimental models of cancer of the urinary bladder. Twelfth Intl. Cancer Congress, 1978. 35. Cohen, S.M., Jacobs, J.B., Arai, M., and Friedell, G.H. Co-carcinogenicity testing of saccharin and DL-tryptophan following oral initiation with N-[4-(5-nitro-2-furyl)-2- Case: 2:13-md-02433-EAS-EPD Doc #: 280472-128F4iled: 04/06/15 Page: 131 of 151 EPXAHGIBEITID1#: Curriculum Vitae Page 101 Samuel M. Cohen, M.D. Ph.D. thiazolyl] formamide. European Research Group for Oral Biology (ERGOB) Conference on Sugar Substitutes, 1978. 36. Friedell, G.H., Cohen, S.M., and Jacobs, J.B. Studies on experimental bladder tumors. Natl. Bladder Cancer Project Investigators' Workshop, p. 6, 1978. 37. Friedell, G.H., Cohen, S.M., and Jacobs, J.B. Studies on experimental bladder tumors. Natl. Bladder Cancer Project Investigators' Workshop, p. 11, 1978. 38. Cohen, S.M., Arai, M., Jacobs, J.B., and Friedell, G.H. Induction of papillary tumors and flat carcinom a-in-situ (CIS) of the urinary bladder by cyclophosphamide in male Fischer rats. Proc. Amer. Assoc. Cancer Res., 20: 231, 1979. 39. Fukushima, S., Cohen, S.M., Jacobs, J.B., and Friedell, G.H. Scanning electron microscopy (SEM) of regenerating hyperplasic urinary bladder epithelium. Proc. Amer. Assoc. Cancer Res., 20: 233, 1979. 40. Jacobs, J.B., Cohen, S.M., and Friedell, G.H. Scanning electron microscopy (SEM) urinary cytology: Pleomorphic microvilli (PMV) as a possible marker of bladder cancer. Proc. Amer. Soc. Clin. Oncol., 20: 407, 1979. 41. Yang, J.P.S., Narang, S., Cohen, S.M., and Templeton, A.C. Immunohistology: Lymphomas versus nonlymphoid tumors. Lab. Invest., 40: 293, 1979. 42. Koo, C.H., Pauli, B.U., Cohen, S.M., and Weinstein, R.S. Angiogenesis during early stages of chemical carcinogenesis of rat bladder epithelium. Fed. Proc., 39: 641, 1980. 43. Cohen, S.M., and Fukushima, S. Hyperplasia of the rat urinary bladder induced by sodium saccharin. Proc. Amer. Assoc. Cancer Res., 21: 111, 1980. 44. Friedell, G.H., Cohen, S.M., Demers, D.M., Fukushima, S., and Jacobs, J.B. Promoting effects of sodium saccharin (NaS) and L-tryptophan (L-T) in rat urinary bladder carcinogenesis and their effects on urinary constituents. Proc. Amer. Assoc. Cancer Res., 21: 111, 1980. 45. Cohen, S.M., Friedell, G.H., and Jacobs, J.B. Studies on experimental bladder tumors. Natl. Bladder Cancer Project Investigators' Workshop, p. 32, 1980. 46. Cohen, S.M., Zenser, T.V., Murasaki, G., Fukushima, S., Mattammal, M.B., Rapp, N.S., and Davis, B.B. Aspirin inhibition of N-[4-(5-nitro-2-furyl)-2-thiazolyl] formamide (FANFT)-induced lesions of the urinary bladder correlated with inhibition of metabolism by bladder prostaglandin endoperoxide synthetase (PES). Fed. Proc., 40: 748, 1981. 47. Cohen, S.M. Promotion of urinary bladder carcinogenesis. Organ and Species Specificity in Chemical Carcinogenesis, pp. 41-42, 1981. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-128F5iled: 04/06/15 Page: 132 of 151 EPXAHGIBEITID1#: Curriculum Vitae Page 102 Samuel M. Cohen, M.D. Ph.D. 48. Murasaki, G., Fukushima, S., Greenfield, R.E., and Cohen, S.M. Effect of ulceration on urinary bladder carcinogenesis induced by N-[4-(5-nitro-2-furyl)-2-thiazolyl] formamide (FANFT) and sodium saccharin (SAC). Proc. Amer. Assoc. Cancer Res., 22: 128, 1981. 49. Mattammal, M., Zenser, T., Cohen, S.M., and Davis, B. Co-oxidation by prostaglandin hydroperoxidase mediates chemically-induced bladder cancer. Fed. Proc., 40: 1712, 1981. 50. Cohen, S.M., Greenfield, R.E., and Ellwein, L.B. Multi-stage carcinogenesis in the urinary bladder. Proc. Second Intl. Conf. On Carcinogenic and Mutagenic NSubstituted Aryl Compounds, 1982. 51. Zenser, T.V., Cohen, S.M., Mattammal, M.B., Wise, R., and Davis, B.B. Prostaglandin hydroperoxidase-catalyzed activation of certain N-substituted aryl renal and bladder carcinogens. Proc. Second Intl. Conf. On Carcinogenic and Mutagenic N-Substituted Aryl Compounds, 1982. 52. Murasaki, G., and Cohen, S.M. Effect of sodium saccharin on urinary bladder epithelial regenerative hyperplasia following freeze ulceration. Proc. Amer. Assoc. Cancer Res., 23: 56, 1982. 53. Cohen, S.M., Ellwein, L.B., and Greenfield, R.E. Experimental and computer modeling of two-stage carcinogenesis. Proc. Amer. Assoc. Cancer Res., 23: 101, 1982. 54. Davis, B.B., Cohen, S.M., Palmier, M.O., Mattammal, M.B., Murasaki, G., and Zenser, T.V. Activation of 5-nitrofuran renal and urinary tract carcinogens by prostaglandin endoperoxide synthetase. Central Soc. Clin. Res., 1982. 55. Kadish, S.P., Jacobs, J.B., Cohen, S.M., and Friedell, G.H. Scanning electron microscopic examination of urinary cytology specimens in irradiated bladder cancer patients. Amer. Soc. Therapeutic Radiologists 21st Annual Mtg., 1982. 56. Helgeson, S., Nagel, D., Stohs, S., Cohen, S., and Lawson, T. Comparative metabolism of carcinogenic nitrosamines by mixed function oxidases and prostaglandin endoperoxide synthetase. Proceedings, The Nebraska Academy of Sciences, pp. 23-24, 1983. 57. Cohen, S.M., and Fukushima, S. Diagnostic electron microscopy. Second National Bladder Cancer Conf., Advances in Bladder Cancer Research, p. 62, 1983. 58. Cohen, S.M., Hasegawa, R., Suzuki, T., Greenfield, R.E., and Ellwein, L.B. Studies on experimental bladder tumors. Second National Bladder Cancer Conf., Advances in Bladder Cancer Research, p. 83, 1983. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-128F6iled: 04/06/15 Page: 133 of 151 EPXAHGIBEITID1#: Curriculum Vitae Page 103 Samuel M. Cohen, M.D. Ph.D. 59. Zenser, T.V., Cohen, S.M., Mattammal, M.B., Wise, R.W., Palmier, M.O., Murasaki, G., and Davis, B.B. Bladder cancer: Metabolism of carcinogens and prevention. Second National Bladder Cancer Conf., Advances in Bladder Cancer Research, p. 87, 1983. 60. Cohen, S.M., and Murasaki, G. Co-carcinogenicity of sodium saccharin and N-[4-(5nitro-2-furyl)-2-thiazolyl] formamide for the urinary bladder. Proc. Amer. Assoc. Cancer Res., 24: 113, 1983. 61. Skibba, J.L., Cohen, S.M., Erturk, E., and Bryan, G.T. Induction of lymphomas and squamous cell carcinomas by azathioprine in rats. Proc. Amer. Assoc. Cancer Res., 24: 91, 1983. 62. Nagel, D., Helgeson, A.S., Stohs, S.J., Cohen, S.M., Raha, C., and Lawson, T. Metabolism of beta keto nitrosamines by cytochrome P450 and prostaglandin endoperoxide synthetase dependent microsomal preparations. Proc. Amer. Assoc. Cancer Res., 24: 79, 1983. 63. Zenser, T.V., Cohen, S.M., Mattammal, M.B., Rice, J.R., Murasaki, G., Davis, B.B., and Greenfield, R.E. Prostaglandin endoperoxide synthetase involvement in 5nitrofuran-induced bladder cancer. Proc. Amer. Assoc. Cancer Res., 24: 76, 1983. 