Moving the Implementation of Digital Technologies in Pharmaceutical Manufacturing Forward

Industry 4.0 encompasses a wide range of technologies including the industrial internet of things (IIOT), artificial intelligence (AI), and digital twins that have the potential to significantly increase the efficiency and robustness of pharmaceutical manufacturing. The implementation of Industry 4.0 technologies within the context of pharmaceutical manufacturing especially for applications that impact the control of the process or quality decision making may be subject to additional uncertainty in determining how the technologies fit within existing regulatory approaches. The presentation will describe FDA’s manufacturing science research programs that aim to proactively address such regulatory uncertainties. Case studies on the application of digital twins and advanced process control will be highlighted.
Presented by Thomas O’Connor, Scientist at FDA


Dr. O’Connor is a senior chemical engineer in Division of Product Quality Research in the OPQ’s Office of Testing and Research and is a member of CDER’s Emerging Technology Team. His responsibilities include coordinating and directing regulatory science projects to support the implementation of emerging technologies. His team’s independent research has centred on advancing the utilization models in pharmaceutical development and manufacturing. He originally joined the FDA as chemistry reviewer and has served as a primary and secondary reviewer for NDAs and ANDAs. Tom is a co-author of several papers and book chapters on continuous manufacturing and emerging technology. He has consulted on several regulatory applications utilizing continuous manufacturing and is one of the government liaisons to the US Pharmacopeia expert committee on continuous manufacturing.
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. He is an experienced practitioner of advanced process control techniques including statistical process control and holds patents related to the development of statistical monitoring systems for industrial plants. Dr. O’Connor earned a B.S. in chemical engineering from the Cooper Union and a Ph.D. in chemical engineering from Princeton University.
 
Followed by an Industry Perspective by Mark Demesmaeker, Head of Data Analytics at Sartorius Stedim Biotech

Dr. Mark Demesmaeker is Head of Data Analytics, Sartorius Stedim Data Analytics (SSDA), part of Sartorius-Stedim Biotech. Mark joined SSDA in 2018. He is a life science professional with over 20 years of experience in pharmaceutical R&D, analytics and business intelligence, and has held leadership positions at the World Health Organization, Spotfire, TIBCO Software, IBM, and Integrated Clinical Systems. Most recently, he served as Vice President, Clinical & Translational Analytics at PerkinElmer Informatics. Mark holds a Ph.D. in drug metabolism and pharmacokinetics from the German University of Kiel.
And followed by Chris McCready, Lead Data Scientist at Sartorius Stedim Biotech

Chris McCready is Principal Research Scientist with Sartorius Corporate Research with chemical engineering degrees from University of Waterloo and McMaster University. Before joining Umetrics (aquired by Sartorius) Chris worked in Oil & Gas with Petro-Canada and in power systems with United Technologies developing and implementing advanced process control strategies, providing dynamic simulation packages and systems design. Presently Chris is Research Lead in development of next generation biopharmaceutical analytics and automation based on mechanistic modeling.
Sponsored by Sartorius Stedim Data Analytics

Sartorius Stedim Data Analytics develops software under the Umetrics Suite for design of experiments and multivariate data analysis, for the individual user as well as for on-line continuous and batch processes.
The stability of Umetrics founding principles and the flexibility of our services enables us to promote every way of implementation of design of experiments and multivariate technology that our clients require. We are committed to supporting our clients in their mission to take control over their data flow, by conveying our advanced expertise in advanced data analytics technology. Our mission is to provide comprehensive solutions which create value from data, enabling better decision making and process excellence.
Our market exists in every sector of industry where there are manufacturing, testing or data analysis activities, but historically the highest number of collaborations has been in the life science, semiconductor and chemical industries. Umetrics is since April 2017 owned by Sartorius Stedim Biotech AS.