Seda Given

Seda Given
Maximising your value through the integrated application of Pharmaceutical Development and Clinical Pharmacology expertise
How do I balance risk versus cost in my development plan?
How do I gain adequate exposure in pre-clinical studies?
How do I accelerate my candidate to First in Human studies?
What technologies are available for drug targeting and intracellular delivery?
What pharmacokinetic profile should we aim for?
How do we bridge between formulations?
How do we meet the requirements for paediatric development?
How do we develop an appropriate Regulatory Control Strategy?
CellCentric’s first-in-class p300/CBP inhibitor CCS1477 publishes in Cancer Discovery
Publication of Influential Workshop Output on Physiologically Based Biopharmaceutics Modelling (PBBM)
Bionow Oncology Conference: Pharmaceutical Development Session featuring Paul Stott and Claire Patterson
Finding your perfect outsourcing partner
MDC Connects: A Guide to Complex Medicines, featuring SEDA
SEDA Facilities Update – We have moved!
Latest Trends in Clinically Relevant Dissolution Specifications
New Facility Update: Two weeks ‘til moving day!
Monday Musings: SEDA modeller Jake Dickinson’s reflections on QSP Conference 2022
It’s DNA Day! How do you deliver yours?
SEDA’s Lorraine Jones Undertakes PIAT Master’s Course
Facilities Update: Cracking a few eggs to make an omelette!
Review publication inspires SEDA scientists to reflect on their involvement in the commercial development of five kinase inhibitors
SEDA announces £4m investment in new state-of-the-art facilities
SEDA Scientists Author New Biopharmaceutics Textbook
Continued Growth for SEDA’s Analytical Capabilities
SEDA named ‘Best CRO’ at OBN Awards 2021
Long Acting Injectables: Model Integrated Approaches for Bioequivalence
Movers and Shakers in BioBusiness 2021
Dissolution testing: Real-world evaluation of UV arch probes
SEDA Shortlisted as Finalist for Best CRO
AAPS PharmSci 360: Jake Dickinson presents non-linear IVIVC
Life Science Integrates Presentation with Paul Stott
SEDA’s Elen Roberts Accepted onto Master’s Course
SEDA’s cutting-edge Differential Scanning Calorimetry capabilities
SEDA’s Jake Dickinson Promoted to Senior Modeller
A Novel Insight into Pharmaceutical Polycrystalline Materials
Fanny Joubert Joins the Seda Team as Senior Scientist
Formulating Complex Medicines: A simple solution?
Linette Ruston joins Seda in ADME role
Is powder segregation driving you nuts?
Offering clarity to the scope of the term ‘complex medicines’
Seda named ‘One to Watch’ in Alantra’s annual ranking of the fastest growing private pharma companies in the UK
New Publication from Seda’s Joanna Denbigh and the University of Manchester on novel, high resolution, label-free imaging in live cells with applications in complex targeted drug delivery systems
New Publication from Seda’s Modelling Group
Seda’s Jake Dickinson Shortlisted as Bionow Promising Technologist of the Year 2020
Claire Patterson as co-lead author in high impact complex targeted nanomedicine (dendrimer) publication
Paul Dickinson Presents: Developing Clinically Relevant Dissolution Specifications in APS Virtual Webinar Series
CellCentric’s first-in-class p300/CBP inhibitor CCS1477 publishes in Cancer Discovery
Publication of Influential Workshop Output on Physiologically Based Biopharmaceutics Modelling (PBBM)
Bionow Oncology Conference: Pharmaceutical Development Session featuring Paul Stott and Claire Patterson
Finding your perfect outsourcing partner
MDC Connects: A Guide to Complex Medicines, featuring SEDA
SEDA Facilities Update – We have moved!
Latest Trends in Clinically Relevant Dissolution Specifications
New Facility Update: Two weeks ‘til moving day!
Monday Musings: SEDA modeller Jake Dickinson’s reflections on QSP Conference 2022
It’s DNA Day! How do you deliver yours?
SEDA’s Lorraine Jones Undertakes PIAT Master’s Course
Facilities Update: Cracking a few eggs to make an omelette!
Review publication inspires SEDA scientists to reflect on their involvement in the commercial development of five kinase inhibitors
SEDA announces £4m investment in new state-of-the-art facilities
SEDA Scientists Author New Biopharmaceutics Textbook
Continued Growth for SEDA’s Analytical Capabilities
SEDA named ‘Best CRO’ at OBN Awards 2021
Long Acting Injectables: Model Integrated Approaches for Bioequivalence
Movers and Shakers in BioBusiness 2021
Dissolution testing: Real-world evaluation of UV arch probes
SEDA Shortlisted as Finalist for Best CRO
AAPS PharmSci 360: Jake Dickinson presents non-linear IVIVC
Life Science Integrates Presentation with Paul Stott
SEDA’s Elen Roberts Accepted onto Master’s Course
SEDA’s cutting-edge Differential Scanning Calorimetry capabilities
SEDA’s Jake Dickinson Promoted to Senior Modeller
A Novel Insight into Pharmaceutical Polycrystalline Materials
Fanny Joubert Joins the Seda Team as Senior Scientist
Formulating Complex Medicines: A simple solution?
