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Cancer Policy Monitor: Nov. 7, 2017      

Cancer Policy Updates from Capitol Hill     

In October, Congress narrowly passed a budget blueprint that Congressional Republicans hope to use to advance tax reform legislation. Congress still needs to reach an agreement that lifts caps on non-defense discretionary spending before final passage of appropriations bills that raise funding for NIH by $2 billion over FY 2017.

Budget/Appropriations Update

Late last month, Congress narrowly passed a budget agreement that cleared the way for Republicans to advance tax reform legislation this fall. Since shifting from failed health care reform efforts, the tax debate has taken up most of Congress’ time. Though the House has passed appropriations bills, Congress will still need to come to a budget agreement that raises caps on discretionary spending in order to make proposed increases for the National Institutes of Health (NIH) and other agencies. The government is currently funded under a continuing resolution (CR) for fiscal year (FY) 2018, which started Oct. 1. This CR will expire Dec. 8, and it is likely that Congress will need to approve another CR to complete its work on appropriations. 

AACR Members on the Hill

Members of the AACR Science Policy and Government Affairs Committee attended meetings with key congressional offices during a visit to Capitol Hill Nov. 1. Members met with Senator DianeFeinstein (D-CA), the office of Senate Majority Leader Mitch McConnell (R-KY), the office of Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Lamar Alexander (R-TN), and the office of Rep. Mark Walker (R-NC), who is chairman of the Republican Study Committee. Members urged these congressional leaders to support a budget agreement that would lift the spending caps currently in place and to increase the NIH budget by $2 billion for FY 2018.

CDMRP

A conference committee consisting of members of the House and Senate Armed Services Committees has been meeting to work out differences in the two chambers’ versions of the National Defense Authorization Act (NDAA). One topic of discussion is the Congressionally Directed Medical Research Programs (CDMRP) under the Department of Defense. Fifty-four members of the Senate and 160 members of the House signed “Dear Colleague” letters to the leaders of the Armed Services Committees, asking them to remove provisions included in the Senate bill that would have the effect of weakening the CDMRP. The House, which had earlier passed an appropriations bill including significant funding for CDMRP, did not include the troubling provisions in its version of the NDAA.

Childhood Cancer STAR Act

The Childhood Cancer Survivorship, Treatment, Access, and Research (STAR) Act is gaining momentum. The STAR Act, the most comprehensive childhood cancer legislation ever taken up by Congress, currently has over 300 co-sponsors in the House and more than 25 in the Senate. For more information on the STAR Act, please visit the Alliance for Childhood Cancer website. To see if your congressmen are co-sponsors, please see the House co-sponsor list and the Senate co-sponsor list. If they are not listed, please consider reaching out to your member of Congress and asking them to support this legislation.

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Norman (“Ned”) Sharpless, MD Sworn in as Director of the National Cancer Institute      

The AACR congratulates Norman “Ned” Sharpless, MD, on being sworn in as the 15th director of the National Cancer Institute (NCI). Prior to his appointment, Dr. Sharpless served as director of the NCI-Designated Lineberger Comprehensive Cancer Center at the University of North Carolina School of Medicine, Chapel Hill. He was also a member of the AACR’s Science Policy and Government Affairs Committee.

“We are extremely excited to be able to now officially welcome Dr. Sharpless as the next NCI Director. He brings impressive qualifications to this extremely important position, including his background as a top-tier physician-scientist and his previous positions at the University of North Carolina (UNC), including his current role as director of the prestigious UNC Lineberger Comprehensive Cancer Center," said AACR President Michael A. Caligiuri, MD, director, The Ohio State University Comprehensive Cancer Center and chief executive officer of the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. "His enthusiasm for innovative scientific methods and ideas, as well as his appreciation for the value and importance of basic research to advancing translational discoveries, will allow the NCI to continue leading the way in programs aimed at preventing disease, improving health and reducing suffering from cancer, while also helping to maintain America’s edge in the life sciences."

