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Edward R. Frizell M.D., Ph.D.

Highlands, NJ 07732 (215) 840-7656 EduardoFrizell@gmail.com OBJECTIVE: I seek employment as a Toxicologist/Study Director/Study Monitor in non-clinical toxicology research. Note: I relocated to New Jersey on October 2013. Ideally, a good job opportunity for me would be one located in the Garden State. However, I am open to relocation, depending on agreement. SUMMARY: Mid-career Toxicologist. PhD in Developmental Biology and Teratology. 12+ years of experience as Investigator and Study Director in nonclinical toxicology (CRO environment). 5 years of experience in Academic research. Expert in designing, directing, and interpreting GLP and non GLP Developmental and Reproductive Toxicology (DART) study types (reproduction, embryo-fetal and postnatal toxicity), including Juvenile toxicity, and EPAs Tier 1 Endocrine Disruptor Screening Program (EDSP). Skilled in the design, direction, and evaluation of GLP and non GLP general toxicity studies in rodents (MTD/7-day, 28-Day, 90-Day). Experienced in the design, direction, and evaluation of non-standard toxicity studies in rodents, custom designed to answer particular research questions (mechanism of action and in vivo teratogenicity). Successfully established CROs capabilities for developmental/reproductive and neurobehavioral evaluations. Key participant in the CROs coordination and performance of non GLP and GLP toxicology studies (including protocol generation, test animal procurement, study scheduling, and timely report production in a matrixed environment). Directed and closely monitored contracted studies for protocol execution and GLP (FDA/OECD) compliance. Routinely communicated with Principal Investigators and/or Contributing Scientists to appraise progress, data quality and GLP compliance of ancillary sub-reports. Maintained Sponsors/Study Monitors informed of progress of the contracted studies, to solve any potential issues, and to assure that the CROs deliverables were achieved within established timelines, and within budget. Demonstrated record of effective communication and teamwork in general complex study designs/validations. Assisted in Project Management and manage multiple projects simultaneously. Authored diverse study reports for DART, EDSP and General toxicology studies (generated the corresponding common technical documents CTDs, when required by the Sponsors). In depth knowledge of biostatistical methods and tools, required for the interpretation of reproductive and/or embryo-fetal endpoints. WORK EXPERIENCE Developmental and Reproductive Toxicologist, Tox/Safety Pharmacologist IV May 2011 July 2013 (2 years and 2 months) Life Sciences - Battelle Memorial Institute | Columbus, Ohio Served as Battelles Developmental and Reproductive Toxicologist, and as Subject Matter Expert in charge of Developmental and Reproductive Toxicology (DART) and EPA's Endocrine Disruptor Screening

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Program (EDSP) Services. I also functioned as DART Discipline Leader for Government contracts (i.e., The National Toxicology Program NTP). Represented Battelle as Principal Investigator (PI) for in vivo mammalian assays in the re-bidding of EPA/Battelles Endocrine Disruptor Screening Program: Laboratory Assays and Validation Studies (SOL DC-11-00006), under Dr. David Houchens. This EPA million dollar contract was awarded to Battelle. I was hired to start and manage DART and EDSP services at Battelle Memorial Institute. By the end of my employment, I had completed those tasks through a series of successful internal validation studies, some of which was published: EPAs EDSP Tier 1 Mechanistic studies: The Hershberger Bioassay and the Uterotrophic Assay (2011). EPA's EDSP Pubertal Development and Thyroid Function Assays in Intact Juvenile/Peripubertal male and female Rats (2012). All aspects of the Segment 1 (effects on Fertility and Early Embryonic Development) and Segment 3 (effects on pre- and postnatal development, including maternal function) ICH study designs (20112012). The evaluation of Cesarean section parameters and external, visceral and skeletal malformations, in support of a Segment 2 (effects on embryo-fetal development), in the rat (2012). I utilized a classical approach consisting in the administration of single doses of acetylsalicylic acid on different gestational days to generate fetal malformations. Rodent (in the rat and mouse) Vaginal Cytology sample collection and interpretation (2012-2013). Computer Assisted Sperm Assessment (Tox IVOS) in the rat and mouse (TOX IVOS) (2011-2013). I also successfully conducted proficiency studies for study designs proper of the National Toxicology Program (NTP): the Modified One Generation (MOG) and the Reproductive Assessment by Continuous Breeding (RACB). I trained Battelles Scientists and Technical staff; and imparted small courses on aspects proper to DART and EDSP techniques and evaluations, including the examination of Genitourinary Malformations for Perinatal studies in the rat (which was a particular need in NTP studies). Scientific communications during this period: Frizell ER, Fallacara D, Toy H, Brys AM, Essman-Wood C, Vasconcelos D, Skowronek AJ, Singer AW, Gerken DK and Sparrow B. Battelles EDSP Services: Tier 1 Male and Female Pubertal Assays. Lessons Learned, Challenges, and Opportunities: The US Endocrine Disruptor Screening Program. North Carolina Biotechnology Center, Research Triangle Park, North Carolina. April 23-24, 2013. Frizell ER, Fallacara D, Kobs CL, Huwar TB, Brys AM, Essman-Wood C, Skowronek AJ, Singer AW, Gerken DK and Sparrow B. Battelles EDSP Services: Tier 1 In Vivo Mechanistic Studies, Life Sciences Research, Battelle Memorial Institute, Columbus Ohio. Lessons Learned, Challenges, and Opportunities: The US Endocrine Disruptor Screening Program. North Carolina Biotechnology Center, Research Triangle Park, North Carolina. April 23-24, 2013.