Linette Ruston joins Seda in ADME role
Is powder segregation driving you nuts?
Offering clarity to the scope of the term ‘complex medicines’
Seda named ‘One to Watch’ in Alantra’s annual ranking of the fastest growing private pharma companies in the UK
New Publication from Seda’s Joanna Denbigh and the University of Manchester on novel, high resolution, label-free imaging in live cells with applications in complex targeted drug delivery systems
New Publication from Seda’s Modelling Group
Seda’s Jake Dickinson Shortlisted as Bionow Promising Technologist of the Year 2020
Claire Patterson as co-lead author in high impact complex targeted nanomedicine (dendrimer) publication
Paul Dickinson Presents: Developing Clinically Relevant Dissolution Specifications in APS Virtual Webinar Series
CellCentric’s first-in-class p300/CBP inhibitor CCS1477 publishes in Cancer Discovery
Publication of Influential Workshop Output on Physiologically Based Biopharmaceutics Modelling (PBBM)
Bionow Oncology Conference: Pharmaceutical Development Session featuring Paul Stott and Claire Patterson
Our purpose is to provide the very highest levels of applied scientific expertise to our Clients to maximise the value of their development assets.
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.
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.
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.
Aligned to Product Design it is critical to develop an understanding of likely Product Performance. SEDA have expertise with in silico and in vitro techniques to predict performance and inform design optimisation.
To be effective, any new product development must meet the regulatory requirements for approval. Our Project Leaders have extensive regulatory experience from First Time in Human through to full Marketing Authorisation.
Excellence in Product Supply with a focus on Quality is a specific skill set and is rarely well aligned with excellence in Product Design. At SEDA we do not manufacture clinical supplies, rather we work with a range of CDMOs and select the most suitable to meet our Clients’ needs.
A key driver for success is excellent product design. This is the step that will determine if your candidate drug achieves adequate exposure, reaches the site of action, is manufacturable and robust.
Aligned to Product Design it is critical to develop an understanding of likely Product Performance. SEDA have expertise with in silico and in vitro techniques to predict performance and inform design optimisation.
To be effective, any new product development must meet the regulatory requirements for approval. Our Project Leaders have extensive regulatory experience from First Time in Human through to full Marketing Authorisation.
Excellence in Product Supply with a focus on Quality is a specific skill set and is rarely well aligned with excellence in Product Design. At SEDA we do not manufacture clinical supplies, rather we work with a range of CDMOs and select the most suitable to meet our Clients’ needs.
A key driver for success is excellent product design. This is the step that will determine if your candidate drug achieves adequate exposure, reaches the site of action, is manufacturable and robust.
Aligned to Product Design it is critical to develop an understanding of likely Product Performance. SEDA have expertise with in silico and in vitro techniques to predict performance and inform design optimisation.
To be effective, any new product development must meet the regulatory requirements for approval. Our Project Leaders have extensive regulatory experience from First Time in Human through to full Marketing Authorisation.
Excellence in Product Supply with a focus on Quality is a specific skill set and is rarely well aligned with excellence in Product Design. At SEDA we do not manufacture clinical supplies, rather we work with a range of CDMOs and select the most suitable to meet our Clients’ needs.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
First in human, modular study of samuraciclib (CT7001), a first-in-class, oral, selective inhibitor of CDK7, in patients with advanced solid malignancies
Predicting bioavailability of monoclonal antibodies after subcutaneous administration: Open innovation challenge
Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report
IMI – Oral biopharmaceutics tools project – Evaluation of bottom-up PBPK prediction success part 4: Prediction accuracy and software comparisons with improved data and modelling strategies
Integrated Multi-stakeholder Systems Thinking Strategy: Decision-making with Biopharmaceutics Risk Assessment Roadmap (BioRAM) to Optimize Clinical Performance of Drug Products
Effect of multiple-dose osimertinib on the pharmacokinetics of simvastatin and rosuvastatin
Seda Pharmaceutical Development Services provide Pharmaceutical Development and Clinical Pharmacology services and consultancy to the Pharma and Biotechnology Industry. We enable the rapid and efficient development of optimal medicinal products by providing coherent and synergistic support.
Seda Pharmaceutical Development Services Unit 4 Oakfield Road Cheadle Royal Business Park Cheadle SK8 3GX Seda Pharmaceutical Development Services Block 21, Alderley Park Alderley Edge Cheshire SK10 4TG
Seda Pharmaceutical Development Services® is the business name and registered trademark of Seda Pharma Development Services Ltd, a company incorporated in England and Wales with registered number: 9442533 and registered office: 3 Castlebrook Close, Unsworth, Bury, Lancashire, UK, BL9 8JE.
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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
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