Yutao HUA

The Vice President of Shanghai BiBo Biopharma Engineering Co., Ltd., formerly served as Director of the Department of Chemical Drugs and Medical Devices and the Department of Biological Resources and Safety at the China National Center for Biotechnology Development. In 2019, he was appointed by the Organization Department of the Communist Party of China as Director of Planning, Development, and Informatization at the Health Commission of Hainan Province.
His experience includes contributing to the drafting of the "Key Special Projects for New Drug Innovation" implementation plans, developing the strategic roadmaps for biomedicine and medical devices for the Ministry of Science and Technology, assisting in formulating the "National Biotechnology Development Strategy Outline," and leading revisions to the "Implementation Rules for the Administration of Human Genetic Resources" and the "14th Five-Year Plan for Health and Wellness in Hainan." Skilled in strategic planning, policy development, and corporate management.
Yutao Hua graduated from Tsinghua University with a MS in Microbiology.

John Lepore

John Lepore is an industry consultant specializing in small molecule process development, development quality systems, and regulatory strategy. Prior to his retirement from Merck (MSD) John Lepore was CMC and QbD practices lead for small molecules and led API process development for Merck synthetic compounds. In this role, he was responsible for process definition and optimization, including the application of appropriate phenomenological and empirical models with the goal of gaining technical understanding of API chemical processes, and enabling a science and risk based approach to API process development. During his 32-year career with Merck, John has led the API launch of nine products, operation of pilot plant facilities at Rahway, and the compliance function, encompassing safety, environmental, and GMP areas. With an in-depth knowledge of drug development and process and product economics, Dr. Lepore is a regular instructor for training of FDA staff (ORA), and a guest lecturer at both the University of Michigan (Pharmaceutical Engineering Program), and Rutgers University (Lerner Center for Pharmaceutical Management Studies). He serves on the ISPE PQLI Technical Steering Committee and was Chair of the Design Space Task Team. John received a Ph.D in Chemical and Biochemical Engineering at Rutgers University in New Brunswick, NJ, and a BS degree in Chemical Engineering from Worcester Polytechnic Institute.

高杨 博士

高杨博士目前担任上海邦耀生物科技有限公司的首席战略官，全面负责公司基因和细胞治疗产品的开发、申报、项目资产管理等工作，协助CEO整个公司的经营
加入上海邦耀生物科技有限公司之前，高博士在制药行业拥有近20年的管理和开发经验，先后在国家药品监管机构、跨国制药企业、生物科技公司和全球CRO公司担任技术/管理工作，熟悉制药行业全链条的运转之道，尤其在药物开发策略、申报策略、质量体系建设和商业化战略方面有着全面、丰富的经验。曾是中国国家药品监督管理局药品审评中心的高级审评官，8年时间内审评过千份申报项目并执行过几十次现场检查，涵盖跨适应症领域的新药临床申请、新药上市申请、仿制药申请、上市后补充申请等技术审评工作，对监管科学和CDE、FDA、EMA及ICH的技术指南有着全面深刻的理解。之后4年担任礼来公司的法规CMC和医疗器械负责人，领导多个创新药CMC策略、技术转移策略和医疗器械注册策略的制定和执行，参与礼来全球加快研发的改革工作，并为礼来在华合作伙伴的创新药研发和商业化提供技术支持。同期兼任RDPAC的CMC委员会轮值主席，领导7个工作组为2015年启动的中国药监改革积极建言献策，为构建支持药物创新的新生态系统做出了杰出贡献。曾担任苏州亚盛制药的法规事务总监，制定并执行中美研发和注册策略，成功获批中、美多个IND。之后担任PAREXEL的首席药物研发和法规顾问，3年时间内为多达30家国内外生物制药公司约50个项目提供研发和监管策略的咨询服务，成功助力他们在中美获得监管部门的批准并开展新药研发。业余时间，高博士积极探索和实践人工智能和数字技术赋能药物研发，设计并开发远程智能化临床试验平台。

Shanshan LIU

Shanshan Liu is the current Technical Director at No deviation, responsible for the company's technology and innovation roadmap, as well as the professional growth of employees. She also sits on the Core Team, defining the company's international growth and business strategy. She received her M.Sc. in Biochemical Engineering from the University of Birmingham and brings an international perspective to her work from her experiences in various continents.
Throughout her 18-year career, Shanshan has held various technical roles within consulting firms and major pharmaceutical companies, including Novartis, where she worked within the Global Engineering organization and gained exposure to well established engineering and quality systems. With a solid technical background, Shanshan expanded her expertise into the Quality, Compliance, and Regulatory domains, where she has assisted pharmaceutical and medical device manufacturers in establishing quality systems, remediating quality, and compliance risks, and forming regulatory strategies. Through these projects, Shanshan has developed close collaborations with manufacturers, associations, and international regulators.
Shanshan is passionate about continued education and knowledge sharing. She has been serving as President of the ISPE Singapore Affiliate for the past years and is the current Chair of the ISPE APCA Council. She is also actively involved in other working groups, such as the Drug Shortage Initiative Team. To further share her knowledge, Shanshan is qualified as an ISPE instructor for various modules, i.e. C&Q and ATMP.

