WuXi Biologics Forum Highlights Commercialization and Global Collaboration as Takeda, Hutchmed Executives Join GenScript ProBio’s GMP Facility Launch

Forum Name:Opening Ceremony of Shanghai Jinsrui Fuming Biotechnology Co., Ltd. GMP Facility for Antibody Protein Drugs & Viral Commercialization and Bio-pharmaceutical Elite Industry Forum

Forum Time:April 18, 2024 - April 19, 2024

Hosted by:Shanghai Jinsrui Fuming Biotechnology Co., Ltd, BioValley

Supporting Unit:"SciTech China" Biomedical Industry Science and Technology Service Group, Chinese Biopharmaceutical Association (CBA)

Schedule Framework

With 25 years of experience in the pharmaceutical industry, has successively completed global international multicenter clinical trials across multiple therapeutic areas, including oncology, immunology, gastroenterology, neurology and psychiatry, rare diseases, cell therapy, and more.The majority of the products responsible have currently been approved for marketing by the U.S. Food and Drug Administration (FDA) and the National Medical Products Administration (NMPA) in China, with over 80 small molecule and large molecule products submitted and approved in China.Currently serving as the Vice President of the company, fully responsible for pharmaceutical registration affairs in Greater China. Graduated from the Department of Chemistry at Lanzhou University with a Bachelor of Science degree, and obtained a Higher Education Certificate in Organizational Leadership from Harvard Business School in the United States between 2014 and 2015.

Dr. Karen Twu has successfully led more than ten CMC projects and was responsible for refining the CMC process development team, establishing a complete CMC system.Before returning to China, she served as the Chief Scientist at Novartis, deeply engaging in the operations of pharmaceutical R&D related departments, including DS SOURCING, formulation development, analysis, quality control, and regulatory submissions.She is one of the main contributors to the Phase II/III clinical project of the large-molecule new drug BEOVU (BROLUCIZUMAB).At the same time, she has participated in product launches and regulatory management at national and regional levels in multiple countries. Before joining Novartis, she worked at a start-up vaccine company, where she was involved in various aspects of work from research and development, production, testing to submission. She holds a bachelor's degree from National Taiwan University and a Ph.D. from the University of Texas at Austin; during her postdoctoral research at Stanford University Medical Center, she was awarded the U.S. National Institutes of Health doctoral fellowship. Later, she obtained a Master's degree in Business Administration from the NEELEY School of Business. She owns more than ten U.S. patents and publications and has been selected as a Jiangsu Province Double Innovation Talent and an innovation leading talent under the "Taihu Talent Plan."

Dr. Wang Liqun has rich professional technical and R&D management experience in the biopharmaceutical field in the United States and China. Before founding Neukio Biotherapeutics, he served as Vice President and Chief Technology Officer of Fosun Pharma, and President of Fosun Kite, a joint venture between Fosun Pharma and Kite Pharma in the U.S.In less than three years, led Fosun Kite to complete the technical implementation, registration clinical trials, and production of Yikaida, becoming the first CAR-T product approved for marketing by the China NMPA.

Dr. Wang Liqun has held key management positions at P&G, Bristol-Myers Squibb, AstraZeneca, and GlaxoSmithKline's R&D center in China for nearly 20 years, participating in and leading the development and translation of multiple new drugs. During his tenure as Chief Operating Officer at Cellular Biomedicine Group, he was fully responsible for company operations, production of cell therapy products, pharmacology, and clinical research, while also serving as the General Manager of the Stem Cell Division.

Zhou Jingmin is the CEO and co-founder of Whale Bio, with an undergraduate degree from Peking University, a Ph.D. from the University of Tsukuba in Japan, and a postdoctoral fellowship from the University of Tokyo.Zhou Jingmin is a member of the USP's 2021-2025 AAV Gene Therapy Expert Panel, which is responsible for developing USP standards for the design, manufacturing, quality control, and regulation of AAV vectors.After coming to the U.S., I started process development and GMP production of viral vector AAV at the Wistar Institute of the University of Pennsylvania and the Children's Hospital of Philadelphia (CHOP). Later, I entered the industry and continued to focus on the CMC (Chemistry, Manufacturing & Control) direction of AAV. Over the past 20 years, I have cumulatively participated in more than 10 FDA-approved AAV INDs and one AAV BLA (Luxturna). I have experienced three Nasdaq IPOs (Intrexon 2013, Spark 2015 & Prevail 2019) and two successful company acquisitions (Roche acquired Spark for $4.8 billion in 2019, and Eli Lilly acquired Prevail for $1 billion in 2021).

