Discovery Toxicology: An Early Drug Discovery Survival Guide
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To further its mission to educate, lead, and serve, the American College of Toxicology is proud to offer an eLearning seminar focused on "Discovery Toxicology: An Early Drug Discovery Survival Guide." This seminar introduces the key principles of discovery toxicology, beginning with target identification and the development of a target safety profile through qualitative assessment of desired and undesired effects. It continues with the prediction of potential safety concerns using in silico and in vitro activity profiles, includes a thorough evaluation of secondary pharmacology, and concludes with in vivo studies aimed at understanding and predicting clinical safety to support candidate selection.
These modules feature presentations by recognized experts in the field. Modules are available for purchase as a set. Once the live module presentations conclude, registrants will have on-demand access to the modules for 30 days from the time each archive is first accessed. Each module is approximately 90 minutes.
Disclaimer:
This seminar reflects the views of the speaker and should not be construed to represent the views or policies of the American College of Toxicology. Examples presented in this seminar may have required unique strategies that do not necessarily apply to other modalities or situations. Regulatory guidelines and best practices are constantly evolving, and the viewer is encouraged to independently confirm their understanding with what was presented in this seminar.
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Contains 3 Component(s) Recorded On: 02/19/2026
Discovery Toxicology Series
Target safety assessment encompasses two key aspects that are critical to the early discovery phase. First, a comprehensive evaluation must identify potential unintended adverse consequences that result from engagement of the specific target. Second, the discovery toxicologist must be able to present the identified risks and a mitigation strategy that will assess potential on-target toxicities in order to guide program development decisions. There are several approaches that can be used to continuously assess target safety during the drug discovery process. This module will provide an in-depth explanation of how to understand an early-stage target from a safety perspective as well as strategies for derisking a target of interest.
Ruth A. Roberts, PhD, ATS, FBTS, ERT, FRSB, FRCPat
ApconiX, Ltd.
Professor Ruth A. Roberts is Chair and Director of Drug Discovery at Birmingham University and Cofounder of ApconiX, an integrated toxicology and ion channel research company. Previously, Professor Roberts was Global Head of Regulatory Safety at AstraZeneca (2004–2014). Professor Roberts is former president of several international scientific societies including the BTS and EUROTOX, and is recent past Chair of the HESI Board. She was elected fellow of the Royal College of Pathologists in 2012 and the Royal Society of Biology in 2014. She has received numerous awards including the SOT 2018 Founders Award and the ATS 2022 ‘Millie’ award. Her company ApconiX received the Queen’s award for Enterprise in 2022, the King’s Award for Enterprise 2024 followed by the King’s Award for Innovation, 2025 for work on drug safety and CNS liability. She has >190 publications in peer reviewed journals and is a regular invited speaker on the international stage. Ruth is interested in developing and implementing innovative models in drug discovery and development.
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Contains 3 Component(s) Recorded On: 02/19/2026
Discovery Toxicology Series
Clinical stage attrition is detrimental to patients and expensive for the pharmaceutical industry. In the past decade, effort has been made to develop, define, and implement a drug discovery toxicology paradigm to deliver the best development candidates by failing early and cheap unfavorable compounds. The drug discovery process involves a multistep toxicology screening funnel that filters potential drug candidates through increasingly complex and costly stages—starting with thousands of compounds and narrowing down to one approved drug. It begins with in silico (computer-based) screening to predict activity and toxicity, followed by in vitro (cell-based) high-throughput assays for basic toxic effects. Compounds that pass move on to more advanced in vitro testing. In the later preclinical stage, in vivo (animal) testing and safety pharmacology evaluate effects on organ systems. This funnel approach improves cost and time efficiency, allows for early risk identification, optimizes resources, and integrates various testing methods to build a comprehensive safety profile for drug candidates.Yvonne Will, PhD, ATS
SCIENTIA-Consultants LLC
Dr. Yvonne Will is an independent consultant specializing in nonclinical drug safety, discovery toxicology, and the strategic application of new approach methodologies (NAMs) to support decision-making and regulatory readiness in drug development. Through her consulting practice, SCIENTIA-Consultants LLC, she advises biotechnology and pharmaceutical companies on predictive safety strategies, mechanistic toxicology, and fit-for-purpose nonclinical programs from early discovery through IND/CTA-enabling stages.
Dr. Will brings more than two decades of experience in global pharmaceutical R&D, having previously held senior leadership roles including Vice President of Nonclinical Drug Safety and Toxicology at Crinetics Pharmaceuticals, Global Science and Technology Lead for Drug Safety at Pfizer, and senior positions in predictive and investigative toxicology at Janssen (Johnson & Johnson). Across these roles, she has led multidisciplinary teams, shaped nonclinical safety strategy, and advanced the integration of human-relevant in vitro and mechanistic models into discovery and development workflows.
