2025年10月22日（星期三） – 主要会议第2天 2025年10月22日（星期三） - 日本时间（GMT+09:00）

08:25 - 08:305 分钟

Plenary Session - Global Regulatory Alignment and Harmonization
全体会议 - 全球监管协调与统一

Chairperson’s Welcome and Opening Remarks: Global Regulatory Alignment and Harmonization
主席致欢迎词及开幕词：全球监管协调与统一

08:30 - 09:0030 分钟

Plenary Session - Global Regulatory Alignment and Harmonization
全体会议 - 全球监管协调与统一

Early Development of a Global Regulatory Strategy
尽早制定全球监管战略

Jack Wong - CEO and Founder, Asia Regulatory Professionals Association (ARPA)

09:00 - 09:3030 分钟

Plenary Session - Global Regulatory Alignment and Harmonization
全体会议 - 全球监管协调与统一

Strategies for Meeting U.S. FDA Cell Therapy IND Requirements: A Case Study Approach
满足美国 FDA 细胞疗法 IND 要求的策略：案例研究方法

Minghua Liu - CMC Consultant, Regulatory Affairs, Eliquent Life Sciences

09:30 - 10:0030 分钟

Plenary Session - Global Regulatory Alignment and Harmonization
全体会议 - 全球监管协调与统一

Navigating China’s Evolving Regulatory Landscape and Bridging it with Global Development
配合中国不断变化的监管情势并衔接全球发展

Wendy Yan - MBA, former SVP & Global Head of Regulatory Affairs, BeiGene

10:00 - 10:4545 分钟

Networking Refreshment Break in Poster/Exhibit Hall
海报/展览厅的交流茶歇

10:45 - 11:1530 分钟

Adopting AI, Automation, and Advanced Analytics
AI、自动化和高级分析的引进

PAT and AI in Biologics Production: Fact or Fiction
生物制剂生产中的 PAT 和 AI：是事实还是虚构？

Niki Wong - Director, Global Technical Operations CMC, AbbVie Operations Singapore Pte Ltd

10:45 - 11:1530 分钟

Regulatory & CMC Strategies for Emerging Modalities
新兴模式上的监管和CMC策略

How Startups and Researchers Can Collaborate with Government and Support Organizations
新创公司和研究人员如何与政府和支援团体合作

Maggie Lo - Senior VP, Life and Health Technology, Office for Attracting Strategic Enterprises

11:15 - 11:4530 分钟

Adopting AI, Automation, and Advanced Analytics
AI、自动化和高级分析的引进

AI-Driven Bioprocessing: Innovations in Upstream and Downstream Development
AI 驱动的生物加工：上下游开发创新

Mark Duerkop - Chief Executive Officer, Novasign, Austria

11:15 - 11:4530 分钟

Regulatory & CMC Strategies for Emerging Modalities
新兴模式上的监管和CMC策略

Future Direction on CMC of Next Generation ADCs
下一代ADC的CMC未来方向

Gang Qin, PhD - President, GeneQuantum Healthcare (Suzhou) Co., Ltd.

11:45 - 12:1530 分钟

Adopting AI, Automation, and Advanced Analytics
AI、自动化和高级分析的引进

The Future of Biopharma: AI-Enabled Automation and Continuous Processing for Faster, Smarter Production
生物制药的未来：AI 支援的自动化和连续处理，实现快速智慧生产

Mrinal Bachute - Head Industry Connect, Associate Professor, Symbiosis Institute of Technology, Symbiosis International University

11:45 - 12:1530 分钟

Regulatory & CMC Strategies for Emerging Modalities
新兴模式上的监管和CMC策略

Building a Harmonized CMC and Regulatory Framework for Emerging Modalities to Accelerate Their Development and Approval
建立统一的 CMC 和监管框架，以加快新兴模式的开发和审批

A Representative from Cell & Gene Catalyst, (pending)

12:15 - 12:4530 分钟

Adopting AI, Automation, and Advanced Analytics
AI、自动化和高级分析的引进

Scientific Track Presentation
科学专题简报

12:15 - 12:4530 分钟

Regulatory & CMC Strategies for Emerging Modalities
新兴模式上的监管和CMC策略

Scientific Track Presentation
科学专题简报

12:45 - 13:5570 分钟

Luncheon in the Poster/Exhibit Hall
海报/展览厅的午餐会

13:55 - 14:005 分钟

Achievements in Intensified, Continuous, and Sustainable Bioprocessing
强化、连续和永续生物加工方面的成就

Chairperson’s Remarks: Achievements in Intensified, Continuous, and Sustainable Bioprocessing
主席致辞：强化、连续和永续生物加工方面的成就

Takashi Kaminagayoshi - Head of Biotherapeutics Process Development - Japan, Takeda Pharmaceutical Company Limited, Japan

13:55 - 14:005 分钟

Regulatory & CMC Strategies for Emerging Modalities
新兴模式上的监管和CMC策略

Chairperson’s Remarks: Regulatory & CMC Strategies for Emerging Modalities
主席致辞：新兴模式上的监管和CMC策略

14:00 - 14:3030 分钟

Achievements in Intensified, Continuous, and Sustainable Bioprocessing
强化、连续和永续生物加工方面的成就

Revolutionising Resource Efficiency Based on mAb Production for Different Process Options
基于不同制程方案上的单株抗体生产，彻底革新资源效率

Yuki Abe, Ph.D., - Director, BioPharm Services Ltd.

