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。

李月霞 博士 Yuexia Li, Ph.D.

专业知识及经验概述
参与制定和实施内部程序和质量标准，为多学科的科学和专业人员提供科学和技术指导.
参与质量标准和运行流程以及良好风险管理研究实践的制定，促进和倡导高质量的以科学为基础的运行方针.
主导和协调各种科学和技术的运营，达到有效的和高质量的完成预定的计划和目标.
具有以下方面的丰富经验：应对FDA/USDA现场审核/审计，解读和理解CFR法规及ICH/GFI指南，创建SOP，特别是对制药，医疗设备和生物技术包括细胞和基因治疗行业的法规要求.
参与CGT领域的QC检测方法设计，特别是设计如何用in vitro方法检测RCL以及检测载体的质量（HIV基因治疗）
对于科学领域中复杂的和长期的以及新出现的问题和冲突，有能力制定政策和运营方针以解决此类问题和冲突，并确保解决方案和公司的大方向及长运目标是一致的.
领域专长
就监管策略提供策略性建议
如何与监管机构进行有效的沟通
如何准备美国FDA及中国的CDE/CFDI批前/常规审计以及可能需要的整改措施
对没有通过美国FDA批准前审计的生物仿制药公司进行现场数据评估，数据评估包括数据完整性，良好的文档实践，数据的完整性和可靠性，特别是生物类似产品和原研产品的相似性的生物测定。评估公司对FDA的一系列问题的回复信的质量及可行性，并为客户提供最为合理可行的策略及建议
对细胞和基因治疗产品的供应及制造厂家（CDMO）进行现场模拟审计，并提供满足法规要求的整改建议
为客户提供有关cGMP，变更控制，官方审计准备和应对以及质量体系许多其他方面的培训
学历:
博士后：美国国家过敏和传染病研究所，免疫调节实验室，注重HIV/AIDS的致病机理免疫学，
博士：美国阿拉巴马大学，伯明翰分校，分子生物及病毒学，HIV病毒的基因多样性
学士：中国科学技术大学，生物系

张平

Connie Langer

Connie Langer is a chemical engineer and director at Pfizer Global Product Development in Groton, CT. She has 24 years of experience in the pharmaceutical industry including extensive practice implementing science- and risk-based approaches in support of innovative products. She is currently accountable to recommend strategic regulatory options to achieve product approvals globally. She is a member of both ISPE PQLI ICH Q12 and RQHC Modernization of Module 3 Working Teams, a member of PhRMA ICH M4Q Limited Duration Team, and chair of the IQ ICH Q12 Working Group. Connie holds a BS and an MS, both from the University of Connecticut, and a Drug Development Certificate from Temple University.

1 C. S. Langer, M. J. Cohen, L. S. Gorka, M. E. McMahon, R. Nosal and T. Watson, “CASE STUDY: Facilitating Efficient Life-Cycle Management via ICH Q12”. Pharmaceutical Engineering 2020 Issue July/August, Pages 49-57.

James Krupa

James J. Krupa, Pharm.D., Director, Clinical Supply Team Lead, Operations at Takeda in Lexington, MA. In this position, I am responsible for providing the leadership and strategic direction in terms of planning, budget, coordination, scheduling, resources, and tracking the distribution of global clinical trial materials. I have over 42 years of Industrial R&D Pharmaceutical experience of which 28 years have been spent working as a Clinical Supply Chain professional. Building upon experience as a bench pharmacist in multiple dosage form drug development and non-clinical supplies, solid, semi-solid, and parenteral formulations, process development and technical services, I have contributed to the success of early and late stage development programs intended for regulatory approvals in women’s health, pain, oncology, CNS disorders, anti-inflammatory diseases, metabolic disorders, anti-infectives, cardiovascular, gastroenterology, gene therapy, and rare disease therapeutic areas.

潘兴华

* 潘兴华博士目前担任北京因诺惟康医药科技有限公司首席技术官，负责病毒载体和非病毒载体的工艺开发工作。曾在密西根大学医学院和杜克大学生物医学工程系从事非病毒载体的基因治疗的研究工作
* 潘博士曾在工业界从事基于合成生物学的重组蛋白酶的CMC工作，解决了上游高产量和下游纯化的工业界瓶颈问题。曾在Lonza 担任高级工艺科学家，期间创新了不同病毒载体的生产工艺，提高了生产效率。为多个临床试验提供了病毒载体生产的技术路线。同时领导了多个基因治疗产品的早期和商业化的工艺路线优化和放大生产。
* 潘博士在西安交通大学取得学士学位，在德州农工大学取得化学工程博士学位。