Dr. Sharpless succeeds Doug Lowy, MD, who has served as acting director of the NCI since the spring of 2015. During his two years as acting director, Dr. Lowy provided critical leadership to advance the National Cancer Moonshot Initiative that former Vice President Joe Biden spearheaded during the final year of the Obama Administration.

“The entire cancer research and patient care community owes Dr. Lowy a tremendous amount of gratitude over the past two years for his extraordinary dedication and outstanding commitment to reducing cancer incidence, morbidity, and mortality,” said Margaret Foti, PhD, MD (hc), chief executive officer of the AACR. “As the new NCI director, Dr. Sharpless will ensure a continuity in leadership and management that is especially needed during this historic era of unprecedented scientific opportunities that are before us. Therefore, we are absolutely thrilled about Dr. Sharpless’ new role as we greatly respect and value his expertise and leadership in the cancer research community, and the AACR truly looks forward to working with Dr. Sharpless in the months and years to come.”

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Apply Today: 20th Annual Scientist↔Survivor Program at the AACR Annual Meeting      

Cancer patient advocates who support cancer research through policy advocacy, research advocacy, and/or community outreach are invited to apply for the Scientist↔Survivor Program at the 2018 AACR Annual Meeting. The Annual Meeting highlights the best cancer science and medicine from institutions all over the world. Application deadline is Dec. 5.

Survivor and patient advocates who participate in the Scientist↔Survivor Program at the annual meeting:

  • Attend special lectures about cancer research that are tailored to a lay audience;
  • Discuss relevant and timely cancer topics during small group meetings, roundtable discussions and meetings with scientific mentors;
  • Explore the scientific sessions of the annual meeting on heir own or with scientific mentors or other advocates;
  • Communicate to scientists the key issues, questions and concerns of the survivor and patient advocacy communities;
  • Promote their organizations' missions by participating in their own poster sessions; and
  • Network with scientists and fellow advocates from local, national, and international cancer organizations.

The AACR covers travel and lodging for accepted participants during the program. Participants are responsible for any incidental expenses, including tips, meals outside the program, phone, laundry, baggage fees, poster costs, and rental cars.

Scientist↔Survivor Program participants are accepted by competitive application. Survivor and patient advocates are encouraged to apply if they:

  • Actively support cancer research through policy advocacy, research advocacy, and/or community outreach;
  • Have a constituency with which they will share the knowledge they gain through the program;
  • Have access to avenues for disseminating the knowledge gained from the program to colleagues and/or constituents;
  • Are able to present an advocate poster during a poster session;
  • Are able to participate in all components of the four-day program.
Learn more and access application materials here.


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Highlights from the AACR Conference on the Science of Cancer Health Disparities      

The Tenth AACR Conference on The Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved was held in Atlanta, Georgia. With over 650 people attending, it was the largest AACR Disparities Conference yet.

Major themes discussed included the need for increased minority participation in clinical trials, the importance of primary care physicians in recommending appropriate prevention strategies and screenings to minority populations, the role of the Affordable Care Act (ACA) in decreasing health disparities, the need to understand the role that behavioral health and social determinants of health play in reducing health disparities, and the impact of tobacco use on the health of minority populations.

Michael A Caligiuri, MD, AACR president 2017-18 and director of The Ohio State University Comprehensive Cancer Center, opened the conference, stating that reducing disparities in health care is a passion of his that comes from the heart. Addressing cancer health disparities is one of Dr. Caligiuri's main goals during his term as president of the AACR.

Dr. Caligiuri highlighted both biological and social determinants of health disparities. He discussed a 2016 study where his collaborators and he looked into whether environmental enrichment could protect against cancer. Mice were placed in either an enriched or control environment to study the potential impact on the progression of cancer. Researchers found that mice that were placed in the enriched environment overexpressed brain-derived neurotrophic factor (BDNF), which in turn induced T-cell development. This increase in T-cells led to the halt of cancer progression.

