| MATERIALS AND LINKS Meeting Information: Agenda Participant List Presentations: Session 1 Jean-Michel Pawlotsky (Moderator) Robert Kauffman (Moderator) Patrick Harrington Filip Josephson George Kukolj Oliver Lenz Fiona McPhee Hongmei Mo Tami Pilot-Matias Jacqueline Reeves Session 3 David Back (Moderator) Ira Jacobson (Moderator) Vikram Arya Courtney Fletcher Filip Josephson Jennifer Kiser Jules Levin Gene Morse Andrew Owen Shirley Seo Andrew Talal |
The Forum for Collaborative HIV Research convened the 10th HCV Drug Development Advisory Group (DrAG) Meeting in Amsterdam, in conjunction with the 48th annual European Association for the Study of the Liver (EASL) conference.
Topics of discussion included:1) Genotypic assays and their ability to distinguish among a variety of genotypes and subtypes, their utility in clinical trials, and current use in clinical practice.
2) Phenotypic assays and their potential use: clinical relevance, relative potency among different HCV genotypes, quantifying the resistance barrier, reference standards, role of pharmacokinetics and protein binding.
3) Pharmacokinetics and drug interaction studies in special populations with emphasis on prioritizing populations and drug classes/drug panels for studies, available technologies, and assay standardization.
Background:
The Drug Development Advisory Group (DrAG) is an outgrowth of a proposal from the 1st International Workshop on Hepatitis C: Resistance and New Compounds in October 2006. The goal of HCV DrAG is to bring together parties interested in and working on various aspects of HCV drug/biologic drug development on a continuing basis to discuss issues pertinent in the field.
Objectives:
The DrAG objectives are to produce consensus recommendations on a variety of issues in HCV drug/biologic development ranging from appropriate methodology for HCV resistance testing to providing scientific guidance for clinical trial design by facilitating discussions among all stakeholders (industry, academia, patient advocates and regulatory agencies).
Status:
The meeting was held on Tuesday, April 23, 2013 at Hotel Pulitzer in Amsterdam, The Netherlands.
The Steering Committee for this project includes:
Daria Hazuda, PhD - Merck Research Laboratories
Ira Jacobson, MD - Weill Medical College of Cornell University
Donald Jensen, MD, FACP - University of Chicago Medical Center
Filip Josephson, MD, PhD - European Medicines Agency
Robert Kaufmann, MD, PhD* - Vertex Pharmaceuticals, Inc.
Ann Kwong, PhD - InnovaTID
Nina Mani, PhD, MPH - Forum for Collaborative HIV Research
Veronica Miller, PhD - Forum for Collaborative HIV Research
Jeffrey Murray, MD, MPH - Center for Drug Evaluation and Research, Food and Drug Administration
Isabel Najera, PhD - Hoffmann La Roche
Jean-Michel Pawlotsky, MD, PhD* - Universite Paris Est
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