Thomas B. Hartman

Hong FANG

* 国家癌症中心/中国医学科学院肿瘤医院 药物临床试验研究中心（GCP） 机构秘书/运营总监
* 中国协和医科大学，药学，硕士研究生
* 中国GCP联盟青委会副主委，北京肿瘤学会临床研究专委会秘书长，
国家药品监督管理局药物临床试验检查员， 中国抗癌协会肿瘤临床
试验稽查协作组委员，中国药学会中国临床药理学杂志千人新苗青年
委员会委员，北京健康促进会临床研究专家委员会委员。
* 2012年开始从事临床研究相关工作，工作内容涉及制度建设、机构管理、质量控制、人员管理及培训、监管及业务沟通等。以第一作者发表临床研究相关学术文章10+篇，作为项目骨干参与国家重点研发计划、中国医学科学院创新工程等课题。

Erich Bozenhardt

Erich Bozenhardt is a BioProcess SME and internationally recognized authority in the domains of cell and gene therapy and bioprocessing. He is a Lead Process Engineer in Regenerative Medicine Operations, at United Therapeutics Corporation. During his career, Erich has led the process activities for several biopharmaceutical projects, provided internal and external project leadership, is a published author of more than 30 technical papers, and a conference presenter on process technologies and operations. He is an active member of several Communities of Practice and a contributor to guidance documents. He is the Chair of the ISPE ATMP Community of Practice (CoP).

Weiping YE

Dr. Ye obtained Bachelor's degree in Chemistry from Peking University and PhD degree from National University of Singapore. After working in GSK and Pfizer, he founded Raffles PharmaTech. He has about 20 years’ experience in asymmetric catalysis, chemical process development and industrialization.

Shannon Couger

ChapmanJonathan 柴俊

onathan Chapman is the International Relations Specialists covering the drug portfolio for the FDA’s OGPS Beijing China Office. Mr. Chapman has been in China since 2018 and before taking the role as the Drug IRS, he served as the Associate Country Director where he supervises a team of investigators who were responsible for performing inspections of pharmaceutical, device, and biomedical research facilities in China. Prior to becoming the Medical Products Supervisor, Mr. Chapman was a drug investigator for OGPS’ Beijing China Office and ORA’s Baltimore District Office. In these roles Mr. Chapman conducted complex drug inspections both in the US and abroad. Mr. Chapman earned a Bachelor of Science (BS) in Human Nutrition, Foods, and Exercise with a Minor in Medicine and Society from Virginia Polytechnic Institute and State University and a Master of Science in Regulatory Affairs and Quality Assurance (RAQA) from Temple University. 柴俊是FDA全球政策与战略办公室(OGPS)下设的中国办公室负责药品国际关系专家。柴俊先生2018年开始在FDA驻华办工作，在担任药品国际关系专家前，他曾担任负责医疗产品检查的副主任，主管药品和医疗器械检查员，负责对中国药品、生物医学研究和医疗器械企业的检查。在成为中国办公室检查员主管之前，柴俊在OGPS中国办公室和监管事物办公室（ORA）巴尔的摩地区办公室担任药品检查员，开展过国内和国际的复杂药品检查。柴俊先生获得了弗吉尼亚理工学院暨州立大学的人类营养、食品和运动理学学士学位（辅修医学和社会学）以及天普大学的法规事务和质量保证 (RAQA) 理学硕士学位 。

Marcus Ray马思睿

Marcus Ray joined FDA in 2014 and currently serves as an Assistant Country Director with FDA’s Office of Global Policy and Strategy (OGPS), Beijing China Office. Mr. Ray has experience in conducting both domestic (US) and foreign pharmaceutical inspections. Prior to joining FDA’s Beijing Office, Mr. Ray performed pharmaceutical inspections for the Office of Regulatory Affairs (ORA), serving as a member of the Dedicated Foreign Drug Cadre. Mr. Ray earned a Bachelor of Science (B.S.) degree in Biology (Micro) from Hampton University and Master of Public Health (MPH) degree from Liberty University.

马思睿，2014年加入FDA，目前在FDA的全球政策和战略办公室(OGPS)中国办公室担任助理主任。他在美国本土和国外的药品企业检查方面积累了经验。在加入中国办公室之前，马思睿在法规事物办公室(ORA)进行药品检查，是专职海外检查组的成员。马思睿于汉普顿大学获得生物学学士学位，利伯缇大学获得公共卫生硕士学位。

Xuecheng JIAO

He graduated from East China University of Science and Technology in 2016 and joined Kelleying in the same year. At present, he is the senior director of Kellein Biosynthesis Technology Research and Development Center, responsible for enzyme technology development. More than 50 patents have been applied for, and 30 patents have been authorized. He won the honorary titles of "131 Talents of Tianjin" and "Outstanding Young Scientific and Technological Worker of Tianjin Binhai New Area".

Andrei Spinei

Andrei Spinei is the lead for the manufacturing group in the Inspections Office of the European Medicines Agency. He has joined EMA in 2014 and has since taken up different roles within the manufacturing area, being involved in GMP inspections, market surveillance, international collaboration and policy making. He is working closely with the EU GMP Inspectors Working Group and PIC/s.
Andrei holds an MSc. in Pharmacy and before joining the European Medicines Agency he has worked in the Pharmaceutical Industry.

