The Paradigm Evolves

November 13 – 14, 2019 • Harvard Medical School, Boston, MA

Schedule

PART I

Diagnosing, Different

8:00 a.m.
Registration and Continental Breakfast

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

8:55 a.m.
Opening Remarks

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

9:00 a.m.
Opening Keynote Speaker

During this opening keynote address, a prominent leader whose work will help determine the pace of progress in personalized medicine will preview the conference agenda by sharing his/her perspective on the field’s evolving opportunities and challenges.

SPEAKER | Gianrico Farrugia, M.D., CEO, President, Mayo Clinic (invited)

9:30 a.m.
Transformative Technologies: Previewing the Value Proposition and Outlook for Disruptive Tools Designed to Enable Personalized Medicine

Emerging personalized medicine technologies may help facilitate earlier interventions that eliminate the need for expensive treatment of advanced diseases that have devastating consequences for patients. They can also help target treatments to only those patients who will benefit. But the success of these technologies depends on whether they can be integrated into a health system that has historically focused on treating diseases after symptoms have intensified, usually based on the assumption that every patient taking a given medication will respond to the treatment in a similar way.

During this session, Section 32 Managing Partner Michael J. Pellini, M.D., M.B.A., will moderate a discussion between industry representatives and a payer about the value proposition and outlook for disruptive technologies that are designed to support more informed disease prevention and treatment plans. The conversation will focus on how developments in areas including but not limited to artificial intelligence, data analytics, genomic sequencing, liquid biopsies, and proteomics may impact the prevention, diagnosis, and treatment of diseases including cancer, cardiovascular diseases, and diabetes.

MODERATOR | Michael J. Pellini, M.D., Managing Partner, Section 32

Helmy Eltoukhy, Ph.D., CEO, Guardant Health (invited)

Nancy Mendelsohn, M.D., Chief Medical Officer, Special Needs Initiative, UnitedHealth Group

Eric Schadt, Ph.D., CEO, Sema4 (invited)

Roy Smythe, M.D., CEO, SomaLogic

10:30 a.m.
Networking Break
11:15 a.m.
Developing Diagnostics — Opportunities and Challenges in Personalized Medicine: A Two-Part Discussion

Diagnostic test developers are working to make personalized medicine possible by giving physicians tools that help them select the optimal treatment for every patient. Doing so requires that they navigate a complex business and policy landscape while being mindful of the day-to-day needs of payers and health care providers.

In this context, Mark P. Stevenson, Executive Vice President, Chief Operating Officer, Thermo Fisher Scientific, will take 10 minutes to introduce this two-part discussion titled “Developing Diagnostics — Opportunities and Challenges in Personalized Medicine.”

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

Discussion Part 1
Developing Diagnostics — From Concept to the Clinic: Perspectives on the Landscape for Developing and Integrating Personalized Medicine Diagnostics into Health Systems

To kick off the “Developing Diagnostics” discussion, Moffitt Cancer Center’s DeBartolo Family Personalized Medicine Institute Medical Director Howard McLeod, Pharm.D., will moderate a conversation among leaders from the clinical, diagnostics, IT, and pharmaceutical communities about the landscape for developing and integrating personalized medicine diagnostics into health systems.
» Read Backgrounder

MODERATOR | Howard McLeod, Pharm.D., Medical Director, DeBartolo Family Personalized Medicine Institute at Moffitt Cancer Center

Kris Joshi, Ph.D., Executive Vice President, President, Network Solutions, Change Healthcare

Peter Maag, Ph.D., CEO, CareDx

Hakan Sakul, Ph.D., Vice President, Head of Diagnostics, Worldwide R & D and Medical, Pfizer

Kenna R. Mills Shaw, Ph.D., Executive Director, MD Anderson Institute for Personalized Cancer Therapy

Discussion Part 2
Developing Diagnostics — The Role of Research: A Closer Look at Efforts to Encourage the Clinical Adoption of Personalized Medicine Diagnostics by Studying the Clinical and Economic Utility of Genomic Sequencing

During the second portion of the “Developing Diagnostics” session, a health care provider, a health economist, an industry leader, and a payer representative will join moderator and Personalized Medicine Coalition Senior Vice President for Science Policy Daryl Pritchard, Ph.D., to examine the impact of emerging research on the clinical and economic utility of genomic sequencing for patients with diseases including but not limited to cancer and suspected rare diseases.

