Charles River, Quintiles and City of Hope, with funding from the California Institute for Regenerative Medicine (CIRM), have entered into a collaboration to form the Translating Center in San Diego, CA. This center is one of three new infrastructure programs under CIRM 2.0 that together are poised to improve the efficiency by which stem cell therapies reach patients in need through grants for researchers in this field. The center offers a unique integrated preclinical, clinical and manufacturing service for the development of stem cell therapies with the aim of significantly reducing the time and cost of moving potentially life-saving stem-cell-based therapies, devices, diagnostics or tools from bench to bedside. The cooperative model for the center’s operations addresses current industry challenges most investigators face, such as limited end-to-end development experience and regulatory considerations.
While CIRM funds research carried out in California, it is not exclusive to investigators or organizations based in the state, and researchers from around the world are considered to bring their work to the center. Interested researchers are encouraged to apply for funding; applications for this program will be accepted three times per year, or approximately every four months.
- Quintiles: Program management and regulatory support
- Charles River: Nonclinical program design and study conduct
- City of Hope: CMC strategy, planning, and manufacturing
- Improved operational efficiency, reducing delays in investigator programs
- End-to-end service
- Shared cross-learnings between projects
- Standardized processes and common technology platforms
- Application of advanced statistical techniques for analysis
- Use of robust experimental design to minimize bias
- Consultative guidance for model selection
- Regulatory-compliant programs