Senior Toxicologist and Study Director (Reproductive, Developmental and General Toxicology). September 2006 - May 2011 (4 years and 8 months) Huntingdon Life Sciences | Somerset, New Jersey I served as a Study Director and internal Consultant for animal studies and projects conducted under the direction of the Safety Assessment Group. I was responsible for the overall design, conduct,

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interpretation, and reporting of safety/toxicity studies of all types, performed in small animal species, with special emphasis on DART (including Juvenile Toxicity studies in the rat). I designed, directed and interpreted DART studies [ICH guideline S5(R2): Fertility and Early Embryonic Development to Implantation, Embryo-fetal development, and Pre- and postnatal development, including maternal function], EPAs EDSP male and female Pubertal assays. In addition I designed, directed and interpreted General Toxicity study designs aimed to evaluate Endocrine endpoints, behavioral tests, the validation of Auditory Startle Habituation and Prepulse inhibition of Auditory Startle; the evaluation of Locomotor activity, and the conduction of Neurotoxicity study designs. I interacted with the CROs Clients and their Consultants, and with members of the pharmaceutical, chemical and food industries in the U.S.A., Europe and Japan, as well as with regulatory agency personnel (FDA, EPA) in reference to my assigned studies. Scientific communications during this period: E Frizell, G Theerman, C Savidge, S Wilcox and R Parker. Validation of an Automated Auditory Startle Response (ASR) System by Chemical and Non-chemical Means. Society of Toxicology Annual Meeting March 2010 Salt Lake City, Utah, USA E.T.M. Horsley, K. Hazelden, E.R. Frizell and R.M. Parker. Male Pubertal Assay: Validation Using Known Endocrine Disruptors. . Presented at the Society of Toxicology Annual Meeting March 2010 Salt Lake City, Utah, USA E Frizell, E Horsley, K Hazelden and R Parker. Female Pubertal Assay: Validation Using Known Endocrine Disruptors. Society of Toxicology Annual Meeting March 2010 Salt Lake City, Utah, USA.

Study Director DART and General Toxicology October 2002 - September 2006 (3 years and 11 months) Huntingdon Life Sciences | Somerset, New Jersey I served as Study Director and internal consultant for animal studies and projects conducted under the direction of the Safety Assessment group. I was responsible for the overall design, conduct, interpretation and reporting of safety/toxicity studies of all types, performed in large and small animal species, with special emphasis on DART. I was a Study Director for the inter-laboratory validation of EPA's Tier 1 in vivo mammalian assays in intact peripubertal rats. I also conducted Single-dose, 7-day, 14-day and 90-day General toxicity studies. I Interacted with members of the pharmaceutical, chemical and food industries in the U.S.A., Europe and Japan, as well as with regulatory agency personnel (FDA, EPA) in reference to my assigned studies. Scientific communications during this period: Frizell ER, RM Mandella and KP Hazelden. Prepulse Inhibition of Auditory Startle in 60-days old rats: System Validation with Apomorphine. Neurobehavioral Teratology Society meeting, June 2630, Vancouver, Canada. 2004

