Cell and Gene Therapy Development Request for Proposals, Summer 2021
The Innovative Medicines Accelerator, partnering with the Center for Definitive and Curative Medicine (CDCM) and the Center for Cancer Cell Therapy (CCT), seeks to accelerate the development of promising and innovative early-stage translational stem cell and gene therapies that fill unmet clinical needs. Competitive projects will have a well-justified, novel therapeutic hypothesis and a clearly articulated clinical need. They will also have the potential for taking advantage of Good Manufacturing Practice-compatible preparation of clinical materials in the Stanford Laboratory for Cell and Gene Medicine. The ideal milestone of a successful project will be an INTERACT or Pre-IND Food and Drug Administration meeting that provides clear, actionable guidance to the applicants regarding an IND submission, or sufficient data to support IND submission.
Support Provided: Selected projects will receive up to $100,000 per year for up to 2-years, with the second year of funding contingent on progress and attainment of milestones made in the first year. Up to 3 awards will be selected in this first round of awards.
In addition to financial support, selected projects will receive access to the CDCM and/or CCT programs to support future downstream planning for a successful project, including assistance in planning process development for cell and gene therapy manufacturing, design and execution of proof-of-concept clinical trials, and planning for use of clinical trial research beds in the Stanford hospitals if needed.
Deadline: All application materials must be received by 5pm on July 16, 2021.
Eligibility: All Stanford faculty with PI eligibility are welcome to apply.
Application Instructions: Proposals should be submitted as single PDF files containing the following materials in the order indicated below. All documents should be single-spaced, Arial 11-point font with 1-inch margins.
- Title page (1 page): Project title; Investigator name(s), department, address, phone number, email address, a project summary for a lay audience (150 words max).
- Project (3 pages maximum): Briefly describe the therapeutic hypothesis and unmet clinical need, and the case for the biological target of the anticipated cell and gene therapy being developed. Provide a technical summary of the manufacturing process and anticipated manufacturing needs. If applicable, please include how they might use current CDCM or CCT technology platforms. Please include up to 5 key references within the 3-page limit.
- Milestones (1/2 page): Using a bulleted format, briefly describe achievable milestones for Years 1 and 2 and any GO/NO-GO decisions being made along the way.
- Budget: (1/2 page) Briefly describe how the grant funding will be used. Funds cannot be used for PI salary support.
- NIH-format biosketch for each main investigator
Proposals should be submitted directly through the SlideRoom portal found at: Stanford ChEM-H SlideRoom Portal
You do not need to submit your applications to your Research Process Manager (RPM) in RMG or through your Office of Sponsored Research (OSR) Contract and Grant officer (CGO) for their approval at this time.
Selection Process & Timeline: Proposals will be reviewed by a faculty panel knowledgeable in translational research and evaluated according to the following criteria:
- Novelty and significance of the therapeutic hypothesis
- Strength of the evidence for the therapeutic hypothesis
- Availability of needed process development expertise
- Feasibility of cell and gene therapy development using technologies/platforms available in the CDCM/CCT.
Final decisions on full proposals will be made by the end of August 2021.
Contact: For questions about the Cell, Gene and Microbiome Therapies module of the IMA, please contact: Michael Fischbach, Ph.D., firstname.lastname@example.org
For questions about the funding opportunity, please contact: Amy Jacobson, Ph.D., email@example.com