2025年10月20-22日
日本、京都市、ウェスティン都ホテル京都
Wednesday, October 22, 2025 - Main Conference Day 2 - JT (Japan Time, GMT+09:00)
Wednesday, October 22, 2025 - Main Conference Day 2
- JT (Japan Time, GMT+09:00)
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08:30 - 08:355 mins
Optimizing Efficiency & Quality Control While Reducing Cost of Manufacturing
Chairperson’s Opening Remarks: Optimizing Efficiency & Quality Control While Reducing Cost of Manufacturing
- Scott Wheelwright, PhD - Co-Founder and President, BEI
08:30 - 08:355 mins
Global Regulatory Alignment and Harmonization
Chairperson’s Welcome and Opening Remarks: Global Regulatory Alignment and Harmonization
08:35 - 09:0530 mins
Optimizing Efficiency & Quality Control While Reducing Cost of Manufacturing
Accelerating Process Development and Reducing Manufacturing Cost for Biologics: A Case Study
08:35 - 09:0530 mins
Global Regulatory Alignment and Harmonization
Early Development of a Global Regulatory Strategy
- Jack Wong - CEO and Founder, Asia Regulatory Professionals Association (ARPA)
09:05 - 09:3530 mins
Optimizing Efficiency & Quality Control While Reducing Cost of Manufacturing
Streamline Biologics Process Characterization and Control Strategy Development
- Sadettin Ozturk, Ph.D. - Chief Technology Officer, STRM.BIO
09:05 - 09:3530 mins
Global Regulatory Alignment and Harmonization
Strategies for Meeting U.S. FDA Cell Therapy IND Requirements: A Case Study Approach
- Minghua Liu - CMC Consultant, Regulatory Affairs, Eliquent Life Sciences
09:35 - 10:0530 mins
Optimizing Efficiency & Quality Control While Reducing Cost of Manufacturing
Optimizing Process Development and Clinical Production Efficiency with Continuous Improvement Projects
09:35 - 10:0530 mins
Global Regulatory Alignment and Harmonization
How Startups and Researchers Can Collaborate with Government and Support Organizations
- Maggie Lo - Senior VP, Life and Health Technology, Office for Attracting Strategic Enterprises
10:05 - 10:4540 mins
Networking Refreshment Break in Poster/Exhibit Hall
10:45 - 11:1530 mins
Adopting AI, Automation, and Advanced Analytics
Leveraging AI And Advanced Analytics to Enhance Bioprocess Efficiency
- Niki Wong - Director, Global Technical Operations CMC, AbbVie Operations Singapore Pte Ltd (pending)
10:45 - 11:1530 mins
Global Regulatory Alignment and Harmonization
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 - 11:4530 mins
Adopting AI, Automation, and Advanced Analytics
AI-Driven Bioprocessing: Innovations in Upstream and Downstream Development
- Mark Duerkop - Chief Executive Officer, Novasign, Austria
11:15 - 11:4530 mins
Global Regulatory Alignment and Harmonization
Ensuring Quality and Safety for Cell & Gene Therapy Products Under Evolving Guidelines
11:45 - 12:1530 mins
Adopting AI, Automation, and Advanced Analytics
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
11:45 - 12:1530 mins
Global Regulatory Alignment and Harmonization
Global Regulatory Strategy, Policy Harmonization, and Bridging Japan’s Requirements with Global Development Programs
12:15 - 12:4530 mins
Adopting AI, Automation, and Advanced Analytics
Scientific Track Presentation
12:15 - 12:4530 mins
Global Regulatory Alignment and Harmonization
Scientific Track Presentation
12:45 - 13:5570 mins
Luncheon in the Poster/Exhibit Hall
13:55 - 14:005 mins
Achievements in Intensified, Continuous, and Sustainable Bioprocessing
Chairperson’s Remarks: Achievements in Intensified, Continuous, and Sustainable Bioprocessing
13:55 - 14:005 mins
Regulatory & CMC Strategies for Emerging Modalities
Chairperson’s Remarks: Regulatory & CMC Strategies for Emerging Modalities
14:00 - 14:3030 mins
Achievements in Intensified, Continuous, and Sustainable Bioprocessing
Enabling Robust Continuous Biomanufacturing Using Digital Twins
- Christoph Herwig - Founder, Lisalis GmbH
14:00 - 14:3030 mins
Regulatory & CMC Strategies for Emerging Modalities
Future Direction on CMC of Next Generation ADCs
- Gang Qin, PhD - President, GeneQuantum Healthcare (Suzhou) Co., Ltd.
14:30 - 15:0030 mins
Achievements in Intensified, Continuous, and Sustainable Bioprocessing
Sustainability Considerations in Regards to Geographical and Process Intensification
- Yuki Abe, Ph.D., - Director, BioPharm Services Ltd.
14:30 - 15:0030 mins
Regulatory & CMC Strategies for Emerging Modalities
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 - 15:3030 mins
Achievements in Intensified, Continuous, and Sustainable Bioprocessing
Scientific Track Presentation
15:00 - 15:3030 mins
Regulatory & CMC Strategies for Emerging Modalities
Scientific Track Presentation
15:30 - 16:0030 mins
Networking Refreshment Break in Poster/Exhibit Hall
16:00 - 16:3030 mins
Next Generation Bioprocessing, Digitalisation and Facilities of the Future
Establishing Flexible, Fully Disposable GMP Facility
16:00 - 16:3030 mins
Upstream and Downstream Case Studies for Emerging Modalities
Process Automation with AI Technology for Cell Therapies
- Yasuhiro Takagi - Senior Director, Astellas Pharma Inc., Japan
16:30 - 17:0030 mins
Next Generation Bioprocessing, Digitalisation and Facilities of the Future
Designing High Productivity, Cost Effective Modular Bioprocessing Facilities - Successes and Lessons Learned
16:30 - 17:0030 mins
Upstream and Downstream Case Studies for Emerging Modalities
Utilizing Semi-Automated, Intensified Processes for Allogeneic Cell Therapies
17:00 - 17:3030 mins
Next Generation Bioprocessing, Digitalisation and Facilities of the Future
Global Strategies for Operating in an Evolving Landscape - Next Generation Bioprocessing, Digitalisation and Facilities of the Future
- Daisuke Kajihara - Senior Director of Bioprocess Technology Research Laboratories, Daiichi Sankyo Co., Ltd., Japan
17:00 - 17:3030 mins
Upstream and Downstream Case Studies for Emerging Modalities
Benefits and Challenges of Adopting Novel Platforms to Intensify Processes and Ensure Quality in Next-Generation Biologics Manufacturing
17:30 - 17:355 mins
Close of BPI Asia 2025