St. Judes R&D

St. Jude Children’s Research Hospital partners with commercial pharmaceutical companies to mass-produce and market its drugs.

While St. Jude discovers and creates novel therapies, it is a research hospital rather than a commercial drug manufacturer. 

It handles the early stages of drug development on-site but transitions to the pharmaceutical industry for large-scale production, commercial testing, and global distribution.

How St. Jude’s Drug Process Works

On-Site Discovery and Small-Scale Manufacturing: 

St. Jude features an internal, 64,000-square-foot Good Manufacturing Practice (GMP) facility. This specialized lab manufactures early-stage biological products, experimental vaccines, and gene therapies specifically for its own pediatric patients and clinical trials.

Licensing to Pharmaceutical Companies: When a drug discovered at St. Jude proves successful in laboratory settings or early trials, the hospital licenses the patent rights to major pharmaceutical firms. These corporate partners possess the infrastructure required to fund late-stage clinical trials, secure final FDA approvals, and mass-produce the medication for the public.

Real-World Examples: 

Decades of research at St. Jude led to the discovery of the ALK gene abnormality in pediatric cancers. 

St. Jude non-exclusively licensed this technology to drug companies like Novartis, Cephalon (Teva), and Ariad, who then manufactured and brought FDA-approved cancer therapies like Xalkori® and Zykadia™ to market.

The Global Platform for Access: 

To ensure children worldwide can access critical treatments, St. Jude collaborated with the World Health Organization (WHO) to create the Global Platform for Access to Childhood Cancer Medicines. 

Through this initiative, St. Jude purchases and distributes generic cancer drugs directly from the global pharmaceutical industry to deliver them to low- and middle-income nations at no cost.