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Wednesday, October 22, 2025 – Main Conference Day 2 - JT (Japan Time, GMT+09:00)
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Wednesday, October 22, 2025 – Main Conference Day 2 - JT (Japan Time, GMT+09:00)
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Showing 1 of 1 Streams
Plenary Session - Global Regulatory Alignment and Harmonization
08:25 - 08:30
Chairperson’s Welcome and Opening Remarks: Global Regulatory Alignment and Harmonization
08:30 - 09:00
Early Development of a Global Regulatory Strategy
- Jack Wong - CEO and Founder, Asia Regulatory Professionals Association (ARPA)
09:00 - 09:30
Strategies for Meeting U.S. FDA Cell Therapy IND Requirements: A Case Study Approach
- Minghua Liu - CMC Consultant, Regulatory Affairs, Eliquent Life Sciences
09:30 - 10:00
Navigating China’s Evolving Regulatory Landscape and Bridging it with Global Development
- Wendy Yan - MBA, former SVP & Global Head of Regulatory Affairs, BeiGene
10:00 - 10:45
Networking Refreshment Break in Poster/Exhibit Hall
Showing 2 of 2 Streams
Adopting AI, Automation, and Advanced Analytics
Regulatory & CMC Strategies for Emerging Modalities
10:45 - 11:15
Leveraging AI And Advanced Analytics to Enhance Bioprocess Efficiency
- Niki Wong - Director, Global Technical Operations CMC, AbbVie Operations Singapore Pte Ltd (pending)
11:15 - 11:45
AI-Driven Bioprocessing: Innovations in Upstream and Downstream Development
- Mark Duerkop - Chief Executive Officer, Novasign, Austria
11:45 - 12:15
The Future of Biopharma: AI-Enabled Automation and Continuous Processing for Faster, Smarter Production
- Mrinal Bachute - Head Industry Connect, Associate Professor, Symbiosis Institute of Technology, Symbiosis International University
12:15 - 12:45
Scientific Track Presentation
10:45 - 11:15
How Startups and Researchers Can Collaborate with Government and Support Organizations
- Maggie Lo - Senior VP, Life and Health Technology, Office for Attracting Strategic Enterprises
11:15 - 11:45
Future Direction on CMC of Next Generation ADCs
- Gang Qin, PhD - President, GeneQuantum Healthcare (Suzhou) Co., Ltd.
11:45 - 12:15
Building a Harmonized CMC and Regulatory Framework for Emerging Modalities to Accelerate Their Development and Approval
- A Representative from Cell & Gene Catalyst, (pending)
12:15 - 12:45
Scientific Track Presentation
12:45 - 13:55
Luncheon in the Poster/Exhibit Hall
Showing 2 of 2 Streams
Achievements in Intensified, Continuous, and Sustainable Bioprocessing
Regulatory & CMC Strategies for Emerging Modalities
13:55 - 14:00
Chairperson’s Remarks: Achievements in Intensified, Continuous, and Sustainable Bioprocessing
- Takashi Kaminagayoshi - Head of Biotherapeutics Process Development - Japan, Takeda Pharmaceutical Company Limited, Japan
14:00 - 14:30
Revolutionising Resource Efficiency Based on mAb Production for Different Process Options
- Yuki Abe, Ph.D., - Director, BioPharm Services Ltd.
14:30 - 15:00
Building Next-Generation Single-Use, Digitally Enabled Biomanufacturing Facilities to Improve Efficiency and Sustainability
- Makoto Sadamitsu - Integrated Early Process Development Head, Takeda Pharmaceutical Company Limited
15:00 - 15:30
Panel Discussion - Impact of Sustainability Initiatives
- Yuki Abe, Ph.D., - Director, BioPharm Services Ltd.
15:30 - 16:00
Scientific Track Presentation
13:55 - 14:00
Chairperson’s Remarks: Regulatory & CMC Strategies for Emerging Modalities
14:00 - 14:30
An Automated Controlled Bioreactor Platform for Scalable 3D Expansion of iPSCs
- Andy Wiranata Wijaya - Bioprocess Team Lead, Nestlé Research
14:30 - 15:00
Qualifying and Validating Cell Counting and Viability Methods: Practical Considerations
- Christopher Bravery, Ph.D. - Principal Consultant, Consulting on Advanced Biologicals
15:00 - 15:30
Advancing mRNA-LNP GMP Manufacturing: Comparative Insights into Mixing, TFF Technologies, AI/ML Applications, and Scale-Up Approaches
- Tomomi Sato - Associate Director, Parenteral DP, Drug Product & Device Development, Takeda Pharmaceutical Company Limited (pending)
15:30 - 16:00
Scientific Track Presentation
16:00 - 16:30
Networking Refreshment Break in Poster/Exhibit Hall
Showing 2 of 2 Streams
Next Generation Bioprocessing, Digitalisation and Facilities of the Future
Development, Production and Validation Strategies for Emerging Modalities
16:30 - 17:00
Digitally Integrated Product Life Cycle – The Role of End-to-End Digital Transformation
- Seishiro Sawamura - Purification Process Development, Takeda Pharmaceutical Company Limited (pending)
17:00 - 17:30
Key Technology Considerations for High-potency Biologics (Facility Layout, Single-use Technologies, Data-Driven Process Controls, Risk-based Containment Strategy)
- Osamu Shirokizawa - President and CEO, Life Scientia Ltd.
17:30 - 18:00
Panel Discussion: Asia's Bioprocessing Boom: Integrating Digitalization and Navigating Geopolitical Investment Strategies
- Daisuke Kajihara - Senior Director of Bioprocess Technology Research Laboratories, Daiichi Sankyo Co., Ltd., Japan
16:30 - 17:00
Utilizing Site-Specific Integration Cell Line Platform to Improve Product Quality and Development Efficiency for Complex Next-Gen Formats
- Changlin Dou - R&D President, Chief Operating Officer, Executive Board Member, Shandong Boan Biotechnology Co., Ltd, China
17:00 - 17:30
Implementing Continuous Processing for Novel Modalities from Small to Large Scale – Overcoming Current and Planning for Future Challenges
- Scott Wheelwright, Ph.D. - Chairman, CTO & Co-Founder, BioChromatographix International Pte. Ltd. (BCI)
17:30 - 18:00
Process Automation with AI Technology for Cell Therapies
- Yasuhiro Takagi - Senior Director, Astellas Pharma Inc., Japan
18:00 - 18:05
Close of BPI Asia 2025
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