AMERICAN ASSOCIATION FOR CANCER RESEARCH 99
to robust, annual increases for the NIH so that funding can
continue to recover lost ground and thereby yield results for
all Americans and people around the world.
THE BEAU BIDEN CANCER
MOONSHOT: TOWARD “ENDING
CANCER AS WE KNOW IT.”
The Beau Biden Cancer Moonshot is entering its second
year, and in December 2016, the initiative received its
first federal funding of $300 million through the NIH
Innovation Fund, which was established in the 21st Century
Cures Act (see sidebar on Working Together to Implement
the Beau Biden Cancer Moonshot, p. 100). The initiative
seeks to double the rate of progress toward a cure for cancer
by making ten years of progress in five years.
Prior to leaving office, Vice President Biden delivered the
Cancer Moonshot Task Force’s comprehensive report
to President Obama (210). In this report, Biden and his
colleagues set forth a strategic plan for transforming
cancer research and care through five overarching goals.
The first goal, which is to catalyze scientific breakthroughs,
will be accomplished through implementation of the
recommendations of the Blue Ribbon Panel. The second goal
is to unleash the power of data through several approaches,
including the NCI Genomic Data Commons, which was
unveiled in late 2016. This resource promotes the sharing
of genomic and clinical data between researchers and serves
to facilitate precision medicine in oncology. The third goal,
to accelerate the delivery of new therapies to patients, is
being accomplished in part through the creation of the FDA
Oncology Center of Excellence (OCE) and the Partnership
for Accelerating Cancer Therapies (PACT), which is a
collaboration between the NIH and twelve biopharmaceutical
companies, research foundations, and philanthropies.
The fourth and fifth goals are to strengthen the prevention
and diagnosis of cancer, and to improve patient access and
care, respectively. In conjunction with the release of the
Cancer Moonshot Task Force report, Vice President Biden
announced new commitments from both the public and
private sectors to accomplish the goals set forth in the plan,
including partnerships to advance data tools and patient
services such as affordable and reliable transportation.
ENHANCING SUPPORT FOR
REGULATORY SCIENCE AND
POLICY ACTIVITIES AT THE FDA
The FDA is an integral part of the biomedical research cycle
(see Figure 8, p. 49). Support of this critical agency through
robust, annual appropriations from Congress is crucial
if we are to continue to make advances against cancer
through the delivery of safe, effective, and precise medical
products to patients. This is because annual funding for the
FDA from Congress goes toward the agency’s regulatory
science initiatives that seek to promote and develop new
evidence-based regulatory policies that balance innovation
and the expedited approval of medical products that are
safe and effective.
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
government. In recent years, Congress has recognized
that it must equip the agency with the resources it needs to
support these regulatory processes. Thus, the 21st Century
Cures Act included important provisions that provide a
dedicated stream of funding to assist with innovation,
expand hiring authority at the agency, and ensure continued
professional development of staff.
• Ensuring that the patient perspective is
considered in the regulatory decision-making
process through a Patient-Focused Drug
• Encouraging novel clinical trial designs.
• Modernizing the eligibility criteria of cancer
clinical trials by enrolling patients who reflect
the real-world population, such as allowing
more older adults to enroll.
• Striving for “excellence” within the OCE
by collaborating externally with academia,
industry, patient groups, and professional
societies with the goal of expedited, risk-benefit ratio balanced drug development.
The Aims of the
FDA Oncology Center
The FDA Oncology
Center of Excellence (OCE)
brings together regulatory
scientists and reviewers with
oncology expertise to support an integrated
approach to driving progress against cancer.
The goals of the OCE include: