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From THE WHITE HOUSE:Office of the
Press Secretary
FACT SHEET: President Obama’s
Precision Medicine Initiative
January 30, 2015
Building on President Obama’s announcement in
his State of the Union Address, today the Administration is unveiling details
about the Precision Medicine Initiative, a bold new research effort to
revolutionize how we improve health and treat disease. Launched with a $215
million investment in the President’s 2016 Budget, the Precision Medicine
Initiative will pioneer a new model of patient-powered research that promises to
accelerate biomedical discoveries and provide clinicians with new tools,
knowledge, and therapies to select which treatments will work best for which
patients.
Most medical treatments have been designed
for the “average patient.” As a result of this “one-size-fits-all-approach,”
treatments can be very successful for some patients but not for others. This is
changing with the emergence of precision medicine, an innovative approach to
disease prevention and treatment that takes into account individual differences
in people’s genes, environments, and lifestyles. Precision medicine gives
clinicians tools to better understand the complex mechanisms underlying a
patient’s health, disease, or condition, and to better predict which treatments
will be most effective.
Advances in precision medicine have already
led to powerful new discoveries and several new treatments that are tailored to
specific characteristics of individuals, such as a person’s genetic makeup, or
the genetic profile of an individual’s tumor. This is leading to a
transformation in the way we can treat diseases such as cancer. Patients with
breast, lung, and colorectal cancers, as well as melanomas and leukemias, for
instance, routinely undergo molecular testing as part of patient care, enabling
physicians to select treatments that improve chances of survival and reduce
exposure to adverse effects.
The potential for precision medicine to
improve care and speed the development of new treatments has only just begun to
be tapped. Translating initial successes to a larger scale will require a
coordinated and sustained national effort. Through collaborative public and
private efforts, the Precision Medicine Initiative will leverage advances in
genomics, emerging methods for managing and analyzing large data sets while
protecting privacy, and health information technology to accelerate biomedical
discoveries. The Initiative will also engage a million or more Americans to
volunteer to contribute their health data to improve health outcomes, fuel the
development of new treatments, and catalyze a new era of data-based and more
precise medical treatment.
Key Investments to Launch the Precision
Medicine Initiative:
Complementing robust investments to broadly
support research, development, and innovation, the President’s 2016 Budget will
provide a $215 million investment for the National Institutes of Health (NIH),
together with the Food and Drug Administration (FDA), and the Office of the
National Coordinator for Health Information Technology (ONC) to support this
effort, including:
- $130
million to NIH for development of a voluntary national research cohort of a
million or more volunteers to propel our understanding of health and disease and
set the foundation for a new way of doing research through engaged participants
and open, responsible data sharing.
- $70
million to the National Cancer Institute (NCI), part of NIH, to scale up efforts
to identify genomic drivers in cancer and apply that knowledge in the
development of more effective approaches to cancer treatment.
- $10
million to FDA to acquire additional expertise and advance the development of
high quality, curated databases to support the regulatory structure needed to
advance innovation in precision medicine and protect public health.
- $5
million to ONC to support the development of interoperability standards and
requirements that address privacy and enable secure exchange of data across
systems.
Objectives of
the Precision Medicine Initiative:
- More and better treatments for cancer:
NCI will accelerate the design and testing of effective, tailored
treatments for cancer by expanding genetically based clinical cancer trials,
exploring fundamental aspects of cancer biology, and establishing a national
“cancer knowledge network” that will generate and share new knowledge to fuel
scientific discovery and guide treatment decisions.
- Creation of a voluntary national research
cohort: NIH, in collaboration with other agencies and stakeholders, will
launch a national, patient-powered research cohort of one million or more
Americans who volunteer to participate in research. Participants will be
involved in the design of the Initiative and will have the opportunity to
contribute diverse sources of data—including medical records; profiles of the
patient’s genes, metabolites (chemical makeup), and microorganisms in and on the
body; environmental and lifestyle data; patient-generated information; and
personal device and sensor data. Privacy will be rigorously protected. This
ambitious project will leverage existing research and clinical networks and
build on innovative research models that enable patients to be active
participants and partners. The cohort will be broadly accessible to qualified
researchers and will have the potential to inspire scientists from multiple
disciplines to join the effort and apply their creative thinking to generate new
insights. The ONC will develop interoperability standards and requirements to
ensure secure data exchange with patients’ consent, to empower patients and
clinicians and advance individual, community, and population health.
- Commitment to protecting privacy: To
ensure from the start that this Initiative adheres to rigorous privacy
protections, the White House will launch a multi-stakeholder process with HHS
and other Federal agencies to solicit input from patient groups, bioethicists,
privacy, and civil liberties advocates, technologists, and other experts in
order to identify and address any legal and technical issues related to the
privacy and security of data in the context of precision medicine.
- Regulatory modernization: The
Initiative will include reviewing the current regulatory landscape to determine
whether changes are needed to support the development of this new research and
care model, including its critical privacy and participant protection framework.
As part of this effort, the FDA will develop a new approach for evaluating Next
Generation Sequencing technologies — tests that rapidly sequence large segments
of a person’s DNA, or even their entire genome. The new approach will facilitate
the generation of knowledge about which genetic changes are important to patient
care and foster innovation in genetic sequencing technology, while ensuring that
the tests are accurate and reliable.
- Public-private partnerships: The Obama
Administration will forge strong partnerships with existing research cohorts,
patient groups, and the private sector to develop the infrastructure that will
be needed to expand cancer genomics, and to launch a voluntary million-person
cohort. The Administration will call on academic medical centers, researchers,
foundations, privacy experts, medical ethicists, and medical product innovators
to lay the foundation for this effort, including developing new approaches to
patient participation and empowerment. The Administration will carefully
consider and develop an approach to precision medicine, including appropriate
regulatory frameworks, that ensures consumers have access to their own health
data – and to the applications and services that can safely and accurately
analyze it – so that in addition to treating disease, we can empower individuals
and families to invest in and manage their health.
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