James Tsai, Ph.D., boasts a remarkable track record of success. He has successfully founded and led Deesse Vivante Biomed and Unicocell Biomed to a successful public listing and OTC listing. Furthermore, he has achieved significant accomplishments in the field of clinical product development, spearheading human clinical phase I/IIa trials for allogeneic adipose mesenchymal stem cell therapy for degenerative joint diseases, with TFDA IND approvals at Chang Gung and Tri-Service General Hospitals.
In the realm of GXP, he established Taiwan’s first cell therapy PICS/GMP pilot factory and the country’s first early-stage cell therapy GTP facility, earning recognition from Japan’s PMDA for overseas CPC (cell processing center). Additionally, he obtained TAF ISO/TES 17025 certification in cell therapy and collaborated with multiple hospitals on special permit applications.
His IMPAC award in large-scale production is a testament to his achievements. He developed a semi-automated production line for adherent MSCs, obtained FDA DMF (Drug Master File) certification, and invented the first Class II medical device for automated filling and sealing of cell storage containers.
Dr. Shen is a dedicated researcher in the fields of stem cells and regenerative medicine. His work focuses on the reprogramming of somatic cells, investigating key mechanisms of cell differentiation and transformation. He has published 90 journal articles, cited nearly 3300 times. His research areas include:
Using cell reprogramming techniques to develop diabetes cell therapy strategies.
Applying patient-derived induced pluripotent stem cells to study metabolic diseases and develop novel glucose-regulating drugs.
Employing 3D tissue imaging and metabolic reprogramming analysis to explore pancreatic tissue transformation mechanisms.
Developing gene and cell therapy strategies for pancreatic cancer treatment.
Outside of research, Dr. Shen has pursued legal and technology management studies at Taiwan University and National Chengchi University. He has also been involved in various academic roles and served as an executive director. He played a key role in establishing the Taiwan Stem Cell Society and served as its first secretary-general. Additionally, he held the position of president from 2017 to 2021 and is currently an executive director of the Taiwan Cell Therapy Association and the Regenerative Medicine Society, actively involved in promoting legislation and policies related to cell therapy and planning physician training courses. Since January 2019, he has been leading the Biomedical Translation Core Facility, providing technical platforms for the biotechnology research community. From September 2019, he has served as the acting CEO of the Academia Sinica Biomedical Translation Research Center’s Innovation and Incubation Center, supporting the growth of Taiwan’s biotech startups in the national biotech research park.
Edward Chen是一位資深研究科學家,在新藥開發發領域擁有超過十年研發的成功經驗。Edward在國立台灣大學取得毒理學博士學位,專精於腫瘤學以及各種人類幹細胞,如MSC、ESC、iPSC和癌幹細胞研究。轉換跑道至生技製藥產業後,Edward致力於新藥開發、體外毒性評估、動物疾病模型建立、PK/PD動物實驗,並與全球的臨床前CRO公司密切合作。Edward熱愛挑戰,渴望將自己的專業知識貢獻給貴組織。
Patryk Chojecki is an up-and-coming professional with a master’s degree in International Affairs from National Chengchi University. In the early stages of his career, Patryk gained valuable experience as a Research Assistant at Academia Sinica, making significant contributions to projects related to the US government. Additionally, he served as a Contributing Researcher at the Taiwan Architecture & Building Center (TABC), where he forged partnerships with European companies and authored articles on governance, the economy, and ESG investing. Patryk’s passion for economics, politics, and his growing interest in future startup ventures reflect his potential to make meaningful contributions to the global biotech landscape.