= Members Only
2020 Educational Course
Toxicology for Pharmaceutical and Regulatory Scientists
Amy M. Avila, PhD
Dr. Avila earned her Bachelor of Science degree in Biochemistry from the University of Delaware. She then received her PhD in pharmacology from Georgetown University, with a focus in neuropharmacology. Her thesis research involved the study of neuronal nicotinic acetylcholine receptors and their functional regulation by nicotine and nerve growth factor. After receiving her PhD, she conducted postdoctoral research at the National Institute of Neurological Disorders and Stroke at the National Institutes of Health. She worked in the Neurogenetics Branch studying the neuromuscular disease Spinal Muscular Atrophy and investigating possible pharmacological therapies using cell-based models and transgenic mouse models. In 2006, Dr. Avila joined the Food and Drug Administration where she is currently serving as a pharmacologist/toxicologist reviewer in the Division of Psychiatry Products in the Center for Drug Development and Research (CDER). She is an active member of the Committee for Advanced Scientific Education in CDER, was a member of the Education Subcommittee of the Pharmacology/Toxicology Coordinating Committee and has contributed to the development of a training course for new pharmacologist/toxicologist reviewers. Her areas of interest are psychopharmacology, and assessment of seizures in nonclinical drug development.
Lorrene A. Buckley, PhD, DABT, ATS
Dr. Buckley is a board-certified toxicologist with over 30 years of experience in the active practice of toxicology. She earned her Masters degree in Toxicology at the University of Arizona and a doctorate, also in Toxicology, at the University of North Carolina in Chapel Hill in collaboration with the laboratories of the National Institute of Environmental Health Sciences and the US Environmental Protection Agency.
Dr. Buckley’s diversity of professional experience as a toxicologist is reflected in her work spanning basic and applied toxicology research and risk assessment in the industrial chemical, agrochemical, and pharmaceutical industries. In her current position as a Senior Research Fellow at Eli Lilly & Company, she is responsible for the design and execution of nonclinical safety assessment programs, including general and other toxicology studies, as well as for nonclinical aspects of global regulatory submissions and interactions for a variety of drugs in the development and commercialization phases. Dr. Buckley has authored the pharmacology/toxicology sections of numerous regulatory documents including briefing documents, INDs/IMPDs, BLAs/NDAs, investigator brochures, annual reports, as well as safety information on product labels/package inserts.
Dr. Buckley has also authored numerous journal articles and book chapters concerning the toxicologic assessment of environmental contaminants as well as approaches to pharmaceutical safety assessment. She has served on the Boards of the American Board of Toxicology (ABT) and on the Academy of Toxicological Sciences (ATS), and on the Councils of the American College of Toxicology (ACT) and the Society of Toxicology (SOT). She is board certified by the ABT and is a Fellow of the ATS.
Florence Burleson, PhD
Dr. Burleson received her PhD from the University of Notre Dame. She has over 20 years professional experience in immunotoxicology studies. Her background includes research at the National Institute of Environmental Health Sciences (NIEHS) and dermal molecular immunology studies at Procter and Gamble. She is presently Executive Vice President and Director of Laboratory Operations at BRT and has served as Study Director for GLP-compliant studies for pharmaceutical clients including host resistance studies and anti-fungal, bacterial, and viral evaluations, immunoassay development (ELISA) for immunogenicity studies, cytokine production, irritancy and hypersensitivity assays, LLNA, and interferon bioassays. She is a member of the Society of Toxicology (SOT), the American College of Toxicology (ACT), and of the International Journal of Toxicology editorial board.
