Understanding what the concentration of a compound in the body is and how the concentration varies with time (pharmacokinetics) is an essential foundation of modern drug discovery and development. Taking this further and developing an understanding of how these concentrations are driving in vivo effects (biomarkers/efficacy/toxicity) and the time that these concentrations need to be maintained for a positive outcome starts to allow rational decisions to be made about the dose and pharmacokinetics (PK) profile required in patients. These are the fundamentals of PKPD modelling. This allows a drug developer to answer questions such as:
As a compound progresses into safety testing and especially clinical development there are strong regulatory, and publication needs to describe the pharmacokinetics of a compound. This is initially via non-compartmental analysis (NCA) which is used to establish descriptive statics of the compound’s human pharmacokinetics and provide insight on its performance (for instance does exposure increase proportionally with dose and are the pharmacokinetics time independent?). Focused absorption modelling can build understanding of the properties that effect drug exposure and inform formulation strategies. Alongside NCA characterisation of PK, translational PKPD (pharmacodynamics) modelling can be performed to place emerging clinical data into context with preclinical data, understand potential sources of variability and uncertainty, and guide clinical investment decisions.
As clinical development progresses Population PK and Population PKPD modelling becomes increasingly important to:
This analysis will be a key part of the argument justifying the choice of Phase 3 and Commercial dose to Regulatory Authorities while also allowing sponsors to understand if different doses are required for different sub-populations.
In later development an area of modelling that is becoming more important is physiologically based pharmacokinetic (PBPK) analyses for biopharmaceutics. Regulators, especially USA FDA, are promoting PBPK as a tool to focus on drug product quality attributes and a mechanistic understanding of their interaction with physiology to affect in vivo drug performance resulting in the definition of critical attributes of the drug product, manufacturing process and input materials. The application of PBPK analyses for biopharmaceutics is considered an important tool to support the more frequent development of clinically relevant drug product specifications
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| NCA |
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Seda’s team of experts has many years of experience of all forms of pharmacokinetic modelling across large pharma and biotech and across late discovery to launch. Seda’s focus is on modelling in real time (rather than a retrospective justification) to aid clear, objective, and decisive decision making. Our PKPD modellers are particularly experienced in the Oncology Therapeutic area. The unique combination of biopharmaceutics, clinical pharmacology and dissolution expertise that resides in Seda alongside our modellers means we are well placed to support PBPK analyses for biopharmaceutics.
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Paul A. Dickinson is a prominent pharmaceutical scientist specialising in biopharmaceutics and clinical pharmacology and is the Founder and Chief Scientist of Seda. Alongside his scientific leadership, Paul has played a central role in building Seda into a successful, high‑growth consultancy, including securing growth investment from BGF and achieving recognition as an LDC Top 50 business in 2025. An internationally recognised, multidisciplinary scientist with extensive regulatory experience, Paul has contributed to the approval of many medicines and has helped shape modern, scientifically rigorous, efficient, and patient‑centric drug development practices.
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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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Valentina Bucur
MMATH PhD
Senior Scientist, Modeller
Valentina has a masters in applied mathematics and a PhD in mathematical modelling of biological systems, obtained from the University of Liverpool. In addition, she has vast experience in modelling both ordinary and partial differential equations, which helps her develop and understand pk models. At Seda Valentina is part of the modelling team, working as a senior scientist analysing preclinical and clinical data, and building models to help clients get a better understanding of the effectiveness of their compounds.
Gong Chen
MSc
Modeller
Gong Chen holds a master’s degree in Model‑Based Drug Development from the University of Manchester. His final project focused on PBPK modelling in obesity, evaluating alternative hepatic scaling approaches. Gong has joined Seda as a Modeller, building experience in pharmacometrics, including population PK, PK/PD, QSP and PBPK modelling.
Heather Collis
MSci, PhD
Associate Principal Scientist, Modeller
Heather has a master’s degree in mathematics from the University of Birmingham and a PhD in Mathematical Biology from the University of Nottingham. Prior to working for Seda, Heather completed a 2-year postdoc in disease modelling of metabolic dysfunction-associated steatotic liver disease with AstraZeneca in Gothenburg, Sweden. She has a broad mathematical skillset including ODE and PDE modelling as well as knowledge of machine learning classification algorithms such as random forests. Heather is working as a senior scientist in the modelling team at Seda.
Harri Dickinson
BSc (Hons)
Associate Principal Modeller
Harri Dickinson is an Associate Principal Scientist and Team Leader at Seda, supporting a wide range of pharmaceutical and biotechnology clients across all stages of drug development. His experience spans mechanistic PK/PD modelling, translational modelling, tumour growth inhibition modelling, clinical pharmacokinetics, and non-compartmental analysis. Harri’s core expertise is in population pharmacokinetic/pharmacodynamic (PopPK/PD) modelling and statistical exposure-response analysis, which he applies across Phase I to Phase III clinical programmes to characterise drug behaviour, understand variability, and support dose selection and optimisation.
