Cell & Gene Unscripted: Pre-Clinical

While meaningful modernization is happening in the pre-clinical regulatory landscape, opportunities remain for greater global regulatory harmonization and earlier, more effective engagement between sponsors and regulators.

In this episode of Cell & Gene Unscripted, Parexel's Head of Cell & Gene Therapy and Early Phase, Chris Learn, Ph.D. M.B.A., P.M.P., and Principal Regulatory Consultant Liz Spehalski, Ph.D., look at opportunities for regulators to continue to improve processes, especially when it comes to precision therapies like gene editing. They also dive into pre-IND meetings, and how sponsors can set themselves up for success.