Table of Contents

Foreword.

Keynote Addresses. (H. Varmus, J. Henney) Toward a structured national program to speed the invention and development of new technologies for measuring the progression of chronic diseases (J.F. Niblack).

Biomarkers and Surrogate Endpoints in Clinical Research: Definitions and Conceptual Model. Plenary Sessions. Plenary Session 1: Historical Perspectives.

Biomarkers as surrogate endpoints in clinical trials for HIV/AIDS: A model for other diseases? D. Mildvan). Biomarkers for HIV/AIDS: challenges ahead (J.M. Kagan). Biomarkers as Surrogates in Clinical Research (S.L. Zeger).

Plenary Session 2: The Need and Prospects for Biomarkers in Therapeutic Development.

Contribution of pharmacology markers (P. Rolan). The importance of markers in drug discovery and development (M.B. Silber). Prospective search for AD biomarkers (T. Sunderland). Use of modern proteomics to discover protein biomarkers of disease (R. Parekh). The early detection cancer research network (R.D. Klausner).

Plenary Session 3: Opportunities for Developing Biomarkers for Central Nervous System Disorders.

Biomarkers for the experimental therapeutics of Huntington's disease and Parkinson's disease (I. Shoulson). Imaging the addicted brain (N.D. Volkow). Cognitive biomarkers and the treatment of schizophrenia (B.A. Cornblatt). Genetic and epidemiologic basis for developing biomarkers of complex diseases (K.R. Merikangas).

Plenary Session 4: Immune and Inflammatory Markers.

Introduction and Overview. (A. Fauci). Immune memory and protective immunity (R. Ahmed). Seeing is believing: monitoring in vivo gene expression by magnetic resonance imaging (T.J. Meade). Gene expression in inflammatory disease using multiple DNA array technologies (D.H. Mack). Challenges in discovery of useful biomarkers (G. Ringold).

Plenary Session 5: Emerging Technologies: Insight Into Novel Biomarkers.

From ambiguities to insights (D.J. Lipman). Emergent order in systematic genome-scale observations in variation in gene expression patterns and its implication for diagnosis and surveillance (P.O. Brown). cDNA approaches to analysis of human disease (J.H. Eberwine). SAGE and expression technologies-potential biomarker applications (G. Riggins).

Breakout Sessions.

Neurosciences I - Neurodegenerative and Neuropsychiatric Disorders (I. Shoulson, L.S. Brady). Neurosciences II - Biomarkers for Alcohol and Drug Abuse (E.D. London, F. Vocci). Neurosciences III - Biomarkers for Pain Assessment (G. Fischbach, H. Slavkin, C. Kitt). Biomarkers for Chronic Lung Diseases (S. Buist). Pharmacokinetic and Pharmacodynamic Methods in Biomarker Development and Application (S.C. Piscitelli, C.C. Peck). Biomarkers of Toxicity and Surrogate Endpoints for Safety (F.D. Sistare, J.D. Morrow, P. Clax). Biomarkers in Cardiovascular Diseases (G. Sopko, L. Friedman). Cardiovascular I - Acute Ischemic Coronary Syndromes (J. Hochman, V. Dzau). Cardiovascular II - Stable Cardiovascular Disease (R. Califf, R.S. Balaban). Biomarkers for Transplantation (W. Harmon et al.). Cancer Prevention - Biomarkers and Surrogate Endpoints in Clinical Trials (E.R. Greenberg, W. Ki Hong). Biomarkers in Cancer Therapeutics (A.F. LoBuglio, J.M. Pluda, P. Ivy). Biomarkers of Severe Infections and Septic Shock (T.R. Martin, A.F. Suffredini). Biomarkers in the Spectrum of Autoimmune Diseases (D.S. Pisetsky, E. Collier). Biomarkers of Osteoporosis (S.R. Cummings, S. Sherman, J. McGowan). Biomarkers of Joint Destruction and Repair (K.D. Brandt, S. Serrate-Sztein). Establishing the Research Infrastructure to Develop and Classify