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Cancer Policy Monitor: June 13, 2023

AACR President Phil Greenberg Participates in AACR-AACI Joint Hill Day to Advocate for NIH and NCI Funding

-Blake Rostine

On May 18, the American Association for Cancer Research (AACR) partnered with the Association of American Cancer Institutes (AACI) to host its annual Joint Hill Day in support of federal funding for cancer research through the National Institutes of Health (NIH) and the National Cancer Institute (NCI). Nearly 100 participants from 27 states, including patient advocates, researchers, physician-scientists, and other leaders from cancer centers, took part in the event. This was the first in-person Joint Hill Day since 2019, with participants getting to meet with their legislators face-to-face.  Both AACR President Philip D. Greenberg, MD, FAACR and AACR Science Policy and Government Affairs Committee Chairperson Roy S. Herbst, MD, PhD were in attendance and met with several legislators.

Throughout the Hill Day, participants met with more than 110 members and Congress or their staff and made three specific requests:

  • Thank Congress for its bipartisan support for cancer research and the NIH, specifically for providing a $2.5 billion increase for the NIH in Fiscal Year (FY) 2023.
  • Ask Congress to continue to prioritize funding for medical research in the regular appropriations process and provide $50.924 billion (a $3.465 billion increase) for the NIH in FY 2024.
  • Ask Congress to provide at least $9.988 billion for the National Cancer Institute (NCI) in FY 2024. This request is supported by the NCI director’s Professional Judgment Budget.

The AACR and AACI also organized a special Hill Day reception for participants which featured remarks from Dr. Greenberg and AACI Executive Director Jennifer Pegher. During the program, the two organizations honored Rep. Brian Fitzpatrick (R-PA) and Rep. Debbie Wasserman Schultz (D-FL) with the 2023 Cancer Research Ally Award in recognition of their outstanding support for cancer research and patients living with cancer. After receiving her award, Rep. Wasserman Schultz spoke of the importance of continual cancer research funding and applauded the work of the AACR and AACI. AACI Government Relations Chair Matthew Swaback, Sidney Kimmel Cancer Center at Jefferson Health, and Dr. Jonathan Licht, director of UF Health Cancer Center, all highlighted the incredible work done by the participants in the event and their hopes for the future.

Hill Day participants reported positive meetings with their representatives and senators, many of whom expressed strong support for medical research funding as a top priority. The AACR and AACI will continue to work together to advocate for NIH and NCI funding to advance cancer research.

President Biden Nominates Monica Bertagnolli to Lead NIH

-Matthew Gontarchick

President Joe Biden announced his intent to nominate National Cancer Institute (NCI) Director Monica Bertagnolli, MD, to be director of the National Institutes of Health (NIH). The NIH has been without a permanent director since Francis S. Collins, MD, PhD, stepped down from the role in December 2021. Since then, Lawrence A. Tabak, DDS, PhD, has been fulfilling the duties of the NIH director.

A Wyoming native, Dr. Bertagnolli began her career as a surgical oncologist. Prior to becoming the first female NCI director in August 2022, she was the chief of surgical oncology at the Dana-Farber Cancer Institute, where she led research on the role of adenomatous polyposis coli (APC) mutations in colorectal carcinogenesis. Dr. Bertagnolli’s experience also includes being an associate surgeon at the Strang Cancer Prevention Institute, an attending surgeon at NewYork-Presbyterian Hospital-Cornell, and a faculty member of Harvard Medical School.

The Senate must first confirm Dr. Bertagnolli’s nomination before she can become NIH’s newest leader. In upcoming confirmation hearings, she is likely to face questions on the origins of the COVID-19 pandemic, the use of march-in rights to address high prescription drug prices, and the pace of biomedical innovation.

Of note, Dr. Bertagnolli has been undergoing treatment for early-stage breast cancer since December 2022. In April 2023, she participated in a fireside chat at the AACR Annual Meeting 2023 with then-AACR President Lisa M. Coussens, PhD, FAACR, where she discussed NCI’s recently released National Cancer Plan. 