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Postdoctoral Research Fellow in Reproductive Toxicology (Joseph Mitala, Ph.D., Director). October 2000 - October 2002 (two years) Johnson and Johnson | Raritan, New Jersey I designed a new model for male reproductive toxicity screening in the rabbit (under Joseph Mitala, Ph.D., Director). I demonstrated the successful use of the new screening model by means of transitory hormonal axis ablation. Scientific communications during this period: Frizell ER, Filian JJ, Mitala JJ. The rabbit as a model for assessment of male reproductive toxicity. Excellence In Science, Symposium sponsored by Johnson & Johnson Corporate Office of Science and Technology, Hyatt Regency, New Brunswick, NJ, November 5, 2001. Clinical Coordinator/Research Fellow April 1995 - July 1997 (2 years and 3 months) Thomas Jefferson University | Philadelphia, PA Clinical Coordinator/Research Fellow for the Department of Dermatology. My work in Dermatology was geared to Clinical Coordination and prenatal diagnosis of inheritable skin diseases, as well as to the actual research analysis of the probands and their families. I was also a Certified Laboratory Safety Trainer and supervised and trained Faculty, Staff and graduate students in laboratory safety. Scientific communications during this period: Yoon K., Santana E., Peritz A., Frizell E., Iyer S., and Uitto J. Targeted mutagenesis by the RNA-DNA oligonucleotide in keratinocytes. Journal of Investigative Dermatology, 108(4), 588-588, (1997). Instructor of Medicine/ Senior Research Associate October 1992 - March 1995 (2 years and 5 months) Thomas Jefferson University, Gastroenterology and Hepatology Division | Philadelphia, PA Supervised the research facilities, consisting in three laboratories, until 1995. I was appointed Faculty at TJU and promoted to Senior Research Associate. I continued my work on liver fibrogenesis. Scientific communications during this period: Frizell E, SL Liu, A Abraham, I Ozaki, M Eghbali, E H Sage and M A. Zern. Expression of SPARC in Normal and Fibrotic Livers. Hepatology 21: 847-854, 1995. Frizell E, R. Perkinson, et al. Rapamycin In Liver Fibrogenesis. East Coast Connective Tissue Society. March, 1995. J Zhu, J Wu, E Frizell, S-L Liu, R Bashey, R Rubin, P Norton and M A. Zern. Rapamycin inhibits hepatic stellate cell proliferation in vitro and limits fibrogenesis in an in vivo model of liver fibrosis. Gastroenterology 117:1198-1204, 1999 A. Mirza, E. Frizell, SL Liu, et al. Tissue transglutaminase gene expression in hepatic fibrogenesis and its regulation by NF- . Temple University. May, 1995. A. Mirza, S. L. Liu, E. Frizell, J. Zhu, S. Maddukuri, et al. A role for tissue transglutaminase in hepatic injury and fibrogenesis, and its regulation by NF-kappa . American Journal of Physiology Gastrointestinal and Liver Physiology 272: G281-G288, 1997.

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Frizell E, A Abraham, M Doolittle, R Bashey, T Kresina, D Van Thiel and M A. Zern. FK506 Enhances Fibrogenesis in in vitro and in vivo Models of Liver Fibrosis in Rats. Gastroenterology 107: 492-498, 1994.

Post-doctoral fellow/Research Associate March 1990 - October 1992 (2 years and 7 months) Brown University | Providence, RI I researched the molecular basis of Liver Diseases (particularly liver fibrosis). I employed and refined state of the art methodologies in molecular biology, both in in vitro and in vivo models of liver cirrhosis. My work was instrumental in re-obtaining NIH funding. I was promoted to Research Associate. I identified a new gene product involved in liver fibrogenesis, and I conducted preliminary work in therapeutic modulation of liver fibrosis. Scientific communications during this period: Frizell E, S. Degli Esposti, et al. IL-1 receptor antagonist therapy of hepatic fibrosis. Hepatology 16: 552 A (abstract 341), 1992. Degli Esposti S., E. Frizell, et al. The role of TGF- isoforms in hepatic fibrosis. Hepatology 16: 130 A. 1992. Degli Esposti, E. Frizell, et al. The multifaceted effects of Enisoprost, a prostaglandin E1 analog, in inhibiting hepatic fibrosis. Hepatology 14: 113A, 1991. Frizell E, Q. He, et al. FK-506 enhances fibrogenesis in an In vitro and In vivo models of liver fibrosis. Hepatology 14: 47A, 1991. Degli Esposti, E. Frizell, et al. Improved rat model of alcoholic liver disease: Omega 3-fatty acids (3FAs) plus ethanol administration. Hepatology 14: 47A, 1991. Frizell E, L. Shu-Ling, et al. SPARC gene-expression in normal and fibrotic livers. Hepatology 12:917, 1990. EDUCATION Second Doctorate, Developmental Biology and Teratology, 2000 Thomas Jefferson University/Developmental Biology and Teratology | Philadelphia, Pennsylvania I conducted my second doctoral research under Prof. Joan Overhauser, Ph.D., in the Department of Biochemistry and Molecular Pharmacology. I utilized positional candidate cloning to identify genes potentially involved in the genesis of the 18q-haploinsufficiency phenotype. I identified and cloned two novel cell adhesion molecules (Cadherin 7 and Cadherin 7b) in the critical region for genitourinary malformation seen in 18q-. I also identified and partially cloned the murine analog of Cadherin 7b. My thesis work included the construction of physical and transcriptional maps, as well as the expression analysis of candidate genes in a developmental mouse model by means of Northern blotting, In Situ Hybridization, Fluorescent In Situ Hybridization (FISH) and RT-PCR. I graduated MAGNA CUM LAUDE. Scientific communications during this period: E R Frizell, Characterization of genes mapping to chromosome 18q that are potentially involved in Genitourinary development, Doctoral Thesis, 2000.

