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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 2 of 2 Streams
Optimizing Efficiency & Quality Control While Reducing Cost of Manufacturing
Global Regulatory Alignment and Harmonization
08:25 - 08:30
Chairperson’s Opening Remarks: Optimizing Efficiency & Quality Control While Reducing Cost of Manufacturing
- Scott Wheelwright, PhD - Co-Founder and President, BEI
08:30 - 09:00
Accelerating Process Development and Reducing Manufacturing Cost for Biologics: A Case Study
09:00 - 09:30
Streamline Biologics Process Characterization and Control Strategy Development
- Sadettin Ozturk, Ph.D. - Chief Technology Officer, STRM.BIO
09:30 - 10:00
Optimizing Process Development and Clinical Production Efficiency with Continuous Improvement Projects
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
How Startups and Researchers Can Collaborate with Government and Support Organizations
- Maggie Lo - Senior VP, Life and Health Technology, Office for Attracting Strategic Enterprises
10:00 - 10:45
Networking Refreshment Break in Poster/Exhibit Hall
Showing 2 of 2 Streams
Adopting AI, Automation, and Advanced Analytics
Global Regulatory Alignment and Harmonization
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
Navigating China’s Evolving Regulatory Landscape and Bridging it with Global Development
- Wendy Yan - MBA, former SVP & Global Head of Regulatory Affairs, BeiGene
11:15 - 11:45
Ensuring Quality and Safety for Cell & Gene Therapy Products Under Evolving Guidelines
11:45 - 12:15
Global Regulatory Strategy, Policy Harmonization, and Bridging Japan’s Requirements with Global Development Programs
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
14:00 - 14:30
Enabling Robust Continuous Biomanufacturing Using Digital Twins
- Christoph Herwig - Founder, Lisalis GmbH
14:30 - 15:00
Revolutionising Resource Efficiency Based on mAb Production for Different Process Options
- Yuki Abe, Ph.D., - Director, BioPharm Services Ltd.
15:00 - 15:30
Scientific Track Presentation
13:55 - 14:00
Chairperson’s Remarks: Regulatory & CMC Strategies for Emerging Modalities
14:00 - 14:30
Future Direction on CMC of Next Generation ADCs
- Gang Qin, PhD - President, GeneQuantum Healthcare (Suzhou) Co., Ltd.
14:30 - 15:00
Implementing Continuous Processing for Novel Modalities from Small to Large Scale – Overcoming Current and Planning for Future Challenges
- Scott Wheelwright, PhD - Co-Founder and President, BEI
15:00 - 15:30
Scientific Track Presentation
15:30 - 16:30
Networking Refreshment Break in Poster/Exhibit Hall
Showing 2 of 2 Streams
Next Generation Bioprocessing, Digitalisation and Facilities of the Future
Upstream and Downstream Case Studies for Emerging Modalities
16:30 - 17:00
Implementing Continuous Processing for Novel Modalities from Small to Large Scale – Overcoming Current and Planning for Future Challenges
- Scott Wheelwright, PhD - Co-Founder and President, BEI
17:00 - 17:30
Designing High Productivity, Cost Effective Modular Bioprocessing Facilities – Successes and Lessons Learned
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
Process Automation with AI Technology for Cell Therapies
- Yasuhiro Takagi - Senior Director, Astellas Pharma Inc., Japan
17:30 - 18:00
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)
18:00 - 18:05
Close of BPI Asia 2025
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