Chong hock Sia

Mr. Sia Chong Hock has been the Director of Quality Assurance and Senior Consultant of Audit and Licensing at the Singapore Health Sciences Authority (HSA) since 2015, where he was previously the Director of the Audit and Licensing Division in the period 2008 to 2015. From 1995 to 2022, he was also an Adjunct Associate Professor at the Department of Pharmacy and Pharmaceutical Sciences of the National University of Singapore (NUS). He had been a member of the Singapore Pharmacy Council and its predecessor Singapore Pharmacy Board from 2002 to 2018, including being the Chair of its Complaints Panel. He holds a Bachelor’s degree in Pharmacy from NUS, as well as a Master’s degree in Healthcare Management (with Distinction) from the University of Wales, UK.
Mr. Sia has played a monumental role in, and won several awards for, shaping Singapore to be a world leader in pharmaceutical regulation. He took up the challenge to set up the GMP Audit Unit and led Singapore to become the first Asian member of the international Pharmaceutical Inspection Co-operation Scheme (PIC/S) in 2000, and was subsequently appointed Chair of the ASEAN MRA Task Force and Joint Sectoral Committee on GMP Inspection from 2005 to 2020. In 2013, he was conferred the Industry Pharmacist of the Year Award by the Pharmaceutical Society of Singapore, and in 2016, he was honored with the International Pharmaceutical Society of Pharmaceutical Engineering (ISPE) Singapore Affiliate Lifetime Achievement Award for his contributions to the field of Pharmaceutical Regulatory Practices in Singapore and the ASEAN region. More recently, he was a recipient of the PS (Health) Award 2023 for his key role as a core team member responsible for HSA being the first National Regulatory Authority (NRA) in the world to achieve Maturity Level 4 under the World Health Organization Global Benchmarking Tools (WHO GBT) assessment. This WHO GBT certification confirms HSA as an NRA that is operating at an advanced level of regulation in medicinal products and vaccines. On the academic front, he contributes review articles regularly to international scientific journals, covering the regulation of pharmaceuticals and biopharmaceuticals. In 2016 and 2019, two of his articles won the ISPE Roger Sherwood Article of the Year Award.

Jerry ZHENG

郑磊明，毕业于华东理工大学制药工程专业，并获得硕士学位。目前，他在柯尔柏医药科技
（上海）有限公司担任董事总经理一职，主导该集团在中国的最高级别的管理事务，致力于
寻找新的商业机会，以实现销售和服务的快速扩展。
他在生命科学行业拥有超过二十年的深厚经验，尤其在研发、生产、中试、生产工艺、生产
设备以及自动化软硬件等领域具有丰富的知识和实践。他对制药和生物技术行业的全流程有
深入的理解，是生产数字化转型领域的权威专家。
在郑磊明的职业生涯中，他曾在 Harro Höfliger、罗克韦尔自动化等多家行业领先的企业担
任技术、销售、业务开发等高级管理职务，并凭借卓越的业绩多次获得表彰。自 2019 年 3
月起，他开始在柯尔柏医药科技中国区担任董事总经理。
他以出色的领导力和强烈的责任感，成功地制定并实施了公司的战略目标，带领团队取得了
突破性的发展，从而进一步扩大了公司在中国的销售和市场影响力。
Jerry Zheng, a Master's degree holder in Pharmaceutical Engineering from East China
University of Science and Technology, currently serves as the Managing Director of
Körber Pharma (Shanghai) Co., Ltd. He oversees the highest level of management affairs
of the Körber Business Area Pharma in China, committed to seeking new business
opportunities to achieve rapid expansion of sales and services.
He has more than twenty years of profound experience in the life sciences industry,
particularly in areas such as research and development, production, pilot production,
production processes, production equipment, and automation hardware and software. He
has an in-depth understanding of the entire process of the pharmaceutical and
biotechnology industry, as well as is an authoritative expert in the field of digital
transformation in production.
During Jerry's career, he has held senior management positions in technology, sales, and
business development in several industry-leading companies such as Harro Höfliger and
Rockwell Automation. He has been recognized multiple times for his outstanding
performance. Since March 2019, he has been serving as the Managing Director of Körber
Business Area Pharma in China.
With his excellent leadership and strong sense of responsibility, he successfully
formulated and implemented the company's strategic goals, leading the team to achieve
breakthrough development, thereby further expanding the company's sales and market
influence in China.

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

Vivien Santillan

Vivien Santillan 女士是 Novatek International 的亚洲区域总监和项目顾问，该公司是一家总部位于加拿大的生命科学 IT 公司，提供符合监管要求的软件解决方案，服务于制药、生物技术及其他医疗保健行业。
Vivien 曾担任 ISPE 菲律宾分部主席（2017-2020）和亚太委员会主席（2019-2020），也是多个ISPE 实践社区（COP）指导委员会的成员，如药品短缺倡议团队和质量控制/分析小组。她目前是 ISPE 女性制药国际指导委员会的主席，以及 ISPE GAMP 南亚小组的联席主席。Vivien 在计算机系统验证、数据完整性、污染控制策略、数字化及其他行业和监管相关主题上进行演讲和培训。
作为一名杰出的技术销售总监、业务发展和市场营销专业人士，Vivien 在信息技术和服务行业拥有超过 25 年的经验。在过去 17 年里，她一直在帮助制药公司实现监管合规，提供技术支持、差距分析、计算机系统验证、文档及 LIMS、数字化质量管理系统和污染控制解决方案的实施和使用培训。她毕业于德拉萨大学，获得计算机应用学位，并持有全面质量管理（TQM）认证。

