In the context of unprecedented gene therapy investment and clinical progress, with mounting regulatory scrutiny, Gene Therapy Analytical Development Europe will unite innovative biotech and pharma organisations to develop robust analytical tools to guarantee the consistency, quality, and safety of gene therapy products.
Whether you're looking for specific characterisation, potency or infectivity approaches to improve your current analytical toolbox or if you're seeking to understand how gene therapy analytics differ from other biologics you've worked on in the past, this focused, technical event will provide insights specifically on the unique analytical challenges posed by gene therapy vectors, delivered by 'boots on the ground' scientists grappling with these challenges first-hand.
Join 150+ analytical pioneers to discover the realities of working with tools like dPCR, AUC and HPLC, as well as how and where these tools can be most effective in process development, and what the European regulators expect in order to grant approval. Whether you're working with AAV or lentiviral vectors, this is your opportunity to enhance your existing analytical methods and explore innovative new tools to support safe and effective gene therapy development.
Speakers: Axel Ståhlbom, Current Member, EDQM Gene Therapy Products working party, Sol Ruiz, Head of Biologics, Biotechnology, and Advanced Therapies, Spanish Medicines Agency (AEMPS), Luca Biasco, Translational research, AvroBio, Guillaume Cornelis, Senior Scientist, Team Leader, Cellectis, Shyamtanu Datta, Bioassay Expert Gene Therapy Scientist, Roche, Xiaohui Lu, Senior Director, Analytical Development, Ultragenyx, Christine LE BEC, Head of CMC Gene Therapy, Sensorion, James Norton, MSAT Analytical Development Lead, MeiraGTx Gene Therapy Facility, Niamh Kinsella, Global Regulatory CMC Early Development Gene Therapy Lead, Biogen, Simon Briggs, Head of Gene Therapy Technical Product Development, Biogen, Nathalie Uzcátegui, Senior Scientist, Hansa Biopharma, Chaminda Salgado, Vice President of CMC, T-Cypher Bio, Guoxiu Breslau, Senior Scientist, PTC Therapeutics, Tushar Patel, Associate Director, Analytical Development, Vedere Bio, Felix Fuchsberger, Tech Development Scientist, Takeda, Paul Devine, Senior Scientist, AstraZeneca, Bernd Innthaler, Lead Separation Methods, Gene Therapy Process Development, Takeda, Jenifer Kaplan, Principal Scientist I, Novartis, Steven Wolk, Vice President, Analytical Chemistry & Site Head Boulder, Editas, Ernest Milian, CMC Manager, VCN Biosciences, François Gianelli, Senior Director, CMC, Voisin Consulting, Roland Pach, Global Expert CGT Analytics, Roche, Elaine Peters, CMC & Director Analytics iNest, Genentech, Judy Shimoni, Technical Development Lead, Pharma Technical Development Project and Portfolio Management, Genentech, Ilya Shestopalov, Director and Analytical, Product Lead, bluebird bio, Speaker to be confirmed, Sciex, Speaker to be confirmed, Coriolis Pharma, Speaker to be confirmed, Sartorius, Speaker to be confirmed, Bio-Rad, Speaker to be confirmed, Beckman Coulter, Speaker to be confirmed, Unchained Labs, Speaker to be confirmed, Progen, Speaker to be confirmed, Refeyn
Schedule:
Time: 9:00 AM - 5:10 PM