National Resilience, Inc. (Resilience), a technology-focused biomanufacturing company dedicated to broadening access to complex medicines, was named by the California Institute for Regenerative Medicine (CIRM) as one of the initial Industry Resource Partners within its Industry Alliance Program (IAP).

“One of the biggest challenges facing regenerative medicine right now involves manufacturing”

With $5.5B in funding from the state of California, CIRM has funded 81 clinical trials and currently supports over 161 active regenerative medicine research projects spanning candidate discovery through phase III clinical trials. CIRM established the IAP in 2018 to give grantees working on stem cell and regenerative medicine access to partners in pharma, biotech and venture capital firms, with the goal of building a collaborative network to support the development and commercialization of CIRM-funded programs.

As a GMP manufacturing partner, Resilience will launch an offering to support translational and clinical phase grant applications (TRAN, CLIN1, and CLIN2 grants) for cell therapy programs, with the potential to expand to other modalities including gene therapies and biologics in the future. Resilience will also provide project consultation that could aid CIRM applicants in drafting manufacturing plans and budgets for their applications to the program.

CIRM applicants who partner with Resilience will have access to the company’s wide network of manufacturing sites across North America, as well as in depth experience and expertise to optimize production of their drug substance and product for future scalability.

“Regenerative medicines and cell therapies show great promise, but the complexity of manufacturing these treatments has prevented them from reaching patients in need,” said Rahul Singhvi, ScD, Chief Executive Officer of Resilience. “By working with CIRM grant applicants at the earliest stages of their research, we aim to support investigators in weighing critical manufacturing decisions at pivotal moments in development.”

“One of the biggest challenges facing regenerative medicine right now involves manufacturing,” says Dr. Maria T. Millan, President and CEO of CIRM. “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.”

In addition to collaborating to advance regenerative medicines and cell therapies, the organizations will also collaborate to develop workplace opportunities in biomanufacturing, including internships to benefit underrepresented individuals in the biopharma industry.