Scientific Program
GENAP Summit 2023 Official Agenda
Networking Events 
APT Track 
GCT Track
Day 1 - Thu, February 23rd
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Registration & Coffee
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Annex 1 - GMP Compliance when working with Robotics in Aseptic Processing
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Richard Denk, Senior Consultant Aseptic Processing & Containment at SKAN AG
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Aseptic processing applied in Gene & Cell therapy following QRM principles
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James Drinkwater, Head of GMP Compliance at Franz Ziel
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Speed Networking
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Morning Coffee Break
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Modular and Flexible Robotics Systems for CGT
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Fabian Stutz, CEO at Pharmabotix AG
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FDA's Regulatory Review and Inspection of Biological Products Manufactured Using Aseptic Processing
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Zhihao Peter Qiu, External Advocacy Lead China at Roche Genentech
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Meeting the challenges of Annex 1 with innovation in rapid H2O2 validation.
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Kate Marshall, Technical Director at Protak Scientific
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Overcome development and manufacturing challenges for viral vector sterilizing filtration
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Chiara Pacini, Bioprocess Specialist at Pall Corporation
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Lunch & Networking Break
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Developing stem cell-based gene therapy for RAG1 and RAG2 deficient SCID
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Frank J.T. Staal, Professor at Leiden University Medical School
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Sleeping Beauty Transposon Vectors for Therapeutic Applications
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Zsuzsanna Izsvák, Group leader at Max Delbrück Center of Molecular Medicine, Berlin
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CMC considerations for Cell and Gene therapy products
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Alison Armstrong, Senior Director, Global Head Technical and Scientific Solutions at Merck KGaA
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DGE-AUC: Adapting the Power of Density Gradient Separations for Gene Therapy Analytics
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Lutz Ehrhardt, Senior Marketing Manager Centrifugation at Beckman Coulter Life Sciences
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DGE-AUC: Adapting the Power of Density Gradient Separations for Gene Therapy Analytics
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Lutz Ehrhardt, Senior Marketing Manager Centrifugation at Beckman Coulter Life Sciences
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Afternoon Coffee Break
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Panel Discussion
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Ensuring clinical success: Clinical data generation
The future and commercial sustainability of ATMPs
ATMP – Regulatory, process and supply chain: Challenges & opportunities
CGT Bioprocessing and digitalization
Viral-Vector Therapies at scale: today’s Challenges and future opportunities -
Chairperson Closing Remarks and end of the 1st day sessions
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Gala Dinner at Mélia Milano Hotel
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With Live Portuguese FADO Music
Day 2 - Fri, February 24th
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Registration & Coffee
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Contamination Control with Efficiency – Integrating Annex 1, Automation and Microbiology
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Donald Singer | Chris Berridge, Ecolab Life Sciences
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Vaporized hydrogen peroxide (VHP) sterilization and biodecontamination technologies – implications from new regulatory and standards developments (EU Annex 1:2022 and ISO 22441:2022)
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Juha Mattila Director, Sterilization Technologies at STERIS Life Sciences
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Morning Coffee Break
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Microbial data investigations and effective implementation roadmap of Contamination Control Strategy
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Michele Simone, Corporate Quality Management Director at Bracco
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Pattern Recognition and Trending for Regulatory Compliancy and Contamination Control Strategy
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Susan Cleary, Director Product Development at Novatek International
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The Facility Evolution of Small-Scale Cell Therapy
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David Estapé, Senior Process Specialist & Senior Fellow at CRB
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Panel Discussion
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EU GMP Annex 1 Revision Implementation
Aseptic Packaging Sustainability
Contamination Control Strategies -
Lunch & Networking Break
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Novel Concept for Isolators to Manufacture ATMP and Biologics
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Silvia Aldi, Product Manager for Cell & Gene Therapy at SKAN AG
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Comparability for genetically modified cells: challenges for vectors and cells
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Christiane Niederlaender, Vice President Technical CMC at Parexel
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Viral vector development and manufacture
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Magnus Gustafsson Chief Business Officer at Biovian
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Alternative in vitro models to animal testing : what are the new challenges and opportunities?
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Edith Filaire, Professor and Scientific Director at ICARE GROUP
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Chairperson Closing Remarks and end of the GENAP Summit
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