Leadership

Dr. Manoj Aggarwal is a distinguished global leader in regulatory toxicology, currently serving as Global Preclinical Safety Lead at Merck & Co., USA (MSD outside North America), with over 15 years of expertise spanning multiple continents. He holds a degree in Veterinary Medicine and a PhD in Pharmacology and Toxicology from India, and is certified as a Diplomate of the American Board of Toxicology (DABT). A DAAD Fellowship recipient, he spent four formative years as a Research Scientist at the WHO Collaborative Research Centre (IfADo) in Germany, laying the foundation for a truly global career.

Dr. Aggarwal built his industry expertise as a Global Regulatory Toxicologist at Dow (now called Corteva) across the UK (2010–2018) and US (2018–2022), before assuming his current role at Merck & Co. He has engaged with regulatory agencies across major markets including the USA, EU, China, India, and Brazil, and has been instrumental in reshaping international standards, most notably contributing to EFSA and OECD guidance on dermal absorption. His pioneering development of a New Approach Methodologies (NAMs)-based framework earned him his company's prestigious Regulatory Science Innovation Award.

He is also a prolific scholar with over 25 peer-reviewed publications and extensive collaborations across academia, industry, and government institutions, including EPAA, NC3Rs, and industry associations. A dedicated member of the Society of Toxicology (SOT) for over a decade, Dr. Aggarwal has actively organized sessions, workshops, and webinars at leading global events including the IUTOX, SOT, EUROTOX, ASIATOX, STOX, and SBTOX congresses, while championing SOT Specialty Section outreach initiatives. His expansive international experience, diverse professional network, and passion for cross-border collaboration uniquely position him to drive impactful partnerships and address the most pressing challenges in regulatory safety evaluation worldwide. Manoj Aggarwal DVM, PhD, DABT | LinkedIn

April O’Connell is currently a scientific associate director at Amgen in the department of Translational Safety and Risk Sciences. She has a cumulative 11 years of experience in the pharmaceutical industry. She has supported a broad range of therapeutic areas in drug development from anti-viral to metabolic and rare disease indications as a project toxicology lead spanning the start of her career at Gilead Sciences in 2015 to Horizon Therapeutics in 2021 and Amgen in 2023.

April received her PhD in Pharmacology and Toxicology from the University of Arizona in 2013 with a focus on hepatic stress response mechanisms in liver disease. She continued her research into hepatic chemical modes of action in postdoctoral studies 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. Her research resulted in 8 peer-reviewed first author publications in the toxicology field and resulted in several productive workstreams as a supporting author.

She has been a member of the Society of Toxicology since 2008, which has provided the valuable networking and mentorship that has sustained her career. She has served previously in elected positions on the Postdoctoral Assembly as elected treasurer and later as councilor and secretary-treasurer for the Regulatory and Safety Evaluation Specialty Section. She looks forward to advancing the goals, outreach and mentoring in her current elected role with RSESS.

Dr. William (Bill) Klaren is a board-certified toxicologist at ToxStrategies and currently the Vice President-Elect 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 “Mimi” Huang is a Senior Toxicologist at Premier Research. At Premier, she provides input on nonclinical aspects of therapeutic product development for biotech and specialty pharma companies, ranging from small molecules, biologics, cell and gene therapies, as well as marketing applications via the FDA’s 505(b)(2) pathway. She obtained a PhD in Toxicology at the University of North Carolina at Chapel Hill and did postdoctoral training at the National Toxicology Program. Dr. Huang has been an active member of the Society of Toxicology since 2012, from volunteering for continuing education courses, planning webinars, submitting and chairing multiple sessions over the years. She has a passion for helping trainees develop transferable skills and professional networks in industry and has coordinated or supported numerous career development events locally and nationally. Dr. Huang currently serves RSESS as the chair of the Endowment Committee and the steward for the RSESS endowment fund and supports the administration of the awards made possible through the fund. She is excited to be able to continue supporting the RSESS community in the junior councilor position.

Aishwarya (Aishu) is a Postdoctoral fellow in the Nonclinical Drug Safety department at Merck & Co., Inc, West Point, PA. Aishu currently works on developing screening assays to address developmental toxicity concerns for targeted protein degraders. Prior to joining Merck & Co., Inc, Aishu was a postdoctoral associate at the University of Wisconsin-Madison. She also completed her PhD training from the University of Wisconsin-Madison in reproductive physiology where she worked on building in vitro models for assessment of endothelial function in the context of pregnancy/preeclampsia. Aishu received her B.Tech in Biotechnology from National Institute of Technology, Warangal, India. Aishu has been a member of the Society of Toxicology since 2024.

Hannah Roe is a doctoral candidate in Toxicology at Texas A&M University under the mentorship of Dr. Ivan Rusyn. Her research focuses on the systematic evaluation of read-across and New Approach Methodologies in regulatory decision-making, with a particular emphasis on analyzing acceptance and rejection patterns in over 4,000 decisions by the European Chemicals Agency (ECHA) and the US EPA. She has published multiple papers on the results of these analyzes and how they can be used to inform the next generation of regulatory risk assessment. Beyond her research, Ms. Roe has served in leadership roles within Texas A&M's Graduate and Professional Student Government, where she worked to promote graduate student involvement across the university, including on the planning committee for the university's largest student-run research symposium. She is an active member of SOT, serving as the RSESS Graduate Student Representative and on the WIT Programming Review Committee. In these roles, she hopes to support graduate student engagement within RSESS and highlight the accomplishments of the next generation of toxicologists.