Cancer Policy Monitor: Dec. 6, 2016
21st Century Cures Act Makes Its Way Through Congress
On Dec. 5, the Senate voted to advance the 21st Century Cures Act, which was
part of a larger bill, H.R. 34
, by a bipartisan vote of 85-13. Vice President Joe Biden presided over the vote. This follows the Nov. 30 vote by the House of Representatives to overwhelmingly
approve this landmark medical innovation bill, which would authorize additional
funding for medical research, by a vote of 392-24. The Senate is expected to take up the bill for a final vote on Dec. 6 or 7.
Prior to voting to advance the bill, Senate Majority Leader Mitch McConnell introduced an amendment co-sponsored by Senate Minority Leader Harry Reid that would rename the section of the bill that includes cancer research funding into the "Beau Biden Cancer Moonshot and NIH Innovation Projects," after the vice president's son who passed away from brain cancer last year. The amendment passed by unanimous consent.
Of particular note, the legislation provides $4.8 billion
for the three signature Obama Administration research programs – Vice President
Biden’s National Cancer Moonshot Initiative, the Brain Initiative and the
Precision Medicine Initiative. Specifically, the bill includes $1.8 billion in
mandatory funding over seven years for cancer research, including the moonshot
initiative with $300 million available
in Fiscal Year (FY) 2017.
Immediately after strong bipartisan passage of 21st
Century Cures in the House, the White House issued a statement,
noting that this “critically important legislation responds to the vice
president’s call for a moonshot in cancer research by investing $1.8 billion in
new resources to transform cancer research and accelerate discoveries” and
calling on the Senate to “promptly pass this bill” so that it can be enacted
The bill specifies the establishment of an “NIH Innovation
Account,” to which $4.8 billion “shall be transferred” over 10 years,
with specific amounts set aside each year. The fund is administered by the
Appropriations Committees to the NIH Director. For cancer research,
the bill authorizes $1.8 billion over seven years (to begin in FY 2017). The
language reads as follows: “to support cancer research, such as the development
of cancer vaccines, the development of more sensitive diagnostic tests for
cancer, immunotherapy and the development of combination therapies, research
that has the potential to transform the scientific field that has inherently
higher risk, and that seeks to address major challenges associated with
Because a portion of the cancer research money is to be made
available in FY 2017, it is critical that the money be available to NIH as soon
as possible, which means the $300 million allocated for FY 2017 need to be
included as a part of an otherwise flat NIH budget in the second, short-term spending
bill, known as a Continuing Resolution (CR) that Congress is expected to pass
in December, which will likely run through March 31.
In addition to meeting with congressional offices to build
support for 21st Century Cures, the AACR sent a letter
sent to members of Congress, expressing its support for the bill, specifically
the funding for the National Cancer Moonshot Initiative, and calling on both
chambers to pass the legislation before the end of the lame duck session. The
AACR also issued an action alert to its 37,000 members urging them to contact
their Senators to vote “yes” for the House-passed bill.
We must seize this unprecedented opportunity to accelerate
our scientific efforts for the benefit of the millions of Americans and their
loved ones touched by cancer. You can help make a difference by adding your
voice in support of this bill! Please take a moment to urge your senators to
vote in favor of the 21st Century Cures Act. Every voice helps
ensure that cancer research receives the funding it needs. It only takes a few
Email your senators. Call your senators. Tweet
your senators. Thank
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AACR Hosts Ninth
Annual Conference on Science of Cancer Health Disparities
The AACR hosted its ninth Conference on the Science of Cancer Health
Disparities, Sept. 25-28, in Fort Lauderdale, Florida. Held in association with the
AACR’s Minorities in Cancer Research Council, the annual
brings together all levels of basic, population, clinical and transdisciplinary
research related to cancer and brings together physicians, scientists, health
professionals and health care leaders to discuss the latest findings in their
fields, foster collaborative interdisciplinary interactions and partnerships
and to stimulate the development of new research in cancer health
The keynote speaker, Dr. Eliseo Perez-Stable, director, National
Institute on Minority Health and Health Disparities (NIMHD), outlined the
agency’s vision and agenda to improve minority health and reduce cancer health
disparities. Perez-Stable underscored the importance of conducting and
supporting research in minority health and health disparities, promoting and
supporting the training of a diverse research workforce and translating and
disseminating research information that will ultimately lead to continued
progress against cancer disparities. NIMHD is the lead organization at NIH for
planning, reviewing, coordinating, and evaluating minority health and health
disparities research activities conducted by NIH institutes and centers.
