HCV DrAG Meeting#13

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On November 11, the Forum for Collaborative HIV Research convened the 13th HCV Drug Development Advisory Group (DrAG) Meeting in Boston, MA in conjunction with the 65th annual meeting of the American Association for the Study of Liver Diseases.

Hepatitis C Diagnostics-the Bottleneck to Unlocking a Global Market

Prior to the 13th HCV DrAG meeting, the Forum and the Foundation for Innovative New Diagnostics (FIND) convened a side meeting on Hepatitis C Diagnostics-the Bottleneck to Unlocking a Global Market. In this side meeting, the potential of diagnostic tests to drive access to hepatitis C care and treatment in limited-resource settings will be discussed. Please see below for meeting materials.

Agenda

Participant List

Background document

FIND presentation

13th HCV DrAG Meeting

At the 13th HCV DrAG meeting, topics of discussion included:

  • Control arms and the design of future clinical trials
  • DAA considerations in the pediatric population
  • Management of patients who fail treatment

Please see below for meeting materials.

Agenda

Participant List

Welcome and Updates-Veronica Miller and Nivedha Panneer

Session 1

Control arms for future clinical trials-Jeff Murray

Session 2

Regulatory requirements for pediatric drug development-Linda Lewis

The Steering Committee for this project includes:

Patrick Harrington, PhD - Center for Drug Evaluation and Research, Food and Drug Administration
Daria Hazuda, PhD - Merck Research Laboratories
Ira Jacobson, MD - Weill Medical College of Cornell University
Filip Josephson, MD, PhD - European Medicines Agency
Tara Kieffer, PhD - Vertex Pharmaceuticals, Inc.
Veronica Miller, PhD - Forum for Collaborative HIV Research
Andrew Muir, MD MHS - Duke University
Jeffrey Murray, MD, MPH - Center for Drug Evaluation and Research, Food and Drug Administration
Neil Parkin, PhD - Data First Consulting
Jean-Michel Pawlotsky, MD, PhD* - Universite Paris Est
Gaston Picchio, PhD*- Janssen Pharmaceuticals
Stuart Ray, MD - Johns Hopkins University School of Medicine
Kimberly Struble, PharmD - Center for Drug Evaluation and Research, Food and Drug Administration
Tracy Swan - Treatment Action Group
Heiner Wedemeyer, MD - Medizinische Hochschule Hannover

* Co-Chair