Running the Virtual R&D Model

A company created to advance a novel cell therapy from the academic environment to GMP batch manufacture and first-time-in-man studies, and understand commercialization potential.

C2C provided a Chief Scientific Officer and Chief Medical Officer, CMC, Clinical, Regulatory and Project Management and successfully prepared a pre-CTA data package which was presented to Health Canada.

C2C has maintained technical oversight for process development, optimization and stability studies of the proposed finished product, GMP training and documentation support (SOPs, methods).  C2C also continues in its role as an embedded executive reporting directly to Board management and maintaining responsibility for strategic development and clinical trial design.