Over 35 years of global industry experience in biologics development and GMP manufacturing

In-depth technical expertise in upstream and downstream processes, product formulation/delivery, design/implementation of single-use systems, biosafety testing, and compliance

Offer advanced expertise in bioprocess development, GMP manufacturing, regulatory consultations, seminars and trainings for biopharmaceutical clients in the USA, Latin America, and Asia-Pacific

VP and Senior Advisor at WuXi AppTec, Corporate Fellow and VP at WuXi Biologics, CTO at Livzon, VP at La Jolla Biologics/ Tanvex, Co-founder and CTO at Henlius, Global Technical Director at Danaher

Developed a CHO-based monoclonal antibody technology platform for biosimilars for Henlius, which is the first completed 200L single-use bioreactors for GLP manufacture 

Led late-stage clinical/commercial biomanufacturing facility with a 30,000L bioreactor capacity, encompassing fed-batch and perfusion cell culture. Successfully completed the initial PPQ campaign for MNC client within the first year

Founded a non-government-affiliated enterprise to offer biosafety testing services in China and Asia-Pacific region

11 publications and 1 patent

Ph.D. of Chemical Engineering at University of Delaware

20+ years' experience in analytical development and CMC for mAb, ADC, CAR-T, and mRNA therapeutics

Senior scientist and group leader at Biogen and MedImmune/AstraZeneca, VP and Sr VP at Zhejiang Teruisi, Changchun Gensciences, and Suzhou Abogen, CEO at Guangzhou Bio-Gene

Experience of supporting dozens of IND, BLA/NDA regulatory filings in China and United States

Adjunct professor of Jilin University and member of the editorial board of Chinese Journal of Mass Spectrometry

30 journal publications and 13 patents

B.S. of Physics at Jilin University, Ph.D. of Chemistry at University of Kent at Canterbury, and post-doctorate research at Osaka University and New York University School of Medicine

30+ years of experience in R&D and manufacturing for biopharmaceutical industry

Worked at Protein Sciences, Human Genome Sciences, Eli Lilly, Progenics, RemeGen, Henlius, and Zelgen

Led the development of over 50 monoclonal and polyclonal antibody drugs

Supported the launch of 11 products in China, Europe, and USA

Achieved technical breakthroughs in large-scale production of monoclonal antibodies and recombinant proteins using mammalian cells in terms of titer, scale, and quality.

Familiar with cGMP standards in Europe and the US, with extensive management experience in large-scale antibody and recombinant protein production; proficient in the entire process of cGMP production facility design, construction, validation, and operation, including expertise in designing large-scale cell culture facilities; led the design and construction of cGMP a variety of production facilities (with 200 liters to 20,000 liters in scale, single-use or stainless steel bio-reactors) .

Published over 50 papers and scientific reports

Selected into the National Talent Program, the Innovation of Shanghai Program, and the Entrepreneurship and Innovation of Jiangsu Program 

Served as a member of the Global Expert Group on ICH Q13 Continuous Manufacturing Technical Guidelines, a contributor of technical guidelines for the China National Medical Products Administration (NMPA), a member of the Drug Development Committee of China Pharmaceutical Promotion Association

B.S.& M.S. of Chemical Engineering at China University of Petroleum, MBA of University of Phoenix, Ph.D. of Biotechnology at University of Calgary

30 years' experience in biotechnology and biopharmaceuticals, and CMC product development management

Rich experience in quality management that meets the requirements of FDA, NMPA, and ICH GXP guidelines

Worked at Chime Biologics, MabPlex, Livzon Monoclonal Antibody, Teruisi, Wuxi Biologics, ARI (USA), and Eli Lilly

Responsible for establishing and implementing QA, QC, and validation systems during his tenure as Senior Vice President/QP at Chime Biologics. Responsible for overseeing the quality system and supporting GXP quality operations, including preclinical development, clinical product manufacturing, and clinical trials when served as VP of QA at Livzon.

Member of the Chinese Antibody Society, the Chinese American Biomedical Association (CABA), and the Sino-American Pharmaceutical Professionals Association (SAPA)

B.S. of Science in Chemistry at Nanjing University, M.S. of Science in Chemistry at University of Louisville, MBA of Kelley School of Business, Indiana University

25 years of experience in academia and regulatory affairs directly related to the R&D and manufacturing of biopharmaceuticals. Familiar with FDA regulations

Worked at Food and Drug Administration/Center for Drug Evaluation and Research (FDA/CDER), National Cancer Institute/Clinical Center Research (NCI/CCR), US R&D Branch/ISU Abxis Korea, and National Heart Lung and Blood Institute (NHLBI)

13 years of Product Quality (aka CMC) reviewer, reviewing Biologics License Applications (BLAs) and Investigational New Drugs (INDs) for biotechnology products under 351(a) and 351(k) BLA pathways during FDA

Participated in the BLA approval process under PDUFA and BSUFA timelines, resulting in the approval of five BLAs and one Complete Response (CR). Reviewed over 40 Supplement BLAs (PAS, CBE30, and CBE), specializing in assay method validation and manufacturing process validation for cell line changes, process scale-up, process changes, and analytical method changes

Expert in FDA compliance regulations for developing biotech products, including monoclonal antibody (mAb), antibody-drug conjugate (ADC), recombinant protein, insulin, and biosimilar products

16 journal publications and 1 US patent

M.S. and Ph.D. of Pharmacology at Seoul National University

10 years' experience in corporate strategy and operation management, including corporate strategy, effective sales management and consulting management  

Founded an independent e-sports service brand and serve as CEO 

Responsible for the company's strategic planning and construction of organizational operation management system in Zencore 

