Contact us

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

Scroll

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.

Ask us a question

Do you have a specific question not listed above? Ask one of our leaders or experts who will be happy to help.
Expect a reply typically within 48 hours.

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

    View Bio Ask me a question

    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

      View Bio Ask me a question

      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

          View Bio Ask me a question

          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.

            Andy Mellor

            CIMA

            Finance Director

            Andy Mellor

            CIMA

            Finance Director

            View Bio Ask me a question

            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:

                            • 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

                            Ask me a question

                              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:

                                • 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 Biopharmaceutics scientist having spent 12 years with former employer AstraZeneca with roles in Early and Late Stage Product Development, linking in vitro to in vivo product performance. Current focus areas include subcutaneous and complex parenteral biopharmaceutics (including nanomedicines) and other non-oral routes of administration.

                                      ‪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

                                                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.

                                                    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.

                                                    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

                                                    View Bio Ask me a question

                                                    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:

                                                      • Human Resources

                                                      Faye Briffa

                                                      BA (Hons) FCIPD

                                                      HR Business Partner

                                                      Faye Briffa

                                                      BA (Hons) FCIPD

                                                      HR Business Partner

                                                      View Bio Ask me a question

                                                      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.

                                                        Team page >

                                                        Our latest news

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

                                                        Read

                                                        May 2022

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

                                                        Read

                                                        Jan 2022

                                                        Biopharmaceutics: From Fundamentals to Industrial Practice

                                                        Read

                                                        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

                                                        Read