Caring Cross is dedicated to the development and implementation of affordable CAR-T and other advanced therapies in the US and around the world. Caring Cross is collaborating with select Academic Medical Centers (AMC) in the US and around the world to accelerate research and clinical development, regulatory approval, and patient access to affordable and sustainable treatments.
Creating a global Academic Medical Center network
As AMC have been manufacturing transplantation products for decades, and even FDA approved products, they have the knowledge and infrastructure to manufacture cell and gene therapy (CGT) products safely and cost-effectively. For example, an AMC network in Spain manufactures an anti-CD19 CAR-T cell product for approximately €89,000 (US$95,000) [1], demonstrating that these products can be manufactured in a hospital environment for a price that is fully reimbursable under a national insurance system. Such pricing would be affordable and sustainable in the USA, especially since the material cost of about $20,000 per product would provide sufficient reimbursement for the cost of clinical care and therefore would be fully reimbursable at the $257,958 CAR-T cell therapy product limit set by Medicare in 2024. In a low- and middle-income country, an AMC manufactured an anti-CD19 CAR-T cell product for approximately $35,000, leveraging a highly skilled but less expensive technical labor force to reach a more affordable cost in that country. Therefore, AMC have the potential to significantly reduce the cost and improve access of CGT products for patients located in their region, which is of particular importance for patients in low and middle-income countries, where current access is either extremely limited or does not exist.
How to join the AMC network
Caring Cross is engaging with AMCs to:
- Accelerate research and development collaborations
- Enable point-of-care GMP capabilities at the AMC
- Initiate Investigator Initiated Phase I/II Clinical Trials (IIT) with AMC clinical investigators
- Coordinate point-of-care (POC) clinical trials to support regulatory filings of cellular gene therapy products
- Obtain regulatory approval of cellular gene therapy products
- Support obtaining available reimbursements of affordable cellular gene therapy products
- Expand the network to increase treatment access for patients
To inquire about collaboration opportunities, please contact [email protected].
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