overview

agenda

selected references

remote video conference participation

contact'

NIH

National Institues of Health - Food and Drug Administration

FDA

Biomarkers and Surrogate Endpoints: Advancing Clinical Research and Applications

April 15-16, 1999

CONFERENCE AGENDA

Thursday, April 15, 1999

AGENDA-AT-A-GLANCE

7:00 a.m. - 8:00 a.m:
Registration

8:00 a.m. - 8:10 a.m.:
Welcome and Conference Objectives
Lana R. Skirboll, Ph.D., Office of Science Policy, Office of the Director, National Institutes of Health
Gregory J. Downing, D.O., Ph.D., Office of Science Policy, Office of the Director, National Institutes of Health

8:10 a.m. - 8:45 a.m.:
Plenary Session 1: Historical Perspectives

Biomarkers as Surrogate Endpoints in Clinical Trials for HIV/AIDS: A Model for Other Diseases?
Speakers: Donna Mildvan, M.D., Beth Israel Medical Center
Jonathan M. Kagan, Ph.D., National Institute of Allergy and Infectious Diseases

Biomarkers as Surrogates in Clinical Research
Speaker: Scott L. Zeger, Ph.D., Johns Hopkins University School of Hygiene and Public Health

8:45 a.m. - 9:00 a.m.:
Keynote Address: Harold Varmus, M.D., Director, National Institutes of Health

9:00 a.m. - 10:30 a.m.:
Plenary Session 2: The Need and Prospects for Biomarkers in Therapeutic Development

Moderator: John A. Oates, M.D., Vanderbilt University

Case Presentation: Contribution of Pharmacology Markers
Speaker: Paul Rolan, M.D., University of Manchester and Medeval Co., United Kingdom

The Prospective Search for Alzheimer's Disease Biomarkers
Speakers: B. Michael Silber, Ph.D., Pfizer, Inc.
Trey Sunderland, M.D., National Institute of Mental Health
Raj B. Parekh, M.A., D.Phil., Oxford Glycosciences

Developing the Research Infrastructure To Evaluate Cancer Biomarkers: The Early Detection Cancer Network
Speaker: Richard D. Klausner, M.D., Director, National Cancer Institute

10:30 a.m. - 10:45 a.m.:
BREAK

10:45 a.m. - 11:00 a.m.:
Keynote Address: Jane Henney, M.D., Commissioner, U.S. Food and Drug Administration

11:00 a.m. - 12:30 a.m.:
Plenary Session 3: Opportunities for Developing Biomarkers for CNS Disorders

Moderator: Linda S. Brady, Ph.D., National Institute of Mental Health

Biomarkers for the Experimental Therapeutics of Huntington's Disease and Parkinson's Disease
Speaker: Ira Shoulson, M.D., University of Rochester

Imaging the Addicted Brain
Speaker: Nora D. Volkow, M.D., Brookhaven National Laboratory

Cognitive Biomarkers and the Treatment of Schizophrenia
Speaker: Barbara A. Cornblatt, Ph.D., Hillside Hospital

Genetic and Epidemiologic Basis for Developing Biomarkers of Complex Diseases.
Speaker: Kathleen R. Merikangas, Ph.D., Yale University

Discussants:  Stanley J. Watson, Jr., M.D., Ph.D., University of Michigan
Richard C. Mohs, Ph.D., Mount Sinai School of Medicine and Veterans Affairs Medical Center

12:30 p.m. - 1:30 p.m.:
LUNCH

1:30 p.m. - 4:30 p.m.:
Concurrent Breakout Sessions

Click on button for detailed information on concurrent breakout sessions.

button Biomarkers for Chronic Lung Diseases
button Pharmacokinetic and Pharmacodynamic Methods in Biomarker Development and Application
button Neurosciences INeurodegenerative and Neuropsychiatric Disorders
button Cardiovascular IAcute Ischemic Coronary Syndromes
button Transplantation IPhysiologic, Histologic, and Pharmacologic Markers of Graft Function
button Cancer PreventionBiomarkers and Surrogate Endpoints in Clinical Trials
button Biomarkers of Joint Destruction and Repair
button Severe Infections and Septic Shock
button Neurosciences IIIBiomarkers for Pain Assessment

