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Representative Toxicologist Biographies
Drew Badger, Director of Global Regulatory Affairs at Amgen and President of ACT
Drew Badger, PhD, DABT is a Director of Global Regulatory Affairs at Amgen and President of ACT. In this capacity, he provides strategic leadership of global regulatory teams for biologic and small molecule programs spanning multiple therapeutic areas (neurology, oncology, inflammation, rheumatology) and various stages of development. This includes global regulatory submissions, ethnic bridging strategies, pediatric strategies, and device and companion diagnostic strategies, among others. Prior to Amgen, Drew served as Senior Director of Toxicology and Regulatory Affairs at Amira Pharmaceuticals. Prior to this, he was the Director of Discovery Toxicology and Scientific Operations at Allergan following his entry role as Toxicology Study Director and Project Representative. Prior to this, Drew was a scientist at Procter & Gamble where he participated as Toxicology Project Representative for global chemical registrations in the consumer products division. Collectively, Drew has been employed with large, mid-size and small companies, worked in EPA and FDA-regulated arenas, supported development of small molecules and biologics, and served in various toxicology and regulatory leadership roles.
So how did this career path manifest? From the time of entering Humboldt State University as an art major and music minor, Drew never had a master plan for developing his career. By serendipity, in college he took elective courses in chemistry and toxicology that were so enriching and interesting, he opted to change his major to biochemistry and applied to graduate programs in toxicology. With his major advisor at The University of Arizona being President of SOT at this time, Drew was exposed to influential individuals who were active in the scientific community and he admired the pleasure and influence they derived from serving in those roles. Following a 3-year stint at Procter & Gamble, Drew took his second job in industry at Allergan and recognized that he didn’t know much about discovery toxicology, his key job function at the time. As such, he proactively founded and presided over the drug discovery toxicology specialty section of SOT in order to establish contacts, develop expertise, and to provide a venue for like-minded scientists. Concurrently, he rotated through the presidential chain of Southern California SOT. Both of these leadership roles facilitated the opportunity to serve as Councilor and ultimately in the Presidential chain of ACT, and the development of many friendships across industry. It also allowed a toxicologist like Drew to transition into leadership roles in regulatory affairs at both Amira and Amgen without having a traditional background of more junior roles in regulatory affairs.
David Compton, Toxicologist in Preclinical Safety, Sanofi
David Compton was born and raised in Missouri where he received his BA degree in chemistry from Washington University in St. Louis. Subsequently he received his PhD from the Department of Pharmacology and Toxicology at UTMB (University of Texas Medical Branch) in Galveston, where his dissertation research was on the neuropharmacology of antipsychotic medications, which was funded in part by an Individual Predoctoral Grant from the Scottish Rite Schizophrenia Foundation. At graduation he received both the Academic Excellence Award and the Jason E. Perlman Research Award. He conducted postdoctoral research on the neuropharmacology of drugs of abuse at MCV (Medical College of Virginia) in Richmond, the professional campus of VCU (Virginia Commonwealth University). During his two years on an Institutional Training Grant of the Department of Pharmacology and Toxicology, Dr. Compton was awarded a Pharmaceutical Manufacturers Association Foundation Award funding postdoctoral research into “Receptor and Nonspecific Mechanisms of Cannabinoid-Induced Alterations of Neurotransmission.” Subsequently he received a NIDA Individual Postdoctoral Grant to conduct research on the neurochemical/neurobehavioral effects of chemical analogs of Δ9-tetrahydrocannabinol (the psychoactive constituent of marihuana).
During his academic career as assistant and associate professor at MCV-VCU in the Department of Pharmacology and Toxicology, Dr. Compton taught professional students (medical, pharmacy, etc.), was the advisor and/or committee member who mentored graduate (Masters and PhD) students, and continued research on drugs of abuse funded by NIDA grants (as individual primary investigator, as co-investigator, and as part of a multifaculty Center Grant). As a faculty member he published extensively in peer reviewed journals, co-authored books on abuse liability, and co-authored chapters in medical pharmacology texts. One of his most prized accomplishments was not his research on cannabinoids, stimulants, and anabolic steroids, but rather his Students’ Choice Award for Faculty of the Year in 1994.
