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Tuesday, June 26 • 8:00am - 9:15am
#214: CMC Challenges for Breakthrough Therapies and Other Worldwide Accelerated Approval Programs

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-567-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.


Peter Richardson, PhD


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

CMC Challenges for Breakthrough Therapies
Ronald Imhoff, MS

CMC Challenges and Opportunities for the Expedited Development Program
T. G. Venkateshwaran, PhD

avatar for Ronald Imhoff

Ronald Imhoff

Senior Director, CMC Regulatory Affairs, Janssen Biologics
Ronald Imhoff is senior director of global regulatory affairs - CMC at Janssen based in Leiden, The Netherlands and is responsible for leading a global team of regulatory affairs-CMC professionals. His team provides strategy for multiple biological products and vaccines at all stages... Read More →
avatar for Christine Kolz

Christine Kolz

Associate Director, Global Regulatory CMC, Pfizer Inc
Christine is an Associate Director of Regulatory CMC, with 20 years of experience at Pfizer, responsible for developing and executing regulatory CMC strategies for a portfolio of small molecule products spanning early clinical phases through registration. Christine completed an NIH... Read More →
avatar for Peter Richardson

Peter Richardson

Head of Quality, Specialised Scientific Disciplines Department, European Medicines Agency (EMA)
Dr Richardson is a pharmacist, with a Ph.D. in pharmaceutics from The Queens University, Belfast. He worked in industry in the area of formulation research and on drug delivery and controlled release systems for small and large molecules. He has worked for the UK MHRA as a pharmaceutical... Read More →
avatar for T. Venkateshwaran

T. Venkateshwaran

Associate Vice President and Global Head CMC Biologics, Medical Devices and Comb, Merck & Co., Inc.
T.G. Venkateshwaran (TG) currently serves as an associate vice president - Chemistry, Manufacturing & Controls Biologics and Combination Products, GRACS,Merck. TG joined Merck in November 2015 and has 18 years of pharmaceutical industry experience in R&D, quality, regulatory and manufacturing... Read More →

Tuesday June 26, 2018 8:00am - 9:15am EDT
Room 253C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  10: RegCMC-Product Quality, Session