PREPARING FOR
THE NEW POSSIBLE

November 14 – 15, 2018 • Harvard Medical School, Boston, MA

Schedule

Part I

The Infrastructure for Innovation

We need to make the transition to a predict, prevent and protect health system.

Joshua Ofman, M.D., M.S.H.S.
Senior Vice President, Global Value, Access and Policy, Amgen

*** Speakers will be added to the schedule on a rolling basis as they are confirmed. ***

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

8:10 a.m.
Setting the Stage: Exploring the Promise of Personalized Medicine — A Keynote Address

SPEAKER | Elizabeth Nabel, M.D., President, Brigham and Women’s Hospital

8:55 a.m.
Shifting Systems: Identifying the Common Challenges and Notable Achievements of Government Efforts to Advance Personalized Medicine

Government executives have an enormous influence over the direction of health systems and can therefore play a role in developing personalized medicine — but they need to know what works and what doesn’t if their respective efforts to promote personalized medicine are going to succeed. With that in mind, government representatives from around the globe will discuss the competitive advantages various countries have in personalized medicine and explore the common challenges and notable achievements of government initiatives to advance the field during this panel discussion.

MODERATOR | Antonio L. Andreu, M.D., Ph.D., Scientific Director, EATRIS European Infrastructure for Translational Medicine

Ora Dar, Ph.D., Senior Expert, National Research & Development Projects, Technological Infrastructure Division, Israel Innovation Authority

Tom Fowler, Ph.D., Deputy Chief Scientist, Genomics England

Marc LePage, President, CEO, Genome Canada

Liisa-Maria Voipio-Pulkki, M.D., Ph.D., Director General, Chief Medical Officer, Ministry of Social Affairs and Health, Finland

10:10 a.m.
Networking Break

Light refreshments provided.

10:40 a.m.
Evaluating Patients’ Priorities: Understanding Perspectives on Personalized Medicine — A Fireside Chat

MODERATOR | Susan McClure, Founder, Publisher, Genome magazine; Board Member, Personalized Medicine Coalition

Emily Kramer-Golinkoff, Co-Founder, Emily’s Entourage, cystic fibrosis patient

Bryce Olson, Global Marketing Director, Health and Life Sciences Group, Intel Corporation; stage IV prostate cancer patient

11:10 a.m.
Automating Actionable: How Artificial Intelligence May Chart a Course for Personalized Medicine

Artificial intelligence may help inform personalized medicine in the future by perceiving which genes, proteins and other biological characteristics contribute to human disease. During this session, a diverse panel will discuss how artificial intelligence may accelerate drug development, improve clinical decision support and drive patient outcomes — and what that might mean for the future of health care.

MODERATOR | William S. Dalton, Ph.D., M.D., Founder, Executive Chairman, M2Gen; Board Member, Personalized Medicine Coalition

Colin Hill, Chairman, CEO, Co-Founder, GNS Healthcare

Tom Miller, Managing Partner, GreyBird Ventures LLC

Gregg Talbert, Ph.D., Global Head of Digital and Personalized Health Care Partnering, Roche

Darrell M. West, Ph.D., Vice President of Governance Studies and Director of Center for Technology Innovation, Douglas Dillon Chair in Governance Studies, The Brookings Institution

12:25 p.m.
Seated Luncheon
1:40 p.m.
The Lay of the Lab: Exploring the State of the Clinical Laboratory Testing Industry— A Keynote Address

SPEAKER | David King, J.D., Chairman, CEO, LabCorp

2:25 p.m.
The Diagnostics Discussion: Evaluating the Extent to Which the Regulatory and Reimbursement Environment for Diagnostic Tests May Help or Hinder Personalized Medicine

The U.S. Food and Drug Administration and the U.S. Centers for Medicare and Medicaid Services have been working for over a decade to develop regulatory and reimbursement pathways that promote the development of innovative diagnostic tests. Many observers, however, believe the current regulatory and reimbursement landscape still limits the field. This panel of business leaders will discuss the extent to which the existing frameworks and proposed policies may help or hinder personalized medicine.

MODERATOR | Joseph V. Ferrara, CEO, Boston Healthcare Associates

Michael Doherty, Senior Vice President, Head of Product Development, Head of Research & Development, Foundation Medicine

Julie Khani, President, American Clinical Laboratory Association

Kimberly Popovits, Chairman of the Board, CEO, President, Genomic Health

Mark P. Stevenson, Executive Vice President, Chief Operating Officer, Thermo Fisher Scientific

3:25 p.m.
Networking Break

Light refreshments provided.