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E R Frizell, R Sutphen, F B Diamond Jr., M Sherwood and J Overhauser. t(1;18)(q32.1;q22.1) associated with genitourinary malformations. Clinical Genetics 54: 330-333, 1998 J. Overhauser, E. R. Frizell, R. Dolsky, K. Rojas, R. Sutphen Identification of candidate genes involved in genitourinary malformations. Journal: Genetics in Medicine Vol. 1, no. 2, 1999 Frizell ER, Sutphen R, et al. Microcephaly and genitourinary malformations in a patient with a t(1;18)(q32;q22): identification of a candidate gene associated with the 18q- syndrome. Am. Society of Hum. Gen. 48th annual meeting, Denver, CO, 1998. First Doctorate, Developmental Biology and Teratology and MD, 1981-1988 Universidad de Navarra and Universidad Complutense de Madrid, Schools of Medicine (Spain) I attended Medical school, received my M.D, and my first Doctorate in Spain. My doctorate work dealt with the reproductive toxic effects of chronic alcohol consumption and with the production of Fetal Alcohol Syndrome in a rat model. I generated the first successful protocol for cytogenetic analysis of adult and fetal rat tissues in Spain. I demonstrated the impact of confinement-stress on bone marrow functioning in the rat. I successfully designed a Fetal Alcohol Syndrome animal model in this Species. I graduated SUMMA CUM LAUDE, by unanimity. I received the 1988's University of Navarres Special Award to Research. I was admitted to the Royal College of Physicians (Navarre/Spain) At the school of Medicine, I completed studies in biochemistry, anatomy, physiology, microbiology, parasitology, embryology teratology, pathology, pharmacology, and toxicology. Advanced medical training courses included internal medicine, pediatrics, psychiatry, obstetrics and gynecology, dermatology, infectious diseases, oncology, orthopedic surgery, rheumatology, emergency medicine, and general surgery. Scientific communications during this period: Frizell ER Relationship between zinc deficiency and alcoholism in the experimental production of Fetal Alcohol Syndrome in rat. Doctoral Thesis, 1988 Fresnillo M. Villa-Elzaga I. Olazabal A. Frizell E. Lpez de Ochoa JA. Ballesteros A. and Sierrasesumaga L. Alterations in the nuclear volume of neurons from the hypothalamic magnocellular nuclei of fetuses born to rats subject to chronic alcoholism. Rev Esp Fisiol 45 Suppl:43-47S. 1989 Lpez de Ochoa JA. Villa-Elzaga I. Frizell E. Fresnillo M. Ballesteros A. Olazabal A. and Sierrasesumaga L. Alterations in deoxyribonucleic acid and proteins in cerebral tissues from fetuses subject to alcohol in utero. Rev Esp Fisiol. 45 Suppl:35-42. 1989 Specialty of Pediatrics Clnica Universitaria, University of Navarre, School of Medicine (Spain) | Pamplona, Navarre Clinical training consisted of medical residency in perinatology; infectious diseases; emergency, pediatric and neonatal intensive care; cardiology; neurology; oncology; and outpatient clinics. I also completed special seminars in pediatric pharmacology and developmental outcomes. LANGUAGES Spanish: Fluent

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PROFESSIONAL MEMBERSHIPS / AFFILIATIONS Society of Toxicology (SOT) SOT - Reproductive and Developmental Toxicology Specialty Section (RDTSS) Teratology Society REFERENCES Robert M Parker, PhD Director, Developmental and Reproductive Toxicology, Huntingdon Life Sciences, Princeton Research Center 732-873-2550 ext 2389 ParkerR@princeton.huntingdon.com Allen Singer, DVM Former Vice-President, Center for Life Sciences Research Battelle Memorial Institute. 614-570-5299 SingerA@Battelle.org Barney Sparrow PhD, DABT Manager, Battelle Life Sciences. 614-424-7145 SparrowB@Battelle.org

Keith P. Hazelden, BSc, C Biol, MI Biol Former Director, Reproductive and Developmental Toxicology, Huntingdon Life Sciences (PRC) 01144 777 579 5755 kphazelden@mac.com