Register: FDA in 2025: Navigating an Uncertain Regulatory Future

ABOUT THE EVENT

Date: Wednesday, November 5, 2025 11am–12pm EST
Event Location: Virtual

From Commissioner’s National Priority Vouchers to a push to move away from animal studies to new guidances for oncology and vaccine approvals, the FDA is making considerable changes to its drug approval pathways and standards. The agency is also adjusting how it conducts its regulatory oversight, including promising to make complete response letters available in real time and report adverse events daily, launching a series of expert panels while considering pulling back from advisory committees and, importantly, implementing an AI tool called Elsa to help its staffers conduct their work. Through it all, Health Secretary Robert F. Kennedy Jr. has emphasized the department’s goals of “radical transparency” and a return to “gold-standard science.”

Join us for a live webinar as we dive into what this all means for biopharma companies working to bring innovative treatments to market.

Evan Seigerman
Managing Director and Head of Healthcare Research | BMO Capital Markets
Evan is a Managing Director and Head of Healthcare Research at BMO Capital Markets. He is also the firm’s Senior Research Analyst covering Pharmaceuticals and Biotechnology companies. Prior to joining BMO, Evan was a Senior Research Analyst at Credit Suisse, covering BioPharma companies. He started his Wall Street Career at Deutsche Bank and later was on the #2 Institutional Investor ranked Biopharma team at Barclays. Before equity research, Evan was a strategy consultant for the BioPharma industry.

Evan is consistently recognized as a top research analyst and leading voice on the sector. Among his achievements, he hosted the first obesity and metabolic disease focused investor conference in 2024. In 2021, he was named a Rising Star of Equity Research by Business Insider. He is regularly a guest on CNBC’s Fast Money, Squawk Box, and Power Lunch; Yahoo Finance and Canada’s BNN Bloomberg. He is also frequently quoted in The Wall Street Journal, The Financial Times, The New York Times, and industry trade publications. Evan holds a BBA in Finance and Accounting and BA in Spanish, both from the University of Michigan.
Dr. Rahul Gupta, MD, MPH, MBA
President | GATC Health
Dr. Rahul Gupta is President of GATC Health, where he leads the company’s work applying AI and multiomics to accelerate drug discovery and development. From 2021 to 2025, he served as Director of the White House Office of National Drug Control Policy, the first physician to hold this Cabinet-level role. In that position, he directed a $44 billion national strategy and advanced innovative approaches to addressing the overdose crisis. His career spans medicine, public health, and biotechnology, making him a trusted leader at the intersection of science, policy, and innovation.
Steven A. Grossman, JD
President | HPS Group, LLC
Steven A. Grossman, JD, is President of HPS Group, LLC, a policy and regulatory consulting firm, and author of “FDA Matters: The Grossman FDA Report” (https://www.fdamatters.com/).

Mr. Grossman co-founded and later served as Executive Director of the Alliance for a Stronger FDA. This multi-stakeholder coalition has helped grow the FDA’s appropriated budget from $1.6 billion to $3.5 billion. Mr. Grossman’s advocacy is rooted in public service, having spent six years as counsel and Health Staff Director on the Senate HELP Committee and four years as a Deputy Assistant Secretary for Health at HHS. While working in the Senate, he was one of the chief Senate negotiators on the Orphan Drug Act (ODA) and the Drug Price Competition and Patent Term Restoration Act (known as Hatch-Waxman). In recognition of his advocacy and policy leadership, he has been honored by the Reagan-Udall Foundation for the FDA with its Innovations in Regulatory Science Award.

Jef Akst
Jef Akst
Managing Editor | BioSpace
Jef is the Managing Editor for BioSpace. She earned her master’s degree from Indiana University in April 2009 studying the mating behavior of seahorses and spent the first 13 years of her career at The Scientist, where she edited features and oversaw the production of the publication’s digital and print magazines. In 2022, her feature on uterus transplantation earned first place in the trade category of the Awards for Excellence in Health Care Journalism. She is a member of the National Association of Science Writers. She lives in Fredericksburg, Virginia, with her husband, two young kids, wild coonhound and aging cat. Her hobbies including hiking, camping, and shooting pool.

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