Dr. Jacobs, PhD has 38 years of experience as a toxicologist/pharmacologist and 26 years of experience in the Center for Drug Evaluation and Research at the US FDA. For more than 20 years, she was an associate director for Pharmacology and Toxicology, involved in development of internal US FDA and external international guidance documents, secondary and tertiary review of regulatory decisions, mentoring reviewers and supervisors, resolving controversial issues, and addressing queries, both internal and external to the US FDA. Before joining the US FDA, she worked for three different small companies with contracts with the NIH. She was originally trained as a chemist and biochemist, with postdoctoral experience in immunochemistry and immunology. She has a BS in chemistry from the University of Michigan, Ann Arbor, and a PhD in biochemistry from the University of California, Berkeley. She was selected to be a Fellow of Academy of Toxicological Sciences.
Tracey is a scientific and regulatory subject matter expert with over 30 years of experience in toxicology. Her perspective on drug development and objectivity in scientific evaluation were shaped by her experience with a broad spectrum of products that crossed her desk as a Consultant, FDA reviewer, and Study Director. Tracey is known for developing nonclinical testing strategies for products targeted to treat a variety of therapeutic areas, and special populations such as pediatrics, geriatrics, and those afflicted with rare diseases. She is recognized for her expertise in developing drugs, devices, biologics and combination products using novel technologies. Tracey provides scientific and regulatory oversight for regulatory filings and participates in meetings with regulatory authorities at all stages of product development. She has served as an expert panelist on bone health for the FDA, and for professional organizations focused on neuromuscular and rare diseases. During her tenure as a reviewer in the FDA Center of Drug Evaluation and Research, Tracey served on committees and working groups, addressing issues such as carcinogenicity testing strategy, the use of novel excipients in pharmaceutical products, and testing strategies to support pediatric safety. Her experience as a Study Director, where she conducted toxicity, developmental and reproductive, and carcinogenicity studies, in a variety of laboratory species using various routes of administration, provides a solid technical knowledge base from which Tracey designs and provides oversight on programs and studies. Tracey contributed to the scientific community by serving as President of the American College of Toxicology (2017), maintaining active memberships in the Society of Toxicology and the Teratology Society, and serving as a core member of the Advisory Committee for Therapeutics to Treat Neuromuscular Disease (TREAT-NMD, TACT).
Dr. Mary Beth Genter, PhD, DABT, ATS 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. 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. As a professor in the University of Cincinnati’s Department of Environmental and Public Health Sciences, she teaches survey courses in toxicology and physiology, as well as advanced lectures on various topics, including pharmacogenetics, pesticide toxicology, neurotoxicology, and dermal toxicology. She also coordinates the Environmental Public Health course in the department’s Master of Public Health (MPH) Program. Dr. Genter has published over 80 peer-reviewed manuscripts and has mentored MS, MPH, and PhD students, as well as a postdoctoral fellow.
Before joining the University of Cincinnati, Dr. Genter was a faculty member in the North Carolina State University Department of Toxicology, where she had broad responsibilities, including coordinating a risk assessment course for the department and serving as the first toxicologist for the North Carolina Cooperative Extension Service.
In terms of service to the field of toxicology, Dr. Genter served as a member of the North Carolina Secretary’s Scientific Advisory Board on Toxic Air Pollutants and as an advisor for the US Environmental Protection Agency during the reevaluation of the IRIS naphthalene document. Dr. Genter was an invited reviewer of the Styrene Assessment in the National Toxicology Program’s 12th Report on Carcinogens. She was also invited by Secretary of Health and Human Services Kathleen Sebelius to serve on the National Toxicology Program’s Board of Scientific Counselors.
Dr. Genter is a Diplomate of the American Board of Toxicology (ABT) and served a four-year term on the ABT Board of Directors. She is a member of the American College of Toxicology (ACT), Society of Toxicology (SOT), Association for Chemoreception Sciences, Academy of Toxicological Sciences (ATS), and Sigma Xi. She is currently Editor-in-Chief of the official ACT journal, International Journal of Toxicology, and a reviewer for approximately two dozen papers for other journals each year. Dr. Genter served on the SOT Scientific Program Committee, as a SOT Councilor, and as a member of the ATS Nominating Committee. She serves as a consultant for the ACT Early Career Professional Subcommittee and as co-organizer of the ACT Advanced Comprehensive Toxicology course. She has also served as a speaker during the ACT Toxicology for Pharmaceutical and Regulatory Scientists course.
Dr. Julie Castañeda, PhD is a Pharmacology/Toxicology reviewer for the Division of Pulmonary, Allergy and Critical Care (DPACC) products at the US Food and Drug Administration. She currently supports new drug and biologic development across multiple clinical indications, including COVID-19. Previously, she completed her undergraduate studies at Eastern Kentucky University and received her PhD in molecular toxicology from the University of California, Los Angeles. Dr. Castañeda has attended the ACT annual meetings since 2012. She has formed part of the Program Committee, Early Career Professional (ECP) Subcommittee, Finance Committee, and 40th Anniversary Planning Group. She has delivered multiples talks at the annual conferences, and during her graduate career, she was the recipient of two ACT Furst Awards, three ACT travel grants, and the North American Graduate Fellowship.
Dr. Castañeda is a strong advocate for the involvement of ECPs in the future of the College, assuring that their voice is always heard. She has organized speed networking events, hosted a podcast, and served as an ECP liaison across several Committees. She encourages mentorship, networking, building connections, and most importantly honing friendships during each Annual Meeting.
Adedeji AO, Pourmohamad T, Chen Y, et al. “Investigating the Value of Urine Volume, Creatinine, and Cystatin C for Urinary Biomarkers Normalization for Drug Development Studies.” Int J Toxicol 2019 38(1):12–22.
Karen Chiu, University of Illinois at Urbana-Champaign
Courtney McClure, University of California at Los Angeles
Asha Rizor, Florida A&M University
Emily Brehm, University of Illinois at Urbana-Champaign
Benjamin Elser, University of Iowa
Tetyana Kobets, New York Medical College
Olalekan Ogunsakin, Touro College of Osteopathic Medicine
Jiajun (Brian) Zhou, Eli Lilly and Companies
Doherty Funmilayo, Yaba College of Technology, Nigeria
Janet Olugbodi, Bingham University, Nigeria
Thilini Wijerathna, SACTRC at University of Peradeniya, Sri Lanka