Workshop Open to Industry and the General Public
Join global experts, regulators, and industry leaders for a two-day workshop focused on Chemistry, Manufacturing, and Controls (CMC) considerations for biotechnology and advanced therapy products (ATPs). Co-hosted by USP and NEU under the APEC Center of Excellence for Advanced Therapies, this event will explore the evolution from traditional biologics to cutting-edge gene and cell therapies from a CMC perspective. Attendees will gain insights into regulatory expectations, comparability approaches, platform strategies, and the challenges of global harmonization.
This workshop is ideal for regulatory professionals, CMC scientists, and developers of advanced therapy products seeking to stay ahead in this rapidly evolving field. The workshop will be translated English to Korean to English.
$499 (All attendees)
$249 (Academia, Government, Non-Profits)
About the event View the agenda Register here
Day One: Wednesday, October 1, 2025
• 9:00 AM – 9:10 AM Welcome and Opening Remarks
Speakers: Fouad Atouf, Chief Science Officer, United States Pharmacopeia (USP) Jeewon Joung, Director, National Institute of Food & Drug Safety (NIFDS)
• 9:10 AM - 9:45 AM – Keynote Talk: TBD
Session – From Traditional Biologics to Advanced Therapies
• 9:45 AM – ATMP development strategies and considerations
Srinivasan Kellathur, Technical Regulatory Policy APAC, Roche
• 10:10 AM – rAAV as a Heterogeneous Particle Ensemble: Current Understanding of Its Quality Attributes
Speaker: Susumu Uchiyama, Professor, The University of Osaka
• 10:35 AM – Moving from mAbs to rAAV: how long is the journey to assess product quality? Focus on differences/challenges that spice up the analytical road to Gene Therapy
Speaker: Gael Debauve, Head of Gene Therapy CMC Analytics, UCB Session – Platform Strategy
• 11:15 AM – Evolution of CAR-T manufacturing process - from manual to automated – from open-system to closed system
Speaker: Chris Lee, Executive Director, Head of CMC & Clinical Supply, SK Life Science
• 11:40 AM – Establishing Platform Technologies in CGT: CMC and Analytical Frameworks as Pillars of Quality
Kok-Seong Lim, Senior Director of Analytical Sciences and Quality Control, formerly Metagenomi
• 12:05 PM –12:30 PM – Panel Discussion (Sessions 1 & 2 Speakers) Session – Comparability in Cell and Gene Therapy
• 1:30 PM Establishing comparability for novel therapeutics within the context of the CMC considerations for AAV-based gene therapies
Speaker: Steven H. Lee, Director, Clinical Development, CdmoGen
• 1:55 PM – TBD Session – Future Trends in CGT
• 2:20 PM – AI in Cell & Gene Therapy (CGT): From Design to Smart Manufacturing
Speaker: Rominder Singh, Professor of Practice, Regulatory Sciences, Northeastern University
• 3:10 PM – 3:40 PM
Q&A / Wrap-up Discussions
Day Two: Thursday, October 2, 2025
• 9:00 AM – Opening Remarks
Jared Auclair Dean, College of Professional Studies and Professor, Northeastern University
Session – Regulatory Frameworks for Cell and Gene Therapies
• 9:10 AM – Strategic Regulatory and CMC Approaches for Cell and Gene Therapy Development
Jun Park, Executive Consultant, Korea Health Industry Development Institute (KHIDI)
• 9:35 AM – Global Regulatory Trends and Challenges in Managing Raw and Starting Materials for CGT
Meehyun Jung, Executive Director, CTX, Inc.
• 10:00 AM – Quality Attribute Characterization and Specification Development for rAAV Products
Susumu Uchiyama, Professor, The University of Osaka
• 10:25 – AM ATMP regulatory harmonization and convergence: global perspectives
Srinivasan Kellathur, Technical Regulatory Policy APAC, Roche Session – Industry Perspective on Regulatory (Case Studies)
• 11:05 AM – Case studies for CAR-T supply disruption due to sub-optimal specification strategy
Chris Lee, Executive Director, Head of CMC & Clinical Supply, SK Life Science
• 11:30 AM – Sharing Experience of CMC Reviews for Cell and Gene Therapy Products
Atsushi Nishikawa Principal Reviewer, Pharmaceuticals and Medical Devices Agency (PMDA)
• 11:55 – AM Regulatory CMC Considerations for ATMPs – A Comparability Case-Study Natalie Ward Director, Global Regulatory Sciences – CMC, Cell Therapy, Bristol Myers Squibb Session – Regulatory Panel Discussion
Jun Park, Executive Consultant, Korea Health Industry Development Institute (KHIDI) Atsushi Nishikawa, Principal Reviewer, Pharmaceuticals and Medical Devices Agency (PMDA) Ilona Reischl Chair, Committee for Advanced Therapies, European Medicines Agency (EMA)
• 2:30 PM – 3:00 PM – Closing Remarks / Networking