Dr. Caligiuri also addressed data collection in cancer research, particularly the need for more data on minority health. To increase the participation of minorities in data sets, such as Oncology Research Information Exchange Network (ORIEN) and AACR's Project Genomics Evidence Neoplasia Information Exchange (GENIE), he began the 2020 by 2020 Presidential Initiative. The goal of this initiative, for which the Morehouse School of Medicine is a strategic partner, is to collect cancer genomes and clinical data sets from 2020 African-American cancer patients by 2020.

Conference co-chairs, John M. Carethers, MD (chair of Internal Medicine at the University of Michigan School of Medicine), Rick Kittles, PhD (founding director of the Division of Health Equities at the City of Hope Comprehensive Cancer Center), Christopher Li, MD, PhD (co-program head of the Translational Research Program at the Fred Hutchinson Cancer Research Center), and Electra D. Paskett, PhD (director of the Division of Cancer Prevention and Control at the Ohio State University College of Medicine), provided an overview of the progress that has been made in the decade since the first AACR Conference on the Science of Cancer Health Disparities.

Dr. Carethers stated that one of the most positive developments of the past decade is that, as of July 2017, the U.S. Preventative Services Task Force now recommends that African-Americans be screened for colon cancer at age 45, as opposed to age 50 for other racial groups. Dr. Li stated that breast cancer disparities seen in the 1990s still persist today. Dr. Kittles added that not much progress has been made in the past 10 years in prostate cancer, either, where, despite a risk allele being identified in African-American men, there has been little understanding of the role of that allele. However, recent studies on alternate splicing and epigenetics in African-Americans as well as on vitamin D deficiency are starting to explain some of the biological factors leading to prostate cancer. Dr. Paskett discussed the progress that has been made in cervical cancer in the past 10 years. Desipte the incidence of cervical cancer decreasing worldwide, disparities remain among some minority populations where many women still lack access to follow-up care to abnormal pap test or do not have access to the HPV vaccine on the proper dosing schedule.

This year’s AACR Distinguished Lecture on Science of Health Disparities, funded by Susan G. Komen, was awarded to Julie R Palmer, ScD, professor of epidemiology at Boston University. Dr. Palmer was one of the leaders in the Black Women’s Health Study, which in 1995 enrolled 59,000 African-American women and then followed them for over 20 years to study the impact of various factors on their health. She discussed the widening mortality gap in breast cancer, where African-American women have a 43 percet higher death rate than Caucasian women. Access to care as well as biology are both factors that contribute to this disparity in outcomes.

Learn more about the conference. Learn more about the AACR's  Minorities in Cancer Research (MICR) group.

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Materials from the Latest FDA-AACR Workshops Now Available    

Materials, including transcripts, from the two most recent FDA-AACR Regulatory Science and Policy workshops, Oncology Dose Finding Workshop Part III and Liquid Biopsies in Oncology Drug and Device Development Part II, are now available on the AACR website, where you can also sign up to receive updates about upcoming workshops.  

FDA-AACR: Oncology Dose Finding Workshop Part III

This workshop focused on approaches to combination therapy and best practices regarding patient and dose selection, biomarkers to aid in selection, and novel endpoints that can define patient benefit.

See the agenda and view workshop slides.

Read the transcripts: Session 1. Session 2. Session 3.

Watch the videos: Session 1. Session 2. Session 3.

Read the speaker bios.

FDA-AACR: Liquid Biopsies in Oncology Drug and Device Development Part II

This workshop built upon a previous FDA-AACR co-sponsored workshop on liquid biopsies and examined the regulatory challenges in adopting this technology for early detection, disease monitoring, and the potential use as surrogate end point markers for drug development.

See the agenda and view the workshop slides.

Read the transcripts: Session 1. Session 2. Session 3. Session 4.

Read the speaker bios.

Sign up here to receive updates about upcoming Regulatory and Science Policy Workshops, including information about workshop registration.

