Biomarkers and Surrogate Endpoints: Advancing Clinical Research and
Applications
A Multidisciplinary, International Conference Hosted by
NIH and FDA
April 15-16, 1999
Natcher Conference Center
National Institutes of Health
Bethesda, Maryland
OVERVIEW
Scope and Purpose
The National Institutes of Health (NIH) and the U.S. Food and
Drug Administration (FDA) are featuring a multidisciplinary conference to address the
research needs and scientific opportunities to develop and apply biomarkers for safety and
efficacy evaluations of novel disease interventions. This forum will emphasize the
application of fundamental biology and emerging technologies for clinical assessment.
Presentations will focus on concepts and approaches for the use of biomarkers in early
drug development and as surrogate endpoints in clinical trials.
Conference Objectives
- Communicate the state of current biomarkers and surrogate endpoints in specific disease
areas and therapeutic areas
- Encourage innovative collaboration among public and private partners in the clinical
trials enterprise in evaluating biomarkers that may be used as surrogate endpoints
- Address how emerging technologies and fundamental biology can be applied as assessment
tools in therapeutics
- Examine means to improve the efficiency of therapy development through development of
precise and accurate clinical measures
- Broaden awareness in the scientific and medical community of the issue of substituting
biomarkers for clinical endpoints in evaluating the safety and efficacy of novel therapies
- Explore medical and scientific education and training activities to broaden research and
application in clinical trials
Program Format
The program will feature keynote addresses by the leadership of Federal agencies and
the pharmaceutical industry, providing their perspectives on the future of clinical trials
and the development of new therapeutic agents. Plenary sessions will address concepts,
definitions, and common principles for the development of biomarkers and their application
as surrogate endpoints in clinical trials. These sessions will cover the following themes:
- History of the development and application of biomarkers and surrogate endpoints
- Need and prospects for new and improved biomarkers in therapeutic development
- Development of the research infrastructure to evaluate biomarkers
- neuroscience, behavior, and cognitive markers
- Use of imaging and emerging technologies in the development of biomarkers
Each day will include a variety of 3-hour breakout sessions featuring a series of case
studies or panel presentations focused on selected diseases or technologies. These
sessions are designed to focus on key issues to improving the clinical trials
infrastructure, encouraging innovative clinical research, and promoting the translation of
basic research information to clinical application. The sessions have been designed to
encourage the participation of meeting attendees in interactive discussion of the
development of biomarkers and their potential application as surrogate endpoints in
clinical trials.
- Biomarkers for Chronic Lung Diseases
- Pharmacokinetic and Pharmacodynamic Methods in Biomarker Development and Application
- Neurosciences INeurodegenerative and Neuropsychiatric Disorders
- Cardiovascular IAcute Ischemic Coronary Syndromes
- Transplantation IPhysiologic, Histologic, and Pharmacologic Markers of Graft
Function
- Cancer PreventionBiomarkers and Surrogate Endpoints in Clinical Trials
- Biomarkers of Joint Destruction and Repair
- Severe Infections and Septic Shock
- Neurosciences IIIBiomarkers for Pain Assessment
- Biomarkers of Toxicity and Surrogate Endpoints for Safety
- Osteoporosis Biomarkers and Surrogate Endpoints
- Biomarkers in Cancer Therapeutics
- Transplantation IIImmune Markers of Graft Dysfunction
- Immune Correlates of Protection and Recovery: Hepatitis C Virus
- Biomarkers in the Spectrum of Autoimmune Diseases
- Neurosciences IIBiomarkers for Alcohol and Drug Abuse
- Cardiovascular IIStable Cardiovascular Disease
- Establishing the Research Infrastructure To Develop and Classify Clinical Biomarkers
Overview Agenda
Selected References
Remote Video Conference Participation Contact
NIH Home Page
|