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FINDING CURES TOGETHER<sup>SM</sup>

​​Cancer Policy Monitor: May 2, 2017     

Share Your Story for National Cancer Research Month     

May is National Cancer Research Month, during which the American Association for Cancer Research partners with advocacy groups, cancer centers, and research institutions to raise awareness of the high-quality, innovative cancer research happening across the country and around the world.

Starting this month, and moving forward throughout the year, we’re looking for inspiring stories from researchers and advocates about why they became interested in cancer research or advocacy and how they work in their own way on behalf of cancer patients and survivors. You can submit your story starting today for a chance to be featured on our Take Action website and future editions of the Cancer Policy Monitor.

You can be as creative as you like. Write your story in your own words, make an online mini-site, create a video, or submit a digital collage. Any way you think would best tell your story is acceptable. You can submit your story and/or links here. There is no deadline to submit your story. We will be accepting stories throughout the year.

Additionally, during May, we are continuing to ask those affected by cancer to share their messages of real hope, like this short video featuring five cancer survivors sharing what hope means to them. Post a photo or video on your social networks using the hashtag #RealHopeIs to let the world know what real hope means to you. Or, post it to the National Cancer Research Month Facebook page.

For more resources and information on National Cancer Research Month and how you can support cancer research, visit www.AACR.org/NCRM, like National Cancer Research Month on Facebook, and follow #NCRM17 and #RealHopeIs on Twitter.

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Congress Extends Its Deadline to Fund Government, Including NIH      

On April 28, Congress passed another short-term Continuing Resolution (CR) that keeps the government funded through May 5 while the House and Senate work on a deal to fully fund the government through Sept. 30, 2017. After a weekend of negotiations, an agreement was reached on the Fiscal year (FY) 2017 omnibus appropriations bill. The bill, released very early May 1, includes a total funding level of $34.1 billion for the NIH, a $2 billion increase above the FY 2016 enacted levels.

The bill also includes a total funding level of $5.69 billion for the NCI, an increase of $475 million over enacted FY 2016. The text states that this includes $5.39 billion in “general” funding for the NCI, AND the $300 million provided in December in the Continuing Resolution for the Beau Biden Cancer Moonshot.

The last time that Congress provided NIH with a $2 billion increase in FY2016 resulted in the U.S. seeing an additional economic gain of $4 billion compared to 2015. In 2016, NIH funding and jobs generated by that funding produced $64.799 billion in new economic activity compared to $60.717 billion in 2015. Nineteen states saw an economic gain of $1 billion or more. Check out this fact sheet for other information about the impact of NIH funding.

We’ve made it quick and simple for you to connect with members of Congress and the White House to urge them to support lifesaving cancer research during this critical time. On our Take Action site, you’ll be able to email, call, and tweet policymakers, check cancer news from around the country, and find the latest cancer-related legislation.

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Nomination of Scott Gottlieb for FDA Commissioner Advances in the Senate     

On April 27, the Senate Health, Education, Labor and Pensions (HELP) Committee advanced the nomination of Scott Gottlieb to lead the Food and Drug Administration to the full Senate in a 14-9 vote. Gottlieb, a survivor of Hodgkin’s lymphoma, was an FDA official during the George W. Bush administration, where he served as FDA deputy commissioner. He also served as a senior adviser to the administrator at the Centers for Medicare and Medicaid Services and is a member of the federal Health IT Policy Committee.

In his opening statement during his HELP Committee confirmation hearing, Gottlieb, who has been endorsed by former FDA Commissioners Robert Califf and Margaret Hamburg (both Obama appointees) stated that the FDA should be guided by scientific rigor. He later also added that he would defer to the expertise of career FDA staff before making decisions.

During the hearing, Senator Patty Murray (D-Washington) expressed concern regarding Gottlieb’s role in overseeing regulation of medical tests given his investments in several companies involved in the development of such tests. She also reiterated her concern over keeping tobacco products out of the hands of children.

