CIRM Strategic Plan

CIRM Awards $21.3 Million to Foster Collaboration Through Shared Labs

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Shared resources, including state-of-the art lab equipment and expertise, foster collaboration (above). Photo courtesy of UCLA Broad Stem Cell Research Center. 

The California Institute for Regenerative Medicine (CIRM) has approved awarding $21.3 million to create a network of Shared Resources Laboratories (SRLs) for Stem Cell-Based Modeling.

The SRLs are an important component of CIRM’s Infrastructure Program, which is designed to address the challenges that hinder progress in the regenerative medicine field.

The approved awards include: 

Application Program Title Program Director – Institution Amount 
INFR6.1-15357 Stem Cell-based Disease Modeling Shared Resource Laboratory Carlesso, Nadia – City of Hope  $5,400,000 
INFR6.2-15383 A modular automation approach to stem cell modeling to increase throughput, reproducibility and access Plath, Kathrin – UCLA $3,999,999 
INFR6.2-15368 Shared Resources Laboratories to Enhance In Vitro Stem Cell Modeling and Training Walsh, Craig – UC Irvine $4,000,000 
INFR6.2-15527 A Center for Stem Cell Disease Modeling and Therapeutics Conklin, Bruce – Gladstone Institutes $4,000,000 
INFR6.2-15400 0 CIRM ASCEND Center – Advancing Stem Cell Education and Novel Discoveries Lindstrom, Nils – USC $3,946,795 

The CIRM Board also recommended that 11 applicants may revise and resubmit their applications for funding approval.

The goal of the SRLs is to foster collaboration among California researchers, break down research silos, and provide students and researchers access to top-notch resources and training in using stem cell-based models to accelerate world class science. These stem cell-based models include various cell types of the brain, cardiovascular system, and other organ systems and will help advance knowledge of human diseases to identify potential therapies, biomarkers, and drug candidates. 

The SRL network will also support the use of state-of-the-art technologies, including CRISPR, omics analyses, and automation workflows. 

In a previous Infrastructure Program in 2007, CIRM awarded more than $50 million to finance the construction of shared research laboratories at 17 academic and non-profit institutions, which dedicated lab space for research using human embryonic stem cells (hESCs).  

At the time, hESC research was still in its infancy, and federal policy prohibited research involving hESCs from being conducted in laboratories constructed with any federal funding. 

“By investing in shared resources laboratories, we are not only providing essential infrastructure for stem cell research but also positioning California at the forefront of this transformative research. These new SRL awards showcase the remarkable progress in stem cell research and highlight CIRM’s pivotal role in propelling stem cell research forward,” said Dr. Rosa Canet-Aviles, VP of Scientific Programs and Education at CIRM.  

“Through these awards, CIRM will continue to drive progress, now focusing on cutting-edge disease modeling using human stem cells.” 

Finding solutions for affordable and accessible cell and gene therapies

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The California Institute for Regenerative Medicine (CIRM) is not alone in seeking a way to make cell and gene therapies more affordable and accessible.

The Innovative Genomics Institute (IGI) just completed a year-long effort to consider how treatments could be made more accessible. This effort involved creating a task force comprised of 30 participants to develop options. The participants hail from diverse fields including genome engineering, economics, manufacturing, venture capital, intellectual property and more.

The task force’s recommendations were published recently in a report titled: Making Genetic Therapies Affordable and Accessible.

The report describes the gene therapy landscape and discusses research, development and manufacturing factors that impact the cost of treatments. The authors also suggest ways to reduce these costs and include discussion of how government funding in general, and CIRM funding specifically, can augment some of these development costs.

One specific model proposed by the authors involves a development partnership between academic researchers, non-profit medical research organizations and public benefit corporations. Through this model, the aim would be to significantly reduce the costs of therapy delivery. The report also includes a set of policy recommendations deemed important supporting this outcome.

The progress made since 2004, when stem cell research was still in its nascent stages, is truly remarkable. Within a relatively brief period, the focus has shifted from the exploration of stem cell potential to the development of therapies for clinical trials.
Now, we are looking to the next stage of this journey to increase access to the availability of innovative treatments for patients.

IGI’s work and a broader body of knowledge will be taken under consideration by CIRM’s Access and Affordability Working Group as they seek ways to enable access to CIRM-funded treatments for all Californians.

