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.

Daniel GAO

David SUN

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。

Kristin Prescott

Kristin Prescott has been in the pharmaceutical industry for 25 years. Early experience in technical roles in drug substance and drug product process development, manufacturing, and technology transfer provided a foundation for managing vendors and external operations. For the past 10 years, she has leveraged her strengths in project and operations management working in various vendor management and project management roles for small and large companies. Experiences include managing vendors throughout a product life cycle, including raw material, drug substance, drug product, and finished goods vendors across a range of modalities and therapeutical areas. Ms. Prescott currently manages Comparator Sourcing and Packaging and Labelling vendor management within the Global Clinical Supply Chain team at Takeda. With expertise in site, local, and central sourcing models she helps study teams to balance cost efficiency and meeting quality and regulatory needs in comparator sourcing.

Totsapon Santitewagun

Totsapon Santitewagun has more than 30-year experience in pharmaceutical HVAC systems. He is a Cleanroom Performance Testing Professional (CPT) accredited by National Environmental Balancing Bureau (NEBB) USA.
Totsapon started his work in the Carrier Air Conditioning Company in Thailand so involved in HVAC system design, equipment/apparatus selection, installation and services. He has experiences in various kinds of equipment such as reciprocating, screw, centrifugal and absorption chillers. In GMP environment, Totsapon has designed and installed many of pharmaceutical cleanrooms both in Thailand and neighboring countries. He has been responsible for all design and implementation for the pharmaceutical facilities, participating in the engineering design, construction, commissioning, qualification and start-up for sterile and non-sterile manufacturing facilities including vaccine and biopharmaceutical plants. He was the lead engineer who involved in the design, construction and GMP project management of Greater Pharma Manufacturing plant who won the Facility of the Year Award (FOYA) 2016 from ISPE. Moreover, he is not only an expert on cleanroom HVAC system but also on containment HVAC system such as the BSL-3 laboratories.
Totsapon has been delivering training on the cleanroom and HVAC including the GMP related topics to the universities, industries and other government organization.

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.

Darko Vrhovac

With over 20 years of experience in supply chain logistics, I have a deep understanding of global trade operations within the pharmaceutical industry. I’ve worked with a diverse range of organizations — from small startups to large pharmaceutical companies, CROs, customs brokers, and 3PLs — providing strategic support across the clinical supply chain.
Areas of Expertise Include:
o Advising clients on international trade and clinical supply logistics
o Navigating global trade compliance requirements and identifying supply chain efficiencies
o Managing import/export shipments of APIs, drug products, clinical supplies, and commercial goods
o Preparing and reviewing import/export documentation (Customs invoices, FDA End Use Letters, product codes, etc.)
o Coordinating international cold chain logistics and clinical supply distribution (including import licenses)
o Overseeing Customs and FDA clearance processes
o Providing expertise in Customs classification, valuation, VAT, and EORI strategies

Feifei QI

Expert in Gene and Cell Therapy Drug Development and Production Management with over a decade of dedicated experience in the biopharmaceutical field, specializing in the full lifecycle development of CAR-T cell therapy products. As a core technical leader, successfully spearheaded the end-to-end development of the company’s first CAR-T cell therapy product, including process development, technology transfer, clinical batch production, GMP facility construction and validation, and IND/BLA filings, while establishing a quality management system compliant with NMPA standards. Actively participated in the discussion, drafting, and formulation of multiple regulations and guidelines for cell therapy products.

Xiao LING,Ph.D.

Dr Ling Xiao, Director of External Affairs of the US Pharmacopoeia Commission-China Office, member of 12th China Pharmacopeia Committee, and Master's tutor of Shandong University. Graduated from the School of Pharmacy of Shandong University with a PhD in Natural MedicinalChemistry. From 2009 to 2010, she worked as a Postdoctoral Researcher at Virginia Commonwealth University in the United States. In 2018, she worked
as a Visiting Scientist at the U.S. Pharmacopoeia Commission. From 2002 to 2019, she was engaged in the
quality control and standard revision of chemical drugs and pharmaceutical excipients in the IFDC pool. From
2005 to 2006, she was engaged in drug review work in CDE as an external expert.

