10:30 am

BREAK

10:45 am

Technological Hurdles: Professional Perspectives

Clinician Perspective – Richard Schilsky, University of Chicago; Cancer and Leukemia Group B

Drug Developer Perspective – Robert Mass, Genentech, Inc.

Diagnostic Developer Perspective – Steven Shak, Genomic Health, Inc.

Patient Perspective – Amy Bonoff, National Breast Cancer Coalition

Moderator – Richard Schilsky, University of Chicago; Cancer and Leukemia Group B

12:45 pm

LUNCH

1:45 pm

Regulatory Hurdles: Overview of Past Recommendations

The Original Secretary’s Advisory Committee on Genetic Testing – Wylie Burke, University of Washington

The Secretary’s Advisory Committee on Genomics, Health and Society – Andrea Ferreira-Gonzalez, Virginia Commonwealth University

Moderator – Steven Gutman, University of Central Florida

2:45 pm

BREAK

3:00 pm

Regulatory Hurdles: What Is the Status Quo?

What Is the Food and Drug Administration Currently Doing? – Alberto Gutierrez, Office of In Vitro Diagnostic Devices, Food and Drug Administration

How Do the Clinical Laboratory Improvement Amendments Oversee Laboratory-Developed Tests? – Penelope Meyers, Division of Laboratory Services, Centers for Medicare & Medicaid Services

What Can the Center for Disease Control and Prevention Do to Help in the Assessment of New Tests? – Ralph Coates, Coordinating Center for Health Promotion, Center for Disease Control and Prevention

Moderator – Steven Gutman, University of Central Florida

4:30 pm

Adjourn Day 1



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