In the third part of this five part series, Marc Wolman, labs manager, biopharmaceutical at PPD Laboratory services, GMP Lab, & Jurgen Hannig, senior principal scientist at PPD Laboratory services talk about new analytical tools for cell & 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.