Joseph A. Francisco, PhD
Dr. Joseph Francisco is a Scientific Advisor in the business development unit at Charles River. In this role he provides scientific and regulatory guidance on the preclinical development of small molecule drugs and biotechnology derived therapeutics. His primary area of focus is the pharmacology and toxicology of therapeutic proteins, with an emphasis on monoclonal antibodies. Previously within Charles River, Dr. Francisco was a Senior Program Advisor in the Navigator group. In these roles he has provided strategic and tactical guidance to a diverse array of domestic and international pharmaceutical and biotechnology companies ranging from small virtual companies to large multinational organizations. Also, Dr. Francisco has experience as an independent consultant, working with small biotechnology companies to establish preclinical strategies to support the development of novel therapeutics. Prior to joining Charles River, He had spent seven years at Seattle Genetics in positions of increasing responsibility focusing on the research and development of therapeutic monoclonal antibodies and antibody-drug conjugates. Before joining Seattle Genetics, Dr. Francisco had been a scientist in the Protein Sciences division of Monsanto and a scientist in the Pharmaceutical Research Institute of Bristol-Myers Squibb. He received his PhD in Chemical Engineering from the University of Texas at Austin and his bachelor’s degree in Chemical Engineering and Biochemistry from Rice University. He has co-authored over 20 scientific publications and a number of US and international patent applications. Dr. Francisco is a member of the Society of Toxicology (SOT), a member of the Pacific Northwest regional chapter of the SOT (PANWAT), and serves as a councilor in the Biotechnology Specialty Section; a member of the American College of Toxicology (ACT) and serves on the program committee (2015 and 2016); and an ACT representative on the Scientific Liaison Coalition.
Mary Beth Genter, PhD, DABT, ATS
Dr. Mary Beth Genter has been an academic toxicologist since completing graduate studies in the Integrated Toxicology Program at Duke University and postdoctoral studies at the Chemical Industry Institute of Toxicology in 1990. Dr. Genter’s background is in neurotoxicology, and she has a special interest in the olfactory system, both as a target for toxicant-induced damage and as a route of drug delivery. Prior to joining the University of Cincinnati Department of Environmental Health, Dr. Genter was employed by the North Carolina State University Department of Toxicology, where, among other responsibilities, she served as the toxicologist for the North Carolina Cooperative Extension Service. She also served as a member of the North Carolina Secretary's Scientific Advisory Board on Toxic Air Pollutants. Dr. Genter has published over 70 peer-reviewed manuscripts, and served as an advisor for the US EPA during the reevaluation of the IRIS naphthalene document. Dr. Genter is a diplomate of the American Board of Toxicology (ABT; 1992–present) and served on the ABT Board of Directors (2004–2008). She was named a Fellow of the Academy of Toxicological Scientists in 2012. She is currently (2008–present) Editor-in-Chief of International Journal of Toxicology, the official journal of the American College of Toxicology, where she also serves as a Councilor.
Dr. Genter is also a member of the Toxicology in Vitro Editorial Board, and a reviewer for approximately 2 dozen papers for other journals per year. Dr. Genter serves on the Council of the Society of Toxicology (2016–2019) and recently completed a term on the National Toxicology Program Board of Scientific Counselors (2013–2017). She is a member of the American College of Toxicology, the Society of Toxicology, the Association for Chemoreception Sciences, and Sigma Xi.
Hanan Ghantous, PhD, DABT
Dr. Ghantous joined the US Food and Drug Administration as a pharmacology/toxicology reviewer in 2001, and since 2007 she has been the Pharmacology/Toxicology supervisor at the Division of Antiviral Products, Center for Drug Evaluation and Research. 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 FDA, Dr. Ghantous worked for approximately 10 years at the DuPont Company.
She has been a member of the Society of Toxicology since 1989 and the American College of Toxicology since 2000. She served on the Continuing Education Committee of the Society of Toxicology (2010–2013). Dr. Ghantous is one of the founders of the Biotechnology Specialty Section and served as a VP-Elect, VP, President and past president of the specialty section (2010–2013). She also served as a member of the Board of Directors of the American Board of Toxicology (2010–2014) and was the president of the board for 2013–2014. She also served on council of the American College of Toxicology (2011–2013) and is the president of the American College of Toxicology (2015–2016).
Dr. Ghantous received 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 was a postdoctoral fellow in the Department of Anesthesiology, University of Arizona, and received her board certification as a Diplomate of the American Board of Toxicology (DABT) in 1995. Dr. Ghantous has over 20 years of combined experience in general and regulatory toxicology and has published peer-reviewed scientific papers and book chapters.