Mark Hernick

李锦才博士

现任药明生物控股子公司药明合联CEO, 领导药明合联的一站式生物偶联药CRDMO业务。
2011年加入药明生物，负责筹建和领导药明生物的细胞培养工艺开发和中试生产的团队，以及生物制药一部(MFG1), 上海GMP车间(MFG3)的运营和生物制药五部(MFG5) 的建设启用。
拥有20年的生物制药研发和产业化经验，精通生物药的细胞培养表达，工艺研发，放大和临床及商业化GMP生产。
领导团队完成了中美40多个IND申报工作，以及多个上市产品的CMC工作。
负责MFG1期间，带领团队成功通过了药明生物第一个美国药监局和欧盟药监局的上市前审计。
现任ISPE中国理事暨生物药分委会主席（2025年）

Ping ZHANG

Ping Zhang, currently Senior Vice President of Global Industrial Affairs at Hepalui, holds an MBA degree and international work and study experience. Previously, he served as the Head of Sanofi Industrial Affairs in China, responsible for Sanofi's industrial operations in China, and led the implementation of several new products and group product transfer projects in China. Prior to that, he worked for Xi 'an Janssen Pharmaceutical Company, one of the first foreign-invested enterprises in China. Zhang Ping has more than 30 years of experience in drug production management in foreign-funded enterprises and has obtained the first Six Sigma Black belt certification in China.

Yutao HUA

The Vice President of Shanghai BiBo Biopharma Engineering Co., Ltd., formerly served as Director of the Department of Chemical Drugs and Medical Devices and the Department of Biological Resources and Safety at the China National Center for Biotechnology Development. In 2019, he was appointed by the Organization Department of the Communist Party of China as Director of Planning, Development, and Informatization at the Health Commission of Hainan Province.
His experience includes contributing to the drafting of the "Key Special Projects for New Drug Innovation" implementation plans, developing the strategic roadmaps for biomedicine and medical devices for the Ministry of Science and Technology, assisting in formulating the "National Biotechnology Development Strategy Outline," and leading revisions to the "Implementation Rules for the Administration of Human Genetic Resources" and the "14th Five-Year Plan for Health and Wellness in Hainan." Skilled in strategic planning, policy development, and corporate management.
Yutao Hua graduated from Tsinghua University with a MS in Microbiology.

Norman Goldschmidt

Norman Goldschmidt is President of Genesis Architects, Engineers & Constructors. He has over 35 years of experience in engineering management, planning, design and construction in the pharmaceutical and biotech industry.
Prior to joining Genesis, Norman served in numerous capacities during 20 years with Bristol-Myers Squibb (BMS). Starting as a Mechanical Engineer / Project Manager and culminating as Executive Director, Global Engineering for Strategy and Design. His industry experience spans the many types of facilities and processes necessary to bring a drug to market - from R&D through Manufacturing.
Mr. Goldschmidt studied Engineering Management at the State University of New York and Mechanical Engineering at the University of Buffalo. He holds 4 patents for innovations in HVAC and Pharmaceutical Processing, is an International Standards Organization (ISO) Author/Expert, Adjunct Professor at the New Jersey Institute of Technology, Lead/Contributing Author on 8 ISPE Guides well as author, contributor and instructor for ISPE, ASHRAE, NSF, FDA, HCA, TGA and others.

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

Shanshan LIU

Shanshan Liu is the current Technical Director at No deviation, responsible for the company's technology and innovation roadmap, as well as the professional growth of employees. She also sits on the Core Team, defining the company's international growth and business strategy. She received her M.Sc. in Biochemical Engineering from the University of Birmingham and brings an international perspective to her work from her experiences in various continents.
Throughout her 18-year career, Shanshan has held various technical roles within consulting firms and major pharmaceutical companies, including Novartis, where she worked within the Global Engineering organization and gained exposure to well established engineering and quality systems. With a solid technical background, Shanshan expanded her expertise into the Quality, Compliance, and Regulatory domains, where she has assisted pharmaceutical and medical device manufacturers in establishing quality systems, remediating quality, and compliance risks, and forming regulatory strategies. Through these projects, Shanshan has developed close collaborations with manufacturers, associations, and international regulators.
Shanshan is passionate about continued education and knowledge sharing. She has been serving as President of the ISPE Singapore Affiliate for the past years and is the current Chair of the ISPE APCA Council. She is also actively involved in other working groups, such as the Drug Shortage Initiative Team. To further share her knowledge, Shanshan is qualified as an ISPE instructor for various modules, i.e. C&Q and ATMP.

Maurice B. Parlane

Maurice Parlane is Principal of New Wayz Consulting Ltd in New Zealand and a Director of CBE Pty Ltd in Australia. He is a professional engineer with 30 years’ experience within the biopharmaceutical industry, including 20 years as an industry consultant providing support to manufacturing and compliance management; validation and operational excellence projects in Australasia and the Asia Pacific region. Prior to this, he held senior engineering and manufacturing roles within the Glaxo group of companies. He has a Bachelor of Manufacturing Technology (Hons) as well as mechanical and electrical engineering qualifications. Maurice is past president and current director of the ISPE Australasian Affiliate. He is the co-lead of ISPE’s Asia Pacific Regulatory and Quality Harmonization committee and leader of the Process Validation Team and is a member of the Guidance Documents Committee. He is an ISPE PV Instructor and was named ISPE Member of the year in 2016. He is currently serving as the Leader of the ISPE Process Validation Team.