张平

Praveen Pai

Hong FANG

* 国家癌症中心/中国医学科学院肿瘤医院 药物临床试验研究中心（GCP） 机构秘书/运营总监
* 中国协和医科大学，药学，硕士研究生
* 中国GCP联盟青委会副主委，北京肿瘤学会临床研究专委会秘书长，
国家药品监督管理局药物临床试验检查员， 中国抗癌协会肿瘤临床
试验稽查协作组委员，中国药学会中国临床药理学杂志千人新苗青年
委员会委员，北京健康促进会临床研究专家委员会委员。
* 2012年开始从事临床研究相关工作，工作内容涉及制度建设、机构管理、质量控制、人员管理及培训、监管及业务沟通等。以第一作者发表临床研究相关学术文章10+篇，作为项目骨干参与国家重点研发计划、中国医学科学院创新工程等课题。

李玉玲 Yu-ling LI

李玉玲博士有二十多年生物制药工艺开发及生产的丰富经验，带领先进生物药的研究和CMC开发管理，并参加了多个生物制药生产基地包括两万升单克隆抗体生产线的设计，是浙江健新原力制药有限公司共同创始人和首席执行官。李博士曾经担任Apollomics（冠科美博, APLM）公司高级副总裁、 AstraZeneca(阿斯利康)旗下美国生物制药公司MedImmune的Fellow和工艺研发总监, 以及美国人类基因科学公司(HGS, 已经被葛兰素药业并购)的高级总监, 和罗氏药业的科学家。她先后参与了40多个临床药品项目的工艺开发, 贡献过9个成功上市的生物药， 并主持了其中三个抗体产品BLA的CMC申报。李博士发表了40多篇科学论文,有5项授权专利。她在中山大学完成学士和硕士学位，于美国罗格斯大学医学院获得博士学位。
李博士是美国华人生物医药科技协会（CBA）2007-2008年度会长和顾问董事会的成员，她也是美华生物医药联盟(All‐CABPA) 的发起人和创任会长之一(该联盟于 2008年5月成立)。2014年，李博士获得了国际医疗行业女企业家协会新星奖。
Dr. Yuling Li is the co-founder and CEO of Innoforce Pharmaceuticals, a pharmaceutical development company established in 2018 at Hangzhou, China with the focus of building CDMO capabilities for innovative drug development including nucleic acid products (plasmid DNA and RNA), viral vector and cell therapy and monoclonal antibody products. She was the Sr. Vice President of Process Development and Manufacturing of Apollomics (Foster City, CA and Hangzhou), the R&D Fellow/Director in BioPharmaceutical Development at MedImmune/AstraZeneca (Gaithersburg, MD), the Senior Director in BioPharmaceutical Development at Human Genome Sciences Inc. (now part of GSK, Rockville, MD) and an Associate Scientist at Hoffmann-La Roche Inc. in Nutley, New Jersey. In the past 30 years, Dr. Li led CMC activities for 3 (Belimumab, Raxibacumab and Brodalumab) and contributed to 9 approved products plus 30+ biopharmaceuticals through various clinical stages of CMC development.
During the course of her career, Dr. Li published 40+ peer-reviewed articles and book chapters and is the inventor for five issued patents. In 2014, Dr. Li received the Rising Star Award from the Healthcare Businesswomen Association. Dr. Li served as the President (2007-2008), Board of Directors, member of the Advisory Board for the Chinese Biopharmaceutical Association-USA (CBA, www.CBA-USA.org), a non-profit professional organization. Dr. Li also co-founded the Alliance of Chinese-American Biotechnology and Pharmaceutical Associations (ALL-CABPA) in 2008. She is a BayHelix member.

李锦才博士

Yong LU

Qiu YAN

She has nearly 20 years of working experience in pharmaceutical related fields, worked as a national GMP inspector from 2013 to 2020, and has rich experience in various kinds of compliance inspection. Now she is the deputy General manager of Quality Management Department of Shanghai Pharmaceutical Manufacturing Management Center.

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。

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。

Xuegong WANG

Hong ZHANG

Zhang Hong is the senior director of Intelligent Information Department of Shanghai Junshi Bioengineering Co., LTD
Master's degree, worked in Emerson Process Control Company, Rockwell Automation Company. In 2017, I joined Junshi Biology and participated in the design, debugging, operation and maintenance of the industrial control network infrastructure, automation and information system of the Lingang factory. Experience in CSV and GMP.

Chip Bennett

A Project Manager and Senior Validation Engineer, Chip is a PMI® Certified Project Management Professional (PMP), a recognized industry expert, speaker, and published author, and a consultant with over 20 years of experience in the pharmaceutical and regulated non-pharmaceutical industries and with expertise in risk-based verification, aseptic manufacturing, cleaning validation, quality systems, and owner project management. Chip is responsible for developing and implementing Quality Risk Management (QRM) based Commissioning and Qualification programs and projects, with a focus on assessing and training clients regarding development, implementation, and transition to risk-based approaches. Chip was a lead author on the ISPE Good Practice Guide: Good Engineering Practice, 2nd Edition (2021).

