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Maximising your value through the integrated application of Pharmaceutical Development and Clinical Pharmacology expertise

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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

View Bio Ask me a question

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

Ask me a question

    Expect a reply typically within 48 hours.

    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

    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

      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

      Ask me a question

        Expect a reply typically within 48 hours.

        Expertise:

        • Oral Drug Delivery
        • Paediatric Product Development

        Shanoo Budhdeo

        BSc (Hons)

        Director: Pharmaceutical Sciences

        Shanoo Budhdeo

        BSc (Hons)

        Director: Pharmaceutical Sciences

        View Bio Ask me a question

        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

        Ask me a question

          Expect a reply typically within 48 hours.

          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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            Expect a reply typically within 48 hours.

            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.

            Ask me a question

              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

              Ask me a question

                Expect a reply typically within 48 hours.

                Our Subject Matter Experts

                Expertise:

                • Analytical Sciences
                • Chemical Development
                • CMC Regulatory
                • Complex Medicines

                Effi Baetzner

                PhD

                Director, Quality Control

                Effi Baetzner

                PhD

                Director, Quality Control

                View Bio Ask me a question

                Effi is a dedicated QC Director at Seda, she is a Principal Scientist and Leader within the pharmaceutical industry. Joining Seda with Line Management responsibilities, she immersed herself in Pharmaceutical Development, gaining valuable insights into the nuanced needs of our clients. In her prior role at a distinguished GxP-accredited CRO, Effi emerged as a leader in analytical testing, specializing in Oligonucleotides and RNA for both commercial and developmental Drug Substance and Product. Drawing on her background as a studied organic chemist, she possesses a wealth of knowledge in small molecules and their comprehensive analysis, cultivated over years of focused expertise. Effi’s multifaceted experience uniquely positions her to understand and address the diverse needs of Seda. As she journeyed from an R&D environment during her studies and PhD to a GxP environment, the understanding and implementation of good quality control processes increased throughout her career and brought her to this exciting opportunity

                ‪Effi Bätzner‬ – ‪Google Scholar‬

                 

                Ask me a question

                  Expect a reply typically within 48 hours.

                  Expertise:

                  • GMP Facilities Management
                  • Validation of equipment and Services
                  • Drug Product Manufacture
                  • API Particle Size Reduction Processing

                  Darren Gill

                  BTEC HND (Biology)

                  Director, Facility Management

                  Darren Gill

                  BTEC HND (Biology)

                  Director, Facility Management

                  View Bio Ask me a question

                  Prior to joining Seda, I have worked for in the pharmaceutical industry for 26 Years. During this time, I have been involved in R&D Projects across a wide range of Therapeutic areas and in Sterile Manufacturing, Solid Oral Dosage Forms and in Active Pharmaceutical Ingredients (API). I have managed the Facilities team for many years upgrading a number of existing facilities, introducing new equipment, new technologies and services (eg purified water systems, HVAC Systems) as well as System owner for a number of GMP IT systems. In addition, the team I managed ensured the routine cleaning, maintenance and calibration of the Drug Product and API manufacturing plants along with the large High bay warehouse. In the last 2 years before joining Seda I worked within the Development Quality function responsible for the Quality Management System (QMS) and GMP Training.

                  Ask me a question

                    Expect a reply typically within 48 hours.

                    Expertise:

                    • GMP Manufacture
                    • New Product Introduction (NPI)
                    • Respiratory Drug Development (Generics)
                    • Drug Delivery Devices

                    Mike Hingley

                    MIM, MCMI

                    Director, GMP Operations

                    Mike Hingley

                    MIM, MCMI

                    Director, GMP Operations

                    View Bio Ask me a question

                    Mike has over 15 years’ experience in respiratory drug delivery and diagnostic manufacturing. Prior to working with Seda, Mike was based in Boston, MA as VP Device Manufacturing Operations at Sense Biodetection with responsibility for contract manufacture, and distribution of all North American and European diagnostic products.  Before joining Sense, Mike held the role of Director of NPI and GMP Manufacture with Vectura Ltd, with responsibility for the manufacture and supply of pilot and clinical scale dry powder inhaler and nebuliser drug delivery systems.

                    Ask me a question

                      Expect a reply typically within 48 hours.