Fritz Röder

Fritz Roeder is Director - Site Account Engineer at Merck Healthcare KGaA in Germany. He has over 15 years of broad experience in pharmaceutical manufacturing in engineering, quality, project managment and other fields. Fritz is a frequent speaker at events and author of various books, articles and ISPE guides on pharmaceutical topics. Fritz is also serving as current ISPE Chair of the Critical Utilities Steering Committee and as a member at the water group at "EDQM" which is maintaining the European Water Monographs.

Christian Wölbeling

Christian Wölbeling is a seasoned ISPE member with 25 years of experience. He currently serves as Chair of the ISPE Pharma 4.0™ Community of Practice and is actively involved in the GAMP® and Process Analytical Technology (PAT) Communities of Practice. A recognized expert in pharmaceutical digitalization, Christian has contributed to several ISPE guides, including the GAMP® Guide: Records and Data Integrity and the APQ Guide: Process Performance and Product Quality Monitoring System. He is currently leading a team to develop an ISPE guidance document on Pharma 4.0™.
With over 30 years at Körber, Christian now holds the position of Executive Industry Advisor and Senior Strategic Account Manager, based in Lüneburg, Germany. A pioneer in pharmaceutical digitalization, he joined Werum Software & Systems (now part of Körber) in 1992, where he led the development of production management software for top pharmaceutical companies such as Bayer, Novartis, and AstraZeneca. In 2015, he co-created the Pharma 4.0™ concept with Marcel Staudt, bridging Industry 4.0 automation with pharmaceutical ICH guidelines to drive digital transformation in the industry.
Christian believes that breaking silos between quality, operations, and engineering enables data-driven control strategies, accelerating therapeutic innovation and optimizing production processes for the benefit of patients. His work has had a profound impact on the digitalization and automation of the pharmaceutical industry.
Christian Wölbeling 是ISPE的资深成员，拥有25年的会龄。他现任ISPE Pharma 4.0™实践社区主席，并积极参与GAMP®和过程分析技术（PAT）实践社区的工作。Christian 在制药行业数字化领域具有丰富经验，曾参与编写多部ISPE指南，包括《GAMP®指南：记录与数据完整性》和《APQ指南：过程性能与产品质量监控系统》。目前，他正领导团队制定关于Pharma 4.0™的ISPE指导文件。
Christian 在柯尔柏工作超过30年，现任执行行业顾问和高级战略客户经理，常驻德国吕讷堡。作为制药行业数字化的先驱，他于1992年加入维隆软件与系统公司（现为柯尔柏集团的成员公司），主导开发了多项制药生产管理软件，客户包括拜耳、诺华、阿斯利康等全球顶级制药企业。2015年，他与Marcel Staudt共同提出Pharma 4.0™概念，旨在将工业4.0的自动化理念与制药行业特有的ICH指南相结合，推动制药行业的数字化转型。
Christian 坚信，通过打破质量、运营和工程之间的壁垒，制药企业可以实现数据驱动的整体控制策略，加速治疗创新并优化生产流程，最终造福患者。他的工作对制药行业的数字化和自动化发展产生了深远影响。

Irene Zhang

Dr. Xiuqin Zhang has nearly 20 years of experience in the biopharmaceutical industry, with a focus on process development ,scale-up, technology transfer, and GMP production management of biologics. product. She has successfully led her team in completing nearly 500 batches of GMP drug substance production,accumulating extensive practical expertise in scale-up risk management, production operations, quality enhancement,multi-product facility management, and contamination/cross-contamination control. Dr. Xiuqin Zhang joined WuXi Biologics in 2012 and currently serves as the head of MFG3.

Shanti Marlina Sibuea

Shanti Marlina Sibuea is a seasoned professional with a strong educational background and over 15 years of experience as a GMP Inspector and WHO Temporary Advisor. She earned her PhD in stem cell biology from Monash University, Australia, and holds a Master’s degree in Biopharmaceutical Science from Leiden University, the Netherlands, along with Pharmacy and Apothecary degrees from the University of Indonesia. Throughout her career at the Indonesian FDA (Badan POM), she has led and participated in numerous high-level inspections of ATMPs, vaccines, biosimilars, and sterile pharmaceutical facilities. She is also an experienced speaker at national and international forums, including the PDA Conference, WHO meetings, and the PIC/S Expert Circle, and has served as a trainer in GMP forums and regulatory strengthening programs in countries such as India, China, Papua New Guinea, Thailand, the Philippines, and Malaysia. Her international engagement includes serving as a WHO consultant and expert trainer, supporting regulatory system strengthening, quality assurance, and biopharmaceutical product oversight across various countries.

Xiaolin YANG

Since 1998, he has dedicated himself to research on dynamic stability control in cleanroom HVAC systems, with over two decades of in-depth expertise in pharmaceutical cleanroom system design, construction management, and consulting. Possessing extensive experience in project design, consultation, and management, he pioneered the industry-leading concept of “Dynamic Complex HVAC Systems” to address common challenges in pharmaceutical cleanroom environments. He excels in implementing the philosophy of “Dynamic Stability with Compliance-Driven Cost Optimization” in new and retrofit pharmaceutical cleanroom projects. Having led hundreds of projects across diverse scales and dosage forms (oral, injectable, biologics, etc.）.

Ing Hou Loh

With over 25 years of professional experience in the bio-pharmaceutical sector, Mr. Ing Hou Loh carries a wealth of expertise from various esteemed organizations, including Schering-Plough, Genentech/Roche (Singapore), and CMAB Biopharma (Suzhou). His extensive knowledge spans across Quality Systems in DS manufacturing, Quality Compliance with a focus on managing both internal and external inspections, Supplier Quality Management, Material Management, Quality Control, and multiple facets of Validation, encompassing Equipment, Process, Analytical Method, Utilities, and Computer System Validation, along with proficiency in medical laboratory testing.

