Experimental Human Biology

The IMA is accepting proposals to address unmet medical needs through human subjects 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 enhance clinical use of existing ones.

The purpose of this request for letters of intent (LOI) is to leverage the capacity and infrastructure at Stanford to address unmet medical needs through human subjects research. Competitive projects will have a strong mechanistic basis or empirical rationale and will utilize either the Stanford School of Medicine Clinical and Translational Research Unit (CTRU), or IMA COVID CTRU where patients can be safely tested and/or treated. Research on any indication, therapy, or disease including SARS-CoV2 or COVID-19 is eligible for support through this mechanism.

Of particular interest are projects that seek to:

• Use clinically available disease management tools (e.g., drugs, diagnostics, imaging tools) to validate a new drug or indication 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

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 are eligible for additional support from the IMA Experimental Human Biology module staff. Staff support includes protocol development, project management, EDC database build and testing, clinical research coordination, monitoring, operations, and regulatory activities. Please indicate the type of support needed in the budget justification. Further details regarding specific roles and responsibilities of personnel support and financial allocations will be elaborated in individual award letters issued to selected projects. The specific level of support will vary by project need. Projects that achieve pre-defined milestones may be eligible for additional follow-on funding to continue supporting the clinical trial.

Deadline:

Letters of Intent must be received by December 16, 2022, 11:59pm.

Eligibility:

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

Application Instructions:

Submit a letter of intent as a PDF (Arial, 11 point font, 0.5 inch margins, 4 pages) containing:

1. A list of investigators. Each team must include a physician and a statistician. Please contact the program manager for assistance with finding a statistician.
2. Briefly describe the value proposition of the study and the goal of the work. Include the unmet medical need, current standard of care, and how the study outcome supports the stated goal. Example goals: publication, additional clinical studies, external license or partnership with an existing company, a new company, or a new drug campaign. Applicants are encouraged to consult the program manager about how the value proposition fits within the IMA mission.
3. Project description in the format of a Protocol Synopsis, including at a minimum the rationale, indication, key objectives, study endpoints, planned enrollment, and most pertinent inclusion/exclusion criteria for subjects enrolled in the study.
4. Timeline encompassing the entire clinical development plan required to bring the final product to patients. Indicate where the project currently stands, what is requested of IMA, and how this year of IMA support fits into the development timeline. State clear go/no-go milestones and dependencies that will ensure the feasibility of achieving the targeted deliverable.
5. Total trial cost and budget. Please indicate which areas you are requesting in-kind IMA staffing or financial support from IMA. Please note that the IMA cannot support faculty/PI effort.

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:

A committee of faculty reviewers will identify the most meritorious LOIs based on the novelty, significance, and feasibility of the proposed clinical study. PIs whose project ideas are selected will be invited to submit full protocols including detailed budgets, which will be developed collaboratively with the Experimental Human Biology team. Final funding decisions are contingent upon full protocol review, including an evaluation of the feasibility of all regulatory and contractual aspects of the proposed research. Projects that achieve pre-defined milestones may be eligible for additional follow-on funding to continue supporting the clinical trial.