Thursday, March 25, 2021
A broad coalition of biopharmaceutical and technology leaders announced a new strategic collaboration to promote new and updated standards for advanced therapies. The new collaboration, which will work across the biopharmaceutical and technology sectors, seeks to enable the wider adoption of cell and gene therapies through standardized, automated processes that promote patient safety and control costs.
The collaboration includes a wide range of advanced therapy innovators, including Achilles Therapeutics, Adaptimmune, Genentech Inc, Marker Therapeutics Inc., Novartis Pharma AG, PACT Pharma, Takeda Pharmaceutical Company Ltd., and Tessa Therapeutics.
“Individualized cell therapies have the potential to be an incredibly effective way to redirect a patient’s own immune system to fight cancer,” said J. Andrew Case, Head of Clinical Supply Chain at Genentech. “To reach all patients in need, we need new standards and systems that support these new therapies at scale.”
The collaboration’s work kicks off with a proposal for a modern patient identifier for advanced therapies. This proposal, which is being made freely available for consideration and use to all stakeholders in the advanced therapy ecosystem, is intended to provide an unprecedented level of trust, traceability, transparency, and patient safety for advanced therapeutics. The proposed patient ID structure is flexible, and can cover all types of advanced therapeutics, including autologous cell and gene therapies, allogeneic therapies, and cancer immunotherapies, such as personalized cancer vaccines. This digital “ID badge” enables reliability and patient safety by providing a clear link, end to end, between the patient and their treatment as it is being manufactured and shipped.
“We are focused on therapies with transformative and curative potential, and the Takeda team is creating innovations that will benefit patients worldwide and support healthcare providers in their life-saving work,” said Nebojsa Milovic, Head of Cell Therapies Translational Engine for Takeda. “We know that a key part of realizing cell therapy’s potential lies in creating new infrastructure to reach clinicians and patients worldwide.”
The type of patient-to-product linkage provided by this new approach is essential for patient safety. Current patient identifiers used for legacy cell-based treatments, such as stem cell transplants or bone marrow transplants, are based on standards that do not always cover all the use cases presented by today’s personalized therapeutics. The new proposed patient ID, developed by Vineti, is intended to provide a single identifier that enables patient safety and patient care end to end across the complex advanced therapy treatment process. The proposed ID is designed to meet the data and safety needs of the patients, hospitals and healthcare providers, and biopharmaceutical developers, across a broad range of personalized therapeutics.
The proposed ID approach is also intended to support the rapid growth of advanced therapies, so that these transformative treatments can reach all patients in need. Advanced therapeutics continue to grow rapidly, even amid disruptions caused by the COVID-19 pandemic. The sector attracted $19.9 billion in financing in 2020, shattering all previous records, according to the Alliance for Regenerative Medicine. More than 1,220 advanced therapy clinical trials are currently running worldwide, with more than half focused on oncology, according to ARM.
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. Simplifying production and delivery processes through reliable, standardized mechanisms will control complexity, reduce costs, and increase feasibility, adoption, and safety.
“Patient-specific therapeutics must be delivered to the patient they are intended to treat. That concept is easy to say -- and often not easy to do,” said Vineti CEO and Co-founder Amy DuRoss. “It’s time for a patient ID that is as advanced as the therapies themselves, so that personalized medicine has a safer, scalable future. We’re very honored to work in this collaboration to drive standards that ensure the growth of all advanced therapies.”
The full patient ID proposal can be viewed here. Vineti has already presented this COI ID vision to the Standards Coordinating Body for Regenerative Medicine, which has an industry-wide working group addressing updated standards for cell therapy in-process drug labeling.