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About the Presentation:

Drug makers have used cutting-edge science to discover medicines, but they have generally manufactured these medicines using techniques that have not progressed much over the past decades. Accelerating the development and adoption of pharmaceutical manufacturing innovations is needed to keep pace with advances and evolution in drug clinical research and development. It is also a key component of long-term strategies aimed at addressing the underlying causes of product recalls and shortages.

One of today’s most important tools for modernizing the pharmaceutical industry is a process known as continuous manufacturing (CM). This approach transforms the traditional, step-wise manufacturing processes into a single system that’s based on modern process monitoring and controls. It enables a steady output of finished drug products as raw materials are continuously added to the closed system.

3D printing is another approach to advanced manufacturing. These methods are capable of manufacturing pre-determined 3D geometric structures of solid drug products in various shapes, strengths and distributions of active and inactive ingredients. This approach provides a unique opportunity to produce medicines that are tailored for individual needs of patients.

This presentation will provide an overview of these advanced manufacturing technologies, discuss the many steps the FDA is taking to help realize the potential of advanced manufacturing, and highlight success stories of successful implementation of advanced manufacturing which holds great potential for improving the quality assurance of drugs.

About the Speaker(s):

Thomas O’Connor, Ph.D.
Senior Chemical Engineer
Office of Testing Research, Office of Pharmaceutical Quality
CDER

Bio:

Dr. O’Connor is a senior chemical engineer in the Office of Testing and Research in the Office of Pharmaceutical Quality and is a member of CDER’s Emerging Technology Team. His responsibilities include managing regulatory science projects to support the implementation of emerging technologies in pharmaceutical manufacturing such as continuous manufacturing, 3D printing, and the utilization of modeling and simulation for quality assurance. Tom is a co-author of several papers and book chapters on continuous manufacturing and emerging pharmaceutical technology. He has participated in the review of several regulatory applications utilizing continuous manufacturing and is a member of the continuous manufacturing guidance working group.

Prior to joining the FDA, Tom worked at ExxonMobil Research and Engineering where he held job functions in both process analytical technology and process control. Dr. O’Connor earned a B.S. in chemical engineering from the Cooper Union and a Ph.D. in chemical engineering from Princeton University.

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