                      Expertise:

                      • Quality Assurance
                      • QMS
                      • Quality Management
                      • Regulatory Guidance
                      • Good Manufacturing Practice

                      Vijay Masaun

                      BSc (Hons)

                      Director, Quality Assurance

                      Vijay Masaun

                      BSc (Hons)

                      Director, Quality Assurance

                      View Bio Ask me a question

                      Vijay is an experienced Quality Professional with a distinguished career marked by several senior quality roles within various pharmaceutical organisations primarily in the CDMO/CMO space.

                      His comprehensive understanding of the pharmaceutical landscape, coupled with his strategic thinking, has enabled him to navigate the complexities of the evolving industry standards.

                      Vijay has a proven track record spanning over 9 years in the pharmaceutical industry as well as training to be a Qualified Person (QP), which will bring valuable experience to the Seda GMP team and ensuring a commitment to upholding regulatory standards.

                      Ask me a question

                        Expect a reply typically within 48 hours.

                        Expertise:

                        • Oral Drug Delivery
                        • Paediatric Product Development

                        Shanoo Budhdeo

                        BSc (Hons)

                        Director: Pharmaceutical Sciences

                        Shanoo Budhdeo

                        BSc (Hons)

                        Director: Pharmaceutical Sciences

                        View Bio Ask me a question

                        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

                        Ask me a question

                          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

                          Ask me a question

                            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

                            View Bio Ask me a question

                            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

                            Ask me a question

                              Expect a reply typically within 48 hours.

                              Expertise:

                              • Pharmacokinetic Modelling

                              Jake Dickinson

                              BSc (Hons)

                              Associate Principal Modeller

                              Jake Dickinson

                              BSc (Hons)

                              Associate Principal Modeller

                              View Bio Ask me a question

                              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.

                                Paula Goddard

                                BA (Hons)

                                Head of Sales & Marketing

                                Paula Goddard

                                BA (Hons)

                                Head of Sales & Marketing

                                View Bio Ask me a question

                                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.

                                Ask me a question

                                  Expect a reply typically within 48 hours.

                                  Expertise:

                                  • Complex Medicines

                                  Fanny Joubert

                                  BSc (Hons) PhD

                                  Senior Scientist

                                  Fanny Joubert

                                  BSc (Hons) PhD

                                  Senior Scientist

                                  View Bio Ask me a question

                                  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

                                  Ask me a question

                                    Expect a reply typically within 48 hours.

                                    Expertise:

                                    • Oral Drug Delivery
                                    • CMC Regulatory
                                    • Analytical Sciences

                                    Arun Kamath

                                    MChem (Hons)

                                    Associate Principal Scientist

                                    Arun Kamath

                                    MChem (Hons)

                                    Associate Principal Scientist

                                    View Bio Ask me a question

                                    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.

                                    Ask me a question

                                      Expect a reply typically within 48 hours.

                                      Expertise:

                                      • Oral Drug Delivery

                                      Wang Wang Lee

                                      MPharm (Hons) PhD GPhC

                                      Principal Scientist

                                      Wang Wang Lee

                                      MPharm (Hons) PhD GPhC

                                      Principal Scientist

                                      View Bio Ask me a question

                                      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.

                                      ‪Wang Wang Lee‬ – ‪Google Scholar‬

                                      Ask me a question

                                        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

                                        View Bio Ask me a question

                                        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.

                                        Ask me a question

                                          Expect a reply typically within 48 hours.

                                          Expertise:

                                          • Complex Medicines
                                          • Clinical Pharmacology

                                          Claire Patterson

                                          MPharm (Hons) PhD

                                          Director: Complex Medicines

                                          Claire Patterson

                                          MPharm (Hons) PhD

                                          Director: Complex Medicines

                                          View Bio Ask me a question

                                          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

                                          Ask me a question

                                            Expect a reply typically within 48 hours.

                                            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

                                            View Bio Ask me a question

                                            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

                                            Ask me a question

                                              Expect a reply typically within 48 hours.

