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Meet our team |
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| Michael Gamlen MRPharmS PhD Managing Director Expert in outsourcing all aspects of product development. Rare expertise in particle science and particle size analysis. Responsible for product development of at least 7 new drugs currently on the market. Michael has over 30 years experience of tablet development. He specialises in managing product development, formulation, tablet and process development studies. He was Head of Tablet Development at the The Wellcome Foundation for 15 years, and has since worked for Vanguard Medica and as a consultant. Awarded a First Class Honours degree in Pharmacy, specialising in Pharmaceutical Engineering, he studied for PhD at Nottingham University. Chris Barnett MA MSc MBA CChem MRSC MIQA Director, Quality and Compliance Chris has a talent for coaching and explaining complex regulations in a straightforward manner. He recently spent time in India patiently explaining regulatory procedures to people unfamiliar with European practices. He's an expert in quality management, technology transfer and new product introduction. Chris specialises in Quality Management, Technology Transfer and New Product Introduction Chris has a background as an analytical chemist and over 20 years experience in QA roles, with the Wellcome Foundation and GlaxoSmithKline. He has had QA management posts in India and Mexico, as well as new product introduction project management roles in pharma manufacturing. Chris ran his own consulting company for several years prior to joining PDS in 2002. Chris graduated from Cambridge in natural sciences, with an MSc in analytical chemistry, and subsequently an MBA from Greenwich University. Paul Sugden BSc PhD MTOPRA Director, Regulatory Affairs "One of my major projects involved obtaining a licence for an antimigraine drug in Europe and USA. Both applications submitted within 3 months of each other." "Other assignments include filing applications for 2 clinical studies for a DNA flu vaccine." Paul is responsible for all regulatory affairs projects. He has prepared MAAs and NDAs for products involving novel dose forms, biologicals, OTC products and generics, as well as provision of advice on medical devices and cosmetics. He worked as a registration officer for Ciba-Geigy, and as a registration manager for Sterling Research Group. He was head of regulatory affairs at Veram Til Occam (now part of Parexel), and associate director of regulatory at Vanguard medica (now Vernalis). Paul graduated as a toxicologist with a BSc and subsequently a PhD from Bristol University. Simon Forster MSc PhD CBiol MIBiol Quality Management Consultant, Biotechnology "I provided interim QA Management for a small biotech company on a part-time basis. Following an initial six-month contract, they renewed the contract for a further six months, then for a further year. The client received the benefit of continuity and avoided expensive overheads." "A major company asked for advice on timing of analytical activities for the first clinical trial of a new drug. I gave independent advice on what needed to be done, which was greatly valued. This minimised unnecessary expenditure by the company. The client continued to rely on my advice for the latter stages of clinical trials and the marketing application." Simon joined PDS in 2005 as a quality management consultant and brings particular expertise in biotechnology. He worked for a number of UK biotech companies, most notably Cambridge Antibody Technology, where he was head of Quality Control and also held a number of positions in Quality Assurance. During this time he established from scratch a GMP-compliant quality management system. Simon graduated from the University of Kent with a first degree in Microbiology and a Master's in Biochemistry. He then completed a PhD in tumour biology at the University of Leicester. Julie Jennings Regulatory Affairs Adviser Worked as project manager at Veram Til Occam (now part of Parexel) and as a regional manager for regulatory affairs, Middle East and Africa, at Novartis in Switzerland, strategic planning for new product registration and international communications. Julie graduated from St Andrews University with a BSc in Biochemistry and with an MSc in toxicology from University of Surrey. Janet Ellis Regulatory Affairs Manager Janet has worked in the regulatory consultancy sector for all of her career. She has handled the regulatory affairs of products from the biotechnology, pharmaceutical and complementary therapy industries including vaccines, novel dosage forms, generics, OTC products, herbal and homeopathic medicines, food supplements and borderline products. She has project managed a wide range of submissions including EU mutual recognition, centralised and national marketing authorisation applications, clinical trial applications and submissions to Ethics Committees and has also handled applications to regulatory authorities in the middle and far east, South America, Asia and Australasia. She has a special interest in borderline substances and can provide advice on the advertising and promotion of products, including the preparation of labels and leaflets. Janet has a background as a pharmacist, with a PhD in pharmaceutical microbiology from the University of Nottingham. Eve Roodhouse Regulatory Affairs and Technical Adviser Eve joined PDS in 2007 as a Regulatory Affairs and Technical Adviser with valuable experience in many areas of drug development. She has worked for a large Pharma company for most of her career, in various roles from analytical chemist and development scientist (providing product development project management), to senior technologist in the operations and supply chain group, where she provided technical and management support for technology transfers, change control coordination and process development with third party contractors. In her current role at PDS she has undertaken a contract in the regulatory group of another large Pharma company, preparing variation applications for changes to the SmPC and PIL and for quality changes to a haematology product. In addition to this, she has prepared chemistry/pharmacy modules of Marketing Authorisation applications for submission in the EU, prepared clinical overview and summaries of a well established medicine, compiled Ethics Committee applications and performed regulatory due diligence. Eve graduated from Greenwich University with an honours degree in Chemistry. |
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© 2008 Pharmaceutical Development Services Limited. All Rights Reserved. Pharmaceutical Development Services Limited The Surrey Technology Centre, 40 Occam Road, The Surrey Research Park Guildford, Surrey GU2 7YG, UK Tel +44 1483 685420, Fax: +44 1483 685421 Registered in England and Wales, Number 4476828 VAT registration number 761 1430 60 |
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