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Manufacturing & Analytical Characterization
Hot Topic

Hot Topic: Phase-Appropriate Strategies for Gene and Cell Therapy Regulatory Compliance

Tuesday, October 22, 2024
9:00 AM – 10:00 AM MT
Location:155 A

Manufacturing and Analytical Characterization Hot Topic

Gene and cell therapy products (GCTP) represent a transformative frontier in healthcare, yet their regulatory landscape often lags behind scientific advancements, posing challenges for developers and patients alike. This presentation underscores the importance of proactive compliance planning in navigating the complex regulatory environment of GCTPs. Through case studies and real-world examples, attendees will gain insights into the implications of regulatory delays and compliance failures, highlighting the critical role of early planning in mitigating risks and maximizing success opportunities. Key topics include the establishment of robust quality systems, proactive engagement with regulatory authorities, and the integration of compliance considerations throughout product development stages. Attendees will also explore evolving regulatory expectations for GCTPs, including updates to guidelines on potency, manufacturing, and quality control. By emphasizing proactive compliance planning, this presentation aims to empower developers to navigate regulatory challenges effectively and accelerate the translation of innovative GCTPs from the lab to the clinic, ultimately improving patient access to cutting-edge therapies.

Learning Objectives:

  • Understand the concept of phase-appropriate GMPs and their relevance in the development and manufacturing of cell and gene therapies
  • Gain insights into the regulatory expectations and compliance requirements at different stages of the product lifecycle, from clinical Phase I to commercialization
  • Learn strategies for establishing and maintaining effective quality systems to ensure compliance with regulatory standards and facilitate successful product approval