Michael LI

Dr. Li Zhu is the Chief AI Scientist at Mingdu Cloud. He earned his Ph.D. in Statistical Machine Learning from the University of Oxford under the supervision of Professor Dino Sejdinovic. During his doctoral studies, his theoretical research on accelerating AI algorithms was nominated for the Best Paper Award at the International Conference on Machine Learning (ICML), a top-tier AI conference. Following his Ph.D., Dr. Li pursued postdoctoral research at the Gatsby Computational Neuroscience Unit, founded by Geoffrey Hinton, the "father of modern deep learning," where he worked with Professor Arthur Gretton, Chief Scientist at DeepMind (the company behind AlphaGo and AlphaFold). After completing his postdoctoral fellowship, he served as an Assistant Professor in the Department of Mathematics at Imperial College London. Dr. Li's research contributions have been recognized with multiple prestigious awards in the AI field, and he has been invited as a keynote speaker at numerous international conferences. Currently at Mingdu Cloud, he focuses on advancing AI-driven scientific research and industrial applications in the pharmaceutical sector. He leads the development of the ​​Atlas Agent Platform​​, which transforms AI algorithms into self-evolving tools for the life sciences industry, enabling end-to-end, multi-chain empowerment across drug discovery and development.

Jessica WEN

With extensive experience in innovative drug development and registration, she oversees the end-to-end management of pre-IND/BLA consulting, project management, and regulatory submissions for the company's cell and gene therapy products. She has successfully led dozens of New Drug Applications (NDAs) covering chemical drugs and biologics, and has accumulated rich hands-on R&D expertise in stem cell therapy products, accelerating the market entry of innovative therapies for the enterprise.

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.

Susie ZHOU

Ms. Zhou has accumulated rich experience in the pharmaceutical industry, focusing on quality management, system building, and optimization for both clinical and commercial products. She has led teams to successfully pass GMP inspections by the US FDA, EU, and other countries, covering both APIs and drug products. Ms. Zhou is familiar with regulatory requirements of major markets such as China, the EU, and the US. She has been deeply involved in the listing, distribution, and post-market maintenance of pharmaceuticals in Europe and America, accumulating solid practical experience, especially in the understanding and application of GMP and GDP regulations.
Currently, Ms. Zhou serves as the Head of MAH Quality Affairs at Shenzhen Hepalink Pharmaceutical Group Co., Ltd, where she is responsible for the vertical management of quality activities for products in Europe, America, and several other overseas countries.

Krystal CAO

Ms.Cao is an expert in clinical trial supply management, holding a Bachelor’s degree in Medicine from Jilin University and a Master’s degree in Public Health from Monash University. With previous roles at Parexel and Viedoc, she has gained extensive experience in managing global multicenter clinical trials. Her expertise lies in optimizing and digitalizing global clinical trial supply management, with a strong focus on enhancing efficiency and reliability in trial supplies. She currently serves as a Solution Strategic Consultant at Medidata, where she is dedicated to leveraging industry-leading cloud-based solutions to help pharmaceutical companies, CROs, and research institutions optimize clinical trial supply efficiency and minimize operational risks.

Rui LI

University of Texas at Houston Science Center School Master of Biomedical Information Donghua University MBA
As a visionary technology leader with over 15+ years of specialization in Healthcare Information Systems (HIS) and AI-driven medical innovation, excel at bridging advanced technologies like LLM, machine learning, NLP, and big data analytics with clinical workflows to revolutionize precision medicine and healthcare efficiency. Expertise at spans of E2E(eSource-to-EDC), DCT, AI model development at clinical trial lifecycle management (GCP/CTMS compliance), and the design of intelligent hospital ecosystems, including research-oriented platforms and specialized disease databases.
Have led 7+ national R&D initiatives in medical AI and intelligent consultation systems, delivering scalable solutions adopted across 20+ multinational clinical trials. Recognized for architecting 10+ data governance frameworks and AI-powered diagnostic tools that enhance clinical decision accuracy. The member of China DCT Regulatory Strategy Expert Group and
play a pivotal role in shaping China’s Decentralized Clinical Trial (DCT) regulatory strategies.

