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OPEN SESSION
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8:00 am
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Continental Breakfast
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8:30 am
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Welcome and Opening Remarks
John Ball, Committee Chair
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9:00 am
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Sponsor Presentation: Kathy Ellwood and Paula Trumbo, CFSAN, FDA
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9:45 am
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Sponsor Presentation: Federico Goodsaid, CDER, FDA
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10:30 am
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Invited Presentation: Joseph Bonventre, Harvard Medical School
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11:15 am
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Biostatistics and Surrogacy: David DeMets and Victor DeGruttola, committee members
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CLOSED SESSION
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12:00 pm
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Lunch and Bias Discussion
Clyde Behney, IOM Deputy Executive Officer
John Ball, Committee, and IOM staff
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OPEN SESSION
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1:00 pm
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Public Comment Period
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1:30 pm
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Preliminary Discussion of the Statement of Task: Reflection on Morning Presentations, preparation for perspective of topical areas
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Discussion of topics relevant to the charge, developing a work plan
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1:45 pm
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1. FDA Needs and Challenges (i.e. need for qualification framework, cross-FDA applicability, problems with surrogate endpoints)
Robert Califf, Allan Jaffe, Harlan Krumholz
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2:00 pm
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2. Statistical Issues
David DeMets, Victor De Gruttola
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2:15 pm
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3. Epidemiological Issues
Bill Harlan, Roberta Ness
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2:30 pm
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4. Need for and Use of Qualified Biomarkers in various “User Groups” (i.e. FDA, food companies, pharmaceutical industry, patients, health care professionals, policy makers, etc.)
Michelle Albert, Fred Apple, John Wagner
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2:45 pm
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5. Types/Uses of biomarkers (i.e. exploratory, diagnostic, surrogate endpoints, multi-biomarker panels, genomic, etc.)
Robert Gerszten, Jenny Van Eyk
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3:00 pm
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6. Case Studies/Specific Chronic Diseases
Ron Krauss, Maria Lopes-Virella
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3:15 pm
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BREAK
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3:30 pm
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Discussion of the Statement of Task – Members perspectives, Drop-back plan; What is the Task? What segments are of primary importance? What will the output be?
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4:30 pm
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Wrap-up – Discussion, Assignments, and Summarize Next Steps
John Ball, Committee Chair
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5:00 pm
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Adjourn
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