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Download Program CONFERENCE PROGRAM From Concept to the Clinic November 14–16, 2017 JOSEPH B. MARTIN CONFERENCE CENTER • HARVARD MEDICAL SCHOOL 77 AVENUE LOUIS PASTEUR, BOSTON, MA 02115 CONFERENCE PROGRAM | PRESIDENT’S MESSAGE President’s Message Dear Colleague: “The standard of care is just not good enough,” Michael Pellini, M.D., M.B.A., Chairman, Board of Directors, Foundation Medicine, told the audience at the 12th Annual Personalized Medicine Conference. It is time, Pellini said, to think about the space differently. Guided by that premise, the 13th Annual Personalized Medicine Conference will facilitate dialogue focused on translating the concept of personalized medicine into improved clinical care. Participants will engage with thought leaders and health professionals from the front lines to explore, among other subjects, how an under-studied value proposition, information technology challenges, and practical obstacles at the point of care complicate efforts to bring personalized medicine to patients — and how emerging partnership models, economic utility studies and real-world evidence may help to eliminate these impediments. The agenda includes: ¢ An exploration of the implications of CRISPR-Cas9 and gene therapy for medicine and humanity ¢ A fireside chat with a pharmaceutical industry representative on the pricing of personalized medicines ¢ A discussion of case studies on the economic value of personalized medicine ¢ Detailed clinical insights from patients, providers, and payers Thank you for joining us as we chart a course for the future of personalized medicine — from concept to the clinic. Sincerely yours, Edward Abrahams, Ph.D. President Personalized Medicine Coalition 1 SUPPORTERS | CONFERENCE PROGRAM Thank You to Our Supporters DIAMOND PLATINUM GOLD SILVER BRONZE CONTRIBUTOR MEDIA PARTNERS 2 RECEPTION November 14, 2017 The 13th Annual Personalized Medicine Conference will begin with informal discussions on the field and its future during a welcome reception at the Hotel Commonwealth at 5:30 p.m. ET on November 14. HOTEL COMMONWEALTH • 500 COMMONWEALTH AVE., BOSTON, MA 02215 3 4 PART I November 15, 2017 “It’s not really ‘should we do this.’ We have to do this. We don’t get to decide what the biology of these diseases are, we just have to work with it.” — Barbara Weber, M.D., Venture Partner, Third Rock Ventures JOSEPH B. MARTIN CONFERENCE CENTER • HARVARD MEDICAL SCHOOL, BOSTON, MA 02115 5 AGENDA | CONFERENCE PROGRAM · NOVEMBER 15, 2017 Agenda · Part I 7:00 am Registration and Breakfast Discussion Part 1 Joseph B. Martin Conference Center 9:35 am A Model for Risk-Sharing Agreements Harvard Medical School Between Payers and the Pharmaceutical 77 Avenue Louis Pasteur Industry Boston, MA 02115 Many payers are reluctant to assume that 8:00 am Opening Remarks covering personalized medicines will help mitigate costs associated with major medical SPEAKER | Edward Abrahams, Ph.D., President, events that require hospitalization. During Personalized Medicine Coalition this fireside chat, however, representatives 8:10 am The State of Personalized Medicine from Amgen and Harvard Pilgrim Health Care will discuss the logic and implications of their INTRODUCTION | , M.D., Steven D. Averbuch groundbreaking agreement to share the Head, Precision Medicine Research & financial risks of covering a targeted medicine Development, Bristol-Myers Squibb; Board based on that premise. Under the terms of the Member, Personalized Medicine Coalition agreement, Amgen agreed to cover treatment KEYNOTE | Thomas J. Lynch, Jr., M.D., costs for patients who have a heart attack or Executive Vice President, Chief Scientific stroke while taking its personalized therapy for Officer, Research & Development, familial hypercholesterolemia. Bristol-Myers Squibb MODERATOR | Meg Tirrell, M.S.J., Reporter, CNBC 8:40 am 13th Annual Leadership in Personalized Medicine Award Joshua Ofman, M.D., M.S.H.S., Senior Vice President, Global Value, Access and AWARDEE | Jay T. Flatley, M.S., Executive Chairman, Illumina Policy, Amgen Michael Sherman, M.D., M.B.A., M.S., 9:10 am Networking Break Chief Medical Officer, Senior Vice President, Harvard Pilgrim Health Care; Board Member, 9:35 am Progress in Partnerships: Personalized Medicine Coalition A Two-Part Discussion Aligning the constructs of the health system Discussion Part 2 with the principles of personalized medicine will 10:05 am Models for the Development of Personalized require stakeholders to scale the most promis- Medicine Diagnostics ing cross-sector partnership models. This series Pharmaceutical and diagnostics companies of conversations will examine the potential of have responded to a host of complex scientific, several of the most promising models that have regulatory and reimbursement challenges partly emerged thus far. by developing innovative partnership mod- els around companion diagnostics. This panel discussion will feature representatives from the pharmaceutical and diagnostics industries, who will discuss the challenges partnerships have helped industry overcome as well as the obsta- cles that continue to inhibit the development of the diagnostic tools upon which personalized medicine depends. 