Experimental Human Biology RFLOI Winter 2022
Request for Letters of Intent: Experimental Human Biology
Stanford University’s Innovative Medicines Accelerator (IMA) aims to accelerate the prototyping of innovative medicines and vaccines, and to enable hypothesis-driven studies in human subjects. The purpose of this request for letters of intent (LOI) is to leverage capacity and infrastructure at Stanford to address unmet medical needs through human subject research. Through this solicitation, the IMA seeks to support research projects aimed at testing hypotheses in human subjects that, if validated, have the potential to pave the road to new medicines, vaccines and diagnostics or to enhanced clinical use of existing ones. Competitive projects will have a strong mechanistic basis or empirical rationale and will utilize the Stanford School of Medicine Clinical and Translational Research Unit (CTRU), where patients can be safely tested and/or treated. Of particular interest are proposals that seek to:
- Use clinically available disease management tools (e.g., drugs, diagnostics, imaging tools) to validate a new drug target in patients;
- Verify the potential of a biomarker to substantially reduce the size and/or duration of Phase 2 clinical trials for an unmet medical need;
- Evaluate the efficacy of an approved/investigational drug in an orphan/neglected disease;
- Evaluate the utility of an approved molecular imaging tool in a secondary indication; or
- Undertake a high-content analysis of an approved vaccine in healthy volunteers.
- Evaluate safety of an investigational drug in healthy volunteers
Research on any indication, therapy, or disease including SARS-CoV2 or COVID-19 is eligible for support through this mechanism.
Support Provided: Applicants are expected to receive up to $100k for a 6- to 12-month workplan. Projects may be fully or partially funded. Awarded projects will also be eligible for support from the IMA clinical research coordinator (CRC). Estimated CRC time should be included in the full proposal budget. Projects that achieve pre-defined 6- or 12-month milestones may be eligible for additional follow-on funding to continue supporting the clinical trial.
Deadline: Letters of Intent must be received by January 18, 2022.
Eligibility: All Stanford faculty with PI eligibility, including faculty in the Clinical Educator line are welcome to apply.
Submit a letter of intent as a PDF (Arial, 11 point font, 0.5 inch margins, 2 pages) containing:
- A list of investigators. Each team must include a physician and a statistician.
- Project description in the format of a Protocol Synopsis, including at a minimum the rationale and key objectives of the study as well as the endpoints, planned enrollment, and most pertinent inclusion/exclusion criteria for subjects enrolled in the study.
- Projects where follow-on funding is required must propose clear go-no-go milestones that will ensure feasibility of the entire study.
- Total requested budget. (Do not include indirect costs or faculty effort). Indicate whether your study requires follow-on funding.
Letters of Intent should be submitted directly to the Stanford ChEM-H SlideRoom portal: https://chemh.slideroom.com/#/permalink/program/64913 . Applicants do not need to submit the LOI to the Research Management Group (RMG) or Office of Sponsored Research (OSR).
Selection Process & Timeline: A committee of faculty reviewers will identify the most meritorious LOIs based on the novelty and significance of the proposed clinical study. PIs whose project ideas are selected will be invited to submit full proposals (including detailed budgets), which will be developed collaboratively with a staff member from the IMA. Final funding decisions are contingent upon full proposal review, including an evaluation of the feasibility of all regulatory and contractual aspects of the proposed research. If milestones are reached, investigators may be eligible for follow-on funding.
Selection of LOIs is estimated to be completed by mid-February 2022. The submission deadline for full proposals will be early March. Final decisions on full proposals will be made by May 2022.
For questions about the funding opportunity, please contact the program manager:
Elizabeth Sefton, Ph.D.
Senior Scientific Program Manager, Innovative Medicines Accelerator
For questions about IMA, please contact:
Chaitan Khosla, Ph.D.
Director, Innovative Medicines Accelerator
Professor, Departments of Chemistry and Chemical Engineering
For questions about the Stanford School of Medicine CTRU, please contact:
Executive Director, Clinical and Translational Research Unit
Stanford School of Medicine