                                              GMP Implementation Team

                                              Expertise:

                                              • Analytical Sciences
                                              • Chemical Development
                                              • CMC Regulatory
                                              • Complex Medicines

                                              Effi Baetzner

                                              PhD

                                              Director, Quality Control

                                              Effi Baetzner

                                              PhD

                                              Director, Quality Control

                                              View Bio Ask me a question

                                              Effi is a dedicated QC Director at Seda, she is a Principal Scientist and Leader within the pharmaceutical industry. Joining Seda with Line Management responsibilities, she immersed herself in Pharmaceutical Development, gaining valuable insights into the nuanced needs of our clients. In her prior role at a distinguished GxP-accredited CRO, Effi emerged as a leader in analytical testing, specializing in Oligonucleotides and RNA for both commercial and developmental Drug Substance and Product. Drawing on her background as a studied organic chemist, she possesses a wealth of knowledge in small molecules and their comprehensive analysis, cultivated over years of focused expertise. Effi’s multifaceted experience uniquely positions her to understand and address the diverse needs of Seda. As she journeyed from an R&D environment during her studies and PhD to a GxP environment, the understanding and implementation of good quality control processes increased throughout her career and brought her to this exciting opportunity

                                              ‪Effi Bätzner‬ – ‪Google Scholar‬

                                               

                                              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

                                                Chief Technology Officer & Co-Founder

                                                Marcel de Matas

                                                BSc (Hons) PhD FRSC CChem

                                                Chief Technology Officer & Co-Founder

                                                View Bio Ask me a question

                                                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

                                                Ask me a question

                                                  Expect a reply typically within 48 hours.

                                                  Expertise:

                                                  • GMP Facilities Management
                                                  • Validation of equipment and Services
                                                  • Drug Product Manufacture
                                                  • API Particle Size Reduction Processing

                                                  Darren Gill

                                                  BTEC HND (Biology)

                                                  Director, Facility Management

                                                  Darren Gill

                                                  BTEC HND (Biology)

                                                  Director, Facility Management

                                                  View Bio Ask me a question

                                                  Prior to joining Seda, I have worked for in the pharmaceutical industry for 26 Years. During this time, I have been involved in R&D Projects across a wide range of Therapeutic areas and in Sterile Manufacturing, Solid Oral Dosage Forms and in Active Pharmaceutical Ingredients (API). I have managed the Facilities team for many years upgrading a number of existing facilities, introducing new equipment, new technologies and services (eg purified water systems, HVAC Systems) as well as System owner for a number of GMP IT systems. In addition, the team I managed ensured the routine cleaning, maintenance and calibration of the Drug Product and API manufacturing plants along with the large High bay warehouse. In the last 2 years before joining Seda I worked within the Development Quality function responsible for the Quality Management System (QMS) and GMP Training.

                                                  Ask me a question

                                                    Expect a reply typically within 48 hours.

                                                    Expertise:

                                                    • GMP Manufacture
                                                    • New Product Introduction (NPI)
                                                    • Respiratory Drug Development (Generics)
                                                    • Drug Delivery Devices

                                                    Mike Hingley

                                                    MIM, MCMI

                                                    Director, GMP Operations

                                                    Mike Hingley

                                                    MIM, MCMI

                                                    Director, GMP Operations

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                                                    Mike has over 15 years’ experience in respiratory drug delivery and diagnostic manufacturing. Prior to working with Seda, Mike was based in Boston, MA as VP Device Manufacturing Operations at Sense Biodetection with responsibility for contract manufacture, and distribution of all North American and European diagnostic products.  Before joining Sense, Mike held the role of Director of NPI and GMP Manufacture with Vectura Ltd, with responsibility for the manufacture and supply of pilot and clinical scale dry powder inhaler and nebuliser drug delivery systems.

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                                                      Expect a reply typically within 48 hours.

                                                      Expertise:

                                                      • Quality Assurance
                                                      • QMS
                                                      • Quality Management
                                                      • Regulatory Guidance
                                                      • Good Manufacturing Practice

                                                      Vijay Masaun

                                                      BSc (Hons)

                                                      Director, Quality Assurance

                                                      Vijay Masaun

                                                      BSc (Hons)

                                                      Director, Quality Assurance

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                                                      Vijay is an experienced Quality Professional with a distinguished career marked by several senior quality roles within various pharmaceutical organisations primarily in the CDMO/CMO space.

                                                      His comprehensive understanding of the pharmaceutical landscape, coupled with his strategic thinking, has enabled him to navigate the complexities of the evolving industry standards.

                                                      Vijay has a proven track record spanning over 9 years in the pharmaceutical industry as well as training to be a Qualified Person (QP), which will bring valuable experience to the Seda GMP team and ensuring a commitment to upholding regulatory standards.

