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Clinical trials in China: unlocking the potential of advanced therapies

In recent years, China has become an important player in the field of advanced therapies by increasing its focus on cutting-edge innovations and international collaborations. Immuno-oncology, Vaccines, Cell & Gene, RNA, and other therapies all thrive in this environment. With a rich patient population, strategic investments in research infrastructure, a more streamlined supportive regulatory environment, and a vast talent pool, China has become an attractive destination for international biotechs and pharma companies seeking to unlock the potential of advanced therapies.

What are the strengths of China in advanced therapies? How can we tackle potential dilemmas when conducting clinical trials of advanced therapies in China? What are the current opportunities and future challenges? We would like to invite you to join us at this webinar to gain a deeper understanding of China by discussing topics on the current environment, market potential and synergistic advantage for conducting clinical trials of advanced therapies in China.

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Yi Zhang

Yi Zhang

Director, Biological Cell Therapy Center, The First Affiliated Hospital of Zhengzhou University

Yi ZHANG, Zhongyuan Scholar, Tier-2 Professor, Doctoral Supervisor, Academic Vice President of Zhengzhou University College of Medicine, Head of Biological Cell Therapy Center/Biological Immunotherapy Department of The First Affiliated Hospital of Zhengzhou University. He has been engaged in basic research and clinical application of cancer immunotherapy for more than thirty years. He has received a PhD in tumor immunology from the KU Leuven, Belgium. He was a postdoctoral fellow at the Ludwig Cancer Research, a research assistant professor at the University of Chicago, and an assistant professor at The Medical University of South Carolina. He is the Deputy Director of State Key Laboratory of Esophageal Cancer Prevention and Treatment, Henan Province Key Laboratory of Tumor Immunology and Biological Therapy, and Henan Provincial Center for Tumor Immunotherapy Research and Engineering.

Since 2015, he has taken 43 immunotherapy-related clinical trials. He has presided over fund projects initiated by the National Cancer Institute (NCI), American Cancer Society (ACS) and the National Institutes of Health (NIH). After returning to China, he has led the team to undertake 37 projects of the National Natural Science Foundation of China and 5 key projects of the Special Foundation for National Key Research and Development Project of China. He has published more than 300 papers, with 232 of them being published in reputable SCI journals. With nearly 10,000 citations, he has achieved recognition as a Highly Cited Researcher in China and consistently ranks among the top 100,000 scientists worldwide. He was an esteemed member of the editorial boards, including widely recognized journals such as J Hematol Oncol , Biomarker Research, Front. Cell Dev. Biol.,Asia Pac J Clin Nutr.,Cancer Control, Front Oncol., and over 10 prominent Chinese core journals. In addition, he has successfully applied for over 30 patents related to national cancer therapy, with 14 of them being granted authorizations and 7 resulting in actual transformations. The cumulative value of these transformations has surpassed 80 million Yuan.

He led the team to win the first prize of Henan Provincial Natural Science Award, China Anti-Cancer Association Science and Technology Award, Chinese Medical Science and Technology Award and Overseas Chinese Contribution Award. He also served as Chairman of Committee of Tumor Immunology and Biotherapy, Chinese Society for Immunology, Vice Chairman of The Cancer Biotherapy Special Committee of Chinese Anti-cancer Association, Deputy Chairman of China Committee of Quality Management and Research of Cell Therapy, Vice Chairman of Chinese Society for Biological Therapy in Research-oriented Hospitals, Vice Chairman of Chinese Society for Biophysics, Infection, and Immunology, Chairman of Henan Anti-Cancer Association/Tumor Immunotherapy Special Committee of Henan Immunology Association, as well as Henan Cell Industry Alliance.

Angela Men

Angela Men

Chief Medical Officer, Zhejiang Haichang Biotech Co., Ltd.

Ph.D. in Pharmaceutical Science, Virginia State University. Clinical Medicine of Tianjin Medical University/Resident Physician at the Second Hospital of Tianjin Medical University.

Previously served as a Senior, Special Approving Officer and Head of the Drug Approval Team of the US FDA Center for Drug Approval.

Xiaoye He

Xiaoye He

Head of Medical & PV, Novotech China

MD & PhD, Internal Medicine, Fudan University; 13+ years of clinical practice as senior attending physician with rich clinical experience; About 9 years industry journey in global CRO with rich experience in medical support such as R&D strategy consulting, protocol design deliberations, and medical monitoring for multiple Phase I ~ IV global and local clinical trials; Over 5 years management experience of leading APAC and China medical team; Extensive clinical trial experience in several therapeutic areas, including respiratory, endocrinology and rare diseases, etc.

Charley Sha

Charley Sha

Head of Regulatory Affairs, Novotech China

Graduated from Beijing University of Chinese Medicine with a master’s degree; More than 13 years regulatory affairs experience in multinational pharmaceutical company and CRO; Extensive experience in drug clinical trial applications, marketing applications, regulatory maintenance during clinical development and post-marketing stage, HGRAC-related affairs; Experienced in medical device marketing applications and regulatory intelligence; Previously worked as RA at Novo Nordisk, Ferring, Janssen and Pharmanet.

Arsalan Arif
moderator

Arsalan Arif

Founder & Publisher, Endpoints News

Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.

Anshul Mangal
moderator

Anshul Mangal

President & General Counsel, Project Farma

Anshul Mangal is President of Project FARMA and Precision ADVANCE. Anshul founded and grew PF into a leading global biologics and advanced therapy engineering consulting firm. Under Anshul’s leadership, PF has partnered with over 100+ therapeutic innovators, developed state-of-art manufacturing facilities for complex biologics and pioneered the industrialization of advanced therapies including many commercially approved cell and gene therapies. PF was acquired by Precision Medicine Group in 2020 to be the cornerstone of Precision ADVANCE. ADVANCE is a collection of Precision's services uniquely focused on the complexities of research and clinical development, regulatory, manufacturing, and commercial needs to successfully bring an advanced therapy to market. In addition, Anshul is an investor, board member and advisor at several biotech organizations. Prior to PF, Anshul was a patent litigator at Jones Day and a consultant at Morgan Stanley & Discover Financial Services.