Melanie T. Hartsough, PhD
Dr. Hartsough is a Senior Consultant at Biologics Consulting Group, Inc. She utilizes her expertise in the strategy and development of drug products to assist clients with nonclinical development of biologics and small molecules.
Dr. Hartsough received her PhD in Pharmacology from Pennsylvania State University, College of Medicine. After a postdoctoral fellowship at NIH, Melanie joined US FDA’s Center for Biologic Evaluation and Research (CBER), Division of Therapeutic Proteins, as a full-time product reviewer. During this time, she performed chemistry, manufacturing and controls (CMC) and immunogenicity reviews for biotechnology-derived products. In 2004, Melanie transferred to the Division of Biologic Oncology Products, Center for Drug Evaluation and Research (CDER), as a pharmacology/toxicology reviewer. During this time she also performed consult reviews for the Office of Vaccines Research and Review and Office of Blood Research and Review, CBER. In 2006, she left the US FDA and joined Aclairo Pharmaceutical Development Group, Inc as a consultant. In 2007, Melanie left Aclairo and joined the Biologics Consulting Group, Inc.
Dr. Hartsough’s expertise focuses primarily on US FDA regulatory issues and strategies associated with nonclinical pharmacology and toxicology development of biologic (including cell and gene therapies, prophylactic and therapeutic vaccines, blood products and recombinant therapeutic proteins and monoclonal antibodies) and small molecule products. She is able to aid sponsors in the overall strategy and development of drug products, including relevant species, pharmacokinetic, tissue cross-reactivity, comparability and immunogenicity issues. For immunogenicity-related issues, her expertise encompasses both nonclinical and clinical disciplines. Melanie is able to provide general regulatory advice, perform reviews of the nonclinical development plan to determine regulatory gaps, design and interpret toxicology studies, interface with toxicology CROs, aid in the preparation of regulatory submissions (prepreIND, preIND, IND, BLA, NDA, response to hold, etc) and participate in US FDA meetings with the sponsor.
Kenneth L. Hastings, DrPH, DABT, ATS
Kenneth L. Hastings received his Doctor of Public Health from the University of North Carolina at Chapel Hill School of Public Health in 1987. He completed his doctoral research at the Chemical Industry Institute of Toxicology under the direction of Dr. Jack Dean. Dr. Hastings then served as a US Peace Corps volunteer in Fiji under the Permanent Secretary for Health. From 1988 to 1991, Dr. Hastings completed a postdoctoral fellowship and was then appointed research associate in the Pharmacology/Toxicology Research Laboratory of the Department of Anesthesiology within the University of Arizona College of Medicine, under the direction of Dr. A. Jay Gandolfi. From 1991 to 2007, Dr. Hastings worked in the US FDA Center for Drug Evaluation and Research (US FDA/CDER) in various positions: pharmacology/toxicology reviewer in the Division of Anti-viral Drug Products (1991–1997), pharmacology/toxicology supervisor in the Division of Special Pathogen and Immunologic Drug Products (1997–2003), and associate director in the Office of New Drugs (2003–2007). Dr. Hastings served on numerous committees and working groups while at US FDA, including lead representative for US FDA/CDER on the ICCVAM validation of the murine local lymph node assay and as lead negotiator on ICH S8 (Immunotoxicology Evaluation of New Drugs). From 2007 to 2014, Dr. Hastings was associate vice president for regulatory policy at Sanofi US, serving as corporate representative on numerous industry working groups dealing with regulatory science and policy. Dr. Hastings has served in many professional societies (President, American College of Toxicology; President, Society of Toxicology [SOT] Immunotoxicology Specialty Section; President, SOT Regulatory and Safety Evaluation Specialty Section). Dr. Hastings served as President of the American Board of Toxicology and has numerous publications, included editor of books on use of minipigs in biomedical research and international standards for nonclinical safety evaluation of medical products. Dr. Hastings is currently an independent consultant specializing in toxicology studies in drug development.
A. Wallace Hayes, PhD, DABT, ATS, FIBiol, FACFE, ERT
Dr. Hayes is a toxicologist with over 35 years of experience in industry and academics. He holds degrees from Auburn University (PhD and MS) and Emory University (AB). Dr. Hayes was a NSF predoctoral fellow at Auburn University, a NIH individual postdoctoral fellow at the Vanderbilt University School of Medicine, a NATO Senior Scientist at the Central Veterinary Laboratory in Weybridge, England and held a NIH Research Career Development Award.