64. Zenser, T.V., Cohen, S.M., Palmier, M.O., Mattammal, M.B., Murasaki, G., and Davis, B.B. Molecular mechanisms of chemically-induced transitional cell carcinoma: Co oxidation by prostaglandin synthetase. Proc. Amer. Soc. Clin. Invest., 1983. 65. Coon, J., Cohen, S., and Pauli, B. Change of peanut lectin receptors during carcinogeninduced transformation of rat urinary bladder. Fed. Proc., 1983. 66. Cohen, S.M., Greenfield, R.E., and Ellwein, L.B. Urinary Bladder Carcinogenesis. Symposium on Role of Co-carcinogens and Promoters in Human and Experimental Carcinogenesis, Budapest, Hungary, 1983. 67. Ellwein, L.B., Cohen, S.M., and Greenfield, R. A probabilistic model of carcinogenesis and its application to experimental urinary bladder studies. ORSA/TIMS Mtg., Orlando, FL, 1983. 68. Suzuki, T., Jacobs, J.B., Friedell, G.H., and Cohen, S.M. Scanning electron microscopic observation of urinary exfoliated cells in patients with urological diseases. 39thMtg. Jpn. Elec. Microscopy Assoc., 1983. 69. Cohen, S.M., Hasegawa, R., Greenfield, R.E., and Ellwein, L.B. Studies on experimental bladder carcinogenesis. Tenth National Bladder Cancer Project Investigators' Workshop, p. 29, 1984. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-128F7iled: 04/06/15 Page: 134 of 151 EPXAHGIBEITID1#: Curriculum Vitae Page 104 Samuel M. Cohen, M.D. Ph.D. 70. Zenser, T.V., Cohen, S.M., Mattammal, M.B., Rice, J.R., and Davis, B.B. Bladder cancer: Metabolism of carcinogens and prevention. Tenth National Bladder Cancer Project Investigators' Workshop, p. 32, 1984. 71. Suzuki, T., Nijima, T., Cohen, S.M., Jacobs, J.B., and Friedell, G.H. Scanning electron microscopic urinary exfoliative cytology. Tenth National Bladder Cancer Project Investigators' Workshop, p. 36, 1984. 72. Hasegawa, R., Suzuki, T., Murasaki, G., Cano, M., and Cohen, S.M. Concanavalin A agglutination of rat bladder epithelial cells following ulceration induced by freezing or cyclophosphamide and the effect of sodium saccharin. Fed. Proc., 43: 591, 1984. 73. Eccleston, C.A., Murasaki, G., St. John, M.K., and Cohen, S.M. Toxicity of the renal carcinogen 3-hydroxymethyl-1-[3-(5-nitro-2-furyl) allydidene]-amino hydantoin in rats. Fed. Proc., 43: 662, 1984. 74. Julius, A.D., Cohen, S.M., and Birt, D.F. Vitamin B6 status and urinary tryptophan metabolites in N-[4-(5-nitro-2-furyl)-2-thiazolyl] formamide (FANFT) treated rats. Fed. Proc., 43: 856, 1984. 75. Hasegawa, R., St. John, M.K., Issenberg, P., Walker, B.A., Jones, J.W., and Cohen, S.M. Analysis of urine for nitrosamines, mutagens and bacteria following bladder freeze ulceration and sodium saccharin feeding in the rat. Proc. Amer. Assoc. Cancer Res., 25: 96, 1984. 76. Cohen, S.M., Hasegawa, R., Greenfield, R.E., and Ellwein, L.B. Freeze ulceration induced irreversible initiation of bladder carcinogenesis followed by saccharin promotion--Comparison of mathematical and rat models. Proc. Amer. Assoc. Cancer Res., 25: 144, 1984. 77. Spry, L.A., Zenser, T.V., Cohen, S.M., and Davis, B.B. Studies on the mechanism of aspirin inhibition of chemically-induced uroepithelial cancer. Clin. Res., 32: 774A, 1984. 78. Cohen, S.M., Suzuki, T., Hasegawa, R., and Cano, M. Scanning electron microscopic urinary cytology. First Nebraska Symposium on Cancer and Smoking-Related Diseases, 1984. 79. Walters, F., Davis, B.B., Johansson, S.L., Cohen, S.M., and Zenser, T.V. Nitrofurans cause chronic interstitial nephritis and are activated by prostaglandin H synthase: A proposed molecular mechanism of chronic nephrotoxic reactions. Kidney Intl., 27: 239, 1985. 80. Zenser, T.V., Spry, L.A., Rice, J.R., Cohen, S.M., Mattammal, M.B., and Davis, B.B. Metabolism and excretion of 5-nitrofuran bladder carcinogens by the isolated perfused kidney. Proc. Amer. Assoc. Cancer Res., 26: 111, 1985. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 42288 04/06/15 Page: 135 of 151 EPXAHGIBEITID1#: Curriculum Vitae Page 105 Samuel M. Cohen, M.D. Ph.D. 81. Hasegawa, R., Greenfield, R.E., and Cohen, S.M. Effect of different salts of saccharin on the rat urinary bladder. Proc. Amer. Assoc. Cancer Res., 26: 121, 1985. 82. Williamson, D.S., Nagel, D.L., Markin, R.S., and Cohen, S.M. Effect of pH and cations on the tautomeric forms of saccharin. Proc. Amer. Assoc. Cancer Res., 26: 123, 1985. 83. Hasegawa, R., Suzuki, T., and Cohen, S.M. Initiation of urinary bladder freeze ulceration in rats two-stage urinary bladder carcinogenesis. Proc. Jpn. Cancer Assoc., 44th Annual Meeting, 35, 1985. 84. Cohen, S.M., and Johansson, S.L. Cancer of the urinary bladder under the age of 30. U.S.-Japan Cooperative Cancer Research Program Workshop on Adult-Type Cancer Under 30 Years, 1985. 85. Lemon, H.M., Foley, J.F., Bresnick, E., Kessinger, M.A., Birt, D., Tempero, M., and Cohen, S.M. Education in cancer prevention. Amer. Assoc. Cancer Ed. Annual Meeting, 1985. 86. Williamson, D.S., Nagel, D.L., Markin, R.S., and Cohen, S.M. Improved performance in 2-dimensional (2-D) nuclear magnetic resonance (NMR) spectroscopy. University of Nebraska Medical Center Student Research Forum, 1985. 87. Sakata, T., Hasegawa, R., Zenser, T.V., Johansson, S.L., and Cohen, S.M. Effect of aspirin on initiation and promotion of urinary bladder carcinogenesis. Proc. Amer. Assoc. Cancer Res., 27: 124, 1986. 88. Birt, D.F., Julius, A.D., St. John, M.K., Hasegawa, R., and Cohen, S.M. Effects of Ltryptophan excess and vitamin B6 deficiency on urinary bladder carcinogenesis in rats. Proc. Amer. Assoc. Cancer Res., 27: 128, 1986. 89. Williamson, D.S., Cremonesi, P., Cavalieri, E., Nagel, D.L., Markin, R.S., and Cohen, S.M. Use of multiple quantum filtration for simplification of proton NMR spectra of polycyclic aromatic hydrocarbons. Proc. Amer. Assoc. Cancer Res., 27: 151, 1986. 90. Williamson, D.S., Nagel, D.L., Markin, R.S., and Cohen, S.M. Multiple quantum and multiple spin filtration for simplification of 1-D and 2-D proton NMR spectra. Exptl. NMR Conference, 1986. 91. Ellwein, L.B., and Cohen, S.M. Modeling of bladder carcinogenesis in risk assessment. Soc. Risk Analysis, 1986. 92. Jackson, M.C., Sakata, T., Johansson, S.L., Tibbels, T.S., and Cohen, S.M. Effect of sodium saccharin and calcium saccharin on urinary electrolyte excretion when fed to rats in Agway vs. AIN-76 diet. Fed. Proc., 46: 586, 1987. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 42289 04/06/15 Page: 136 of 151 EPXAHGIBEITID1#: Curriculum Vitae Page 106 Samuel M. Cohen, M.D. Ph.D. 93. Cano, M., Johansson, S.L., Sakata, T., Ellwein, L.B., and Cohen, S.M. Ultrastructural study of rat urinary bladder embryology. Fed. Proc., 46: 427, 1987. 