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CONFERENCE PROGRAM November 15–17, 2016, Boston, MA

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CONFERENCE PROGRAM November 15–17, 2016, Boston, MA CONFERENCE PROGRAM November 15–17, 2016, Boston, MA CONFERENCE PROGRAM | MESSAGE President and Chair’s Message Dear Colleague: “What we need is a national conversation of experts,” Mark Levin, Partner, Third Rock Ventures, once told the audience at the Annual Personalized Medicine Conference. “Across the industry, across government, the best people in this country to come together to tell us how to maximize value for patients. That is the big challenge in our future.” The 12th Annual Personalized Medicine Conference responds to Levin’s call to action with a concentrated focus on generating solutions to the field’s challenges. It will showcase what is new, offer insights into the issues, and provide partnership and networking opportunities for attendees. But most importantly, it will examine the unique contributions that researchers, investors, industry representatives, policy experts, payers, health care providers and patients can make at each stage in the development of personalized medicine products and services to forge a path through the field’s barriers. The conference program, which is organized around those stages, will go beyond defining personalized medicine’s challenges by, for example: ¢ Exploring the latest trends in research and development ¢ Analyzing the issues facing the diagnostic industry ¢ Finding commonalities in multiple definitions of “value” in health care ¢ Providing examples of the kinds of evidence appropriate for coverage and payment ¢ Examining the best practices for integrating personalized medicine into clinical settings ¢ Debating the circumstances that warrant the sharing of data for research We are pleased to present the entire conference program here, which covers these and many other topics. Sincerely yours, Edward Abrahams, Ph.D. William Dalton, Ph.D., M.D. President Chair of the Board 1 SPONSORS | CONFERENCE PROGRAM Thank You to Our Sponsors PLATINUM GOLD SILVER BRONZE CONTRIBUTOR MEDIA PARTNERS 2 CONFERENCE PROGRAM | PROGRAM Program Day 1 • November 15, 2016 David Altshuler, M.D., Ph.D., Executive Vice President, Global Research, Chief 5:30 pm Opening Reception Scientific Officer, Vertex Hotel Commonwealth Michael Panzara, M.D., M.P.H., Franchise Lead, 500 Commonwealth Avenue Neurology, WAVE Life Sciences Boston, MA 02215 Barbara Weber, M.D., Interim Chief Medical Officer, Neon Therapeutics Day 2 • November 16, 2016 9:45 am Networking Break 7:00 am Registration and Continental Breakfast 10:15 am Money Talks: The Future of Investment in Joseph B. Martin Conference Center Personalized Medicine Harvard Medical School Innovation requires investment. During 77 Avenue Louis Pasteur this discussion, a panel of diverse investors Boston, MA 02115 will illuminate the most promising business opportunities for advancing personalized 8:00 am Opening Remarks medicine, focusing on both macro and micro Edward Abrahams, Ph.D., President, environments while also discussing the barriers Personalized Medicine Coalition to investment and potential solutions for removing them. 8:05 am The Personalized Medicine Report William S. Dalton, Ph.D., M.D., CEO, M2Gen, MODERATOR | Edward Winnick, Editor in Chief, Chairman, Personalized Medicine Coalition GenomeWeb Alexis Borisy, M.S., Partner, Third Rock Ventures 8:15 am Keynote Speaker Vamil Divan, M.D., M.B.A., Senior Research Greg Simon, J.D., Executive Director, Cancer Analyst, Credit Suisse Moonshot Task Force Ryan Lindquist, M.B.A., Director, Investment 8:45 am Pioneering Precision: Charting a Course for Banking, Leerink Partners Cutting-Edge Innovations 11:15 am You + 999,999: How a 1 Million-Person Cohort Many scientists believe innovations in Can Pave the Way for Personalized Care personalized medicine are poised to yield major breakthroughs in coming years, but not all Eric Dishman, Director, Precision Medicine members of the health care system are clear on Initiative Cohort Program, National Institutes which research topics have the most potential. of Health The participants in this panel will identify the 12:00 pm Luncheon most encouraging scientific directions for personalized medicine and point to the most 1:15 pm Update: Kraft Precision Medicine Accelerator promising topics for future research. & Trials Challenge Award MODERATOR | Stephen Eck, M.D., Ph.D., Vice An update on the activities of the Kraft President, Oncology Medical Sciences, Astellas Precision Medicine Accelerator and interviews Pharma Global Development with the winners of Harvard Business School’s “Precision Trials Challenge,” sponsored by Kraft Precision Medicine Accelerator. 