David SUN

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。

Daniel GAO

庞飞飞 Sophie

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。

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

Yuexia LI

With over 20 years experiences including FDA, pharmaceutical, biotech, in vitro diagnostic, and gene therapy Dr. Li can provide a full range of technical services across multiple disciplines including scientific leadership and technical direction to a multidisciplinary medical, scientific and professional staff engaged in developing and implementing internal procedures, standards, and regulatory policy. Dr. Li’s areas of expertise including: regulatory affairs for regulated biopharmaceutical industry (small molecules, large molecules, ADC drugs, biosimilar, cell and gene therapy etc…), cGMP compliance for biopharmaceutical industry, data integrity auditing and staff training, Quality Management System set up and Operational excellence.

Dr. Li received her BS from University of Science and Technology of China and Ph.D. from University of Alabama at Birmingham, Post Dr. training at NIAID/NIH.

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）

Daniel GAO

David SUN

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.

康伟

0+ years of ISPE member Member of ISPE China Biological Committee Vice President, Austar, 2019-01 to Present Senior specialist and SME, NNE 2007- 2019
 With 28+ years of work experience in biopharmaceutical and pharmaceutical industry as project sponsor and project lead, Mr. Kang Wei takes role as Vice President in AUSTAR Group at present and focus on pharmaceutical engineering and project management. He works on strategy planning and biotech facility engineering as international biotech facility expert with visionary approach. Highlight clients & projects (GMP commercial production facility) as follows: Bill & Melinda Gates Foundation, NovoNordisk, GSK, Novozymes, Boehringer-Ingelheim, Adimmune, Henlius, Wuxi Biologics, Junshi, BeiGene, Carsgen, Gracell.
 Mr. Kang Wei coordinated with international team to provide professional consulting services for international and domestic clients in terms of Vaccine, Monoclonal Antibody, ATMP, ADC, etc., the project standards comply with FDA, EMA, WHO and NMPA.
 International organizations and forums：
 “Establishing Biotech Manufacturing Capacity in China” in 2015, IBC Life Sciences D development and Production (BDP) Week, in Huntington Beach, CA. 
 “Bio facility consideration from engineering perspective” in 2016, ISPE Biologics Development Symposium in Hangzhou
 “Best practice for Bio project execution “in 2017, ISPE Biologics Forum in Benxi 
 “Global Practice Bridge to Local Manufactures “in 2018, ISPE / CIPM in Chongqing
 “THE MANUFACTURING ROAD “Panel discussion in 2019, BioCentury & BayHelix China Summit in Shanghai
 “GMP trend and expectation for cell therapy facility” in 2019, ISPE "Innovative technology and concept for state-of-the-art biologic facility" session in Changsha
 “Case study - Compliant and Efficient biologic facility “in 2020, ISPE / CIPM in Chongqing

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

Rosemary Hu

Rosemary Hu is the leader of Deloitte Nanjing tax team. She is also a tax partner in International Tax and M&A service line with 22 years of professional tax consulting experiences. She has a diverse background serving MNC, SOE, listed companies, and high potential local large enterprise groups in Jiangsu and Anhui province. She has significant experience across a range of industries. Rosemary was continuously nominated as Highly Regarded Practitioner and Women Leader in Tax by World Tax. She is also an executive director of Jiangsu CCTAA (“The China Tax Certified Tax Agents Association”). Ms. Hu holds a BA from the law School of Nanjing University and she is a member of Chinese Institute of Certified Public Accountants (CICPA) and Certified Tax Agent in PRC. Ms. Hu is the vice chair of Amcham Nanjing Center Advisory Council.