Dr. Hayes has held tenured Professorships at the University of Alabama, the University of Mississippi Medical Center and Wake Forest University School of Medicine. Dr. Hayes has served on committees and expert panels for the National Academy of Sciences, the National Institutes of Health, the Environmental Protection Agency and the Department of Defense. Dr. Hayes has served on a number of GRAS Expert Panels. He currently serves on the US FDA Food Safety Committee.
Dr. Hayes has authored more than 225 peer-reviewed publications, is the editor of Hayes’ Principles and Methods of Toxicology, 6th edition, Human and Experimental Toxicology, Cutaneous and Ocular Toxicology and co-editor of the Target Organ Toxicity Series. He is the Editor-in-Chief, Food and Chemical Toxicology. Dr. Hayes is a past Secretary-General of IUTOX (two terms), past treasurer and board member of the American Board of Toxicology, a past president of the American College of Toxicology, the Toxicology Education Foundation, and the Academy of Toxicological Sciences and a past member of the council of the Society of Toxicology. Dr. Hayes is a diplomate of the American Board of Toxicology, the Academy of Toxicological Sciences, the American Board of Forensic Medicine, and the American Board of Forensic Examiners. He is a Fellow of the Academy of Toxicological Sciences, the Institute of Biology (UK), the American College of Forensic Examiners and the American College of Nutrition. Dr. Hayes is a registered toxicologist in the European Union (ERT) and a certified nutrition specialist (food safety). Dr. Hayes was honored by the Society of Toxicology in 2006 with the Society’s Merit Award, by the Mid-Atlantic Society of Toxicology with its Ambassador Award in 2012, by the American College of Toxicology in 2012 with its Distinguished Scientist Award and by the International Dose-Response Society in 2013 with its Outstanding Leadership Award. Dr. Hayes was named a Distinguished Fellow by the American College of Toxicology in 2013.
Alan M. Hoberman, PhD, DABT, ATS
Dr. Hoberman has been employed by Charles River Laboratories, Preclinical Services, Pennsylvania (formerly Argus Research Laboratories, Inc.) since 1981. Currently he is Executive Director, Global Developmental, Reproductive, and Juvenile Toxicology. He is a Diplomat of the American Board of Toxicology and a Fellow of the Academy of Toxicological Sciences, with over 85 publications and book chapters. He is the co-editor of Pediatric Non-Clinical Drug Testing, Principles, Requirements, and Practices published in January 2012.
Dr. Hoberman has been a member of the American College of Toxicology since 1979 and is currently the Treasurer. He has been a member of the Teratology Society since 1978 and is currently the Vice-President. He is past president of the Reproductive and Developmental Toxicity Specialty Section of the Society of Toxicology and past president of the Middle Atlantic Reproductive and Teratology Association, as well as past president of the Arkansas Biotechnology Organization.
Debie J. Hoivik, PhD, DABT
Dr. Hoivik received her PhD in Toxicology from the University of Connecticut and conducted her postdoctoral research at Texas A&M. She started her career at GlaxoSmithKline where she held a variety of roles in Medicine Safety. She was responsible for the nonclinical product development strategy and execution as well as regulatory interactions and submissions for new therapeutic entities. She then joined Boehringer-Ingelheim Pharmaceuticals where she functioned in several diverse roles including therapeutic product development and toxicology operations. Dr. Hoivik currently works at Akebia Therapeutics where she has oversight for the nonclinical safety team. Dr. Hoivik has authored five invited book chapters and 29 publications. She has served ACT and SOT in a variety of roles as well as the Northeast Society of Toxicology. Dr. Hoivik has also served on multiple pharmaceutical consortiums and workgroups. She has been a member of the Editorial Review Board for International Journal of Toxicology since 2004 and serves as a reviewer for Toxicological Sciences. Dr. Hoivik was certified by the American Board of Toxicology in 1999.
