AACR-FDA-NCI Cancer Biomarkers Workshop

In an effort to understand how disparate stakeholder motivations and perspectives contribute to the stagnation of biomarker development and clinical integration, the American Association for Cancer Research (AACR), in partnership with the Food and Drug Administration (FDA), the National Cancer Institute (NCI), and the Pharmaceutical Research and Manufacturers Association (PhRMA), convened a two-day workshop to discuss the use of biomarkers in oncologic drug development and therapy in November 2006.

The AACR-FDA-NCI Cancer Biomarkers Workshop brought together distinguished experts from academia, government, industry, and the patient advocacy community to identify ways to promote the use of predictive biomarkers in drug development and clinical practice and thereby improve outcomes for patients with cancer. The Workshop was organized into four sessions that framed the issues from FDA, NCI, academic, and industry perspectives and addressed major themes in cancer biomarker and drug development.

It is hoped that the ideas and suggestions brought forth at the Workshop and further developed by the AACR-FDA-NCI Cancer Biomarkers Collaborative will help accelerate the future approval of validated biomarkers for use in clinical practice.

WORKSHOP PARTICIPANTS

William N. Hait, M.D., Ph.D., Co-Chairperson
Johnson & Johnson Pharmaceutical Research & Development L.L.C.

Samir N. Khleif, M.D., Co-Chairperson
National Cancer Institute

James H. Doroshow, M.D., Co-Chairperson
National Cancer Institute

Darrick Fu, Co-Chairperson
Pharmacology Research and Manufacturer’s Association

Alex A. Adjei, M.D., Ph.D.
Roswell Park Cancer Institute

Cheryl B. Anderson, Pharm.D.
Eli Lilly and Company

Peter E. Barker, Ph.D.
National Institute of Standards and Technology

J. Carl Barrett, Ph.D.
Novartis Institute for BioMedical Research, Inc.

Robert C. Bast, Jr., M.D.
UT M. D. Anderson Cancer Center

David D. Chang, M.D., Ph.D.
Amgen, Inc.

Glen Clack, M.D.
AstraZeneca Pharmaceuticals

Edwin A. Clark, Ph.D.
Bristol-Myers Squibb Company

Gary M. Clark, Ph.D.
OSI Pharmaceuticals

Carolyn Compton, M.D., Ph.D.
National Cancer Institute

George D. Demetri, M.D.
Dana-Farber Cancer Institute

Kapil Dhingra, M.B.B.S.
Hoffmann-La Roche, Inc.

Nicholas C. Dracopoli, Ph.D.
Bristol-Myers Squibb Company

John A. Foekens, Ph.D.
Erasmus Medical Center Rotterdam

Cindy Geoghegan
Susan G. Komen Breast Cancer Foundation

Gary B. Gordon, M.D., Ph.D.
Abbott Laboratories

Steven I. Gutman, M.D.
Food and Drug Administration

Elizabeth H. Hammond, M.D.
University of Utah School of Medicine

Christopher M. Haqq, M.D., Ph.D.
Amgen, Inc.

Daniel F. Hayes, M.D.
University of Michigan Comprehensive Cancer Center

M. Carolina Hinestrosa
National Breast Cancer Coalition

Malik Juweid, M.D.
University of Iowa

Lee Kaiser, Ph.D.
Genentech, Inc.

Gary J. Kelloff, M.D.
National Cancer Institute

Pamela M. Klein, M.D.
Genentech Inc.

Robert J. Lechleider, M.D.
Food and Drug Administration

Lisa M. McShane, Ph.D.
National Cancer Institute

Brian P. Mullaney, M.D., Ph.D.
Eli Lilly and Company

Yusuke Nakamura, M.D., Ph.D.
University of Tokyo

Perry D. Nisen, M.D., Ph.D.
GlaxoSmithKline

Gunaretnam Rajagopal, Ph.D.
Bioinformatics Institute, Singapore

Richard L. Schilsky, M.D.
University of Chicago

Manfred Schmitt, Ph.D.
Technical University of Munich

Adrian M. Senderowicz, M.D.
Food and Drug Administration

Lalitha K. Shankar, M.D., Ph.D.
National Cancer Institute

Barry Sickels, Ph.D.
AstraZeneca Pharmaceuticals

Steven Skates, Ph.D.
Massachusetts General Hospital

Dominic G. Spinella, Ph.D.
Pfizer Global Research and Development

Sheila E. Taube, Ph.D.
National Cancer Institute

Elizabeth Thompson
Pancreatic Cancer Action Network, Inc.

Joseph E. Tomaszewski, Ph.D.
National Cancer Institute

JoAnne Zujewski, M.D.
National Cancer Institute