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Modelling Services

PK Modelling services, building confidence in your drug development.

Computer modelling and simulation is a method that can be used to predict and/or confirm drug and formulation behaviour in vivo and facilitates the understanding of the exposure/response relationship. Seda provide PK modelling services for the integration of data to mitigate the risks of drug properties impacting drug absorption and uncovers the relationship between dose, exposure and biological effect.

Model-informed drug development helps solve the following challenges / questions:

  • Dose selection
  • Scaling and prediction of human pharmacokinetics
  • What formulation type is required for clinical studies?
  • Which formulations to use in preclinical studies?
  • How does drug exposure relate to safety and efficacy?
  • What are the best designs for preclinical and clinical studies to see activity?
  • Which patients are most likely to respond?
  • Representation of client companies in interactions with health agencies
  • How do I translate my knowledge in one patient population to another population (e.g. adult to paediatric)?

Modelling and simulation is used throughout development to guide and support longer term development strategy and clinical investment decisions. It puts emerging clinical data into context with preclinical and clinical data already available. Modelling and simulation can therefore build confidence in the development of your chosen compound/formulation leading to reduced clinical testing and costs.

PBPK modelling is the combination of a set of known physiological parameters, in vitro ADME and invivo PK data, along with certain in silico values to create a dynamic model that describes the PK of a drug. This model can be used to understand and simulate PK in pre-clinical species and for first-in-human PK predictions. If PBPK models can be successfully be developed they have the potential to reduce the need for animal and human testing.

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Expertise:

  • DMPK Consultancy and Dose Selection
  • Pharmacokinetic Modelling
  • Complex Medicines
  • CMC Regulatory
  • Clinical Pharmacology
  • Analytical Sciences

Paul A Dickinson

BPharm (Hons) PhD

Chief Scientific Officer & Co-Founder

Paul A Dickinson

BPharm (Hons) PhD

Chief Scientific Officer & Co-Founder

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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.

‪Paul A Dickinson‬ – ‪Google Scholar‬

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    Expect a reply typically within 48 hours.

    Expertise:

    • Oral Drug Delivery
    • DMPK Consultancy and Dose Selection
    • Pharmacokinetic Modelling
    • Clinical Pharmacology

    Linette Ruston

    BSc (Hons) PhD

    Director: ADME and Modelling Sciences

    Linette Ruston

    BSc (Hons) PhD

    Director: ADME and Modelling Sciences

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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.

    ‪Linette Ruston‬ – ‪Google Scholar‬

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      Expect a reply typically within 48 hours.

      Expertise:

      • Pharmacokinetic Modelling

      Jake Dickinson

      BSc (Hons)

      Associate Principal Modeller

      Jake Dickinson

      BSc (Hons)

      Associate Principal Modeller

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      A physics graduate, with over 3 years’ experience in the pharmaceutical industry. Jake has applied analytical, mathematical, and problem-solving skills to the assessment of the likelihood of drug candidate success and to identify the likely risks involved in the formulation of a drug. Areas of expertise include PK / PK-PD-TGI modelling in preclinical species and translation to man to aid in dose prediction. Jake has developed models and applications including Nora Max, an in silico absorption model, that aids decision making in late preclinical and early clinical drug development phases of drug development and enables the identification of the formulation technologies required for FiH.

      ‪Jake Dickinson‬ – ‪Google Scholar‬

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        Expect a reply typically within 48 hours.

        Expertise:

        • Pharmacokinetic Modelling

        Harri Dickinson

        BSc (Hons)

        Senior Modeller

        Harri Dickinson

        BSc (Hons)

        Senior Modeller

        Harri is able to apply commercially available software PK-Sim, in order to form translational PB-PK modelling for different species or populations and help with dose selection in the early clinical stage settings. As a Mathematics graduate his background enables him to bring systems thinking to PK modelling to identify sources of uncertainty and risk.

        ‪Harri Dickinson‬ – ‪Google Scholar‬

        Expertise:

        • Pharmacokinetic Modelling

        Jingrao Fei

        BSc (Hons) MSc

        Modeller

        Jingrao Fei

        BSc (Hons) MSc

        Modeller

        BSc in Pharmaceutical Science, MSc in Model-based Drug Development from the University of Manchester. At Seda, Jingrao’s role is to create translational PB-PK modelling for various species or populations and assist with dose selection in early clinical stage settings.

        Expertise:

        • Pharmacokinetic Modelling

        Emily Fell

        MEng (Hons)

        Modeller

        Emily Fell

        MEng (Hons)

        Modeller

        First from the University of Birmingham studying Mechanical Engineering with a final year focus in biomedical engineering. Using my academic background with my interest in this area, I will be working with the modelling team within Seda.