Dr. Han-Chung Cheng received his doctoral degree in industrial engineering and engineering management from National Tsing Hua University. Also, He received his master's degree in management science from National Cheng Kung University, and held several international certificates, such as PMP, NPDP.
Dr. Cheng has plentiful experience in the development of cell-based therapeutic product and management of biotechnology companies. He was the general manager of a listed stem cell company in the biomedical park. During his tenure, he led the development of a new stem cell drug in a clinical trial for liver cirrhosis/fibrosis (GXHPC1). Through early industry-academia cooperation, technology transfer, station in the Hsinchu Biomedical Park, and establishment of a clinical level laboratory in compliance with GTP, he helped the former company to get GXHPC1 certification of Biotech and New Pharmaceutical Development Act. He also settled the process of GXHPC1(including efficacy tests, safety tests, and CMC data establishment), and then promoted the product into the preclinical and clinical trials, Moreover, he is familiar with regulations of ISO 9001, ISO 17025 and GTP quality systems. In the later stage of his early working period, he hosted a development project of healthy food supplements which can increase endogenous stem cell numbers and prolong the lifecycle of stem cells through enhancing the telomerase activity.
Vice General Manager,Head of R&D
Dr. Tu graduated from National Taiwan University with major in Molecular and Cellular Biology. During his postdoctoral research in Surgery Department of National Taiwan University Hospital, he is specialized in the studies of adipose-derived stem cells and amnion stem cells for disease of liver fibrosis/cirrhosis, and gained a lot of experience in establishment of regenerative biosafety level 2 laboratory. Dr. Tu has been involved with new chemically defined stem cell culturing and conditioned medium R&D at ITRI, a leading biomedical R&D institution in Taiwan. He also ever took part in TFDA GTP-inspection and new stem cell drugs IND for clinical trials in former company. His expertise includes stem cell drugs development, design and manufacturing, scale-up and process development etc., especially focus on regulatory affairs of clinical trials compliance with GLP, GTP and PIC/S GMP. He is responsible for MitoCell and MitoBio CMC-related activities, including development and manufacturing of drug substance and drug product, to support preclinical development through supplies for clinical phases. He led an intensive R&D team to get the MitoCell certification from Biotech and New Pharmaceutical Development Act of Ministry of Economic Affairs, R.O.C. Now, MitoCell are prepared with CMC data and ready for clinical trial I. Furtheremore, Dr. Tu also led his team in development of isolation, scale-up, and cryopreservation process of mitochondria products for augment therapy and builds an innovative mitochondria function analysis platform to assess cell drugs quality and to apply in preventive medicine.
Stem Cell R&D Project Manager
Dr. Kuo-Wei Hsueh received his doctoral degree in Aging Medicine Program from China Medical University and his postdoctoral research experience in Hualien Tzu Chi Hospital. His expertise is in the development of small molecule drugs for the amyotrophic lateral sclerosis and in the field of regenerative medicine including culture of stem cell and the development of cell products for clinical applications.
Product Development Project Manager
Dr. Chih-Kai Hsu received his doctoral degree in Biomedical Sciences from Chang Gung University and his postdoctoral research experience in National Health Research Institutes. His expertise is in the field of immunology, respiratory system, and regenerative medicine and 3D bioprinting of stem cell applications.
Product Research Project Manager
Dr. Shun-Chieh Yang received his doctoral degree in Biochemistry and Biotechnology from Chung Shan Medical University and his postdoctoral research experience in National Health Research Institutes. His expertise includes Chinese herbal medicine extraction, establishment and validation of animal models for efficacy, and establishment of cell platform for product development.