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Complex Medicines

Enabling the next wave of novel therapeutic modalities

It is not always possible or desirable for medications to be delivered orally. In such cases, formulations can be given by injection e.g., via intravenous, intramuscular, subcutaneous, or other less common routes of administration. Seda’s Project Leaders have experience of the design, development, and regulatory authorisation of parenteral products and complex medicines across all phases, including commercialisation.

Additionally, diversification of the types of active pharmaceutical ingredients and the site of the biological target as well as the rate and extent to which they must be delivered for optimal balance of safety and efficacy can often mean that a conventional formulation approach is inadequate. These new molecular types or modalities are becoming ever more prevalent in the oncology and vaccine space and require delivery via a complex medicine:

“A complex medicine is one which requires application of novel technologies for delivery
and targeting of drugs through modification of API (Active Pharmaceutical Ingredient) (e.g.,
drug-dendrimer complexes), formulation (e.g. liposomes) and/or novel routes of delivery (e.g.,
intratumoural delivery).”

What can Seda offer:

  • For candidate drugs that require advanced technologies to ensure sufficient drug exposure in the
    patient, we can determine the scientific approach most likely to succeed. We can identify the most
    appropriate drug delivery technologies and providers which match the science (‘drug delivery
    scouting’).
  • We can assess the market opportunity / differentiation potential of selected technologies and provide
    an evaluation of the probability of regulatory and technical success.
  • The independence of Seda from specific platform technology
    companies enables us to make recommendations for product development based on an impartial
    knowledge of technical requirements rather than the need to commercialize specific proprietary
    technologies.
  • Access via our network to experts in complex parenteral characterisation techniques, and guidance on characterisation appropriate for phase of development and to provide product performance understanding to maximise chances of translational success.

Why choose Seda?

Seda’s team of experts has direct experience of taking several nanomedicine and other complex delivery systems from preclinical to clinical development. We have established a network of experts in the diverse array of advanced characterisation techniques that are so vital to success in this field. In addition, we can leverage in-house modelling and simulation expertise to guide the development and selection of formulation candidates for optimal in vivo performance. Our in-house DMPK and Clinical Pharmacology capability, together with close alliances to other non-clinical and clinical experts (including our link to the Medicines Discovery Catapult) are ideal for ensuring the seamless communication required to maximise success of complex medicines, where minor changes in formulation or manufacturing process can have major impact on biodistribution (and hence safety/efficacy).

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Ask our Complex Medicines experts a question

Expertise:

  • Oral Drug Delivery
  • Complex Medicines
  • Paediatric Product Development
  • CMC Regulatory

Paul W Stott

BPharm (Hons) PhD

Director & CEO

Paul W Stott

BPharm (Hons) PhD

Director & CEO

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Paul is an established pharma executive with extensive global experience. Prior to joining SEDA he was Vice President, Global Product Development at AstraZeneca, leading a group of over 350 scientists and engineers in the development of all products, manufacturing processes and analytical methods for the AstraZeneca small molecule portfolio.

AstraZeneca Global Product Development has centres in the UK, Sweden, US and China and a network of partnerships with colleagues all over the world and under Paul’s stewardship registered 10 global products.

At AstraZeneca Paul was accountable for the Drug Product CMC component of all Due Diligence assessments and was CMC lead on several multibillion dollar acquisitions. In addition, Paul is a visiting Professor of Pharmaceutics at the University of Manchester, UK and founder of the North West Centre for Drug Delivery (NoWCADD) at the University.

He is a proven senior manager and strategic leader in Pharmaceutical Development with experience across geographical boundaries. Passionate about the development of individual and group capabilities and the application of innovation and scientific rigour to bring new medicinal products to market.

He is recognised within the Industry and with Regulatory Agencies as a driving force in the establishment and realisation of best practice in CMC Quality by Design.

Ask me a question

    Expect a reply typically within 48 hours.

    Expertise:

    • Oral Drug Delivery
    • Complex Medicines
    • Paediatric Product Development
    • CMC Regulatory
    • Analytical Sciences

    Marcel de Matas

    BSc (Hons) PhD FRSC CChem

    Director & Co-Founder

    Marcel de Matas

    BSc (Hons) PhD FRSC CChem

    Director & Co-Founder

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    Marcel has a track record in a range of management and senior scientific positions in industry and academia. Most recently he was a Principal Scientist in Product Design and Innovation at AstraZeneca, where he was responsible for introducing the latest science, new technologies (advanced drug delivery and manufacturing) and product design thinking into the Product Development group.