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                                                        Expect a reply typically within 48 hours.

                                                        Asimo Michail

                                                        Bsc (Hons) Msc (Hons)

                                                        Senior Scientist

                                                        Asimo Michail

                                                        Bsc (Hons) Msc (Hons)

                                                        Senior Scientist

                                                        Asimo has a Bachelor’s in Biological Sciences and a Master’s in Biotechnology with 12 years of experience working in Molecular Diagnostics and in Pharma Biotech. She specialises in assay product development (Oncology and Infectious Diseases portfolios), analytical design transfer and laboratory management.  She has previously worked as a Laboratory Manager for a couple of organisations where she was involved in setting up laboratories and making sure that the labs are audit ready at all times. 

                                                        Dominic Parry

                                                        BSc (Hons) MChem

                                                        Senior Scientist

                                                        Dominic Parry

                                                        BSc (Hons) MChem

                                                        Senior Scientist

                                                        Dominic is a Senior Scientist at Seda. He completed an MChem at the University of Bradford and has over 8 years GMP experience having spent most of his career working in pharmaceutical testing environments.

                                                        Kieran Sproston

                                                        MPharm

                                                        Senior Scientist

                                                        Kieran Sproston

                                                        MPharm

                                                        Senior Scientist

                                                        Kieran completed an MPharm at the University of Manchester and is a registered Pharmacist. He has 4 years of experience as a formulation scientist responsible for formulation design and manufacturing process optimisation for a range of OSD projects. He will support the GMP Operations team to establish a robust, GMP manufacturing capability. 

                                                        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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                                                          Expect a reply typically within 48 hours.

                                                          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.

                                                          Ask me a question

                                                            Expect a reply typically within 48 hours.

                                                            Expertise:

                                                            • Oral Drug Delivery
                                                            • Amorphous Solid Dispersions

                                                            Elen Roberts

                                                            BSc (Hons)

                                                            Senior Scientist

                                                            Elen Roberts

                                                            BSc (Hons)

                                                            Senior Scientist

                                                            Elen has a Bachelors degree in Medical Sciences from the University of Leeds and is currently undertaking a Masters in Industrial Pharmaceutical Sciences at the University of Manchester. Since 2019, Elen has been working in Seda’s pharmaceutical development team as a formulation scientist, developing pre-clinical and clinical client drug products with a focus on oral drug delivery (tablets, capsules, oral solutions and suspensions, semi-solid matrices) and a particular interest in amorphous solid dispersions (ASDs). As Elen moves into Seda’s clinical manufacturing team, she will translate her formulation design and development knowledge into her role as a senior scientist within GMP Operations, where she will be involved in new product introduction, tech transfer and clinical manufacturing, and her prior experience with the development of ASDs will allow her to play a vital role in Seda’s spray drying capabilities.

