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Session Details

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ATMP Regulatory Interplay: Difficulties in Navigating Quality and Regulatory Standards of Cell-Based Starting Materials in an Era of Regulatory Resilience and Harmonization
Thursday, September 5, 2024 01:45 PM - 02:45 PM  
F3
Concurrent Session

Chair:

  • Michela Gabaldo, PharmD, EVOTEC, Italy
Speakers: 
  • Stefaan Van der Spiegel, MD, MBA, European Commission, Belgium - The new SoHO regulation: streamlining the EU-landscape for cell and tissue therapies 
  • Ilona Reischl, PhD, Assessor, AGES MEA, Austria - The SOHO interface from the cell-based ATMP perspective
Panel Discussion:
  • Jacqueline Barry, PhD, Cell and Gene Therapy Catapult, United Kingdom
  • Nina Worel, MD, PhD, Medical University of Vienna, Austria

In an era of regulatory harmonization and resilience, we’re still facing uncertainties on regulatory and quality requirements of human-derived material donor eligibility, collection and movement among different jurisdictions (focus on US, EU). Additionally, some differences exist also across different EU member states, increasing hurdles to advance therapy developers to fulfill requirements for cell-based material cross-border movement. Dealing with unmanipulated starting material (i.e., apheresis, BM, lipoaspirate, etc) or with substantially manipulated cell-derived material (cell lines, cell banks) implies navigating the grey area of different legal frameworks interplay enabling  global ATMP production and distribution.

Session Objectives
  1. Discuss how the cell- and tissue-based ATMP developers could benefit from Substance of Human Origin (SoHO) regulation implementation and analyze the complex interplay between SoHO and ATMP regulations.
  2. Examine changes within SoHO regulation in donor eligibility requirements, testing panel/time windows, and SoHO cross-border movement harmonization to enable global procurement of cell-based ATMPs.
  3. Explore the role of the SoHO national and central bodies in classifying borderline drug products vs EMA CAT's role.
     
Michela Gabaldo PharmD
VP ATMP Global Regulatory Affairs
 EVOTEC
 Chair
Jacqueline Barry PhD
Chief Clinical Officer
 Cell and Gene Therapy Catapult
 Panelists
Nina Worel
Physician
 Medical University of Vienna
 Panelists
Stefaan Van der Spiegel
Head of Sector, Health Innovation and Substances of Human Origin (DG SANTE)
 European Commission
 Remote Speaker
Ilona Reischl PharmD, PhD
Assessor
 AGES MEA
 Speakers
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