Leadership

Dr. Aggarwal is currently serving as a global preclinical safety lead at Merck & Co. (AH Business), and he has accumulated over 15 years of expertise in the field of regulatory toxicology. He holds a veterinary medicine degree and a PhD in pharmacology and toxicology from India. Following his studies, he spent four years as a research scientist at a WHO collaborative research center in Germany. He later transitioned to the chemical and pesticide industry, working as a global regulatory toxicologist for Dow Chemicals in the UK from 2010 to 2018 and in the US from 2018 to 2022. More recently, he has joined the animal health industry.

Dr. Aggarwal’s work has spanned various cultural and geographical contexts, involving interactions with regulatory agencies in both developed countries such as the US and across the EU, as well as developing nations like China, India, and Brazil. Dr. Aggarwal has played a significant role in shaping regulatory guidelines and standards. His leadership on multiple projects has led to the establishment and/or update of guidance documents issued by organizations across Europe and New Zealand and the OECD. He has obtained the European Registered Toxicologist (ERT) and the American Board of Toxicology (DABT) certifications, highlighting his expertise and recognition in the field.

In addition to his research and regulatory work, Dr. Aggarwal has authored more than 25 papers that have been published in reputable journals focusing on regulatory toxicology and pharmacology. He has engaged in collaborations with scientists from academia, industry, and government sectors, cultivating a diverse network within the field.

Dr. Aggarwal’s involvement in various scientific conferences and workshops worldwide demonstrates his commitment to knowledge sharing and collaboration. He has organized sessions and workshops at prominent events such as the IUTOX International Conference, SOT Annual Meeting, EUROTOX Annual Congress, ASIATOX International Congress, STOX (India) Conference, and SBTOX (Brazil) Congress. As an active member of the Society of Toxicology for over a decade, he has not only participated in Annual Meetings but has also undertaken outreach initiatives on behalf of SOT Special Interest Groups. Overall, Dr. Aggarwal’s broad range of experiences, extensive network, and dedication to global collaboration position him well to contribute to the organization of international events and facilitate collaborations to address common challenges in regulatory safety evaluation.

Dr. April Lake O’Connell is currently a nonclinical safety scientist at Amgen in the Translational Safety and Risk Sciences department since late 2023. Prior to this role, she was with Horizon Therapeutics for two years and even now continues to support the late-stage rare disease portfolio which is now merged with Amgen. April began her career in the pharmaceutical industry at Gilead Sciences in 2015 as a Project Toxicologist for antiviral and inflammation therapeutics.

April conducted postdoctoral studies on chemical liver tumor modes of action at the Environmental Protection Agency’s Integrated Systems Toxicology Division in Research Triangle Park, NC with support from University of North Carolina-Chapel Hill and ORISE from 2013-2015. She received her PhD in 2013 at the University of Arizona Tucson, AZ in Pharmacology and Toxicology with a focus on Nonalcoholic Fatty Liver Disease.

April is a member of the Society of Toxicology and has served as an elected councilor and secretary-treasurer for the Regulatory and Safety Evaluation Specialty Section previously. She looks forward to advancing RSESS goals, outreach and mentoring as VP Elect in 2025.

Dr. William (Bill) Klaren is a board-certified toxicologist at ToxStrategies and currently the Secretary/Treasurer for RSESS. As a consultant with ToxStrategies, he assists clients in systematic reviews and consumer product risk assessments specializing in pesticides, microbials, food ingredients, and cosmetic products. He received his doctorate in Human Toxicology from the University of Iowa in 2016 and was a Postdoctoral Research Fellow at Texas A&M University from 2016-2018. Before joining ToxStrategies, Dr. Klaren was a Senior Associate in Toxicology at the consumer goods company, S.C. Johnson and Son, Inc. where he performed consumer goods risk assessments and supported pesticidal product registrations under the US EPA and the EU BPR. He is the author/co-author of 25 peer-reviewed publications including several in vivo mechanistic investigations, comparative analyses of in vitro bioactivity data and in vivo transcriptomic concordance, and the development of frameworks to assess publication study quality. He has been a member of SOT since 2012 and has been involved with several specialty sections (In Vitro and Alternative Methods (IVAM), Mixtures, and Risk Assessment Specialty Sections (RASS)) as well as several regional chapters. He has served as Councilor and Secretary-Treasurer of RSESS.

