Personalized Health Project
Personalize Health Project study, 83-pages (Kauffman Foundation)
Authors: David Ewing Duncan; Frank Douglas, MD, PhD; Linda Molnar, PhD; Stephen Spielberg, MD, PhD
Personalized Health Project Summit, UC San Francisco (Videos)
Expert Advisory Panel
Thanks to the expert panel that provided input for this study and reviewed the final draft. The panel of thirty-six life science leaders was chosen to represent a wide range of specialists, stakeholders, critics, and points of view.
Adam Gazzaley, MD, PhD, neurologist and neuroscientist, University of California at San Francisco
Anthony Atala, MD, board member, Regenerative Medicine Foundation; director, Wake Forest Institute for Regenerative Medicine
Arthur Caplan, PhD, bioethicist, University of Pennsylvania
Atul Butte, MD, PhD, geneticist and bioinformaticist, Stanford University Medical School
Brook Byers, MBA, venture capitalist, Kleiner Perkins Caufield & Byers
Christopher Austin, MD, neurologist; director, Chemical Genomics Center, National Institutes of Health
Daniel Kraft, MD, PhD, oncologist; stem cell researcher, Stanford University Medical School
David Agus, MD, oncologist, proteomics researcher, entrepreneur, University of Southern California; co-founder, Navigenics
David Ewing Duncan, journalist and life science policy analyst; director, The Center for Life Science Policy, University of California at Berkeley
Dietrich Stephan, PhD, geneticist; founder and director, Institute for Individualized Health (IGNITE); cofounder, Navigenics; director, The Gene Partnership, Harvard Medical School
Edward Abrahams, PhD, president, Personalized Medicine Coalition
Eric Schadt, PhD, biocomputationist; chief scientific officer, Pacific Biosciences; cofounder, Sage Bionetworks
Eric Topol, MD, cardiologist and translational geneticist; director, Scripps Translational Science Institute
Frank L. Douglas, MD, PhD, president and CEO, Austen BioInnovation Institute in Akron, Ohio; founder and first executive director of the MIT Center for Biomedical Innovation, Massachusetts Institute of Technology; former chief scientific officer, Aventis
Frederick Frank, MBA, life sciences investment banker; vice chairman, Peter J. Solomon Company; former vice chairman, Lehman Brothers
George Church, PhD, molecular biologist, professor of genetics, and director, Center for Computational Genetics, Harvard Medical School
George Poste, PhD, researcher, policy analyst, and former pharmaceutical executive; chief scientist, Complex Adaptive Systems Initiative; professor of Health Innovation, Arizona State University; former president, R&D, SmithKline Beecham
Greg Simon, JD, senior vice president for worldwide policy, Pfizer; former president, Faster Cures; former chief domestic policy advisor to Vice President Al Gore
Gregory Stock, PhD, MBA, founding CEO, Signum Biosciences; founding director, Program on Medicine, Technology and Society, University of California at Los Angeles School of Medicine
Hank Greely, JD, professor of law, Stanford University; director, Center for Law and the Biosciences The Personalized Health Project Page 6
James Heywood, cofounder and chairman, PatientsLikeMe
James Thomson, VMD, PhD, stem cell scientist; director of Regenerative Biology, The Morgridge Institute for Research, University of Wisconsin School of Medicine and Public Health
Joshua Adler, MD, physician, chief medical officer, University of California at San Francisco Medical Center
Lee Hood, MD, PhD, molecular biologist and bioinformaticist; founder and director, Institute for Systems Biology
Linda K. Molnar, PhD, entrepreneur, personalized medicine and nanotechnology expert; founding principal, LKM Strategic Consulting
Margaret Anderson, executive director, FasterCures
Martyn Smith, PhD, professor of toxicology, School of Public Health, Division of Environmental Health Sciences, University of California at Berkeley
Michael Roizen, MD, preventive medicine; director, Wellness Institute, Cleveland Clinic
Misha Angrist, PhD, assistant professor, Duke University Institute for Genome Sciences & Policy
Nathaniel David, PhD, entrepreneur and venture capitalist; venture partner, Arch Venture Partners
Paul Billings, MD, PhD, clinical geneticist; chief medical officer, Life Technologies
Ray Woosley, MD, PhD, president and CEO, Critical Path Institute
Safi Bahcall, PhD, entrepreneur; CEO, Synta Pharmaceuticals Corp.
Stephen Friend, MD, PhD, president, CEO, cofounder, Sage Bionetworks; former senior vice president and franchise head for Oncology Research, Merck
Stephen P. Spielberg, MD, PhD, pediatrician; director, Center for Personalized Medicine and Therapeutic Innovation, Children‘s Mercy Hospital, Kansas City, Mo.; former dean, Dartmouth Medical School
Steve Wiggins, venture capitalist and former health insurance executive; managing director of Essex Woodlands Health Ventures; founder and former CEO, Oxford Health Plans
Zack Lynch, entrepreneur; executive director, Neurotechnology Industry Organization
Report: Table of Contents
Summary
- Background
- Methods
- Conclusions
- Call to action
- A note on tone: optimism versus pragmatism
- Life Sciences in the twenty-first century
- Where we are
- The promise of personalized health and medicine
- Predictive tests, risk factors, and early detection
- Biomarkers and targeted therapeutics
- Tools and software
- Preventive health
- Impact of the environment
- Rise of the patient consumer
- How we are doing: outcomes and costs
- The nature of the gap
- Describing the gap
- Is the gap “natural”?