                                                            Team page >

                                                            Our latest news

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                                                            Introducing Seda Clinical Manufacturing Services (CMS) 
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                                                            Seda wins King’s Award for Enterprise 2024
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                                                            Case Study: Seda develops preclinical formulation for The Institute of Cancer Research
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                                                            Seda collaborates with Medicines Discovery Catapult to support the manufacture and characterisation of lipid nanoparticles
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                                                            Introducing the Clinical Manufacturing Division Leadership Team
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                                                            Seda announces establishment of GMP manufacturing capability
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                                                            Appointment of Van Thuy Truong (Senior Scientist: Modeller)
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                                                            Recent Promotions – Alex Clout and Harri Dickinson
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                                                            Seda are Exhibiting – CPHI Barcelona 2023
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                                                            Matthew Quinn enrolled on Apprenticeship Scheme
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                                                            New Senior Principal Scientist – Alison Wilby
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                                                            2023 Medilink UK Export Achievement Award
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                                                            New Head of Sales & Marketing – Paula Goddard
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                                                            New Appointments: Pankaj Mittal and Essyrose Mathew
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                                                            Medilink North of England Export Achievement Award 2023
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                                                            Seda: Winners of Bionow Business Growth Award 2022
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                                                            Seda joins Scientist.com enhancing global accessibility of our services
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                                                            Could Nasal Biopharmaceutics models help you pick a winner?
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                                                            Life Sciences Innovator Category Winner 2023
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                                                            Analyse this! Seda appoints two new Analytical Scientists
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                                                            Oncology Development Programme (ODP2): Apply Now
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                                                            Continued Growth for Seda’s PK Modelling Capabilities
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                                                            Career Progression at Seda: Promotions Announced
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                                                            Seda hosts Open Day
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                                                            AAPS PharmSci 360 2022 – Seda on Tour!
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                                                            Seda announces Open Day
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                                                            Seda’s HAPI Place
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                                                            Seda acquires top-of-the-range Zetasizer for nanomedicine characterisation
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                                                            Expanding Frontiers in Model Informed Drug Development
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                                                            New Scientists – July 2022
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                                                            Finding your perfect outsourcing partner
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                                                            MDC Connects: A Guide to Complex Medicines, featuring Seda
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                                                            Seda’s Lorraine Jones Undertakes PIAT Master’s Course
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                                                            Seda Facilities Update – We have moved!
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                                                            Latest Trends in Clinically Relevant Dissolution Specifications
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                                                            New Facility Update: Two weeks ‘til moving day!
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                                                            Monday Musings: Seda modeller Jake Dickinson’s reflections on QSP Conference 2022
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                                                            It’s DNA Day! How do you deliver yours?
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                                                            Facilities Update: Cracking a few eggs to make an omelette!
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                                                            Review publication inspires Seda scientists to reflect on their involvement in the commercial development of five kinase inhibitors
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                                                            Seda announces £4m investment in new state-of-the-art facilities
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                                                            Seda Scientists Author New Biopharmaceutics Textbook
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                                                            Continued Growth for Seda’s Analytical Capabilities
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                                                            Seda named ‘Best CRO’ at OBN Awards 2021
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                                                            Long Acting Injectables: Model Integrated Approaches for Bioequivalence
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                                                            Movers and Shakers in BioBusiness 2021
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                                                            Appointment of Paul Gellert
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                                                            Bionow – 2021 Oncology Conference
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                                                            Dissolution testing: Real-world evaluation of UV arch probes
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                                                            Seda Shortlisted as Finalist for Best CRO
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                                                            AAPS PharmSci 360: Jake Dickinson presents non-linear IVIVC
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                                                            Life Science Integrates Presentation with Paul Stott
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                                                            Seda’s Elen Roberts Accepted onto PIAT Master’s Course
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                                                            Seda’s cutting-edge Differential Scanning Calorimetry capabilities
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                                                            Seda’s Jake Dickinson Promoted to Senior Modeller
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                                                            A Novel Insight into Pharmaceutical Polycrystalline Powders
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                                                            Fanny Joubert Joins the Seda Team as Senior Scientist
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                                                            Formulating Complex Medicines: A simple solution?
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                                                            Linette Ruston joins Seda in ADME role
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                                                            Is Powder Segregation Driving You Nuts?
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                                                            Offering clarity to the scope of the term ‘complex medicines’
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                                                            Alantra’s Pharma Fast 50: Seda named ‘One to Watch’
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                                                            New Publication from Seda’s Joanna Denbigh on label-free imaging of complex drug delivery systems
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                                                            New Publication from Seda’s Modelling Group
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                                                            Pharmacokinetic Modelling: Seda’s Jake Dickinson Shortlisted as Bionow Promising Technologist of the Year 2020
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                                                            Claire Patterson as co-lead author in high impact complex targeted nanomedicine (dendrimer) publication
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                                                            Paul Dickinson Presents: Developing Clinically Relevant Dissolution Specifications in APS Virtual Webinar Series
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                                                            CellCentric’s first-in-class p300/CBP inhibitor CCS1477 publishes in Cancer Discovery
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                                                            Publication of Influential Workshop Output on Physiologically Based Biopharmaceutics Modelling (PBBM)
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                                                            Bionow Oncology Conference: Pharmaceutical Development Session featuring Paul Stott and Claire Patterson
                                                            All News >

                                                            Our latest Research Papers & Books

                                                            July 2022

                                                            Population PK modelling as an alternative route to bioequivalence

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                                                            May 2022

                                                            Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products: Virtual Webinar Series

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                                                            Jan 2022

                                                            Biopharmaceutics: From Fundamentals to Industrial Practice

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                                                            September 2021

                                                            First in human, modular study of samuraciclib (CT7001), a first-in-class, oral, selective inhibitor of CDK7, in patients with advanced solid malignancies

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