Use of Computational Modelling in Specification Setting and Establishing Control Strategy

15th July 2019 | 10.00 am EST | Thomas O'Connor, Scientist at FDA and Sean Bermingham, Head of Formulated Products at PSE Ltd |WATCH FOR FREE

The proportion of scientific evidence supporting medical product regulatory applications derived from modeling and simulation studies is expected to continue to grow into the future. In the Quality by Design framework, mathematical models can and have be utilized at every stage of product development and manufacturing. Thus, the regulatory assessment of product quality models is not unprecedented but the frequency, types of models, and applications are evolving.  This evolution is being driven in part by the adoption of advanced manufacturing such as continuous pharmaceutical manufacturing.

The ICH Quality Implementation Working Group points to consider document categorizes models based on the model’s contribution in assuring the quality of the product. Models utilized as part of the control strategy are typically categorized as either high or medium impact depending on the role of the model. Minimal guidance though is provided on model validation. A recent standard (ASME V&V 40) outlines a process for making risk-informed determinations as to whether a model is credible for decision-making for a specified context of use. The presentation will discuss how the framework could be used to develop model validation plans and support regulatory assessment using case studies from both drug substance and drug product manufacturing.

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.

And Sean Bermingham, Head of Formulated Products at PSE Ltd

Sean joined PSE in 2000, and has been Head of PSE’s Formulated Products business unit since 2010. Prior to this role, he was PSE’s Global Head of Consulting. Throughout his career at PSE he has acted as a Principal Consultant in over 30 crystallization and solids processing projects.

In his current role, he is responsible for strategic business development, software product development and services delivery for the pharma, food, consumer good, specialty & agrochemical industries.
Sean is a leading figure in the development and adoption of mechanistic model-based tools for increasing R&D efficiency and managing risk in areas ranging from clinical trials to tech transfer and operations. He is the driver behind QbD 2.0, which focuses on improving the efficiency of QbD by reintroducing the “sound science” element of the original QbD definition.

He is one of the founders of the Systems-based Pharmaceutics Alliance with Eli Lilly, GSK, Pfizer and Roche. Sean is the lead for the £20.4m ADDoPT “Digital Design” Project with partners including AZ, BMS, GSK & Pfizer.
Sean is a Chemical Engineer with an MSc in Chemical Engineering and a PhD in crystallization from Delft University of Technology and an Executive MBA from Imperial College London.

About Process Systems Enterprise Ltd

PSE is the world’s foremost provider of Advanced Process Modelling software and services for digital design and operation to the process industries. Companies apply digital design to explore the process decision space rapidly and effectively, in order to reduce uncertainty and make better, faster and safer formulation, process design and operating decisions.

PSE provides the gPROMS FormulatedProducts modelling suite for optimising the formulation and manufacture of drug substances and drug products using mechanistic process and material models of unit operations – such as crystallization, spray drying and granulation – combined with in-vitro/vivo product performance models.

Use of PSE’s technology and services results in faster innovation, more rapid formulation screening, improved process and product designs, enhanced operations, reduced risk, more effective R&D and experimental campaigns and better capture and transfer of corporate knowledge across the organisation.

The company is pioneering the emerging science of Systems-based Pharmaceutics with Eli Lilly, Pfizer, GSK and Roche, and is the leader of the £20.4m digital design ADDoPT project.

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