Maurice B. Parlane

Maurice Parlane is Principal of New Wayz Consulting Ltd in New Zealand and a Director of CBE Pty Ltd in Australia. He is a professional engineer with 30 years’ experience within the biopharmaceutical industry, including 20 years as an industry consultant providing support to manufacturing and compliance management; validation and operational excellence projects in Australasia and the Asia Pacific region. Prior to this, he held senior engineering and manufacturing roles within the Glaxo group of companies. He has a Bachelor of Manufacturing Technology (Hons) as well as mechanical and electrical engineering qualifications. Maurice is past president and current director of the ISPE Australasian Affiliate. He is the co-lead of ISPE’s Asia Pacific Regulatory and Quality Harmonization committee and leader of the Process Validation Team and is a member of the Guidance Documents Committee. He is an ISPE PV Instructor and was named ISPE Member of the year in 2016. He is currently serving as the Leader of the ISPE Process Validation Team.

James SUN

With 10 years of work experience in the pharmaceutical engineering project management and equipment cleaning and maintenance.
Proficient in developing technical solutions for cleaning, derouging and passivation of clean utilities, key process systems and equipment..
Led the organization and served as Editor-in-Chief of the ＂Handbook of Pharmaceutical Derouging Process Implementation " .
Led the implementation of specialized technical projects encompassing corrosion management strategy development, rouging and corrosion detection & analysis, and derouging technology implementation for stainless steel systems at multinational corporations including Pfizer, Lily, Sanofi, and Baxter, as well as leading domestic pharmaceutical companies like Wuxi Biologics and Innovent Biologics.

Cheng PENG

Cheng Peng graduated from Tianjin University with a major in Chemical Engineering and Technology. Cheng has worked at GSK Pharmaceuticals Ltd. and Novo Nordisk (China) Pharmaceuticals Ltd. In these multinational companies, Cheng held positions such as Quality Manager, Utility Engineering Manager, and Senior Manager of the Finished Products Department. Cheng has been dedicated to the introduction, validation of new products and new production lines, Capacity ramp up for new lines. supporting various quality audits and inspections, as well as managing the asset entire lifecycle process.

William GUO

He has more than 15 years of experience in the medical device industry and has worked for the world's top pharmaceutical and medical device companies. He is currently the Vice President R&D at Shanghai Xinyao Pai Medical Technology Co., LTD.

Feng NI

Dr. Ni has worked in new drug research and process development for several years, with rich experience working in research institute and listed large companies. Familiar with drug discovery, setting up R&D system, strategy planning and enterprise operation and management. Currently serving as the Deputy General Manager of CSIPI, Director of Shanghai Engineering Center of Drug Synthesis. Doctoral Supervisor at CSIPI and at many domestic universities; Member of the China Biobased Materials Special Committee and the Shanghai Pharmaceutical Society Medicinal Chemistry Special Committee; Experts from the Ministry of Industry Technology, the Ministry of Science and Technology, the Ministry of Education; Previously awarded titles such as Shanghai Oriental Talent, SASAC Outstanding Innovative Talent, Shanghai Outstanding Technical Leader, Shanghai Pujiang Talent, etc
Dr Ni worked as Vice President for listed company, Head of the National Oral Solid Dosage Industry Chain Platform

Christoph Herwig

Christoph Herwig, bioprocess engineer from RWTH Aachen, worked in industry in the design and commissioning of large chemical facilities prior to entering his interdisciplinary PhD studies at EPFL, Switzerland in bioprocess identification. Subsequently he positioned himself at the interface between bioprocess development and facility design in biopharmaceutical industry. From 2008 to 2023, he was a full professor for biochemical engineering at the Vienna University of Technology. The research area focuses on the development of data science methods for integrated and efficient bioprocess development along PAT and QbD principles for biopharmaceuticals. In 2013 he founded the company Exputec, which is now part of Körber Pharma Austria, pioneering data science software solutions for the biopharma life cycle. Here, Christoph currently acts as senior scientific advisor for Körber.

Christoph Herwig，生物过程工程师，毕业于亚琛工业大学（RWTH Aachen），在进入瑞士洛桑联邦理工学院（EPFL）攻读跨学科生物过程识别博士学位之前，曾在工业界从事大型化工设施的设计和调试工作。随后，他将自己的职业定位在生物制药行业的生物过程开发与设施设计之间的交叉领域。从2008年到2023年，他担任维也纳工业大学（Vienna University of Technology）生物化学工程的全职教授，研究领域主要集中在开发生物制药过程中基于过程分析技术（PAT）和质量源于设计（QbD）原则的数据科学方法，以实现集成和高效的生物过程开发。2013年，他创立了Exputec公司，该公司现已成为柯尔柏医药科技奥地利公司的一部分，致力于为生物制药生命周期提供领先的数据科学软件解决方案。目前，Christoph Herwig在柯尔柏担任高级科学顾问。