Mary Jeanne Kallman, PhD, DSP
Dr. Kallman is currently Vice-President and consultant for Kallman Preclinical Consulting, which has a focus on abuse liability potential assessment and safety pharmacology issue resolution for multiple pharmaceutical companies. She received her PhD from the University of Georgia in Neuroscience and was a postdoctoral research fellow at Virginia Commonwealth University in Pharmacology and Toxicology. Prior to her work in the pharmaceutical industry, she was a tenured Associate Professor at the University of Mississippi and director of the graduate training program in pharmacology and psychology. She maintained an active research laboratory supported by federal funding from NIMH, NIDA, and EPA. She worked for Lilly Research Labs as Group Leader for Safety Pharmacology for 17 years where she provided oversight for rodent and large animal GLP-compliant studies, issue resolution, and FDA document preparation for Lilly compounds. She also worked for Covance, a large contract research organization, for seven years as Director of Global Neuroscience and a member of the management team in Greenfield, IN.
Dr. Kallman frequently presents at national and international scientific meetings; she has published numerous journal articles and book chapters focused on safety pharmacology issues and specific topics on abuse liability potential assessment. She is a past president of the Safety Pharmacology Society and she has been involved in the development of the Diplomate in Safety Pharmacology (DSP) and testing procedures for certification. She has also been involved in the evaluation of the clinical and preclinical Cross-Company Abuse Liability Consortium and served as co-lead of the group for several years. In addition, she worked on the committee drafting the first version of the SEND document for reporting safety pharmacology data to FDA. She is a member of ACT, SOT, NBTS, CPDD, SFN, and a fellow of the Psychopharmacology and the Neuroscience Divisions of the American Psychological Association. Currently she is the Safety Pharmacology representative to Scientific Liaison Coalition of SOT and a participant on the HESI Neurotoxicity Biomarker effort.
Timothy J. McGovern, PhD
Dr. Tim McGovern is currently an Office Associate Director for Pharmacology/Toxicology in FDA CDER’s Office of New Drugs where he interacts with nonclinical review teams in the review of IND, NDA, and BLA submissions, advises Office Directors on nonclinical issues, and is involved in development of policy and guidances related to nonclinical and regulatory issues. Prior to returning to FDA in 2013, he spent five years as a nonclinical/regulatory consultant where he assisted pharmaceutical companies in designing and conducting nonclinical programs including safety pharmacology studies. In a previous tenure at FDA, he was a primary nonclinical reviewer and then supervisor in the Divisions of Pulmonary and Allergy Products and Anesthetic, Critical Care and Addiction Products.
Paul Nugent, PhD, DABT
Dr. Nugent is an ABT-certified toxicologist at Pfizer’s R&D facility in Groton, CT, where he leads a group involved in the preparation of nonclinical toxicology documents destined for regulatory submission. He has more than 14 years of drug development experience in the pharmaceutical industry, during which time he has served as a study director in developmental and reproductive toxicology and in general toxicology, a toxicology representative on project teams engaged in the development of drugs in a variety of therapeutic areas, and a member of a team of senior toxicologists involved in regulatory strategy and compliance.
Prior to joining Pfizer, he was an assistant professor at the University of Louisville Birth Defects Center and a postdoctoral fellow at Thomas Jefferson University (Philadelphia), his research focusing on molecular interactions in embryonic craniofacial development. He received his BSc and PhD degrees at University College Dublin, Ireland.
Dr. Nugent has published in the area of cell and molecular biology, developmental toxicology/teratology, and biomarkers. He recently co-authored a chapter entitled “The Preparation of a Preclinical Dossier to Support an Investigational New Drug (IND) Application and First-In-Human Clinical Trial” for the 2013 book “A Comprehensive Guide to Toxicology in Preclinical Drug Development” (Elsevier) (update to be published in a second edition in 2016). He is a member of the American College of Toxicology (ACT) and the Society of Toxicology (SOT), and has been actively involved in education in SOT, and in the organization of the local SOT chapter (NESOT).