Harri has supported programmes from first-in-human studies through to marketing application, including paediatric, rare disease, and ultra-rare disease indications where quantitative approaches are critical to development and regulatory decision-making. Despite being early in his career, he has already gained extensive experience supporting regulatory interactions and submissions with both the FDA and EMA, contributing to successful marketing applications. In addition to his technical work, Harri leads a team of modellers, driving project delivery and mentoring colleagues in quantitative clinical pharmacology.
Jake Dickinson is a Principal Scientist and Team Leader at Seda, specialising in modelling and simulation, translational PK/PD, and physiologically based biopharmaceutics modelling. He leads Seda’s Modelling & Simulation team and has developed innovative quantitative approaches that support drug development programmes from preclinical research through to clinical and regulatory decision-making. Jake is the creator of Seda’s Nora PBBM absorption model and has worked with pharmaceutical and biotechnology companies worldwide to apply modelling strategies across a range of novel therapeutic modalities and complex parenteral formulations, accelerating development and reducing risk.
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Emily Fell
MEng (Hons)
Senior Modeller
Emily has a master’s degree in mechanical engineering from the University of Birmingham, where she developed a particular interest in biomedical engineering during her final year of study. Since joining Seda in 2022, she has been part of the modelling team and now works as a Senior Scientist. Her work includes pharmacokinetic (PK), pharmacokinetic/pharmacodynamic (PKPD), and population PK (PopPK) modelling, as well as non-compartmental analysis (NCA), helping clients gain a deeper understanding of their compounds and supporting drug development decision-making.
Rohit Jain
MS PhD
Senior Modeller
Rohit Jain is a Senior Modeller at Seda with a PhD in Statistical Physics from the Indian Institute of Science (IISc). He has extensive experience in mathematical and stochastic modelling, including ODE- and PDE-based models, numerical simulation, and data analysis across biological, physical, and industrial applications. At Seda, Rohit is part of the modelling team, where he supports the analysis of preclinical and clinical data and the development of population PK, PKPD, and mechanistic models to help clients better understand compound behaviour and support decision making.
Ashwin Kaleeswaran
PharmD MS
Modeller
Ashwin has a background in pharmacometrics and in-silico modelling, with experience applying mechanistic PK/PD approaches to support drug development. During his MS at the University of Manchester, his thesis focused on GalNAc conjugated siRNA therapeutics, where he adapted and applied a mechanistic PBPK-PD framework and used global sensitivity analysis to examine parameter influence on drug disposition, intracellular processes, and downstream protein knockdown.
He has training in clinical pharmacy and patient-focused care, with experience in hospital and community settings, supporting an understanding of real-world healthcare practice alongside quantitative modelling.
Xiuhan Li
BSc MSc
Modeller
Xiuhan has a background in clinical pharmacy and model-based drug development, combining expertise in PBPK and PK/PD modelling with quantitative analysis to support decision-making throughout the drug development process. During her MSc at the University of Manchester, she focused on developing population pharmacokinetic models to optimise dosing strategies for paediatric patients. This gave her hands-on experience in translating preclinical and clinical data into actionable insights.
At Seda, she works as an ADME Sciences Modeller, applying both mechanistic and data-driven modelling approaches to inform drug absorption, distribution, metabolism, and excretion (ADME) predictions, and to support project progression from preclinical to clinical stages.
Ashleigh Lomax
BSc MSc
Modeller
Ashleigh has a background in both in-silico modelling and chemistry, understanding both compound analysis and the modelling approaches harnessed in drug development. During her MSc, she spent her final months developing a Mechanistic Kidney Model to predict creatinine Drug-Biomarker Interactions (DBIs) aiming to reduce false-positive predictions of Acute Kidney Injury (AKI.)
In her spare-time, she worked within community pharmacy where she gained a strong understanding of patient welfare and pharmaceutical demand.
Adam Mitchinson
BSc PHD
Senior Scientist, Modeller
Adam holds a first-class BSc in Mathematics and has recently completed his PhD in Mathematical Biology. Adam’s PhD work explored the influence of topography and connexin mimetic peptides (CMPs) on cutaneous wound healing using agent-based and mechanistic modelling approaches. Specifically, the work explored how tissue and substrate structure influences fibroblast cell migration behaviour, how the CMP Gap27 disrupts connexin 43 cycling dynamics and hemichannel formation and how Gap27 binding subsequently prevents within population fibroblast cell-cell interactions and cell aggregation, restoring migration into a wound region. Adam joins Seda as a Senior Modeller looking to build experience and expertise in pharmacometric modelling with a focus on developing population PK, PKPD, PBBM and PBPK models.
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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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.