This annual Advanced Comprehensive Toxicology Course provides basic training in general toxicology. Participants will obtain an overall understanding of the principles of toxicology and nonclinical safety evaluation with a focus on pharmaceutical development. By popular demand, the course will include discussion of regulatory case studies and hands-on analyses of nonclinical data. The course is intended to benefit individuals working with small and large molecules from biotechnology and pharmaceutical companies, CROs, and regulatory agencies, or individuals interested in or currently practicing toxicology.

The Advanced Comprehensive Toxicology Course will be held in person in Gaithersburg, Maryland, from July 26–30, 2027. More information about the schedule and registration will be available soon.

The Advanced Comprehensive Toxicology  course is only being offered as an in-person format. Virtual or hybrid participation is not an option.

The American College of Toxicology (ACT) offers the comprehensive Biologics Nonclinical Drug Development Course. The course offers an in-depth exploration of regulatory considerations and the toxicologic evaluation and development of protein biologics, modified protein biologics, and specialized biologics, including cell and gene therapies, and oncolytic viruses.

Participants will gain a thorough understanding of the key principles and methodologies employed in the nonclinical safety assessment of these advanced therapeutic modalities. The curriculum covers a wide range of studies essential for advancing biotherapeutic drug candidates through all stages of drug development from candidate selection to marketing authorization. These include general toxicity studies and a variety of specialized studies, including off-target assessment, safety pharmacology, carcinogenicity, and reproductive and developmental toxicity studies. Additionally, the course provides insight into pharmacokinetic and biodistribution assessments and the potential impact of immunogenicity for various of different therapeutic modalities. Several case studies will be used to highlight how specific strategies and issues are approached on a case-by-case basis.

The Biologics Nonclinical Drug Development Course will be held in person in Gaithersburg, Maryland, from June 14–16, 2027. More information about the schedule and registration will be available soon.

The ACT course is only being offered as an in-person format. Virtual or hybrid participation is not an option.

To further its mission to educate, lead, and serve, the American College of Toxicology is proud to offer the eLearning seminar, "Are You Positive? Navigating Genetic Toxicology Challenges." This eLearning seminar series focuses on genetic toxicology, with an emphasis on navigating challenges associated with positive assay results. Each module covers a core component of the genetic toxicology battery—including in silico assessments, Ames, in vitro micronucleus, and in vivo genetic toxicology assays such as comet and in vivo micronucleus—and addresses relevant guidance, assay design, and their application in drug development. The series goes beyond the fundamentals to explore advanced topics such as historical control data, assay-specific data analysis best practices, and study design factors that influence result interpretation. Case studies illustrate strategies for managing positive findings, including follow-up study options and regulatory considerations. Overall, the series aims to provide participants with practical tools and real-world examples to support informed decision-making in genetic toxicology.

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.

This annual ACT course provides basic training in general toxicology. Participants will obtain an overall understanding of the principles of toxicology and nonclinical safety evaluation with a focus on pharmaceutical development. The course includes a mix of lectures with breakout group discussions of regulatory case studies and hands-on analyses of nonclinical data, to give participants the opportunity to apply the concepts of toxicology in the context of drug development. The course is intended to benefit individuals working with small and large molecules from biotechnology and pharmaceutical companies, CROs, and regulatory agencies, or individuals interested in or currently practicing toxicology. 

The Toxicology for Pharmaceutical and Regulatory Scientists Course will be held in person in Gaithersburg, Maryland, from April 26–30, 2027. More information about the schedule and registration will be available soon.

The ACT course is only being offered as an in-person format. Virtual or hybrid participation is not an option.

