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Virtual

Sep 15, 2026 11:00 AM - Sep 15, 2026 12:00 PM

DIA Direct: Unlocking the Plausible Mechanism Framework: Advancing Innovation in Cell and Gene Therapies

An overview of the Plausible Mechanism Framework and its role in supporting the development of Advanced Therapies.

Overview

This webinar will provide an overview of the Plausible Mechanism Framework and its role in supporting the development of advanced therapies. Through expert presentations and an interactive Q&A, attendees will explore the framework’s scientific and regulatory foundations, the use of prior knowledge in regulatory decision-making, and key policy considerations for its application to cell and gene therapies.

Featured topics

  • Understanding the framework and its role in advancing cell and gene therapies
  • Exploring the evidence base and regulatory principles that support the framework
  • Key opportunities, challenges, and considerations for implementing the framework

Who should attend?

Who should attend: The webinar is designed for Biopharmaceutical and biotechnology professionals, Regulatory affairs professionals, Clinical and translational researchers, CMC, nonclinical, and clinical development teams, Policy and government affairs professionals.

Learning objectives

  • By the end of this webinar, participants will be able to:

    • Explore the purpose, principles, and potential impact of the framework in advancing innovative therapeutic development.
    • Learn how existing scientific evidence and prior knowledge can inform regulatory assessment and approvals.
    • Examine key policy issues and implementation challenges related to cell and gene therapy development.

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