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Modelling Services

In Silico Modelling, 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. Modelling and simulation integrates 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.

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Expertise:

  • DMPK and Dose Selection
  • Pharmacokinetic Modelling
  • Complex Parenterals
  • Regulatory CMC
  • Clinical Pharmacology

Paul A Dickinson

BPharm (Hons) PhD

Director & Co-Founder

Paul A Dickinson

BPharm (Hons) PhD

Director & 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.

 

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    Expect a reply typically within 48 hours.

    Expertise:

    • Pharmacokinetic Modelling

    Jake Dickinson

    BSc (Hons)

    Modeller

    Jake Dickinson

    BSc (Hons)

    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.

    Ask me a question

      Expect a reply typically within 48 hours.

      Expertise:

      • Complex Parenterals
      • Pharmacokinetic Modelling
      • Clinical Pharmacology

      Claire Patterson

      MPharm (Hons) PhD

      Senior Principal Scientist

      Claire Patterson

      MPharm (Hons) PhD

      Senior Principal Scientist

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      Claire Patterson is Senior Principal Scientist at Seda with a Master of Pharmacy (MPharm) and a Ph.D. in Pharmaceutics from the Universities of Nottingham and University College London respectively. Claire is an experienced Biopharmaceutics scientist having spent 12 years with former employer AstraZeneca with roles in Early and Late Stage Product Development, linking in vitro to in vivo product performance. Current focus areas include subcutaneous and complex parenteral biopharmaceutics (including nanomedicines) and other non-oral routes of administration.

      Ask me a question

        Expect a reply typically within 48 hours.