Though still currently an affiliate associate professor at VCU, after leaving his primary academic appointment, Dr. Compton gained valuable GLP (Good Laboratory Practices) experience in preclinical/ nonclinical toxicology as a Study Director on both US Environmental Protection Agency (US EPA)- and US Food and Drug Administration (US FDA)-mandated regulatory studies in general toxicology, reproductive toxicology, and safety pharmacology while working for Huntingdon Life Sciences, a CRO (Contract Research Organization) at the Princeton Research Center in New Jersey. Subsequently, he was an associate principal scientist at the Schering-Plough Research Institute focussing on drug development as the drug safety evaluation representative to project teams, prior to his positions as principal and lead (as of 2013) research investigator—toxicology and project team expert within preclinical safety at Sanofi US in New Jersey. Since 2007 he has served within Sanofi as one of a three-member expert group advising company project teams on development issues related to abuse potential. In 2010 he was the Sanofi US representative to PhRMA team generating the industry response to the US FDA draft guidance on Assessment of Abuse Potential of Drugs.
Dr. Compton has more than 25 years of combined academic, contract laboratory, and pharmaceutical experience in the fields of neuroscience/neuropharmacology, abuse liability/assessment, education, study directing, toxicology, and preclinical drug development. In 1999 he was certified as a diplomate of the American Board of Toxicology (DABT). He has been a member of The NYAS since 1984.
He has been a full member of ACT (American College of Toxicology) since 1997 and has served on numerous elected positions. As of 2013, he is serving his final year (of a three year elected term) as a council member of ACT. He has been a full member of SOT (Society of Toxicology) since 2011, and is currently a full member of both CPDD (College on Problems of Drug Dependence) and the Society for Neuroscience, having first joined each as an associate/student member in the 1980’s. As a member of these organizations he has presented numerous scientific posters, given multiple symposia presentations, as well as organized and served as co-chair of symposia on drug abuse/liability.
Dr. Compton was a founding member of the non-profit New Jersey Brain Bee Association in 2002 and served as the moderator of this annual spelling-bee style competition for high school students (qualifying the winner to compete in the International Brain Bee competition co-sponsored by the Society for Neuroscience). Other professional activities include serving as both instructor and member of the planning committee for the New Jersey Association for Biomedical Research-sponsored IACUC Training Workshops from 2006 to 2010, serving within Sanofi as the primary voting member for Drug Safety Evaluation of the US-based IACUC (Institutional Animal Care and Use Committee), and organizing/teaching in educational outreach programs to grade school- through college-aged students.
Hanan Ghantous, Toxicologist in the Division of Antiviral Products, US Food and Drug Administration (US FDA)
Hanan Ghantous PhD, DABT, is a pharmacology/toxicology supervisor at the Division of Antiviral Products, Center for Drug Evaluation and Research, US FDA. Since joining the US FDA in 2001 as a pharmacology/toxicology reviewer, she has evaluated data to support the safe clinical development of small molecule drugs and biological products with anti-viral, oncology, and internal medicine indications. Dr. Ghantous has presented at national and international scientific and regulatory meetings, has served on several US FDA committees, has been involved in writing Guidance documents and has represented the Agency at various public forums. Before coming to US FDA, Dr. Ghantous worked for approximately 10 years at the DuPont Company, starting her career as a research toxicologist at DuPont Haskell Laboratory, with responsibilities of a study director. Dr. Ghantous filled a number of other positions at the DuPont Company including project registration manager, US regulatory toxicologist, and NAFTA regulatory toxicologist in the Crop Protection Division.
Dr. Ghantous has a BSc in pharmacy from the University of Baghdad, Iraq, an MSc in pharmacology from the University of Strathclyde, Scotland, and a PhD in toxicology from the University of Uppsala, Sweden. She is a diplomat of the American Board of Toxicology (DABT) and did postdoctoral training at the Department of Anesthesiology, Pharmacology/Toxicology Division, University of Arizona. Dr. Ghantous has over 20 years of combined experience in general and regulatory toxicology, and has published numerous pier reviewed scientific papers.
