The promise of cell therapies is often tempered by the many complexities of transitioning these innovations from R&D to the clinic. For early-phase programs, there are many aspects to consider, from understanding evolving regulatory guidelines and review pathway options to addressing common manufacturing-related issues such as scalability, high cost of goods, and workforce retention. Additionally, organizing and executing a successful cell therapy clinical trial can be challenged by a limited number of qualified clinical sites with experience in conducting advanced therapy studies, access to desired patient populations, and managing the complex supply chain required to deliver therapies to patients in a timely fashion.
Through a series of brief presentations on three key topic areas, this webinar will help early-phase cell therapy developers identify insights to mitigate risk and ensure clinical readiness to position their programs for success. Specific topic areas of focus include:
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