Quantitative Structure-Activity Relationship (QSAR) approaches are integral to modern toxicology. They enable predictive hazard assessment, prioritization, and regulatory decision-making without reliance on animal testing. However, many toxicologists have little experience or hands-on familiarity with how QSAR tools work or how to interpret their results. This CE course provides a structured learning pathway from foundational QSAR principles to standardized modeling and best practices to regulatory application and finally to hands-on implementation. This course will begin by establishing foundational knowledge, including an overview of the scientific principles underlying various QSAR tools and Science Behind Structure-Activity Relationships. After the foundational instruction, the session will move to a forward-looking discussion on implementing QSAR modeling using a standardized, step-by-step workflow and regulatory expectations, with each covering a distinct, non-overlapping layer of QSAR competency. The final 90-minute segment will be a fully interactive, hands-on walkthrough of the OECD QSAR Toolbox, during which participants will practice chemical profiling, analogue selection, and the execution of a regulatory-relevant read-across prediction. In summary, this session is intended to provide both informative and practical training. Designed for scientists at all experience levels, this course emphasizes transparency, reproducibility, and real-world regulatory application. Attendees will leave with a clear understanding of QSAR principles, knowledge of best-practice modeling pipelines, insight into how regulators evaluate QSAR predictions, and practical skills to apply OECD QSAR Toolbox workflows in their own safety assessments.

CE Course Chair: Chandrakant Patel, MSc, MBA, DABT – JRF Global
CE Course Chair: Ricardo Scheufen Tieghi, BS – National Institutes of Health
CE Course Speaker: Alexandre Borrel, PhD – Sciome
CE Course Speaker: Shagun Krishna, PhD – PCRM

Genetic toxicology is integral to pharmaceutical development, providing a scientific framework for the identification and mitigation of genotoxic risks associated with new chemical entities, metabolites, and impurities. This course critically examines the implementation of genotoxicity risk assessment throughout the drug development continuum. The course is designed to present information in a stage-specific manner, starting with early discovery screening to de-risk drug candidates, regulatory assays to support IND filing, and continuing on through post-marketing. The course reviews multiple regulatory requirements, most notably ICH S2(R1) and M7, for the evaluation of drugs and genotoxic impurities, ensuring compliance and harmonization across ICH regions. Strategic approaches are explored, including tiered testing paradigms that combine in silico computational modeling, in vitro assays, and in vivo studies to generate comprehensive safety data packages. Modern methodologies, including new approach methodologies and advanced modeling techniques, are highlighted for their potential to enhance the predictive power of genotoxicity assessments, reduce animal use, and improve translational relevance. The course further addresses the follow-up and resolution of unexpected positive findings, such as Ames-positive results, as per the recent FDA guidance. Before the course concludes with an interactive case study, the FDA will provide their perspectives on navigating positive genotoxicity results. Designed for professionals in nonclinical safety, regulatory affairs, and drug discovery, this course equips participants with the requisite knowledge to ensure patient safety and manage the genotoxicity complexities of contemporary drug development.

CE Course Chair: Dana Minnick, PhD, DABT, RAC – SciLucent, Inc.
CE Course Chair: Rohan Kulkarni, MSc, PhD – Enveda
CE Course Speaker: Lisa Beilke, MSPH, PhD, DABT, ATS – Toxicology Solutions, Inc.
CE Course Speaker: Steven Bryce – Litron Laboratories
CE Course Speaker: Matt Tate, PhD – Scantox
CE Course Speaker: Zheng Li, PhD, DABT – US FDA

Immunotherapies constitute a rapidly growing class of pharmaceuticals which have significant potential benefit for numerous indications. The nonclinical development of immunotherapeutics requires a variety of scientific experts, including immunologists, pathologists, toxicologists, and regulatory personnel working together to ensure these products are safe and effective. Such assessments require a thorough understanding of the immune system as well as the often complex pharmacology and toxicology of each product, and assessing potential effects (intended or unintended) often requires specialized nonclinical safety testing and endpoints. In this session, five scientific experts (discovery and NAMs immunologists, pathologists, toxicologists, and regulatory personnel) with unique roles will provide their complementary perspectives for a comprehensive immunotherapy risk assessment and highlight the challenges faced throughout the nonclinical safety assessment of immunotherapies. Practical suggestions on the contextualization and communication of immunosafety endpoints will be provided. An interactive round table session that incorporates concepts from the speakers will be included in the 2nd half of the session. The interactive session will center around an immunosafety (case study) scenario that will include a round table discussion with opportunities for an interactive question and answer component, as well as, time for additional Q&A and discussion. This session is hosted in collaboration with the HESI Immunosafety Technical Committee (HESI-ITC).