94. Smith, R.A., Pinnt, I.M., Sysel, I.A., and Cohen, S.M. Detection of acrolein-nucleic acid adducts by 32P post-labeling analysis. Fed. Proc., 46: 744, 1987. 95. Johansson, S.L., Sakata, T., Hasegawa, R., Zenser, T.V., Davis, B.B., and Cohen, S.M. Effects of long-term administration of aspirin and sodium saccharin on the rat kidney. Fed. Proc., 46: 1328, 1987. 96. Ellwein, L.B., and Cohen, S.M. Modeling of bladder carcinogenesis in risk assessment. Nebraska J. Med., 72: 54, 1987. 97. Smith, R.A., Pinnt, I.M., Williamson, D.S., Sysel, I.A., and Cohen, S.M. Interactions of acrolein with homopolynucleotides and deoxynucleotides in vitro. Nebraska J. Med., 72: 59, 1987. 98. Smith, R.A., Williamson, D.S., Tibbels, T.S., and Cohen, S.M. Structure of acroleinmodified deoxynucleoside-5'-monophosphates. Proc. Amer. Assoc. Cancer Res., 28: 100, 1987. 99. Cohen, S.M., and Ellwein, L.B. Cell growth dynamics in long-term bladder carcinogenesis. 17th Conference on Toxicology, Fairborn, OH., 1987. 100. Garland, E.M., Kraft, P., Shapiro, R., and Cohen, S.M. Lipid and vitamin levels in 30 day old rats administered sodium saccharin since conception. The Toxicologist, 8: 85, 1988. 101. Sysel, I.A., Smith, R.A., and Cohen, S.M. Detection of nitrofuran-DNA adducts by 32P post-labeling. FASEB J., 2: A1155, 1988. 102. Smith, R.A., Williamson, D.S., and Cohen, S.M. Detection and characterization of an acrolein adduct in polydeoxyadenylic acid. FASEB J., 2: A1155, 1988. 103. Sakata, T., Miyake, K., and Cohen, S.M. Effect of acrolein on rat bladder epithelium. Japanese Urological Assoc., 76: 166, 1988. 104. Masui, T., Sakata, T., Garland, E.M., Ellwein, L.B., Johansson, S.L., and Cohen, S.M. Effects of sodium saccharin (NaS) on rat fetal and neonatal urinary bladder. Proc. Amer. Assoc. Cancer Res., 29: 161, 1988. 105. Ellwein, L.B., and Cohen, S.M. Biologically-based quantitative modeling for cancer risk assessment: Sodium saccharin. AAAS Mtg., 1989. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-129F0iled: 04/06/15 Page: 137 of 151 EPXAHGIBEITID1#: Curriculum Vitae Page 107 Samuel M. Cohen, M.D. Ph.D. 106. Cohen, S.M., and Ellwein, L.B. Carcinogenicity of 2-acetylaminofluorene in Balb/c mice: Two-stage modeling of the ED01 study based on DNA adducts, hyperplasia, and tumor formation. The Toxicologist, 9: 206, 1989. 107. Garland, E.M., Sakata, T., Jackson, M.C., Masui, T., Cano, M., and Cohen, S.M. Diet and strain influences on the proliferative effect of sodium saccharin on the rat urinary bladder. The Toxicologist, 9: 256, 1989. 108. Sysel, I.A., Smith, R.A., and Cohen, S.M. Detection of nitrofuran-DNA adducts in the liver and bladder of male rats by 32P post-labeling. Proc. Amer. Assoc. Cancer Res., 30: 122, 1989. 109. Smith, R.A., Cohen, S.M., and Lawson, T.A. Mutation of Chinese hamster V79 cells by acrolein. Proc. Amer. Assoc. Cancer Res., 30: 141, 1989. 110. Masui, T., Garland, E.M., Ellwein, L.B., Cohen, S.M., and Wang, C.Y. Hyperplastic changes at the limiting ridge of the forestomach in rats induced by continuous administration of sodium saccharin and effects of dietary differences on these lesions. Proc. Amer. Assoc. Cancer Res., 30: 208, 1989. 111. Cohen, S.M., Cano, M., Garland, E.M., and Earl, R.A. Silicate crystals in the urine and bladder epithelium of male rats fed sodium saccharin. Proc. Amer. Assoc. Cancer Res., 30: 204, 1989. 112. Mann, A.M., Borgeson, C.D., Stevenson, M., and Cohen, S.M. Transfection of nontransformed rat bladder epithelial cells with v-Harvey-ras oncogene. Proc. Amer. Assoc. Cancer Res., 30: 450, 1989. 113. Smith, R.A., Williamson, D.S., Lawson, T.A., Sakata, T., Garland, E.M., and Cohen, S.M. Relationship of acrolein to cigarette smoking-induced bladder cancer. Nebr. Med. J., 74: 251-252, 1989. 114. Garland, E.M., Shapiro, R., Kraft, P., Mattson, B.J., and Cohen, S.M. Starting sodium saccharin exposure at conception produces dose-dependent but reversible increases in serum lipids in weanling rats. The Toxicologist, 10: 168, 1990. 115. Mann, A.M., Chlapowski, F., Masui, T., Borgeson, C.D., and Cohen, S.M. Neoplastic transformation of rat bladder epithelial cells after exposure to 2-amino-4-(5-nitro-2furyl)thiazole (ANFT) in vitro. Proc. Amer. Assoc. Cancer Res., 31: 110, 1990. 116. Masui, T., Mann, A.M., Garland, E.M., Sakata, T., Okamura, T., and Cohen, S.M. Point mutation in codons 12 and 61 of the H-ras gene in rat urinary bladder carcinoma induced by N-[4-(5-nitro-2-furyl)-2-thiazolyl]formamide. Proc. Amer. Assoc. Cancer Res., 31: 132, 1990. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-129F1iled: 04/06/15 Page: 138 of 151 EPXAHGIBEITID1#: Curriculum Vitae Page 108 Samuel M. Cohen, M.D. Ph.D. 117. Cohen, S.M., Okamura, T., Wehner, J., Masui, T., and Garland, E.M. Evaluation of bladder tumor promoting activity of sodium saccharin, calcium saccharin, and related chemicals in rats. Proc. Amer. Assoc. Cancer Res., 31: 138, 1990. 118. Okamura, T., Garland, E.M., Sakata, T., Masui, T., and Cohen, S.M. Lack of bladder tumor promoting activity in rats fed sodium saccharin in AIN-76A diet. Proc. Amer. Assoc. Cancer Res., 31: 150, 1990. 119. Cohen, S.M., Mann, A.M., and Masui, T. Bladder cancer. Samuel Roberts Noble Foundation, Inc., 1990. 120. Mann, A.M., Masui, T., Macatee, T.L., and Cohen, S.M. Oncogene expression levels in nitrofuran transformation of rat bladder epithelial cells. UCLA Symposium on Instability and Cancer. Tamarron, CO, 1990. 121. Masui, T., Mann, A.M., Macatee, T.L., and Cohen, S.M. H-ras mutations in rat urinary bladder carcinomas induced with N-[4-(5-nitro-2-furyl)-2-thiazolyl]-formamide (FANFT) and sodium saccharin, sodium ascorbate, or other salts. UCLA Symposium on Instability and Cancer. Tamarron, CO, 1990. 122. Sisson, J.H., Leise, K.L., Rennard, S.I., Smith, R.A., and Cohen, S.M. Acrolein induces bronchial epithelial cell ciliastatis that can be blocked by N-acetyl-cysteine. American Thoracic Society, 1990. 123. Cohen, S.M., Garland, E.M., and Ellwein, L.B. Cancer enhancement by cell proliferation. M.D. Anderson Symposium, Austin, TX, 1990. 124. Garland, E.M., Okamura, T., Johnson, L.S., Johansson, S.L., and Cohen, S.M. Acute toxicity of tetraethylorthosilicate (TES) and relationship to bladder changes produced by sodium saccharin (NaS) in rats. The Toxicologist, 11: 145, 1991. 125. Cohen, S.M. Cell proliferation, genotoxicity, and carcinogenesis. Fourth International Symposium of the Foundation for Promotion of Cancer Research, Tokyo, Japan, 1991. 