James A. Popp, DVM, PhD, DACVP, ATS
Dr. Popp is widely recognized for his research and leadership contributions in toxicology and toxicologic pathology. He has expertise in development of strategic approaches to nonclinical drug development and assessing potential human risk of identified nonclinical safety findings through analysis of toxicology and toxicologic pathology observations. Hepatotoxicity and carcinogenesis are specific areas of expertise. Dr. Popp received a DVM degree followed by residency training in veterinary pathology and a PhD degree in Comparative Pathology. Following post-doctoral training in biochemical pathology and chemical carcinogenesis, he served on the faculty of the University of Florida before joining the Chemical Industry Institute of Toxicology (CIIT) shortly after the Institute was founded. Over the ensuing 15 years, Dr. Popp developed and directed a productive research program in hepatotoxicity and hepatocarcinogenesis with emphasis on liver tumor promotion. During part of his tenure at CIIT, he served as a Department Head and Vice President of the Institute. He has held the position of Vice President in several pharmaceutical companies (Sterling Winthrop, Sanofi Pharmaceuticals, Dupont Pharmaceuticals and Purdue Pharma) for 11 years. Responsibilities included scientific and managerial leadership for toxicology and toxicologic pathology for domestic and international operations in all companies. Responsibilities also included leadership of DMPK in Sterling Winthrop and Purdue Pharma. In 2004, Dr. Popp founded Stratoxon LLC, a toxicology consulting organization providing advice and support regarding issues identified in animal toxicity studies. Professional expertise is recognized by board certification as a Diplomate, American College of Veterinary Pathology and by peer recognition as a Fellow, The Academy of Toxicological Sciences and as a Fellow, International Academy of Toxicologic Pathology. Dr. Popp has served in the leadership of several professional societies including service as President of the Society of Toxicologic Pathology, President of The Academy of Toxicological Sciences and President of The Society of Toxicology. Dr. Popp is a frequent contributor to governmental toxicology efforts including completed service of a 3 year term on the NTP Board of Scientific Counselors and the Report on Carcinogens subcommittee, as Chair of several NTP special workshops and as Chair of the Board of Scientific Advisors for the FDA National Center for Toxicological Research. Dr. Popp is co-editor of the Toxicologic Pathology text entitled: Toxicologic Pathology: Nonclincial Safety Assessment. Sahota, P.S., Popp, J. A., Hardisty, J.A., Gopinath, C. eds: CRC Press, Taylor and Francis Group, New York, New York 2013 and is co-author of 2 chapters in the text. The book is currently being revised and updated.
Mark Powley, PhD
Mark received a PhD in toxicology from Purdue University and completed postdoctoral training at the University of North Carolina. He was subsequently employed in the pharmaceutical industry where his responsibilities included serving as study director, providing toxicokinetic support, and contributing to in silico evaluations for predicting mutagenicity. In 2009, Mark moved to US FDA Center for Drug Evaluation and Research (CDER) where he currently works as a pharmacology/toxicology reviewer in the Office of New Drugs (OND). In addition to reviewing nonclinical data, Mark is involved with the Computational Toxicology Consultation Service and co-chairs the CDER Pharmacology/Toxicology Genetic Toxicology and Computational Toxicology Subcommittees. He is also a past Chair of the Genetic Toxicology Association Board of Directors.
