FDA and life sciences attorney Seth Olson recently moderated a panel of esteemed FDA and life science experts at the BioUtah 2025 Utah Life Sciences Summit and offered insights into how evolving FDA and HHS policies are impacting Utah’s life science industry. Seth was joined by Peter Marks, MD, PhD, former director of FDA’s Center for Biologics Evaluation and Research (CBER) and current senior VP of Molecular Discovery and head of Infectious Disease at Eli Lilly; and industry experts Chris Rogers, VP of Regulatory Affairs at Becton Dickinson (BD), and Dana Andersen, PhD, chief technical & manufacturing officer at Denali Therapeutics.
Panel members addressed several timely topics, including:
- Promising regulatory initiatives at FDA and HHS, which are on the horizon
- Regulatory strategies for interacting with FDA around early-stage product development
- Actions industry may take when regulatory submissions get off track, or require escalation
- Changes in how sponsors are conducting clinical trials
- Introducing novel approaches to drug development and potential barriers to modernizing activities in the U.S. and internationally