During the questioning rounds, Senator Mike Enzi (R-Wyoming) asked Gottlieb about plans to move the field of precision medicine forward, especially for small clinical trials, such as those for rare diseases where the sample size is small. Gottlieb highlighted the opportunity to improve the discovery process through the 21st Century Cures Act, which he hopes to seamlessly implement at the FDA if confirmed.

On the topic of tobacco regulation and e-cigarettes, Senator Bill Cassidy (R-Louisiana) asked about the role of the Center for Tobacco Products (CTP) in evaluating tobacco. Gottlieb stated that he is committed to considering the role of e-cigarettes as smoking cessation tools, but added that certain flavorings, such as cookie dough, are not appropriate for smoking cessation. Senator Murray later asked if Gottlieb would commit to the 2016 Deeming Rule, which extended the ban on the sale of tobacco products to youth under the age of 18 years to include e-cigarettes. Gottlieb replied that he realizes that there’s a difference between e-cigarettes as a cessation tool and marketing to kids and added that he is committed to providing CTP career staff with the necessary resources to make that decision.

Gottlieb’s nomination is expected to go before the full Senate in mid-May.

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Congressman Advocates for Increased Funding for Cancer Research and Prevention    

In March, U.S. Rep. Donald Payne Jr. (D-New Jersey), led a roundtable discussion at University Hospital in Newark, New Jersey, titled "Cancer Research Today: Innovation, Progress and Promise." The event was co-sponsored by the American Association for Cancer Research, University Hospital, and Rutgers Cancer Institute of New Jersey to underscore the importance of cancer research, supported by strong federal investments in the National Institutes of Health (NIH) to accelerate the development of new and more effective ways to prevent, detect, diagnose, and treat cancer. Rep. Payne's story was featured in the AACR Cancer Progress Report 2016, where he highlighted his father's courageous battle with colorectal cancer. This post originally appeared on the AACR blog, the Cancer Research Catalyst.

On March 6, I had the opportunity to speak at a roundtable, hosted by University Hospital and Rutgers Cancer Institute of New Jersey, about my efforts in Congress to promote colorectal cancer awareness and to advocate for cancer research, prevention, education, and treatment.

I speak at many events like this, and I'm always honored to join with patients, advocates, and medical professionals in the fight against cancer. But this event was especially meaningful to me. On that same day, five years earlier, I lost my father to colorectal cancer.

My father, Congressman Donald M. Payne Sr., served the people of New Jersey's 10th Congressional District for 23 years. Losing him was devastating not just for my family, but for our entire community.

My father's passing was a wake-up call. I decided that I needed to get screened myself. The doctor found 13 polyps and, thankfully, they were all removed with no issues. But I was lucky because I was really late in getting screened. Now, I get screened every year as a birthday present to myself.

I have also made it my mission to do everything I can, through both legislative and advocacy efforts, to raise awareness, educate, and help save lives.

Earlier this year, I joined Congressmen Charlie Dent of Pennsylvania and Leonard Lance of New Jersey in introducing the Removing Barriers to Colorectal Cancer Screening Act of 2017. This legislation waives cost-sharing under Medicare for preventive colonoscopies, even if a polyp or tissue is removed. By reducing disincentives for screenings, the bill will improve health outcomes and save money for both seniors and taxpayers.

In 2016, I introduced the Donald Payne Sr. Colorectal Cancer Detection Act of 2016. This bill would provide Medicare coverage for U.S. Food and Drug Administration-approved qualifying colorectal cancer screening blood-based tests.

Additionally, in my role as co-chair of the Congressional Men's Health Caucus, I'm working to help improve the health and wellness of men and boys. We have hosted a number of cancer awareness briefings, including colorectal cancer. I'm also working in this role to address minority health disparities and promote culturally appropriate health education.

Whenever I have a chance to talk about colorectal cancer, I always deliver the same message: Get tested—it can save your life. Colorectal cancer is highly preventable and treatable—but you have to catch it early. That is why it's so crucial to get the word out about this disease and make sure people are aware of the importance of screening.

