OCE Insights is an occasional column developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Julie A. Schneider, PhD, Associate Director for Research Strategy and Partnerships, OCE; Jennifer J. Gao, MD, Associate Director for Education, OCE; Martha B. Donoghue, MD, Associate Director for Pediatric Oncology and Rare Cancers, OCE; Lola Fashoyin-Aje, MD, MPH, Deputy Director of the Division of Oncology 3, Office of Oncological Diseases (OOD), and Associate Director for Science and Policy to Address Disparities, OCE; Jeff Summers, MD, Acting Associate Director for Translational Sciences, OOD; Paul G. Kluetz, MD, Deputy Director, OCE, and Acting Supervisory Associate Director, OOD, Center for Drug Evaluation and Research (CDER); Marc R. Theoret, MD, Deputy Director, OCE; and Richard Pazdur, MD, Director, OCE, discuss extramural research funded by the OCE.
Why does OCE fund extramural research?
OCE conducts many internal research projects that focus on questions emerging from regulatory review. These projects include those that aim to build a deeper understanding of the safety and efficacy of oncology therapeutics and generate insights into subpopulations, endpoints, clinical outcome assessment data, and other drug development issues. In 2019, OCE began funding a limited number of projects undertaken by outside investigators (extramural projects). Funding extramural research provides new opportunities for OCE staff to collaborate with academic experts outside the FDA to investigate research questions with regulatory importance.
Extramural Research
What type of extramural research does OCE fund?
The OCE has funding to support applied regulatory science research related to the development of oncology therapeutics. OCE defines applied regulatory science research as research that addresses questions identified during regulatory review of oncology therapeutics, rather than research that seeks to expand general knowledge about cancer.
What current funding opportunities are available from the FDA to support extramural research projects?
OCE recently announced two funding opportunities to support applied regulatory science research in two specific areas:
- Novel approaches to support therapeutic development in ultra-rare cancers1
- Understanding factors that affect the safety and efficacy of historically underrepresented populations in oncology therapeutic development.2
Applications for RFA-FD-23-008, which focuses on developing therapies for ultra-rare cancers, are due by February 27, 2023, 11:59 PM EST. Applications for RFA-FD-23-006, which focuses on historically underrepresented populations in oncology therapeutic development, are due by April 3, 2023, 11:59 PM EST.
For more information about OCE’s efforts to promote the development of new drug and biological products to treat rare and ultra-rare cancers, visit the OCE Rare Cancer Program website (fda.gov/about-fda/oncology-center-excellence/oce-rare-cancers-program). For more information about OCE’s work relating to historically underrepresented populations in oncology therapeutic development, visit the OCE Project Equity website (fda.gov/about-fda/oncology-center-excellence/project-equity).
Other Funding Mechanisms
What other funding mechanisms does OCE use to support extramural research?
OCE uses other mechanisms to support extramural research, including the FDA Broad Agency Announcement (BAA) and the Centers for Excellence in Regulatory Science and Innovation (CERSI). OCE has identified nine scientific interest areas and one cross-cutting area of interest (summarized on the OCE Scientific Collaborative website3). OCE actively engages in multiple scientific and research activities to address important aspects of drug development in these areas. For these mechanisms, OCE accepts proposals addressing topics related to applied regulatory science research in oncology.
The BAA solicits proposals from external investigators on a rolling basis. FDA experts (including OCE and CDER Office of Oncologic Drugs staff) review proposals for scientific and technical merit, program relevance, offeror capability, and budget in two stages, which may result in a research contract for a maximum of 5 years. The CERSI program consists of cooperative agreements with institutions selected through a competitive process. OCE may support new research projects with any full, assistant, or associate professor working at a CERSI institution. Examples of BAA and CERSI projects that OCE has previously funded are described in a previous article in The ASCO Post.4
To Learn More
How can I learn more about OCE science and research activities?
You can visit the OCE Scientific Collaborative webpage (fda.gov/about-fda/oncology-center-excellence/oce-scientific-collaborative) to learn more about OCE scientific interest areas and funding opportunities.
For more information about all OCE activities, follow us on Twitter @FDAOncology or contact us via e-mail at FDAOncology@fda.hhs.gov.
DISCLOSURE: All authors reported no conflicts of interest.
REFERENCES
1. U.S. Food and Drug Administration: Department of Health and Human Services: Part 1: Overview information. Available at https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-23-008.html. Accessed January 18, 2023.
2. U.S. Food and Drug Administration: Department of Health and Human Services: Part 1: Overview information. Available at https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-23-006.html. Accessed January 18, 2023.
3. U.S. Food and Drug Administration: OCE Scientific Collaborative. Available at https://www.fda.gov/about-fda/oncology-center-excellence/oce-scientific-collaborative. Accessed January 18, 2023.
4. Schneider JA, Gao JJ, Rivera DR, et al: The Oncology Center of Excellence encourages submissions of applied regulatory science research proposals. The ASCO Post. December 25, 2021. Available at https://ascopost.com/issues/december-25-2021/the-oncology-center-of-excellence-encourages-submissions-of-applied-regulatory-science-research-proposals/. Accessed January 18, 2023.