Haidong XU

Haidong Xu is a partner at EY Shanghai’s Indirect Tax practice, with over 15 years of experience at EY.
‐ He possesses extensive expertise in customs and indirect tax advisory projects across diverse industries. His engagements include customs compliance reviews, risk assessments, VAT risk analysis and quantification, and advising clients on optimizing business operational structures to streamline supply chain processes and enhance indirect tax efficiency.
‐ Haidong has robust hands-on experience in international trade consulting, encompassing trade business model planning, feasibility analysis, risk evaluation, audit project support, assisting with voluntary disclosures, and system design.
‐ His client portfolio primarily spans the medical device, pharmaceutical, and manufacturing sectors.

Min XU

Mr. Xu worked for several large companies (including MNCs) as Aseptic DP Production manager, he is now responsible for biopharmaceutical product process transfer, process optimization, and risk management for marketed products as a Technology Expert in GeneSience Pharmaceutical Co.,Ltd.
Mr. Xu has been in the pharmaceutical industry for more than 15 years, well-versed in Aseptic DP Production management for PFS and vials, covering areas from CDMO, clinical production, and large-scale commercial production. Familiar with domestic and foreign regulations in Aseptic production , involved in several new plant construction projects ，led and passed GMP inspections by FDA and EU as a main person in charge, have extensive hands-on experience in solving production technical issues.

李香玉博士

Mark Stephens

Mark is a seasoned professional in the Biopharma & Life Sciences sector, with extensive expertise in designing and constructing biopharmaceutical facilities. He has a proven track record of effectively overseeing prominent projects in Australia, Europe, and China, and has established collaborative partnerships with industry leaders such as Novartis, Merck, Pfizer, and other key players. Mark's unwavering commitment to excellence, combined with his profound knowledge, drives his mission to lead the industry forward and foster continuous progress.

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。

Jiali TANG

Tang Jiali is currently a Senior Sterile Assurance Engineer in the Manufacturing Science and Technology Department at Lilly Suzhou Pharmaceutical Co., Ltd. She has extensive experience in the production and manufacturing of sterile products, aseptic process simulation, aseptic interventions and technologies, airflow pattern testing, isolators/RABS, and more. She has participated in the development and validation of new sterile processes at Lilly's US plant. She has also been involved in provincial, national, and EU PAI/GMP audits, contributing to audit responses and decision-making. Ms. Tang has frequently been invited as a speaker for IPEM courses and has presented at PDI and CPAPE conferences.

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.

Mark FANG

明度智云CGT行业质量负责人 ，具有10+年药企经验，专注生命科学领域信息化、数据完整性、CSV业务。熟悉国内外针对细胞治疗行业产品追溯系法规和指南，参与开发个性化治疗信息管理平台等软件系统。为细胞治疗、抗体、疫苗、血液制品等生物制药企业提供计算机化系统质量体系建设、项目管理、IT系统搭建及验证服务。

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.）.

Yukan JI

Mr. Ji, Vice President of the Healthcare & Pharmaceuticals Group at CICC’s Investment Banking Department, holds qualifications as an A-share Sponsoring Representative, Hong Kong Securities License holder, and CPA. With over a decade of experience in audit and cross-border capital operations, Mr. Ji specializes in healthcare. His key professional achievements include leading STAR Market IPOs for BeiGene (688235.SH) ,Junshi Bioscience (688180.SH), INT Medical and STAR Sports Medicine, a Main Board refinancing for Fosun Pharma (600196.SH), and a Hong Kong IPO for Junshi Bioscience (1877.HK) ,etc.

