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Cancer Policy Monitor: February 13, 2024

AACR Celebrates “FDA Legend” Janet Woodcock, MD

After a remarkable 38 years of public service, Janet Woodcock, MD, has retired as the Food and Drug Administration’s (FDA) Principal Deputy Commissioner. During her tenure, her leadership and commitment to public health helped the United States become the pinnacle of excellence in the review and assessment of lifesaving products. Her innovations include work on the 21st Century Cures Act and reshaping the drug approval process, easing the criteria for essential drugs, including vaccines and treatments for COVID-19.

“During her tenure at the FDA, Dr. Woodcock has been dedicated to driving change in drug development that results in more efficient and accessible clinical trials, more effective and safer medical products, and better outcomes for patients, including patients with cancer,” said Margaret Foti, PhD, MD (hc), chief executive officer of the American Association for Cancer Research. “The entire medical research and clinical care community is fortunate to have had Dr. Woodcock in the leadership ranks of the U.S. agency that is charged with advancing public health through expediting the approval of safe and effective therapies for patients.”

Read AACR’s press release here.

Congressional Update

-Benjamin Krinsky, PhD

On January 19, President Biden signed H.R. 2872 into law, a temporary spending measure, or continuing resolution (CR), that will keep the government open while Congress continues its negotiations on a final fiscal year (FY) 2024 budget. Like the prior CR passed in November 2023, the current law sets up two staggered deadlines: the agencies and programs corresponding to four appropriations bills (Agriculture, Rural Development, Food and Drug Administration; Energy and Water Development; Military Construction and Veterans Affairs; and Transportation, Housing, and Urban Development) are funded through March 1. The remaining eight bills, including Labor, Health and Human Services, Education, and Related Agencies (which funds biomedical research and health programs) are funded through March 8.

Earlier in January, House and Senate leaders reached an agreement on overall levels of defense and domestic spending for FY 2024. However, with the prior CR expiring in early February, there was not sufficient time for Congress to finalize FY 2024 spending bills. The current CR was passed to give the appropriations committees more time to finalize the allocations to each of the twelve appropriations subcommittees and to resolve policy disputes between the two parties. Speaker of the House Mike Johnson (R-LA) has said that he is opposed to a single all-encompassing spending measure (or omnibus). It is therefore likely that a final budget would be split into at least two pieces of legislation, possibly corresponding to the two sets of bills in the CR.

Even with a deal on overall spending and negotiations on bills moving forward, other challenges remain. The level of non-defense spending agreed to by the House and Senate — approximately $773 billion — is roughly the same as the FY 2023 amount. It will therefore be challenging for Congress to provide increases for domestic programs, including the National Institutes of Health (NIH). In addition, ongoing negotiations over a separate bill to provide supplemental funding to aid Israel and Ukraine, as well as provide money for U.S. border enforcement, have the potential to influence the outcome of the FY 2024 budget. For example, if a supplemental aid bill does not pass, Republicans in the House and Senate may press for more border security funding in FY 2024 appropriations legislation.

AACR will continue to advocate for a swift resolution to the FY 2024 budget and the highest possible levels of federal funding for biomedical science and training.

Watch the Latest Episode of Project Livin’ Label featuring Tebentafusp-tebn

Project Livin’ Label is a collaboration between the U.S. Food and Drug Administration (FDA) and the American Association for Cancer Research to help educate the cancer community about recently approved cancer therapies. Episode 12 highlights Tebentafusp-tebn, a bispecific gp100 peptide-HLA-directed CD3 T cell engager that is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. All 12 episodes are available for free-on-demand streaming and include perspectives from the FDA, industry, academia, patients, and in this episode, nursing, and pharmacy.

CME credits, NCPD credits, and CPE hours will be awarded for watching the episode.

In this episode:

  • Timil Patel, MD, medical oncologist, Division of Oncology 3, Oncology Center of Excellence, FDA
  • Jamie Brewer, MD, medical oncologist and acting clinical team lead, Division of Oncology 3, Office of Oncologic Diseases, FDA
  • Mark Moyer, senior vice president, head of regulatory sciences, Immunocore
  • Richard D. Carvajal, MD, deputy physician-in-chief, director of hematology/oncology, Northwell Health Cancer Institute
  • Jianan (Carlos) Sheng, patient and clinical trial participant
  • Carol Ann Wiggs, clinical research nurse manager, Duke Cancer Institute
  • Heather Armbruster, PharmD, BCOP, outpatient clinical pharmacy manager, James Cancer Hospital & Solove Research Institute

There is Still Time to Register for the FDA-AACR Workshop on Optimizing Dosages for Oncology Drug Products 

The U.S. Food and Drug Administration (FDA) Office of Clinical Pharmacology and the American Association for Cancer Research are co-hosting a public workshop on Optimizing Dosages for Oncology Drug Products on February 15 and 16. There is still time to register for virtual attendance. The workshop agenda, speaker bios, and background blog are now available on the workshop website!  

The Regulatory Science and Science Policy Sessions at the 2024 AACR Annual Meeting

Register now for the AACR Annual Meeting 2024 at the San Diego Convention Center, April 5-10. The AACR Annual Meeting 2024 will bring together voices from regulatory agencies, the private sector, academia, patients, and advocacy groups to discuss advances in cancer science and highlight the latest developments in regulatory science and science policy.

We hope to see you there! Please click the here to learn more.

Saturday, April 6

  • 2:30-4 p.m. – FDA’s Project Endpoint and Overall Survival in Oncology Clinical Trials

Sunday, April 7

  • 1-2:30 p.m. – Perioperative Pandemonium: Trial Designs in Solid Tumors

Monday, April 8

  • 10:15-11:45 a.m. – Trading Places: Regulator as Patient, Patient as Regulator
  • 10:15-11:45 a.m. – FDA Center for Tobacco Products’ Priorities to Address Tobacco Use and Support the Cancer Moonshot
  • 12:30-2 p.m. – Disparities in Pediatric Oncology
  • 2:30-4 p.m. – Negating the Null Hypothesis: When Equipoise is Lost in Randomization

Tuesday, April 9

  • 10:15-11:45 a.m. – Diversity Plans in Action – FDA, Industry and Community Perspectives
  • 12:30-2 p.m. – Intent-to-Treat vs Intent-to-Harm: Putting the Precision Back in Precision Oncology

Advocate Registration Rates for AACR Annual Meeting 2024

We are pleased to invite patient advocates to attend the AACR Annual Meeting 2024, April 5-10 in San Diego, California. The theme of this year’s meeting is “Inspiring Science • Fueling Progress • Revolutionizing Care.” Reduced registration rates are available for all patient advocates. Learn more on the AACR website.

Save the Date for the 2024 AACR-AACI Hill Day

The American Association for Cancer Research (AACR) and the Association of American Cancer Institutes (AACI) invite you to participate in a Capitol Hill Day to support cancer research on Thursday, May 16. This Hill Day will bring cancer center directors, researchers, physician-scientists, cancer survivors, and other advocates together to build support for a strong federal investment in biomedical research, and cancer research in particular, through the National Institutes of Health and the National Cancer Institute.

Participation is open to AACR and AACI members. Registration will open this spring; stay tuned for more information.