Sep 5

Past Event

Advancing the Use of Biomarkers and Pharmacogenomics in Drug Development

Summary

Modern advances in the basic biomedical sciences are creating opportunities to support personalized medicine through the development of targeted therapies tailored to the biological characteristics of individual patients. The evolution of personalized medicine is dependent upon the development and application of clinically valid biomarkers, as well as companion diagnostics capable of accurately identifying and measuring a particular biomarker of interest. However, ongoing challenges in the discovery, validation, and clinical application of biomarkers present significant barriers to progress. As part of its mandate under the Prescription Drug User Fee Act Reauthorization of 2012, the U.S. Food and Drug Administration (FDA) is committed to advancing the development and use of biomarkers in clinical trials by enhancing its regulatory review and communication processes.

On September 5, the Engelberg Center for Health Care Reform hosted a public workshop to help advance biomarker science in the context of therapeutic product development. Discussions identified challenges for biomarker applications in early and late phase clinical trials, as well as best practices for successful biomarker-based programs (including the co-development of in-vitro diagnostic devices and the use of biomarkers as outcome measures in clinical trials). This meeting was convened by Brookings under a cooperative agreement with FDA.

Event Agenda

  • 9:00 - 9:10

    Welcome

  • 9:10 - 9:30

    Critical Issues in the Application of Biomarkers in Clinical Trials

    • Janet Woodcock

      U.S. Food and Drug Administration

    • Briggs Morrison

      AstraZeneca

  • 9:30 - 10:45

    Session IA: Critical Issues in Biomarker Development for Clinical Trial Enrichment

    • mmclellanimage

      Mark B. McClellan

      Director, Health Care Innovation and Value Initiative

      Senior Fellow, Economic Studies

    • Lisa Meier McShane

      National Cancer Institute

    • Rebecca Blanchard

      Merck

    • Dietmar Berger

      Genentech

    • Michael Pacanowski

      U.S. Food and Drug Administration

  • 10:45 - 11:00

    Break

  • 11:00 - 12:15

    Session IB: Approaches to Collaborative Co-Development of Therapies and Diagnostics

    • mmclellanimage

      Mark B. McClellan

      Director, Health Care Innovation and Value Initiative

      Senior Fellow, Economic Studies

    • Tracy Bush

      Roche Diagnostics

    • Mya Thomae

      Illumina

    • Jeffrey Roche

      Centers for Medicare and Medicaid Services

    • Jeff Allen

      Friends of Cancer Research

    • Elizabeth Mansfield

      U.S. Food and Drug Administration

    • Chris Leptak

      U.S. Food and Drug Administration

  • 12:15 - 1:15

    Lunch

  • 1:15 - 2:45

    Session IIA: Accelerating the Use of Biomarkers as Replacement or Surrogate Endpoints

    • mmclellanimage

      Mark B. McClellan

      Director, Health Care Innovation and Value Initiative

      Senior Fellow, Economic Studies

    • Thomas Fleming

      University of Washington

    • Victor De Gruttola

      Harvard School of Public Health

    • Sue-Jane Wang

      U.S. Food and Drug Administration

    • Robin Isaacs

      Merck

    • Jeffrey Silber

      AbbVie

  • 2:45 - 3:00

    Break

  • 3:00 - 4:20

    Session IIB: Evidentiary Needs and Implications of Biomarkers as Surrogate Endpoints

    • mmclellanimage

      Mark B. McClellan

      Director, Health Care Innovation and Value Initiative

      Senior Fellow, Economic Studies

    • Marc Buyse

      International Drug Development Institute

    • Daniel Hayes

      University of Michigan

    • Rob Scott

      Amgen

    • Robert Temple

      U.S. Food and Drug Administration

    • Estelle Russek-Cohen

      U.S. Food and Drug Administration

    • John Walsh

      COPD Foundation

  • 4:20 - 4:30

    Closing Remarks

Details

September 5, 2014

9:00 AM - 4:30 PM EDT

Washington Plaza Hotel

10 Thomas Circle, NW

Map

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For More Information

Joanna Klatzman

202.536.3634