齐菲菲 博士

*齐菲菲博士担任北京艺妙神州医药科技有限公司的联合创始人&首席技术官，负责公司产品的工艺开发和生产，主导公司首款CAR-T细胞产品开发、技术转移、临床试验样品生产、商业化厂房建设&验证和注册申报工作，建立了公司基因细胞药物的开发和GMP生产体系。荣获北京市科技新星和中关村高端领军人才等荣誉称号。发表SCI论文18篇，授权发明专利11项。
*齐博士在基因细胞药物领域有8年的开发经验，多次参与该领域国家相关指导原则、指南和法规的撰写和研讨工作，见证该领域在国内的蓬勃发展。尤其在基因细胞药物的CMC方面具有丰富的知识和经验，拥有基因细胞药物全流程开发经验。
*齐博士在河北大学生命科学学院取得生物学学学士学位，在清华大学取得生物学博士学位。

Ian Richard Thrussell

Chemist by training, a Chartered Chemist and a Fellow of the Royal Society of Chemistry of Great Britain. Eligible to act as a Qualified Person in the EU.
Retired from WHO Geneva as Head of PQT Inspections in November 2016. Now providing audit and consultancy services to National Regulatory agencies and International NGOs. Based in the UK but frequently in Geneva, Switzerland.
GMP Expert Inspector to the Inspection Services Group of the consolidated WHO Pre-qualification Team for Medicines, Vaccines, Devices and Diagnostics October 2013-2016
Head of Inspections of Medicines, PQ, WHO Geneva 2011 - 2013
Highly experienced in GMP from Regulatory Inspection for over 25 Years at both national and international level and almost 20 years industrial experience gained in development, production technical support and validation, quality and regulatory roles in the EU Pharmaceutical and Medical Device Industries, and more latterly as a trainer to industry groups.
Previously worked in the Pharmaceutical Industry for 18 years prior to joining MCA mainly in sterile product R&D, manufacturing, RA and QA. Worked for over 10 years as an EU QP releasing product to market in the EU. 5 years as UK Group Quality head for a German manufacturer.
In 1994 joined the GMP Inspectorate of the then UK MCA (Medicines Control Agency) and immediately before moving to Geneva, was one of the UK MHRA GMP Inspectorate Expert Inspectors, a member of the GMP Inspectorate’s Strategic Group with the responsibility of representing the UK Agency’s GMP interests at an EU and an international level
Has conducted over 1000 inspections in UK and over 500 inspections in 43 countries on 7 continents but primarily in USA, Japan, India and China. Specialist in Sterile and Biological Product GMP inspection.
A tutor and trainer at many EMEA, MHRA, PIC/s and WHO organised GMP training symposia in Africa, China, India for Industry as well as those for training of National Medicines Regulatory Authorities CMC assessment and inspection personnel in these countries as well as PQ product recipient nations.

YI XIAO

Dr. Xiao received his Ph.D. degree from Nagoya University in 1994. He studied under Professor Ryoji Noyori, winner of the 2001 Nobel Prize. After that, he did postdoctoral research in the laboratory of Professor L. Hegedus at Colorado State University in the United States.
Dr. Yi Xiao has more than 20 years of experience in pharmaceutical process research and development, having worked in the process departments of Merck and Squibb in the United States. He founded the Catalyst Research Laboratory for Squibb, introducing high-throughput screening technologies and data-driven research and development methods. He has participated in dozens of research and development projects, published more than 50 papers, won several international awards, including the President's Award for Green Chemistry, and delivered more than 40 academic lectures around the world. In 2017, he was elected as the 2019 Gordon Conference (GRC) Industry Chairman of Organic Reactions and Processes in the United States. It became the first in the 65-year history of the GRC-Organic Reactions and Processes Conference
The election of a Chinese national as President of the Conference fully represents the international recognition of his personal research prowess. In 2018, I returned to China to join Kelaiyin Pharmaceutical Group and served as senior vice President, responsible for the company's overall process research and development and new technology development, etc. During this period, I was honored as "Teda High-level Talent" and "Leading Talent of Innovation and Entrepreneurship in Binhai New Area".

Amy Kuntzman

Amy Kuntzman is a Principal Consultant with CAI, with over 20 years of pharmaceutical and biotechnology experience in the fields of Quality and Project Management. For the last five years Amy has concentrated on digital transformation, specifically the implementation and enhancement of integrated GxP systems to support large-scale manufacturing of pharmaceutical products. She has managed multiple successful cross-functional teams both as a Project Manager and as a Functional Manager, including the implementation of eVLM applications as well as transition of a legacy electronic / paper hybrid documentation system to fully electronic, integrated QMS / ERP platforms.