Apply Now for New Manufacturing Funding Opportunity

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The California Institute for Regenerative Medicine (CIRM) has set goals through its five-year strategic plan to continue to deliver the full potential of regenerative medicine to the people of California and around the world. 

One of those goals is to overcome manufacturing hurdles for the delivery of regenerative medicine therapies by building a public-private manufacturing partnership network. 

This is essential because the field needs to create standardized manufacturing processes to transition from the production of smaller batches of therapies for use in clinical trials, to the larger batches required by full-scale commercialization. The manufacturing process for cell and gene therapies is more complex than for other biologics, so CIRM is committed to creating a network to overcome those challenges.

In working towards that goal, CIRM is pleased to announce a new funding opportunity within our Infrastructure Program, the INFR5 Cell and Gene Therapy Manufacturing Network (Phase 1) Awards.  
 
The California Cell and Gene Therapy Manufacturing Network aims to establish a statewide manufacturing network comprising academic process development and GMP manufacturing facilities as well as industry manufacturing partners that will: 

  1. Accelerate and de-risk pathways to commercialization for cell and gene therapies 
  1. Advance industry standards and incorporate quality-by-design in cell and gene therapy manufacturing, and 
  1. Build a diverse, highly skilled manufacturing workforce in California. 

CIRM will issue two phases of awards governed by two separate requests for applications (RFAs). This RFA describes the first phase of awards that will fund California academic cell and gene therapy GMP manufacturing facilities to make initial progress toward the three network goals (described above) at their individual facilities. 

To apply for this award, please visit our website to download the Program Announcement and access a link to the application.  

Update: If you’re interested in learning more about the INFR5 Phase 1 Awards, eligibility requirements, the application and review process, and more, the CIRM team hosted an informational webinar in November. Watch a video recording of the webinar here. The slide deck is available here.

State Stem Cell & Gene Therapy Agency Sets up Support Program to Help Patients Participate in Clinical Trials

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For many patients battling deadly diseases, getting access to a clinical trial can be life-saving, but it can also be very challenging. Today the governing Board of the California Institute for Regenerative Medicine (CIRM) approved a concept plan to make it financially and logistically easier for patients to take part in CIRM-funded clinical trials.

The plan will create a Patient Support Program (PSP) to provide support to California patients being evaluated or enrolled in CIRM-supported clinical trials, with a particular emphasis on helping underserved populations.

“Helping scientists develop stem cell and gene therapies is just part of what we do at CIRM. If those clinical trials and resulting therapies are not accessible to the people of California, who are making all this possible, then we have not fulfilled our mission.” says Maria T. Millan, M.D., President and CEO of CIRM.

The Patient Support Plan will offer a range of services including:

  • Clinical trial navigation, directing patients to appropriate CIRM-supported clinical trials.
  • Logistical support for patients being evaluated or enrolled in clinical trials.
  • Financial support for under resourced and underserved populations in CIRM-supported clinical trials, including the CIRM Patient Assistance Fund (PAF).  This support includes transportation/travel expenses, such as gasoline, tolls, parking, airfare, taxi, train, lodging, and meals during travel.
  • Providing nurse navigator support for the psychosocial, emotional, and practical needs of patients and their families.

The funds for the PSP are set aside under Proposition 14, the voter-approved initiative that re-funded CIRM in 2020. Under Prop 14 CIRM money that CIRM grantees earn from licensing, inventions or technologies is to be spent “offsetting the costs of providing treatments and cures arising from institute-funded research to California patients who have insufficient means to purchase such treatment or cure, including the reimbursement of patient-qualified costs for research participants.”

Currently, the CIRM Licensing Revenues and Royalties Fund has a balance of $15.6 million derived from royalty payments.

“The patient support program and financial resources will not only help patients in need, it will also help increase the likelihood that these clinical trials will succeed,” says Sean Turbeville, Ph.D., Vice President of Medical Affairs and Policy at CIRM. “We know cell and gene therapies can be particularly challenging for patients and their families. The financial challenges, the long-distance traveling, extended evaluation, and family commitments can make it difficult to enroll and retain patients. The aim of the PSP is to change that.”

