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

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

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

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

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

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.

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.

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

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

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.

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.

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.

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

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

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

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

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.

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

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.

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.

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

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

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

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

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.

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.

Elisha has 6 years of experience in the pharmaceutical industry. She has experience in inhalation, OSD and liquids/suspensions. She has a broad range of skills in analytical, formulation, packaging and cleaning verification. She has experience in the following analytical aspects early-stage development, method validation, early stage/registration stability and QC. She also has formulation experience in early-stage formulation development, batches for bioequivalence/bioavailability, registration, engineering and scale up of commercial OSD products for EU and US markets. She has also gained additional skills and experience in selecting/optimising packaging, procurement of lab scale/commercial manufacturing equipment and the re-design of an analytical and formulation lab.

Elisha will continue to apply her broad range of skills in building a robust GMP facility.

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.

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 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 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. 

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

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.

Alan is an overseas Pharmacist with 9 years’ experience in the pharmacy environment. He has an MSc degree with distinction in Drug Design and Discovery from the University of Salford, and another MSc in Pharmaceutical Analysis from the University of Strathclyde. Alan has experience working as a QC analyst for almost 2 years in a GMP environment, and has worked for 2 years as an assistant lecturer in the School of Pharmacy at University of Sulaimani. He has special interests in characterisation of pharmaceutical materials, nanomedicines, analytical method development and utilising spectroscopy and chromatography in chemical and bioanalysis.

‪Alan Raoof‬ – ‪Google Scholar‬

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.