Shanshan LIU

Shanshan Liu is the current Technical Director at No deviation, responsible for the company's technology and innovation roadmap, as well as the professional growth of employees. She also sits on the Core Team, defining the company's international growth and business strategy. She received her M.Sc. in Biochemical Engineering from the University of Birmingham and brings an international perspective to her work from her experiences in various continents.
Throughout her 18-year career, Shanshan has held various technical roles within consulting firms and major pharmaceutical companies, including Novartis, where she worked within the Global Engineering organization and gained exposure to well established engineering and quality systems. With a solid technical background, Shanshan expanded her expertise into the Quality, Compliance, and Regulatory domains, where she has assisted pharmaceutical and medical device manufacturers in establishing quality systems, remediating quality, and compliance risks, and forming regulatory strategies. Through these projects, Shanshan has developed close collaborations with manufacturers, associations, and international regulators.
Shanshan is passionate about continued education and knowledge sharing. She has been serving as President of the ISPE Singapore Affiliate for the past years and is the current Chair of the ISPE APCA Council. She is also actively involved in other working groups, such as the Drug Shortage Initiative Team. To further share her knowledge, Shanshan is qualified as an ISPE instructor for various modules, i.e. C&Q and ATMP.

Gary LIU

Gary has been in pharmaceutical industry for more than 25 years with extensive experience covering areas from drug research and development to production operation and the design, construction and commissioning of GMP facilities. Familiar with process optimization, setting up quality system and day to day quality operation. Led and passed GMP inspections by FDA，EU, Brazil, Columbia, PIC/S and many other countries, for drug substances and drug products, including oral products, gels, liquid and lyophilized sterile injections products. Familiar with domestic and foreign GMP regulations, and has plenty of practical implementation experience.
Gary worked for several large companies as production head, he is now responsible for whole operation.as a GM in Shanghai Henlius Biologics Co.,Ltd..

Martin Schöler

Currently working as Vice President • Technology of Engineering and Design, with responsibility for mechanical and electrical design, software development and documentation. Focus on pharmaceutical processes and GMP, machine safety, leadership and organizational development. Special interest in the field of pharmaceutical containment, scientific collaboration and academic lecturing

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

Jerry ZHENG

郑磊明，毕业于华东理工大学制药工程专业，并获得硕士学位。目前，他在柯尔柏医药科技
（上海）有限公司担任董事总经理一职，主导该集团在中国的最高级别的管理事务，致力于
寻找新的商业机会，以实现销售和服务的快速扩展。
他在生命科学行业拥有超过二十年的深厚经验，尤其在研发、生产、中试、生产工艺、生产
设备以及自动化软硬件等领域具有丰富的知识和实践。他对制药和生物技术行业的全流程有
深入的理解，是生产数字化转型领域的权威专家。
在郑磊明的职业生涯中，他曾在 Harro Höfliger、罗克韦尔自动化等多家行业领先的企业担
任技术、销售、业务开发等高级管理职务，并凭借卓越的业绩多次获得表彰。自 2019 年 3
月起，他开始在柯尔柏医药科技中国区担任董事总经理。
他以出色的领导力和强烈的责任感，成功地制定并实施了公司的战略目标，带领团队取得了
突破性的发展，从而进一步扩大了公司在中国的销售和市场影响力。
Jerry Zheng, a Master's degree holder in Pharmaceutical Engineering from East China
University of Science and Technology, currently serves as the Managing Director of
Körber Pharma (Shanghai) Co., Ltd. He oversees the highest level of management affairs
of the Körber Business Area Pharma in China, committed to seeking new business
opportunities to achieve rapid expansion of sales and services.
He has more than twenty years of profound experience in the life sciences industry,
particularly in areas such as research and development, production, pilot production,
production processes, production equipment, and automation hardware and software. He
has an in-depth understanding of the entire process of the pharmaceutical and
biotechnology industry, as well as is an authoritative expert in the field of digital
transformation in production.
During Jerry's career, he has held senior management positions in technology, sales, and
business development in several industry-leading companies such as Harro Höfliger and
Rockwell Automation. He has been recognized multiple times for his outstanding
performance. Since March 2019, he has been serving as the Managing Director of Körber
Business Area Pharma in China.
With his excellent leadership and strong sense of responsibility, he successfully
formulated and implemented the company's strategic goals, leading the team to achieve
breakthrough development, thereby further expanding the company's sales and market
influence in China.

Menglong LI

James SHI

As a seasoned expert in digital transformation and AI with over 20 years of experience in the pharmaceutical industry, James Shi currently serves as the IT Director at Shanghai Argo Biopharmaceutical Co., Ltd. He has achieved remarkable success in driving corporate digital transformation, applying AI technologies, and ensuring regulatory compliance. James has previously developed and executed global information strategies for renowned pharmaceutical companies such as AstraZeneca and Clover Biopharmaceuticals, significantly supporting their rapid business growth. Throughout his career, he has led multiple large-scale digital projects, including the establishment of an AIDD/CADD platform, which greatly enhanced R&D efficiency, and the integration of cloud computing and AI technologies, solidifying the companies' leading positions in the industry.
In the field of regulatory compliance within the pharmaceutical sector, James has successfully established GxP-compliant computerized system management frameworks for several biopharmaceutical companies. These frameworks ensured data integrity and compliance, enabling the companies to pass multiple domestic and international GMP audits. Additionally, he has managed multinational teams, effectively integrating members from diverse cultural backgrounds, improving overall team performance, and achieving global delivery.
With his forward-looking technological vision, exceptional leadership, and extensive industry experience, James Shi continues to drive innovation and digital transformation in the pharmaceutical industry.