Sponsored By

3:55 p.m.
Examining Policies: Exploring How Emerging U.S. Regulatory Approaches May Help Facilitate Personalized Care Regimens

The U.S. Food and Drug Administration (FDA) remains firmly committed to regulatory strategies designed to advance personalized medicine. During this wide-ranging fireside chat, two senior leaders from government and industry will discuss the agency’s latest actions impacting the oversight of personalized medicine products and services. The discussion will cover topics including but not limited to next-generation sequencing, diagnostic test regulation, digital health, and real-world evidence.

MODERATOR | Cynthia A. Bens, Senior Vice President, Public Policy, Personalized Medicine Coalition

Jesse Berlin, Sc.D., Vice President and Global Head of Epidemiology, Johnson and Johnson

Lauren Silvis, J.D., Chief of Staff, Immediate Office of the Commissioner, FDA

4:55 p.m.
Engaging Everyone: Leveraging Diversity and Facilitating Equitable Access to Personalized Care

Advancing a medical paradigm that focuses on the unique characteristics of each patient will require, by definition, that patients from diverse backgrounds participate in the medical studies that advance our understanding of disease. Also critical is the need to ensure that those patients have access to personalized care informed by those studies. During this session, three panelists will discuss the effort to ensure that all patient populations benefit equally from personalized medicine.

MODERATOR | Donna R. Cryer, J.D., President, CEO, Global Liver Institute

Vence L. Bonham, Jr., J.D., Senior Advisor, Director on Genomics and Health Disparities, U.S. National Human Genome Research Institute

Alex J. Carlisle, Ph.D., Chairman, CEO, National Alliance Against Disparities in Patient Health

Adolph P. Falcón, Executive Vice President, National Alliance for Hispanic Health

Edward Tepporn, Executive Vice President, Asian & Pacific Islander American Health Forum

5:55 p.m.
Closing Remarks

SPEAKER | Amy Abernethy, M.D., Ph.D., Chief Medical Officer, Chief Scientific Officer, Senior Vice President, Oncology, Flatiron Health

6:10 p.m.
Departure for the Museum of Fine Arts, Boston
6:30 p.m.
Welcome Reception at the Museum of Fine Arts, Boston

Avenue of the Arts
465 Huntington Avenue
Boston, MA 02115

Sponsored by

Welcome Reception

At the Boston Museum of Fine Arts

November 14, 2018 – 6:15 p.m.
465 Huntington Ave., Boston, MA 02115

We will convene for cocktails and hors d’oeuvres at the Boston Museum of Fine Arts immediately after the first day of conference programming. The museum is in walking distance from the Conference Center.

Sponsored by

6:05 p.m.
Sponsored by

 

Part II

The Business of Personalization

The successful implementation of [personalized medicine] will depend on the embrace of [its] principles in the business community.

Raju Kucherlapati, Ph.D.
Paul C. Cabot Professor of Genetics, Harvard Medical School

*** Speakers will be added to the schedule on a rolling basis as they are confirmed. ***

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 | Stephen L. Eck, M.D., Ph.D., Chief Medical Officer, Immatics U.S. Inc; Board Chair, Personalized Medicine Coalition

8:10 a.m.
Pioneering Precision: Inside the Pharmaceutical Industry’s Push Toward Personalized Medicine — A Fireside Chat

MODERATOR | Meg Tirrell, Reporter, CNBC

Daniel O’Day, CEO, Roche Pharmaceuticals

8:55 a.m.
Considering Costs: Evaluating Emerging Pharmaceutical and Insurance Industry Business Models in Personalized Medicine

The pharmaceutical industry is deeply invested in commercializing personalized therapies that must recoup fixed development costs from smaller patient populations covered by health insurance companies that are increasingly concerned about rising health care costs. In that context, this diverse panel will explore the viability of the business model for developing and paying for personalized medicines, tackling issues related to costs, prices, and access.

MODERATOR | Meg Tirrell, Reporter, CNBC

Nick Leschly, CEO, Bluebird Bio

Joshua J. Ofman, M.D., Senior Vice President, Global Value, Access and Policy, Amgen

Michael Sherman, M.D., Chief Medical Officer, Senior Vice President, Harvard Pilgrim Health Care

Sean Tunis, M.D., Founder, CEO, Center for Medical Technology Policy

9:55 a.m.
Networking Break

Light refreshments provided.