6 NOVEMBER 15, 2017 · CONFERENCE PROGRAM | AGENDA MODERATOR | Alexander Vadas, Ph.D., specific implications of these developments Managing Director, L.E.K. Consulting for health systems around the world remain unclear. During this session, a panel of experts Nicholas C. Dracopoli, Ph.D., Vice President, will discuss the status of these new technol- Head, Oncology Diagnostics, Janssen ogies and how the medical community and Research & Development LLC, Pharmaceutical regulatory agencies may have to adapt to keep Companies of Johnson & Johnson up with forthcoming developments. Joydeep Goswami, Ph.D., M.B.A., M.S., MODERATOR | Kevin Davies, Ph.D., Co-Author, President, Clinical Next-Generation Sequencing, DNA: The Story of the Genetic Revolution (with Oncology, Thermo Fisher Scientific Jim Watson and Andrew Berry); Executive Jacob S. Van Naarden, Chief Business Officer, Editor, The CRISPR Journal Loxo Oncology Katrine Bosley, CEO, Editas Medicine 10:35 am Real-World Personalized Medicine: Arthur L. Caplan, Ph.D., Drs. William F. and Examining the Role of Real-World Evidence Virginia Connolly Mitty Chair, Director, Division in Personalizing Health Care of Medical Ethics, New York University Langone FDA has offered a definition of real-world Medical Center evidence, but the community continues to George M. Church, Ph.D., Professor of debate what is needed to fully integrate it into Genetics, Health Sciences and Technology, decision-making. This panel will explore what Harvard-MIT Division of Health Sciences real-world evidence is, how it is being used and Technology; Director, Harvard Medical and what regulatory requirements are needed School NHGRI-Center of Excellence in to realize its potential. Genomic Science; Director, Harvard Medical MODERATOR | Amy Abernethy, M.D., Ph.D., School Personal Genome Project; Founding Chief Medical Officer, Chief Scientific Officer, Member, Wyss Institute for Biologically Inspired Flatiron Health; Board Member, Personalized Engineering at Harvard University Medicine Coalition Jeffrey D. Marrazzo, M.B.A., M.P.A., Sean Khozin, M.D., M.P.H., Associate Director CEO, Spark Therapeutics (Acting), Oncology Center of Excellence, FDA 2:15 pm Pricing Personalized Medicines Eric G. Klein, Pharm.D., Senior Director, The increasing pressure on industry stakeholders Oncology, Global Patient Outcomes and to alter their drug pricing practices has particular Real-World Evidence, Eli Lilly and Company significance for personalized medicines, which Eleanor M. Perfetto, Ph.D., M.S., Senior Vice must recoup research and development costs President, Strategic Initiatives, National from smaller patient populations. This conversa- Health Council tion will explore the pharmaceutical industry’s Deborah Schrag, M.D., M.P.H., Chief, Division strategies for facilitating sustainable access to of Population Sciences, Medical Oncology, these innovative therapies. Dana-Farber Cancer Institute MODERATOR | Meg Tirrell, M.S.J., Reporter, CNBC 11:50 am Luncheon Stephen J. Ubl, President, CEO, PhRMA 1:00 pm The Designer Genome: Exploring the Implications of Gene Editing and Gene Therapy 2:45 pm Networking Break for the Future of Medicine and Humanity (sponsored by GreyBird Ventures) Many scientists believe the clustered regu- larly inter spaced short palindromic repeats (CRISPR) genetic engineering tool and recent developments in gene therapy will dramati- cally alter the trajectory of medicine, but the 7 AGENDA | CONFERENCE PROGRAM · NOVEMBER 15, 2017 3:15 pm Precision Valuation: A Discussion of How 4:30 pm The Utility Proposition: An Analysis of Value Assessment Frameworks Can Account Case Studies in the Economic Value for Personalized Medicine of Personalized Medicine Payers control access to personalized medicine, Although personalized medicine’s proponents and some have begun to take an interest in contend that the field can deliver economic findings from value assessment frameworks that value by helping doctors avoid prescribing are challenged to account for developments in costly but ineffective therapies, the field lacks the field. In addition to exploring their potential literature testing that hypothesis. This session impact on individualized care, this session will will highlight recent studies on the clinical examine how value assessment frameworks can and economic value of personalized medicine, and should
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