The conference featured a
number of important scientific sessions and also included a town hall and
policy forum on the National Cancer Moonshot Initiative. The speakers provided
an update on the Blue Ribbon Panel Recommendations, which describes 10
transformative research recommendations for achieving the Cancer Moonshot’s
ambitious goal of making a decade’s worth of progress in cancer prevention,
diagnosis, and treatment in just five years.
Through its annual conference and other
initiatives, AACR continues to work to address the issue of cancer health
disparities with the goal of ultimately eradicating them.
Learn more about the AACR Conference on Cancer
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AACR Submits Public Comments in Response to Three FDA Draft Guidances
Oct. 6, 2016, the AACR submitted public comments in response to three
draft guidances issued by the U.S. Food and Drug Administration (FDA) in
July 2016. Two of the draft guidances, "Use
of Public Human Genetic Variant Databases to Support Clinical Validity
for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics" and "Use
of Standards in FDA's Regulatory Oversight of Next Generation
Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing
Germline Diseases," proposed methods to streamline oversight
of Next Generation Sequencing (NGS)-based tests as part of the FDA's
participation in President Obama's Precision Medicine Initiative. The
third draft guidance, "Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product,"
outlined the principles of drug and diagnostic codevelopment for
sponsors advancing a therapeutic alongside a companion diagnostic test.
technologies, which allow for the rapid sequencing of whole genomes and
exomes, have revolutionized the field of oncology from basic research
to clinical treatment. The AACR is pleased to see that the FDA is
committed to implementing a flexible regulatory approach to the
oversight of NGS-based tests, which will continue to foster innovation
and assure that these tests are accurate and meaningful to patients.
NGS database draft guidance describes how publicly accessible databases
of human genetic variants can be a source of valid scientific evidence
to support the validity of NGS-based tests. FDA notes the importance of
genetic variant data aggregation, curation, and interpretation, and
encourages database administrators to consider the opportunities that
may be associated with obtaining FDA recognition. The draft guidance
describes the voluntary recognition process and the database policies
and procedures that would be required to achieve and maintain FDA
The NGS standards draft guidance outlines the FDA's
proposed approach for the use of standards in providing oversight for
whole exome DNA sequencing (WES) or targeted DNA sequencing next
generation sequencing (NGS)-based tests intended to aid in the diagnosis
of individuals with suspected germline diseases. The draft guidance
provides recommendations for designing, developing, and validating
NGS-based tests for germline disease and discusses the possible use of
FDA-recognized standards for the regulatory oversight of these tests.
NGS guidance was specific for oncology tests, and the FDA stated that
they would incorporate the public comments from these guidances into
drafting oncology-specific NGS guidances. The AACR is supportive of both
NGS-draft guidances (AACR's comments to Database Guidance and AACR's comments to Standards Guidance), although there are a few areas in which we believe additional guidance and clarification from the FDA would be beneficial.
FDA released the codevelopment draft guidance with the intent that it
would serve as a practical guide to assist therapeutic product and
in vitro diagnostic (IVD) sponsors in developing a
therapeutic product with an accompanying companion diagnostic in a
process referred to as codevelopment. IVD companion diagnostics are, by
definition, essential for the safe and effective use of a corresponding
therapeutic product and the FDA will generally not approve the
therapeutic product if the IVD companion diagnostic has not already
received marketing authorization, or will not receive contemporaneous
marketing authorization, for use with a specific therapeutic product for
a specific indication. Ultimately, the goal is to align the drug and
test development processes so that the safety and effectiveness of the
two are proven in the same study and the two products reach the market
simultaneously. Therefore, the FDA strongly recommends that sponsors of
the therapeutic product and the IVD meet with the agency prior to the
launch of a clinical trial to advance this codevelopment. The FDA
believes that the codevelopment of IVD companion diagnostics and
therapeutic products is critical to the advancement of precision
The AACR supports the development of high-quality NGS
tests with high analytic performance characteristics, and we commend the
FDA for its commitment to advancing this critical area of precision
medicine that holds great promise for dramatically improving patient
care. The AACR is supportive of the codevelopment guidance but asked for additional guidance and clarification for three specific points.