Howard H. Yuwen

University of Texas at Dr. Howard Yuwen is an experienced regulatory affairs professional. His nearly 35 years of deep knowledge and practice implementing global regulatory strategies have led to multiple drug approvals. Dr. Yuwen began his scientific career in 1989 at the National Institutes of Health. Later, while at the FDA's Center for Biologics Evaluation and Research (CBER), he served as scientific lead for multiple Biologics License Applications (BLAs) and Investigational New Drugs (INDs) in the field of blood, blood derivatives, and recombinant products. Dr. Yuwen has also prepared and participated in numerous CBER guidance documents and held multiple interactions with industry and
academia, coordinating with the FDA review divisions. His extensive pharmaceutical industry experience covers scientific and regulatory positions at Elan Pharmaceuticals, CancerVAX, Shire Human Genetic Therapies,
Alexion Pharmaceuticals, Genesun Biopharma, and Hemay Pharmaceuticals International. Before joining SDM Bioservices, Dr. Yuwen served as SVP of global regulatory affairs and general manager of China at Amador Bioscience.
Dr. Yuwen holds a Bachelor of Science in Medical Sciences and a Master of Science in Microbiology from Jiaotong University Medical School. He also holds a PhD in Molecular Biology & Virology from the Chinese Academy of Medical Sciences. Throughout his successful career, Dr. Yuwen has published numerous scientific articles and has been an invited speaker at many international conferences.

Lucy XI

Lucy XI graduated from Cardiff University in the UK and holds a Master of Science degree in System Engineering with IT applications. She has been deeply engaged in the field of manufacturing automation and digitization for more than 20 years. She has a profound understanding of the production processes and regulations in the pharmaceutical industry, and is particularly skilled in the consultation and planning of overall solutions for digital factories, especially in the application of MES and LIMS. She has been deeply involved in digital benchmark projects of many well-known pharmaceutical companies both at home and abroad, accumulating rich practical experience. She has worked in leading companies in the industry such as Siemens Industry Software, Thermo Fisher Scientific, and PMS of Spectris Group. She has actively promoted the digital transformation of pharmaceutical enterprises, assisted domestic pharmaceutical companies in going overseas.

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.

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.

Jianpeng WANG

Dr. Wang has more than 10 years’ experience in the biopharmaceutical industry. He has successively engaged in R&D process development and production operation management. He is familiar with the process development, quality study, and GMP manufacturing of upstream materials for GCT products, such as sgRNA and HDR knock-in templates. He led the team to complete the product development, GMP facility construction, and production capacity ramp-up of GenScript's gene editing business portfolio.
Currently, GenScript has delivered over 180 batches of GMP products in total for businesses such as sgRNA and HDR knock-in templates, supporting more than 60 global customers to obtain a total of 18 IND approvals.

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.

Vikki WANG

Vikki Wang has been with the China office of Maryland Department of Commerce since 2009 and has accumulated many years of experiences in international trade and investment consulting, supporting for Maryland companies’ business interests in China as well as Chinese companies going to Maryland. Past clients span across industries such as medical health, biotech, manufacturing, logistics, agriculture and others.
 The State of Maryland is a premier location for life sciences companies. With one of the nation’s largest clusters, a community of over 4,100 life science businesses has unparalleled proximity to leading federal institutions such as the National Institutes of Health (NIH), National Institute of Standards and Technology (NIST), and the Food and Drug Administration (FDA). The Maryland Department of Commerce Office is the state government’s official economic development agency, and it has a long history of assisting international businesses to enter the U.S. market through Maryland. Our team members can help with: Customized market research; Identifying investment opportunities; Introductions to potential partners; Site visits and meeting arrangements; Information on Maryland’s business, governance and regulatory framework; Workforce training.

Fred YAO

Fred Yao, Head of Quality at CanPharma Supply Services (Shanghai) Co., Ltd., has extensive experience in Operations and Quality management of Clinical/Commercial Pharmaceuticals, label and packaging components and packaging process design and assessment of pharmaceutical equipment. He established Quality Management System for CanPharma Supply Services (Shanghai) Co., Ltd. in conformity with global GMP/GDP regulations. Mr. Yao is dedicated to providing safe, quality and efficient delivery of clinical medicines.

