CE 3: The ABCs of EFDs: A Modern Guide to Embryofetal Development Testing

This Continuing Education (CE) course aims to discuss the principles applied to plan, deliver, and communicate embryofetal testing for pharmaceuticals in clinical development. The why, when, and how to conduct these studies and the rationale for decisions made in study design, conduct, and interpretation will be addressed. This is a course about the concepts that guide the decisions throughout the process. The first session will focus on setting the overall study strategy on which type of study, in which species, and when they should be conducted. The second session will review aspects of study design and the components of a quality study, including maternal-litter exposure and pharmacodynamic considerations. The applications of these principles to modify study designs for the testing of new modalities will be included. This will be followed by a session on how to manage study conduct when faced with in-life challenges (tolerability, food supplementation, rabbit abortions). Next, a session will cover the data interpretation principles specific to EFDs, followed by a session on the communication of study results, including when expedited reporting is required and how EFD data informs clinical protocol decisions, informed consent, and product labeling.

CE Course Chair: Caren Villano, PhD – Sanofi
CE Course Chair: Ronee Baracani, MS, DABT – Otsuka
CE Course Speaker: Susan Laffan, PhD – Amgen, Inc.
CE Course Speaker: Kary E. Thompson, PhD – Johnson & Johnson
CE Course Speaker: Bethany Hannas, PhD, DABT – Eli Lilly and Company
CE Course Speaker: Tacey E. K White, PhD – Tacey White Tox Consulting, LLC