While there are currently over 1400 clinical cell and gene therapy programs, trial recruitment, raw material supply chains, and low-yield processes are just some of the multiple challenges facing the industry. The recent pandemic revealed that with the proper framework, a drug product can be developed, clinically tested, and produced for hundreds of millions of patients in less than a year. What lessons can we apply from this effort for AAV development and production? How can we rethink regulatory filing strategy? And why does the cell and gene therapy arena so urgently need these learnings?