The European Medicines Agency (EMA) has formally qualified Certara’s Simcyp® Simulator, marking the first and only qualification of any physiologically-based pharmacokinetic (PBPK) platform to date. This milestone signals a major shift in how PBPK models are evaluated, trusted, and used in regulatory submissions.
Join Certara’s PBPK experts as they discuss the significance of this qualification and share insights from the recent EMA workshop on the regulatory assessment of mechanistic models.
In this webinar, you'll learn:
- What the EMA’s qualification of the Simcyp Simulator means for developers, regulators, and broader model-informed drug development (MIDD) community
- Practical guidance on how sponsors can leverage the qualification to streamline regulatory submissions and reduce the need for clinical DDI studies
- Key takeaways from EMA’s workshop on mechanistic model qualification
- Next steps – future areas of qualification including complex DDIs, transporters, specific populations
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Senior Vice President, Client & Regulatory Strategy
Karen is Senior Vice-President, Client & Regulatory Strategy at Certara UK Limited’s Simcyp Division. Prior to this, she was the Head of PBPK Consultancy Services at Simcyp where she led a team of scientists engaged in Consultancy projects relating to the application of physiologically based pharmacokinetic (PBPK) modelling in drug development. Her work has focused on the use of PBPK models for assessment of drug-drug interactions and dosing of special populations and she is the author/co-author of more than 100 peer reviewed articles in these areas.
Senior Vice President, Simcyp Research & Development, Certara
Masoud Jamei is the Senior Vice President of Research and Development at Simcyp Division of Certara UK Limited. He leads a team of around 50 scientists and 35 software developers and testers focusing on the design, development and implementation of various aspects of systems pharmacology models. His active areas of research include in vitro-in vivo extrapolation techniques, Physiologically-Based Pharmacokinetics / Pharmacodynamics (PBPK/PD) models of small and large molecules and applying top-down Population PK (PopPK) data analysis to PBPK models in healthy volunteer and patient populations. He has been the author or co-author of over 100 manuscripts and book chapters and over 165 abstracts in the field of modelling and biosimulation. He has been an invited speaker and a session organiser/moderator at national and international meetings and also leads well-known Simcyp hands-on workshops on model-informed drugs development.
In 2002 he earned a PhD in Control Systems Engineering at the University of Sheffield, UK, and carried out one year of post-doctoral research there. He was an Honorary Lecturer at the University of Sheffield (2008-2011) and a visiting Senior Lecturer at the University of Manchester (2011-2014). In recognition of his professional excellence and sustained superior impact in field of pharmaceutical sciences he became AAPS Fellow in 2022. In 2003 he joined Simcyp Limited.
Sr. Scientific Advisor and Head of Translational Science
Iain leads the science team that is responsible for further developments of the population based physiologically-based PK/PD simulators to meet the needs of Simcyp Consortium members. Prior to joining Certara, he spent 12 years working in the Pharmacokinetics, Dynamics and Metabolism Department at Pfizer Global Research & Development.
Senior Scientific Advisor, Lead of the Transporter Group
Dr. Sibylle Neuhoff is a Senior Scientific Advisor and Deputy Head of the Translational Science Group at Certara Predictive Technologies, where she leads the Transporter Group within Simcyp. With over 25 years of experience in the fields of transport, transporters, and their mechanisms, Dr. Neuhoff is a recognized expert in PBPK/PD modeling, oral drug absorption, transport, metabolism, and toxicity. Her extensive research is documented in numerous peer-reviewed journal articles (Sibylle Neuhoff (0000-0001-8809-1960) – ORCID).
Dr. Neuhoff holds a degree in Chemistry from the Goethe University in Frankfurt am Main, Germany, and earned her PhD from the Department of Pharmacy at Uppsala University, Sweden, in 2006. Her current research focuses on the pharmacogenomics of drug-metabolizing enzymes and transporters, drug disposition and pharmacodynamics, ligand interactions with human metabolizing enzymes and transporters, endogenous biomarkers, and innovative approaches to simulate and predict metabolic clearance, drug-drug interactions, and transporter-related interactions in both healthy subjects and patient populations.
Dr. Neuhoff has taught over 50 PBPK workshops on the Simcyp™ PBPK Simulator, Simcyp Animal, and the Simcyp In Vitro Data Analysis (SIVA) toolkit, covering topics such as MIDD, Transporter, FIH, DDI, and Best Practices. She is regularly invited as speaker to present at national and international conferences and meetings.
Additionally, Sibylle is an active member of The International Transporter Consortium.
Senior Vice President of R&D and Chief Scientific Officer (CSO), Certara
As the Senior Vice President of Research & Development (SVP) and Chief Scientific Officer at Certara, he facilitates the incorporation and integration of the latest advances in translational modelling to bio-simulation platforms offered by Certara to its clients, with the aim of accelerating the development and regulatory approval of safer drug products and bringing them to the patients.
Amin was co-founder of two spin-off companies from the University of Sheffield (Simcyp Limited [now part of Certara Inc]) and Diurnal Limited [now part of Neurocrine Bioscience]). As a leader in the field of Physiologically-based Pharmacokinetics (PBPK) and Quantitative Systems Pharmacology (QSP), he is internationally recognized for his expertise in translational modelling to predict the behavior of drugs in human body, and understanding the associated inter-individual variabilities. He was one of the founding editors of Pharmacometrics and System Pharmacology and serves on the Editorial Boards of several other journals.
The Institute of Scientific Information (ISI, Clativate) listed Amin as one of the world’s most highly cited researchers (under ‘Pharmacology & Toxicology’) in 2017. Amin is also at 0.07% top rank of the Highly Cited Researchers List by Stanford University (published by Elsevier) for Pharmacology (2023). He has published over 330 peer reviewed highly influential scientific articles (>24,500 citations, h-index = 85, Google Scholar).
As the Director of Centre for Applied Pharmacokinetic Research (CAPKR) at the University of Manchester, Amin collaborates with many pharmaceutical companies with a view to transfer latest scientific applications into modern drug development. The work of Professor Rostami covers wide areas of drug development over the last 30 years, ranging from pharmaceutics (e.g. bioavailability and bioequivalence) to clinical pharmacology (e.g. mixture pharmacology of drug/metabolites), translational and systems pharmacology (e.g. quantitative proteomics of enzymes and transporter for in vitro to in vivo (IVIVE) scaling).
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