2024 Experimental Human Biology Request for Proposals
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 is ripe for translation by fostering the clinical development of new or extending the use of existing drugs, vaccines, and companion biomarkers that directly enable drug development. This could be a proof of concept trial for a new medication, a new indication for an existing proprietary or generic drug, or a companion biomarker. We prioritize projects that will generate data to take projects towards external funding for product development. Investigators should be motivated to engage in the clinical and product development process with the IMA. Successful IMA projects have led to the formation of new companies, license agreements with biotech or pharma companies, sponsored research agreements, and grant funding for clinical follow-on studies. Please see the pipeline for currently supported projects.
Of particular interest are projects that seek to:
- Evaluate an approved drug or investigational drug candidate in a new indication
- Evaluate the utility of an approved molecular imaging tool in a secondary indication
- Evaluate a companion biomarker for enabling precision medicine use of an approved or investigational drug or for improving surgical outcomes
Selection Process & Timeline:
Proposals will be reviewed by evaluators knowledgeable in translational medicine and evaluated according to the following criteria:
- Novelty and significance of the hypothesis
- Severity of the unmet medical need
- Feasibility of the proposed study
- Potential for success of the project’s longer-term objectives
- Availability of relevant 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 a 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 July 31, 2024.
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, limit 4 pages) containing:
- A list of investigators. Each team must include a physician and a statistician. Please contact the IMA program manager for assistance with finding a statistician if needed.
- 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: enabling follow-on 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.
- 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.
- Timeline outlining 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.
- 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: https://chemh.slideroom.com/#/permalink/program/78751 Applicants do not need to submit the LOI to the Research Management Group (RMG) or Office of Sponsored Research (OSR).
The IMA seeks to translate promising academic science to a clinical setting. The IMA provides drug and clinical development expertise, financial support, and in-kind resources. We have supported projects in the range of $100K to $1M. For substantial resource needs, the IMA works with the PI to identify scaling partners to defray costs and support continued clinical development. Funds and in-kind resources will be released at key go/no-go milestones, e.g. FDA/IRB/SRC approval, interim enrollment goal, and full study enrollment. Please note that the IMA cannot support faculty/PI effort.
In-kind IMA staff support may include:
- Study planning and operations: The IMA team assists with protocol development, study start-up activities, monitoring, EDC database build and testing, and clinical research coordination activities.
- Regulatory submissions: The IMA team interfaces with regulatory consultants, the FDA, IRB, and SRC administrative boards.
- Project management: The IMA team supports project planning, budgeting, and identifying outsourcing opportunities.
- Access to resources: The IMA team connects to external alliances and Contract Research Organizations (CROs) to meet project needs.
Please indicate the type of support needed in the budget justification. Specific roles and responsibilities of personnel support and financial allocations will be described in 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.