Bin YANG

Mr. Bin Yang, General Manager at Shanghai Rimrock Automation Engineering Co., Ltd. He has been a seasoned project manager with over 15 years of experience in quality management within the pharmaceutical industry. He has held key positions in renowned companies, including Head of the Pharmaceutical Industry China Region at Emerson Process Control Co., Ltd., China Regional Manager at Dwyer Instrument Co., Ltd., etc. With extensive project management expertise, Mr. Yang has led numerous large-scale projects such as the Lonza Guangzhou Base Project, Chongqing Porton Control Projects for Workshops 108 and 110, Nanjing Mindray MES Project, Beijing 302 Hospital Formulation Project, and WuXi AppTec Phase II Project, covering systems like MES, SAP, WMS, and SCADA. Additionally, he holds a PMP certification, is a member of ISPE GAMP and the Expert Group of E-Works, is proficient in English, and has received professional training in Batch/MES/PI/PLC.

Dongming WANG

Mr. Dongming Wang is appointed as Senior Vice President of Quality at Innovent Biologics, responsible for group production quality management. He also serves as Deputy Secretary-General of the Biochemistry Products and Testing Technology and Course Chair at Shenyang Pharmaceutical University’s Yeehong Business School.
He previously held roles at BeiGene, Roche, Novartis, and AstraZeneca, including China Quality Operations Head, Clinical Development QA Expert, Technical Development QA Head, Asia Pacific Distribution Quality Head, QC Manager, Aseptic Production Manager. He engaged in quality management for R&D projects, led site quality operations, and guided teams to align with global QA and business goals. With over 20 years of multinational experience in R&D, production, and supply chain quality, he contributed to drafting/reviewing the 2010 and 2022 GMP sterile guidelines.

Jerry ZHENG

郑磊明，毕业于华东理工大学制药工程专业，并获得硕士学位。目前，他在柯尔柏医药科技
（上海）有限公司担任董事总经理一职，主导该集团在中国的最高级别的管理事务，致力于
寻找新的商业机会，以实现销售和服务的快速扩展。
他在生命科学行业拥有超过二十年的深厚经验，尤其在研发、生产、中试、生产工艺、生产
设备以及自动化软硬件等领域具有丰富的知识和实践。他对制药和生物技术行业的全流程有
深入的理解，是生产数字化转型领域的权威专家。
在郑磊明的职业生涯中，他曾在 Harro Höfliger、罗克韦尔自动化等多家行业领先的企业担
任技术、销售、业务开发等高级管理职务，并凭借卓越的业绩多次获得表彰。自 2019 年 3
月起，他开始在柯尔柏医药科技中国区担任董事总经理。
他以出色的领导力和强烈的责任感，成功地制定并实施了公司的战略目标，带领团队取得了
突破性的发展，从而进一步扩大了公司在中国的销售和市场影响力。
Jerry Zheng, a Master's degree holder in Pharmaceutical Engineering from East China
University of Science and Technology, currently serves as the Managing Director of
Körber Pharma (Shanghai) Co., Ltd. He oversees the highest level of management affairs
of the Körber Business Area Pharma in China, committed to seeking new business
opportunities to achieve rapid expansion of sales and services.
He has more than twenty years of profound experience in the life sciences industry,
particularly in areas such as research and development, production, pilot production,
production processes, production equipment, and automation hardware and software. He
has an in-depth understanding of the entire process of the pharmaceutical and
biotechnology industry, as well as is an authoritative expert in the field of digital
transformation in production.
During Jerry's career, he has held senior management positions in technology, sales, and
business development in several industry-leading companies such as Harro Höfliger and
Rockwell Automation. He has been recognized multiple times for his outstanding
performance. Since March 2019, he has been serving as the Managing Director of Körber
Business Area Pharma in China.
With his excellent leadership and strong sense of responsibility, he successfully
formulated and implemented the company's strategic goals, leading the team to achieve
breakthrough development, thereby further expanding the company's sales and market
influence in China.

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

李锦才博士

现任药明生物控股子公司药明合联CEO, 领导药明合联的一站式生物偶联药CRDMO业务。
2011年加入药明生物，负责筹建和领导药明生物的细胞培养工艺开发和中试生产的团队，以及生物制药一部(MFG1), 上海GMP车间(MFG3)的运营和生物制药五部(MFG5) 的建设启用。
拥有20年的生物制药研发和产业化经验，精通生物药的细胞培养表达，工艺研发，放大和临床及商业化GMP生产。
领导团队完成了中美40多个IND申报工作，以及多个上市产品的CMC工作。
负责MFG1期间，带领团队成功通过了药明生物第一个美国药监局和欧盟药监局的上市前审计。
现任ISPE中国理事暨生物药分委会主席（2025年）

Dr. Huilin ZHU

李锦才博士

现任药明生物控股子公司药明合联CEO, 领导药明合联的一站式生物偶联药CRDMO业务。
2011年加入药明生物，负责筹建和领导药明生物的细胞培养工艺开发和中试生产的团队，以及生物制药一部(MFG1), 上海GMP车间(MFG3)的运营和生物制药五部(MFG5) 的建设启用。
拥有20年的生物制药研发和产业化经验，精通生物药的细胞培养表达，工艺研发，放大和临床及商业化GMP生产。
领导团队完成了中美40多个IND申报工作，以及多个上市产品的CMC工作。
负责MFG1期间，带领团队成功通过了药明生物第一个美国药监局和欧盟药监局的上市前审计。
现任ISPE中国理事暨生物药分委会主席（2025年）

