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Frequently asked questions

How do I balance risk versus cost in my development plan?

At the early stages of development, one must determine the essential experiments to perform to de-risk any clinical studies and meet the regulatory requirements. Equally important is the ability to determine those experiments that can be delayed until the next value inflection so as to manage the spend profile. At Seda we have vast experience in making these judgements and can work with Clients to establish a bespoke development plan that addresses the needs of the molecule and the strategic drivers of the business. We never try to force fit your molecule in to a branded, template development approach. This will ensure that spend is managed without unnecessary delays to the project timeline.

How do I gain adequate exposure in pre-clinical studies?

At Seda we have extensive experience in selecting formulation compositions to optimise exposure in animal studies, particularly those in which large doses are given. Formulations and dosing vehicles are selected based on our knowledge of dosing precedents across a range of preclinical species and the ability of the vehicles to deliver compounds in a solubilised form for oral and parenteral administration. We also have strong expertise in development of long acting formulations for dosing by subcutaneous, intramuscular and intratumoral administration.

How do I accelerate my candidate to First in Human studies?

Seda has established a framework for the rapid, successful and cost-effective development of products for clinical studies in healthy volunteers and patients. Bespoke development strategies for first time in human studies are focused on an understanding of the clinical programme combined with a developability assessment based on compound physicochemical, physicomechanical, drug absorption and pharmacokinetic properties. This allows us to quickly select the most appropriate dosage form and delivery systems for your compound from a range of proven technologies whilst developing relevant analytical methodologies for testing of product quality.

How do I optimise exposure?

Seda has access to an extensive library of enabling technologies for ensuring that the optimal PK profile and bioavailability is achieved for every compound. This covers technologies for the oral delivery of compounds with low aqueous solubility including lipidic delivery systems, liquid and semi-solid filled capsules and amorphous solid dispersions. We also have the ability to rapidly assess the suitability of particle size reduction as a means of enhancing the rate and extent of drug absorption. For compounds requiring parenteral administration, we have significant experience in the development of long-acting injections including polymeric microparticles, in-situ forming systems and oily depots.

How do I predict a Human Dose?

Our in-house drug metabolism and pharmacokinetics (DMPK) experts can guide you in the prediction of human systemic pharmacokinetics parameters. This is coupled with knowledge of the concentration and duration of coverage needed at the target tissue. A crucial additional step is the application of our proprietary in silico absorption modelling software, Nora Max, which is used to predict the fraction of the administered dose that would be absorbed, based on the compound’s physicochemical properties and formulation attributes. Via this approach, Seda can guide you in the selection of an appropriate human dose / schedule, optimising time and costs involved in formulation development for human clinical studies.

What technologies are available for drug targeting and intracellular delivery?

The changing nature of (bio)pharmaceutical pipelines has seen an increasing interest in the development of complex medicines, in particular those administered by injection. This includes a growing appetite for the development of nanomedicines and colloidal systems, including those aimed at promoting the accumulation of molecules in specific target tissues and cells such as lipid, polymeric and inorganic nanoparticles. Seda has a strong track record of supporting research organisations, biotech businesses and drug delivery companies to navigate the journey for these most complex of pharmaceutical systems into the clinic, providing deep technical insights and an understanding of regulatory requirements.

What pharmacokinetic profile should we aim for?

Rather than focussing purely on dose strength, we encourage Clients to consider the desired PK profile for optimum formulation performance. As experts in pharmacokinetic-pharmacodynamic-outcome (PK-PD) and PBPK modelling, we can assist Clients in interrogating preclinical data and translating it to a target human PK profile and thus, optimal release profile for the drug product.

How do we bridge between formulations?

When formulation or manufacturing process changes are made during development, it is important to understand whether there will be any impact on clinical performance of the drug product. Clinically relevant differences in PK profile part way through a development programme may invalidate prior safety and efficacy data or may necessitate a dose adjustment. The stage of development defines how stringently the standards are applied. Supporting data can range from comparative dissolution testing and in silico modelling, to clinical relative bioavailability studies or formal bioequivalence studies. Seda will guide you through rational design of your drug product bridging strategy, allowing your programme to progress at optimal speed and cost.

