Regulators, Industry Agree That Frequent Communication Is Key In Developing Breakthrough, PRIME Therapies

There was agreement among regulators and the pharmaceutical industry that transparent and open communication will unlock the doors in expediting the development of advanced regenerative products such as cell therapies and vaccines for rare diseases approved under the US Food and Drug Administration’s breakthrough designation program and the European Medicines Agency’s PRIME program.

These views were expressed at a recent workshop on accelerated development of advanced therapy products. The workshop report was...