14:00 - 14:3030 分钟

Regulatory & CMC Strategies for Emerging Modalities
新兴模式上的监管和CMC策略

An Automated Controlled Bioreactor Platform for Scalable 3D Expansion of iPSCs
用于iPSC可扩展3D扩增上的自动化受控生物反应器平台

Andy Wiranata Wijaya - Bioprocess Team Lead, Nestlé Research

14:30 - 15:0030 分钟

Achievements in Intensified, Continuous, and Sustainable Bioprocessing
强化、连续和永续生物加工方面的成就

Building Next-Generation Single-Use, Digitally Enabled Biomanufacturing Facilities to Improve Efficiency and Sustainability
构建下一代一次性、数位化生物制造设施，以提高效率和可持续性

Makoto Sadamitsu - Integrated Early Process Development Head, Takeda Pharmaceutical Company Limited

14:30 - 15:0030 分钟

Regulatory & CMC Strategies for Emerging Modalities
新兴模式上的监管和CMC策略

Qualifying and Validating Cell Counting and Viability Methods: Practical Considerations
细胞计数和活力检测方法的鉴定和验证：实用的考虑要点

Christopher Bravery, Ph.D. - Principal Consultant, Consulting on Advanced Biologicals

15:00 - 15:3030 分钟

Achievements in Intensified, Continuous, and Sustainable Bioprocessing
强化、连续和永续生物加工方面的成就

Panel Discussion - Impact of Sustainability Initiatives
小组讨论 - 对永续发展措施的影响

Yuki Abe, Ph.D., - Director, BioPharm Services Ltd.

15:00 - 15:3030 分钟

Regulatory & CMC Strategies for Emerging Modalities
新兴模式上的监管和CMC策略

Advancing mRNA-LNP GMP Manufacturing: Comparative Insights into Mixing, TFF Technologies, AI/ML Applications, and Scale-Up Approaches
mRNA-LNP 的 GMP 生产进展：关于混合、TFF 技术、AI/ML 应用和放大方法的比较见解

Tomomi Sato - Associate Director, Parenteral DP, Drug Product & Device Development, Takeda Pharmaceutical Company Limited

15:30 - 16:0030 分钟

Achievements in Intensified, Continuous, and Sustainable Bioprocessing
强化、连续和永续生物加工方面的成就

Scientific Track Presentation
科学专题简报

15:30 - 16:0030 分钟

Regulatory & CMC Strategies for Emerging Modalities
新兴模式上的监管和CMC策略

Scientific Track Presentation
科学专题简报

16:00 - 16:3030 分钟

Networking Refreshment Break in Poster/Exhibit Hall
海报/展览厅的交流茶歇

16:30 - 17:0030 分钟

Next Generation Bioprocessing, Digitalisation and Facilities of the Future
下一代生物加工、数位化和未来的设施

Digitally Integrated Product Life Cycle - The Role of End-to-End Digital Transformation
数位化整合的产品生命周期 – 端到端数位化转型的作用

Seishiro Sawamura - Purification Process Development, Takeda Pharmaceutical Company Limited

16:30 - 17:0030 分钟

Development, Production and Validation Strategies for Emerging Modalities
新兴模式的开发、生产和验证策略

Utilizing Site-Specific Integration Cell Line Platform to Improve Product Quality and Development Efficiency for Complex Next-Gen Formats
活用基于特定位点整合的细胞株平台，提高复杂的下一代规格的产品质量和开发效率

Changlin Dou - R&D President, Chief Operating Officer, Executive Board Member, Shandong Boan Biotechnology Co., Ltd, China

17:00 - 17:3030 分钟

Next Generation Bioprocessing, Digitalisation and Facilities of the Future
下一代生物加工、数位化和未来的设施

Key Technology Considerations for High-potency Biologics (Facility Layout, Single-use Technologies, Data-Driven Process Controls, Risk-based Containment Strategy)
高活性生物制剂的关键技术考虑因素（设施布局、一次性技术、数据驱动的制程控制、基于风险的控制策略）

Osamu Shirokizawa - President and CEO, Life Scientia Ltd.

17:00 - 17:3030 分钟

Development, Production and Validation Strategies for Emerging Modalities
新兴模式的开发、生产和验证策略

Implementing Continuous Processing for Novel Modalities from Small to Large Scale - Overcoming Current and Planning for Future Challenges
从小规模到大规模，新模式上引进连续流程—克服当前挑战并规划未来

Scott Wheelwright, Ph.D. - Chairman, CTO & Co-Founder, BioChromatographix International Pte. Ltd. (BCI)

17:30 - 18:0030 分钟

Next Generation Bioprocessing, Digitalisation and Facilities of the Future
下一代生物加工、数位化和未来的设施

Panel Discussion: Asia's Bioprocessing Boom: Integrating Digitalization and Navigating Geopolitical Investment Strategies
小组讨论：亚洲生物加工的急速成长：整合数位化及引领地缘政治投资策略

Daisuke Kajihara - Senior Director of Bioprocess Technology Research Laboratories, Daiichi Sankyo Co., Ltd., Japan

17:30 - 18:0030 分钟

Development, Production and Validation Strategies for Emerging Modalities
新兴模式的开发、生产和验证策略

Process Automation with AI Technology for Cell Therapies
透过细胞治疗用AI技术实现流程自动化

Yasuhiro Takagi - Senior Director, Astellas Pharma Inc., Japan

18:00 - 18:055 分钟

Close of BPI Asia 2025
BPI Asia 2025闭幕

* 活动内容有可能不事先告知作更动及调整。

2025年10月22日（星期三） – 主要会议 第2天 2025年10月22日（星期三） - 日本时间（GMT+09:00）

2025年10月22日（星期三） – 主要会议第2天 2025年10月22日（星期三） - 日本时间（GMT+09:00）