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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 reviewing 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:
- Navigating an evolving cell therapy regulatory landscape
- How to assess GMP-readiness and prepare your cell therapy workflow for clinical and commercial manufacturing
- Ensuring patient-centricity in the complex cell therapy ecosystem and leveraging a unique, comprehensive operating model for your product
Learning objectives:
- Strategies to navigate regulatory hurdles and maximize impact of meetings with regulators
- Best practices to address common challenges in cell therapy process development and manufacturing
- Opportunities for a more streamlined, Patient-centric approach to cell therapy clinical trials
- Benefits of working with an integrated CRO/CDMO partner to simplify the cell therapy value chain and improve Patient-centricity
Presenters:
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