My father was my mentor, my confidant, and my best friend. I miss him every day. To honor my father, and to keep other families from experiencing the same loss, I will continue to go anywhere, and speak to anyone, about the importance of getting screened for colorectal cancer. I hope you continue to join me in this effort.

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Register Today: Turning the Tide Against Cancer 2017 National Conference    

In 2012, AACR joined forces with the Personalized Medicine Coalition (PMC), and Feinstein Kean Healthcare (FKH) to convene the Turning the Tide Against Cancer Through Sustained Medical Innovation initiative to address the challenge of identifying policy solutions that will sustain medical innovation, while addressing the issue of rising healthcare costs.

Over the past five years, the initiative has hosted two national conferences in Washington, D.C., and several roundtables to catalyze a dialogue on with an evolving conversation from how to accelerate progress and improve patient care in a deficit reduction environment and to review the current cancer research and care landscape, with a focus on patient-centeredness and issues around value.

Since then, we have deepened our efforts to understand how clinical pathways, and shared decision-making tools can support the delivery of innovative and high-quality cancer care and research. As primary beneficiaries of oncology innovation, patients should play a leading role from research and development to the delivery of care. This summer, leaders from across the oncology community will convene in the nation's capital to explore the role of the patient across the continuum of cancer research and care, and delineate strategies for policymakers to consider that support meaningful patient engagement and deliver value to patients.

Join AACR along with conference co-hosts, PMC, FKH, and CancerCare, for the Turning the Tide Against Cancer Through Sustained Medical Innovation 2017 National Conference on June 29, 2017, at the Ronald Reagan Building and International Trade Center in Washington, D.C. Space is limited, register today.

At the conference, you will have an opportunity to engage with representatives from the clinical, scientific, patient, and policy communities to identify policy pathways related to:

  • Where does oncology innovation stand and where is it headed under a new administration?
  • What is the patient's role in innovation as the key beneficiary of value-based care?
  • What tools can we leverage to incentivize patient-driven value in oncology care?

AACR CEO Margaret Foti, PhD, MD (hc) will give welcome remarks followed by a morning keynote by George D. Demetri, MD, chair of the AACR Science Policy and Government Affairs Committee and Director of the Center for Sarcoma and Bone Oncology at Dana-Farber Cancer Institute.

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AACR Annual Meeting 2017 Webcasts Now Available    

As part of their registration, all paid Annual Meeting registrants receive exclusive online streaming access to the audio and slides of all scientific sessions presented at the AACR Annual Meeting 2017 (pending speaker permission). While registrants can access the complete webcast, selected sessions are currently available free to everyone, including all Regulatory Science and Policy and Science Policy sessions. Click on the links below to access the webcasts.

Special Session. Beau Biden Cancer Moonshot: Progress & Promise (free)

  • Speech by former Vice President Joe Biden
  • Panel Discussion
    • Nancy E. Davidson (moderator) – Fred Hutchinson Cancer Research Center
    • Elaine L Chao – U.S. secretary of transportation
    • Fran Drescher – actress and founder, Cancer Shmancer
    • Richard Pazdur – Director, FDA Oncology Center of Excellence
    • Douglas R Lowy – acting director, National Cancer Institute
    • Michael A Caligiuri – director, The Ohio State University Comprehensive Cancer Center; CEO, James Cancer Hospital and Solove Research Institute
    • Elizabeth M. Jaffee – deputy director, Johns Hopkins Kimmel Comprehensive Cancer Center
    • Roger D. Dansey – senior vice president, Global Clinical Development Oncology, Merck
    • Kevin Yoder – U.S. Representative (R-KS)


Regulatory Science and Policy Sessions (All webcasts free)

RSP01. Understanding Mechanism-based, Cardiovascular Adverse Events Associated with Immune Checkpoint Blockade: Implications for Prevention and Management

  • Laleh Amiri Kordestani (Co-chair) – FDA
  • Javid Moslehi (Co-chair) – Vanderbilt Univ.
  • George Demetri – Dana-Farber Cancer Institute
  • David Feltquate – Bristol-Myers Squibb
  • Shiv Pillai – Harvard Medical School
  • Suzanne Topalian – Johns Hopkins Kimmel Cancer Ctr.


