Our People

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 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.

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.

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.

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.

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.

Jo is an experienced Analytical Chemist (16+ years) with a Masters  degree in Analytical Chemistry (MChem) from the University of Salford and PhD in Bioanalytical Chemistry from the University of Manchester. She has an accomplished track record in both industrial (GSK, Waters, Thermofisher) and academic sectors globally, with specialisms in Chromatography, Mass Spectrometry and Infrared & Raman spectroscopies across a wide range of challenging pharmaceutical and biological applications. Jo is an experienced project manager and works collaboratively with partners in both academia and industry to facilitate progress in the field.

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. Most recently, she is interested in DMPK and clinical pharmacology projects for poorly solubles and complex parenterals.

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

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.

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.

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.

Harri is able to apply commercially available software PK-Sim, in order to form translational PB-PK modelling for different species or populations and help with dose selection in the early clinical stage settings. As a Mathematics graduate his background enables him to bring systems thinking to PK modelling to identify sources of uncertainty and risk.

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.

First class Medical Science graduate with 1.5 years experience working in the pharmaceutical industry. Areas of focus include formulation development for both preclinical and clinical studies across a range of administrative routes and indications, including the use of amorphous solid dispersions to enhance the solubility of poorly soluble compounds.

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.

Sin Nee has a Medicine and tissue engineering background with 1.5 years’ experience working in the pharmaceutical industry. Areas of experience include formulation development for preclinical and clinical studies as well as analytical development for Client specific compounds. Responsible for method development and upkeep of LC systems in Seda.

Biomaterial and tissue engineering graduate with a MRes in regenerative medicine. Working in the pharmaceutical industry for 1 year. Focus on analytical and formulation development for both preclinical and clinical studies.