Speakers
Morning Session: Setting the Scene – Expert Perspectives
There’s no magic fix that will eliminate animal testing at the push of a button. However, the so called “New Approach Methodologies (NAMs)” provide the tools towards a significant optimization in utilizing animal experiments.
Model-informed drug development (MIDD) is a general umbrella for integration of various pieces of information on systems (various organs and tissues in various species of animals and human) with drug-related data obtained in the lab (2D/3D cultures as well as Organ-on-Chip) to help select better drug candidates enter clinical investigation stage. These cover safety aspects (avoiding serious harm to patients) as well as potential therapeutic effects. Physiologically-based pharmacokinetics (PBPK) and quantitative systems pharmacology (QSP) models are used to generate necessary scaffold that hold the data needed to build computer models for assessing the fate of drugs in the body (in each species) and their likely pharmacological/toxicological effects. The wave of regulatory use of PBPK/QSP models that started over a decade ago continues be verified and accepted more widely. However, the journey to get to such level of comfort has been a long, and fraught with many problems over the last two decades. The ideas around the 3Rs (reduce, replace, and refine) principles for animal testing ate not new. The recent shift of paradigm can be attributed to increased reliability of the translatability of information.
In this talk, I will address the principles behind PBPK/QSP and explain how these models moved from academic exercise to practical use in the pharmaceutical industry. The biggest impact in the case of animal use has been related to “indirect” translation (through the models and considering the differences in systems parameters) which define target exposure in certain tissues, and hence equivalent dose.
Some Useful References
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 at 0.07% top rank of the Highly Cited Researchers List by Stanford University (published by Elsevier) for Pharmacology (2024), and ScholarGPS puts him among the top 20 scientists contributing to “drug metabolism” and top 50 for “pharmacokinetics”. He has published over 330 peer reviewed influential scientific articles (>26,000 citations, h-index = 87, Google Scholar) covering various aspects of pharmaceutics, clinical/translational/systems pharmacology.
As the Director of Centre for Applied Pharmacokinetic Research (CAPKR) at the University of Manchester since 2017r, Amin collaborates with many pharmaceutical companies with a view to transfer latest scientific knowledge into model-informed drug development. 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 and he was one of the founding editors of Pharmacometrics and System Pharmacology in addition to serving on the Editorial Boards of many other pharmacology journals.
As the Senior Vice President of Research & Development (SVP) and Chief Scientific Officer at Certara (since 2014), he facilitates the integration of the latest translational modelling to bio-simulation platforms offered by Certara to its clients, with the aim of accelerating the drug development and regulatory approval.