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Cancer Policy Monitor: March 2019

Cancer Policy Monitor: March 12, 2019

Appropriations Update from Capitol Hill

-Brandon Leonard, MA

Congress finalized funding for fiscal year (FY) 2019 Feb. 14, approving a package that included the seven remaining appropriations bills. The deal came after an agreement to end a 35-day partial government shutdown, the longest in U.S. history. The final appropriations package approved by Congress and signed into law by the president includes a $269 million (9 percent) increase for the Food and Drug Administration (FDA), the largest in five years, for a total of $3.08 billion. The Oncology Center of Excellence (OCE) at FDA received funding of $20 million. The National Science Foundation (NSF) received an increase of $307.6 million (4 percent) for a total of $8.1 billion.

Congress will now turn its attention to the budget and appropriations process for (FY) 2020. The president’s budget proposal is generally released in early February but was delayed this year due to the partial government shutdown. An outline of the proposal is now expected to be released the week of March 11, with the full proposal to follow the week of March 18.

Russell Vought, acting director of the Office of Management and Budget (OMB), has stated that the president will propose a 5 percent cut to non-defense discretionary spending in his upcoming budget request. He also said the proposal will adhere “to the spending caps already set in law.” While Congress reviews and responds to the president’s budget, both the House and Senate will then proceed to work on their own budget proposals. Congress must reach a deal to raise the budget caps currently in place or risk slashing defense spending by $71 billion and non-defense spending by $55 billion in FY 2020.

The AACR will continue to advocate for Congress to reach a two-year budget agreement to lift the caps in order to allow for continued investment in priority areas including medical research. The AACR also joins the medical research advocacy community in supporting an FY 2020 funding request of $41.6 billion for the National Institutes of Health (NIH), an increase of $2.5 billion over FY 2019 levels.

AACR Hosts Fourth Early-career Hill Day in Support of NIH Funding

-Brandon Leonard, MA

The AACR held its fourth annual Early-career Hill Day, Thursday, Feb. 28. The event brought 16 early-career scientists to Capitol Hill to advocate for medical research funding at the National Institutes of Health (NIH). Patricia LoRusso, DO, associate director of experimental therapeutics at Yale Cancer Center, served as the senior scientist mentor for the Hill Day.

In all, participants visited 65 congressional offices to ask that they work toward a bipartisan budget deal to lift the caps on nondefense, discretionary spending currently in place due to the Budget Control Act of 2011; and to support an increase of $2.5 billion for the NIH in fiscal year (FY) 2020. The researchers also thanked Congress for passing a $2 billion increase for the NIH in FY 2019.

In conjunction with the Hill Day, participants and the AACR encouraged early-career scientists around the country to join a National Day of Action by writing to their members of Congress or sending them messages on social media in support of NIH funding.

Andreana Holowatyj, PhD, MS, a member of the AACR Associate Member Council (AMC) and returning Hill Day participant, wrote a blog post on her experience highlighting the value of advocacy for researchers. You can find the post on the AACR’s Cancer Research Catalyst blog.

Tobacco and Cancer Session at 2019 AACR Annual Meeting to Discuss U.S. Youth E-cigarette Epidemic

– Nicole Boschi, PhD

U.S. public health officials, including U.S. Food and Drug Administration (FDA) Commissioner, Scott Gottlieb, MD, and Surgeon General Jerome Adams, MD, MPH, have declared that the alarming rise in youth electronic cigarette (e-cigarette) use has reached epidemic proportions. A 2018 national survey highlighted that over 37 percent of 12th graders reported use of e-cigarette products in the past 12 months, compared to 28 percent in 2017. These products are now the most commonly used form of tobacco among youth in the U.S. Most e-cigarettes contain nicotine. The use of these products may lead to addiction and harm the developing adolescent brain. These alarming statistics have led the FDA to announce that it will limit most e-cigarette sales to age-restricted, in-person locations and have prompted a Surgeon General’s Advisory calling upon parents, teachers, health professionals, and government officials to take aggressive steps to keep children from using e-cigarettes. Although e-cigarettes pose a danger to youth, it has been acknowledged that these products are safer than combustible cigarettes for adult tobacco users and that they have a role in a harm reduction approach to tobacco policy. An interesting contrast to the U.S. youth epidemic has been the United Kingdom’s (UK) experience with e-cigarettes. Because of the UK’s implementation of marketing restrictions, control of e-cigarette flavorings, and e-cigarette nicotine content restrictions, concerns regarding youth uptake of these products have not materialized there.

The session, taking place Monday, April 1 from 3 – 4:45 pm at the 2019 AACR Annual Meeting in Atlanta, Georgia, will discuss the growing concern over the significant increase in the use of e-cigarettes among high school and middle school students, and will provide research updates on e-cigarettes related to their initiation, toxicity, and dependence. Additionally, the different viewpoints on and experiences with e-cigarettes will be discussed, including how these products are potentially being used for harm reduction by adult smokers who completely switch from combustible cigarettes to e-cigarettes. The session will be moderated by Roy S. Herbst, MD, PhD, chair of the AACR’s Tobacco and Cancer Subcommittee and will feature speakers from U.S. government agencies such as: Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products; Michele Bloch, MD, PhD, chief of the Tobacco Control Research Branch within the Division of Cancer Control and Population Sciences at the National Cancer Institute; Brian A. King, PhD, MPH, deputy director for research translation in the Office on Smoking and Health within the National Center for Chronic Disease Prevention and Health Promotion at the Centers for Disease Control and Prevention. Additionally, the session will feature Alison Cox, PhD, director for cancer prevention at Cancer Research UK; and D’Jillisser Kelly, MPH an Atlanta-area public health professional.

Cancer Research Advocacy to be Featured in Annual Meeting 2019 Programs and Sessions

Research advocates add tremendous value to cancer research and policy. They lobby on Capitol Hill to increase funding for cancer research and promote science-based policies. They confront disparities in clinical trial participation by increasing awareness and education to underrepresented communities. They partner with researchers to prioritize the research questions and outcomes that are most important to the patient community. They serve as consultants to inform clinical trial designs that can increase efficiencies and reduce patient burden. And, they are critical conduits of communication between the scientific, patient, and medical communities.

The AACR recognizes the important role advocates play in the research ecosystem. A number of programs at the AACR Annual Meeting 2019 support and celebrate cancer survivors and advocates. Below are a few highlighted events and programs. Learn more about the Survivorship Track.

Scientist↔Survivor Program

This unique educational program provides an opportunity for cancer survivors, advocates and scientists to learn about and discuss the latest findings in cancer research, regulatory science, and health science policy. Led by Dr. Anna Barker, the curriculum is designed to build enduring partnerships among the leaders of the scientific, survivor, and advocacy communities. Participants are accepted through a competitive application process.

Exceptional Leadership in Cancer Advocacy Award

The AACR presents special recognition awards to individuals whose work has made extraordinary contributions to the AACR’s mission of accelerating the prevention and cure of all cancers through research, education, communication, and collaboration. The 2019 award recipient will be announced during the opening ceremony!

Making Your Voice Heard: How to Effectively Advocate for Cancer Research and Science-based Policy

Saturday, March 30, 2019, 10:15 a.m.-12:15 p.m., Room A402-403

This educational session will provide attendees with the tools and information needed to advocate for federal investment in cancer research as well as policies important to cancer researchers and survivors. A diverse panel of AACR members who have been active in research advocacy will share their perspectives and experiences, and discuss the AACR’s numerous initiatives in government relations and science policy.

Presidential Select Symposium: Engaging Cancer Patients as Partners in the Research Process

Sunday, March 31, 2019 1-2:30 p.m., Room A311-312

Stakeholders in drug development recognize patients as equitable partners in the research process. As experts in the lived experience of cancer, patients provide a unique first-person perspective that can inform drug development and clinical care. A growing body of evidence indicates that engaging patients in research leads to trustworthy and usable information, which accelerates drug development, and increases the adoption of results by the healthcare community. Yet, while initiatives to improve engagement appear to be on the rise, many organizations fail to deploy even the most basic methods to engage patients. Technological innovations such as wearables, mobile health, and companion apps promise to stimulate adoption efforts. This session will share proven engagement practices, as well as, identify gaps that need to be addressed, if we are to ensure that the patient voice is fully integrated into the research continuum.

Regulatory Science and Policy Sessions at the AACR Annual Meeting 2019

The Regulatory Science and Policy track provides an opportunity to interact with representatives from the FDA, industry, and academia. These informative sessions are designed to highlight recent regulatory developments and provide an open forum for the discussion of cutting-edge issues in cancer drug, biologic, and diagnostic regulation. Learn more about the sessions in our largest Regulatory Science and Policy track ever by following the links below.

PD-1 Pandemonium: FDA Speaks with Industry on the Past, Present, and Future of PD-1 Drugs

Richard Pazdur (Moderator) – FDA, Silver Spring, Maryland
Marc Theoret (Moderator) – FDA, Silver Spring, Maryland

Hesham A. Abdullah – AstraZeneca, Rockville, Maryland
Kevin Chin – EMD Serono, Billerica, Massachusetts
Scot W. Ebbinghaus – Merck, Lansdale, Pennsylvania
Israel Lowy, Regeneron – Tarrytown, New York
Fouad Namouni – Bristol-Myers Squibb, Princeton, New Jersey
Alan B. Sandler – Genentech, South San Francisco, California

FDA 201 – Topics in Oncology Regulation

Harpreet Singh (Cochair) – FDA, Silver Spring, Maryland
Lola A. Fashoyin-Aje (Cochair) – FDA, Silver Spring, Maryland

R. Angelo de Claro – FDA, Silver Spring, Maryland
Nicole J. Gormley – FDA, Silver Spring, Maryland
Ke Liu – FDA, Silver Spring, Maryland
Pallavi Mishra-Kalyani – FDA, Silver Spring, Maryland
Rajeshwari Sridhara – FDA, Silver Spring, Maryland

Cancer Genomic Reference Samples – MDIC Somatic Reference Sample Collaborative Initiative

Živana Težak (Chair) – FDA, Silver Spring, Maryland

Wenming Xiao – FDA, Silver Spring, Maryland
J.D. Alvarez – Janssen, Spring House, Pennsylvania
Chris Karlovich – Frederick National Laboratory, Frederick, Maryland
Diana M. Merino – Friends of Cancer Research, Washington, D.C.
Barbara A. Zehnbauer – Emory University School of Medicine, Atlanta, Georgia

Impact of a Brexit on Oncology Drug Development and Regulation

C. Simone Fishburn (Chair) – BioCentury, Redwood City, California

Susan M. Galbraith – AstraZeneca, Cambridge, United Kingdom
Joanne M. Hackett – Genomics England, London, United Kingdom
John Haurum – Cambridge, United Kingdom
Richard M. Marais – Cancer Research UK Machester Institute, Manchester, United Kingdom

East Looks West: Chinese Pharma Explores Western Markets

Joshua L. Berlin (Chair) – BioCentury, Redwood City, California

Frank Jiang, CStone Pharmaceuticals, Shanghai, China
Joan Shen – I-Mab Biopharma, Shanghai, China
Dan Zhang – Foundation Medical Development, Beijing, China

West Looks East: Western Pharma Explores the China Mainland

Ke Liu (Chair) – FDA, Silver Spring, Maryland

George Chen – AstraZeneca, Shanghai, China
Xiaoyuan Chen – Tsinghua University, Beijing, China
Fangning Zhang – McKinsey & Company, Beijing, China

Hyper-progression and Immuno-oncology: Scientific, Clinical, and Regulatory Challenges

Victoria L. Chiou (Cochair) – FDA, Silver Spring, Maryland
Elad Sharon (Cochair) – NCI, Bethesda, Maryland

Marina C. Garassino – Istituto Nazionale dei Tumori, Milan, Italy
Razelle Kurzrock – UCSD Moores Cancer Center, San Diego, California
Susan L. Leighton – Patient Advocate, Huntsville, Alabama
Lawrence H. Schwartz – Columbia University Medical Center, New York, New York
Jean-Charles Soria – MedImmune, Gaithersburg, Maryland

Artificial Intelligence and Machine Learning for Regulatory Science and Drug Development Applications

Sean Khozin (Chair) – FDA, Silver Spring, Maryland

Metin N. Gurcan – Wake Forest School of Medicine, Winston-Salem, North Carolina
Lawrence H. Schwartz, Columbia University Medical Center, New York, New York
Pratik Shah – Massachusetts Institute of Technology, Cambridge, Massachusetts

Differentiation Syndrome in Acute Myeloid Leukemia: Challenges for Drug Development and Regulation

Kelly J. Norsworthy (Cochair) – FDA, Silver Spring, Maryland
E. Dianne Pulte (Cochair) – FDA, Silver Spring, Maryland

Jessica K. Altman – Northwestern Medicine, Chicago, Illinois
Mark J. Levis – Johns Hopkins Sidney Kimmel Cancer Center, Baltimore, Maryland
B. Douglas Smith – Johns Hopkins School of Medicine, Baltimore, Maryland
Feng Wang – UT MD Anderson Cancer Center, Houston, Texas

ACCELERATE-ing Pediatric Oncology Drug Discovery and Development

Crystal L. Mackall (Chair) – Stanford University School of Medicine, Stanford, California

Gregory H. Reaman – FDA, Silver Spring, Maryland
Peter C. Adamson – Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
Nancy F. Goodman – Kids v. Cancer, Washington, D.C.
Mark W. Kieran – Bristol-Myers Squibb, Lawrenceville, New Jersey
Andrew Pearson – ACCELERATE, London, United Kingdom
Gilles Vassal – Institute Gustave Roussey, Villejuif, France
Susan Weiner – Children’s Cause for Cancer Advocacy, Brooklyn, New York

Recently Approved Breakthrough Therapies

Ashley F. Ward (Chair) – FDA, Silver Spring, Maryland

Emily Y. Jen – FDA, Silver Spring, Maryland
Yvette L. Kasamon – FDA, Silver Spring, Maryland
Roger J. Kurlander – FDA, Silver Spring, Maryland
Leigh Marcus – FDA, Silver Spring, Maryland
David M. Hyman – Memorial Sloan Kettering Cancer Center, New York, New York
Naveen Pemmaraju – UT MD Anderson Cancer Center, Houston, Texas
Lauren Pinter-Brown – University of California Irvine, Irvine, California

Regulatory Considerations for Utilizing Liquid Biopsies in Drug and Diagnostic Development

Gideon M. Blumenthal (Cochair) – FDA, Silver Spring, Maryland
Reena Philip (Cochair) – FDA, Silver Spring, Maryland

Soma Ghosh – FDA, Silver Spring, Maryland
J. Carl Barrett – AstraZeneca, Waltham, Massachusetts
James H. Godsey – Thermo Fisher Scientific, South San Francisco, California
Dana W.Y. Tsui – Memorial Sloan Kettering Cancer Center, New York, New York

Registration Now Open for 2019 NIH-AACR Cancer, Autoimmunity, and Immunology Conference

-Elizabeth Barksdale, PhD

On April 15-16, 2019, the American Association for Cancer Research will join the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) in presenting the NIH-AACR Cancer, Autoimmunity, and Immunology Conference at the National Institutes of Health in Bethesda, Maryland.

Inaugurated in 2018, the Cancer, Autoimmunity, and Immunology Conference was created to delve into 1) understanding the biology of immune-related adverse events that have occurred in cancer patients treated with immunotherapies and how that might inform the study of autoimmune disease; and 2) defining the potential for the study of autoimmune disease to lead to greater understanding of the treatment and management of immune-related adverse events during and following cancer therapies.

The 2019 NIH-AACR Cancer, Autoimmunity, and Immunology Conference is being organized by:

  • Elizabeth M. Jaffee, MD, 2018-2019AACR president; deputy director, Sidney Kimmel Comprehensive Cancer Center
  • Elad Sharon, MD, MPH, senior investigator, NCI
  • Connie Sommers, PhD, program director, NCI
  • Howard Young, PhD, principal investigator, NCI
  • Katarzyna (Kasia) Bourcier, PhD, program officer, NIAID
  • Marie Mancini, PhD, program director, NIAMS

This year, the NIH-AACR Cancer, Autoimmunity, and Immunology Conference will feature sessions focusing on gastrointestinal, neurological, and skin toxicities; and the use of preclinical models and meta-analyses for interrogating immune-related adverse events. Attendees will hear keynote presentations from Arlene H. Sharpe, MD, PhD, of Harvard University, on T-cell co-stimulation in autoimmune diseases and cancer; Elizabeth M. Jaffee, MD, of Sidney Kimmel Comprehensive Cancer Center, on immuno-oncology combination clinical trials; and Jennifer A. Wargo, MD, MMSc, of MD Anderson Cancer Center, on the link between the gut microbiome and immunotherapy response. See the full agenda.

Registration for this two-day conference is free. Those who cannot attend in-person can register to watch via webcast. There will also be a poster session following the main conference on April 15; the deadline to submit an abstract is April 5, 2019.

Registration Open for the 2019 AACR-AACI Hill Day

The AACR and the Association of American Cancer Institutes (AACI) invite you to Capitol Hill, Tuesday, April 30, 2019. This Hill Day will bring cancer center directors, researchers, physician-scientists, cancer survivors and other advocates to Capitol Hill to build support for a strong federal investment in biomedical research, and cancer research in particular, through the National Institutes of Health (NIH) and the National Cancer Institute (NCI).

Learn more information about and register for the Hill Day.