Seda Pharmaceutical Development Services’ Clinical Pharmacology expertise is unique in that it is fully integrated with our Pharmaceutical Development and Biopharmaceutics capability and is aimed at supporting drug product design alongside optimal use in the clinic. Seda’s Clinical Pharmacologists apply their deep understanding of pharmacokinetics (PK), pharmacodynamics (PD), and pharmacology to input to appropriate clinical trial design, contributing to aspects such as start dose, dose escalations, PK sampling schedule, food effect and drug-drug interactions. This service links seamlessly with Biopharmaceutics modelling of drug exposure to enable product design, the development of clinically relevant dissolution tests, food effect and formulation bridging studies (bioequivalence).
Support we can provide includes:
For drugs in the later stages of development, we can provide expert guidance on:
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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 Chief Scientific Officer at Seda and leads the ADME Sciences Division, encompassing DMPK, clinical pharmacology, and modelling. She holds a BSc (Hons) and PhD in Chemistry from the Universities of Glasgow and Edinburgh, respectively.
With over 17 years at AstraZeneca, Linette held senior roles in Discovery and Early Pharmaceutical Development, where she provided expert input into compound design, selection, and progression. Her work focused on integrating physicochemical, ADME, and biopharmaceutics understanding using in vitro, in silico, and in vivo models to support candidate selection and early clinical development.
At Seda, Linette continues to provide strategic consultancy to clients while driving the scientific direction of the company. Her current focus is on translating ADME and pharmacodynamic insights into meaningful formulation and clinical study design to accelerate development and maximise product value.
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Claire Patterson is Director, Complex Medicines at Seda with a Master of Pharmacy (MPharm) and a Ph.D. in Pharmaceutics from the Universities of Nottingham and University College London. Claire is an experienced Project Leader and Biopharmaceutics Scientist having spent 12 years with former employer AstraZeneca with roles in Early and Late Stage Product Development, plus 5 years as a senior leader within Seda. Claire specialises in subcutaneous delivery and complex parenterals (particularly long acting injectables and nanomedicines).
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Alison Wilby
BSc (Hons) MSc PhD
Senior Principal Scientist: Clinical Pharmacology and DMPK
View Bio Ask me a questionAlison 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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Explore our services
Our team of experts have many decades of experience in all stages of Pharmaceutical Development, DMPK and Clinical Pharmacology and the associated regulatory requirements and are on hand to guide the CMC and PK aspects of your development programme.
Seda has state-of-the-art laboratory capabilities for the rapid screening, testing and development of conventional and novel formulations to give your compound the best chance of success. We also specialise in the development of clinically relevant dissolution methods for late phase development / registration.
Seda’s modelling team and our proprietary & commercial software are perfectly placed to support translation of preclinical data to the clinical setting and onwards selection & justification of the go forward dose.