Initiatives to advance stem cell science and medicine at California's $3 billion stem cell agency

The mission of the California Institute for Regenerative Medicine (CIRM) is to accelerate stem cell treatments to patients with unmet medical needs.  With $3 billion in funding and 300 active programs, it is the world’s largest institution dedicated to helping people by developing cell therapies.  To accomplish its mission, CIRM has funded a breadth of activities spanning from basic research to translation to clinical trials.  In addition to individual grants, CIRM has created resources to help the stem cell community worldwide.  Some resources promote research and drug development using stem cells.  CIRM has established an iPSC Repository maintained by the Coriell Institute that is currently the largest publically accessible pluripotent stem cell bank in the world.  CIRM also has a genomics research initiative that applies cutting edge sequencing and bioinformatics approaches to stem cell research and therapeutic development.  Other resources established at CIRM promote the acceleration of stem cell discoveries into therapeutic development.  CIRM is in the process of setting up a system of translational and clinical centers to help researchers move their discoveries into clinical development.  This system includes 1) a Translating Center to support preclinical IND-enabling activities such as process development, safety testing, and cell manufacturing of stem cell therapy candidates, 2) an Accelerating Center that helps with clinical strategy, regulatory submission, and clinical trial management, and 3) an Alpha Clinics network that conducts clinical trials for stem cell related therapies.  In total these resources are designed to catalyze the flow of stem cell discoveries to the clinic, which can come from both inside and outside of California.  CIRM has supported 16 stem cell based clinical trials and the goal is to have 50.  Beyond an overview of CIRM’s programs, this presentation will touch on perspectives around developing stem cell therapies and regulatory hurdles.