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FINDING CURES TOGETHER<sup>SM</sup>

​​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 into law.

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 cancer.”

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 minutes!

Email your senators. Call your senators. Tweet your senators. Thank your representative.

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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 conference 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 disparities. 

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 Disparities. 

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AACR Submits Public Comments in Response to Three FDA Draft Guidances     

On 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.

NGS 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.

The 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 recognition.

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.

Neither 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.

The 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 medicine. 

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.  

The 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 these guidances.

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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.

Apply Now

Deadline: 1 p.m. ET, Monday, Dec. 19, 2016

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