Mansheng DING

Dr. Ding has been engaged in the biopharmaceutical industry and has 20 years of management experience in pharmaceutical companies. He has worked in a number of domestic listed pharmaceutical companies and foreign companies, including Shanghai RAAS, Fosun Pharmaceutical, Baxter Medical and Benemae Biological. He has rich experience in bio-pharmaceutical theory and application technology, proficient in Chinese GMP, EU and FDA cGMP regulatory requirements and product marketing registration process, has rich experience in the construction of quality management system based on risk management and knowledge management, rich experience in international GMP certification, and has led the team to pass FDA, EU and China GMP audits for many times. He has presided over a number of biological drug industrialization projects, including blood products, recombinant protein products, peptides and monoclonal antibodies, etc., and made remarkable achievements in the construction of biological drug plant and product technology transformation.

James Wang，PhD 王永增博士

合源生物首席技术官 （CTO）
诺华全球细胞治疗质量审核师
美国斯隆·凯特琳纪念癌症中心(MSKCC) 细胞疗法生产运营及质量负责人
美国Vivaldi Biosciences公司GMP产品经理
耶路撒冷希伯来大学分子病毒学博士
美国康奈尔大学及爱荷华州立大学分子病理学博士后
国际细胞治疗协会会员（ISCT)
美国单采协会会员（ASFA)
拥有十五以上年CAR-T细胞治疗行业经验，包括临床研发、工艺开发、GMP生产、产品商业化、合作医院对接，和全流程质量管理等。

Liang HAN

识林知识平台负责人，北京大学知识工程与监管科学实验室研究顾问。从事药品生产质量法规政策和产业质量体系研究，牵头负责2010版GMP指南撰写和再版修订工作。长期参与IPEM项目的组织和教学。2014年毕业于北京大学。

Sion Wyn

Sion Wyn, Director, Conformity Ltd., is an acknowledged expert in computer system validation and compliance and international GxP regulations in this field.
He was consultant to US FDA during the re-examination of 21 CFR Part 11, and a member of the core team that produced the FDA Guidance on 21 CFR Part 11 Scope and Application. He was the technical content expert for the FDA’s ORA Virtual University on-line training modules on computerized systems validation and compliance. He received the FDA Group Recognition Award for work on Part 11.
Wyn is the editor of the ISPE GAMP5 Guide - A Risk-Based Approach to Compliant GxP Computerized Systems, and is a member of the ISPE GAMP Global Steering Committee, GAMP Editorial Board, and the GAMP Europe Steering Committee.
Wyn is the lead GAMP, DI, and Part 11 trainer and course developer for ISPE.
At Conformity Ltd., Wyn provides computer validation and compliance consultancy to the pharmaceutical and other regulated life-science industries.
Wyn received the 2006 ISPE Professional Achievement Award, which honours an ISPE Member who has made a significant contribution to the pharmaceutical manufacturing industry. He received the ISPE UK Fellow Award in 2010

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

Yang WANG

Dr. Wang has gained PhD in medicinal chemistry in Aston University in UK, more 4 years of experience in pre-clinical drug discovery in Bioduro and 9 years working experience in Center of Drug Evaluation of National Medical Products Administration in technical review and ICH work. He has been the ICH coordinator and core member for group Q3D, Q13 and QDG. Dr. Wang has extensive experience in both industry and regulatory body.

Charlie Zhang

Dr. Charlie Zhang has 20 years’ experience in the global biopharmaceutical industry with expertise in CMC development, commercialization, and regulatory filing.
Dr. Zhang is currently CEO of Foster Biopharma Zhejiang Co. Ltd., which is a joint venture by Betta Pharmaceuticals (SHE: 300558) and Beijing MabWorks Biotech Co. Ltd. with its business focusing on the biopharmaceutical development and commercialization.
Prior to Foster, Dr. Zhang was Sr. Vice President, CMC, at Akeso Biopharma (HK: 09926) and played a key role in the marketing filing (BLA) of Penpulimab (Anniko®, Anti-PD1) and Cadonilimab (PD-1/CTLA-4 BsAb), and oversaw CMC development of multiple pre-clinical and clinical antibody products. Before joining Akeso, Dr. Zhang was Sr. Vice President, CMC Operation and Regulatory, at I-Mab Biopharma (Nasdaq: IMAB) between 2019 and 2020, where he led the CMC development, CDMO management, BLA preparation as well as building readiness for commercial launch for Felzartamab (Anti-CD38) and other in-licensed biologics products from partners in EU, US and Korea.
Prior to I-Mab, Dr. Zhang had been working at Generon BioMed Holding Ltd. between 2012 and 2019. As the Head of Global CMC Operation & Corporate Strategy and General Manager of Generon Biopharma Beijing Co. Ltd., Dr. Zhang oversaw CMC development, manufacturing and regulatory filings as well as business collaboration of multiple Fc fusion proteins and bi-specific antibodies entering US&EU&CN clinical trials. He also played a leading role in building readiness for marketing application and product launch of Ryzneuta® (G-CSF-Fc, F-627) in US and China.
Prior to 2012, Dr. Zhang had been working in various BioPharmaceutical companies in San Francisco Bay Area. He served as Vectibix® CMC Control Strategy team lead and a key member in Vectibix® global registration and FDA QbD Pilot Program at Amgen. He played functional lead roles for Empliciti®, Praxbind®, Cyltezo®, Regranex® and numerous clinical stage biologics at BI, PDL (AbbVie) and Chiron (Novartis).
Dr. Zhang received his BS from Peking University and Ph.D. from University of Rhode Island.