126. Okamura, T., Garland, E.M., Taylor, R.J., Johansson, S.L., and Cohen, S.M. The effect of cyclophosphamide administration on the female rat kidney. Proc. Amer. Assoc. Cancer Res. 32: 424, 1991. 127. Smith, R.A., Smith, T.E., and Cohen, S.M. Enzymic incorporation of acrolein-adenine adducts into oligomers. Proc. Amer. Assoc. Cancer Res., 32: 139, 1991. 128. Masui, T., Ito, N., Mann, A.M., and Cohen, S.M. Absence of ras oncogene activation in rat urinary bladder carcinomas induced with BBN or MNU. Proc. Jpn. Cancer Assoc., 50: 114, 1991. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 42292 04/06/15 Page: 139 of 151 EPXAHGIBEITID1 #: Curriculum Vitae Page 109 Samuel M. Cohen, M.D. Ph.D. 129. Okamura, T., Cohen, S.M., Taylor, R.J., and Otaguro, K. Effect of chitosan on the hemorrhagic cystitis induced by cyclophosphamide in rats. 80th Annual Meeting of the Japanese Urological Association, 1991. 130. Okamura, T., Cohen, S.M., Taylor, R.J., and Otaguro, K. Effect of chitosan on the hemorrhagic cystitis induced by cyclophosphamide in rats. 42ndMeeting of the Nagoya City University School Association, 1991. 131. Cohen, S.M., Cano, M., Johnson, L., Eklund, S., and Garland, E.M. Saccharin and urothelial proliferation: A threshold phenomenon. FASEB J., 6: 1594, 1992. 132. Smith, R.A., Cohen, S.M., and Lawson, T.A. Mutagenicity of R-(+)- and S-(-)glycidol in the V79 assay. Proc. Amer. Assoc. Cancer Res., 33: 113, 1992. 133. Eklund, S.H., Garland, E.M., and Cohen, S.M. Characterization of proteins of male rat urine which bind saccharin in vitro. Proc. Amer. Assoc. Cancer Res., 33: 189, 1992. 134. Asamoto, M., Mann, A.M., Macatee, T., and Cohen, S.M. p53 expression in rat bladder carcinogenesis in vivo and in vitro. Proc. Amer. Assoc. Cancer Res., 33: 111, 1992. 135. Mann, A.M., Asamoto, M., Masui, T., Macatee, T., and Cohen, S.M. Neu oncogene involvement in N-[4-(5-nitro-2-furyl)-2-thiazolyl]formamide (FANFT) or 2-amino-4(5-nitro-2-furyl)thiazole (ANFT) transformation of rat bladder epithelial cells. Proc. Amer. Assoc. Cancer Res., 33: 107, 1992. 136. Eklund, S.H., Garland, E.M., St. John, M., Asamoto, M., Mattson, B.J., Johnson, L.S., Cano, M., and Cohen, S.M. A comparison of the effects of sodium saccharin in NBR rats and in intact and castrated male F344 rats. The Toxicologist, 13: 74, 1993. 137. Garland, E.M., Shapiro, R., Wehner, J.M., Johnson, L.S., Mattson, B.J., Khachab, M., Asamoto, M. and Cohen, S.M. The effects of dietary iron and folate supplementation on the nutritional and physiological changes produced in weanling rats by sodium saccharin exposure. The Toxicologist, 13: 237, 1993. 138. Cohen, S.M., Garland, E.M., Wehner, J.M., Johnson, L.S., and Cano, M. Relationship between bladder changes produced in male rats by sodium saccharin treatment and formation of an insoluble, amorphous material in the urine. Proc. Amer. Assoc. Cancer Res., 13: 174, 1993. 139. Garland, M.D., Mattson, B.J., Cano, M., St. John, M., and Cohen, S.M. A comparison of the urinary and bladder changes produced by sodium saccharin treatment in male and female F344 rats. The Toxicologist, 14: 129, 1994. 140. Lear, C.L., Garland, E.M., and Cohen, S.M. Saccharin binding to urinary proteins in different species. Proc. Amer. Assoc. Cancer Res., 35: 104, 1994. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 42293 04/06/15 Page: 140 of 151 EPXAHGIBEITID1#: Curriculum Vitae Page 110 Samuel M. Cohen, M.D. Ph.D. 141. Smith, R.A., Smith, T.E., Cohen, S.M., and Lawson, T. 32P-Postlabeling of abasic sites in acrolein-modified DNA. Proc. Amer. Assoc. Cancer Res., 35: 111, 1994. 142. Smith, R.A., Smith, T.E., and Cohen, S.M. DNA adduction by N-[4-(5-nitro-2-furyl)2-thiazolyl]formamide. Proc. Amer. Assoc. Cancer Res., 35: 111, 1994. 143. Mann, A.M., Stevenson, M., Eklund, S., Macatee, T.L., Asamoto, M., and Cohen, S.M. Transfected wild type and mutant p53 on transformed and non-transformed rat bladder epithelial cells. Proc. Amer. Assoc. Cancer Res., 35: 173, 1994. 144. Dalrymple, G.V., Taylor, R.J., Baranowska-Kortylewicz, J., Schneiderman, M.H., Chiou, R.K., Harrison, K.A., Leichner, P.K., Cavanaugh, D.J., Holeman, K.P., Augustine, S.C., Gobar, L.S., DeYoung, L., Jacobson, D.A., Henriksen, J.L., Jenn, J.A., Kelly, R., Lai, J., Schmidt, B., Schneiderman, G.S., Wobig, H., Witte, R.J., Charlton, D.E., Mariani, G., and Cohen, S.M. The potential value of the auger electron emitters 123/125IUDR in the management of bladder cancer. Second Annual Genitourinary Oncology Conference. 145. Holdeman, K., Dalrymple, G., Taylor, R., Cohen, S.M., Schneiderman, M., Baranowska-Kortylewicz, J., Sharp, J., Chiou, R., Harrison, K., Leichner, P., Augustine, S., Jacobson, D., Helseth, L., Clausen, S., Mariani, G., and Charlton, D. 125Iudr auger electron therapy: Preliminary bioeffects studies in a swine model. 36th Annual Scientific Meeting of the American Society for Therapeutic Radiology and Oncology. Int. J. Rad. Oncol. Bio. Phys., 30: Supplemental 1: 305, 1994. 146. Cohen, S.M., Mann, A., Lear, C.L., Mattson, B., and Arnold, L.L. Toxicity of calcium phosphate precipitate and urinary amorphous precipitate toward rat bladder epithelial cells. Proc. Amer. Cancer Res., 36: 178, 1995. 147. Ogawa, K., Sun, T-T., and Cohen, S.M. Analysis of differentiation-associated proteins in rat bladder carcinogenesis. Proc. Amer. Assoc. Cancer Res., 36: 130, 1995. 148. Arnold, L.L., Anderson, T., Cano, M., St. John, M., Mattson, B., Wehner, J., and Cohen, S.M. A comparison of urinary chemistry changes in male and female rats and mice treated with sodium saccharin. The Toxicologist, 15: 201, 1995. 149. Smith, R.A., Smith, T.E., and Cohen, S.M. and Lawson, T.A. DNA crosslinks in V79 cells exposed to acrolein. Proc. Amer. Assoc. Cancer Res., 36: 135, 1995. 150. Holeman, K., Chiou, R., Cohen, S., Harrison, K., Kortylewicz, J., Schneiderman, M., Sharp, J.G., Taylor, R., and Dalrymple, G. Radiodinated iododeoxyuridine (UDR) for the identification and therapy of residual bladder cancer. Int. J. Radiat. Biol., 68: 354, 1995. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-129F4iled: 04/06/15 Page: 141 of 151 EPXAHGIBEITID1#: Curriculum Vitae Page 111 Samuel M. Cohen, M.D. Ph.D. 151. Arnold, L.L., Garland, E.M., Cano, M., St. John, M.K., Khachab, M., and Cohen, S.M. Effects of sodium ascorbate, sodium saccharin and ammonium chloride on the male rat urinary bladder. Proc. Amer. Assoc. Cancer Res., 37: 159, 1996. 152. deOliveria, M.L., Arnold, L.L., St. John, M.K., Cano, M., Anderson, T., Mattson, B., and Cohen, S.M. Effect of dietary sodium, potassium and calcium on urinary composition and bladder epithelium of F344 rats. Proc. Amer. Assoc. Cancer Res., 37: 159, 1996. 