David SUN

Christophe Mermaz

Christophe Mermaz 在欧洲和亚洲拥有超过25年的工业业务管理经验。
2019年，他与 Fabrice Dumont（欧洲生命科学工程专家 SP Groups 的首席执行官）在越南共同创立了 C-CUBE。两人携手引入了一种通过工业化方法建设生命科学模块化设施的创新理念。他们还获得了来自圣戈班集团（www.saint-gobain.com）的投资支持。
经过数年的理念打磨，C-CUBE 成功在欧洲为一家领先的制药公司安装了首个模块化疫苗生产单元。在此基础上，他们正逐步拓展至亚洲和中东市场。
如今，C-CUBE 是全球为数不多能够交付生命科学领域交钥匙模块化设施的供应商之一。

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

Mark FANG

明度智云CGT行业质量负责人 ，具有10+年药企经验，专注生命科学领域信息化、数据完整性、CSV业务。熟悉国内外针对细胞治疗行业产品追溯系法规和指南，参与开发个性化治疗信息管理平台等软件系统。为细胞治疗、抗体、疫苗、血液制品等生物制药企业提供计算机化系统质量体系建设、项目管理、IT系统搭建及验证服务。

Yuexia LI

With over 20 years experiences including FDA, pharmaceutical, biotech, in vitro diagnostic, and gene therapy Dr. Li can provide a full range of technical services across multiple disciplines including scientific leadership and technical direction to a multidisciplinary medical, scientific and professional staff engaged in developing and implementing internal procedures, standards, and regulatory policy. Dr. Li’s areas of expertise including: regulatory affairs for regulated biopharmaceutical industry (small molecules, large molecules, ADC drugs, biosimilar, cell and gene therapy etc…), cGMP compliance for biopharmaceutical industry, data integrity auditing and staff training, Quality Management System set up and Operational excellence.

Dr. Li received her BS from University of Science and Technology of China and Ph.D. from University of Alabama at Birmingham, Post Dr. training at NIAID/NIH.

Jianpeng WANG

Dr. Wang has more than 10 years’ experience in the biopharmaceutical industry. He has successively engaged in R&D process development and production operation management. He is familiar with the process development, quality study, and GMP manufacturing of upstream materials for GCT products, such as sgRNA and HDR knock-in templates. He led the team to complete the product development, GMP facility construction, and production capacity ramp-up of GenScript's gene editing business portfolio.
Currently, GenScript has delivered over 180 batches of GMP products in total for businesses such as sgRNA and HDR knock-in templates, supporting more than 60 global customers to obtain a total of 18 IND approvals.

Feifei QI

Expert in Gene and Cell Therapy Drug Development and Production Management with over a decade of dedicated experience in the biopharmaceutical field, specializing in the full lifecycle development of CAR-T cell therapy products. As a core technical leader, successfully spearheaded the end-to-end development of the company’s first CAR-T cell therapy product, including process development, technology transfer, clinical batch production, GMP facility construction and validation, and IND/BLA filings, while establishing a quality management system compliant with NMPA standards. Actively participated in the discussion, drafting, and formulation of multiple regulations and guidelines for cell therapy products.

Laure Gurcel

Dr. Laure Gurcel is the Business Process Owner for Product Quality Review (PQR) within Global Quality at Sanofi. In this role, Dr. Gurcel implemented the use of GenAI for authoring PQR reports. Dr. Gurcel received her PhD in Biochemistry from the University of Geneva in 2006 where her research focused on immunity and host-pathogen interactions. Following this, Dr. Gurcel engaged in a postdoctoral fellowship at the University of Lausanne and EPFL Dr. Gurcel joined Sanofi as an Affiliate Quality Officer in 2012, and she was subsequently the Sanofi Country Quality Head in Switzerland. Dr. Gurcel has experience in various quality systems as well as in change management and development and implementation of GxP validated computerized systems for training and batch release.

