Blueprint for Drug/Diagnostic Development: Genetic Databases

A Blueprint for Drug/Diagnostic Co-Development:

Genetic Databases

September 9th, 2015 – 9:00am-12:00pm

The Mayflower

1127 Connecticut Ave NW

Washington, DC 20036

Friends of Cancer Research and Alexandria Summit/Alexandria Venture Investments will convene researchers, sponsors, advocates, and regulators for our annual forum addressing challenges in the co-development of drugs and companion diagnostics. Two expert panels will discuss how genetic databases are altering research and treatment paradigms; the challenges and opportunities to standardize practices and use; and how best to use this information in patient care.

9:00am - 9:10am - Welcome/Opening Remarks

  • Ellen Sigal - Chair, Friends of Cancer Research
  • Lynne Zydowsky - President & Co-Founder, Alexandria Summit; Chief Science Advisor to the CEO, Alexandria Real Estate Equities, Inc./ Alexandria Venture Investments

9:10am - 10:30am - Panel 1: Development and Standardization of Curated Genetic Databases 

  • Mya Thomae [Moderator] - Vice President of Regulatory Affairs, Illumina 
  • Roman Yelensky - Director, Clinical Genomic Analysis, Foundation Medicine  
  • Girish Putcha - Director, Laboratory Science, Palmetto GBA 
  • Matthew Marton - Director, Clinical Development Lab, Genomics section, Merck & Co. 
  • Shashikant Kulkarni - Director, Cytogenomics and Molecular Pathology, Washington University, School of Medicine 
  • Gideon Blumenthal - Clinical Team Leader, Thoracic and Head/Neck Oncology, Office of Hematology and Oncology Products, FDA 
  • Zivana Tezak - Associate Director for Science and Technology, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, FDA

10:40am - 12:00pm - Panel 2: Implementation of Genetic Databases and Associated Policy Challenges

  • ​Jeff Allen [Moderator] - Executive Director, Friends of Cancer Research
  • Larry Norton - Deputy Physician-in-Chief, Breast Cancer Programs, Medical Director, Evelyn H. Lauder Breast Center, Memorial Sloan Kettering Cancer Center
  • Jennifer Malin - Staff Vice President, Clinical Strategy, Anthem, Inc.
  • Tamara Syrek Jensen - Director for the Coverage and Analysis Group (CAG) at the Centers for Medicare & Medicaid Services (CMS)
  • Elizabeth Mansfield - Director of Personalized Medicine, Center for Devices and Radiological Health, FDA
  • Janet Woodcock - Director, Center for Drug Evaluation and Research, FDA

Pre-Meeting DRAFT White Paper (As of 9/1/2015)