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Drugmakers Join Vineti to Promote Enhanced Standards for Personalized Cell Therapies

NEW YORK – Eight drug developers have joined health technology firm Vineti to promote updated standards that enable wider adoption of cell and gene therapies including those for cancer.

The drugmakers in the coalition are Achilles Therapeutics, Adaptimmune, Genentech, Marker Therapeutics, Novartis Pharma, PACT Pharma, Takeda Pharmaceutical, and Tessa Therapeutics. These firms have committed to working with San Francisco-based Vineti, which operates a digital platform for integrating logistics, manufacturing, and clinical data for personalized therapies, to promote the adoption of enhanced standards that improve patient safety and control costs for personalized treatments including autologous T-cell therapies, allogeneic treatments, and personalized cancer vaccines.

"Individualized cell therapies have the potential to be an incredibly effective way to redirect a patient’s own immune system to fight cancer," J. Andrew Case, head of clinical supply chain at Genentech, said in a statement. "To reach all patients in need, we need new standards and systems that support these new therapies at scale."

The first project the collaborators are focused on is a proposal to advance a digital ID badge that allows cell and gene-based treatments to be tracked from manufacturing, through shipment, to patient delivery. The patient ID will be developed by Vineti and will meet the safety needs of not only patients but also hospitals, healthcare providers, and drugmakers. According to Vineti, such an ID will also expedite the development of advanced therapies, which attracted $19.9 billion in financing last year, with 1,220 treatments being investigated in clinical trials, more than half of which are for cancer.

"This promising pace of growth, however, will not be sustainable without a rigorous, industrialized, standardized approach to delivering these personalized therapeutics to patients. Personalized therapeutics, such as T-cell therapies, are the most complex treatments to produce in the history of biologics," Vineti said in a statement. "Simplifying production and delivery processes through reliable, standardized mechanisms will control complexity, reduce costs, and increase feasibility, adoption, and safety."

Vineti has already presented its patient ID proposal to the Standards Coordinating Body for Regenerative Medicine's working group focused on updating standards for cell therapies. The company also welcomes industry wide feedback on its proposal.