When you try something that has never been done before, you are bound to face challenges and obstacles. At the California Institute for Regenerative Medicine (CIRM) we are used to coming up with great ideas and hearing people ask “Well, how are you going to do that?”

Our new 5-year Strategic Plan is how. It’s the roadmap that will help guide us as we work to overcome critical bottlenecks in bringing regenerative medicine therapies to people in need.

Providing more than money

People often think of CIRM as a funding agency that provides the money needed to do research. That’s true, but it’s only part of the story. With every project we fund, we also provide substantial support. That’s particularly true at the clinical stage, where therapies are being tested in people. Projects we fund in clinical trials don’t just get money; they also have access to:

• Alpha Stem Cells Clinic Network – A group of specialized medical centers with the experience and expertise to deliver new stem cell and gene therapies.
• The CIRM Cell and Gene Therapy Center – This helps develop projects, overcome manufacturing problems, and offers guidance on working with the US Food and Drug Administration (FDA) to get permission to run clinical trials.
• CIRM Clinical Advisory Panels (CAPs) – These teams advise researchers on clinical trials and help overcome challenges. A crucial element of a CAP is a patient advocate who can help design a trial around patients’ needs and support recruitment and retention.

Partnering with key stakeholders

Now, we want to build on this funding model to create new ways to support researchers in bringing their work to patients. This includes earlier engagement with regulators like the FDA to ensure that projects match their requirements. It also includes meetings with insurers and other healthcare stakeholders to ensure that if a treatment is approved, people can access it and afford it.

In the past, some in the regenerative medicine field saw the FDA as an obstacle to approving their work. But as David Martin, a CIRM Board member and industry veteran, says, the FDA is really a key ally.

“Turning a promising drug candidate into an approved therapy requires overcoming many bottlenecks… CIRM’s most effective and committed partner in accelerating this is the FDA.”

Removing barriers to manufacturing

Another key goal in our Strategic Plan is overcoming manufacturing barriers. Because cell and gene therapies are living medicines, they are complex and expensive to produce. The field also faces a shortage of skilled technicians, and existing facilities may struggle to meet demand once therapies receive FDA approval.

To address these challenges, CIRM plans to create a California Manufacturing Network that combines academic innovation with industry expertise. The network will help remove manufacturing bottlenecks and coordinate training programs to build a diverse, highly skilled workforce.

CIRM will work with academic institutions that already operate manufacturing facilities, such as UC Davis, to develop more efficient ways to produce therapies for research and clinical trials. The network will also include industry partners capable of large‑scale manufacturing once therapies are approved for broader use.

In collaboration with this network, CIRM will support education and hands‑on training programs in cell and gene therapy manufacturing at California community colleges and universities. Through internships and certification programs, we will help build a talented, diverse workforce prepared to meet the industry’s growing needs.

You can read more about these goals in our 2022-27 Strategic Plan.