Open Call for Cell Therapy Accelerator Grants
Manufacturing and Clinical Implementation
Deadline has passed
Results will be available by end of 2012
Full application deadline: September 10, 2012
Funding period: Two years (January 2013 to December 2014)
The Stem Cell Network is providing catalytic funding to enable Canadian cGMP cell manufacturing facilities to accelerate the implementation of clinical trials in their host facility, and to propel the progression of pending trials into the clinic through an OPEN competition for Cell Therapy Accelerator Grants.
A total investment of approximately $1.5 million is available in this one competition. Funding will be distributed through two streams: cGMP Cell Manufacturing Accelerator Grants or Stem Cell Therapy Accelerator Grants. Applicants may apply for one or both streams of funding being made available via this call. Please review the Cell Therapy Accelerator Grants – Manufacturing and Clinical Implementation Application Guidelines for complete details on this competition.
Stream 1: cGMP Cell Manufacturing Accelerator Grants
Each cGMP Cell Manufacturing Accelerator Grant will have a maximum value of $150,000 over two years. Applications must be from cell-manufacturing facilities based in an academic setting in Canada that are already compliant with Health Canada GMP standards for early phase trials, or have a clear plan to become compliant during the period of the grant. The grant must make a clear and compelling case for how the funds will be used to 1) accelerate or increase the implementation of clinical trials in their host facility AND 2) translate the research outcomes to other cGMP receptor sites across Canada. Activities must be eligible under CIHR's research grant expenditure guidelines, and may not include capital costs or the validation of capital equipment. Examples of fundable activities include:
- Development of common Standard Operating Procedures (SOPs) or Patient Outcome reporting;
- Evaluation/implementation of common software management tools; or
- Development of regulatory/CTA/IND advisory capacity that can be made available across Canada.
Stream 2: Stem Cell Therapy Accelerator Grants
Each Stem Cell Therapy Accelerator Grant will have a maximum value of $250,000 over two years. Applicants must be preparing to undertake a clinical trial within Canada deploying novel stem cell-based approaches to tissue repair and regeneration. The therapy must use cells that will be manufactured/more than minimally manipulated at academic cell manufacturing facilities that are compliant with Health Canada's GMP standards for early phase trials within Canada. The applicant must have submitted a Clinical Trial Application (CTA) to Health Canada at the time of application, or can demonstrate that they will do so within one year of the award of the grant. Applicants must present a clear and compelling case as to how the funds will be used to accelerate implementation of the clinical trial. Funds may not be used to support any direct patient costs, but could be used for example, to support the costs of specific pre-clinical research required by regulators prior to CTA approval, the costs of "dry runs" of the manufacturing process prior to cells being prepared for patients, the actual cell manufacturing and characterization expenses related to preparing clinical-grade product for an early phase trial, or analysis of the results in preparation for later Phase trials.
- To submit a proposal, applicants must be eligible to receive grant funding from CIHR, NSERC or SSHRC. Project Collaborators (those not requesting SCN funding) do not need to be eligible for CIHR, NSERC or SSHRC funding. Any person can participate in more than one application.
- In order to receive funds, successful applicants must execute a Standard NCE Network Agreement, through which they will become a member of the Stem Cell Network, and take on all of the associated rights and obligations. These obligations include the requirement to provide SCN office with project reports as requested.
Reviews of applications will be undertaken by a specially convened International Scientific Advisory Panel and SCN's Research Management Committee (RMC). The RMC will make their final funding recommendations to the SCN Board of Directors for approval in October 2012.
Funding of projects is expected to start January 2013.