153. Smith, R.A., Kubik, G.S., and Cohen, S.M. Acrolein-induced mutations in V79 cells. Proc. Amer. Assoc. Cancer Res., 37: 141, 1996. 154. Cohen, S.M., Arnold, L.L., Cano, M., Thorgeirsson, U., and Takayama, S. Lack of effect of sodium saccharin feeding on monkey urine and urinary bladder epithelium. Proc. Amer. Assoc. Cancer Res., 37: 108, 1996. 155. Arnold, L.L., Cohen, S.M., Christenson, R., Cano, M., St. John, M.K., and Wahle, B.S. Tributyl phosphate (TBP) effects on urine and bladder epithelium in male SpragueDawley rats. The Toxicologist, 36: 173, 1997. 156. Andersen, M.B., Robinson, D., and Expert Panel to Evaluate EPA's Proposed Guidelines for Carcinogen Risk Assessment. Chloroform: Exploring non-linear and linear extrapolation models. The Toxicologist, 36: 335, 1997. 157. Cohen, S.M., Arnold, L.L., St. John, M.K., Cano, M., Smith, R.A., Sangha, G., and Christenson, R. Urothelial proliferation induced by high doses of o-phenylphenol (OPP) in male rats. Proc. Amer. Assoc. Cancer Res., 38: 465, 1997. 158. Smith, R.A., Cohen, S.M., Christenson, R., and Sangha, G. Lack of DNA adducts in male rat bladder urothelium by feeding ortho-phenylphenol (OPP). Proc. Amer. Assoc. Cancer Res., 38: 340, 1997. 159. Uzvolgyi, E., Ryder, P.C., Johansson, S.L., Holmang, S., Chan, W.C., Wu, D.C., Ogawa, K., and Cohen, S.M. Clonal analysis of papillary transitional cell carcinoma of the urinary bladder. Proc. Amer. Assoc. Cancer Res., 38: 430, 1997. 160. Cohen, S.M., deOliveria, L., Anderson, T., St. John, M.K., and Arnold, L.L. Tumorigenicity of sodium ascorbate in a two-generation bioassay in male rats. The Toxicologist, 42: 71, 1998. 161. Cohen, S.M., Arnold, L.L., St. John, M.K., and Cano, M. Evaluation of cell proliferative activity in the rat urinary bladder after feeding high doses of cacodylic acid. International Conference on Arsenic Exposure and Health Effects, 1998. 162. Cohen, S.M. Cell proliferation as the basis for carcinogenesis of non-genotoxic chemicals. Gen. Molecular Biol., 21: 35, 1998. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-129F5iled: 04/06/15 Page: 142 of 151 EPXAHGIBEITID1#: Curriculum Vitae Page 112 Samuel M. Cohen, M.D. Ph.D. 163. Arnold, L.L., Cano, M., St. John, M., Eldan, M., van Gemert, M., and Cohen, S.M. Effects of dietary dimethylarsinic acid on the urine and urothelium of rats. Carcinogenesis, 20: 2171-2179, 1999. 164. Cohen, S.M., Arnold, L.L., St. John, M.K., Cano, M., van Gemert, M., and Eldan, M. Effects of dimethylarsinic acid (DMA) on urinary parameters and bladder epithelium in female F344 rats. The Toxicologist, 48: 1086, 1999. 165. St. John, M.K., Cano, M., Anderson, T., Arnold, L.L., and Cohen, S.M. Comparison of the urinary and urothelial effects of o-Phenylphenol (OPP) and sodium OPP (Na-OPP) fed to male F344 rats. The Toxicologist, 48: 1087, 1999. 166. Wagner, B.M., Bernard, B.K., Cohen, S., Weil, C., Goodman, J.I., and McKinney, L. An evaluation of the potential carcinogenicity of dichlorvos (DDVP): Final report of the expert panel. The Toxicologist, 48: 1620, 1999. 167. Ogawa, K., Asamoto, M., Cohen, S.M., and Shirai, T. The expression of uroplakins, specific proteins for terminally differentiated transitional cell, in the Brennor tumors and Walthard rests. Proc. Jpn. Soc. Pathol., 88: 203, 1999. 168. Cohen, S.M. Cell proliferation as a basis for genetic errors in carcinogenesis. Princess Takamatsu Symposium, Tokyo, Japan, November 13-21, 1999. 169. Cohen, S.M., Bidlack, W.R., Dragan, Y., Goldsworthy, T., Hard, G., Howard, P.C., Riley, R., and Voss, K. Apoptosis and its implications for toxicity, carcinogenicity and risk: Fumonisin B1 as an example. International Life Sciences Institute Apoptosis Working Group. Fumonisin Risk Assessment Workshop, College Park, MD, January 10-12, 2000. 170. Yamamoto, L.S., Arnold, L.L., Ryder, P., Uzvolgyi, E., and Cohen, S.M. Cytotoxicity and mitogenicity of arsenicals on rat and human urothelial cells. The Toxicologist, 54: 133, 2000. 171. Cohen, S.M. Apoptosis and its implications for toxicity, carcinogenicity and risk: Fumonisin B1as an example. The Toxicologist, 54: 243, 2000. 172. Yamamoto, S., Arnold, L., Cano, M., St. John, M., and Cohen, S.M. Effects of dimethylarsinic acid (DMA) on cell proliferation and growth factors in female F344 rat urinary bladder. Proc. Amer. Assoc. Cancer Res., 41: 837, 2000. 173. Uzvolgyi, E., Liang, G., Salem, C., Ryder, P., Talmadge, L., Cohen, S.M., and Jones, P.A. Identification and characterization of genes associated with differentially methylated CPG islands in human bladder cancers. Proc. Amer. Assoc. Cancer Res., 41: 345, 2000. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-129F6iled: 04/06/15 Page: 143 of 151 EPXAHGIBEITID1#: Curriculum Vitae Page 113 Samuel M. Cohen, M.D. Ph.D. 174. Cohen, S.M. The carcinogenicity of dimethylarsinic acid (DMA) in rats. Fourth International Conference on Arsenic Exposure and Health Effects, San Diego, CA, June 18-22, 2000, p. 38. 175. Arnold, L.L., Yamamoto, S., Anderson, T.A., St. John, M.K., Cano, M., and Cohen, S.M. Early effects of dietary treatment with dimethylarsinic acid on the bladder epithelium of female F344 rats. Fourth International Conference on Arsenic Exposure and Health Effects, San Diego, CA, June 18-22, 2000, p. 177. 176. Cohen, S.M. Comparative pathology of proliferative lesions of the urinary bladder. Annual Meeting of the Society of Toxicologic Pathologists, Phoenix, AZ, June 24, 2000. 177. Cohen, S.M. The dose makes the poison: Did Paracelsus throw us a curve? International Life Sciences Institute Annual Meeting, Montego Bay, Jamaica, January, 22, 2001. 178. Cohen, S.M. The ILSI-HESI evaluation of alternatives for carcinogenicity testing: What does the data tell us? International Life Sciences Institute Annual Meeting, Montego Bay, Jamaica, January, 22, 2001. 179. Cohen, S.M., and Arnold, L.L., Cano, M., St. John, M., Lu, X., Le, X.C. Effects of co administration of dimethylarsinic acid (DMA) and 2,3-dimercapto-1-propane sulfonate (DMPS) on urinary parameters and the bladder epithelium in F344 rats. The Toxicologist, 60: 285-286, 2001. 180. Cano, M., Arnold, L.L., St. John, M., and Cohen, S.M. Urothelial changes in Syrian Golden hamsters administered different diets. The Toxicologist, 60: 388, 2001. 181. Ryder, P.C., Uzvolgyi, E., Arnold, L.L., Cano, M., St. John, M., and Cohen, S.M. Urinary and molecular studies on urothelial bladder cells of female F344 rats after dimethylarsinic acid (DMA) treatment. The Toxicologist, 60: 389, 2001. 