Twenty-First Century Cell Therapy
Advanced medicines are full of promise, but also pitfalls – not least making sure that manufacturing costs don’t trump the reimbursement price.
Denis Bedoret |
In August, The Medicine Maker’s advanced medicines supplement illustrated the explosive growth of the cell therapy industry (1). Over the last decade, the industry has moved from great expectations to clinical realities, with a growing number of ongoing clinical trials in multiple indications. Clinical trials are now primarily sponsored and driven by industry, rather than academia – an exciting feature of the maturing field. There is also growing acceptance that allogeneic products will not completely replace autologous transplantation approaches – there will be a need for both systems. As more autologous therapies come to market, the industry is also getting to grips with the supply chain and business model challenges.
Initially, approved cell therapy products tended to be focused on regenerative medicine and tissue engineering, but now the field has shifted to immunotherapy. Novartis’ CAR-T therapy, Kymriah, will hit the market soon, after being approved by the FDA at the end of August. It will be manufactured for each individual patient using their own cells and cryopreserved to allow for treatment flexibility. Other companies are also hoping for CAR-T approvals; for example, Kite Pharma won the 2017 “Clinical Trial Result of the Year” for its Pivotal CAR-T Trial in Patients with Aggressive Non-Hodgkin Lymphoma at the Clinical and Research Excellence Awards. It’s safe to say that immunotherapy and cell therapies are in the spotlight.
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