The Precision Medicine Initiative
The Precision Medicine Initiative (PMI) was unveiled
by President Barack Obama in January 2015. The goal
of the PMI is to build on advances in precision oncology
and extend precision medicine treatments to all forms
of cancer and many other diseases.
Of the $300 million assigned to the PMI in the FY 2016
budget, $70 million were directed to the NCI to scale up
efforts to identify genomic drivers of cancer and apply
that knowledge in the development of more effective
approaches to cancer treatment.
One area of particular focus is expanding precision
medicine clinical trials, with an emphasis on supporting
the NCI-Molecular Analysis for Therapy Choice
(MATCH) clinical trial and planning and conducting a
trial that will be known as NCI Pediatric MATCH. Other
areas of focus include exploring fundamental aspects
of cancer biology, and establishing a national “cancer
knowledge network” to generate and share ne w knowledge
to fuel scientific discovery and guide treatment decisions.
ENHANCED SUPPORT
FOR REGULATORY SCIENCE
AND POLICY AT THE FDA
The FDA is an integral part of the biomedical research
community, and the support of this critical agency
through robust, annual appropriations from Congress
is crucial if we are to continue to make progress
against cancer through the delivery of safe, effective,
and increasingly precise therapies to patients. The
advancement of regulatory science, which is the study of
developing new tools, standards, and approaches to assess
the safety, efficacy, quality, validity, and performance of
medical products, is especially important. The regulatory
science initiatives of the FDA are aimed at promoting
and developing evidence-based regulatory policies
that balance innovation and the expedited approval of
medical products with patient safety. These activities are
not supported through user fees, but rather, depend on
annual funding from Congress.
As research leads to more sophisticated and complex
approaches to treatment, the process of approving those
therapies must keep pace. Likewise, the FDA must keep
abreast of the latest scientific and technological progress
through discourse, cooperation, and collaboration with
academia, industry, patient advocacy groups, and the
government. Therefore, Congress must continue to
equip the agency the resources it needs to support these
regulatory processes, professional development of staff,
and expand hiring authority.
DEVELOPING AND
TRAINING THE WORKFORCE
OF TOMORROW
Many of the most innovative research questions and
fresh ideas come from scientists early in their careers.
Ensuring the pace of progress against cancer continues
requires that the next generation of cancer researchers be
recruited, supported and encouraged. A strong pipeline
of talented researchers to whom current leaders in the
field can pass the baton in the years to come will allow
the work to continue in earnest to conquer this disease.
The current generation of early-career investigators has
been privy to the exciting advancements that have been
thus far described. At the same time, they have come of
age in a decade when research funds were scarce, federal
research budgets declined by more than 20 percent when
adjusted for inflation, and the path for ward was uncertain.
Because of the difficult funding environment in recent
years, many young investigators have opted for alternative
career paths, thereby putting future generations of
innovative research in jeopardy.
Our country must continue to invest in education and
training of scientists at all career levels, but especially
in the dawn of their careers. The cancer workforce of
tomorrow also must reflect the increasing diversity in our
country, including disciplinary, gender, racial, ethnic, and
geographic diversity. Robust, sustained and predictable
funding increases for the NIH, coupled with federal,
state, and private sector-funded programs to assist early-career scientists, play an irreplaceable role in attracting
and retaining tomorrow’s scientific leaders.
PRECISION PREVENTION
AND EARLY DETECTION
We know that more than half of global cancer cases are
a result of preventable causes and that prevention is
perhaps the most cost-effective strategy for controlling
cancer in the long run. Thus, an increased focus on cancer
prevention and early detection is required if we are to
decrease cancer incidence, morbidity, mortality, and
cost worldwide.
Thanks to the wealth of research demonstrating the
health consequences of tobacco use, we have seen
dramatic progress in the area of tobacco control
through the implementation of policies and educational
initiatives aimed at preventing use and facilitating
cessation. As electronic nicotine delivery systems
(ENDS), commonly called e-cigarettes, have proliferated
in recent years, the need to understand and balance the
