The California Institute for Regenerative Medicine (CIRM) presented key recommendations from its Strategic Allocation Framework (SAF), offering a structured, data‑driven approach to guide funding decisions and maximize impact.
These recommendations, shared with the Independent Citizens’ Oversight Committee, move CIRM closer to its mission to accelerate the development and delivery of innovative regenerative medicine therapies.
Evolving landscape
The recommendations guide how CIRM allocates its remaining $3.86 billion in funding, including the $1.14 billion designated for neurological research under Proposition 14 (2020). CIRM launched this effort after identifying the need for a more structured prioritization process. Over the past six months, the agency presented its recommendations to joint meetings of the Science Subcommittee and Neuro Task Force, focusing on areas where funding can have the greatest impact.
“The regenerative medicine landscape has evolved dramatically since CIRM’s inception. We must align our focus with the needs of this rapidly expanding field,” said Jonathan Thomas, PhD, JD, President and CEO of CIRM. “The Strategic Allocation Framework is essential to sustaining CIRM’s role as a global leader. We must allocate our remaining resources wisely to drive the greatest impact.”
CIRM based its recommendations on key design questions and extensive internal and external datasets, analyzing this information to shape each recommendation.
Strategic Recommendations from the SAF Process
The recommendations focus CIRM’s resources on measurable impact goals framed within four key categories. Those include Accelerating Discovery & Translation, Cell & Gene Therapy Approvals, Accessibility & Affordability, and Diverse Workforce Development.
The result was a set of six recommendations listed below.
The following are goals and recommendations from the SAF process:
Accelerating Discovery & Translation
| Goals | Recommendations |
| 1. Catalyze the identification and validation of at least 4 novel targets and biomarkers, ensuring integration into preclinical or clinical research for diseases in California. | Establish a Data Coordinating and Management Center (DCMC) to streamline data management and increase the value of cross‑disease data. The DCMC will serve as a central hub for data coordination, improve integration with consortia and research initiatives, and support data‑science collaboration through a dedicated grant program. |
| Establish a Data Coordinating and Management Center (DCMC) to streamline data management and increase the value of cross‑disease data. The DCMC will serve as a central hub for data coordination, strengthen integration with consortia and research initiatives, and support data‑science collaboration through a dedicated grant. | |
| 2. Accelerate development and utilization of 5-8 technologies that have the potential to improve safety, efficacy, and/or quality of cell and gene therapies. | Pilot an INFR Technology Platform Program to help bridge the gap between research and commercialization. The program will foster partnerships between academic researchers and industry, support multi‑stakeholder technology‑incubation efforts, and advance projects to defined technology‑readiness levels to accelerate their application in cell and gene therapy development. |
Cell & Gene Therapy Approvals
| 3. Advance 4-7 rare disease projects to Biologics License Application (BLA) | Accelerate Current rare disease therapy pipelineIncrease and scale CLIN4 funding to comprehensively address BLA readiness gaps in manufacturing clinical/non-clinical research and pre-commercialization |
| Pilot Platform-Based Therapy DevelopmentImplement pilot platform-based approach for gene therapy development using life-threatening monogenic neurological disorders as a test case | |
| 4. Propel 15-20 therapies targeting diseases affecting Californians to late-stage trials. | Streamline Preclinical Development Programs. Consolidate DISC2, TRAN 1-4, and CLIN1 to accelerate the preclinical development incentivizing multidisciplinary collaborations and rapid progression to IND. Incorporate prioritization of innovative therapies for diseases that affect Californians. |
| Update the CLIN2 program to support emerging clinical trial designs and encourage stage‑appropriate market‑access planning. The updated program will also prioritize innovative therapies for diseases that affect Californians. |
Accessibility & Affordability of CIRM-Funded Cell & Gene Therapies
| 5. Ensure that every BLA-ready program has a strategy for access and affordability. | Strengthen Clinical Infrastructure Connectivity. Build interconnectivity & performance metrics between CIRM Clinical Infrastructure (Alpha Clinics, CCCEs, PSP). This is to ensure enhanced referral enrollment & retention of California patients in clinical trials. |
| Support Development of Market Access and Reimbursement Strategies. Resource clinical programs to support stage appropriate planning and evidence generation to inform robust market access & reimbursement strategies. | |
| Influence Policy. Deploy AAWG resources to advocate for policies that advance access and reimbursement. | |
| Enhance Partnerships. Engage state and national partners to align initiatives that expand sustainable access to regenerative medicines. |
Diverse Workforce Development
| 6. Bolster CIRM’s workforce development programs to address gaps and meet evolving demands in regenerative medicine. | Provide high-demand technical training via Bridges & COMPASS program updates. Increase training to diversify internship types and increase integration with CIRM R&D. |
| Create new EDUC program to develop hybrid skillsets. Implement new program structure to focus on cross-disciplinary internships. | |
| Launch outreach campaigns to educate the public. Also increase diversity of California’s regenerative medicine workforce. Develop programming to support outreach education efforts for K-12, teachers, an community members via collaboration with key stakeholders. |
A new ecosystem
CIRM has made a significant impact on the research ecosystem in California, said Rosa Canet-Avilés, PhD, who spearheaded the SAF effort.
“Our new priorities will refine that process, making sure that every dollar is strategically allocated,” Canet-Avilés said. “This ensures resources are spent on projects that have the highest potential to make a significant difference. Additionally, our new priorities are shifting toward overcoming translational bottlenecks and clearly defined success metrics. This ensures that the work being funded is moving closer to commercialization and benefiting patients sooner,” said
Internal Transitions to Support Prioritization Efforts
• CIRM restructured its operations to support implementation of the SAF.
• Dr. Canet‑Avilés transitioned into the role of Chief Science Officer (CSO), overseeing all scientific programs and aligning them with SAF priorities.
• Abla Creasey, PhD, moved from Vice President of Therapeutics Development to Executive Strategy Officer – Rare Diseases. He’ll lead the work on the new rare diseases platform.
• Shyam Patel, PhD, shifted from Senior Director of Business Development to Associate Vice President of Preclinical Development and Infrastructure. He’ll focus on advancing preclinical programs.
• Janie Byrum, PhD, became Senior Science Officer for the CIRM Data Infrastructure for R&D Programs. She’s transitioning from her role in Scientific Programs and Education.
• Sara Taylor, PhD, was promoted to Program Manager in Strategy and Programs. She’ll support the CSO in carrying out CIRM’s strategic priorities.
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