182. Arnold, L.L., Healy, C.E., Cano, M., St. John, M., and Cohen, S.M. Effects of dietary sulfosulfuron on urinary parameters and the bladder epithelium in male SpragueDawley rats. The Toxicologist, 60: 285, 2001. 183. Rubin, R.J., and Cohen, S.M. Risk assessment: Science, regulation and legislation. The Toxicologist, 60: 448, 2001. 184. Ogawa, K., and Cohen, S.M. Biological characteristics of invasive mouse bladder carcinomas induced by N-butyl-N-(4-hydroxybutyl)nitrosamine. Proc. Amer. Assoc. Cancer Res., Washington, D.C., April 20-24, 1996. 185. Uzvolgyi, E.M., Liang, G., Ryder, P., Sumegi, J., Talmadge, C.B., Cohen, and S.M., Jones, P.A. The human homologue of the Caenorhabditis elegans ZYG-11 gene: Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 42297 04/06/15 Page: 144 of 151 EPXAHGIBEITID1#: Curriculum Vitae Page 114 Samuel M. Cohen, M.D. Ph.D. Genomic organization, chromosomal localization and its expression in human colon cancer cell lines. Proceedings of the 92nd Annual Meeting , New Orleans, LA, March 24-28, 2001. 186. Cohen, S.M., Arnold, L.L., Cano, M., Lu, X., and Le, X.C. The presence of dimethylarsinous acid (DMAra) in the urine of rats treated with dimethylarsinic acid (DMA). The Toxicologist, 66: 304, 2002. 187. Oremland, R.S., Herbel, M.J., Blum, J.S., Hoeft, S.E., Arnold, L.L., Cohen, S.M., Lisak, J., and Stolz, J.F. Arsenate respiring bacteria in the gastrointestinal tracts of animals. Fifth International Conference on Arsenic Exposure and Health Effects, p. 176, 2002. 188. Arnold, L.L., Cano, M., Cohen, S.M., Lu, X., and Le, X.C. Dimethylarsinous acid (DMAm) in the urine of female F344 rats treated with dimethylarsinic acid (DMA). Fifth International Conference on Arsenic Exposure and Health Effects, p. 170, 2002. 189. Cohen, S.M., Arnold, L.L., and Le, X.C. Carcinogenicity of dimethylarsinic acid in rats. Fifth International Conference on Arsenic Exposure and Health Effects, p. 66, 2002. 190. Lu, X., Le, X.C., Arnold, L.L., and Cohen, S.M. Development of chromatographic separation techniques for determination of arsenic speciation in urine samples. Fifth International Conference on Arsenic Exposure and Health Effects, p. 207, 2002. 191. Cohen, S.M. Analysis of mode of action of carcinogenesis in animal models. Society of Risk Analysis, 2002. 192. Fenner-Crisp, P.A., and Cohen, S.M. Mode of action in assessing human relevance of animal tumors: improving the framework for analysis. The Toxicologist, 72: 169, 2003. 193. Cohen, S.M. Developing the human relevance framework. The Toxicologist, 72: 170, 2003 194. Arnold, L.L., Cano, M., Cohen, S.M., Le, X.C., and Lu, X. Effects of the dose of dimethylarsinic acid (DMA) on the urinary concentration of dimethylarsinous acid (DMAm). The Toxicologist, 72: 232, 2003. 195. Feron, V.J., Adams, T.B., Cohen, S., Doull, J., Goodman, J.I., Hall, R.L., Marnett, L.J., Munro, I.C., Portoghese, P.S., Smith, R.L., Waddell, W.J., and Wagner, B.M. Safety evaluation of natural flavour complexes. European Society of Toxicology Annual Meeting, 2003. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 42298 04/06/15 Page: 145 of 151 EPXAHGIBEITID1#: Curriculum Vitae Page 115 Samuel M. Cohen, M.D. Ph.D. 196. Cohen, S.M., Wei, M., Arnold, L.L., and Eudy, J.D. Identification of gene expression in the urothelium of rats fed dimethylarsinic acid using microarray analysis. The Toxicologist, 78, 2004. 197. Wei, M., Cohen, S.M., Cano, M., and Arnold, L.L. Lack of inhibition by melatonin of the toxic and proliferative effects of dietary dimethylarsinic acid on rat urothelium. The Toxicologist, 78: 2004. 198. Cohen, S.M. Framework for evaluating the human relevance of carcinogenic modes of action in animals. The Toxicologist, 84: 136, 2005. 199. Dellarco, V.L., Cohen, S., Wolf, D., Maronpot, R., and Jacobson-Kram, D. Rodent hepatic tumors: Cytotoxicity mode of action. The Toxicologist, 84: 137, 2005. 200. Cohen, S.M., Arnold, L.L., Cano, M., and Wei, M. The effects of co-administration of antioxidants and dimethylarsinic acid (DMA) on the bladder epithelium of female F344 rats. The Toxicologist, 84: 306, 2005. 201. Eldan, M., Arnold, L.L., van Gemert, M., and Cohen, S.M. Dimethylarsinic acid (DMA): Results of chronic toxicity/oncogenicity studies in Fischer F344 rats and B6C3F1 mice. The Toxicologist, 84: 307, 2005. 202. Nuber, D.C., Weiner, M.L., Blakemore, W., Harriman, J.F., and Cohen, S.M. A 90-day dietary study on carrageenan with emphasis on the gastrointestinal tract. The Toxicologist, 84: 286, 2005. 203. Olsen, G., Alexander, B., Cohen, S., and Butenhoff, J. Urinary bladder endpoints in workers and rats exposed to perfluorooctanesulfonyl fluoride (POSF) and related compounds. The Toxicologist, 84: 367, 2005. 204. Cohen, S.M., Arnold, L.L., Cano, M., and Ohnishi, T. Carcinogenicity of arsenicals in humans and animal models. The Toxicologist, 90: 761, 2006. 205. Arnold, L.L., Lu, M., Le, X.C., Clark, N., Cano, M., and Cohen, S.M. Effects of treatment with monomethylarsonic acid (MMAV) or dimethylarsinic acid (DMAV) in the diet or sodium arsenate (AsV) in the drinking water on the bladder epithelium of female F344 rats. The Toxicologist, 90: 975, 2006. 206. Van Vleet, T., White, R., Sanderson, T., Waites, C.R., Schilling B., Mitroka, J., Cano, M., Arnold, L., Cohen, S., and Dominick, M. Subchronic urinary bladder effects of muraglitazar in male rats. The Toxicologist, 90: 982, 2006. 207. Ohnishi, T., Arnold, L.L., Cano, M., Clark, N., and Cohen, S.M. Effects of melatonin on dimethylarsinic acid (DMA)-induced cytotoxicity and proliferation of the bladder epithelium of female F344 rats. The Toxicologist, 90: 1657, 2006. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-129F9iled: 04/06/15 Page: 146 of 151 EPXAHGIBEITID1#: Curriculum Vitae Page 116 Samuel M. Cohen, M.D. Ph.D. 208. Tannehill-Gregg, S.H., Cano, M., Tomlinson, L., Cohen, S.M., Sanderson, T.P., Schilling, B.E., and Dominick, M.A. Preliminary evidence of urolithiasis with muraglitazar-related urinary bladder carcinogenesis in male rats. The Toxicologist, 90: 2089, 2006. 209. Cohen, S., Cook, J.C., Doerrer, M.G., and Hammond. T. Carcinogenic modes of action of PPAR agonists: the HESI initiative. J. Toxicol. Sci., 31: SY3-4, 2006. 210. Cohen, S.M., Arnold, L.L., Ohnishi, T., and Le, X.C. Arsenic-induced bladder cancer in an animal model. U.S. EPA Workshop on Arsenic Research and Risk Assessment, 2006. 211. Ohnishi, T., Arnold, L.L., Clark, N.M., and Cohen, S.M. Comparison of endothelial cell proliferation in liver and adipose tissue in B6C3F1 Mice, F344 rats, and humans. The Toxicologist, 96:753, 2007. 