The inaugural Gene Therapy Comparability Summit is the only industry dedicated meeting to ensuring your manufacturing processes are effective and comparable at every stage of development, supporting a seamless transition to the larger scales required for commercialization.
This meeting will unite large pharma and innovative biotechs including Pfizer, Biogen, BioMarin and Takeda as they share best practices, lessons learned and analytical data across the comparability lifecycle.
Focused specifically on enhancing your gene therapy comparability approach, join us to ensure you maintain safety, quality, consistency and efficacy throughout scale-up from clinical to commercial-scale manufacturing, and satisfy regulatory demands to avoid costly delays to clinical programs.
Incorporating insights from leading CMC, Regulatory, Analytical and Process Development experts, this is your opportunity to gain extensive technical information on challenges like ensuring manufacturing processes are comparable when changing facilities and cell lines, developing effective bioassays for use in comparability studies and handling the limited gene therapy lots available.
Join your peers online and discover:
- How Biogen defined a robust comparability strategy for late phase gene therapy products
- Gain insights into the planning and considerations for a comparability study and risk assessment and understand what defines process comparability vs analytical comparability with Amicus Therapeutics
- Hear from the National Institute of Biology and discover if results of non-related analytical methods can be directly compared
- Learn from the Italian Medical Agency and take a deep dive into regulatory expectations for ATMP comparability and comparability exercises
- Explore next generation sequencing (NGS) and how its application can be utilized for comprehensive rAAV genome characterization with Biogen
- Better understand the challenges associated with limited batch retention and sample availability in the context of comparability and learn best practices for mitigating such challenges with Gyroscope Therapeutics
Visit our website and view the full event guide for more information: http://www.genetherapy-comparability.com
Time: 08:00 to 16:00
Conference + 2 Workshops (Standard Rate): USD 2697.00,
Conference + One Workshop (Standard Rate): USD 2348.00,
Conference Only (Standard Rate): USD 1999.00
Speakers: Barbara Bonamassa, Quality Assessor and European Medicines Agency (EMA) Expert for ATMPs, Italian Medicines Agency (AIFA), Mike Lehmicke, Director, Science and Industry Affairs, Alliance for Regenerative Medicine, Lyndi Rice, Head of QC Viral Vector Analytical, BioMarin, Yan Zhi, Director, Analytical Development, Spirovant Sciences, Clare Blue, Director, Analytical Development, Biogen, Reena Patel, Associate Director, Scientific Integrator Biotherapeutics Development, Janssen R and D, Jennifer Lin, Principal Scientist, Orchard Therapeutics, Franz Schnetzinger, Director, Quality Control and CMC Analytical Development, Gyroscope Therapeutics, Robert Pletzenauer, Head of Gene Therapy Analytics, Takeda, David Dobnik, Senior Research Associate, National Institute of Biology, Xiao-Ping Dai, Vice President, Head of Technical Operations, IVERICbio, Scott Burger, Principal Consultant, Advanced Cell and Gene Therapy LLC, Mark Plavsic, Chief Technology Officer, Lysogene, Alexis Cockroft, Principal Consultant, Lex Regulatory, Hui Wen Liu, Scientist, Biogen, Larry Thompson, Senior Principal Scientist, Pfizer, Roman Raim, Head of Gene Therapy Analytical Strategy Manufacturing Sciences, Takeda, Kristin Acker, Senior Scientist Analytical Development, Takeda, Dawn Henke, Senior Scientific Program Manager, Standards Coordinating Body, Christopher Bravery, Consulting Regulatory Scientist and Director, AdvBiols, Kanti Thirumoorthy, Vice President, Technical Operations, Neogene, Khandan Baradaran, Principal Scientist, CMC Product Quality, Ultragenyx Pharmaceutical, Xiaotong Fu, Senior Engineer, Biogen, Streeti Choudhury, Director, Technical Operations, Amicus Therapeutics