Key personnel and thought leaders
PSE employs a large group of domain and modelling experts in all verticals of the process industries. Our key consultants for Formulated Products are:
Sean Bermingham, PhD
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 and has acted as a Principal Consultant in over 30 crystallization and solids processing projects and is currently responsible for strategic business development, software product development and services delivery for the pharma, food, consumer good, specialty & agrochemical industries. 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.
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. This Alliance is developing and promoting a holistic approach to the development and optimization of drug formulations, drug manufacture processes and drug delivery. Sean is the lead for the £20.4m ADDoPT “Digital Design” Project with AZ, BMS, GSK & Pfizer, Britest, Perceptive Engineering, CCDC, STFC Hartree, U. Leeds, U. Cambridge and U. Strathclyde. In addition, he is a board member of CMAC, the Centre for Continuous Manufacturing and Crystallisation at Strathclyde University. Other notable involvements with academia include C-SOPS and RCPE.
David Slade, PhD
David is a Senior Consultant in the Formulated Products business unit at Process Systems Enterprise (PSE). His background spans a variety of disciplines including applied mathematics, mechanical and chemical engineering. He graduated from the University of Leeds in 2013 with a PhD in mechanical engineering. David focuses on the development and use of the model libraries in gPROMS FormulatedProducts, focusing on solids processing applications across industries including pharmaceutics, food and consumer goods and model-based solutions for the food industry. David previously worked for P&G analysing and developing spray drying processes through modelling.
David’s technical interests primarily revolve around drying technologies with a particular focus on spray drying and developing modelling tools that support process design, optimisation and control. Additionally, he has worked in areas such as: powder flow, continuous blending, milling and granulation in the context of continuous drug product manufacture, dairy-related processes, and detergent production. He has been a part of many projects around the subject including an industry-academia collaboration to develop hybrid CFD-PBM techniques.
Dana Barrasso, PhD
Dana is a Senior Consultant on PSE's Formulated Products team. As one of the primary architects of gPROMS FormulatedProducts, Dana has a detailed understanding of the end-to-end drug manufacturing process and product performance science, as well as the advanced process modeling tools that can be used to describe them. She is directly responsible for PSE’s wet granulation model libraries and several other drug product manufacturing process models. Dana works closely with the world’s leading experts in industry and academia to bring systems engineering approaches to pharmaceutical manufacturing, with an active role in PSE’s Systems-based Pharmaceutics Alliance with Pfizer, Eli Lilly, GSK, Roche. She also leads PSE's support and technical interactions with pharmaceutical regulatory bodies.
With a PhD from Rutgers University in Chemical Engineering, Dana's background is in drug product process modelling, with a particular focus on wet granulation processes. Her dissertation involved the development and application of mechanistic models describing wet granulation processes, including multi-scale modeling techniques.
Edd Close, EngD
Edd is a Senior Consultant in the Formulated Products business unit at Process Systems Enterprise (PSE). His main focus is on the development and use of the model libraries of gPROMS FormulatedProducts, focusing on product performance applications in a wide range of industries including pharmaceutics, food and consumer goods, and the development of model-based solutions for bioprocessing.
Edd graduated from the University College London in 2013 with an Engineering Doctorate (EngD) in biochemical engineering. His EngD was in collaboration with Pfizer, and focused on developing mechanistic models of industrial platform purification and selected late stage non-platform purification processes to assist in process design and operation for the production of therapeutic proteins.
Edd’s technical interests primarily revolve around in vivo performance of drug products, with a particular focus on predicting drug absorption as a function of product formulation and ingestion conditions in order to explore the decision space rapidly to identify risk factors, overcome liabilities and optimise the clinical trial pathway. He has been a part of many projects around the subject, and managed the collaborative project that developed Global System Analysis, a tool for global uncertainty and sensitivity analysis within gPROMS FormulatedProducts.
Niall Mitchell, is a Senior Consultant and Strategic Business Developer in the PSE Formulated Products group at PSE and Lead Developer of the drug substance modules of gPROMS FormulatedProducts. His main responsibility is the application and product development of the PSE Formulated Products suite of software tools, gSOLIDS (Solid processing), gCOAS (oral absorption and in-vitro modelling tool) and primarily gCRYSTAL modules, an advanced crystallization modelling tool. He is a Chemical Engineer with a PhD in crystallization from the University of Limerick (2012), whose research was part of the Solid State Pharmaceutical Cluster (SSPC). Niall’s research interests with respect to crystallization include the development of model development and application workflows, application of mechanistic models to reduce the risks often associated with process scale-up or mode change, the development of user friendly modelling tools that can be used by quickly and efficiently by crystallization experts and the enhancement of particle size measurements tools.
As a Senior Consultant, Niall has been involved in numerous crystallization and solids projects for companies including Syngenta, MCC, Pfizer, Eli Lilly, GSK, Roche among others, where modelling was applied to improve process understanding, model validation, scale-up processes and optimise both batch and continuous unit operations.