A Blueprint for Drug/Diagnostic Co-Development:
September 9th, 2015 – 9:00am-12:00pm
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