Gene Therapy and Cell Therapy Manufacturing


December 2014 – Brussels, Belgium

The First Stem-Cell Based ATMP in the EU – CMC and Post-Approval Considerations
09.00 – Holoclar®, the first Stem Cell-based ATMP Approved in the EU: how an academic research became a pharmaceutical product.
Part 1: Regulatory hurdles and key considerations during development
• From Advanced Therapy to ATMP
• Development and implementation of regulatory strategy
• Key CMC, pre-clinical and clinical challenges
 Alex Bloom, Senior Manager, Global Regulatory Affairs, Biologics and Advanced Therapies, Chiesi, UK
09.15 -Part 2: From clinical development to commercialization
• Use of retrospective clinical data from health records to generate regulatory-valuable evidence: issues and   challenges
• Review and contextualization of Holoclar clinical data package within marketing authorization procedures and  clinical practice
• Transition from a single-country clinical experience to EU-wide distribution and commercialization
• Facing post-approval commitments and patient’s access
 Diego Ardigo, Project Leader, Cell and Gene Therapy Products, Chiesi, Italy


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