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DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.

CMC Challenges for Breakthrough Therapies and Other Worldwide Accelerated Approval Programs

    Session Chair(s)
      Peter  Richardson, PhD

      Peter Richardson, PhD

      • Head of Quality, Specialised Scientific Disciplines Department
      • European Medicines Agency (EMA), United Kingdom
    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 : understanding the challenges and opportunities for expedited development program
      T. G. Venkateshwaran, PhD

      CMC Challenges and Opportunities for the Expedited Development Program

      T. G. Venkateshwaran, PhD

      • Associate Vice President and Global Head CMC Biologics, Medical Devices and Comb
      • Merck & Co., Inc., United States
      Ronald  Imhoff, MS

      CMC Challenges for Breakthrough Therapies

      Ronald Imhoff, MS

      • Senior Director, CMC Regulatory Affairs
      • Janssen Biologics, Netherlands
      Christine  Kolz, PhD

      Taking the Leap: CMC Strategies for Supporting External Clinical Studies for a Breakthrough Therapy Designation Product

      Christine Kolz, PhD

      • Associate Director, Global Regulatory CMC
      • Pfizer Inc, United States