2017 DRAFT AGENDA

TUESDAY, NOVEMBER 14, 2017

Morning Keynote: Senate HELP Committee Chairman Lamar Alexander*

  • 9:15am-10:00am: PDUFA VI, New Drug Approvals and Biosimilars

Anna Abram*
Deputy Commissioner for Policy, Planning, Legislation & Analysis
FDA

Peter Stein
Deputy Director, Office of New Drugs, CDER
FDA

Sandra Milligan
SVP, Global Regulatory Affairs & Clinical Safety
Merck

Steven Galson
SVP, Global Regulatory Affairs & Safety
Amgen

Mathias Hukkelhoven
SVP, Global Regulatory, Safety & Biometrics
Bristol-Myers Squibb

Jeff Allen
CEO
Friends of Cancer Research

  • 10:00am-10:45am: Operationalizing Patient Input Into Approval Decisions

Rachel Sherman
Principal Deputy Commissioner
FDA

Wilson Bryan
Director, Office of Tissues & Advanced Therapies (CBER)
FDA

Caroline Kruse
Executive Director
Platelet Disease Society of America

10:45am-11:00am: Break

  • 11:00am-12:00pm: FDA In 2020

Richard Pazdur
Acting Director, Oncology Center of Excellence
Food and Drug Administration (FDA)

Janet Woodcock
Director, Center for Drug Evaluation & Research
FDA

Peter Marks
Director, Center for Biologics Evaluation & Research
FDA

Ellen Sigal
Founder and Chairperson
Friends of Cancer Research

  • 12:15pm-1:15pm: Lunch Keynote Address
  • 1:30pm-2:00pm: Afternoon Keynote
     
  • 2:00pm-2:45pm: State Health Reform Priorities for 2018

    Jeff Myers
    CEO
    Medicaid Health Plans of America

    Kip Piper
    President
    Health Results Group

Tanisha Carino
VP, US Policy
GlaxoSmithKline

2:45pm-3:00pm: Break

3:00pm-3:45pm: The Application of Value Data

Amy Bassano*
Acting Director, Center for Medicare & Medicaid Innovation
CMS

Mike Ryan
SVP-US Value, Access, & Policy
Bristol-Myers Squibb

Mike Kolodziej
National Medical Director, Managed Care Strategy
Flatiron Health

Lyn Fitzgerald
SVP-US & Global Development
National Comprehensive Cancer Network

  • 3:45pm-4:15pm: Pharmaceuticals & The ACA

Joe Grogan
Associate Director, Health
Office of Management & Budget

  • 4:15pm-5pm: Healthcare 2020: Where Health Reform Is Headed For Biopharma

Tom Daschle
Co-Founder, Bipartisan Policy Center
Former Senate Majority Leader

Mark McClellan
Director, Duke-Margolis Health Policy Center
Former CMS Administrator and FDA Commissioner

Cocktail Reception 5:00pm-7:00pm

*invited