Cryoport was honored to be invited to speak at the CAR-T Summit in Shanghai, which gathered the world’s foremost experts on cell and gene therapy. While all presenters highlighted topics that were important to the industry, the CEO round table discussion was particularly insightful into China’s evolving cell and gene therapy market.
The biggest takeaway? The CEOs’ most serious, pressing concern is management of the supply chain – specifically the ability to execute on manufacturing challenges. Unlike traditional drug development, where the regulatory bodies spend 20% of their time evaluating the manufacturing process and 80% of the time looking at clinical data, the reverse is true for cell and gene therapy. There is a strong evidence-based belief that the regulatory bodies are going to overwhelmingly spend their time looking at and evaluating the supply chain. The ability to manufacture beyond a small Phase I trial, coupled with the fragility of the cells and the value of the therapies is pushing these CEOs to consider a different model. More and more, cell and gene therapy companies are looking to take the manufacturing process, especially Phase III and commercial, in-house. Getting from the world of today to the reality of tomorrow is not going to be an easy task.
These therapies are unique. The supply chain stake holders need to lead or at least have a strong voice regarding process design and standardization of the space. What we heard in Shanghai – and this message was amplified by many of the CDMOs presenting – is that the real competitive advantage for these companies is in execution and manufacturing, not outcomes.
As the cell and gene therapy industry continues to rapidly grow, we know that finding talent and deploying resources are going to be at a premium. In the areas where your organization doesn’t have the depth or necessary bench strength, are you partnered with companies that have a demonstrable, successful track record in your areas of need?
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