Senate Panel Reviews NIH Budget Request for FY 2024

-Matthew Gontarchick

In May, the Senate Labor, Health and Human Services, and Education (LHHS) Appropriations Subcommittee held a hearing to review the Biden administration’s Fiscal Year (FY) 2024 budget request for the National Institutes of Health (NIH). The hearing featured testimony from Acting Director Lawrence Tabak, DDS, PhD, who was joined by National Cancer Institute (NCI) Director Douglas Lowy, MD, and three other institute directors to answer questions from subcommittee members.

Throughout the hearing, members from both parties voiced support for cancer research and biomedical innovation. Subcommittee Chair Tammy Baldwin (D-WI), who coincidentally is the granddaughter of an NIH-funded scientist, said that NIH plays an important role in bolstering economic growth and ensuring the nation remains a global leader in biomedical innovation. In response to calls to cut discretionary funding for FY 2024, Baldwin warned that a reduction in NIH funding would stall the training of the next generation of researchers and lead to the development of fewer life-saving treatments.

In her opening remarks, Ranking Member Shelley Moore Capito (R-VW) proclaimed that NIH funding has long been a “bicameral, bipartisan priority.” For the upcoming FY 2024 appropriations process, she urged her fellow subcommittee members to prioritize areas of agreement, such as funding to find cures and treatment for both pediatric and adult cancers as well as funding to support academic research institutions. Of note, both Baldwin and Capito lauded the administration’s budget request for including additional funding for the Cancer Moonshot.

In his opening statement, Dr. Tabak stated that sustained public investment in medical research is essential to the development of new medical treatments and cures. To illustrate the importance of ensuring robust funding for NIH, he cited a recent study that found NIH-backed research grants contributed to 354 of 365 approved by the Food and Drug Administration between 2010 and 2019. 

For the remainder of the hearing, Dr. Tabak, Dr. Lowy, and other NIH leaders fielded questions from members of the subcommittee. For instance, Dr. Lowy shared with Sen. John Boozman (R-AR) how NCI is working to boost clinical trial participation in rural areas, and he assured the senator that NCI Competitive Cancer Grants will be fully funded for FY 2024. Additionally, Dr. Tabak told Baldwin how NIH is using specific award mechanisms to increase the number of early-stage researchers. 

Since the hearing, Senate Appropriations Committee leaders from both parties have announced plans to review bipartisan appropriations bills starting in June. As the appropriations process continues to move forward, the AACR is committed to working with policymakers to advocate for robust funding for medical research.

Register Today! Patient Advocate Forum: The Evolution of FDA Regulatory Science and Its Impact on Cancer

Tuesday, June 27 at 1pm ET. This AACR Patient Advocate Forum will explore how regulatory science is evolving to meet the growing complexities of cancer research and optimize regulation to support the prevention, diagnosis, and treatment of cancers. Click here to learn more.

AACR Endorses Congressional Caucus to End Youth Vaping

–Calais Prince, PhD

On May 31, Representative Raja Krishnamoorthi (D-IL), Representative Chris Stewart (R-UT), and Senator Richard Durbin (D-IL) relaunched the bipartisan “Congressional Caucus to End the Youth Vaping Epidemic.” The overall mission of the caucus is threefold: educate congressional members and staff about the history of tobacco policy and regulation; serve as a resource for evidence-based tobacco policy design; and relay information from Congress about the effects of e-cigarette use on the health outcomes of children, adolescents, and their families.

In 2022, more than 2.5 million adolescents reported that they used e-cigarettes. As described in the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology joint policy statement, electronic nicotine delivery systems, including e-cigarettes, are linked to early stages of cancer development and can serve as the springboard to cigarette use. These products can potentially dismantle the decades of progress made against tobacco use and tobacco-associated mortality.

The AACR enthusiastically supports the “Congressional Caucus to End the Youth Vaping Epidemic” as it is poised to answer the urgent call to stop the unprecedented growth of e-cigarette use.

Register for the FDA-AACR-ASA Workshop on Overall Survival in Oncology Clinical Trials

-Nicholas Warren, PhD

The American Association for Cancer Research (AACR), American Statistical Association (ASA), and U.S. Food and Drug Administration (FDA) are partnering to host a hybrid workshop July 18, 2023, at the Bethesda Marriott Pooks Hill hotel in Bethesda, Maryland, to improve how clinical trials collect and assess overall survival (OS) data and other endpoints. Free registration is now available.