The overall objective of this funding opportunity is to establish a statewide program that, over five years, is expected to support hundreds of patients in need as they participate in the growing number of CIRM-supported clinical trials. The program is expected to cost between $300,000 to $500,000 a year. That money will come from the Medical Affairs budget and not out of the patient assistance fund.

The first phase of the program will identify an organization, through a competitive process, that has the expertise to provide patient support services including:

  • Maintaining a call and support center.
  • Assessing patient eligibility for financial assistance.
  • Reporting to CIRM on patients needs and center performance

 You can find more information about the Patient Support Program on our website here and here.

A grandmother’s legacy, a stem cell scientist

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Emily Smith, CIRM Bridges student

The California Institute for Regenerative (CIRM) has a number of education programs geared towards training the next generation of stem cell and gene therapy researchers. Each student comes to the program with their own motivation, their own reasons for wanting to be a scientist. This is Emily Smith’s story.

Surrounded by the cold white walls of a hospital room, my family suddenly found themselves on the other side of medicine. Void of any answers or cures, this new reality was full of doubt. As we witnessed assurance dwindle into a look of angst, the doctor’s lips stiffened as he faltered to say the words that would change my grandmother’s life forever. The spinal cancer they had gone in to extract was a misdiagnosed nothing. Instead, the exploration of his scalpel left her paralyzed from the chest down.

Seemingly simple day-to-day moments of my life became the building blocks of my passion for science today. Early realizations of the hurdles laced throughout my grandmother’s life. Vivid memories of my mother’s weary smile as she read articles on the newest advancements in stem cell research. Collectively, what these fragments of time nurtured was hope. I grew to have a dream that something different awaited us in the future. With purpose, I dove into the world of research as an undergraduate.

Today, I am a CIRM Bridges to Stem Cell Research Intern at the Sanford Consortium for Regenerative Medicine. I received my acceptance into the program about a month after my grandmother’s passing. She never saw a cure, let alone an effective treatment.

My position allows me to understand why stem cell research takes time. The road from the bench to the clinic is a painstakingly deliberate one. And although we seek reason and order from the world of science, what we often find is how imperfect it all can be. At its root, I found that research is truly a human endeavor. That is why, as scientists, we must grapple with our lack of knowledge and failures with humility.

CIRM’s programs that train tomorrow’s scientists, such as Bridges, are important because they do more than simply transfer over skills from one generation to the next. Over the next year, I get the valuable experience of working with scientists who share a common dream. They understand the urgency of their research, value the quality of their findings, and put patient needs first. This mentorship ensures that a sense of responsibility is carried on throughout this field.

I applied to this program because stem cell research gave my family the gift of hope. Now, on the other side of the wait, I wish to serve patients and families like my own. I am incredibly grateful to be a part of the Bridges program and I will devote the full extent of my knowledge towards the advancement of this field.

Expanding CIRM’s Alpha Clinics Network to deliver transformative regenerative medicine treatments 

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Almost every day, we hear new reports from the thousands of regenerative medicine clinical trials globally sponsored by hundreds of companies and academic researchers. The California Institute for Regenerative Medicine (CIRM) is a leader in this space supporting some of the most advanced cell and gene therapy clinic trials for a variety of unmet medical needs. With all this current activity, it’s easy to forget that there were only a handful of clinical trials going on just seven years ago. 

A New System for Delivering Treatments 

In 2015, CIRM’s leadership recognized that we were on the cusp of introducing an array of new regenerative medicine clinical trials. However, there was one big concern—the existing clinical delivery systems had limited experience and capacity for managing these new and comparatively complex clinical trials. Cell and gene therapy regenerative medicine treatments require new systems for manufacturing, processing, and delivering treatments to patients.  

In anticipation of the need for clinical bandwidth to support clinical trials, CIRM funded a network of California medical centers to develop teams dedicated to supporting regenerative medicine clinical trials. This network was called the Alpha Clinics Network. 

Since 2015, the Alpha Clinics Network has grown to include six academic medical centers in California. The Network has treated over a thousand patients in more than 100 clinical trials. CIRM frequently encounters companies and academic researchers that are specifically interested in bringing their research to California to be performed in the Alpha Clinics Network. These research sponsors cite expertise in manufacturing, process, delivery and regulatory compliance as the Networks value proposition. One sponsor summed it up by indicating there are “fewer protocol deviations (errors)” in the Alpha Clinics. 