How do we meet the requirements for paediatric development?

Changes in the regulations now require the pharmaceutical industry to design and develop age appropriate formulations and perform clinical trials involving paediatrics, in addition to the development and approval of the drug product for adults. Seda has in-house expertise and a network of external thought leaders in the provision of formulation development, in silico PK prediction, taste assessment, and regulatory authoring to help you design and deliver your paediatric development program.

How do we develop an appropriate Regulatory Control Strategy?

One of the fundamental tenets of Quality by Design is to ‘start with the end in mind’. The most effective way to approach this is to think about a final, holistic Control Strategy that will form the basis of your quality assurance at the point of Product Authorisation and to focus your development efforts on this goal. This will structure your assessment and management of risk, your product design goals (through a Quality Target Product Profile) and your analytical method development.
This approach can be applied, as appropriate, at any stage of development and will maximise the value of your development asset.

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Leadership Team

Expertise:

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

Marcel de Matas

BSc (Hons) PhD FRSC CChem

Chief Technology Officer & Co-Founder

Marcel de Matas

BSc (Hons) PhD FRSC CChem

Chief Technology Officer & 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.

‪Marcel de Matas‬ – ‪Google Scholar‬

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    Expertise:

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

    Paul W Stott

    BPharm (Hons) PhD

    Chief Executive Officer

    Paul W Stott

    BPharm (Hons) PhD

    Chief Executive Officer

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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.

    ‪Paul Stott‬ – ‪Google Scholar‬

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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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        Expertise:

        • Oral Drug Delivery
        • Paediatric Product Development

        Shanoo Budhdeo

        BSc (Hons)

        Director: Pharmaceutical Sciences

        Shanoo Budhdeo

        BSc (Hons)

        Director: Pharmaceutical Sciences

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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.

        ‪Shanoo Budhdeo‬ – ‪Google Scholar‬

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          Expertise:

          • Human Resources

          Faye Briffa

          BA (Hons) FCIPD

          HR Business Partner

          Faye Briffa

          BA (Hons) FCIPD

          HR Business Partner

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          After a 20 year career in HR working primarily in the Pharmaceutical Industry, Faye Briffa set up Ashfield HR, an HR Consultancy supporting North West based small and medium sized companies who have no in-house HR capability. Faye is CIPD qualified having achieved a Post Graduate Diploma in HR Management from Manchester Metropolitan University in 2002. Since then, she has held a variety of HR roles, including in Recruitment, Employment, Business Change and HR Business Partnering.

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            Andy Mellor

            CIMA

            Finance Director

            Andy Mellor

            CIMA

            Finance Director

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            Andy’s background started in Community Pharmacy in Finance and Commercial roles.  Since then, Andy has operated as Finance Director/CFO in a number of high-growth, privately owned and private equity backed businesses.  Andy’s experience ranges from education, healthcare, childcare, IT Services & property.

            Andy is a CIMA qualified accountant for over 20 years.

            Andy oversees the Finance team at Seda, ensuring we are growing sustainably, with the appropriate governance, processes and structure.

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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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                Our Subject Matter Experts

                Expertise:

                • Oral Drug Delivery
                • Paediatric Product Development

                Shanoo Budhdeo

                BSc (Hons)

                Director: Pharmaceutical Sciences

                Shanoo Budhdeo

                BSc (Hons)

                Director: Pharmaceutical Sciences

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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.

                ‪Shanoo Budhdeo‬ – ‪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

                  View Bio Ask me a question

                  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:

                    • Complex Medicines
                    • Oral Drug Delivery

                    Alexander Clout

                    BSc (Hons) PhD

                    Associate Principal Scientist

                    Alexander Clout

                    BSc (Hons) PhD

                    Associate Principal Scientist

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                    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.