Dr. Dahea (Diana) You, is a project toxicologist at Takeda Pharmaceuticals in San Diego, where she represents the Drug Safety Research and Evaluation in a project team and drives the nonclinical safety assessment strategies of drug candidates at discovery and development stages to identify and mitigate potential toxicity liabilities. Previously, Dr. You was a postdoctoral fellow in the Division of the National Toxicology Program at the National Institute of Environmental Health Sciences (NIEHS) where she worked on two Tox21 federal interagency collaborative projects which aimed to understand and quantify how genetic variation between individuals or cell lines can influence an individual’s susceptibility to toxicity upon chemical exposure. Dr. You obtained her Doctor of Pharmacy in 2014 and Doctor of Philosophy in Toxicology in 2019, both at Rutgers University, where she investigated the epigenetic regulation of multi drug resistance 1 and breast cancer resistance protein transporters at the blood-brain barrier. Dr. You has published multiple papers and given numerous podium and poster presentations on her research at local, national, and international meetings and received several awards for her works. Since 2014, Dr. You has been an active member and a leader in various professional organizations including SOT. Recently, she has served as Secretary-Treasurer for the Korean Toxicologists Association in America SIG from 2021-2023 and also served as a member of the Podcast Committee in the American College of Toxicology. Dr. You has published multiple papers and given numerous podium and poster presentations on her research at local, national and international meetings, and received several awards for her works, including the 2021 RSESS Postdoc Excellence Award.

Claire joined IDEAYA Biosciences as the Head of Toxicology in 2017, and, in her current role, she is responsible for the strategic direction of Nonclinical Safety and Pharmacology activities to support the entire portfolio of IDEAYA molecules. In addition, she has served as a Project Team Lead for two assets in IDEAYA’s portfolio. Prior to joining IDEAYA, Claire served as a Project Toxicologist and a Project Team Lead at Gilead Sciences, where she was responsible for Nonclinical Safety for small and large molecules indicated for oncology, inflammation, and anti-viral diseases. Claire also worked for 12 years at Incyte, where through increasing positions of responsibility, she contributed to, or led, the Nonclinical Safety strategy for multiple small molecules, two of which are now approved drugs.

Claire received her BSc (Hons) in Medicinal and Pharmaceutical Chemistry and PhD in Pharmacology from the University of Loughborough in the UK. During her PhD, Claire spent time as a visiting graduate student at the University of Michigan, and she completed a postdoctoral fellowship at Memorial Sloan Kettering Cancer Center in New York. Claire obtained the Diplomate of the American Board of Toxicology in 2012. Claire has been a member of SOT since 2007 and has served in the following capacities: NorCal SOT VP-Elect/VP (2022/2023), WIT Program Review Committee (2018–2021), WIT Awards Committee (2018), WIT SOT Awards Nomination Committee (2022), RSESS Program Review Committee (2019–2020, Co-Chair 2021; Chair 2022/2023), RSESS VP-Elect (2023), and SOT Mentor Match program (2021–2023).

Dr. Tim McGovern is an Associate Director for Pharmacology/Toxicology in the Office of New Drugs at US FDA's Center for Drug Evaluation and Research (CDER) and is involved in developing regulatory guidance and policy related to nonclinical drug development. He is one of the FDA leads in for ICH Guidance M7 (DNA-reactive impurities), ICH Q3C (residual solvents), Q3D (elemental impurities) and evaluating weight-of-evidence based proposals for carcinogenicity assessments under ICH Guidance S1B (R2). He joined FDA as a reviewer in 1997 for Pulmonary and Allergy Drug Products and later held roles as a Pharmacology/Toxicology supervisor for teams evaluating anesthetic, critical care and addictions products and pulmonary and allergy products. Dr. McGovern has also worked as a nonclinical/regulatory consultant for companies developing pharmaceutical products. Dr. McGovern received a PhD in toxicology from New York University, New York, NY with a focus on the adverse pulmonary effects of air pollutants. He is an active member of SOT and RSESS and was recently awarded the Specialty Section’s Outstanding Contribution to Regulatory and Safety Evaluation Award. He is also a Past President of the American College of Toxicology. Based on his experience in this field, he is interested in serving the RSESS as a Councilor to assist in its efforts in supporting programs related to regulatory safety evaluation and identifying avenues to further approaches and communication of topical issues.

Dr. Madelyn Huang is a Senior Toxicologist at Premier Research, where she provides input on nonclinical aspects of therapeutic product development for small molecules, biologics, cell and gene therapies, as well as marketing applications via the US FDA’s 505(b)(2) pathway. Previously, Dr. Huang was a postdoctoral fellow at the Division of Translational Toxicology at the National Toxicology Program, where she designed and managed the conduct of regulatory toxicology studies evaluating various environmental chemicals (eg, PFAS, phthalates). She obtained her PhD in Toxicology at the University of North Carolina at Chapel Hill and a B.S. in Biochemistry from the University of Notre Dame. Dr. Huang is a Diplomate of the American Board of Toxicology, from 2022 until present. Dr. Huang has published 18 articles in peer-reviewed journals on topics spanning a wide range of toxicology, from basic environmental chemical research to regulatory strategy in pharmaceutical development. Dr. Huang has been an active member of the Society of Toxicology since 2012: volunteering for continuing education courses as a graduate student, planning webinars, and submitting and chairing multiple SOT sessions over the years. Dr. Huang is a regular volunteer on the RSESS proposals committee and served RSESS as the chair of the Endowment Committee where she was the steward for the RSESS endowment fund and supported the administration of the awards made possible through the fund.

TBA

TBA