- The “conundrum of unexpected complexity”
- Conceptual gaps
- The predominance of illness
- One size fits all
- The pluses and minuses of reductionism Specific gaps
- Tradition and culture
- Basic science
- Clinic
- Technology
- Education and ethics
- Funding
- Commerce
- Reimbursement
- Government and law
- Communication and the media Patients and consumers
- Narrowing the gap
- The need for linkage
- Create a new “science of integration”
- Focus on the human organism
- Projects already under way
- A proposal: The Personalized Health Project
- Key priorities for change:
- Conceptual framework
- Tradition and culture
- Basic science
- Clinic
- Technology
- Education and ethics
- Funding
- Commerce
- Reimbursement
- Regulatory and legal
- Communication and the media
- Patients and consumers
- The Fund for Human Integration
- Emphasis on global health
- Key priorities for change:
- The new “Age of Personalized Health”
Appendix A: The Personalized Health Manifesto
Appendix B: Selected personalized health projects
Appendix C: Project questionnaire
Excerpt from Report:
Background
Recent advances in the life sciences hold great promise to not only improve the health of individuals, but also shift medicine and society away from primarily treating illness toward a greater emphasis on prediction, early diagnosis, prevention, and personalized treatments.1 Exciting breakthroughs have come in a broad range of fields, including genomics, proteomics, epigenomics, neuroscience, nanotechnology, microbiology, environmental toxicology, and systems biology. Translating these discoveries for patients, however, has been slower than many expected. In part, this comes from a ―natural gap‖ that always occurs between innovation and implementation. Yet many inside and outside of the life sciences field contend that this gap is wider than it needs to be. This study assesses this contention. It also delineates possible causes for what might be termed an :artificially created gap,” and offers proposed remedies—many of which are under way, but moving slowly—to shrink the gap and more efficiently facilitate the adoption of new scientific breakthroughs.
Methods
The authors have conducted a survey of major studies and reports addressing aspects and causes of the alleged gap, and a range of proposed solutions and initiatives. We have engaged a group of thirty-six senior leaders from science, medicine, business, government, law, ethics, the media, and patient advocacy to provide input and help assess key features of the gap, and to help formulate proposals to accelerate the application of new biomedical discoveries. The panelists each completed a standard set of eight survey questions (see Appendix C: Project questionnaire).
Conclusions
We are in an unprecedented period of scientific and technological discovery that has placed society on the cusp of a new era of health care. Yet an artificially created gap does exist between innovation and application in the life sciences. (Ninety-seven percent of the expert panel concurred with this assessment. 2) A key obstacle to shrinking this unnatural gap has been a failure to coordinate and communicate new innovations across disciplines and institutions throughout society—in science, medicine, environmental science, industry, finance, patient advocacy, government, politics, ethics, law, and the media. The current system was assembled to serve a biomedical and health care model that is fast becoming outmoded and incomplete, one that (1) emphasizes the diagnosis and treatment of illness without an equal amount of attention paid to keeping people healthy; (2) traditionally has treated patients according to generalized population data and averages rather than as individuals; and (3) depends heavily on a reductionist approach that has served science and society well, but also has led to a ―silo‖ effect that over-emphasizes details and subspecialties and fallen out of balance with the complementary need to integrate. A restoration of this balance would assist in transitioning to a health care enterprise that is more personalized and holistic and emphasizes healthy wellness and illness. The authors are confident these gaps will be addressed, but can happen more quickly and coherently if the life sciences community and society establish a more robust plan to accelerate the translational process.
Call to action
This study concludes with a list of action items the authors and panelists believe will remove barriers and hasten the adoption of new discoveries. These include (1) suggested shifts in thinking, and (2) more practical measures—plus an appeal for our society to encourage the same level of intense and fruitful creativity and innovation in the clinic, business, law, education, ethics community, the media, and government as we have applied in making basic scientific discoveries and in developing new technologies.
A note on tone: optimism versus pragmatism
A debate ensued among some members of the expert panel about the tone of this report—whether it should reflect a robust optimism that the new age of personalized health has arrived, as opposed to a sensibility that progress has been slowed by hurdles that must be addressed with a sober pragmatism. The authors have attempted to offer a balance of tone that falls somewhere between the outer edges of both optimism and pragmatism. Of course, the optimists on the panel have suggested that this tone is too pragmatic, while those more strongly in the pragmatic camp consider some parts of the report to be overly optimistic. In other words, all of the panelists are convinced that a new era of health care based on new discoveries in science and technology is on the horizon, but they differ on how close that horizon might be and how difficult it will be to get there.
— David Ewing Duncan, Frank L. Douglas, Linda K. Molnar, Stephen P. Spielberg