Accelerating cell and gene therapy (CGT) programs from investigator initiated trials (IITs) to IND submission requires CMC strategies that are designed to support both speed and regulatory confidence. Drawing insights from in vivo CAR-T, this session explores how CMC can act as a true enabler of IIT to IND acceleration, one of the most technically demanding and rapidly evolving CGT modalities. Using both viral and non viral delivery approaches, ProBio will discuss how early decisions in vector design, manufacturing strategy, analytical development, and quality control directly influence transduction performance, safety, scalability, and IND readiness.