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DRIVE EUROPEAN ACTIVITIES FOR
ADVANCED THERAPY MEDICINAL PRODUCT
DEVELOPMENT AND IMPLEMENTATION

The JOIN4ATMP project aims to accelerate and de-risk European ATMP development and ensure wide-spread access of ATMPs, through the mapping of obstacles to such development, the audit of real-world-based solutions and the definition of new paths forward.

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With JOIN4ATMP contribution: New Report on Regulatory Strategies for Accelerating Cell & Gene Therapy Development

We are pleased to share the outcomes of a roundtable co-hosted by T2EVOLVE and JOIN4ATMP during the ESGCT Annual Meeting 2024 in Rome, which brought together regulators, developers and researchers to explore how platform approaches and data extrapolation can support faster, safer, and more efficient development of ATMPs in Europe.

Key discussion topics included:

  • How EU regulators approach extrapolation and platform-based submissions
  • The importance of leveraging prior knowledge with scientific justification
  • Bridging data across similar products while ensuring risk-based regulatory compliance
  • Practical insights from CAR-T and gene therapy case studies

Speakers included experts from EMA’s CAT committee, AGES, AIFA, BMS, and leading institutions such as VHIO and Fondazione Telethon.

Find the full report on the T2EVOLVE website.