OS is considered a gold standard endpoint for clinical trials because it measures both the efficacy and safety of new therapies. It is also a relatively simple and straightforward metric that matters to patients who want to know if a drug will help them live longer. Advancements in cancer care have improved the lives of many patients. However, it is becoming increasingly difficult to measure OS in a timely fashion to support the approval of new drugs. This is leading to the growing use of early endpoints like progression-free survival or durable response rates for submissions to the FDA. When early endpoints are used, FDA will often require companies to share OS data when they become available following Accelerated Approval or Traditional Approval. Unfortunately, several factors can pose challenges for monitoring long-term OS, including differences between subpopulations; crossover trial designs; subsequent lines of therapy after a patient leaves a trial; and fluctuations in the magnitude of benefit compared to the control arm over time.

These issues and more will be discussed in the upcoming workshop this July. For more information, please visit the workshop website.

New! Project Livin’ Label Episode 9 – Nivolumab Available for Streaming

Project Livin’ Label is a collaboration between the U.S. Food and Drug Administration (FDA) and the American Association for Cancer Research (AACR) to help educate the cancer community about recently approved cancer therapies, and in particular, to help familiarize both providers and patients with complex product labels. Episode 9 – Nivolumab is now available for on-demand streaming and offers 1.5 CME credits. The episode details the science and the story behind developing the anti-PD1 antibody, nivolumab, including FDA, industry, academic, and patient perspectives.

Register now! Rally for Medical Research!

The 11th Annual Rally for Medical Research will be held September 13-14, 2023, in Washington, D.C. The rally brings together advocates from around the country to call upon the nation’s policymakers to make funding for the NIH a national priority and bring attention to the importance of stable and robust investments in medical research. A participant training and reception will be held September 13, followed by the Rally Hill Day, September 14, in which participants will meet with congressional offices.

Register for the rally. Please contact [email protected] with any questions.

Draft Guidelines Recommend Earlier Breast Cancer Screenings

-Calais S. Prince, PhD

Among women in the United States, breast cancer is the second most common cancer and the second leading cause of cancer death. Approximately 42,000 women die each year from breast cancer. In 2022 alone, more than 43,000 women died from breast cancer. On May 9, the U.S. Preventive Services Task Force published new draft guidelines recommending that all women should get screened for breast cancer every two years beginning at the age of 40. Lowering the recommended age of breast cancer screenings by ten years can be attributed to data showing a 2 percent increase in breast cancer rates in women 40 – 49 years old between 2015 and 2019. It is estimated that the new recommendation would save 20 percent more lives for women that get screened sooner and have comprehensive follow-up care and treatment, potentially decreasing persistent breast cancer disparities.

The opportunity for public comments on the draft recommendations closed in June. Final recommendations for breast cancer screening will be published soon after.

2023-2024 FDA-AACR Oncology Educational Fellowship Application Period Open

-Nicholas Warren, PhD

The FDA-AACR Oncology Educational Fellowship is now accepting applications for the 2023-2024 class. This part-time educational fellowship was created in 2020 to provide early-career cancer researchers and physicians unique learning opportunities related to oncology drug development and the regulatory review process by directly engaging with experts from AACR and FDA on monthly webinars and during the AACR Annual Meeting. The fellowship capstone project involves the fellows developing and leading a mock meeting of the FDA’s Oncology Drug Advisory Committee (ODAC), which simulates how industry sponsors make the case for a novel drug to ODAC and the FDA for their approval. Applications for the new fellowship class will be accepted until 11:59 p.m, ET, August 14, 2023.

To be eligible, candidates must: have an advanced degree (DO, MD, PhD, or MD/PhD); have a current or pending AACR membership; have started their current academic position within the past five years; and be proficient in the English language. Applications are welcomed globally, but meeting visa travel requirements for in-person portions is the responsibility of the fellow. 

The fellowship entails virtual interactive meetings and small group discussions on topics including investigational new drugs (INDs), expedited approval pathways, clinical pharmacology, clinical trial design, companion diagnostics, and animal studies. Fellows will also be provided with travel and lodging assistance to attend the AACR Annual Meeting in San Diego, California, April 5-10, 2024. Additionally, the fellowship capstone, Project ODAC Odyssey, will involve fellows developing and leading an in-person mock meeting of the Oncology Drug Advisory Committee in late spring/early summer 2024.

For more information, please visit the fellowship website.