Advancing Cell And Gene Therapy Clinical Development In 2023

As an increasing number of cell and gene therapy products near clinical trials—a critical step in commercializing advanced therapeutics—it is important to optimize processes and drive greater efficiency, mitigate risk, and improve patient outcomes. Clinical development is a complex endeavor and the path to market requires careful consideration of factors ranging from chemistry, manufacturing, and controls (CMC) and regulatory strategy to study design, CRO selection, and clinical trial diversity.

This white paper is based on a wide-ranging clinical development discussion moderated by Teresa Pokladowski, Regional Vice President of Clinical Business Solutions at Precision for Medicine. Examine considerations on bringing together the CMC and clinical teams early in the development process to address potential issues, promoting transparency and communication with regulators, and increasing patient access and diversity in clinical trials to ensure the development of safe, effective medications that can benefit a wide range of patients.