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​​Cancer Policy Monitor: November 8, 2016      

AACR Congratulates Vice President Biden for his Visionary Leadership in Overseeing the National Cancer Moonshot Initiative

AACR Hosts Ninth Annual Conference on Science of Cancer Health Disparities

AACR Submits Public Comments in Response to Three FDA Draft Guidances

AACR and FDA Host Public Workshop on Immuno-oncology Drug Development

Experts Featured in AACR E-cigarettes Policy Webinar Taking Questions through Nov. 21

Save the Date Feb. 28-March 1: AACR Early-career Hill Day

AACR Congratulates Vice President Biden for his Visionary Leadership in Overseeing the National Cancer Moonshot Initiative  

One year after Vice President Joe Biden called for a moonshot to cure cancer, the American Association for Cancer Research (AACR) expressed its sincere appreciation to Biden for his leadership in spearheading the National Cancer Moonshot Initiative.

In this role, the vice president has galvanized the entire cancer research and patient care community, including bringing together leaders from more than a dozen federal agencies over the past nine months to focus on making the most of federal investments, targeted incentives, private sector efforts from industry and philanthropy, patient engagement initiatives, and other mechanisms to support cancer research and enable progress in treatment and care.

The Cancer Moonshot Task Force Report and the Vice President's Executive Report, which were both released earlier this week, coupled with the Cancer Moonshot Blue Ribbon Panel Report that was released in early September, provide a strategic roadmap for realizing the vice president's goal, to achieve a decade's worth of progress over the next five years.

"During the past year, the entire cancer research and patient care community have come together in ways rarely seen before, and these efforts have resulted in a robust and comprehensive list of innovative proposals and approaches for transforming the ways we will prevent and treat cancer," said AACR President Nancy E. Davidson, MD, director of the University of Pittsburgh Cancer Institute. "In view of all of the extraordinary scientific opportunities that exist today for making major advances against cancer, it will be extremely disappointing if the Obama administration leaves office in January without having secured significant funding and support for the initiatives and programs that have been recommended to advance the National Cancer Moonshot Initiative."

When Congress returns in November for the lame duck session, the AACR will stress to members of Congress the importance of continuing the momentum for medical research in FY 2017 that began in FY 2016 when it provided a $2 billion funding increase for the National Institutes of Health. It is also important that Congress advance the 21st Century Cures legislation, because of this opportunity to provide supplemental funding for the National Cancer Moonshot Initiative. 

"The National Cancer Moonshot Initiative has involved an incredible level of cooperation and coordination among cancer researchers, physician-scientists, patient advocates, government officials, and industry leaders," said Margaret Foti, PhD, MD (hc), chief executive officer of the AACR. "The extraordinary results of this initiative, which include the Cancer Moonshot Task Force Report, the Vice President's Executive Report, and the Cancer Moonshot Blue Ribbon Panel Report, would not have been possible without the vice president's amazing passion and ability to inspire people to come together to pursue the goal of accelerating a marked reduction of cancer incidence, morbidity, and mortality." 

In the next few months, the AACR will be conveying to policymakers the reality that if we are going to make a major difference for cancer patients and their loved ones, it is going to require that significant support for the National Cancer Moonshot Initiative be secured during the upcoming lame duck session of Congress. In addition, it is urgent that this initiative is also supported by the incoming administration and new Congress.   

Watch Vice President Joe Biden and Dr. Jill Biden addressing the cancer research community at the AACR Annual Meeting 2016 in New Orleans.

View the timeline highlighting the AACR's leadership in the National Cancer Moonshot Initiative.

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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. It will take additional time for the edited audio and audio+slide recordings to become available, but once they do, they will be available online.

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Experts Featured in AACR E-cigarettes Policy Webinar Taking Questions Through Nov. 21    

The AACR policy webinar, "E-cigarettes: Research, Public Health Concerns and Opportunities, and Regulations," features key experts presenting current research on the public health impact of e-cigarettes, including from the Food and Drug Administration and the Centers for Disease Control. After viewing the webinar, you're invited to submit your questions to these experts via email to sciencepolicy@aacr.org through Nov. 21. We will post questions and answers at the end of the month under the webinar link page.

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Save the Date Feb. 28-March 1: AACR Early-career Hill Day   

The AACR invites early-career scientists and researchers to Washington, D.C., on Feb. 28-March 1, 2017, to meet with members of Congress and their staff and help push for increased funding for cancer research. Registration will open in mid-November. Stay tuned to the AACR Science Policy and Government Affairs Website for more information.

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