Expanding the Alpha Clinics Network 

As we enter 2022 with CIRM’s new five year strategic plan, a major aim is to create a broad network of medical centers capable of supporting diverse patient participation in clinical trials.  

As a first step in this effort, CIRM recently announced $80 million in funding to expand the Alpha Clinics Network. This funding is intended to expand both the scale and scope of the Network. This funding will allow the scale to grow from six medical center to up to ten. Scale is important because as the number of clinical trials grow, there needs to be increased coordination and sharing of the workload. Alpha Clinic sites already collaborate to conduct individual clinical trials, and an expanded network will enable a greater number of trials to occur simultaneously. 

In addition, the Expansion Awards will enable the Network to expand the scope of its activities to address current needs of the field. These needs include new research platforms for conducting clinical trials. For example, sites are looking at integrating new types of genomic (DNA sequencing) tools to support improved diagnosis and treatment of patients.  

Also, CIRM is committed to funding research to treat neurological diseases. We anticipate network sites will develop advanced systems for delivering treatments to patients and evaluating the effectiveness of these treatments. In addition, sites will be developing training programs to address the growing workforce needs of the field of regenerative medicine. 

In 2015, CIRM invested in the Alpha Clinics Network which positioned California as a leader in supporting regenerative medicine clinical trials. In 2022, we will be expanding the Network with the aim of delivering transformative treatments to a diverse California and the world. The Network will fulfill this aim by expanding its reach in the state, developing advanced research planforms and technologies, and by training the next generations of researchers with the skills to deliver patient treatments. 

Watch a recording of our recent Alpha Clinics concept plan webinar: 

CIRM CNS Consortium Workshop – Held Feb. 24 & 25, 2022

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Note: Post edited to include post-event workshop videos. Watch both workshop videos here and here.

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Shared Stem Cell Laboratory at UCLA

Advance World Class Science, Deliver Real World Solutions, Provide Opportunity for All. 

These comprise the themes of our bold 5-year Strategic Plan. Since its launch less than two months ago, we have hit the ground running. Under the second and third strategic themes, we have already received ICOC approval for 2 concepts: Alpha Clinics Network Expansion and COMPASS educational program. We are now working on the execution of our first theme.  

As indicated in our Strategic Plan, we strongly believe advancing world class science relies on collaborative research that leverages collective scientific knowledge. To that end, we have organized the virtual CIRM CNS Consortium Workshop (click for the agenda and see registration details below) to help us gather feedback from a panel of experts about the best approach for promoting a culture of collaboration.

The vision for this workshop was informed by multiple layers of stakeholder discussions and input that started even prior to the passage of Proposition 14. A quick walk down memory lane reminds us of CIRM’s early and deliberate effort to identify areas of opportunity for promoting a paradigm shift with a “team science” approach, especially in the context of complex diseases such as those affecting the CNS: 

  • In 2019, we organized Brainstorming Neurodegeneration, a workshop where broad stakeholder input was received about the benefits and bottlenecks of developing a consortium approach where genomics and big data, novel stem cell models, and patient data could be collectively leveraged to advance the field of neurodegenerative research in a collaborative manner.  
  • In 2020, just before the passage of Prop 14 and based on input from the 2019 workshop, we already had our eyes on target: the future of collaborative research is in sharable data, and sharing petabytes or more of data requires a collaborative data infrastructure. To better understand the status and bottlenecks of knowledge platforms that could leverage data sharing, we brought together a panel of experts at our 2020 Grantee Meeting. We were encouraged to learn that our laser-focused approach for promoting knowledge sharing was right on target and the panelists suggested that CIRM has a great opportunity to promote a paradigm shift in this area.   
  • In early 2021, immediately after the passage of Prop 14 and building upon our previous conversations, we formed a Strategic Scientific Advisory Panel comprising a distinguished group of national and international scientists in the stem cell field. Once again, we were advised to expand sharable resources (especially in the context of stem cell modeling), bring more attention to complex diseases such as neurodegenerative and neuropsychiatric disorders, and facilitate knowledge sharing.  
  • In mid 2021, as we were forming our Strategic Plan based on the above input, we pressure-tested our paradigm-shifting vision in a Town Hall and further gathered feedback from California stakeholders about their needs. Again, all arrows pointed to shared resources and data as critical elements for accelerating research.  
CIRM Town Hall workshop hosted in 2021
  • Finally, in late 2021, just before the launch of our Strategic Plan, we organized a Data Biosphere Advisory Committee to advise us on ways to facilitate collaborative knowledge sharing. Here, we explored various models for leveraging and/or generating a data infrastructure in which CIRM-funded data could be managed and shared. The main outcome of this meeting was a recommendation to organize a workshop to test the feasibility and approach for generation of a CIRM knowledge platform. The Committee concluded that CIRM is uniquely positioned to contribute a wealth of data to the broader scientific community. A knowledge platform would provide an avenue for data sharing and collaboration with other groups that are dedicated to accelerating progress in the development of therapies, especially for CNS disorders.  