    Marcel has led technical activities, provided project leadership and has managed product development teams responsible for the delivery of drug projects from initial concept design through late stage development, regulatory submission and launch (including advanced drug delivery systems). He has led teams at the drug discovery-development interface, assessing the level of chemistry manufacturing and controls (CMC) technical risk and defining product design strategies in early development. Project experience has covered projects across a range of disease and therapy areas with substantial experience in the oncology field.

    Ask me a question

      Expect a reply typically within 48 hours.

      Expertise:

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

      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.

       

      Ask me a question

        Expect a reply typically within 48 hours.

        Expertise:

        • Complex Medicines
        • 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.

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          Expect a reply typically within 48 hours.

          Expertise:

          • Complex Medicines
          • Oral Drug Delivery

          Paul Gellert

          BA DPhil

          Consultant - Complex Medicines

          Paul Gellert

          BA DPhil

          Consultant - Complex Medicines

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          Paul has 33+ years’ experience in Drug Discovery and Development at AstraZeneca, specialising in novel formulation, drug delivery and product design. He has led many projects and teams in identifying, evaluating and designing novel viable drug delivery-based products and new drug delivery technologies across a broad range of routes of administration and drug modalities including many complex medicines.

          From 2017 to 2021, in additional to his role as Senior Principal Scientist in Drug Delivery, Paul was the Science & Innovation Director for Drug Delivery and Product Design, accountable for driving and championing science and innovation in drug delivery and product design to create new implementable business opportunities. Paul started and led AstraZeneca’s Global Novel Drug Delivery Network for many years and is widely recognised outside AstraZeneca as an expert on drug delivery technologies and the external drug delivery environment, including patent and intellectual property aspects.

          Paul has collaborated extensively with academic groups and drug delivery companies and is the co-author and co-inventor of a number of publications and patent applications. He has been a member of a range of external groups including Editorial advisory board member for the Nanomedicine journal, Scientific Advisory Board member and Programme Chair for the Controlled Release Society Conference, Scientific Consultant to the Wellcome Trust and EPSRC programme External Advisory Board member.

           

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            Expect a reply typically within 48 hours.

            Expertise:

            • Complex Medicines

            Fanny Joubert

            BSc (Hons) PhD

            Senior Scientist

            Fanny Joubert

            BSc (Hons) PhD

            Senior Scientist

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            Fanny has a strong educational training with a bachelor’s degree in chemistry followed by an engineer diploma in Materials Science and finally a PhD in Polymer Chemistry. Following her studies, she has worked as a Research Associate for 6+ years in both Academia and large Pharma focussing on polymers for healthcare and precision nanomedicine applications. She joined Seda as Senior Scientist to facilitate the development of complex parenterals using her knowledge of Nanotechnology.

            Ask me a question

              Expect a reply typically within 48 hours.

              Expertise:

              • Complex Medicines
              • Oral Drug Delivery

              Alexander Clout

              BSc (Hons) PhD

              Senior Scientist

              Alexander Clout

              BSc (Hons) PhD

              Senior Scientist

              Alex has a background in chemistry and holds a PhD in pharmaceutics from University College London, during which he gained extensive experience in the solid-state characterisation of pharmaceutical materials, including polymorphism and co-crystallisation, combining both thermal and structural analyses to develop a full picture of the changes occurring when materials undergo phase transitions. More recently he has worked on projects in formulation development with a particular focus on the microfluidic manufacture of nanomaterials for administration of sustained release parenterals. He also has valuable experience in the development and manufacture of oral solid dosage forms.

              Expertise:

              • Oral Drug Delivery
              • Complex Medicines

              Lorraine Jones

              BSc (Hons)

              Scientist

              Lorraine Jones

              BSc (Hons)

              Scientist

              Lorraine has over 20 years’ high quality laboratory experience at a leading global pharmaceutical company and one of the world’s leading toxicology laboratories. She is experienced in most aspects of drug development and toxicology, ranging from pre-clinical toxicology through to human clinical trials.