It is not always possible or desirable for medications to be delivered orally. In such cases, formulations can be given by injection e.g., via intravenous, intramuscular, subcutaneous, or other less common routes of administration. Seda’s Project Leaders have experience of the design, development, and regulatory authorisation of parenteral products and complex medicines across all phases, including commercialisation.
Diversification of the types of active pharmaceutical ingredients and the site of the biological target as well as the rate and extent to which they must be delivered for optimal balance of safety and efficacy can often mean that a conventional formulation approach is inadequate. These new molecular types or modalities are becoming ever more prevalent in the oncology and vaccine space and require delivery via a complex medicine:
“A complex medicine is one which requires application of novel technologies for delivery
and targeting of drugs through modification of API (Active Pharmaceutical Ingredient) (e.g.,
drug-dendrimer complexes), formulation (e.g. liposomes) and/or novel routes of delivery (e.g.,
intratumoural delivery).”
Seda’s team of experts has direct experience of taking several nanomedicine and other complex delivery systems from preclinical to clinical development. We have established a network of experts in the diverse array of advanced characterisation techniques that are so vital to success in this field. In addition, we can leverage in-house modelling and simulation expertise to guide the development and selection of formulation candidates for optimal in vivo performance. Our in-house DMPK and Clinical Pharmacology capability, together with close alliances to other non-clinical and clinical experts (including our link to the Medicines Discovery Catapult) are ideal for ensuring the seamless communication required to maximise success of complex medicines, where minor changes in formulation or manufacturing process can have major impact on biodistribution (and hence safety/efficacy).
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Paul is an established pharma executive with extensive global experience. Prior to joining Seda he was Vice President, Global Product Development at AstraZeneca, leading a group of over 350 scientists and engineers in the development of all products, manufacturing processes and analytical methods for the AstraZeneca small molecule portfolio.
AstraZeneca Global Product Development has centres in the UK, Sweden, US and China and a network of partnerships with colleagues all over the world and under Paul’s stewardship registered 10 global products.
At AstraZeneca Paul was accountable for the Drug Product CMC component of all Due Diligence assessments and was CMC lead on several multibillion dollar acquisitions. In addition, Paul is a visiting Professor of Pharmaceutics at the University of Manchester, UK and founder of the North West Centre for Drug Delivery (NoWCADD) at the University.
He is a proven senior manager and strategic leader in Pharmaceutical Development with experience across geographical boundaries. Passionate about the development of individual and group capabilities and the application of innovation and scientific rigour to bring new medicinal products to market.
He is recognised within the Industry and with Regulatory Agencies as a driving force in the establishment and realisation of best practice in CMC Quality by Design.
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Marcel de Matas
BSc (Hons) PhD FRSC CChem
Chief Technology Officer & Co-Founder
View Bio Ask me a questionMarcel 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.
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Paul has held several senior science leadership roles in Academia and Large Pharma. These roles focused on applying the best science in projects to ensure optimal product performance in the patient, thus bridging pharmaceutical and clinical disciplines.
Immediately prior to founding Seda Pharmaceutical Development Services Paul was Senior Clinical Pharmacology Scientist at AstraZeneca and led the clinical pharmacology program to NDA/MAA for AZD9291/osimertinib, which had been awarded ‘breakthrough therapy’ status by the FDA. Formerly Paul was a Principal Scientist within Pharmaceutical Development (AZ) leading both the global biopharmaceutics network and the Medicines Evaluation science community (USA, SE, UK).
Paul has been at the forefront of recent advances in the understanding of in vitro performance criteria that assure product performance in the patient including clinically relevant dissolution specifications (CRDS). Paul has co-authored papers with FDA staff focussed on efforts to combine biopharmaceutics with ICH Q8 (BioRAM) and is past Chair of the AAPS ‘QbD and product performance’ focus group.
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Claire Patterson is Senior Principal Scientist at Seda with a Master of Pharmacy (MPharm) and a Ph.D. in Pharmaceutics from the Universities of Nottingham and University College London respectively. 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.
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Effi is a Principal Scientist working in Analytical Sciences at Seda. Since her MSc and PhD and throughout, she has been working with Oligonucleotides/RNA, their synthesis, analysis and in the last 4 years – their pharmaceutical testing in a GxP environment. Coming from an organic Chemistry background and having worked with big biomolecules, she has experience in a multitude of different analytical techniques and their troubleshooting.
With her leadership experience in a CRO, she has the skills to work for Seda as a technical leader to ensure the quality of analytical data is excellent and the customers’ needs are met.
Effi Bätzner – Google Scholar
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Alexander Clout
BSc (Hons) PhD
Senior Scientist
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.
Lorraine Jones
BSc (Hons)
Senior Scientist
Lorraine has over 20 years’ high quality laboratory experience at a leading global pharmaceutical company and one of the world’s leading toxicology laboratories. She is experienced in most aspects of drug development and toxicology, ranging from pre-clinical toxicology through to human clinical trials.
Fanny Joubert
BSc (Hons) PhD
Senior Scientist
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.
Essyrose Mathew
BSc (Hons) PhD
Senior Scientist
Essy has a pharmaceutical science background with a PhD from Queen’s University Belfast. During her PhD she worked on 3D printed systems for transdermal drug delivery and the use of microfluidics for nanoparticle fabrication along with extensive experience in a range of analytical characterisation techniques. At Seda she will use her experience in pharmaceutics within the formulation development team, focusing on oral dosage forms and complex medicines.
Paul has 33+ years’ experience in Drug Discovery and Development at AstraZeneca, specialising in novel formulation, drug delivery and product design. He has led many projects and teams in identifying, evaluating and designing novel viable drug delivery-based products and new drug delivery technologies across a broad range of routes of administration and drug modalities including many complex medicines.
From 2017 to 2021, in additional to his role as Senior Principal Scientist in Drug Delivery, Paul was the Science & Innovation Director for Drug Delivery and Product Design, accountable for driving and championing science and innovation in drug delivery and product design to create new implementable business opportunities. Paul started and led AstraZeneca’s Global Novel Drug Delivery Network for many years and is widely recognised outside AstraZeneca as an expert on drug delivery technologies and the external drug delivery environment, including patent and intellectual property aspects.
Paul has collaborated extensively with academic groups and drug delivery companies and is the co-author and co-inventor of a number of publications and patent applications. He has been a member of a range of external groups including Editorial advisory board member for the Nanomedicine journal, Scientific Advisory Board member and Programme Chair for the Controlled Release Society Conference, Scientific Consultant to the Wellcome Trust and EPSRC programme External Advisory Board member.
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Explore our services
Our team of experts have many decades of experience in all stages of Pharmaceutical Development, DMPK and Clinical Pharmacology and the associated regulatory requirements and are on hand to guide the CMC and PK aspects of your development programme.
Seda has state-of-the-art laboratory capabilities for the rapid screening, testing and development of conventional and novel formulations to give your compound the best chance of success. We also specialise in the development of clinically relevant dissolution methods for late phase development / registration.
Seda’s modelling team and our proprietary & commercial software are perfectly placed to support translation of preclinical data to the clinical setting and onwards selection & justification of the go forward dose.