The first segment of this five-part PPD Tech Talk series on A CMC Roadmap for Cell and Gene Therapies, Katherine Hanson, Ph.D., associate director at PPD Laboratory services, GMP Lab, discusses regulatory considerations for cell and gene therapies.
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.
Ron Scarboro, Azurity Pharmaceuticals, explains why real-world usability belongs at product definition and how post-launch feedback should guide drug formulation.
Gene manufacturing platforms, patient-centric formulations, contract services, packaging innovations, and sterile filling lines are in the spotlight at CPHI Milan 2026.