FDA Under A New Administration

CBER Director Peter Marks & OCE Director Richard Pazdur

Topics: Future of Accelerated Approval, new “Projects” in oncology, approval standards, gene therapy updates, and updates from the biologics center.

Drug Price Negotiations For Second Round Of Selected Drugs

Manatt, Phelps, & Phillips Senior Advisor Ian Spatz

Topics: Lessons learned from Year 1 of the IRA price negotiation program, how the new administration will approach negotiations, and advance planning for the coming years.

AI Policy For New Drug And Biologics Applications

FDA AI Policy Director Tala Fakhouri

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.

More Speakers To Come

As a valued partner of Friends of Cancer Research (Friends), please click the registration button above to receive a complimentary registration to this year’s Biopharma Congress, co-hosted by Friends and Prevision Policy.