212. Dominick, M., White, M.R., Sanderson, T., Van Fleet, T., Cohen, S., Arnold, L.L., Cano, M., Tannehill-Gregg, S., Moehlenkamp, J., Waites, C.R., and Schilling, B. Urothelial carcinogenesis in the urinary bladder of male rats treated with muraglitazar, a PPAR a/y agonist: evidence for urolithiasis as the inciting event in the mode of action. The Toxicologist, 96: 760, 2007. 213. Clark, N.M., Ohnishi, T., He, J., Arnold, L.L., Boyer, C., Kawasaki, S., Liu, X., Rennard, S., and Cohen, S.M. The effects of cigarette smoke inhalation on the bladder urothelium of female C57BL/6 mice. The Toxicologist, 96: 761, 2007. 214. Arnold, L.L., Clark, N.M., He, J., Ohnishi, T., and Cohen, S.M. Effect of treatment with sodium arsenate (ASV) or sodium arsenite (ASIII) in the drinking water n the bladder urothelium of male and female F344 rats and C57BL/6 mice. The Toxicologist, 96: 762, 2007. 215. Ohnishi, T., Izumi, K., and Cohen, S. Comparison of endothelial cell proliferation in liver and adipose tissue in B6C3F1 mice, F344 rats and humans. 66th Annual Meeting of the Japanese Cancer Assoc, 2007. 216. Kakiuchi-Kiyota, S., Singh, R., Suzuki, S., Pennington, K.L., Nascimento, M., Arnold, L.L., and Cohen, S.M. Evaluation of possible cytotoxicity and mitogenesis in human microvascular endothelial cells treated with the PPARy agonist troglitazone. The Toxicologist, 102: 107, 2008. 217. Suzuki, S., Nascimento, M., Kakiuchi-Kiyota, S., Pennington, K.L., Arnold, L.L., and Cohen, S.M. Cytotoxicity of combined arsenicals on rat bladder epithelial cells in vitro. The Toxicologist, 102: 333, 2008. 218. Chen, B., Le, X.C., Suzuki, S., Pennington, K.L., Cohen, S.M., and Arnold, L.L. Determination of arsenic species in urine and serum samples from rats exposed to Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 147 of 151 PAGEID #: 42300 EXHIBIT 1 Curriculum Vitae Page 117 Samuel M. Cohen, M.D. Ph.D. arsenite. # 363, 57th American Society of Mass Spectrometry Conference on Mass Spectrometry, Philadelphia, PA, 2009. 219. Kakiuchi-Kiyota, S., Singh, R.K., Vetro, J.A., Varney, M.L., Han, H.-Y., Suzuki, S., Pennington, K.L., Arnold, L.L., and Cohen, S.M. Evaluation of the effects of the PPARy agonist troglitazone on cytotoxicity and mitogenesis of endothelial cells: Differences between human and mouse. The Toxicologist, 108: 902, 2009. 220. Suzuki, S., Arnold, L.L., Pennington, K.L., Chen, B., Le, X.C., and Cohen, S.M. Dose effects of arsenite on rodent bladder urothelium. The Toxicologist, 108: 1646, 2009. 221. Olin, S., and Cohen, S.M. Characterizing modes-of-action and their relevance in assessing human health risks. The Toxicologist. 108:3, 2009. 222. Kakiuchi-Kiyota, S., Yokohira M., Suzuki S., Arnold L.L., Pennington, K.L., Singh R. K., and Cohen, S.M. Effects of peroxisome proliferator-activated receptor gamma (PPARy) agonists on endothelial cells: differences between sarcomagenic troglitazone and non-sarcomagenic pioglitazone. The Toxicologist, 2010. 223. Yokohira M., Wei, M., Wanibuchi H., Suzuki S., Pennington, K.L., Kakiuchi-Kiyota, S. , Arnold L.L. and Cohen S.M. Effects of oral administration of pioglitazone, sodium saccharin or sodium o-phenylphenate on the expression of oncomodulin in the bladder epithelium of male F344 rats. The Toxicologist, 2010. 224. Yokohira, M., Arnold, L.L., Pennington, K.L., Suzuki, S., Kakiuchi-Kiyota, S., Herbin Davis, K., Thomas, D.J., and Cohen, S.M. Severe systemic toxicity and urinary bladder cytotoxicity and regenerative hyperplasia induced by arsenite in arsenic (+3 oxidation state) methyltransferase knockout mice. The Toxicologist, 2010. 225. Yager, J.W., Clewell, H.J., Thomas, R.S., McKim, J.M., Wilga, P.C., Gentry, R., and Cohen, S.M. Genomic changes in human primary uroepithelial cells following exposures to arsenite and its metabolites. The Toxicologist, 2010. 226. Yokohira, M., Suzuki, S., Imaida, K., and Cohen, S.M. Systemic and urothelial toxicity by the bladder carcinotghen, arsenite, in arsenic methyltransferase knockout mice. Proc. Jpn. Cancer Assoc., 69th annual meeting, 2010. 227. Suzuki, S., Cohen, S.M., Wei, M., Wanibuchi, H., and Shirai, T. Effects of pioglitazone on the urine and urothelium of the rat. Proc. Jpn. Cancer Association, 69th annual meeting, 2010. 228. Yager, J.W., Clewell, H.J., Thomas, R.S., Efremenke, A., Black, M., Gill, G., Wagner, H., McKim, Jr., J.M., Wilga, P.C., Cohen, S.M., Arnold, L.L., and Gentry, P.R. Evaluation of genomic changes in human primary uroepithelial cells following exposures to inorganic arsenic and its methylated metabolites. Sixth Conference on Metal Toxicity and Carcinogenesis, Lexington, KY, 2010. Case: 2:13-md-02433-EAS-EPD Doc #: 280472-130F1iled: 04/06/15 Page: 148 of 151 EPXAHGIBEITID1#: Curriculum Vitae Page 118 Samuel M. Cohen, M.D. Ph.D. 229. Yokohira, M., Arnold, L.L., Pennington, K.L., Suzuki, S., Kakiuchi-Kiyota, S., Herbin Davis, K., Thomas, D.J., Imaida, K., and Cohen, S.M. Severe urinary bladder cytotoxicity and regenerative hyperplasia with dose response induced by arsenite in arsenic (+3 oxidation state) methyltransferase knockout mice. The Toxicologist, Abstract #232, 2011. 230. Kakiuchi-Kiyota, S., Arnold, L.L., Koza-Taylor, P., Suzuki, S., and Cohen, S.M. Analysis of peroxisome proliferator-activated receptor gamma (PPARy) agonist troglitazone-induced transcriptional changes in mouse endothelial cells. The Toxicologist, Abstract #2633, 2011. 231. Cohen, S.M., Arnold, L., Lautraite, S., Sheets, L., Wason, S., Stahl, B. Eigenberg, D., Pennington, K.L., Kakiuchi-Kiyota, S., and Yokohira, M. The effects of oral treatment with transfluthrin on the bladder epithelium of rats and mice and its metabolite, tetrafluorobenzoic acid on urothelial cells in vitro. The Toxicologist, Abstract #2646, 2011. 232. Arnold, L., Kakiuchi-Kiyota, S., Pennington, K.L., and Cohen, S.M. Cytotoxicity of arsenicals on human bronchial epithelial cells in vitro. The Toxicologist, Abstract #2655, 2011. 233. Moretto, A., Boobis, A., Cohen, S.M., Dellarco, M., Doe, J., Embry, M., Hines, R., Pastoor, T., Phillips, R., Rowlands, J.C., Sargent, D., and Wolf, D. Risk assessment in the 21st century: the contributions of HESI's RISK21 project. Soc. Risk Analysis, 2011. 234. Kondo, M., Yamada, T., Miyata, K.,Nagahori, H., Sumida, K., Mikata, K., Cohen, S.M., Isobe, N., and Kawamura, S. Mode of action for the synthetic pyrethroid permethrin-induced mouse liver tumors: evidence for peroxisome proliferator-activated receptor alpha (PPAR a) activation and associated liver changes. The Toxicologist, 2012. 