Lila Ramaiah, DVM, PhD, DACVP
Dr. Lila Ramaiah is a Senior Clinical Pathologist and Biomarker Strategist (board-certified veterinary clinical pathologist) in Drug Safety Research and Development at Pfizer, Inc. She has completed a BSc (Molecular and Cellular Biology, Arizona State University), a DVM (Laboratory Animal Medicine, University of Montréal), a clinical pathology residency (Michigan State University), and a combined residency/PhD (Pathology, Colorado State University). She has 12 years of experience in the CRO/pharmaceutical industry. In her role at Pfizer, Lila serves as Clinical Pathology subject matter expert, Biomarker Strategist on Therapeutic Area Lead Teams, and associate Drug Safety Team Lead. Her other interests revolve around the development of data science tools. Lila aims to foster collaborations within Pfizer and in external consortia, increase Pfizer’s expertise through data-sharing, and contribute to the growth of Pfizer as a pharmaceutical leader in data-driven computational intelligence. At Bristol-Myers Squibb, (2016–2019), Lila served as the sole clinical pathologist for Drug Safety Evaluation in support of FIH and ECN applications. She managed the clinical pathology laboratory, authored contributing scientist reports, and served as project pathologist and clinical pathology subject matter expert. As the sole veterinary clinical pathologist at Envigo (2007–2016), Lila held positions of increasing responsibility, eventually becoming Senior Director of Clinical Pathology and Scientific Reviewer of Regulatory Toxicology Reports. Outside of the workplace, Lila has authored many journal articles and book chapters, and has presented at SOT, ACT, STP and IATP meetings. Topics included career development, evaluation of the hematopoietic system, clinical pathology best practices, changes in moribund animals, microsampling, recovery evaluations, data visualization, correlation, and communication, peer review and renal safety pharmacology. Within the STP, Lila has served as chair of the Clinical Pathology Interest Group, and co-chair of two CE courses. Beyond STP, Lila chaired the Regulatory Affairs Committee (RAC) of the American Society for Veterinary Clinical Pathology. In this role, Lila led the sub-team that authored “Assessing Adversity in Clinical Pathology”, which received the 2018 Toxicologic Pathology Best Paper Award for invited review. Lila has served as an instructor for the ACT Toxicology for Pharmaceutical and Regulatory Scientists course, her presentation on “Clinical Pathology: Principles for Pharmaceutical and Regulatory Scientists” since 2018.
Melissa Rhodes, PhD, DABT
Dr. Rhodes is the Chief Development Officer at Kriya Therapeutics, a gene therapy company developing therapies for highly prevalent polygenic and non-genetic diseases. Prior to joining Kriya Therapeutics, she held the position of Chief Development Officer at Aerami Therapeutics (an inhaled biologics company) and at Altavant Sciences (a rare respiratory disease company), where she led development of clinical assets, translational medicine, chemistry manufacturing and controls, regulatory affairs and project management with budget oversight. Previously, Melissa served as Senior Vice President at Roivant Sciences, where she led a team of scientists conducting nonclinical research for 7 subsidiary companies. She spent almost 10 years at GSK and started in drug development at a biotech university spin-out in oncology. Melissa completed a postdoctoral fellowship at the National Toxicology Program at the National Institute of Environmental Health Sciences, holds a PhD in pharmacology and toxicology from Duke University Medical Center, and is a Diplomate of the American Board of Toxicology.
Sandhya Sanduja, PhD
Dr. Sandhya Sanduja is currently an Acting Team Leader in FDA/CBER/OTAT. Her duties include the preclinical review of regulatory submissions for cellular and gene therapy products, and plasma derivatives. Prior to joining the FDA, she was a postdoctoral fellow at the Whitehead Institute of MIT where she investigated signaling pathways contributing to drug resistance in malignant melanoma. Dr. Sanduja received her BS in Microbiology from Gargi College, New Delhi, India (2003), MS in Biotechnology from Jawaharlal Nehru University (2005), and PhD in Biological Sciences (2011) from University of South Carolina, Columbia. Dr. Sanduja has authored several high-impact, peer-reviewed publications in leading biomedical journals, and received research grants from the American Association for University Women (AAUW) and the Melanoma Research Alliance (MRA). She served on review boards for PLOS ONE, Tumor Biology, and WIREs RNA and on the editorial board of Gastrointestinal Cancer. She is a member of the American Society of Gene and Cell Therapy (ASGCT).
Thomas J. Steinbach, DVM, DACVP, DABT
Dr. Steinbach received his DVM from the College of Veterinary Medicine at the University of Minnesota in 1999. In 2002, he entered residency training for veterinary pathology at the Armed Forces Institute of Pathology and received board certification in 2005. He served as the Chief of Pathology for the Naval Medical Research Center from 2005 to 2008 and then as the Director, Division of Pathology at the Walter Reed Army Institute of Research until 2012. In 2006, Dr. Steinbach joined Experimental Pathology Laboratories as a part-time consultant pathologist. In 2012, he joined EPL full time as a senior pathologist and in 2016, became vice president of EPL. His areas of interest include: electron microscopy, juvenile toxicology, and nanoparticle pathology.