BIOPHARMA CONGRESS V
Monday, October 7, 2019
8:00AM – 5:00PM

PRESENTED BY PREVISION POLICY + FRIENDS OF CANCER RESEARCH

Gene Therapies. New Payment Models. FDA Approval Standards.

2019 CONFIRMED SPEAKERS
SCOTT GOTTLIEB (AEI)

JOHN O’BRIEN (HHS)

AMY HALL (HOUSE WAYS & MEANS COMMITTEE)

For more information, please Click HERE and scroll through below for the full agenda.

FDA Past, Present, and Future: A Conversation with Former FDA Commissioner Scott Gottlieb (8:15am-9:00am)

• Prevision Policy’s Michael McCaughan (Moderator)

Drug Pricing Options Under Single Payer (9:00am-10:15am)

• Johnson & Johnson VP Global Market Access and RWE Christoph Glaetzer
• House Ways & Means Health Subcommittee Majority Staff Director Amy Hall
• ICER Founder and President Steve Pearson
• Patients For Affordable Drugs Founder and President David Mitchell
• Manatt Health Solutions Advisor Ian Spatz (Moderator)

Prescription Drugs and Domestic Policy (10:20 am-10:40am)

• White House Domestic Policy Council Director Joe Grogan
• Prevision Policy’s Ramsey Baghdadi (Moderator)

Break (10:40am-11:00am)

A Center Leadership Perspective: CDER, CBER, and OCE (11:00am-12:00pm)

• CDER Director Janet Woodcock
• CBER Director Peter Marks
• OCE Deputy Director Gideon Blumenthal
• Friends of Cancer Research Chairperson and Founder Ellen Sigal (Moderator)

Lunch Keynote: Acting FDA Commissioner Ned Sharpless

Regulating the Third Era Of Drug Development: Individualization (1:30pm-2:30pm)

• CBER Office of Tissues and Advanced Therapies Director Wilson Bryan
• Lilly Oncology Product Team Leader Symantha Melemed
• OCE Deputy Director Paul Kluetz
• Amgen SVP-Global Development Elliott Levy
• Duke-Margolis Senior Policy Fellow Rachel Sherman
• Prevision Policy’s Cole Werble (Moderator)

Break: (2:30pm-2:50pm)

Subscriptions, Installments, and Indexing: Drug Payment In 2020 (2:50pm-3:50pm)

• Gilead Executive Director of Public Policy Rekha Ramesh
• Blue Cross Blue Shield Director For Cellular Immunotherapy And Gene Therapy Stephanie Farnia
• Former HHS Senior Advisor for Drug Pricing Reform John O’Brien
• Spark Therapeutics Head of Government Affairs Jeremy Allen
• ADVI Founder and CEO Marc Samuels (Moderator)

FDA Rising Stars Panel (3:50pm-5:00pm)

• Office of Hematology & Oncology Products/Division of Oncology Products 2 Associate Director Steven Lemery
• Division of Psychiatry Products Acting Director Tiffany Farchione
• Division of Bone, Reproductive & Urologic Products Director Hylton Joffe
• CDER Deputy Director for Clinical Science Bob Temple
• Prevision Policy’s Kate Rawson (Moderator)