235. Yamada, T., Kondo, M., Miyata, K., Cohen, S.M., Isobe, N., and Kawamura, S. Mode of action for the synthetic pyrethroid permethrin-induced mouse lung tumors: evidence for Clara cell proliferation. The Toxicologist, 2012. 236. Dodmane, P.R., DaRocha, M.S., Arnold, L.L., Pennington, K.L., Anwar, M.M., Adams, B.R., Taylor, S.V., Adams, T.B., and Cohen, S.M. Evaluation of the urothelial cytotoxicity of pulegone. The Toxicologist, 2012. 237. DaRocha, M.S., Arnold, L.L., Pennington, K., Anwar, M.M., Battalora, M. Camargo, J.L.V., and Cohen, S.M. Evaluation of diuron's mode of action: in vivo and in vitro approaches. The Toxicologist, 2012. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 42302 04/06/15 Page: 149 of 151 EPXAHGIBEITID1 #: Curriculum Vitae Page 119 Samuel M. Cohen, M.D. Ph.D. 238. DaRocha, M.S., Arnold, L.L., Pennington, K., Dodmane, P., Anwar, M.M., Muirhead, D., Camargo, J.L.V., and Cohen, S.M. Evaluation of diuron's mode of action. ALAPT Annual Meeting, 2012. 239. DaRocha, M.S., Arnold, L.L., Pennington, K.L., Dodmane, P., Anwar, M.M., de Oliveira, M.L.C.S., Muirhead, D., de Camargo, J.L.V., and Cohen, S.M. Diuron urothelium toxicity. Soc. Toxicol. Pathol. Annual Meeting, Boston, June, 2012. 240. Cohen, S.M. Risk 21. 8th Congress of Toxicology in Developing Countries. Thai J. Toxicol., p. 16, 2012. 241. Feng, S. Ding, S.-J., Dodmane, P.R. Scotchen, J., Arnold, L.L., Young, N.L., Marshall, A.G., and Cohen, S.M. Identification of the interaction of trivalent arsenicals with metallothionein by use of ultrahigh resolution mass spectrometry. Amer. Soc. Mass. Spec., 2013. 242. Kakiuchi-Kiyota, S., Crabbs, T.A., Arnold, L.L., Pennington, K.L., Cook, J.C., Malarkey, D.E., and Cohen, S.M. Expression profiles of hematopoietic stem cell, endothelial cell, and myeloid cell antigens in spontaneous and chemically induced hemangiomas (HA) and hemangiosarcomas (HS) in mice. The Toxicologist, 2013. 243. Arnold, L.L., Dodmane, P.R., Pennington, K.L., and Cohen, S.M., Effects of treatment with dimethylarsinous acid (DMA111) on the urinary bladder epithelium of female arsenic methyltransferase (As3mt) knockout mice and wild type mice. The Toxicologist, 2013. 244. Dodmane, P.R., Arnold, L.L., Pennington, K.L., and Cohen, S.M. Gene expression changes induced by various arsenicals in vitro. The Toxicologist, 2013. 245. Liu, L., Kakiuchi-Kiyota, S., Arnold, L.L., Johansson, S. L., Wert, D., and Cohen, S.M. Pathogenesis of human hemangiosarcomas. College of American Pathologists Annual Meeting, October, 2013. 246. Cohen, S.M. Using mode of action in determining relevance in human carcinogenesis risk assessment. American College of Toxicology Annual Meeting, November, 2013. 247. Boobis, A., Pastoor, T., Bachman, A., Cohen, S.M., Dellarco, M., Dewhurst, I., Doe, J., Doerrer, N., Embry, M., Moretto, A., Phillips, R., Rowlands, J.C., and Tanir, J.Y. Risk 21: A 21st Century roadmap for human health risk assessment. The Toxicologist, 2014. 248. Okuda, Y., Yamada, T., Kushida, M., Takeuchi, H., Nagahori, H., Lake, B.G., Cohen, S. M., and Kawamura, S. Human hepatocytes support the hypertrophic but not the hyperplastic response to the murine nongenotoxic hepatocarcinogen sodium phenobarbital in in vivo study using chimeric mouse with humanized liver. The Toxicologist, 2014. Case: 2:13-md-02433-EAS-EPD Doc #: 2807-1 Filed: 04/06/15 Page: 150 of 151 PAGEID #: 42303 EXHIBIT 1 Curriculum Vitae Page 120 Samuel M. Cohen, M.D. Ph.D. 249. Dodmane, P.R., Arnold, L.L., Pennington, K.L., and Cohen, S.M. Orally administered nicotine induces urothelial hyperplasia in rats and mice. The Toxicologist, 2014. 250. Wolf, D., Bachmann, A., Boobis, A., Cohen, S., Dellarco, M., Dewhurst, I., Doe, J., Doerrer, N., Moretto, A., Pastoor, T., Phillips, R, Rowlands, J.C., Tanir, J., and Embry, M. A 21st century roadmap for human health risk assessment. Soc. Toxicol. Pathol. 33rd Annual Meeting, Washington DC, June, 2014. 251. DaRocha, M.S., Arnold, L., Dodmane, P., de Oliveira, M.L.C.S., Cardoso, A.P.F., Pontes, M.G.N., Pennington, K., Muirhead, D., Qui, F., Cohen, S.M., and Camargo, J.L.V. Elucidating the carcinogenic mode of action of diuron on rat urothelium. Soc. Toxicol. Pathol. 33rdAnnual Meeting, Washington DC, June, 2014. 252. Pandiri, A., and Cohen, S.M. Rodent vs. Human Lung Cancer: the good, the bad, and the ugly! Soc. Toxicol. Pathol. 33rd Annual Meeting, Washington, DC, June, 2014. 253. Ana Paula F. Cardoso, Merielen N. Pontes, Nathalia P. de Souza, Ligia M.M. Gomide, Lora L. Arnold, Samuel M. Cohen, Joao Lauro V. de Camargo. Histological and Immunohistochemical Evaluations of Testicular Germ Cells of Rats Exposed to Cryptorchidism, Orchidopexy and to Di-Butyl-Phtalate or Acrylamide. Central States Soc. Toxicol. Pathol. Annual Conference, Kansas City, KS, October, 2014. h. Published audiovisual or computer-based educational materials and computer software: None i. Published continuing education materials: None Case: 2:13-md-02433-EAS-EPD Doc #: 280472-130F4iled: 04/06/15 Page: 151 of 151 EPXAHGIBEITID1#: Exhibit B Past Depositions and Trial Testimony (last 4 years) Stephen Hynds and Sylvia Hynds v. Dow Chemical Company, et al.. State of Illinois, Circuit Court of the Sixth Judicial Circuit, County of Macon Henry v. Takeda, Circuit Court of Cook County, Chicago, IL MDL 2299-In RE: Actos Products Liability Litigation- Plaintiffs' Steering Committee v. Takeda Pharmaceutical Company, Western District of Louisiana, United States District Court Kincaid v. Eli Lilly, Takeda et al., Court of State of Indiana, County of Marion, Marion Superior Court Civil Division, Cause No. 49DO3-1206-CT-024661 Jack Cooper et al. vs. Takeda Pharmaceuticals America, Inc., et al., Superior Court of the State of California for the County of Los Angeles Camhong An et al. vs. Takeda Pharmaceuticals America, Inc., et al., Circuit Court for Baltimore City, Case No. 24-C-12-003565, Baltimore, MD Terrence and Susan Allen v. Takeda Pharmaceuticals International, Inc., et al., United States District Court for the Western District of Louisiana, Lafayette Division, Lafayette, LA, MDL No. 6:11-md-2299, Case No. 6:12-cv- 00064-RFD-PJH Bertha Triana vs. Takeda Pharmaceuticals America, Inc., et al., District Court, Clark County Nevada, Las Vegas, NV, Case No. A-13-680556-C, and Delores Cipriano et al., v. Takeda Pharmaceuticals America, Inc., et al., Case No. A-13-680922-C Diane Whitlatch, individually and as special administrator for the estate of William M. Whitlatch vs. Takeda Pharmaceuticals America, Inc., et al., Circuit Court of Cook County, Illinois County Department Law Division, Chicago, IL, No. 2011 L 010011, No. 2012 L 006087