David Ewing Duncan
Director, The Center for Life Science Policy, UC Berkeley
This document was prepared with the participation of thirty-five life science
leaders representing science, medicine, business, government, patients, law,
and the media (a complete list of participants appears at the end).
American society is on the cusp of a vital new era of health care, one in which
medicine will shift from primarily addressing illness to a greater emphasis on
prediction and prevention, and on individualized care. This historic transformation
comes from a deepening understanding of biology, the emergence of new
technologies, and a rising demand by individuals to understand and take charge
of their own health. Yet a widening gap exists in integrating and implementing
this promising new epoch of personalized health.
Resistance comes from traditions and attitudes that emerged during an age
when medicine was limited primarily to diagnosing and treating disease, and by
the prevailing use of drugs and protocols targeted more for populations and
averages than for individuals. Even today, the biomedical enterprise
overwhelmingly focuses on developing and paying for costly drugs, procedures,
and devices that will be deployed after a person gets sick, with too little
consideration for their personal physiology and circumstances.
This dominance is now being challenged. Discoveries in genomics, proteomics,
environmental toxicology, microbiology, biocomputing, and many other fields are
poised to provide unheard of insight into a person's future health risks, and also
to offer individualized options for improving health and wellness, and for
Significant impediments and gaps remain however in applying this "new
science"—not only in the clinic, but also in funding, infrastructure, regulation, law,
business, education, and communication. Some of these gaps are unavoidable
and naturally occur with any new discovery, while others are avoidable and
A major hurdle is the unintended consequence of a system that has devoted
considerable time and resources on basic research and on creating an ever more
specialized phalanx of experts delving into the mechanisms of life. Over the
years, this reductionist enterprise has produced critical insights that have made
an age of personalized health possible. But it also has encouraged a parsing of
knowledge and a silo effect that has made it difficult to capitalize on vast new
stores of knowledge about human biology.
The time has come for an intensive focus on integration, the crucial complement
to reductionism. Basic research and specialization remains crucial to the
biomedical enterprise, but a reordering of priorities is required to stress the
application and translation of what has been learned to improve health and to
reduce health care costs.
Integration requires, first, a new urgency for scientists to work together to focus
on the whole human organism; and, second, for society to absorb and implement
scientific discoveries in the realms of clinical medicine, law, government,
education, and commerce with greater creativity and resolve. To realize this
vision will require coordination, funding, and a mandate for bold action.
To launch a new era of personalized health does not require a radical new
blueprint for change. Rather, it can utilize an existing body of suggested
proposals, reforms, and plans already put forth by individuals and organizations
inside and outside of government. Some of these ideas have been tentatively
initiated, but they require significantly more funding and support.
In order to accelerate a transformation to personalized health, we, the
undersigned, call on the life science community, policymakers, patients, and
society to take the following actions:
First, to acknowledge that:
- New scientific discoveries are enabling a shift from a paradigm of health
care based on illness to one equally centered on prediction, prevention,
and personalized health.
- A balance between specialization and integration needs to be restored,
with an emphasis on the whole human organism as much as its parts, and
as much on individual patients as populations.
- Gaps exist that exacerbate the normal lag between discovery and
application, both inside and outside the scientific community.
- Shifting to a health care system based as much on healthy wellness as
illness is achievable, and can be accelerated by systematic planning and
Second, to advocate the following:
A Personalized Health Project that will:
- Recruit key leaders from science, medicine, business, policy,
government, patient advocacy, ethics, law, and the media;
- Study and assess specific "gaps" between innovation and application,
and assign task forces to address each substantial gap;
- Create a blueprint for implementing specific initiatives and enhancing
existing projects in the public and private sectors to support predictive
and preventive health care; and,
- Target, prioritize, and develop funding streams for the validation and
application of new discoveries based on integrating individual
discoveries and projects into a holistic model based on the needs of
individuals and populations.
Third, to offer support for reforms in:
- Establish a new academic discipline focusing on the science of
integration, including educational programs, funding, and journals.
- Modify medical education and scientific training to emphasize wellness
and predictive and preventive medicine, and a deeper understanding of
the links between the new science and the clinic.
- Provide incentives for medical trainees to pursue primary care and
integrative fields such as medical genetics.
- Organize an awareness campaign on the need to integrate fields within
the life sciences and between the life sciences and society.