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

Roy J. Gandolfi, M.D., Medical Director, SelectHealth (invited)

Lincoln Nadauld, M.D., Ph.D., Chief, Precision Health, Intermountain Healthcare

Peter J. Neumann, Sc.D., Director, Center for the Evaluation of Value and Risk in Health at the Institute for Clinical Research and Health Policy Studies, Tufts Medical Center (invited)

Ammar Qadan, Vice President, Global Head of Market Access, Illumina

12:55 p.m.
Seated Luncheon
2:00 p.m.
Rethinking Regulation: Understanding How FDA is Reshaping Regulatory Policies for Diagnostics and Drugs in the Era of Personalized Medicine — A Fireside Chat

Recognizing that diagnostic test developers are increasingly advancing novel personalized medicine tests that may prompt immediate changes to health care plans and that drugmakers are increasingly developing longer lasting, highly personalized treatments, the U.S. Food and Drug Administration is crafting new regulatory policies suitable for evaluating tests and therapies in the era of personalized medicine.

During this wide-ranging fireside chat, Personalized Medicine Coalition Senior Vice President for Public Policy Cynthia A. Bens will discuss FDA’s evolving approach to regulation with officials from its centers for Devices and Radiological Health and Drug Evaluation and Research, touching on issues including but not limited to the paradigm for oversight of laboratory-developed tests as well as the emergence of prevention and treatment strategies made possible by new developments in digital health, direct-to-consumer genetic health testing, gene editing, gene therapies, and next-generation sequencing.

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

Jeffrey E. Shuren, M.D., J.D., Director, Center for Devices and Radiological Health, U.S. Food and Drug Administration (invited)

Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (invited)

2:45 p.m.
The 15th Annual Leadership in Personalized Medicine Award
3:15 p.m.
Networking Break
4:00 p.m.
Wellness in the Workplace: Understanding the Opportunities and Challenges Associated With Employer-Sponsored Genetic Testing Programs for Healthy Patients

Reasoning that genetic testing may encourage healthy lifestyles by providing information about an employee’s relative risk of developing various diseases, employers seeking to improve patients’ lives and mitigate downstream health care costs have begun to sponsor genetic testing for healthy employees by partnering with various genetic testing companies, some of which sell the tests directly to consumers.

This session, moderated by Quest Diagnostics Chief Medical Officer Jay G. Wohlgemuth, M.D., who is responsible for overseeing health care benefits for Quest’s employees, will spotlight two employer-sponsored genetic testing partnerships and explore the relevant issues. The panel discussion will focus on the significance of information generated from genetic testing, the differences between various genetic testing business models, and the privacy risks associated with the collection of genetic data.

MODERATORJay G. Wohlgemuth, M.D., Chief Medical Officer, Senior Vice President, Quest Diagnostics

Jane Cheshire Gilbert, C.P.A., Director, Retiree Health Care, Teachers’ Retirement System of Kentucky

Karen E. Knudsen, Ph.D., Executive Vice President, Oncology Services, Jefferson Health; Enterprise Director, Sidney Kimmel Cancer Center at Thomas Jefferson University

Othman Laraki, CEO, Color Genomics (invited)

Scott Megill, President, CEO, Coriell Life Sciences

5:00 p.m.
Overcoming Opioids: Considering the Potential of Personalized Medicine to Address the Opioid Crisis in the US

Emerging technologies present new opportunities to study the genetic, biological, and environmental factors that drive public health crises, with an eye toward developing personalized medicine health care strategies that can mitigate their devastating consequences.

During this session, Coriell Institute for Medical Research Chief Scientific Officer Alissa M. Resch, Ph.D., will announce the findings from Coriell’s ongoing effort to inform interventions that may help prevent opioid addiction by identifying with more precision which patients are most likely to develop dependency on this class of drugs.

SPEAKER | Alissa M. Resch, Ph.D., Chief Scientific Officer, Coriell Institute for Medical Research

5:15 p.m.
Closing Remarks

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

6:15 p.m.
Welcome Reception at the Isabella Stewart Gardner Museum

Welcome Reception

at the Isabella Stewart Gardner Museum

November 13, 2019 – 6:15 p.m.
25 Evans Way, Boston, MA 02115

We will convene for drinks and hors d’oeuvres at the Isabella Stewart Gardner Museum immediately after the first day of conference programming. The museum is in walking distance from the Conference Center.
25 Evans Way, Boston, MA 02115

We will convene for drinks and hors d’oeuvres at the Isabella Stewart Gardner Museum immediately after the first day of conference programming. The museum is in walking distance from the Conference Center.

