Our Team
Aisha Khan
Co-Owner/President/Chief Scientific Officer
Aisha Khan is a highly accomplished cell biologist with expertise in cell manufacturing, regulatory affairs and business development. A proven executive with more than 20-years professional experience in developing cellular therapy products, Aisha’s expertise includes mesenchymal stem cells, cardiac progenitor stem cell development, and cell and vaccine manufacturing.
Aisha has managed and directed all aspects of cutting-edge clinical research operations focused on developing various types of research and manufacturing a wide variety of cellular products. She also serves as a subject matter expert and consultant for many national and international organizations, providing performance optimization, clinical operations, budgeting, planning, forecasting and strategic guidance for innovative programs that furthers clinical research and development through technology.
In addition, Aisha possesses extensive experience in policy development, training curriculums and standard operating procedures, establishing high-quality clinical and laboratory operations that maintain quality assurance and compliance with FDA, CMS, ICH, FACT, CLIA, AABB and other organization regulations.
With more than 18-years of hands-on experience overseeing clinical trials, and establishing and managing GMP laboratories at world-class research facilities throughout the United States and abroad, Aisha currently serves as the executive director of clinical research and laboratory operations at the University of Miami’s Interdisciplinary Stem Cell Institute and the Miami Project o Cure Paralysis. She is also currently overseeing phase I, II and III cardiac, pulmonary, neurology, cancer, ophthalmology and spinal cord injury clinical trials
Aisha has authored over 40 INDs and multiple Drug Master Files, obtaining approvals, and establishing multiple cellular therapy labs, as well as authored over 100 scientific publications. She has developed over 20 cellular and acellular biological products and obtained more than $10 million in funding from the National Institutes of Health and Department of Defense at the University of Miami to support basic research, GLP and GMP cell therapy strategies and manufacturing.
Xiumin Xu, MS. MT
Co-Owner/CEO/Regulatory Affairs
Xiumin Xu earned her M.S. in Science with Honors of Academic Merit for Academic Excellence from the University of Miami School of Business. She is a highly experienced scientist with additional extensive background overseeing business operations and management. Xiumin has more than 20 years of professional experience including entrepreneurial and business management, board directorship experience, strategic planning, cGMP manufacturing, regulatory affairs compliance, and clinical trials monitoring. Specifically, Xiumin has led and worked with international teams of scientists and investors in cellular therapy product development, process scale-up and manufacturing of various type of cells and vaccines for phase I, II, and III clinical trials.
In seven years of experience as an executive officer of Assureimmune LLC, Xiumin has led research & development of tissue/cellular products for services or commercialization.
In addition, Xiumin is highly experienced in establishing top-quality management systems to ensure compliance with regulatory requirements of FDA, ICH, CMS, CLIA, FACT, AABB and other regulatory organizations. Xiumin also serves as a consultant, providing expert guidance and skills in the cellular therapy field including but not limited to overseeing cGMP facility planning, budgeting, build up, management, development of cellular therapeutic product pipelines, and obtainment of IND approvals for multiple clinical trials. Over the years, Xiumin has brought her robust first-hand experience in the regulatory area into establishing multiple cGMP manufacturing facilities for developing various cellular therapeutic product pipelines. Xiumin has overseen multiple clinical trials and published several pioneering clinical trial studies with mesenchymal stem cell in JAMA, Diabetes Care, EBioMedicine, Stem Cells Translational Medicine, Cytotherapy, etc. Xiumin has authored multiple INDs and Drug Master Files which have obtained FDA approval.
Currently, Xiumin also serves as the Director of the cGMP Advanced Cell and Biologic Products Manufacturing Facility (cGMP Facility) at the Diabetes Research Institute (DRI), University of Miami Miller School of Medicine.