Annual Conference

"From Concept to the Clinic"



"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.
Interim Chief Medical Officer
Neon Therapeutics

November 15


During the first day of formal discussions, the personalized medicine community will analyze how the most significant trends in health care may affect the field — and vice versa. Participants will examine, among other topics, the significance of the emerging conversation on pharmaceutical pricing, the implications of CRISPR-Cas9 and gene editing technologies to the future of medicine and humanity, and the importance of ensuring that value assessment frameworks have mechanisms in place to account for the value of targeting therapies to only those patients who will benefit.


7:00 a.m. — Registration and Continental Breakfast

Joseph B. Martin Conference Center at Harvard Medical School, 77 Avenue Louis Pasteur, Boston, MA 02115


8:00 a.m. — Opening Remarks

SPEAKER | Edward Abrahams, Ph.D., President, Personalized Medicine Coalition


8:15 a.m. — The State of Personalized Medicine

INTRODUCTION | Steven D. Averbuch, M.D., Head, Precision Medicine, R & D
KEYNOTE | Thomas J. Lynch, Jr., M.D., Executive Vice President, Chief Scientific Officer, R & D, Bristol-Myers Squibb


8:45 a.m. — 13th Annual Leadership in Personalized Medicine Award Presentation

PRESENTER | Kimberly Popovits, Chairman of the Board, CEO, President, Genomic Health
AWARDEE
| Jay T. Flatley, Executive Chairman, Illumina


9:15 a.m. — Networking Break

Light refreshments provided


9:45 a.m. — Progress in Partnerships: A Two-Part Discussion


Aligning the constructs of the health system with the principles of personalized medicine will require stakeholders to scale the most promising cross-sector partnership models. This series of fireside chats will examine the potential of two such models.

9:45 A.M. | A Model for Risk-Sharing Agreements Between Payers and the Pharmaceutical Industry

Many payers are reluctant to assume that covering personalized medicines will help mitigate costs associated with catastrophic medical events that require hospitalization. During this fireside chat, representatives from Amgen and Harvard Pilgrim Health Care will discuss the logic and implications of their groundbreaking agreement to share the financial risks of covering a targeted medicine based on that premise. Under the terms of the agreement, Amgen agreed to cover treatment costs for patients who have a heart attack or stroke while taking its personalized therapy for familial hypercholesterolemia.

A FIRESIDE CHAT FEATURING

  • MODERATOR | Meg Tirrell, M.S.J., Reporter, CNBC
  • Joshua Ofman, M.D., M.S.H.S., Senior Vice President, Global Value, Access & Policy, Amgen Inc.
  • Michael Sherman, M.D., M.B.A., M.S., Senior Vice President, Chief Medical Officer, Harvard Pilgrim Health Care

10:15 A.M. | A Model for Universal Companion Diagnostic Agreements Between Diagnostic Companies and the Pharmaceutical Industry

The advent of next-generation sequencing has the potential to revolutionize health care by unlocking an era in which doctors can use a single test to assess which of several treatment regimens is most appropriate for a given patient. During this fireside chat, representatives from Novartis, Pfizer and Thermo Fisher Scientific will discuss their pioneering work in developing the first of these "universal companion diagnostics" to receive FDA approval — an effort that reinvented the traditional "one drug, one test" model.

A FIRESIDE CHAT FEATURING

  • MODERATOR | Alexander Vadas, Ph.D., Managing Director, L.E.K. Consulting
  • Hakan Sakul, Ph.D., Vice President, Head of Diagnostics, Genome Sciences & Technologies, Worldwide R & D, Pfizer
  • Anne-Marie Martin, Ph.D., Senior Vice President, Global Head of Precision Medicine, Novartis (invited)
  • Joydeep Goswami, Ph.D., President, Clinical Next-Generation Sequencing, Oncology, Thermo Fisher Scientific

10:45 a.m. — Real-World Personalized Medicine: Examining the Role of Real-World Evidence in Personalizing Health Care


FDA has offered a definition of real-world evidence, but the community continues to debate what is needed to fully integrate it into decision-making. This session will explore what real-world evidence is, how it is being used and what regulatory requirements are needed to realize its potential.

