Seda’s DMPK consultancy offering recognises the vital importance of understanding the drug metabolism and pharmacokinetic (DMPK) properties of compounds to identify candidate molecules with suitable properties for development such as:
In silico tools, in vitro assays and in vivo pharmacokinetic (PK) studies are used to characterise compound attributes in terms of absorption, distribution, metabolism, and excretion (ADME). This information, combined with data from in vitro pharmacology assays or in vivo pharmacodynamic / efficacy studies, can be used to predict human therapeutic doses. This process, in conjunction with additional studies designed to identify potential DMPK liabilities, can be used to select the best compound for development.
Sufficient exposure in pre-clinical species must be achieved to test pharmacological hypotheses and toxicity, as well as providing confidence that the drug will deliver the desired therapeutic exposure. Certain attributes or liabilities can heavily influence compound selection, and these should be put into context with knowledge of the target patient population and likely co-medications. Cross discipline collaboration with medicinal chemistry (compound design), pharmacology (delivery of desired pharmacological effect), toxicology (drug safety), pharmaceutical sciences (drug delivery) and service providers (quality data) is key to the discovery of compounds with suitable developability profiles.
|How good is my molecule?|
|What do I need to build a human dose prediction?|
|How can I improve the PK profile of the compound?|
|What are the main liabilities of the compound?|
Seda’s team of experts has several years of experience of DMPK across large pharma and biotech assisting in the design and delivery of numerous candidate drugs. Seda has an established network of service providers that can deliver high quality data and can leverage in-house modelling and simulation expertise to understand and predict compound performance in vivo.
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Paul has held several senior science leadership roles in Academia and Large Pharma. These roles focused on applying the best science in projects to ensure optimal product performance in the patient, thus bridging pharmaceutical and clinical disciplines.
Immediately prior to founding Seda Pharmaceutical Development Services Paul was Senior Clinical Pharmacology Scientist at AstraZeneca and led the clinical pharmacology program to NDA/MAA for AZD9291/osimertinib, which had been awarded ‘breakthrough therapy’ status by the FDA. Formerly Paul was a Principal Scientist within Pharmaceutical Development (AZ) leading both the global biopharmaceutics network and the Medicines Evaluation science community (USA, SE, UK).
Paul has been at the forefront of recent advances in the understanding of in vitro performance criteria that assure product performance in the patient including clinically relevant dissolution specifications (CRDS). Paul has co-authored papers with FDA staff focussed on efforts to combine biopharmaceutics with ICH Q8 (BioRAM) and is past Chair of the AAPS ‘QbD and product performance’ focus group.
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Linette is a Senior Principal Scientist at Seda with a BSc (Hons) and PhD in Chemistry from Universities of Glasgow and Edinburgh, respectively. She is an experienced Biopharmaceutics and DMPK scientist having spent 17+ years with AstraZeneca where she held roles in Discovery and Early Pharmaceutical Development, providing expert physicochemical, ADME and Biopharmaceutics input into compound design and selection, and applied knowledge of in vitro, in silico and in vivo models to enable material choice and project progression from discovery to early clinical development. Her current focus is on translation of DMPK/PD and biopharmaceutics understanding into meaningful product and clinical study design within Seda.
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Alison is a Senior Principal Scientist in Clinical Pharmacology and DMPK at Seda with a PhD in Drug Metabolism from the University of Manchester and an MSc in Toxicology from the University of Birmingham. She is an experienced multidisciplinary scientist having spent over 10 years in DMPK Discovery with AstraZeneca and, for the last 10 years, specialised in PBPK modelling using GastroPlus with Quotient Sciences. At Seda she provides scientific input into Clinical Pharmacology and DMPK study design and provides interpretation and analysis of client data.
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