RSP02. Real-World Evidence in Oncology and Its Implications

  • Amy Abernethy (Chair) – FlatIron Health
  • Kassa Ayalew – FDA
  • Sean Khozin – FDA
  • Jeff Allen – Friends of Cancer Research
  • Jacqueline Law – Genentech, Inc.
  • Raymond DuBois – Medical Univ. South Carolina


RSP03. Tables Turned: A Conversation with the Press about the Future of Cancer Research and Treatment

  • Richard Pazdur (Chair) – FDA
  • Adam Feuerstein – The Street
  • Matthew Herper – FORBES
  • Laurie McGinley – The Washington Post
  • Meg Tirrell – CNBC


RSP04. Regulatory Considerations for Utilizing Liquid Biopsies in Drug and Diagnostic Development

  • Pasi Jänne (Co-chair) – Dana-Farber Cancer Institute
  • Gideon Blumenthal (Co-chair) – FDA
  • Reena Philip (Co-chair) – FDA
  • Abraham Tzou – FDA
  • Suzanne Jenkins – AstraZeneca
  • Gary Kelloff – National Cancer Institute
  • Walter Koch – Roche
  • Howard Scher – Memorial Sloan Kettering Cancer Ctr.
  • Phil Stephens – Foundation Medicine
  • AmirAli Talasaz – Guardant Health


RSP06. Reference Materials for Next Generation Sequencing (NGS)-Based Tests

  • Elaine Mardis (Co-chair) – Nationwide Children's Hospital
  • David Litwack (Co-chair) – FDA
  • Zivana Tezak – FDA
  • Maryellen de Mars – ATCC
  • Girish Putcha – Freenome
  • Marc Salit – NIST
  • Kenna Mills Shaw – MD Anderson Cancer Ctr.
  • Jeffrey Trent – TGen


RSP07. Immuno-oncology Combination Therapies

  • Geoffrey Kim (Chair) – FDA
  • Chao Liu – FDA
  • Amy Rosenberg – FDA
  • Daniel Chen – Genentech, Inc.
  • Bernard Fox – Earle A. Chiles Research Inst.
  • Elizabeth Jaffee – Johns Hopkins Kimmel Cancer Ctr.
  • Sreeneeranj Kasichayanula – Amgen, Inc.


RSP08. New Drugs – A Review of Recently Approved Breakthrough Therapies

  • Amy McKee (Chair) – FDA
  • Sanjeeve Balasubramaniam – FDA
  • Leslie Doros – FDA
  • Daniel Suzman – FDA
  • Deborah Armstrong – Johns Hopkins Kimmel Cancer Ctr.
  • Dan Theodorescu – Univ. of Colorado Cancer Ctr.
  • Katie Thornton – Dana-Farber Cancer Institute


Science Policy Sessions (All webcasts free)

SP01. The Potential Impact on Cancer Patients of a Repeal or Revision of the Affordable Care Act

  • Gilbert S. Omenn (Chair) – Univ. of Michigan
  • Andrea Bargellini – Patient Advocate
  • Diana Chingos – Patient Advocate
  • Chiara D`Agostino – Patient Advocate
  • Ernest T. Hawk – UT MD Anderson Cancer Ctr.


SP02. E-cigarettes: Are they a Public Health Threat or a Useful Cessation Tool?

  • Benjamin A. Toll (Chair) – Yale Cancer Center
  • Roy S. Herbst – Yale Cancer Ctr.
  • Rachel Grana – National Cancer Institute
  • Brian A. King – Centers for Disease Control and Prevention
  • Lion Shahab – University College London

Webcasts of the opening and plenary sessions are available for free at this link.