Worked at Nestle Health Sciences and IQVIA 

B.S. of Mathematics and Applied Mathematics at Fudan University

10+ years' experience in biomedical R&D and project management 

Worked at Livzon, Lifetech Scientific, Teruisi, GE healthcare life sciences and Shanghai Destiny Biotech

Deeply engaged in cell culture process development and upstream documentation system Responsible for the construction and process development of upstream cell culture departments, taking charge of the overall management of multiple projects in Zencore  

B.S. of Changchun University of Science and Technology, M.S. of Hunan Normal University, 

15 years' experience in biological quality analysis and project management 

Practical experiences in building an analytical laboratory and setting up biopharmaceutical quality analysis team, with the ability to establish a lean operation management process and document system for the analytical department and excellent biopharmaceutical quality analysis ability 

Extensive experience in building a project management team and establishing a project management system, including project planning, milestone management, project risk analysis and control strategy, project delivery management, project quality management, etc. 

Head of Biological Department of MabSpace Biosciences during Transcenta 

Head of Project Management and Analytical Sciences of CMAB during WuXi Biologics 

Worked at Transcenta and WuXi Biologics 

B.S. of Science Degree at Jiamusi University, M.S. of Science Degree at Zhejiang Normal University, M.S. of Science Degree at Institute of Botany, the Chinese Academy of Sciences

13 years of finance management experience in large multinational enterprises with the ACCA certificate 

Responsible for the finance management of the Life Sciences Department and the Analytical Instruments Department in Asia, and the global business of the Analytical Instruments Department (about $900m annual sales) during PerkinElmer 

Experience of working for multi business groups (medical, energy, finance, aviation, etc.) with three years of overseas work experience during General Electric Company 

Senior finance manager of Asian region during Energy Group 

Responsible for the financial integration of the Asia region post-merger and acquisition during Alstom

Worked at PerkinElmer, General Electric Company, Energy Group, and Alstom 

M.S.,B.S. of Management and Literature at Shanghai University of Finance and Economics

15 years' experience in end-to-end purchasing management, budget control, supply chain digitization, category management, supplier management 

Holds the CPM (Certified Purchasing Manager) certificate and the SA8000 (Accounting for Social Responsibility) certificate 

Procurement Head of R&D Center during Novartis 

Head of Supply Chain Management and Procurement during Columbia Healthcare 

Director of Material Management during Delta Healthcare 

Director of Procurement during Innovent Bio 

Head of Procurement in the R&D center and Global Procurement Compliance manager during Roche 

Worked at Novartis (China), Roche, Delta Healthcare, Columbia Healthcare, and Innovent Bio 

B.S. of Clinical Medicine at Shanghai University of Chinese Medicine 

17+ years' of experience in biopharmaceutical industry

Extensive working experience ranging from antigen and antibody preparation, drug screening to CMC related pharmaceutical research and IND filing, with project experience spanning monoclonal antibodies, bispecific antibodies, combination antibodies, and ADCs

Worked at Shanghai Cancer Research Institute, Shanghai Cellgene, The Central Research Institute of Shanghai Pharmaceuticals Holding Co., Ltd., and Hansoh Pharmaceuticals

Led or involved in the construction of laboratories, production workshops, teams, and document systems from scratch on multiple occasions

Served as project leaders for multiple projects and successfully pushed them from the exploratory phase to IND approval

Authored more than 20 patent applications

B.S. of Chemical Engineering and Technology at Shanghai Normal University, M.S. of Bioengineering at East China University of Science and Technology

10+ years' experience in biomedical R&D and project management 

Responsible for building a medium formula development platform and a cell culture process characterization platform  

Engaged in cell culture process development, process characterization and culture medium formulation development in Shanghai Destiny Biotech 

Developed a highly expressed, animal free and chemically-limited medium formula system for CHO cell culture, and led the team to complete a project based on commercial production scale (500L) in Zencore 

Worked at Shanghai Institute of Pharmaceutical Industry, and Shanghai Destiny Biotech 

B.S. of Bioengineering at Shenyang Pharmaceutical University, M.S.,Ph.D. of Microbiology and Biochemical Pharmacy at Shanghai Institute of Pharmaceutical Industry 

10 years' of biomedicine experience, involving downstream process development, technology transfer and GMP production 

Completed the downstream process development of 8 recombinant proteins, scaling from 2L process to 200L process 

Transferred 4 monoclonal antibody projects from foreign factories to the Shanghai GMP factory, and led the team members to complete multiple batches of 500L and 2,000L GMP production 

Senior scientist of CS & T Department during Boehringer Ingelheim 

Worked at Boehringer Ingelheim, and Genor Biopharma 

M.S. of East China University of Science and Technology

15 years of IT experience, the main achievements including the building of agile product team, e-commerce, digital construction, as well as IT strategic planning and management 

Gile development advocate and global architect for the Chinese team, serving as a leader of multiple teams during Dow Chemical 

Head of IT Department, responsible for taking over and transferring the e-commerce development team of the US branch, ERP team and all IT solutions for the business counterparts of the domestic company during WuXi AppTec 

Senior director of IT Department, build a new IT team for application and solution in one and a half years from scratch during WuXi Diagnostics 

Director of IT Department, build a new IT department, and promoted major projects such as e-DOC system implementation, OA upgrade to E9, BI platform construction, GCP system construction and CTMS system selection within a short period of time during Genor Biopharma 

Worked at Dow Chemical, WuXi AppTec, WuXi Diagnostics, and Genor Biopharma 

B.S. of Information Management and Information System at Tongji University, M.S. of Management Information System at Tongji University