Back to Agenda
CMC Challenges for Breakthrough Therapies and Other Worldwide Accelerated Approval Programs
Session Chair(s)
Peter Richardson
Senior Quality Specialist, European Medicines Agency, Netherlands
Major regions have put in place regulatory processes to support development with the aim of delivering new medicines to patients by accelerated pathways. Reducing the clinical development timeline also impacts on the time available for manufacturing process development. Industry has proposed a number of areas where risk based approaches may be adopted to expedite delivery of a commercial product. In the EU, unmet medical need has utilized the PRIME procedure and designated more advanced therapy medicines for early access support. In the US a number of small and large molecules have also been given Breakthrough status. Experiences of how quality development / CMC has been a factor in delivering these products will be addressed in the session.
Learning Objective : Recognize regulatory mechanisms for early access for unmet needs; Identify how quality and manufacturing development falls on the critical path; Describe where there are opportunities to modify development and control strategies on a risk basis, e.g. using prior knowledge.
Speaker(s)
Christine Kolz, PHD
Associate Director, Global Regulatory CMC, Pfizer Inc, United States
Ronald Imhoff, MS
Senior Director, CMC Regulatory Affairs, Janssen Biologics, Netherlands
T. Venkateshwaran, PHD
Vice President and Global Head CMC Biologics, Medical Devices and Comb, Merck & Co., Inc., United States
Have an account?