USA — Danaher has announced a new collaboration with the University of Pennsylvania (Penn) aimed at addressing the manufacturing challenges that limit the consistency of clinical outcomes and slow the delivery of next-generation engineered cell products.
This multi-year partnership focuses on developing new technologies to overcome bottlenecks in the manufacturing process and improve the scalability of production.
The number of cell and gene therapy products that have been approved for use over the past ten years is relatively low.
Currently, there are only six CAR T cell therapies approved by the FDA, but with at least 560 programs in ongoing clinical trials, the biopharma industry sees significant potential in these therapies to revolutionize the treatment landscape.
However, based on the number of products currently in Phase III clinical trials, it is likely that this number will increase significantly in the near future.
By 2024, it is estimated that up to 21 cell therapy launches and as many as 31 gene therapy launches will occur, including over 29 adeno-associated virus (AAV) therapies.
Vanessa Almendro, VP of Science and Technology Innovation at Danaher, believes that the partnership with the CAR T pioneers at Penn will help accelerate the translation of scientific discoveries into life-changing therapies for patients.
As a part of Danaher’s Beacons program, which supports groundbreaking scientific research conducted in academic settings, the Beacon for Cell Therapy Innovation with Penn has been established with the ultimate goal of developing innovative technologies and applications to enhance human health.
The program’s key focus areas include precision diagnostics, genomic medicines, human systems, data sciences, and next-generation biomanufacturing.
This particular Beacon will concentrate on product solutions that address the manufacturing yield and quality bottlenecks affecting cell therapy.
The launch of cell and gene therapy (CGT) products is a critical step for companies that have invested in their development.
These products have the potential to benefit many patients, but their successful launch is necessary to ensure a sufficient return on investment and encourage continued research in this area. However, CGTs face steeper challenges at launch than traditional drugs do.
The current payer system is not well-suited to accommodate single-dose therapies with uncertain long-term efficacy, risk-benefit ratios, and safety, potentially limiting their adoption.
According to a McKinsey article, CGT patients are burdened with a complex and costly path to treatment, including frequent genetic testing and counseling and long trips to widely spaced healthcare sites.
Healthcare providers must invest significant time in finding and training personnel at new sites, and payers may be hesitant to take on the increased financial risk of treatments with higher one-time costs. Companies also face supply chain, manufacturing, and distribution challenges.
To overcome these obstacles, companies must re-evaluate their go-to-market strategies and prepare adequately for future launches.
This requires establishing payment and risk-sharing mechanisms between pharmaceutical companies and providers, ensuring that potential patients, providers, and payers are in place, and ensuring that the therapy is readily available.
By doing so, companies can maximize the impact of these innovative therapies and ensure that they benefit as many patients as possible,
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