Progress Toward Therapies: Accelerating the path
Eliminating research barriers
CIRM is dedicated to speeding the progress through the phases of developing a new therapy. We do that by thinking ahead to what the medical and regulatory roadblocks might be and specifically funding projects that overcome those barriers before they can slow research.
We funded two rounds of awards called our Tools and Technologies Awards, which encourage research groups to think ahead to what barriers might exist for stem cell research and develop ways of overcoming those barriers. These projects speed research for California scientists and worldwide. You can see a list of all Tools and Technologies awards here. CIRM also proactively funded a round of awards to prevent immune rejection of stem cell based therapies. You can see a list of those awards here.
Smoothing the regulatory path
CIRM has begun holding conversations with the Food and Drug Administration, which oversees which projects can enter clinical trials. The FDA is thinking ahead to how it will regulate trials involving stem cell-based products. By having conversations now, CIRM can help grantees meet FDA requirements and get into clinical trials. CIRM has also held webinars to inform grantees about different areas of stem cell research and the regulatory path.
CIRM provides one of the only stable, ongoing source of funding to move projects smoothly through the phases toward clinical trial. Many organizations fund only early discovery research, or only preclinical research. Under those conditions, researchers continually pause their projects to look for new sources of funding as the project moves through the phases toward clinical trial.
In constrast, CIRM has rounds of funding for all phases of research, from discovery through to clinical trials. As a project progresses, researchers can apply to new rounds of CIRM funding to keep their project moving toward patients.
Research goes faster when smart people work together. That's one of the ideas behind the CIRM Disease Team Awards, which have the ambitious goal of submitting an appication to begin clinical trials within four years. The teams apply together, demonstrating expertise in all areas of therapy development. Basic researchers and clinicians work side by side with therapy development experts who can guide the early stages of research to make sure it meets the standards that will be expected by the FDA.
The sun never sets
CIRM can only fund research taking place in California, but the agency still leverages stem cell expertise worldwide. Countries, international states and U.S. states have entered funding agreements with CIRM. If a team that includes a collaborative funder has a grant approved, CIRM funds the California scientists and the partner agency funds scientists in their jurisdiction. With funded collaborations including scientists in Canada, Australia, Japan, the UK or Germany, the sun never sets on CIRM teams working toward stem cell therapies.