Chenyang HE

As an editorial board member, participated in the preparation of the continuous production and PAT related parts of "Key Technical Points on the Risk Management and Control of Oral Solid Preparation Manufacturing", participated in the preparation of the advanced manufacturing section in the revision of the 2010 "GMP Guidelines", and participated in the drafting seminar of GMP appendices related to PAT. Have made continuous manufacturing related reports in CPEC, IPPM, Ouryao, FHA._____

Susan LI

Susan Li于2020年11月加入赛默飞生物服务于专业物流，担任客户解决方案总监与细胞和基因治疗服务SME。她和她的团队开发创新和定制化的解决方案，以支持客户进行全球临床试验和商业化分发。她曾经担任Celgene（现为Bristol Myers Squibb）细胞治疗物流总监和阿斯利康公司的分析生物学家，拥有丰富的细胞治疗供应链解决方案的知识和药物发现研究知识。

Christian Woelbeling

Christian Wölbeling is Executive Industry Advisor & Senior Strategic Account Manager, at Körber Pharma Software based in Lüneburg, Germany. Körber Pharma Software is the world’s leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharmaceutical and biopharmaceutical industries. He holds a Master Degree in Mechanical Engineering. Since more than 30 years working in Life Sciences Manufacturing IT, Christian has had great experience in all GMP related processes.
Christian Wölbeling是德国Körber Pharma Software公司的执行行业顾问和高级战略客户经理。Körber Pharma Software是全球领先的制药和生物制药行业制造执行系统(MES)和制造IT解决方案供应商。他拥有机械工程硕士学位。Christian在生命科学制造IT行业工作了30多年，在所有GMP相关流程方面都有丰富的经验。
He has broad activities inside the ISPE as Founder & Chairman of the CoP “Pharma 4.0”, ISPE “GAMP MES Special Interest Group” Co-Chair, ISPE GAMP Member at large of the European Steering Committee, “PAT & Lifecycle Control Strategy” CoP Steering Member, ISPE Affiliate DACH Board Member, APQ Core Team Member, European Leadership Team / ELT Member and was named as “Pharma Industry Leader” by the ISPE Pharmaceutical Engineering Magazine 2020.
他在ISPE内部有广泛的活动，作为CoP“制药4.0”的创始人和主席，ISPE“GAMP MES特殊别兴趣小组”联合主席，ISPE GAMP欧洲指导委员会的大成员理事，“PAT和生命周期控制战策略”CoP指导成员，ISPE附属DACH董事会成员，APQ核心团队成员，欧洲领导团队/ ELT成员，并被ISPE制药工程杂志命名为2020年 命名为“制药行业领导者”。

Chiaochun Joanne (Jo) WANG

Chiaochun Joanne (Jo) Wang, Ph.D. is currently Vice President (technical) and APAC lead in Parexel Strategic Compliance Consulting. Dr. Wang is a Subject matter expert in evaluating facilities, process design, and control strategies to assure quality production of large-molecule and small-molecule products at commercial scale. She provides consultation services to global pharmaceutical manufacturers on FDA CMC submission strategy and inspection readiness, specializing in biosimilars, vaccine, cell & gene therapy products, drug-device combination products, first generic and novel inhalation products, emerging technologies and advanced manufacturing techniques. Before she joined Parexel, she was Acting Branch Chief in CDER/OPQ/OPMA. During her tenure, she was a trainer in internal FDA courses/seminars for training CDER SMEs who participates on inspections, ORA field investigators and compliance officers, and demonstrated achievements in developing innovative solutions to facilitate collaborations within multi-disciplinary teams to achieve technical operation goals, e.g. led the development of the CDER/OPQ review templates for manufacturing and facility (CGMP) evaluation for all dosage forms. She had conducted many on-site pre-approval inspections and 704(a)(4) Record request review with a wide array of pharmaceutical manufacturers (ranging from major international pharma sites to first time applicants). Dr. Wang attained her Ph.D. in Biomedical Engineering with focus on cell/tissue engineering and computational modeling in “Lab on a Chip” systems from Johns Hopkins School of Medicine. She received her B.S. in Chemical Engineering (Course 10) from MIT, with Research Advisors Dr. Robert Langer and Dr. Daniel I.C. Wang.

