A Blueprint for Breakthrough – Charting the Course for Precision Medicine
Join us on September 13, 2017, as Friends of Cancer Research and Alexandria Real Estate Equities Inc. host this year’s 6th annual A Blueprint for Breakthrough forum! This year's forum will convene multiple stakeholders across academia, government, industry, research and advocacy organizations, and other interested groups to discuss critical aspects for the future development of diagnostic tests.
Advancements in research continue to help identify and inform the use of biomarkers and genomics for therapeutic decision-making. These potential biomarkers and genomic markers are captured in diagnostic tools that have become increasingly important in selecting the most appropriate therapies for patients. This technology has become increasingly advanced, and diagnostic tools are not always binary indicators (e.g., EGFR positive or negative) of whether a drug would be effective or not in a patient. The use of these diagnostics often evolves at a rapid pace and it is necessary to ensure adaptive regulatory processes are in place. This meeting will help elucidate innovative regulatory pathways that can incorporate the rapid technological improvements in precision medicine and baseline considerations for analytical standardization.
The draft agenda for the meeting is included below. Click the button below to register today!
Finalized Meeting Agenda
8:00 AM - Registration and Breakfast
8:30 AM - Welcome Remarks
- Ellen Sigal, Friends of Cancer Research
- Lynne Zydowsky, Alexandria Real Estate Equities, Inc.
8:40 AM - Morning Keynote Address
- Scott Gottlieb, Commissioner, U.S. FDA
9:00AM - Regulatory Landscape for Precision Medicine
- Adam Berger, U.S. FDA
9:15AM - Current State of Precision Medicine Development
- Julie Dixon, Bristol-Myers Squibb
9:30 AM – Panel 1 Discussion: Establishing Analytical Standards and Identifying Critical Performance Characteristics
- Moderator: Mya Thomae, Regulatory Advisor
- Dara Aisner, University of Colorado Denver
- Rasika Kalamegham, Genentech
- Lisa McShane, NCI
- Jason Merker, Stanford University
- Reena Philip, U.S. FDA
- Erasmus Schneider, NY State Department of Health
10:15 AM – Q&A
10:45 AM – Break
11:00 AM – Panel 2 Discussion: Streamlining Modifications to Diagnostic Tests
- Moderator: Elizabeth Mansfield, GRAIL
- Gideon Blumenthal, U.S. FDA
- Keith Flaherty, Massachusetts General Hospital
- David Kaufman, Merck
- David Litwack, U.S. FDA
- Kelli Tanzella, Thermo Fisher Scientific
11:45 PM – Q&A
12:15PM - Panel 3 Discussion: Driving Uptake of High Quality Precision Medicine Tools
- Moderator: Kate Rawson, Prevision Policy
- Joseph Chin, CMS
- Andrea Ferris, LUNGevity
- Zach Hornby, Ignyta
- John Iafrate, Massachusetts General Hospital
- Michael Pellini, Foundation Medicine
- Jeffrey Shuren, U.S. FDA
12:45 PM - Q&A
1:00 PM – Closing Remarks