We were walking on solid ground! In December of 2021, paralleling the input we had received from experts and stakeholders, we launched our 5-year Strategic Plan with the goal of advancing world class science by promoting a culture of collaboration. 

To deliver on this goal, CIRM’s approach is to build the infrastructure (and we don’t mean bricks and mortar) that organizes and democratizes data through:  

  1. A network of shared resources labs that facilitate validation and standardization to support California regenerative medicine researchers  
  1. A data infrastructure where CIRM-funded data can be shared and external datasets leveraged to maximize real-world impact  
  1. We have held a virtual CNS Consortium Workshop on February 24th and 25th where we explored the development of these two resources through the deployment of a consortium and starting in the CNS space as a use case. While the discussions at the workshop centered on the CNS, the shared resources labs will be implemented across cell types and organs. The Data Infrastructure is intended to be a global resource for data sharing and fostering a culture of open science for all CIRM grantees—and the world. The complete workshop agenda can be found here.  

    Watch video recordings of Day 1 and Day 2 of the CNS workshop.

Making stem cell and gene therapies available and affordable for all California patients

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Developing a new therapy: Photo courtesy UCLA

There is no benefit in helping create a miraculous new therapy that can cure people and save lives if no one except the super-rich can afford it. That’s why the California Institute for Regenerative Medicine (CIRM) has made creating a roadmap to help make new treatments both available and affordable for all Californians a central pillar of its new 5-year Strategic Plan.

New treatments based on novel new technologies often seem to come with a gob-smacking price tag. When Kymriah, a CAR-T cell cancer therapy, was approved it cost $475,000 for one treatment course. When the FDA approved Zolgensma to treat spinal muscular atrophy, a genetic disorder that causes muscle wasting and weakness, the cost was $2.1 million for one dose.

Part of the pricing is due to high manufacturing cost and the specialized resources needed to deliver the treatments. The treatments themselves are showing that they can be one-and-done options for patients, meaning just one treatment may be all they need to be cured. But even with all that innovation and promise the high price may impact access to patients in need.

At CIRM we believe that if California taxpayer money has helped researchers develop a new therapy, Californians should be able to get that therapy. To try and ensure they can we have created the Accessibility and Affordability Working Group (AAWG). The groups mission is to find a way to overcome the hurdles that stand between a patient and the treatment they need.

The AAWG will work with politicians and policy makers, researchers and regulators, insurance companies and patient advocate organizations to gather the data and information needed to make these therapies available and affordable. Dr. Le Ondra Clark Harvey, a CIRM Board member and mental health advocate, says the barriers we have to confront are not just financial, they are racial and ethnic too. 

We have already created a unique model for delivering stem cell therapies to patients through our Alpha Stem Cell Clinic Network. We are now setting out to build on that with our commitment to creating Community Care Centers of Excellence. But having world-class clinics capable of delivering life-saving therapies is not enough. We also need to make sure that Californians who need these treatments can get them regardless of who they are or their ability to pay.

To learn more read out new Strategic Plan.

How these scholars are growing the regenerative medicine field in California

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CIRM Scholar Alessandra Rodriguez y Baena

Through our new Strategic Plan, the California Institute for Regenerative Medicine (CIRM) will build inclusive participation opportunities for all stakeholders, from the students to the workforce to the patients.  

That said, it’s important to recognize the important work CIRM has already done to train the next generation of scientists and grow the field of regenerative medicine. Alessandra’s story illustrates just one of the many ways we have done that in the past, and we intend to do even more in the future. 