Founder, Chairman, and Chief Scientific Officer of Nanjing Beisiao Biotechnology Co., Ltd., Professor and Doctoral Supervisor at China Medical University, Ph.D. in Genetics from the Chinese Academy of Sciences, Postdoctoral Fellow in the Department of Biology at the University of Pennsylvania, and Assistant Researcher at École Normale Supérieure Paris. Originating from UPenn, CHOP, and Spark Therapeutics, the birthplace of the world's first approved AAV gene therapy. With over 20 years of experience in biomedical research and nearly 20 years of R&D and industrialization experience in advanced laboratories abroad. Has participated in the research, production, and quality control of more than 10 clinical gene therapy drugs.Once served as one of the main leaders involved in establishing the CMC platform for Spark Therapeutics' gene therapy company, and participated in the preparation of recombinant viral gene therapy drugs used in the first FDA-approved gene therapy drug (LUXTURNA, 2017) and the first CAR-T therapy (CTL019, 2017) in the United States.

Over 13 years of experience in strategy, pipeline, business development, strategic alliances, and commercialization in European and American multinational pharmaceutical companies in Europe, America, and China.Focusing on ophthalmology, the central nervous system, and fields such as hematology and immunology. Responsible for business development, strategic alliances, and international commercialization at Neurophth.

PhD in Biochemistry and Molecular Biology from the School of Life Sciences, Fudan University. After graduation, worked for various companies including Tellgen Life and Genechem.With years of experience in the development of IVD molecular diagnostic kits, discovery of new targets for cancer treatment, and the development and application of viral vectors. Served as the sub-project leader or main R&D personnel for major projects under the 863 Program, National Key Technology Research and Development Program, and Shanghai municipal projects, with twenty authorized invention patents.Led the establishment of GeneChem Group's Cell and Gene Therapy CDMO platform and served as the head. Joined Starlight BioHealth in 2022, responsible for vector development, production, and quality.

Graduated from Uni-Mannheim and Shanghai Medical University, conducted related professional research at UNC; held positions in Fortune 500 pharmaceutical enterprises such as Schering-Plough, Praxair, Fosun Pharmaceutical Group, and Shanghua Pharmaceutical Group, among other large domestic and international pharmaceutical companies, successively serving as COO, EVP, VP, and other roles in different departments. Possesses over 20 years of pharmaceutical expertise and industry management experience, with full-process drug development experience encompassing management operations, R&D, clinical management, marketing & commercialization across different institutions.In recent years, has focused on leading and participating in the development of several biologics antibody and cell therapy projects, co-authored multiple articles related to antibody target development, and applied for several domestic and international patents.

Previously held positions at renowned biopharmaceutical R&D and manufacturing companies such as中信国健, 维亚生物, and 天境生物, serving as Project Manager, Purification Manager, and Senior Manager of Downstream Process Development, among others.With nearly two decades of experience in protein purification and over a decade of project management experience, has successively led multiple projects that obtained clinical approvals in China, the U.S., and Europe. In recent years, has been deeply engaged in the process development of bispecific and trispecific antibodies, offering unique insights into the process development of complex antibodies.Currently employed at Chengdu Enmu Biotechnology Co., Ltd., as the overall head of CMC, responsible for CMC process development (upstream, downstream, and formulation) and quality analysis for multiple bispecific/trispecific antibody projects within the company. The first trispecific antibody project (First-in-class) that I independently led obtained IND approval from both China and the U.S. by the end of 2021.

Master of Science in Biotechnology Enterprise from Johns Hopkins University;Professional Engineer Certification (PE) in Chemical Engineering;With many years of professional experience, held key positions in Lilly, Baxter, Genentech, Bristol-Myers Squibb, Novartis, Henlius, Wuxi AppTec, IMPAX, etc.With rich consulting experience, having served Direct Biologics, Neurophth Therapeutics, TopAlliance, Toyobo CO, Tracon Pharmaceuticals, Catalent Pharma Company.Multiple successful cGMP facility validations in Asia, with multiple successful implementations of cGMP QMS;Founded and led QA/QC teams as well as CMC teams multiple times in the United States and Asia.Certified with authoritative certificates, such as Kaizen Lean Manufacturing and Six Sigma Green Belt Certification.

Assistant Vice President of Antibody Process Development & Production Department, with 20 years of experience in biologics CMC. Obtained a Master's degree in Biotechnology from Wuhan University in 2003. Served as a scientist and deputy director of the Biologics Development Department at Hengrui from 2004 to 2013. Acted as the head of the Development Center at Furen from 2013 to 2015. Joined GenScript in 2015 as the Director of the Antibody Process Development Department.As the project leader and core member, led dozens of biologics projects, including 4 BLAs, 2 Phase III, and over 20 INDs.

Graduated from Xi'an Jiaotong University in 2006. With fifteen years of experience in viral vector production and research and development,Participated in multiple process development projects for cell therapy viral vectors and successfully completed the registration submissions of 15 US-China projects., currently working at Shanghai Jinsrui Fuming Biotechnology Co., Ltd, responsible for the viral vector CDMO business.

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