ESTABLISHING THE RESEARCH INFRASTRUCTURE TO DEVELOP
AND CLASSIFY CLINICAL BIOMARKERS
Objectives
- Explore the development of a conceptual model that describes the future for biomarker
development and its application as surrogate endpoints
- Establish an action plan throughout the clinical trials enterprise to apply this model
- Evaluate classification systems for surrogate endpoints
- Consider broad infrastructure needs in basic and clinical research areas to apply
fundamental biology and technological advances to foster development of novel clinical
measuring tools
- Characterize the need to organize scientific disciplines that will utilize biomarkers in
evaluation of therapeutic safety and efficacy
Agenda
| Moderators: |
Bert Spilker, Ph.D., M.D., PhRMA (Pharmaceutical Research and
Manufacturers of America)
Scott L. Zeger, Ph.D., Johns Hopkins University School of Hygiene and Public Health |
| Discussants: |
Adam Cohen, M.D., Ph.D., Centre for Human Drug Research, The
Netherlands
John A. Oates, M.D., Vanderbilt University |
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