                    ‪Alexander Clout‬ – ‪Google Scholar‬

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                      Expertise:

                      • Pharmacokinetic Modelling

                      Jake Dickinson

                      BSc (Hons)

                      Principal Modeller

                      Jake Dickinson

                      BSc (Hons)

                      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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                        Paula Goddard

                        BA (Hons)

                        Head of Sales & Marketing

                        Paula Goddard

                        BA (Hons)

                        Head of Sales & Marketing

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                        Paula brings with her to Seda PDS 25 years of commercial sales, business development and marketing experience, gained largely from blue chip, branded FMCG organisations including Diageo and Sara Lee Corporation where she had demonstrable success in identifying and converting brand building opportunities, leading first to market launches and delivering significant profitable growth to both Client and Brand.

                        In recent years she has been working with some of the world’s biggest technology brands to deliver pan European technical projects where her focus was solely on delivering high quality, accurate data on time and in budget, in line with Client expectations.

                        Paula is looking forward to working alongside the team in building, implementing and delivering a strategic sales and marketing plan that will further cement Seda’s growing importance and contribution to the pharma sector.

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                          Expertise:

                          • Complex Medicines

                          Fanny Joubert

                          BSc (Hons) PhD

                          Associate Principal Scientist

                          Fanny Joubert

                          BSc (Hons) PhD

                          Associate Principal Scientist

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                          Fanny has a bachelor’s degree in chemistry, an engineer diploma in Materials Science and a PhD in Polymer Chemistry. Following her studies, she 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.

                          ‪Fanny Joubert‬ – ‪Google Scholar‬

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                            Expertise:

                            • Oral Drug Delivery
                            • CMC Regulatory
                            • Analytical Sciences

                            Arun Kamath

                            MChem (Hons)

                            Associate Principal Scientist

                            Arun Kamath

                            MChem (Hons)

                            Associate Principal Scientist

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                            Arun Kamath is an Associate Principal Scientist in Analytical Sciences at Seda. He has a Master of Chemistry (MChem) from the University of Leeds, with over 14 years’ experience in the global pharmaceutical industry. His area of expertise is in analytical sciences for drug product development, which has involved working with a wide range of analytical techniques and developing a comprehensive understanding of drug project analytical strategy requirements and critical product quality attributes.

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                              Expect a reply typically within 48 hours.

                              Expertise:

                              • Oral Drug Delivery
                              • CMC Regulatory

                              Pankaj Mittal

                              BPharm (Hons) MS

                              Technical Director

                              Pankaj Mittal

                              BPharm (Hons) MS

                              Technical Director

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                              Pankaj has held several senior product development & technology transfer leadership roles in Large & Mid-size Pharma introducing new manufacturing technologies, product innovation & design to expedite the overall drug development pathway.

                              Pankaj has managed product development and technical teams responsible for delivering products to the patients from FTiH through late-stage development, linking regulatory and launch activities in multiple international markets. Passionate about the technical capability build with the application of robust Quality by Design & Quality Risk Management principles, Pankaj will enhance the technical product robustness and business development function at Seda.

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                                Expertise:

                                • Complex Medicines
                                • Clinical Pharmacology

                                Claire Patterson

                                MPharm (Hons) PhD

                                Director: Complex Medicines

                                Claire Patterson

                                MPharm (Hons) PhD

                                Director: Complex Medicines

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                                Claire Patterson is Director, Complex Medicines at Seda with a Master of Pharmacy (MPharm) and a Ph.D. in Pharmaceutics from the Universities of Nottingham and University College London. Claire is an experienced Project Leader and Biopharmaceutics Scientist having spent 12 years with former employer AstraZeneca with roles in Early and Late Stage Product Development, plus 5 years as a senior leader within Seda. Claire specialises in subcutaneous delivery and complex parenterals (particularly long acting injectables and nanomedicines).

                                ‪Claire Patterson‬ – ‪Google Scholar‬

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                                  Expertise:

                                  • DMPK Consultancy and Dose Selection
                                  • Pharmacokinetic Modelling
                                  • Clinical Pharmacology

                                  Alison Wilby

                                  BSc (Hons) MSc PhD

                                  Senior Principal Scientist: Clinical Pharmacology and DMPK

                                  Alison Wilby

                                  BSc (Hons) MSc PhD

                                  Senior Principal Scientist: Clinical Pharmacology and DMPK

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                                  Alison 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.

                                  ‪Alison Wilby‬ – ‪Google Scholar‬

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