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Register Today: Rally for Medical Research    

In March, we were shocked to learn that the Trump administration is proposing to cut $5.8 billion from the National Institutes of Health (NIH) budget in fiscal year (FY) 2018. These draconian proposed cuts make this year’s Rally for Medical Research more important than ever for protecting funding for lifesaving cancer research. The fifth annual Rally for Medical Research Hill Day will be held on Sept. 14, 2017, in Washington, D.C., with a reception on the evening prior. Registration is now open and all interested advocates of biomedical research are invited to register. For those unable to travel to D.C., there will also be a National Day of Action, where advocates will be able to contact their senators and representative from anywhere in the United States to urge support for the National Institutes of Health.

Stay up-to-date on by visiting the Rally website, Facebook, and Twitter pages.


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Save the Date: Upcoming AACR-FDA Regulatory Science & Policy Workshops    

Two upcoming joint AACR-FDA Regulatory Science and Policy workshops are currently planned.

Immuno-oncology Combination Therapies (July 20, 2017): Building on the momentum of the AACR Annual Meeting 2017 "Immuno-oncology Combinations" symposium and two highly successful, AACR co-sponsored, dose-finding workshops with the U.S. Food and Drug Administration (May 2015, June 2016), this interdisciplinary workshop will examine topics such as meaningful biomarker selection for immuno-oncology, optimizing combination approaches for I-O, and discussion of I-O combination labeling.

  • AACR Chair: Elizabeth M. Jaffee, MD, AACR president-elect; deputy director, The Sidney Kimmel Comprehensive Cancer Center; professor, oncology and pathology, The Johns Hopkins University School of Medicine; active staff in oncology, The Johns Hopkins Hospital; associate director for translational research, co-director of gastrointestinal cancer and diseases program, and co-director of The Skip Viragh Center for Pancreatic Cancer Research and Patient Care, The Sidney Kimmel Comprehensive Cancer Center; medical director, Johns Hopkins Oncology Center, Cell Processing and Gene Therapy Facility, and faculty, Graduate Programs in Immunology, Cellular and Molecular Medicine, and Pharmacology, The Johns Hopkins University School of Medicine
  • FDA Chair: Amy E. McKee, MD, deputy officer director (Acting), Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, FDA
     

Liquid Biopsies: Breast Cancer Focus (October 10, 2017): Technology has evolved to enable the development of tests that can detect signs of cancer in blood and other bio-fluids. Liquid biopsies are an exciting development, but this technology presents unique regulatory concerns, particularly in establishing analytic and clinical validity. This breast cancer-focused workshop will build upon the AACR Annual Meeting 2017 symposium "Regulatory Considerations for Utilizing Liquid Biopsies in Drug and Diagnostic Development" and the July 2016 U.S. Food and Drug Administration-AACR co-sponsored workshop on liquid biopsies. Participants will examine regulatory challenges in adopting this technology for early detection, disease monitoring, and the potential use as surrogate end point markers for drug development.

  • AACR Co-chairs:
    • Carlos L. Arteaga, MD, AACR past president (2014-2015); Donna S. Hall chair in breast cancer research; professor of medicine and cancer biology, Vanderbilt University associate director for translational/clinical research; director, Breast Cancer Program; director, Center for Cancer Targeted Therapies; director, Vanderbilt-Ingram Cancer Center Research Network, Vanderbilt-Ingram Cancer Center
    • Pasi A. Jänne, MD, PhD, AACR Regulatory Science and Policy Subcommittee member; director, Lowe Center for Thoracic Oncology; scientific director, Belfer Institute for Applied Cancer Science; senior physician, Dana-Farber Cancer Institute and professor of medicine, Harvard Medical School
  • FDA Co-chairs:
    • Julia Beaver, MD, clinical team leader Breast and Gynecological Malignancies Group, OHOP/CDER/FDA
    • Gideon Blumenthal, MD, clinical team leader, Thoracic and Head/Neck Oncology, Office of Hematology and Oncology (OHOP), Center for Drug Evaluation and Research (CDER), FDA
    • Reena Philip, PhD, director, Division of Molecular Genetics and Pathology (DMGP), Office of In Vitro Diagnostics and Radiological Health (OIR), Center for Devices and Radiological Health (CDRH), FDA
Sign up here to receive updates about these and other upcoming Regulatory and Science Policy Workshops, including information about workshop registration.

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