She has been a member of the American College of Toxicology since 2002, a member of Council (2011–2013) and the chair of the continuing education committee (2013). She also is a member of the Society of Toxicology (SOT) and a member of the Continuing Education Committee of SOT (2010–2013), and serving as a president of the Biotechnology Specialty Section (2012–2013). She is a member of the Board of Directors of the American Board of Toxicology (2010–2014) and is serving as the president for 2013–2014.
Robin Guy, Toxicology and GLP Consultant, Robin Guy Consulting
Robin Guy has always had an interest in science, ever since she was a little girl. Through high school, college, and graduate school, her love for science grew. Robin was a toxicologist in industry with Monsanto/The NutraSweet Company/Searle for 19 years. She assisted with aspartame defense, reaffirmations, and approvals worldwide. She played an important role in the nonclinical development of Neotame in addition to working on the preparation of the two food additive petitions. In 2000, Robin began consulting as a toxicology and GLP consultant with Robin Guy Consulting, LLC. Robin’s activities in toxicology have primarily centered on the safety assessment and regulatory approval of food ingredients and pharmaceutical compounds, including nano materials, small and large molecules, and botanicals. Robin has served on GRAS panels and attends US FDA meetings. As a consultant, Robin helps clients with multiple toxicology and safety issues, for example, planning entire toxicology programs, monitor studies, writing regulatory submissions, and attending client and regulatory agency meetings.
She is a diplomate of the American Board of Toxicology (DABT) and a registered quality assurance professional in GLPs (RQAP-GLP). Robin is a member of the American College of Toxicology (currently president), the Society of Toxicology, the Midwest Chapter of the Society of Toxicology (MRC/SOT), the Roundtable of Toxicology Consultants, and the Society of Quality Assurance. She enjoys volunteering and has worked as either an elected or volunteer positions in all of these organizations. In addition, she currently serves on the Editorial Advisory Board of the International Journal of Toxicology, and has been a reviewer for the Journal of Food Science, and Food and Chemical Toxicology. Ms. Guy currently is appointed to the ANSI-Accredited US Technical Advisory Group (ISO/TC 229, Nanotechnologies). Volunteering in organizations is a great way to give forward, and to meet wonderful people.
Khin Oo, Toxicologist at the US EPA
Khin Oo is originally from Burma (Myanmar) in Southeast Asia. After receiving her MD, for almost 15 years she worked as a Family practice physician in Burma, with the United Nations Development Program in Sri Lanka, and with Ministries of Health Malaysia and Brunei. After immigrating to the United States, she also took and passed US Medical Examinations (USMLEs) and received her second MD in 1996. In the United States she has worked for almost six years in the public health sector with the Missouri State Department of Health as a medical epidemiologist and toxicologist. She is a diplomate of the American Board of Toxicology (DABT) and is a full member the American College of Toxicology, of the Society of Toxicology, and the Association of Government Toxicologists. At present she is an employee of the US Environmental Protection Agency (US EPA). One of Khin’s responsibilities is conducting toxicological review for immunotoxicity studies. She also performs medical literature searches and writes medical and toxicological reviews. In addition, Dr. Oo served as a technical review editor for the sixth edition of the Office of Pesticide Program/US EPA-sponsored publication Recognition and Management of Pesticide Poisoning.
David Serota, Drug Safety and Discovery, MPI Research
David G. Serota, PhD, DABT, is senior vice president of drug safety and discovery, and senior principal study director, having joined MPI Research in March 1997. In this capacity, he oversees all general toxicology, infusion, developmental and reproduction, safety pharmacology, neurobehavioral, PK, ADME, experimental therapeutics, and surgical studies conducted at MPI Research, and manages a staff of approximately 80, including 45 study directors and 15 anatomic and clinical pathologists. Dr. Serota has more than 36 years of experience as a toxicologist in the contract toxicology industry, having previously served as director of toxicology at Southern Research Institute and as director of laboratory operations and senior toxicologist at Hazleton Laboratories Vienna (now Covance) for 15 years.
He received a BS in pharmacy from Auburn University and a PhD in toxicology from the University of Tennessee. Dr. Serota is a diplomate of the American Board of Toxicology and a member of both the American College of Toxicology and the Society of Toxicology. He recently completed a one-year term as president of the American College of Toxicology and this year he is serving as past president and chairman of both the Nominations and the Outreach Committees.