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 I—Neurodegenerative and Neuropsychiatric Disorders
• Cardiovascular I—Acute Ischemic Coronary Syndromes
• Transplantation I—Physiologic, Histologic, and Pharmacologic Markers of Graft Function
• Cancer Prevention—Biomarkers and Surrogate Endpoints in Clinical Trials
• Biomarkers of Joint Destruction and Repair
• Severe Infections and Septic Shock
• Neurosciences III—Biomarkers for Pain Assessment
• Biomarkers of Toxicity and Surrogate Endpoints for Safety
• Osteoporosis Biomarkers and Surrogate Endpoints
• Biomarkers in Cancer Therapeutics
• Transplantation II—Immune Markers of Graft Dysfunction
• Immune Correlates of Protection and Recovery: Hepatitis C Virus
• Biomarkers in the Spectrum of Autoimmune Diseases
• Neurosciences II—Biomarkers for Alcohol and Drug Abuse
• Cardiovascular II—Stable Cardiovascular Disease
• Establishing the Research Infrastructure To Develop and Classify Clinical Biomarkers

Overview  Agenda  Selected References 
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