Her scientific expertise spans mitochondrial toxicity, liver safety, cardiovascular risk assessment, mechanistic toxicology, and the design of tiered screening funnels that integrate NAMs within a regulatory-aligned weight-of-evidence framework. Dr. Will is widely recognized for her thought leadership in modernizing toxicology and bridging the gap between cutting-edge science and regulatory expectations.
Dr. Will is actively engaged in the toxicology community and has served in leadership roles within the Society of Toxicology, including as President of the Drug Discovery Specialty Section. She has contributed extensively to the scientific literature and serves on editorial boards for journals focused on applied and translational toxicology.
She holds a PhD and MS in Biochemistry and Biophysics from Oregon State University and a BS from the University of Bonn.
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Contains 3 Component(s) Recorded On: 04/09/2026
Discovery Toxicology Series
This presentation will explore the role of secondary pharmacology in drug discovery, focusing on the identification and evaluation of off-target effects—pharmacological interactions of a compound with unintended targets. The session will highlight how secondary pharmacology assessments are integrated across all phases of drug discovery, and, when relevant, during clinical development and in regulatory submissions. The presentation will cover a range of methodological approaches, including in silico, in vitro, ex vivo, and in vivo studies used to assess the risk of off-target pharmacologic activity. The approach to off-target profiling across therapeutic modalities will be covered. Real-world case studies involving experimental compounds will be shared to illustrate practical applications and decision-making based on secondary pharmacology data.
Jean-Pierre Valentin, PhD, HDR, ERT, DSP, FRCPath
UCB
Dr. Jean-Pierre Valentin is a scientist with more than 30 years of experience in the pharmaceutical industry in a variety of scientific and leadership roles. After earning his PhD in Physiology and Pharmacology from the University of Montpellier, France, he completed a postdoctoral fellowship at UCSF. He began his career at the Pierre Fabre Research Centre, where he contributed to the discovery and progression of three candidate drugs.
He then joined AstraZeneca, where he established and led the Department of Safety Pharmacology, contributing to the safety evaluation of approximately 200 candidate drugs across a wide range of therapeutic areas, several of which advanced to successful registration. In 2014, he moved to UCB-Biopharma as Senior Director to lead the Investigative Toxicology unit, supporting the company’s portfolio across multiple therapeutic areas and drug modalities, currently acting as Fellow, Strategic Advisor.
Dr. Valentin is actively engaged in the scientific community. He is a former President of the Safety Pharmacology Society; current co-chair of the HESI Proarrhythmia Subcommittee and Cardiac Steering Team; and serves on the HESI Board of Trustees and Executive Committee. He also chairs the IQ-DruSafe Secondary Pharmacology Working Group and represents EFPIA on the ICH E14/S7B committee.
He has been involved extensively in training, education, and mentoring through scientific societies, universities, and trade associations. He is the author or co-author of several patents and more than 250 peer-reviewed publications and book chapters.
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Contains 3 Component(s) Recorded On: 05/07/2026
Discovery Toxicology Series
Following extensive in silico, in vitro, and ex vivo characterization of a drug candidate, the next step is often to further understand potential on-target and off-target safety risk in vivo. This presentation will review different types of exploratory studies that could be considered prior to the FIH-enabling nonclinical toxicology studies. Topics may include early targeted studies evaluating toxicities that often impact drug development, such as cardiovascular safety and hepatotoxicity, the use of exploratory studies to understand a novel mechanism of action, consideration of customized endpoints (biomarkers) in vivo based on the target.
J. Eric McDuffie, PhD
Neurocrine Biosciences, Inc.
Dr. J. Eric McDuffie currently serves as Senior Scientific Director of Investigative Toxicology at Neurocrine Biosciences, Inc. in San Diego, California. Dr. McDuffie has over 25 years of experience in the application of mechanism-based in vitro and in vivo models and related assays as well as expertise in regulatory toxicology to enable early- and late-stage drug candidate development.
He joined Neurocrine in 2021, after a 14-year tenure at Janssen Research & Development, LLC. At Janssen, Dr. McDuffie served as Director of Mechanistic & Investigative Toxicology. Previously (2000 – 2007), he served as Senior Scientist/Manager of the Laboratory Core Group and later the Investigative Pathology and Immunotoxicology groups at Pfizer’s Ann Arbor and Plymouth, Michigan sites, respectively.
Dr. McDuffie earned a PhD degree in Pharmacology from Meharry Medical College and completed a postdoctoral research fellowship at the University of Michigan Medical School in the Pathology Department. He has given numerous platform presentations, co-authored several peer reviewed manuscripts/posters/book chapters, and edited multiple books.