Experimental Human Biology

The Stanford Innovative Medicines Accelerator (IMA) is accepting proposals to address unmet therapeutic needs through human subjects research. Through this solicitation, the IMA seeks to support human subjects research that will advance the clinical development of new—or extend the use of existing—medicines, vaccines and diagnostics. This could be a proof-of-concept trial for new medication, a new indication for an existing proprietary or generic drug, or a companion diagnostic tool.  We prioritize projects that, if completed successfully, will generate data to support grant or sponsor funding for a larger trial and/or a licensing or partnership agreement with an external entity that furthers clinical development of the proposed project. 

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 is eligible for support through this mechanism. 

Of particular interest are projects that seek to:

• 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 an approved or investigational drug in a new indication
• 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 will receive up to $100k for a 6- to 12-month work plan.  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, study 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 November 3, 2023, 11:59pm.

Eligibility:

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

Instructions: Submit a letter of intent as a PDF (Arial, 11 point font, 0.5 inch margins, limit 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 if needed.
2. Briefly describe the objective of the overall project and the goal of the proposed study. 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 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 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 Sarafan 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: Proposals will be reviewed by evaluators knowledgeable in translational medicine and evaluated according to the following criteria:

1. Novelty and significance of the hypothesis and the severity of the unmet medical need.
2. Feasibility of the proposed study.
3. Pending a successful outcome of the proposed study, feasibility of the project’s longer-term objectives.
4. Feasibility of support via available IMA resources.

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. 

Letters of Intent are due Friday, November 3, 2023, at 11:59pm.