4:30 p.m. - 5:30 p.m.:
Summary of Concurrent Breakout Sessions

5:30 p.m. - 7:00 p.m.:
DINNER

7:00 p.m. - 7:30 p.m.:
Keynote Address: John F. Niblack, Ph.D., Executive Vice President,
Pfizer, Inc.

7:30 p.m. - 9:30 p.m.:
Plenary Session 4: Emerging Technologies: Insight Into Novel Biomarkers

Moderator: David J. Lipman, M.D., Director, National Center for Biotechnology Information, National Library of Medicine

From Ambiguities to Insights
Speaker: David J. Lipman, M.D.

cDNA Approaches to Analysis of Human Disease
Speaker: James H. Eberwine, Ph.D., University of Pennsylvania Medical Center

Emergent Order in Systematic Genome-Scale Observations of Variation in Gene Expression Patterns and Its Implication for Diagnosis and Surveillance
Speaker: Patrick O. Brown, M.D., Ph.D., Howard Hughes Medical Institute and Stanford University

SAGE and Expression Technologies—Potential Biomarker Applications
Speaker: Gregory J. Riggins, M.D., Ph.D., Duke University Medical Center

Connecting MRI Imaging Technologies With Physiology
Speaker: Robert S. Balaban, Ph.D., National Heart, Lung, and Blood Institute

Friday, April 16, 1999

7:45 a.m. - 9:30 a.m.:
Plenary Session 5: Immune and Inflammatory Markers

Moderator: Anthony S. Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases

Introduction and Overview
Speaker: Anthony S. Fauci, M.D.

Immune Memory and Protective Immunity
Speaker: Rafi Ahmed, Ph.D., Emory Vaccine Center and Emory University School of Medicine

Seeing Is Believing: Monitoring In Vivo Gene Expression by Magnetic Resonance Imaging
Speaker: Thomas J. Meade, Ph.D., California Institute of Technology

Gene Expression in Inflammatory Disease Using Multiple DNA Array Technologies
Speaker: David H. Mack, Ph.D., Eos Biotechnology

Challenges in Discovery of Useful Biomarkers
Gordon Ringold, Ph.D., SurroMed and GlaxoWellcome

9:30 a.m. - 12:30 p.m.:
Concurrent Breakout Sessions
Click on button for detailed information on concurrent breakout sessions.

button Biomarkers of Toxicity and Surrogate Endpoints for Safety
button Osteoporosis Biomarkers and Surrogate Endpoints
button Biomarkers in Cancer Therapeutics
button Transplantation IIImmune Markers of Graft Dysfunction
button Immune Correlates of Protection and Recovery: Hepatitis C Virus
button Biomarkers in the Spectrum of Autoimmune Diseases
button Neurosciences IIBiomarkers for Alcohol and Drug Abuse
button Cardiovascular IIStable Cardiovascular Disease
button Establishing the Research Infrastructure To Develop and Classify Clinical Biomarkers

12:30 p.m. - 1:45 p.m.:
LUNCH

1:45 p.m. - 2:45 p.m.:
Summary of Concurrent Breakout Sessions

2:45 p.m. - 3:45 p.m.:
Closing Session
Panel Discussion: Research Recommendations for Advancing the Biomarker Field
Moderator:  Gregory J. Downing, D.O., Ph.D.

Panelists: Robert Califf, M.D., Duke University
Steven R. Cummings, M.D., University of California, San Francisco
Donna Mildvan, M.D.
Scott L. Zeger, Ph.D.

Audience:  Questions and Anwers

Overview  Agenda  Selected References 
Remote Video Conference Participation  Contact   NIH Home Page