BIOPHARMA CONGRESS: READY FOR A NEW ERA
April 7, 2025 (In-Person Only)
Ritz-Carlton Washington, DC
(1150 22nd Street, NW)
8am-1pm
The Future of FDA: Where Do We Go From Here (8:30-9:15)
Former Acting FDA Commissioner Janet Woodcock
Former CDRH Director Jeff Shuren
Hyman, Phelps & McNamara’s Frank Sasinowski
Prevision Policy’s Kate Rawson
Topics: Future of FDA, Accelerated Approval, approval standards, considerations in drug development.
Drug Price Negotiations For Second Round Of Selected Drugs (9:15-9:45)
Former CMS Principal Deputy Administrator Jonathan Blum
Prevision Policy’s Ramsey Baghdadi
Topics: Lessons learned from Year 1 of the IRA price negotiation program, a discussion of the second round of selected drugs, how the new administration will approach negotiations, and advance planning for the coming years.
Break (9:45-10:00)
AI Policy For New Drug And Biologics Applications (10:00-10:45)
FDA AI Policy Director Tala Fakhouri*
Novartis’ Nicole Mahoney
Covington & Burling’s Joe Franklin
Prevision Policy’s Grace Moser
Topics: Fakhouri will discuss the new guidance issued by FDA on artificial intelligence, how the guidance will be implemented in the real world, and how sponsors should think about incorporating AI into product applications. *May be unable to attend
Rare Disease “Hubdate” (10:45-11:15)
FDA Associate Director For Rare Disease Strategy Amy Comstock Rick
Pink Sheet’s Derrick Gingery
Topics: Rick will give an update on the Rare Disease Hub, including the newly released strategic agenda, the Rare Disease Policy & Portfolio Council, and future scientific workshop.
Break (11:15-11:30)
Rebuilding FDA: Thoughts On Future Reforms (11:30-12:00)
Former FDA Principal Deputy Commissioner Joshua Sharfstein
Prevision Policy’s Kate Rawson
Political Outlook For 2025 (12:00-12:30)
TD Cowen Chief Political Analyst Chris Krueger
Prevision Policy’s Michael McCaughan