CE Course Chair: Tracey L. Papenfuss, DVM, MS, PhD, DACVP – Papenfuss Consulting Inc.
CE Course Chair: David McMillan, PhD, DABT – US FDA
CE Course Speaker: Nikki B. Marshall, PhD – GSK
CE Course Speaker: Daniel Weinstock, DVM, PhD, DACVP – D Weinstock Consulting
CE Course Speaker: Sarah Benjamin, PhD, DABT – Johnson & Johnson

As the pharma industry evolves toward more ethical, efficient, and human-relevant practices, New Approach Methodologies (NAMs) are reshaping the landscape of drug discovery and safety assessment. This course explores the scientific, regulatory, and technological dimensions of NAMs, including in vitro systems, computational modeling, and organ-on-a-chip platforms. We will examine the validation challenges of NAMs, and the opportunities they present for accelerating drug development. In addition, we will be discussing the U.S. Food and Drug Administration’s 2025 roadmap to reduce animal testing in preclinical safety studies, particularly in the development of monoclonal antibody (mAb) therapies. This strategic plan encourages the use of scientifically validated NAMs in Investigational New Drug (IND) applications. Through case studies, attendees will gain a comprehensive understanding of how NAMs can be integrated into modern workflows to enhance predictivity, reduce costs, and align with global regulatory trends. This course is ideal for professionals and students in pharmacology, toxicology, regulatory science, and biomedical innovation.

CE Course Chair: Kristina Howard, DVM, PhD, DABT – US FDA
CE Course Chair: Alok Sharma, BVSc, MVSc, MS, PhD, DACVP, DABT, FIATP – Labcorp
CE Course Speaker: Radhakrishna Sura, BVSc, PhD, DACVP, DABT, Fellow IATP – Gilead Sciences, Inc. 
CE Course Speaker: Dinesh S. Bangari, BVSc & AH, PhD, DACVP – Sanofi
CE Course Speaker: John S. Kendrick, PhD – Labcorp

At the 2025 ACT Annual Meeting, a basic/practical mini-symposium was held on best practices for optimizing FDA interactions. Building on this foundation, the proposed advanced/practical Continuing Education (CE) course will delve deeper into the regulatory interactions, with presentations from pharma and regulatory on numerous interactive case studies. We will not only present the FDA perspective on topics like how to deal with "clinical hold issues" and the use of NAMs in compound development, but we also bring the EMA perspective on, e.g., innovative task force meetings, enhanced regulatory support, and support for small and medium-sized enterprises. We will also hear about FDAs interactions during (early) development and at the marketing stage, as well as product labeling interactions. Learnings will be presented by pharma with a focus on key strategic considerations for sponsors using case examples involving different modalities to address the human relevance of nonclinical findings. In addition, experiences from regulatory interactions on advanced therapies with the FDA's Center for Biologics Evaluation and Research (CBER), as well as with EMA, will be shared. The course concludes with an interactive workshop with breakout groups and plenary feedback and discussion afterwards on when to apply for a regulatory interaction, what type of interaction is needed, and what questions to ask. During the workshop, all chairs/speakers will serve as faculty to provide break-out groups with potential answers to questions they might have. The goal of this CE course is to present top tips that can be used to support successful global regulatory agency interaction in the future.

CE Course Chair: Mary Ellen Cosenza, PhD, DABT, ERT, RAC, FATS – MEC Regulatory & Toxicology Consulting, LLC
CE Course Chair: Marlies De Boeck, PhD – Johnson & Johnson Innovative Medicine
CE Course Speaker: Paul Baldrick, PhD – Charles River Laboratories
CE Course Speaker: Shaji Theodore, MVSc, PhD, DABT – US FDA
CE Course Speaker: Britt Duijndam, MSc – Medicines Evaluation Board
CE Course Speaker: John Vahle, DVM, PhD, DACVP – Eli Lilly and Company