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..

Cui WANG

Dr. Cui Wang is the Senior Quality Assurance Manager at Sanofi (Beijing) Pharmaceuticals, with 10+ years of experience in microbiology and pharmaceutical quality compliance. Ph.D. in Microbiology (Georgia State University, USA), and has led industry-academia collaborative projects on influenza vaccine process development. Currently Dr. Wang oversees site quality assurance across the entire lifecycle of sterile and non-sterile drug products, specializing in sterility assurance systems, contamination control strategy (CCS), and GMP compliance. She has extensive experience in domestic and international GMP audits and driving quality compliance enhancements.

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

Roger CHEN

: Roger Chen has over 15 years of experience in customs work and has long been engaged in on-site business and functional management in various positions such as inspection, material control, customs clearance, comprehensive coordination, and enterprise inspection. He is proficient in customs classification, valuation, origin, processing trade, tax reduction and exemption, enterprise inspection, and enterprise management. Since joining Deloitte in 2015, Roger Chen has mainly assisted clients in tariff and tax planning, resolving customs clearance difficulties, applying for customs certification, conducting tariff health checks and proactive disclosure, and providing tax consulting services related to customs inspections and anti smuggling case handling. In recent years, Roger has also focused on overseas business, providing services such as overseas site selection, origin consultation, and overseas compliance process setting for enterprises.

Limin GUAN

Limin Guan has 17 years of experience in the pharmaceutical industry, beginning with technical roles in drug substance process development within a pilot plant setting. Over the past 10 years, he has honed his expertise in clinical supply chain management, starting his journey at Novartis. His professional background includes integrating global supply chain experience across the US, EU, APAC, and beyond, through roles at Novartis, Zailab, Beigene, and Takeda, with a particular focus on the Asia-Pacific region. Currently, Limin provides leadership and strategic direction for Clinical Supply Chain activities in China and the APAC region. His responsibilities include overseeing outsourced operations, serving as the Global Clinical Supply Chain representative to local functions, and advancing capabilities in project planning and execution.

Diyu FU

Mr. Orville Fu brings over 14 years of experience in clinical trial supply chain management at multinational pharmaceutical companies, specializing in strategic design and global end-to-end clinical supply management. He previously held key leadership roles at renowned biopharmaceutical organizations including Bayer Pharma, Pfizer, and BeiGene, where he led teams to successfully support clinical supply operations for innovative drugs across critical markets such as Europe, the U.S., and Asia-Pacific, driving comprehensive advancement in drug development.
Currently serving as Head of Clinical Supply Management at CanPharma Supply Services (Shanghai) Co., Ltd. Mr. Fu is dedicated to building high-efficiency, compliant, and intelligent clinical drug supply systems to assist domestic and international biopharma companies in achieving global expansion. Galleon Pharma specializes in providing integrated supply solutions for clinical development and post-clinical drug products worldwide, offering end-to-end services spanning drug development, packaging, sample testing, storage, distribution, inspection, destruction, project management, and clinical study forecasting. The company has established an extensive operational network across Europe, the U.S., and mainland China, delivering precision-driven clinical supply support to global industry leaders such as Janssen, Eli Lilly, Novartis, and BeiGene.

Krystal CAO

Ms.Cao is an expert in clinical trial supply management, holding a Bachelor’s degree in Medicine from Jilin University and a Master’s degree in Public Health from Monash University. With previous roles at Parexel and Viedoc, she has gained extensive experience in managing global multicenter clinical trials. Her expertise lies in optimizing and digitalizing global clinical trial supply management, with a strong focus on enhancing efficiency and reliability in trial supplies. She currently serves as a Solution Strategic Consultant at Medidata, where she is dedicated to leveraging industry-leading cloud-based solutions to help pharmaceutical companies, CROs, and research institutions optimize clinical trial supply efficiency and minimize operational risks.

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

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。

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.

