RESEARCH STRATEGIES, STUDY DESIGNS AND STATISTICAL APPROACHES TO BIOMARKERS VALIDATION FOR CANCER DIAGNOSIS AND DETECTION

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8:00 a.m.

Welcome
Dr. Peter Greenwald, Director, DCP

8:10 a.m.

Institute / Agency Perspectives
NCI (Dr. Anna Barker) and FDA (Dr. Theresa Mullin)

8:45 a.m.

Workshop Goals and Objectives
Dr. Sudhir Srivastava

9:00 a.m.

Biomarkers in the clinical trial design for diagnosis and early detection
Dr. Don Berry

9:30 a.m.

Biomarkers of Early Detection: Statistical Perspectives
Dr. Stuart Baker

10:00 a.m.

Some aspects of the use of high dimensional data for cancer risk determination
Dr. Ross Prentice

10:30 a.m.

Break

10:50 a.m.

Panel Discussion: Review and Weaknesses of Observational Data on Biomarkers Utility in Cancer Detection and Diagnosis
Moderators: - Drs. Susan Ellenberg and Ross Prentice

Strengths and Weaknesses of Observational Validation Designs for High Dimensional Data: - Dr. Richard Simon

Proteomics: - Dr. Ziding Feng

Genomics: - Dr. Yudong He

12:00 noon

Lunch Break

1:30 p.m.

Panel Discussion: Strengths and Weaknesses of Longitudinal and Cohort-based Designs; Piggy-Backing Approach through Treatment and/or Prevention Trials
Moderators: Drs. Bob O'Neil and Richard Schilsky

Dr. Donna (Pauler) Ankerst
Dr. Garnet Anderson
Dr. Sylvan Green

3:00 p.m.

Break

3:15 p.m.

Experimental Designs and Analytical Methods To Support Validation of Biomarkers for Detection and Diagnosis:
Moderators: Drs. Lance Liotta and Sylvan Green

• Definitions of risk, early detection, diagnosis and prognosis for biomarkers and algorithms in statistical and clinical contexts: -Dr. Steven Skates
• Flexible study designs for ongoing and future trials to accommodate emerging biomarkers and technology: -Dr. Sue-Jane Wang
• Acceptable data reduction approach for high dimensional data derived from high throughput assays:- Dr. Yu Shyr
• Non-traditional methods, including modeling for biomarker validation: - Dr. Robert Boer
• Algorithms to combine multiple markers deriving from high throughput discovery: -Dr. Martin McIntosh

5:30 p.m.

Adjourn Day I

8:00 a.m.

FDA Guidelines for Technology and Biomarker Evaluation
Dr. Steven Gutman

9:00 - 12:00 P.M.

Breakout Group I

Analytical and Performance Characteristics
Co Chairs: Drs. Stuart Baker, Martin McIntosh, Steven Skates and Yu Shyr

Breakout Group II

Considerations for Biomarker validation regulatory requirements for Commercialization
Co-Chairs: Drs. Emmanuel Petricoin, Sudhir Srivastava, and Lakshmi Vishnuvajjala

Breakout Group III

Development of Alternative, Non-Traditional Approaches to Biomarker Validation Co-Chairs: Drs. Ziding Feng, Sue-Jane Wang, Ralph Kodell

Breakout Group IV

Clinical and biological challenges: Biological perspective Co-Chairs: Drs. William Grizzle, Dean Brenner, and Jose Costa

Breakout Group V

Biological specimen from large Institutional Trials In Support of Biomarker Validation Co-Chairs: Drs. Steven Hirschfeld, Ross Prentice, and Padma Maruvada

10:00 a.m.

Break

12:00 noon

Lunch Break

1:30 p.m.

Report Presentation of Breakout Sessions
Discussants:

3:00 p.m.

Development of a Position Paper on Biomarker Validation Assignment of Report Writers

Non-NCI and Non-FDA Chairs: Chairs of Breakout Groups

NCI and FDA: Drs. Lance Liotta, Greg Downing, Greg Campbell, Ziding Feng, Sudhir Srivastava, and Padma Maruvada

4:00 p.m.

Adjourn at Day II