Clinical Operations & Regulatory Affairs (CORA)
Core B, the Clinical Operations and Regulatory Affairs (CORA) is located at both the University of Pennsylvania and Columbia University and will serve as the translational ‘bench to bedside’ Good Clinical Practice resource for trials at Cornell and UCSF, and thereby provide the necessary infrastructure to carry out trials of Tregs and other cell based therapies for treatment of T1D. The mission of the CORA infrastructure will be accomplished by the following activities:
- To provide support for a Clinical Operations Center at Columbia University.
- To provide regulatory affairs support necessary for the filing and maintenance of physician sponsored INDs for the manufacturing of Tregs at the University of Pennsylvania.
- To provide support for monitoring and quality assurance, ensuring data integrity and compliance with applicable local and federal regulations.
- To carry out data management and analysis of the clinical protocols.
Successful translation of experimental cell therapies for T1D from concept through to clinical study demands a complex skill set of specialized scientific, technical and regulatory expertise. This expertise must be accompanied by a dedicated infrastructure that meets or exceeds the rigorous requirements and regulatory guidelines necessary to ensure patient safety, particularly in early trials. The Office of Human Research and the Clinical Trials Units at the University of Pennsylvania in conjunction with the Clinical Operations Center at Columbia University are uniquely and ideally suited to perform the core functions in support of the translational and clinical research plans of the JDRF Collaborative Center for Cell Therapy. The CORA provides an experienced team of physician scientists, and regulatory specialists with expertise in complex clinical trials involving T1D and cell based therapies. In addition, extensive preliminary data has established Standard Operating Procedures to permit efficient and safe evaluation of new cell based therapies for T1D according to Good Clinical Practices.