Yen-Michael Hsu is a distinguished board-certified clinical pathologist and blood bank physician, currently serving as a Processing Laboratory Inspector at the Foundation for the Accreditation of Cellular Therapy (FACT). With over a decade of experience in the field, Yen-Michael has honed his expertise in directing...
Yen-Michael Hsu is a distinguished board-certified clinical pathologist and blood bank physician, currently serving as a Processing Laboratory Inspector at the Foundation for the Accreditation of Cellular Therapy (FACT). With over a decade of experience in the field, Yen-Michael has honed his expertise in directing clinical immune effector cell and hematopoietic stem cell laboratories. His role at FACT involves ensuring that laboratories adhere to rigorous standards, including Common Standards and specialized protocols for Immune Effector Cells, Hematopoietic Cell Therapy, and Cord Blood. His keen eye for detail and extensive knowledge of cGMP regulations are instrumental in maintaining compliance with FDA, CLIA, and CAP guidelines.
Yen-Michael's leadership experience is underscored by his successful operationalization of two cGMP cellular therapy facilities, where he played a pivotal role in translating innovative research into clinical applications. His work spans the entire spectrum of early-stage translational research, from research and development (R&D) to Investigational New Drug (IND) submissions. This comprehensive understanding of the regulatory landscape, combined with his practical experience in clinical chemistry, hematopathology, and immunohistochemistry, positions him as a key figure in advancing cellular therapies.
In addition to his regulatory and operational expertise, Yen-Michael is well-versed in the complexities of the bone marrow microenvironment and hematopoiesis, which are crucial for developing effective therapies. His proficiency in utilizing mouse models for research further enhances his ability to contribute to the field of osteoimmunology and cell culture techniques. As a team leader, he fosters collaboration and innovation, driving projects that aim to improve patient outcomes through cutting-edge cellular therapies. Yen-Michael Hsu's commitment to excellence and his multifaceted skill set make him a valuable asset in the rapidly evolving landscape of cellular therapy.
