OCTOBER 7, 2019


Ritz-Carlton Washington, DC

1150 22nd Street, NW


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

Former FDA Commissioner Scott Gottlieb

Prevision Policy’s Michael McCaughan (Moderator)


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

PhRMA VP-Policy and Research Randy Burkholder

ICER Founder and President Steve Pearson

Senior Policy Advisor to Rep. Kurt Schrader (D-Ore.) Kelly Nickel

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 

Acting FDA Commissioner Ned Sharpless

Introduction by Friends of Cancer Research VP-Public Affairs Ryan Hohman


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)