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FDA to Hold Special Session for Patient Advocates at SABCS    

Patient advocates who are planning on attending the San Antonio Breast Cancer Symposium (SABCS) this year are invited to participate in a special U.S. Food and Drug Administration (FDA) session for patient advocates. The session will take place Thursday, Dec. 7, from noon-1 p.m. in Room 221 of the Henry B. Gonzalez Convention Center. This session provides an opportunity for patient advocates to learn more about the role of the FDA in oncology drug development and interact with key FDA officials.

Participating in the FDA’s special session for advocates are several key FDA staff members who provide regulatory oversight for breast cancer treatments, including Julia Beaver, MD, director of the Division of Oncology Products 1 (DOP1) at the FDA’s Office of Hematology and Oncology Products; as well as members of the DOP1’s Breast Cancer Team including clinical team leader Laleh Amiri-Kordestani, MD; Suparna Wedam, MD; Tatiana Prowell, MD; Nancy Scher, MD; Sara Horton, MD; Jennifer Gao, MD; and Lynn Howie, MD.

Date: December 7

Time: noon-1 p.m.

Location: Room 221, Henry B. Gonzalez Convention Center

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FDA-AACR-ASCO-ASH Workshop: Partners in Progress, Cancer Patient Advocates and FDA    

The Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) announces the first annual educational workshop for new cancer patient advocates entitled, "Partners in Progress: Cancer Patient Advocates and FDA." The meeting will be held Nov. 13, 2017, from 9 a.m. - 4 p.m. at the FDA White Oak Campus, Building 31 Great Room, 10903 New Hampshire Ave, in Silver Spring, Maryland.

The objectives of this meeting are to provide basic training on the role of the FDA and cancer patient advocates in oncology product development. This broad introduction to FDA regulatory aspects of oncology product development will be most relevant to attendees with limited knowledge and experience in cancer product development and patient advocacy.

Support for this meeting is provided by the following organizations: The American Association for Cancer Research (AACR), the American Society of Clinical Oncology (ASCO), and the American Society of Hematology (ASH).

 I
n-person registration is limited to 150 persons due to space limitations and registration applications will be reviewed prior to finalization to ensure broad representation of individual groups. However, webcast attendance is available to all who register.

Register for in-person or webcast participation.

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FDA Public Workshop: Assessment of Cardiovascular Toxicities in Immuno-oncology Trials    

On Dec. 1, the U.S. Food and Drug Administration (FDA) is announcing a full-day public workshop entitled, “Assessment of Cardiovascular Toxicities in Immuno-oncology Trials” organized by the FDA Oncology Center of Excellence (OCE) with support from the American Association for Cancer Research (AACR), American College of Cardiology (ACC), American Heart Association (AHA) and American Society of Clinical Oncology (ASCO), with Co-Chairs Laleh Amiri-Kordestani, MD and Javid Moslehi, MD.

This workshop will provide a forum for discussion of cardiovascular toxicities in immuno-oncology clinical trials. The focus of the workshop is to identify best practices to assess cardiovascular and metabolic toxicities in patients receiving cancer immunotherapies.

The workshop will be held at the FDA White Oak Campus, Building 31, Room 1503 - Great Room A, 10903 New Hampshire Ave, in Silver Spring, Maryland. In-person registration is limited to first 110 people; however, the FDA will provide a free-of-charge, live webcast of the workshop for those who cannot attend in person. Further information regarding the webcast, including the web link for the webcast, will be made available closer to the workshop date.

Register for in-person or webcast participation.

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Share Your Cancer Research or Advocacy Story    

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. There is no deadline to submit your story. We will be accepting stories throughout the year. Submit your story and/or links​.

Ken Dutton-Regester, a melanoma researcher who serves as the chairperson of the AACR Associate Member Council, the leadership body of the associate members of the AACR, shared the story of his work. Ivy Elkins, a lung cancer advocate in the AACR Scientist↔Survivor Program, shared the story of how she became a lung cancer advocate. Kerie Berkowitz shared the story of how she survived ovarian cancer and became an advocate for survivorship issues.

Read more stories​ and submit yours today!

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