The FDA Oncology Center of Excellence (OCE) requests one-page proposals from CERSIs for potential regulatory science research projects, such as those that address one of the nine scientific interest areas and/or one cross cutting area described on the OCE Scientific Collaborative website. OCE focuses on supporting applied research that solves a particular, practical problem in developing oncology therapies. OCE is particularly interested to receive proposal ideas in the following areas: (1) health equity and special populations in cancer drug development; (2) immuno-oncology; (3) pediatric oncology; (4) precision oncology; and (5) rare cancers.
The OCE will review the one page proposals and determine whether to invite investigators to submit a full CERSI research proposal.
OCE requests that the following information be included in the one-page proposal:
1. Names and titles of key personnel
2. Objective of the research
3. Relevance to OCE scientific interest areas and regulatory impact
4. Brief description of the proposed approach and scientific methodology that includes:
5. Picture/graphic that illustrates the research
6. Key anticipated challenges
7. Major project milestones and anticipated output
8. Proposed budget and anticipated timeline
Investigators should propose a budget that is sufficient to complete the proposed work; however, OCE prefers to fund smaller pilot projects (~$100 - $300 K) rather than larger studies.
Deadline to send to Dr. James E. Polli at jpolli@rx.umaryland.edu is Jan 10 2021. And please copy Sarah Laye.