Research Management Group (RMG)

California Institute for Regenerative Medicine (CIRM)
RFA 12-09: Strategic Partnership II Awards

New-$10M CIRM funding opportunity for Stanford faculty with PI eligibility

Summary: The objectives of the proposed project must address a serious unmet medical need/injury and must include the completion, in 4 years or less, of a Phase I or Phase 2 clinical trial under an Investigational New Drug (IND) application filed with the Food and Drug Administration (FDA). The proposed clinical trial(s) will evaluate both preliminary safety and preliminary biological activity/ efficacy in humans.

The CIRM program official, Dr. Caras, said for this Strategic Partnership II RFA:

Webinar: CIRM will conduct a webinar for prospective applicants on December 4, 2012 from 1-2 pm PST to address questions about the RFA and application process. To participate in this webinar please go to: http://tinyurl.com/SPwebinarCIRM

Guidelines:
http://www.cirm.ca.gov/RFA/rfa-12-09-cirm-strategic-partnership-ii-awards

Number of applicants: unlimited (an internal selection process is not required).

Timeline:
Letter of intent deadline (required): Dec. 18, 2012, 5 p.m. PST
Only those applicants that submitted an LOI that was accepted by CIRM may submit an application. Applicants will be notified if their LOI was NOT accepted.
Full application: January 30, 2013 5 p.m. PDT
Note: Evidence of Commercial Validation must be provided as part of the Letter of Intent. See the readiness section below.


Amount of funding*:
total of $10M per award over 4 years or less (justifiable costs include direct project costs, direct facilities costs, and indirect costs). In exceptional circumstances, there is the potential to increase the award up to $15 million per project only if fully justified and subject to the CIRM Governing Board, the ICOC. (up to 4 to be awarded)

**CO-FUNDING (MATCHING FUNDS) REQUIRED: CIRM will require co-funding from the applicant, which may come from the applicant’s own assets, from an industry partner, or from another funding source arranged by the applicant. Applicants must match 100% of the total CIRM funding requested (i.e. one-to-one match) and must use their matching funds (co-funding) to support only direct research project costs. In their application, applicants will be required to address the status and sources of cofunding required for achievement of the RFA objective as well as the longer term development objective."

ELIGIBILITY


Existing CIRM funding restrictions


Project eligibility:

A proposal previously reviewed under a prior Strategic Partnership RFA may be submitted provided that the eligibility requirements of this RFA are met.

i. Project Objective

The proposed project must address a serious unmet medical need/injury and must include the completion, in 4 years or less, of a Phase 1 or Phase 2 clinical trial under an Investigational New Drug (IND) application filed with the Food and Drug Administration (FDA). The proposed clinical trial(s) will evaluate preliminary safety and assess measures of preliminary biological activity/efficacy in humans.

ii. Therapeutic Candidate

Each funded Research Award will support a project for a single therapeutic candidate (that is or will be the subject of a single IND filing) that meets any of the following criteria:

Therapeutic candidates that fall outside the scope of this RFA include the following:

 

iii. Readiness
Strategic Partnership II Awards is designed to capture mature development projects that are at/near an early clinical research stage.
Eligible projects will meet the following criteria:

 

Evidence of commercial validation
In order to attract projects having or likely to attract industry investment, including follow-on financing of Phase 3 clinical trials (which CIRM does not intend to fund), or having adequate self-funding, applicants must provide evidence of commercial validation as part of the submitted application.
Such evidence will require submission of supporting documentation as part of the CIRM LOI submission, satisfying at least one of the following: 1) Financial Strength and Historical investment (for profit applicants) or 2) Collaborative development arrangements (see page 10-11 of the guidelines).

 

CIRM’s priorities for this RFA include:

In addition, special consideration will be given to applications previously submitted under a prior Strategic Partnership RFA that (i) meet the eligibility requirements of this RFA and (ii) have appropriately and satisfactorily addressed all of the comments of prior reviewers as determined by the current GWG reviewing the re-submitted application.


 

 

 

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