Gaining Exposure to Innovative Research

CIRM Scholar Alessandra Rodriguez y Baena was a Master’s student at Cal Poly, San Luis Obispo. With the support of CIRM’s Bridges Program, she became a CIRM intern in the Willert Lab at UC San Diego.  

As a student researcher, CIRM provided her with supportive mentors (both at Cal Poly and UCSD), hands-on training in the field of regenerative medicine, and exposure to innovative ideas and research. The program also provided Alessandra with a stipend to help cover expenses. This was particularly helpful for students from low-income backgrounds who otherwise might not be able to afford to go to college. 

“I always recommend my undergraduate students who are interested in research to apply to the Bridges programs because, to me, it was a defining experience that led me to pursue my passion for stem cell research as well as teaching,” Alessandra says. 

Alessandra is now a fourth-year PhD student in the Forsberg Lab in the department of Molecular, Cell & Developmental Biology at UC Santa Cruz where she is studying the epigenetic regulation of aging in bone marrow stem cells.  

In addition to Alessandra, CIRM has provided opportunities in science to nearly 3,000 students across California. These include high schoolers in our SPARK Program, as well as undergrads and graduate students in our Bridges Program and pre and post-doctoral students in our Research Training program. Many of these are from diverse backgrounds.  

A Game Changer

Sneha Santosh, another CIRM Scholar, first heard about CIRM’s Bridges to Stem Cell Therapy and Research internship when she was graduating from the UC Davis. She was pursuing a degree in microbial biotechnology and thinking about getting a master’s degree in biotechnology. She said the opportunity to be part of a program that is training the next generation of scientists was a game changer for her.  

Through the Bridges Program, she learned about stem cells’ power to treat a disease’s root cause rather than just the symptoms. She saw how these transformative therapies changed people’s lives. 

Today, she is a cell culture associate with Novo Nordisk, a leading global healthcare company in Fremont, California 

CIRM’s New Strategic Plan

Alessandra and Sneha’s stories capture CIRM’s commitment to building education and training programs, and providing opportunities to build a diverse, highly skilled regenerative medicine workforce. We’ll be covering this ambitious yet achievable goal in our upcoming blog posts.  

To learn more about CIRM’s work and plans build the regenerative medicine field, check out our new 5-year strategic plan on our website.  

Overcoming obstacles and advancing treatments to patients

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UC Davis GMP Manufacturing facility: Photo courtesy UC Davis

When you are trying to do something that has never been done before, there are bound to be challenges to meet and obstacles to overcome. 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, providing the money needed to do research. That’s true, but it’s only part of the story. With every project we fund, we also offer a lot of 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 – This is a group of specialized medical centers that have the experience and expertise to deliver new stem cell and gene therapies.
  • The CIRM Cell and Gene Therapy Center – This helps with developing projects, overcoming 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 are teams put together to help advise researchers on a clinical trial and to overcome problems. A crucial element of a CAP is a patient advocate who can help design a trial around the needs of the patients, to help with patient 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 includes meetings with insurers and other healthcare stakeholders, to make sure that if a treatment is approved, that people can get access to it and afford it.

In the past, some in the regenerative medicine field thought of the FDA as an obstacle to approval of 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 area highlighted in our Strategic Plan is overcoming manufacturing obstacles. Because these therapies are “living medicines” they are complex and costly to produce. There is often a shortage of skilled technicians to do the jobs that are needed, and the existing facilities may not be able to meet the demand for mass production once the FDA gives permission to start a clinical trial. 

To address all these issues CIRM wants to create a California Manufacturing Network that combines academic innovation and industry expertise to address critical manufacturing bottlenecks. It will also coordinate training programs to help build a diverse and expertly trained manufacturing workforce.

CIRM will work with academic institutions that already have their own manufacturing facilities (such as UC Davis) to help develop improved ways of producing therapies in sufficient quantities for research and clinical trials. The Manufacturing Network will also involve industry partners who can develop facilities capable of the large-scale production of therapies that will be needed when products are approved by the FDA for wider use.

CIRM, in collaboration with this network, will also help develop education and hands-on training programs for cell and gene therapy manufacturing at California community colleges and universities. By providing internships and certification programs we will help create a talented, diverse workforce that is equipped to meet the growing demands of the industry.

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