AACR commends the FDA for its commitment to incorporating scientific
advances into its regulatory framework. All three sets of AACR comments
emphasized that the primary concern of the AACR is patient safety and
the development of high quality tests. The AACR is pleased to extend its
resources and broad expertise to the FDA as the agency further refines
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AACR and FDA Host Public Workshop on Immuno-oncology Drug Development
On Oct. 13-14,
2016, the AACR co-sponsored an Immuno-oncology Drug Development public
workshop with the FDA in Washington, D.C., to develop a path forward for
evaluating an immuno-oncology-focused nonclinical and clinical
development paradigm. There were more than 1,400 registered participants
between the webcast and the in-person workshop. These participants
represented a various sectors including academia, government, industry,
and nonprofit organizations. The workshop helped to educate those who
were not as familiar with these novel therapies as well as to redefine
biological outcome measures and clinical endpoints leading to innovative
clinical trial designs.
The workshop was co-chaired by AACR
Regulatory Science and Policy Subcommittee member Suzanne L. Topalian,
MD, professor of surgery and oncology at the Johns Hopkins University
School of Medicine, director of the Melanoma Program at the Sidney
Kimmel Comprehensive Cancer Center at Johns Hopkins; Jedd D. Wolchok,
MD, PhD, the Lloyd J. Old/Virginia and Daniel K. Ludwig chair in
clinical investigation and chief of the Melanoma and Immunotherapeutics
Service at Memorial Sloan Kettering Cancer Center; Marc Theoret, MD,
lead medical officer, Division of Oncology Products 2, Office of
Hematology Oncology Products, Center for Drug Evaluation and Research at
the FDA; and Maitreyee Hazarika, MD, medical officer, Division of
Oncology Products 2, Office of Hematology Oncology Products, Center for
Drug Evaluation and Research at the FDA. AACR board of directors member
Antoni Ribas, MD, PhD, of the University of California, Los Angeles,
also participated as a speaker.
The agenda of the workshop was
designed to provide an interdisciplinary forum to discuss the unique
aspects of immunotherapy treatments and sessions included:
Considerations in the Preclinical Evaluation of Immuno-oncology
Products, Considerations for Dose-finding, Evaluation of Immune-mediated
Adverse Events, Endpoints for Immuno-oncology products – Considerations
for Unique Efficacy Based on Unique Biology of Checkpoint Inhibitors,
Use of Alternate Efficacy Endpoints with Immuno-oncology Products, and
Considerations for Novel Trial Design.
Transcripts and slides
have now been posted on our website. Some speakers have not given
permission to post their slides in the master slide deck PDFs, and their
slides have been omitted. Audio recordings or audio plus slide recordings of individual presentations and panel discussions are now available on our AACR website. Please note that recordings of some of the presentations have been withheld at the request of individual speakers. Additionally, as noted in the previous update, transcripts and the master slide deck PDF of presentations are also available.
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Apply Now: AACR Early-career Hill Day
Following the recent election cycle in the United States, the new Congress presents a great opportunity to engage and educate key congressional leadership regarding the needs of cancer researchers, particularly those early in their careers. As such, Associate Members in good standing are encouraged to apply to participate in the second annual AACR Early-career Hill Day, Feb. 28-Mar. 1, 2017 in Washington, D.C.
Overview of Hill Day Activities:
- Participants will be divided into groups to meet face-to-face with senators and House representatives and/or their key staff member(s).
- Each group will attend four or five meetings on Capitol Hill during the event.
- During each meeting, participants will have the opportunity to share first-hand stories about the impact of cancer research funding on their career and how cancer may have personally touched their life or that of a loved one.
- A special training webinar will be held in advance, in addition to the welcome and briefing dinner on Feb. 28, to emphasize key messaging points for the event.
- In addition to activities during the Hill Day, participants may be asked to contribute to further advocacy efforts after the event.
Don't miss out on your chance to participate in this opportunity to interact with, and advocate to, the new congressional leadership. A limited number of spots are available. All applications will be evaluated based on a variety of factors including the applicant's overall level of interest and any previous experience. Effort will also be made to maximize the number of congressional districts represented. Upon submitting one's application, applicants should review their membership record in myAACR to ensure the most up-to-date information.
Deadline: 1 p.m. ET, Monday, Dec. 19, 2016
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