Sponsored By

10:25 a.m.
Reinventing Research: Are Adaptive Platform Trials the Model of the Future? (A Harvard Business School Case Study)

Recognizing that traditional randomized controlled clinical trials can only study the safety and efficacy of a single therapy in one large population of patients, researchers in personalized medicine increasingly hope that “adaptive platform trials,” which employ advanced statistical techniques to simultaneously test the effectiveness of several personalized treatments in multiple sub-populations of patients, may be the key to new drug approvals in the future. Adaptive platform trials may make drug development more efficient by revealing which of several drug candidates are most promising for which patients, but maximizing the potential of these trials requires unprecedented collaboration among the institutions conducting and sponsoring research on various personalized treatments — and no obvious business models have emerged.

During this interactive case study discussion, professors from Harvard Business School will help us examine how researchers at the Dana-Farber Cancer Institute considered and addressed myriad challenges in their effort to design and operationalize an adaptive platform trial for glioblastoma patients, a deadly disease state for which there are few existing treatment options.

PRESENTED BY

Richard Hamermesh, D.B.A., Co-Faculty Chair, Harvard Business School Kraft Precision Medicine Accelerator; and

Ariel D. Stern, Ph.D., Assistant Professor, Technology and Operations Management Unit, Harvard Business School

11:40 a.m.
The 14th Annual Leadership in Personalized Medicine Award

INTRODUCTION | Steven D. Averbuch, M.D., Vice President, Head of Precision Medicine, Bristol-Myers Squibb

AWARDEE | Ellen V. Sigal, Ph.D., Chairperson, Founder, Friends of Cancer Research

12:10 p.m.
Bag Lunch
1:10 p.m.
Predicting and Preventing: Evaluating Progress Toward Personalized Medicine

The original architects of the personalized medicine paradigm envisioned an era in which clinicians could predict, prevent and treat disease based on an improved understanding of how human biology interacts with external environments. During this session, a panel of experts will examine our progress on each of these fronts during a wide-ranging conversation about personalized medicine’s past, present and future.

MODERATOR | Cynthia Casson Morton, Ph.D., William Lambert Richardson Professor of Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School

Sean George, Ph.D., CEO, Invitae

Luba Greenwood, J.D., Strategic Business Development and Corporate Ventures, Verily (an Alphabet company)

Keith Stewart, M.B., CH.B., Carlson and Nelson Endowed Director, Center for Individualized Medicine, Mayo Clinic

2:10 p.m.
Assessing the Assays: Determining the Clinical and Economic Utility of Genomic Sequencing

Advocates for personalized medicine have contended that genomic sequencing can deliver clinical and economic value to patients and the health system by allowing providers to more efficiently diagnose disease and develop treatment plans. Following increased use of genomic sequencing in clinical settings, many stakeholders, including payers, have begun to examine that value proposition more closely. During this session, a pharmaceutical industry representative, a payer, and a health economist will discuss the status and future of the emerging evidence regarding the clinical and economic utility of genomic sequencing, including studies recently commissioned by the Personalized Medicine Coalition.

MODERATOR | Daryl Pritchard, Ph.D., Senior Vice President, Science Policy, Personalized Medicine Coalition

Aris Baras, M.D., Vice President, Head, Regeneron Genetics Center, ‎Regeneron Pharmaceuticals

Kristine Bordenave, M.D., F.A.C.P., Corporate Medical Director, Humana

Scott Ramsey, M.D., Ph.D., Full Member, Fred Hutchinson Cancer Research Center; Director, Hutchinson Institute for Cancer Outcomes Research

3:10 p.m.
Networking Break

Light refreshments provided.

3:40 p.m.
Impasse or Inflection Point? — An Investment Analysis

Sustaining the pace of innovation in personalized medicine will require continued investment in new initiatives, but the financial outlook for the field remains unclear. In that context, this panel of investors will examine whether personalized medicine is at an impasse, an inflection point or somewhere in between.

MODERATOR | William A. Sahlman, Ph.D., Baker Foundation Professor, Harvard Business School

Gregory Dorn, M.D., President, Hearst Health

Cary Pfeffer, M.D., Partner, Third Rock Ventures

Michael Pellini, M.D., Managing Partner, Section 32; Chairman, Foundation Medicine; Board Member, Personalized Medicine Coalition

4:40 p.m.
Closing Remarks

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