CE 4: Working with Global Regulators for Streamlined Nonclinical Development

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