- Refocus regulation and oversight to better utilize science and technology
to streamline the drug and diagnostic approval process.
- Embrace a new model based on predictive and preventive medicine, and
- Develop standard data elements for this new and emerging field.
- Remove barriers to the flow of scientific information by adopting open
source models for publishing studies and organizing databases.
- Support improvements in information technology to better integrate data
and to develop effective predictive models for populations and individuals.
- Create methods and programs to assess the true cost-benefit of
personalized health science and protocols.
- Encourage and enable the rise of the patient-consumer in health care.
- Arm people with validated information on predictive and preventive tests
and protocols, and on lifestyle options such as nutrition, diet, and exercise.
- Encourage entrepreneurs, investors, and commercial efforts to develop
new products and protocols based on the science of personalized health.
- Create a Human Integration Fund: a hybrid of public and private money
dedicated to investing not in individual efforts, but in groupings of efforts
that jointly target a disease or system, or the human body.
- Establish a reimbursement process that pays for and encourages
predictive tests, prevention, healthy wellness, and targeted treatments.
Ethics and Global Health
- Study the impact and the ethics of personalized health initiatives to ensure
their adoption is safe and effective, and that privacy, personal choice, and
access are protected.
- Work to develop predictive and preventive strategies that are suitable for
both the developed and developing world, and work to develop funding
and initiatives for global personalized health.
End of Life
- Acknowledge that illness and death remain a part of life, and continue a
dedicated focus on personalized medicine to better customize treatment
options, and encourage the use of palliative care where indicated.
Shifting to a health care paradigm that embraces healthy wellness and
personalized health is a formidable challenge that will take many years. Yet we
believe that this transformation can be accelerated with a thoughtful and
comprehensive plan to advance the science and practice of personalized health,
and that no time is better than now to launch this effort.
The following individuals participated in the development of the Personalized
Health Manifesto and have endorsed it; neither they nor anyone else has had
any editorial influence over this document.
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
ATUL BUTTE, MD, PhD, geneticist and bioinformaticist, Stanford University
BROOK BYERS, MBA, venture capitalist, Kleiner Perkins Caufield & Byers
CHRIS AUSTIN, MD, neurologist; director, Chemical Genomics Center, National
Institutes of Health
DANIEL KRAFT, MD, PhD, oncologist; stem cell researcher, Stanford University
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, UC Berkeley
DIETRICH STEPHAN, PhD, geneticist; director, Ignite Institute; co-founder,
EDWARD ABRAHAMS, PhD, president, Personalized Medicine Coalition
ERIC SCHADT, PhD, biocomputationist; chief scientific officer, Pacific
Biosciences; co-founder, Sage Bionetworks
ERIC TOPOL, MD, cardiologist and translational geneticist; director, Scripps
Translational Science Institute
FRANK DOUGLAS, MD, PhD, president and chief executive officer, Austen
BioInnovation Institute of Akron, Ohio; founder and first executive director of the
MIT Center for Biomedical Innovation, Massachusetts Institute of Technology;
former chief scientific officer, Aventis
FRED 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 and professor of
Health Innovation, Arizona State University; former president, R&D, of SmithKline
GREG SIMON, JD, senior vice president for Worldwide Policy, Pfizer; former
president, FasterCures; former chief domestic policy advisor to Vice President Al
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
JAMES HEYWOOD, co-founder 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
MARGARET ANDERSON, executive director, FasterCures
MARTYN SMITH, PhD, professor of Toxicology, School of Public Health,
Division of Environmental Health Sciences, University of California Berkeley
MICHAEL ROIZEN, MD, preventive medicine; director, Wellness Institute,
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; director, Genomic Medicine
Institute, El Camino Hospital
RAY WOOSLEY, MD, PhD, president and CEO, Critical Path Institute
SAFI BAHCALL, PhD, entrepreneur; CEO, Synta Pharmaceuticals Corp
STEPHEN FRIEND, MD, PhD, president, CEO, co-founder, Sage Bionetworks;
former senior vice president and franchise head for Oncology Research, Merck
STEPHEN SPIELBERG, MD, PhD, pediatrician; director, Center for
Personalized Medicine and Therapeupic Innovation, Children's Mercy Hospital,
Kansas City, Missouri; 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, executive director, Neurological Industry Organization