丛征宇

现任南京驯鹿生物技术有限公司高级副总裁，主要职责包括供应链管理、仓储物流、采购、人力资源、信息技术。
在此之前，曾任默沙东中国供应链负责人、杜邦亚太区精益生产体系导师、诺华化学运营供应链负责人、勃林格殷格翰大中华供应链负责人、复星凯特供应链负责人。

拥有16年医药供应链管理和11年运营管理经验，在化药和细胞治疗供应链管理、世界级供应链体系、精益生产体系方面拥有深厚的理论和实践经验。曾两度带领团队完成Oliver Wight世界级供应链项目：默沙东卓越运营项目；诺华NOSSCE项目。

Hongyang LI

Hongyang Li, currently Novartis Technical Operations Manufacturing Science & Technology (MS&T) Head for Ophthalmology & Local Market Manufacturing platform, responsible for 10 sites in EU，Asia Pacific, Africa, Latin America and Russia. Previously Novartis Solids APAC MS&T Head, Quality Head at Suzhou Novartis Pharm Technology, VP of Quality at Novo Nordisk’s Tianjin plant and quality leader in Eli Lilly in the United States. He has over 20-year experiences in pharmaceutical manufacturing, technology, and quality management, including over 5 year hands on experiences in the US. He has hosted and been involved in many GMP inspections, including two sites in China, under his quality leadership, passed the US FDA inspection with no 483. He holds a Bs. and Ms. in Biology from Nankai University, a Master degree in Manufacturing and Quality Management from Penn State University, USA, and a Diploma In Management from CEIBS. He is a Certified Quality Manager (CQM) and Certified Quality Auditor (CQA) from American Society for Quality (ASQ). He served as former Vice Chair of ISPE China Board (2015-2016) and also as a country representative of the Regulatory Affairs and Quality Advisory Board (RAQAB) of PDA (2012-2018). He also participated in drafting CFDA two GMP appendixes (CSV & Validation) ， Drug Data Management Practice，and ICH Q9 translation. He was also a certified QRM instructor in China by ISPE.

罗建军 博士

罗建军博士现任药明生物旗下无锡药明合联生物技术有限公司副总裁和无锡新区生产基地负责人。 罗博士先后就读于北京化工大学和中国科学院过程工程所，硕士毕业留所工作4年。1995年出国留学加拿大，在新斯科省的达尔豪斯 （Dalhousie University at Nova Scotia）大学获化工博士学位，尔后在美国工作12年，最后工作公司是在美国北卡罗来纳州（North Carolina）的康泰伦特制药公司（Catalent Pharmaceutical Solutions）担任无菌制剂研发部负责人和项目管理主任，研发30多个制剂配方包括在美上市药品，并且领导技术转移和cGMP无菌制剂产品的生产。2011年12月回国工作至今12年，先后担任上海药明康德和药明生物制剂研发和生产部高级主任和执行主任。在他的领导下创建了上海制剂研发团队，领导了200多个制剂配方开发，包括相继进入商业化生产的制剂配方，同时，他还组建了无锡制剂GMP灌装团队。他从2013年开始领导高活ADC制剂的研发以及随后的GMP生产，并于2018年4月调到无锡新区负责筹建专门生产高活生物偶联药的药明偶联生产基地，领导建成并运营能生产高活OEB4/5级偶联药（DS和DP）的GMP生产基地，迄今已生产300多批次。

Dr. J.J. Luo is currently the Vice President of Wuxi XDC Co., Ltd., a subsidiary of WuXi Biologics, and the Site Head of the production base in Wuxi New District. Dr. Luo successively studied in Beijing University of Chemical Technology and Institute of Process Engineering, Chinese Academy of Sciences, and worked in the Institute for 4 years after graduation. In 1995, he went abroad to study in Canada and obtained a Ph.D. in chemical engineering from Dalhousie University at Nova Scotia. Then he had worked in the United States for 12 years, and his last company was Catalent Pharma Solutions in North Carolina, USA. He served as the Head of the R&D department of sterile Product Development and the Director of project management. He developed more than 30 formulations including drugs marketed in USA and led the technology transfer and production of cGMP sterile products. He returned to China in December 2011 and has been working for 12 years. He has successively served as Senior Director and Executive Director of Shanghai WuXi AppTec and WuXi Biologics Formulation Product Department. Under his leadership, he established the Shanghai formulation development team and led the development of more than 200 formulations, including formulations that have entered commercial production. At the same time, he also established the Wuxi GMP fill/finish team. Since 2013, he has led the formulation development of highly potent ADC formulations and the subsequent GMP production. In April 2018, he was transferred to Wuxi New District to be responsible for the establishment of a WuXi conjugate production base specializing in the production of highly potent bioconjugates. He led the construction and operation of the GMP production base capable of producing highly potent OEB4/5 grade conjugated drugs (DS and DP). So far, this site has produced more than 300 batches.

