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CMC Challenges for Breakthrough Therapies and Other Worldwide Accelerated Approval Programs
Session Chair(s)
Peter Richardson, PhD
Head of Quality, Specialised Scientific Disciplines Department
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)
Taking the Leap: CMC Strategies for Supporting External Clinical Studies for a Breakthrough Therapy Designation Product
Christine Kolz, PhD
Pfizer Inc, United States
Associate Director, Global Regulatory CMC
CMC Challenges for Breakthrough Therapies
Ronald Imhoff, MS
Janssen Biologics, Netherlands
Senior Director, CMC Regulatory Affairs
CMC Challenges and Opportunities for the Expedited Development Program
T. Venkateshwaran, PhD
Merck & Co., Inc., United States
Vice President and Global Head CMC Biologics, Medical Devices and Comb
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