3 PROGRAM | CONFERENCE PROGRAM PRESENTER | Richard Hamermesh, D.B.A., 2:45 pm Networking Break Faculty Co-Chair, Kraft Precision Medicine Accelerator, Harvard Business School 3:15 pm Diagnostics Debate: Regulatory and Reimbursement Hurdles for Personalized WINNER | MatchMiner Medicine Diagnostics Team Lead: Ethan Cerami, Ph.D., Director, Nowhere are the regulatory and reimbursement Knowledge Systems Group, Department of challenges facing personalized medicine more Biostatistics and Computational Biology, evident than in the diagnostics industry, where Dana-Farber Cancer Institute the routes to market are often hampered by a lack of clarity regarding the possible changes RUNNER UP | No Patients Left Behind to the regulatory pathway for laboratory- Team Lead: Gavin MacBeath, Ph.D., developed tests, ambiguity regarding the kinds Co-Founder and Senior Vice President, of evidence that justify payment, and the Merrimack Pharmaceuticals need for large marketing budgets to sell RUNNER UP | iCare for Cancer Patients low- cost procedures, all of which impede the development of sophisticated diagnostics Team Member: Leylah Drusbosky, Ph.D., with the power to transform medicine. During Associate Professor of Medicine, University this panel discussion, representatives from of Florida, Scientific Director, iCare for a diverse range of diagnostics companies Cancer Patients and a payer will identify the most promising 1:45 pm Keynote Speaker | Reforming Clinical Trials: strategies to alter the landscape to encourage How Alternative Trial Designs May Reshape the investment in personalized medicine Regulatory Review diagnostic products, including the roles of other stakeholders such as the pharmaceutical Traditional clinical trial designs are often industry and integrated health systems. too cumbersome and expensive to study the efficacy of personalized medicine products MODERATOR | Ronnie Andrews, Founder and and services in sub-populations of patients. Principal, The Bethesda Group Yet there is no consensus on which methods Suzanne Belinson, Ph.D., M.P.H., Executive have the most promise to speed trials and Director, Center for Clinical Effectiveness, Blue lower costs. The participants in this panel will Cross Blue Shield Association discuss which of the latest progressive designs are best suited to demonstrate the efficacy of Brad Gray, CEO, NanoString personalized medicine based on past successes Elizabeth Mansfield, Ph.D., Director for and proposed reforms. Personalized Medicine and Molecular Genetics, Office of In Vitro Diagnostics and Radiological INTRODUCTION | Bonnie J. Addario, Founder, Health, FDA Chair, Bonnie J. Addario Lung Cancer Foundation, Founder, Addario Lung Cancer Michael J. Pellini, M.D., CEO, Foundation Medical Institute Medicine KEYNOTE | Janet Woodcock, M.D., Director, 4:30 pm Visions of Value: Evaluating Evidence for Center for Drug Evaluation and Research, Personalized Medicine U.S. FDA The fact that payers, providers, patients, 2:15 pm Fireside Chat industry representatives and regulators all define value differently makes it difficult MODERATOR | Alexander Vadas, Ph.D., for personalized medicine’s champions Managing Director and Partner, L.E.K. to contribute to and communicate about Consulting the body of evidence supporting the field. KEYNOTE | Peer M. Schatz, M.B.A. CEO, Qiagen Participants in this panel discussion will 4 CONFERENCE PROGRAM | PROGRAM bring the personalized medicine community the evidence they consider appropriate for closer to an accepted definition of value by coverage and payment. identifying common elements in multiple stakeholders’ understanding of the concept. MODERATOR | Amy M. Miller, Ph.D., Executive Vice President, Personalized Medicine Coalition MODERATOR | Susan Dentzer, President Kristine Bordenave, M.D., Lead Medical and CEO, Network for Excellence in Director, Humana Health Innovation Matthew Fontana, M.D., Vice President and Peter B. Bach, M.D., M.A.P.P., Director, Center Chief Medical Officer, Pharmacy, Health Care for Health Policy and Outcomes, Memorial Service Corporation Sloan Kettering Cancer Center Elaine Jeter, M.D., MolDx Medical Director, Donna Cryer, J.D., President and CEO, Global Palmetto GBA Liver Institute Lori Reilly, J.D., Executive Vice President, 9:45 am Networking Break Policy & Research, PhRMA 10:15 am HBS Case Presentation Michael Sherman, M.D., M.B.A., M.S., Senior The CRISPR-Cas9 technology has the potential Vice President, Chief Medical Officer, Harvard to deliver precision medicine in its most basic Pilgrim HealthCare form by allowing precise gene editing. The technique could possibly be used to cure many 5:30 pm Elements Café Cocktail Reception of the most intractable of diseases and has enormous scientific and commercial potential. Currently, the intellectual property rights to Day 3 • November 17, 2016 the CRISPR-Cas9 technology are the subject of a patent dispute between the Broad Institute 7:00 am Registration and Continental Breakfast
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