Chen GU

Engineering Master Degree. 12 year pharma liquid machine experience, focus on Isolator technology product development.

Susan LI

Susan Li于2020年11月加入赛默飞生物服务于专业物流，担任客户解决方案总监与细胞和基因治疗服务SME。她和她的团队开发创新和定制化的解决方案，以支持客户进行全球临床试验和商业化分发。她曾经担任Celgene（现为Bristol Myers Squibb）细胞治疗物流总监和阿斯利康公司的分析生物学家，拥有丰富的细胞治疗供应链解决方案的知识和药物发现研究知识。

张宏伟 Anson Zhang

现任诺和诺德中国制药有限公司IT与自动化业务负责人，负责诺和诺德中国工厂的整体数字化业务和百余人数字化团队管理工作。南开大学MBA。十余年生命科学领域从业经验，先后帮助数十家医药企业完成数字化顶层架构设计及IT合规体系搭建，并参与多家跨国医药企业的数字化多项建设工作。

Claude Vella Bonanno

Graduated as a pharmacist from the University of Malta in 2005, Claude worked in the pharmaceutical industry since then. After working in Malta and abroad in Italy and Spain, he set up Quintian Pharma in 2015. Quintian Pharma is an API manufacturing facility with EU-GMP certificate and have endeavored in developing three main areas: GMP/GDP, Pharmacovigilance and Regulatory Affairs. Also, Quintian Pharma have set up EU-GDP and GMP licenses’ to ensure Batch-releasing and wholesale dealing in Europe. Today, Quintian Pharma is proudly federated and co-owned by PQE Group, one of the world's largest consulting companies fully dedicated to Lifesciences since 1998.

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。

齐菲菲 博士

*齐菲菲博士担任北京艺妙神州医药科技有限公司的联合创始人&首席技术官，负责公司产品的工艺开发和生产，主导公司首款CAR-T细胞产品开发、技术转移、临床试验样品生产、商业化厂房建设&验证和注册申报工作，建立了公司基因细胞药物的开发和GMP生产体系。荣获北京市科技新星和中关村高端领军人才等荣誉称号。发表SCI论文18篇，授权发明专利11项。
*齐博士在基因细胞药物领域有8年的开发经验，多次参与该领域国家相关指导原则、指南和法规的撰写和研讨工作，见证该领域在国内的蓬勃发展。尤其在基因细胞药物的CMC方面具有丰富的知识和经验，拥有基因细胞药物全流程开发经验。
*齐博士在河北大学生命科学学院取得生物学学学士学位，在清华大学取得生物学博士学位。

James Wang，PhD 王永增博士

合源生物首席技术官 （CTO）
诺华全球细胞治疗质量审核师
美国斯隆·凯特琳纪念癌症中心(MSKCC) 细胞疗法生产运营及质量负责人
美国Vivaldi Biosciences公司GMP产品经理
耶路撒冷希伯来大学分子病毒学博士
美国康奈尔大学及爱荷华州立大学分子病理学博士后
国际细胞治疗协会会员（ISCT)
美国单采协会会员（ASFA)
拥有十五以上年CAR-T细胞治疗行业经验，包括临床研发、工艺开发、GMP生产、产品商业化、合作医院对接，和全流程质量管理等。

丛征宇

现任南京驯鹿生物技术有限公司高级副总裁，主要职责包括供应链管理、仓储物流、采购、人力资源、信息技术。
在此之前，曾任默沙东中国供应链负责人、杜邦亚太区精益生产体系导师、诺华化学运营供应链负责人、勃林格殷格翰大中华供应链负责人、复星凯特供应链负责人。

拥有16年医药供应链管理和11年运营管理经验，在化药和细胞治疗供应链管理、世界级供应链体系、精益生产体系方面拥有深厚的理论和实践经验。曾两度带领团队完成Oliver Wight世界级供应链项目：默沙东卓越运营项目；诺华NOSSCE项目。

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

谢国亮 Guo-liang XIE

上海君实生物工程有限公司生产负责人（执行总监），浙江大学生物化学专业本科，华东理工大学制药工程硕士，具有十几年生物医药行业经验，包括抗体的生产管理、技术转移、工艺设计及工厂建设，曾经负责过500-5000L的单抗不锈钢产线以及500-2000L规模的一次性产线的建设和运营。
Introduction： Head of manufacturing (Executive Director) , Shanghai Junshi Biotechnology Co., Ltd.; has a bachelor degree in biochemistry from Zhejiang University and a master degree in pharmaceutical engineering from East China University of Science and Technology. With more than ten years of experience in biopharmaceutical industry, including antibody production management, technology transfer, process design and plant construction; and has been responsible for the construction and operation of 500-5000L stainless steel mAbs production lines and 500-2000L scale Single-use Systems (SUS) mAbs production lines.