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.

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.

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.

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.

‪Claire Patterson‬ – ‪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.

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.

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.

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.

‪Claire Patterson‬ – ‪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.

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

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

Parmesh has a strong mathematical background with a BA (Hons) & MMath from the University of Cambridge and a PhD in Applied Mathematics from the University of Manchester. He has 8 years of pharmaceutical experience, across both orally inhaled products and pharmacometrics. For 5+ years Parmesh worked on the physical characterisation of inhalation medicines alongside large Pharma and Contract Drug Manufacturing Organisations (CDMOs). Parmesh has more than two years of experience in pharmacometrics.

At Seda, Parmesh works on pharmacokinetic and pharmacodynamic modelling. He has published on Population PK modelling and been an invited speaker at a FDA/CRCG workshop on modelling integrated approaches for long-acting injectables. He has a range of experience across preclinical and clinical PK-PD modelling, including absorption and dissolution modelling alongside performing NCA.

‪Parmesh Gajjar‬ – ‪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.

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

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.

Nicola holds a MSc in Pharmaceutical Chemistry from the University of Messina and a PhD in Pharmaceutics from UCL School of Pharmacy. He is an accomplished Formulation Scientist with 9+ years’ experience in the field and roles at AstraZeneca and GlaxoSmithKline. He additionally holds a qualification from the Association for Project Management (PFQ). He is expert in planning, leading and managing clinical drug product development projects and has a deep understanding of change control, risk and stakeholder management processes.

‪Nicola Parisi‬ – ‪Google Scholar‬

Dr Talbir (Tal) Austin is a consultant providing expertise in solid state, material design and characterisation, and development with particular focus on the early development phase.

Dr Austin is a structural organic chemist who has worked within the pharmaceutical industry for nearly three decades. Her previous positions involved complex problem solving and troubleshooting of projects – overseeing material design, selection and development, from the Preclinical phase through to Early Development at AstraZeneca. She also led the design and implementation of AstraZeneca’s material selection strategy at the discovery and development interface. Dr Austin has extensive experience in optimising material properties for different therapy areas (Respiratory, Inflammation, CNS, CV, GI and Oncology) and modes of administration; oral, inhalation, parenteral, topical.

Peter has worked in the pharmaceutical and healthcare sector for over 25 years with leadership and scientific positions at J&J, AstraZeneca and Glaxo. He has extensive experience in the management of outsourced projects with a focus on analytical development activities. Peter has authored many regulatory submissions from FiH to NDA / MAA and has an expert understanding of the regulatory requirements at each stage of development. He has been a consultant to the biotech sector since 2017.

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.

Roy is an experienced Pharma Industry & Regulatory CMC professional having spent time as a quality assessor at MHRA and with over 25 years in large pharma organisations leading numerous small molecule projects from FTiH through Marketing Authorisation and launch. As an Independent Consultant he has worked with many small companies as well as collaborating with consultancy firms and is currently supporting the South African Agency (SAHPRA) as a Quality/CMC reviewer supporting their generic backlog programme.

Roy has successfully led 4 major global submissions through Phase 3 to marketing authorisation approval. His key area of regulatory scientific expertise and interest centres on biopharmaceutics aspects of solid oral dosage forms of small molecules and the bridge between quality performance and the pharmacokinetic profile linked to safety and efficacy.

Dr Bill Moss has over 25 years’ experience as a scientist and leader working in the following areas:

• Chemical Development and manufacture of clinical and commercial drug substance
• Expertise in the Discovery interface, Preclinical and Phase1/Phase II development, supporting the progression of new candidate drugs from discovery into development
• Drug substance project strategy development and integration with drug product, safety and clinical planning
• Extensive experience of outsourcing drug substance development and manufacture
• Authoring and reviewing regulatory submissions from Phase I to marketing submissions