Part II

Targeting Treatment

8:00 a.m.
Registration and Continental Breakfast

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

8:55 a.m.
Opening Remarks

SPEAKER | Stephen L. Eck, M.D., Ph.D., Chief Medical Officer, Immatics US

9:00 a.m.
Fireside Chat

During this fireside chat with CNBC Reporter Meg Tirrell, Johnson & Johnson Chief Scientific Officer Paul Stoffels, M.D., will help frame the second half of the conference program by sharing the pharmaceutical industry’s perspective on the emerging issues in health care, touching on topics including costs, prices, and access.

MODERATOR | Meg Tirrell, Reporter, CNBC (invited)

Paul Stoffels, M.D., Vice Chairman, Executive Committee, Chief Scientific Officer, Johnson & Johnson

9:30 a.m.
Prospecting the Pipeline: Exploring the Implications of a Biopharmaceutical Pipeline Dominated by Personalized Treatments

As researchers develop an enhanced understanding of the molecular causes that underpin various diseases, many biopharmaceutical companies have begun to develop therapies that are targeted to patient subgroups and even personalized to individual patients. In oncology, for example, there are reportedly more than 900 personalized “immunotherapy” treatments being tested in the clinic, with more than 1,000 in preclinical development. The challenging scientific questions and systemic implications associated with these new therapies do not always fit neatly into existing regulatory, payment, and care delivery frameworks.

During this session, CNBC Reporter Meg Tirrell will moderate a panel discussion that explores the scientific, regulatory, reimbursement, and other systemic issues associated with future gene editing treatments, gene therapies, immunotherapies, and targeted therapies. The panelists, who include an industry representative, a government payer, a researcher, and an academic leader, will also consider a new approach to immunotherapy for cancer patients in which a unique product is developed for every patient treated.

MODERATOR | Meg Tirrell, Reporter, CNBC (invited)

George Poste, Ph.D., D.Sc., Director, Complex Adaptive Systems, Arizona State University

Tamara Syrek Jensen, J.D., Director, Coverage and Analysis Group, U.S. Centers for Medicare and Medicaid Services (invited)

Harpreet Singh, Ph.D., President, CEO, Immatics US

Alex Vadas, Ph.D., Managing Director, Partner, LEK Consulting

10:30 a.m.
Networking Break
11:00 a.m.
Harvard Business School Case Study: Dementia Discovery Fund

This interactive case study discussion will explore how and why a group of government agencies, nonprofit organizations, and pharmaceutical companies came together to support the Dementia Discovery Fund, focusing on whether a disease-specific venture that seeks to create meaningful new medicines in part by capitalizing on the evolving science underpinning personalized medicine can successfully balance social and business objectives.

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

12:00 p.m.
Bag Lunch
1:00 p.m.
Toward a Shared Value Proposition in Health Care: Pursuing Value-Based Solutions in Research, Regulation, Reimbursement, and Clinical Adoption

To advance the principles of personalized medicine, the field’s proponents will need to align representatives from multiple sectors of the health system on a shared value proposition that recognizes the importance of addressing the shortcomings of one-size-fits-all medicine.

During this session, M2Gen Executive Chairman William S. Dalton, Ph.D., M.D., will convene a commercial payer, an industry representative, a patient, and a value assessment framework developer to explore research, regulatory, clinical adoption, and especially reimbursement solutions that will, in the interest of patients, advance the principles of personalized medicine.

MODERATOR | William S. Dalton, Ph.D., M.D., Executive Chairman, M2Gen

Bonnie J. Addario, Co-Founder, Chair, GO2 Foundation for Lung Cancer

Sarah K. Emond, M.P.P., Executive Vice President, Chief Operating Officer, Institute for Clinical and Economic Review

Anne-Marie Martin, Ph.D., Senior Vice President, Global Head of Precision Medicine, Novartis Pharmaceuticals Corporation

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

2:00 p.m.
Going Global: Learning From Governmental Efforts to Advance Personalized Medicine Around the World

Global leaders are working to accelerate an era of personalized medicine around the world by encouraging innovation, modernizing policies, and reforming health systems to speed the clinical adoption of personalized medicine products and services.

During this panel discussion, four governmental representatives will share their visions for the future of personalized medicine and elaborate on their efforts to accelerate progress in the field.

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

Asmaa Ali J. F. Althani, Ph.D., Dean, College of Health Sciences, Qatar University; Chair, Qatar Genome Program Committee; Board Vice Chairperson, Qatar Biobank

Tore Duvold, Ph.D., Managing Director, Innovation Fund Denmark (invited)

Eric Green, M.D., Ph.D., Director, National Human Genome Research Institute, U.S. National Institutes of Health (invited)

Raquel Yotti, M.D., Ph.D., General Director, Instituto de Salud Carlos III (Spain)

3:00 p.m.
Closing Remarks

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