Chen GU

2008 Master of Engineering in Electrical Engineering and Information Engineering, Graduated from University of Wollongong, Australia
2011-2017 Technical Sales, Syntegon Packaging Technology (former Bosch Packaging Technology）
2017-present Senior Product Manager of Pharma Liquid, Syntegon Packaging Technology

Norman Goldschmidt

Norman Goldschmidt is President of Genesis Architects, Engineers & Constructors. He has over 35 years of experience in engineering management, planning, design and construction in the pharmaceutical and biotech industry.
Prior to joining Genesis, Norman served in numerous capacities during 20 years with Bristol-Myers Squibb (BMS). Starting as a Mechanical Engineer / Project Manager and culminating as Executive Director, Global Engineering for Strategy and Design. His industry experience spans the many types of facilities and processes necessary to bring a drug to market - from R&D through Manufacturing.
Mr. Goldschmidt studied Engineering Management at the State University of New York and Mechanical Engineering at the University of Buffalo. He holds 4 patents for innovations in HVAC and Pharmaceutical Processing, is an International Standards Organization (ISO) Author/Expert, Adjunct Professor at the New Jersey Institute of Technology, Lead/Contributing Author on 8 ISPE Guides well as author, contributor and instructor for ISPE, ASHRAE, NSF, FDA, HCA, TGA and others.

SuJian LIU

With two decades of experience in the aseptic pharmaceutical manufacturing industry, currently serve as a Senior Principal Engineer in the Sterility Assurance Department at Lilly Suzhou Pharmaceutical Company. Expertise include aseptic manufacturing processes, growing procedures, environmental monitoring, personnel training in aseptic techniques, and media fill simulations. Participated multiple times in internal and external GMP audits for companies and was involved in the drafting of the national pharmaceutical GMP guidelines in 2021. Dedicated to improving the quality standards and compliance levels in the aseptic pharmaceutical industry.

于大鹏

于大鹏先生在药包材行业拥有16年以上的工作经验, 具有丰富的药包材相关知识和经验，熟悉生物制品及化药的上市流程，并精通于注射笔产品相关法规与市场推广。

Sheng WANG

Sheng Wang, Sun Yat-sen University Pharmacology Master, Engineer, has been in the pharmaceutical industry for 20 years. Familiar with lab management, quality system establishment and day to day quality operation and has plenty of practical implementation experience. Led quality system establishment. Led and passed GMP inspections by China，EU, Australia and other countries, including oral products and injections. Familiar with domestic and foreign regulations, participated in many guidelines and industry standards revision led by health authority and industry association. Sheng Wang is also the Chinese GMP Annex Sterile Medicinal Product revision member.
Sheng Wang worked for several large companies (including MNCs) as quality head, he is now responsible for the quality management operation as Head of Quality in BeiGene Guangzhou Biologics Manufacturing Co., Ltd.

Min REN

Min REN has been in the pharmaceutical industry for over 30 years, with experience in quality control, quality assurance, and localization projects at numerous domestic and international pharmaceutical companies, including Roche Vitamins, Wyeth Nutrition, USP China, Abbott Eye Care, Baxter Shanghai, Medtronic China, BeiGene Shanghai, and Changchun Jinsai. He is currently employed at Keymed Biosciences, where he is in charge of operational management.
During 2009-2010, he was involved in the compilation of the quality management system and active pharmaceutical ingredients sections of the 2010 edition of the GMP guidelines. From 2015 to 2017, he participated in the Chinese Pharmacopoeia General Rules project, which included topics such as isolators, pharmaceutical water, and quality metrics. In 2018-2020, he took part in the first pilot projects for domestic biological and medical device marketing authorization holder (MAH) systems. In 2021, he contributed to the development of the monoclonal antibody inspection guidelines. Between 2021 and 2023, he was involved in the revision of the GMP guidelines, focusing on sterile products and computerized system validation. He have also participated in multiple domestic and international GMP inspections by the NMPA, FDA, and other regulatory bodies, as well as several overseas inspection activities for drugs and devices conducted by the NMPA.

李锦才博士

现任药明生物控股子公司药明合联CEO, 领导药明合联的一站式生物偶联药CRDMO业务。
2011年加入药明生物，负责筹建和领导药明生物的细胞培养工艺开发和中试生产的团队，以及生物制药一部(MFG1), 上海GMP车间(MFG3)的运营和生物制药五部(MFG5) 的建设启用。
拥有20年的生物制药研发和产业化经验，精通生物药的细胞培养表达，工艺研发，放大和临床及商业化GMP生产。
领导团队完成了中美40多个IND申报工作，以及多个上市产品的CMC工作。
负责MFG1期间，带领团队成功通过了药明生物第一个美国药监局和欧盟药监局的上市前审计。
现任ISPE中国理事暨生物药分委会主席（2025年）

Kerry YU

She is currently the chairman of Akso Information.
With 30 years of experience in quality management in the pharmaceutical industry, I have successfully passed dozens of official global drug regulatory inspections.
With years of working experience at Chongqing Institute for Drug Control, GlaxoSmithKline, Fosun Kailin Pharmaceutical and Bioton Pharmaceutical, covering areas such as active pharmaceutical ingredients, aerosols, OSD, ointments and sterile products, I have been responsible for quality QA/QC, registration, data innovation, CSV and HR, etc. My multiple digital practices have made me a benchmark for digital transformation in the pharmaceutical industry.
Holds a bachelor's degree in Pharmaceutical Analysis from China Pharmaceutical University, a Master's degree in Management from Chongqing University, and an EMBA from China Europe International Business School.