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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 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 parenteral medicine:

“A complex parenteral 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:

  • 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:

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

    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:

      • DMPK and Dose Selection
      • Pharmacokinetic Modelling
      • Complex Medicines
      • 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:

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

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          Expect a reply typically within 48 hours.

          Expertise:

          • Oral Drug Delivery
          • Paediatric Product Development
          • Complex Medicines

          Shanoo Buhdheo

          BSc (Hons)

          Principal Scientist

          Shanoo Buhdheo

          BSc (Hons)

          Principal Scientist

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          Shanoo is an experienced pharmaceutical development scientist with many years’ experience in large pharma and the biotech sector. She has a particular interest in biopharmaceutics, development of clinically relevant in vitro tests and the development of products for paediatrics.

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            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.

            Ask me a question

              Expect a reply typically within 48 hours.

              Expertise:

              • Oral Drug Delivery
              • Complex Medicines
              • Regulatory CMC

              Nicola Parisi

              MSc PhD

              Principal Scientist

              Nicola Parisi

              MSc PhD

              Principal Scientist

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              Nicola holds a MSc in Pharmaceutical Chemistry from the University of Messina and a PhD in Pharmaceutics from UCL School of Pharmacy. He is an accomplished Formulation Scientist with 9+ years’ experience in the field and roles at AstraZeneca and GlaxoSmithKline. He additionally holds a qualification from the Association for Project Management (PFQ). He is expert in planning, leading and managing clinical drug product development projects and has a deep understanding of change control, risk and stakeholder management processes.

              Ask me a question

                Expect a reply typically within 48 hours.

                Expertise:

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

                Wang Wang Lee

                MPharm (Hons) PhD GPhC

                Principal Scientist

                Wang Wang Lee

                MPharm (Hons) PhD GPhC

                Principal Scientist

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                Wang Wang Lee is a GPhC registered pharmacist with a PhD in Pharmaceutical Sciences and MBA from the University of Strathclyde. She has deep industry and academic experience particularly in the areas of biopharmaceutics and product development. Her expertise in early and late stage development, risk assessing and mitigating the development challenges has helped clients transition compounds into the clinic from discovery. Most recently, she is interested in DMPK and clinical pharmacology projects for poorly solubles and complex parenterals.

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                  Expect a reply typically within 48 hours.

                  Expertise:

                  • Oral Drug Delivery
                  • Complex Medicines

                  Talbir Austin

                  BSc (Hons) PhD CChem MRSC

                  Consultant - Material Sciences

                  Talbir Austin

                  BSc (Hons) PhD CChem MRSC

                  Consultant - Material Sciences

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                  Dr Talbir (Tal) Austin is a consultant providing expertise in solid state, material design and characterisation, and development with particular focus on the early development phase.

                  Dr Austin is a structural organic chemist who has worked within the pharmaceutical industry for nearly three decades. Her previous positions involved complex problem solving and troubleshooting of projects – overseeing material design, selection and development, from the Preclinical phase through to Early Development at AstraZeneca. She also led the design and implementation of AstraZeneca’s material selection strategy at the discovery and development interface. Dr Austin has extensive experience in optimising material properties for different therapy areas (Respiratory, Inflammation, CNS, CV, GI and Oncology) and modes of administration; oral, inhalation, parenteral, topical.

                  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

                    Elen Roberts

                    BSc (Hons)

                    Scientist

                    Elen Roberts

                    BSc (Hons)

                    Scientist

                    First class Medical Science graduate with 1.5 years experience working in the pharmaceutical industry. Areas of focus include formulation development for both preclinical and clinical studies across a range of administrative routes and indications, including the use of amorphous solid dispersions to enhance the solubility of poorly soluble compounds.