California's Stem Cell Agency
How CIRM is Partnering with Industry to Accelerate Cures
Introduction
In the ambitious quest to transform revolutionary scientific discoveries into life-saving treatments, a crucial gap often remains: the formidable journey from laboratory research to commercially viable medicines. The California Institute for Regenerative Medicine (CIRM), established with $5.5 billion in state funding, has emerged as a catalytic force in bridging this divide 7 .
Through strategic industry partnerships, CIRM is ensuring that promising stem cell and gene therapies don't languish in laboratories but instead reach the patients who desperately need them. By actively courting industry partners, CIRM is building a collaborative ecosystem where academic innovation meets commercial expertise—accelerating the delivery of transformative regenerative medicines to a diverse California and beyond.
The Industry Alliance Program: Building Bridges to Commercialization
A Strategic Framework for Collaboration
CIRM established the Industry Alliance Program (IAP) as a direct opportunity for industry to partner in accelerating the most promising stem cell, gene, and regenerative medicine therapy programs toward commercialization 1 .
This initiative recognizes that moving treatments from bench to bedside requires more than just brilliant science—it demands the manufacturing expertise, regulatory experience, and scalability that industry partners provide.
Tangible Outcomes of Collaboration
The power of these industry partnerships is reflected in CIRM's track record. The agency has funded and supported over 100 clinical trials and driven more than $25 billion in follow-on funding from biotech, pharma, and industry partners 1 2 .
These metrics signal strong confidence from the commercial sector in CIRM-funded science and demonstrate how strategic collaboration can leverage public investment to attract substantial private capital.
Industry Resource Partners
Case Study: The ElevateBio Partnership - Accelerating iPSC Therapeutics
The Promise and Challenge of iPSC Technology
Induced pluripotent stem cells (iPSCs) represent one of the most promising frontiers in regenerative medicine. These cells, which can be reprogrammed from adult tissues and differentiated into any cell type in the body, offer potential treatments for conditions ranging from Parkinson's disease to heart failure. However, developing consistent, high-quality iPSC lines suitable for clinical use presents significant technical hurdles.
iPSC Technology Applications
A Partnership for End-to-End Development
In August 2022, CIRM announced a strategic partnership with ElevateBio to advance iPSC-based regenerative medicines 7 . This collaboration provides CIRM Discovery and Translational Grant awardees access to ElevateBio's well-characterized iPSC lines produced under xeno-free, feeder-free conditions using non-integrating technologies.
"This exciting partnership with CIRM reflects the novelty of our iPSC platform and recognition of our next-generation cell lines that address industry challenges and could potentially save time and costs for partners developing iPSC-derived therapeutics,"
Beyond cell lines, the partnership offers academic researchers access to ElevateBio's integrated ecosystem, including viral vector technology, process development, analytical development, and Good Manufacturing Practice (GMP) manufacturing capabilities 7 . This end-to-end support system helps researchers overcome the translational "valley of death" between basic discovery and clinical application.
The Manufacturing Solution: Resilience Biotechnologies
Addressing the Critical Manufacturing Bottleneck
One of the most significant challenges in regenerative medicine involves the complex manufacturing required for cell and gene therapies. Recognizing this bottleneck, CIRM named National Resilience, Inc. as one of its initial Industry Resource Partners .
"One of the biggest challenges facing regenerative medicine right now involves manufacturing. Providing researchers with access to high quality starting materials and advanced manufacturing capabilities is going to be essential in helping these projects maintain high quality standards and comply with the regulatory frameworks needed to bring these therapies to patients."
Therapy Development Pipeline
Comprehensive Manufacturing Support
Resilience provides CIRM TRAN, CLIN1, and CLIN2 grant applicants with GMP manufacturing support and project consultation to help draft manufacturing plans and budgets . This early-stage guidance is crucial for helping academic researchers navigate the complex transition from lab-scale proof-of-concept to clinically viable, scalable production processes.
CIRM applicants who partner with Resilience gain access to the company's extensive network of manufacturing sites across North America, along with expertise to optimize production of their drug substance and product for future scalability .
Fueling Clinical Advancement: CIRM's CLIN2 Program
Direct Support for Clinical Trials
CIRM's commitment to advancing treatments extends directly to clinical testing through its CLIN2 funding program 4 . This program supports phase 1, 2, or 3 clinical trials—including pivotal trials—for regenerative medicine therapies that address significant unmet medical needs.
Strategic Funding with Industry Engagement
The CLIN2 program offers awards ranging from $8 million to $15 million, with specific co-funding requirements that ensure committed partnerships 4 . The funding structure encourages industry involvement at various stages of clinical development.
CLIN2 Funding Distribution
CIRM CLIN2 Award Funding Levels and Co-funding Requirements
| Trial Phase | For-Profit Award Cap | Non-Profit Award Cap | Co-funding Requirement |
|---|---|---|---|
| First in Human (Phase 1) | $8 million | $12 million | 30% (for-profit); None (non-profit) |
| Phase 2 or Subsequent | Up to $15 million | Up to $15 million | 50% (for-profit); None (non-profit) |
| Phase 3 or Pivotal | Up to $15 million | Up to $15 million | 50% (either for-profit or non-profit) |
This structured approach ensures that projects have a comprehensive clinical development strategy aimed at obtaining marketing approval, with well-developed plans for ensuring access and affordability 4 .
The Scientist's Toolkit: Key Resources for Regenerative Medicine Research
The transition from basic research to commercial therapy requires access to specialized tools and technologies. Through its Industry Resource Partner Program, CIRM provides researchers with access to critical resources:
iPSC Lines
Well-characterized induced pluripotent stem cell lines for research through clinical development
ElevateBio's xeno-free, feeder-free iPSC lines 7GMP Manufacturing
Current Good Manufacturing Practice production for clinical-grade therapeutics
Resilience's manufacturing networkViral Vector Technology
Engineering and production of viral vectors for gene delivery
ElevateBio's viral vector platform 7Process Development
Optimization of production processes for scalability and regulatory compliance
Integrated services from ElevateBio and Resilience 7Analytical Development
Characterization and quality control testing of therapeutic products
Capabilities provided through Industry Resource Partners 7Partnership Access
Strategic connections between academic researchers and industry experts
CIRM's Industry Alliance Program 1Conclusion: A Collaborative Future for Regenerative Medicine
California's CIRM has fundamentally redefined the role of a public funding agency by actively building bridges between academic research and industry expertise. Through its strategic Industry Alliance Program, targeted clinical trial funding, and access to essential manufacturing resources, CIRM has created an ecosystem that acknowledges a critical reality: scientific brilliance alone cannot deliver cures.
Academic Discovery
Basic research identifies promising therapeutic approaches
Industry Partnership
CIRM connects researchers with industry expertise and resources
Translation & Development
Therapies move from lab to manufacturing and preclinical testing
Clinical Trials
Funding and support for phases 1-3 clinical trials
Commercialization
Successful therapies reach patients through commercial partners
The agency's proactive approach to "courting industry" represents a pragmatic recognition that addressing manufacturing challenges early, providing access to specialized resources, and structuring funding to encourage partnership are essential components in accelerating the development of transformative treatments. As these collaborative efforts continue to mature, they offer a powerful model for how public institutions can leverage strategic partnerships to overcome the traditional barriers between laboratory discovery and commercial therapeutic reality—ultimately fulfilling the promise of regenerative medicine for patients in California and around the world.