Dr. Wannhsin Chen

Dr. Wannhsin Chen is a distinguished scientist and leader in stem cell research and regenerative medicine, with more than 30 years of experience spanning fundamental stem cell biology, translational research, therapeutic product development, and regulatory advancement. She currently serves as President of the Taiwan Association for Cellular Therapy (TACT) and Vice President & Chief Technology Officer of Hexun Biosciences Co., Ltd., where she leads innovative programs in cell therapy and extracellular vesicle (EV)-based therapeutic development.

Dr. Chen received her Ph.D. through the joint program of Academia Sinica and the National Defense Medical College in Taiwan. After completing her doctoral training, she joined the Biomedical Engineering Research Laboratories at the Industrial Technology Research Institute (ITRI), where she played a pioneering role in advancing stem cell science and translational biotechnology in Taiwan. During her tenure at ITRI, Dr. Chen led the establishment of Taiwan’s first human embryonic stem cell (hESC) lines, laying a critical foundation for pluripotent stem cell research in Taiwan. She also contributed to the development of multiple pluripotent stem cell culture and differentiation platforms, such as feeder-free culture system and iPSC platform, etc.

In the field of regenerative medicine, Dr. Chen has been deeply involved in bridging laboratory discoveries to clinical applications. She led the development of a clinical-grade mesenchymal stem cells (MSCs)-based investigational product for acute myocardial infarction, including GTP-compliant manufacturing process development, regulatory documentation, and submission to the Taiwan Food and Drug Administration (TFDA) for clinical trial approval. Following TFDA approval and technology transfer, she continued to support the partner company in conducting the clinical trial.

In 2024, Dr. Chen transitioned to industry leadership as Vice President and CTO of Hexun Biosciences Co., Ltd. In this role, she oversees research strategy, product development, regulatory submissions, and clinical translation. Under her leadership, a clinical-grade MSC product targeting vascular diseases has entered patient enrollment, and two additional investigational programs have received U.S. FDA authorization, with plans to initiate trials in Taiwan upon TFDA approval.

Dr. Chen has been actively engaged in the international cell therapy community since the early stages of her career, participating in activities of the International Society for Cell & Gene Therapy and the Asia Cellular Therapy Organization (ACTO), where she previously served as an industry member representative. Through decades of translational research and product development, she has developed a strong appreciation for the importance of regional collaboration. In recent years, while advancing cell therapy programs and navigating multi-jurisdictional regulatory pathways, Dr. Chen has recognized that closer cooperation among Asian countries can significantly accelerate clinical translation. She believes that harmonizing regulatory frameworks, leveraging complementary national strengths, and fostering cross-border scientific and industrial partnerships will enable Asia to achieve faster and more impactful progress in regenerative medicine.

Through ACTO’s organizational framework, Dr. Chen aims to promote regulatory dialogue, technical collaboration, and strategic alignment among Asian countries. By integrating diverse expertise across research, clinical medicine, manufacturing, and regulation, she envisions building a coordinated regional ecosystem that accelerates the realization and responsible advancement of clinical applications of cell therapies throughout Asia.

Dr. Chen has published more than 40 scientific papers and holds over 20 granted patents worldwide. In addition to her scientific achievements, she is a founding member and current President of TACT, a founding member of the Taiwan Society for Stem Cell Research (TSSCR), a certified instructor for Ministry of Health and Welfare (MOHW)-approved cell therapy physician training programs, and a former member of the TFDA Regenerative Medicine Consulting Committee, where she contributed actively to policy development and regulatory science. Through her integrated roles in scientific innovation, industrial translation, and regulatory policy, Dr. Chen remains committed to advancing safe, effective, and globally harmonized cell therapy development. She believes that strong collaboration across Asia—supported by ACTO’s leadership and collective expertise—will unlock the full therapeutic potential of cellular therapies for patients throughout the region and beyond.

Dr. Wannhsin Chen

whsin.chen@hexunbio.com