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Research Strategies, Study Designs and Statistical Approaches to Biomarkers Validation for Cancer Diagnosis and Detection


Wednesday, July 28, 2004
8:00 amWelcome
Dr Peter Greenwald, Director, DCP
8:10 amInstitute / Agency Perspectives NCI (Dr Anna Barker) and FDA (Dr Theresa Mullin)
8:45 amWorkshop Goals and Objectives
Dr Sudhir Srivastava
9:00 amBiomarkers in the clinical trial design for diagnosis and early detection
Dr Don Berry
9:30 amBiomarkers of Early Detection: Statistical Perspectives
Dr Stuart Baker
10:00 amSome aspects of the use of high dimensional data for cancer risk determination
Dr Ross Prentice
10:30 amBreak
10:50 amPanel 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 noonLunch Break
1:30 pmPanel 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 pmBreak
3:15 pmExperimental 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 pmAdjourn Day I

Thursday, July 29, 2004
8:00 amFDA Guidelines for Technology and Biomarker Evaluation Dr Steven Gutman
9:00 - 12:00 pm 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 amBreak
12:00 noon Lunch Break
1:30 pmReport Presentation of Breakout Sessions Discussants:
3:00 pmDevelopment 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 pmAdjourn at Day II

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