  • MODERATOR | Amy Abernethy, M.D., Ph.D., Chief Medical Officer, Senior Vice President, Oncology, Flatiron Health
  • Sean Khozin, M.D., M.P.H., Associate Director (Acting); Oncology Center of Excellence, FDA
  • Eric G. Klein, Pharm.D., Senior Director, Oncology, Global Patient Outcomes and Real World Evidence, Eli Lilly and Company
  • Maria Koehler, M.D., Ph.D., Vice President, Oncology Strategy, Innovation and Collaborations, Pfizer Oncology
  • Deborah Schrag, M.D., M.P.H., Chief, Division of Population Sciences, Medical Oncology, Dana-Farber Cancer Institute

12:00 p.m. — Lunch Break

A seated luncheon


1:00 p.m. — The Designer Genome: Exploring the Implications of Gene Editing and Gene Therapy for the Future of Medicine and Humanity


Many scientists believe the regularly interspaced short palindromic repeats (CRISPR-Cas9) genetic engineering tool and recent developments in gene therapy will dramatically alter the trajectory of medicine, but the implications of these developments for health systems around the world remain unclear. During this session, a panel of experts will discuss the status of these new technologies — and how the medical community and regulatory agencies may have to adapt to keep up with forthcoming developments.

  • MODERATOR | Kevin Davies, Ph.D., author, The $1,000 Genome
  • Katrine Bosley, CEO, Editas
  • Arthur L. Caplan, Ph.D., Drs. William F. and Virginia Connolly Mitty Chair; Director, Division of Medical Ethics, New York University Langone Medical Center
  • George Church, Ph.D., Professor of Genetics, Health Sciences, Technology, Harvard and MIT; Director of HMS NHGRI-Center of Excellence in Genomic Science; Director of the Personal Genome Project, Broad Institute & Wyss Harvard Institute of Biologically Inspired Engineering Harvard Medical School

2:15 p.m. — Pricing Personalized Medicines


The increasing pressure on industry stakeholders to alter their drug pricing practices has particular significance for personalized medicines, which must recoup research and development costs from smaller patient populations. This conversation will explore the pharmaceutical industry's strategies for facilitating patient access to these therapies.

A FIRESIDE CHAT FEATURING

  • MODERATOR | Meg Tirrell, M.S.J., Reporter, CNBC
  • Stephen J. Ubl, President, CEO, PhRMA

2:45 p.m. — Networking Break

Light refreshments provided


3:15 p.m. — Precision Valuation: A Discussion of How Value Assessment Frameworks Can Account for Personalized Medicine


Payers control access to personalized medicine, and some have begun to take an interest in findings from value assessment frameworks that are challenged to account for scientific developments in the field. In addition to exploring their potential impact on individualized care, this session will examine how value assessment frameworks can and should consider personalized medicine as part of their processes for evaluating therapeutic options.

  • MODERATOR | Jennifer Snow, M.P.H, Director, Health Policy, Xcenda
  • Dane J. Dickson, M.D., CEO, Cure-One (formerly MED-C); Director, Precision Medicine Policy and Registries, Knight Cancer Center at OHSU
  • Robert Dubois, M.D., Ph.D., Chief Science Officer, Executive Vice President, National Pharmaceutical Council
  • Steven Pearson, M.D., M.Sc., Founder and President, Institute for Clinical and Economic Review (ICER)
  • Andrea Ferris, M.B.A., President, Chairman of the Board, LUNGevity Foundation

4:30 p.m. — The Utility Proposition: An Analysis of Case Studies in the Economic Value of Personalized Medicine


Although personalized medicine’s proponents contend that the field can deliver economic value by helping doctors avoid prescribing costly but ineffective therapies, the field lacks literature testing that hypothesis. This session will highlight recent studies on the clinical and economic value of personalized medicine, shedding light on what we know about personalized medicine’s clinical and economic utility — and what we don’t.

  • MODERATOR | Invitation pending
  • Lincoln Nadauld, M.D., Ph.D., Executive Director, Precision Medicine and Precision Genomics, Intermountain Healthcare
  • Scott Ramsey, M.D., Ph.D., Director, Fred Hutchinson Institute for Cancer Outcomes Research
  • David Roth, M.D., Ph.D., Director, Penn Center for Precision Medicine

5:45 p.m. — Elements Café Cocktail Reception