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The CGTP 2020 Symposium will explore how to continue to adapt concepts applied to other biologics and how to establish novel approaches where they are needed.
Innovative regulatory pathways for cell and gene products have accelerated product development and approval allowing patients in need to access transformative therapies. However, the shortened development timeline has exerted significant pressure to accelerated CMC development.
One of the biggest challenges is to develop, characterize, and validate the manufacturing process under these compressed clinical development timelines while ensuring comparability between process versions and maintaining the link to clinical data. In the past few years, several cell and gene therapy products have overcome this challenge and successfully launched new CGTPs. This session will provide the challenges industry is facing and approaches to speed up the CMC development. Perspectives from regulators will help set the expectations of CMC acceleration and pathways to facilitate innovation.
Specifically, the session will demonstrate how risk assessments are leveraged to guide process development activities for these products to ensure that the CGTP can be manufactured commercially and meet the CQAs established during registration trials.
The maturing of Cell and Gene Therapy products provides an opportunity to serve patients with options for treatment where none have previously existed. In the past few years, several cell and gene therapy products have gained regulatory approval in the US and EU…