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March 2021 Human Experimental Biology

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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.

Research on SARS-CoV2 or COVID-19 is ineligible 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 receive partial support from the IMA clinical research coordinator (CRC). Estimated CRC time should be included in the full proposal budget. Randomized clinical trials that achieve pre-defined milestones may be eligible for additional follow-on funding.

Deadline: Letters of Intent must be received by April 5, 2021.

Eligibility: All Stanford faculty with PI eligibility, including faculty in the Clinical Educator line are welcome to apply.

Application Requirements and Instructions:

Submit a letter of intent as a PDF (Arial, 11 point font, 0.5 inch margins, 2 pages) containing:

  1. A list of investigators. Each team must include a physician and a statistician.
  2. 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.
  3. Projects where follow-on funding is required must propose clear go-no-go milestones that will ensure feasibility of the entire study.

Letters of Intent should be submitted directly to the Stanford ChEM-H SlideRoom portal.  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 in partnership with a staff member from IMA and CTRU to ensure that the proposed studies are compatible with the CTRU workflow and operations. 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. Selection of LOIs is estimated to be completed by April 19, 2021. The submission deadline for full proposals will be May 17, 2021. Final decisions on full proposals will be made by June 1, 2021.

Contact

For questions about the funding opportunity, please contact the program manager:

Elizabeth Sefton, Ph.D. Scientific Program Manager, Stanford ChEM-H esefton@stanford.edu

For questions about IMA, please contact: Chaitan Khosla, Ph.D. Director, Innovative Medicines Accelerator, Professor, Departments of Chemistry and Chemical Engineering khosla@stanford.edu

For questions about the Stanford School of Medicine CTRU, please contact: Rebecca Osborne, Executive Director, Clinical and Translational Research Unit, Stanford School of Medicine rebecca.osborne@stanford.edu