Alex WANG

Dr. Wang has been in the pharmaceutical industry for more than 30 years, covering areas from drug research and development to quality management and operation. Familiar with lab management, setting up quality system and day to day quality operation, especially corporate quality management of Group Company. Led and passed GMP inspections by FDA，EU， Japan, WHO, and many other countries, for drug substances and drug products, including API ( sterile APIs), oral products, injection, and veterinary medicine. Familiar with domestic and foreign regulations, and has plenty of practical implementation experience. Dr. Wang also was the editorial board member of Guideline of Chinese GMP (2010).
Dr. Wang worked for several large companies (including MNCs) as quality head, he is now responsible for whole operation.as a VP in Nhwa Pharmaceutical Co.,Ltd

Huilin ZHU

Head of Clinical Manufacturing at WuXi Biologics, with 15 years of experience in the biopharmaceutical industry.
Supervising a clinical manufacture network with cell banking and drug substance GMP facilities operating at multiple sites, to deliver DS with global quality standards.
Deep expertise spanning cell culture process development, DS technology transfer & scale-up, pilot production , GMP manufacturing and quality management.
Multiple years of end to end CMC lifecycle management of biopharmaceutical products with modalities encompassing mAb, bsAb and ADC.
Core member of ISPE China Biologics Process and Production sub-committee since 2022. Led planning and execution of ISPE activities including ISPE China Annual Meetings, online and offline sub-committee activities.

Chen GU

Gu Chen Graduated with a degree in engineering and computer engineering. Joined Syntegon (former Bosch Packaging Technology) in 2011. Experienced with kinds of aseptic filling finish process and now is dedicated on complex filling process solutions, technical transfer and market promotion.

Tony MAO

Tony Mao holds a Master’s degree from the University of Chinese Academy of Sciences and a Bachelor’s degree from Beijing University of Posts and Telecommunications. He currently serves as Head of the IT Department at Lepu Biopharma Co., Ltd., where he is driving digital transformation and AI-powered intelligence across key domains—including preclinical R&D, clinical trials, CMC, quality management, marketing and sales operations, supply chain management, and human resources management etc. His leadership has delivered compliant, efficient, and intelligent business outcomes.
Previously, Mao Lei served as IT Leader at China Potevio Corporation (a central SOE and former top-ranked enterprise in China’s Top 100 Electronics List) and BlueFocus Group (China’s largest digital marketing group), bringing extensive cross-industry and enterprise-group experience in digitalization, and large-scale IT governance.

Lan SHI

Lan SHI, currently Director of the Drug Supervision Division, Shanghai Administration for Drug Control. She has previously served in policy, legal affairs and inspection departments.
Her major research fields include drug regulatory policies, marketing authorization holder (MAH) supervision, digital traceability of pharmaceuticals, standards for modern pharmaceutical logistics, classified credit supervision of pharmaceuticals, etc.
She has been awarded the title of Advanced Individual in Legal Publicity and Education of the National Food and Drug Administration System, as well as the First Prize Paper Award at the First National Symposium on Health Legal Theory. She is also a specially invited expert of the National Institute for Food and Drug Administration Education, National Medical Products Administration (NMPA).

Xiaofeng SUN

Sun Xiaofeng holds a Master's degree in Mechanical Engineering from Hohai University and is a Senior Engineer. He currently serves as Deputy General Manager of Shandong Weigao Pury Pharmaceutical Packaging Co., Ltd., and concurrently as General Manager of the Injection Pen Division, where he is responsible for the company's R&D strategy formulation and industrialization advancement in the fields of pre-filled syringes and drug delivery devices.With over a decade of experience in the pharmaceutical packaging and medical device industry, he has long focused on the R&D and engineering translation of drug-device combination products, possessing full lifecycle management experience from product definition and design development to mass production introduction.In the technical domain, he has led the R&D and industrialization of key technologies such as precision drive mechanisms for auto-injector pens and multi-dose delivery control. He holds multiple domestic and international invention patents (including core patents related to auto-injector pens and adjustable-dose injection pens) and has led the domestic standardization and adoption of ISO 11608-5.In terms of R&D management and industrialization, he has driven the establishment of an engineering-deterministic-oriented R&D system, promoted the platform-based development and large-scale manufacturing of pre-filled syringe and injection pen products, and supported the company in maintaining a leading position in China's pharmaceutical packaging and drug delivery system field.Since assuming the concurrent role of General Manager of the Injection Pen subsidiary, he has further promoted the deep integration of R&D and manufacturing, achieving systemic capability building for high-end drug delivery devices from conceptual design to commercial launch.

Jeffery N. Odum

Jeff Odum’s career encompasses over 30 years of experience in the development, execution, delivery, and management of facility and operational programs in the biotechnology and pharmaceutical industries. During his career, he has been involved in leading and managing strategic planning, feasibility and conceptual planning/design, design, construction, start-up, and validation support, in addition to participating in the development and presentation of licensing packages to the FDA. Specific responsibilities have included positions as Global Lead, Operations Director, Design Manager, Facility/Engineering Manager, Owner’s Representative, Program Manager, and Construction Site Manager for projects focused on the manufacture of human therapeutics including vaccines, cancer therapeutics, generics, and ATMPs. These efforts ranged in size from $1 million to more than $2 billion in total program costs.
Jeff was the North American Education Advisor to ISPE, where he also is currently the Chair of the Global Biotechnology Community of Practice and the Project Lead for the ATMP Guide for Autologous Cell Therapy Products, co-Lead for the new revision of the Biotech Manufacturing Facilities Baseline Guide, chapter author for the Biotech Product and Process Development Baseline Guide, and a lead author for the BPOG Closed Systems Closure Playbook. He has written over 50 Technical articles and published four Industry reference books.
He is a member of the BTEC teaching faculty in NC State University’s Gradute program in Biomanufacturing.

Shuting XU

Hui WANG

With nearly three decades of international experience across technical, commercial and management roles in APAC, Europe and the Middle East, Hui focuses on deploying engineering-grade process digital twins in life sciences and broader process industry applications. From R&D to manufacturing, not just a model but an engineering-grade decision engine.

Ziran TANG

Joined WuXi Biologics in 2011, bringing 17 years of specialized experience in cell culture process development. Demonstrated expertise across early- and late-phase projects with strong technical proficiency in perfusion and fed-batch culture systems. Successfully led GMP manufacturing digital transformation initiatives and currently oversee the implementation of a fully automated, end-to-end disposable continuous manufacturing platform at MFG17.

Huilin ZHU

Head of Clinical Manufacturing at WuXi Biologics, with 15 years of experience in the biopharmaceutical industry.
Supervising a clinical manufacture network with cell banking and drug substance GMP facilities operating at multiple sites, to deliver DS with global quality standards.
Deep expertise spanning cell culture process development, DS technology transfer & scale-up, pilot production , GMP manufacturing and quality management.
Multiple years of end to end CMC lifecycle management of biopharmaceutical products with modalities encompassing mAb, bsAb and ADC.
Core member of ISPE China Biologics Process and Production sub-committee since 2022. Led planning and execution of ISPE activities including ISPE China Annual Meetings, online and offline sub-committee activities.