Zhi LI

Li Zhi, an expert in sterile production environment monitoring at Novo Nordisk, has over sixteen years of experience in sterile pharmaceutical production. Li Zhi possesses a solid theoretical foundation and practical experience in environmental monitoring, contamination prevention, and aseptic assurance for cleanrooms in sterile production. Li Zhi has a deep understanding of domestic and international regulations and extensive auditing experience. Li has contributed to the drafting of the "Guideline for aseptic Assurance (Draft)," "Technical Guidelines for CCS" and "Technical Specifications for Airflow Visualization of UDF in Cleanrooms (Zones) in the Pharmaceutical Industry."

Zhenrong GUO

Dr. Zhenrong Guo currently is SVP at Pharmaron, responsible for commercial manufacturing processes. He previously held positions such as Executive Vice President at Medicilon., Executive Vice President at Sundia, Senior Vice President and General Manager of the CDMO Division at Zhejiang Jiuzhou Pharmaceutical Co., Deputy General Manager at Apeloa Pharmaceutical Co., Ltd., and Senior Researcher at Bristol-Myers Squibb in US. Dr. Guo has been engaged in new drug and generic drug research and development for 30 years in both US and China, with multiple innovative drugs already marketed in EU, US, China, and other countries. His main research areas include new drug development and industrial production in fields such as anti-tumor, anti-diabetes, and anti-Alzheimer's disease. His work experience includes preclinical, Phase I to Phase III new drug API development, pilot scale-up, process validation, commercial production, and registration (IND and NDA). He is an expert in process development, process design, process optimization, process validation, quality research, pilot scale-up, commercial production, technology transfer, registration, and official audits. Dr. Guo graduated from The University of Western Ontario in Canada and obtained an MBA in Pharmaceutical Management from Fairleigh Dickinson University in US. He conducted postdoctoral research at the Monell Chemical Senses Center and the University of California, Berkeley. Dr. Guo has published numerous papers in well-known chemical or pharmaceutical journals and holds several patents in US and China.

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.

庞飞飞 Sophie

康伟

0+ years of ISPE member Member of ISPE China Biological Committee Vice President, Austar, 2019-01 to Present Senior specialist and SME, NNE 2007- 2019
 With 28+ years of work experience in biopharmaceutical and pharmaceutical industry as project sponsor and project lead, Mr. Kang Wei takes role as Vice President in AUSTAR Group at present and focus on pharmaceutical engineering and project management. He works on strategy planning and biotech facility engineering as international biotech facility expert with visionary approach. Highlight clients & projects (GMP commercial production facility) as follows: Bill & Melinda Gates Foundation, NovoNordisk, GSK, Novozymes, Boehringer-Ingelheim, Adimmune, Henlius, Wuxi Biologics, Junshi, BeiGene, Carsgen, Gracell.
 Mr. Kang Wei coordinated with international team to provide professional consulting services for international and domestic clients in terms of Vaccine, Monoclonal Antibody, ATMP, ADC, etc., the project standards comply with FDA, EMA, WHO and NMPA.
 International organizations and forums：
 “Establishing Biotech Manufacturing Capacity in China” in 2015, IBC Life Sciences D development and Production (BDP) Week, in Huntington Beach, CA. 
 “Bio facility consideration from engineering perspective” in 2016, ISPE Biologics Development Symposium in Hangzhou
 “Best practice for Bio project execution “in 2017, ISPE Biologics Forum in Benxi 
 “Global Practice Bridge to Local Manufactures “in 2018, ISPE / CIPM in Chongqing
 “THE MANUFACTURING ROAD “Panel discussion in 2019, BioCentury & BayHelix China Summit in Shanghai
 “GMP trend and expectation for cell therapy facility” in 2019, ISPE "Innovative technology and concept for state-of-the-art biologic facility" session in Changsha
 “Case study - Compliant and Efficient biologic facility “in 2020, ISPE / CIPM in Chongqing

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。

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.

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.