Clinical and Regulatory Operations

The Clinical and Regulatory Operations team at Orca Bio leads the development and implementation of clinical trials while ensuring compliance with regulatory standards. Comprised of experts in clinical operations, translational research, and regulatory affairs, this team coordinates the execution of high-precision allogeneic cell therapy studies, evaluates biomarker research, and navigates the complexities of obtaining necessary approvals to advance innovative therapies aimed at transforming patient care. Their collaborative efforts facilitate the safe and effective testing of therapeutic products, ultimately aiming to improve outcomes for patients with blood and immune system disorders.