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

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

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

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

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.

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

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.

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