Meet our Pharma Training experts

Michael Gamlen

Michael is managing director of Pharmaceutical Development Services Limited, a Nottingham UK-based technical consultancy. Michael has over 30 years experience of tablet development. Awarded a first class honours degree in pharmacy, specialising in pharmaceutical engineering. He studied for a PhD at Nottingham University. He was head of tablet development at the The Wellcome Foundation for 15 years, and has since worked for Vanguard Medica Limited and as a consultant. He specialises in managing product development, formulation, tablet and process development studies. He has been teaching professional tabletting courses for many years. His courses are highly rated, often exceeding the expectation of participants.

Michael continually updates the content of his courses with guidance and extracts from latest scientific papers. He provides a substantial amount of relevant literature to all course participants and copies of all notes and guidance used. He is very popular presenter.

Mark Powell

Mark is a Fellow of the Royal Society of Chemistry with over twenty years" experience as an analytical chemist. He is an expert in chromatography (liquid and gas), spectroscopy (atomic and molecular) and thermal methods of analysis. Mark joined Liverpool John Moores University"s School of Pharmacy and Chemistry in 1997 as a Senior Lecturer. He was Programme Leader for the University"s MSc in Instrumental Chemical Analysis and was also active in research and consultancy.

In 2003, Mark joined the newly-formed Quay Pharmaceuticals, a contract research and manufacturing organisation specialising in early-stage drug development, where he was responsible for analytical development. In 2010 he was appointed Quay's Scientific Manager, becoming involved more generally with drug development programmes and establishing collaborations with several UK universities and instrument manufacturers. His work at Quay has resulted in a number of published papers and presentations at scientific conferences. Mark left Quay Pharmaceuticals in September 2013 to set up as a consultant.

Mark is also in demand as an expert witness in legal cases where the outcome depends on the results of chemical analysis.

Dick Boddy

After working as a process development chemist for one of the UK's largest manufacturers, Dick retrained as a statistician and spent several years as a senior lecturer in statistics. He realised that there was a huge gap between theoretical statistics taught in higher education and the practical application of statistics needed to give companies a competitive edge. As well as designing the workshops and writing much of the course materials, Dick also develops and runs bespoke in-house courses. His consultancy work with many global companies in the UK, Europe and America means that in a world of ever evolving technology, Dick has first-hand experience of the latest tools, techniques and methods which can be used to make sense of the huge amounts of data now available. Industry experience: Chemicals, Pharmaceuticals, Oil, Food, Research, Cement, Household Products, Retail, Utilities, Space Exploration, Nuclear fuel

Susan Rocca

Susan is a Chemist who has held senior QA roles with fine chemical companies and latterly with GlaxoSmithKline.

Site roles included qualification of a new purified water system, design of a new archive building, redesign of a suite of laboratories to incorporate "Smart" instrumentation, plus day-to-day quality management and inspection preparation.

Head office roles included quality strategy development, interaction with commercial companies across the world, supply chain management, distribution quality risk management and cold/cool chain quality issue management.

Areas of Expertise

  • Active pharmaceutical manufacturing: complying with cGMP requirements
  • Experienced auditor for APIs, distribution and cold chain, in the UK, Europe, India, Singapore, Dubai, Mexico, Panama, Costa Rica, Puerto Rico and the USA
  • Auditing specialisation in good laboratory practice, distribution and cold chain
  • Incident management: troubleshooting and problem solving to "root cause". Rapid response to global quality issues
  • Quality management systems: development through simplification
  • Quality leadership: promoting that quality makes sense for a better business and helping quality departments integrate their plans with site business plans
  • Application of lean sigma tools to reduce errors and continuously improve processes
  • Application of quality procedures to non-manufacturing areas: eg logistics, commercial operations and regulatory processes
  • Inspection preparation, including one-to-one preparation clinics
  • Group training and one-on-one coaching for quality management understanding and application
  • Cold/cool chain processes for quality assurance
  • Preparation of sites for FDA, MHRA and other agency inspections, with successful outcomes

Mark Cornell Manning

Dr. Manning is Chief Scientific Officer for Legacy BioDesign LLC in the USA Previously, he was Chief Technical Officer at HTD BioSystems. Before that he held a position as Associate Professor of Pharmaceutics at the University of Colorado School of Pharmacy. He received his B.A. in Chemistry from Hope College and his Ph.D. in Inorganic Chemistry from Northwestern University. After postdoctoral work at Colorado State University, he joined the Department of Pharmaceutical Chemistry at the University of Kansas as Assistant Professor. In 1990, he joined the faculty at the School of Pharmacy at the University of Colorado Health Sciences Center, where he was co-founder and co-director of the University of Colorado Center for Pharmaceutical Biotechnology (a joint enterprise between the schools of pharmacy and engineering). Dr. Manning is an affiliate faculty member in chemistry at Colorado State University and an adjoint faculty member at the University of Colorado. He has published over 100 scientific articles, received four US patents, and has co-edited three books in the series, Pharmaceutical Biotechnology. He has worked on a wide variety of formulation projects and drug delivery systems. His research interests include protein stabilization, drug delivery, and spectroscopy.

Roland Collicott

As an experienced consultant Roland provides assistance to the pharmaceutical industry in the areas of chiral analysis, polymorphic characterisation, stability studies, chemical analysis in a GMP environment, specifications and all aspects of international CMC documentation. He also runs training courses to cover many areas of analytical chemistry, particularly in chromatography, chiral and polymorphic analysis. He has served as an expert witness and consulted in trials in Canada, UK, South Africa and Germany.

Before becoming a consultant in 2005, Roland was analytical section manager at OSI Pharmaceuticals responsible for delivering validated analytical chemistry methods and CMC documentation for OSIs regulatory submissions. In this role, he was responsible for collating and interpreting data from a wide range of analytical techniques, acquired in-house or at contract, for the characterisation of new compounds. There he also gained valuable international experience, working closely with regulatory and clinical groups as well as manufacturing and analytical contractors in Asia, Europe and the US.

Roland began his career in physical chemistry at Glaxo Group Research and originally specialised in chromatography, introducing the use of chiral HPLC columns to resolve enantiomers. He gained a PhD from his research into novel silicon-based chiral derivatisation reagents for HPLC, GC and NMR analysis. In 1998 he joined British Biotech, where he became involved in many other areas of analytical chemistry including polymorphism in pharmaceutical products. As Group Leader, he managed British Biotech's QC procedures, stability testing and the analytical development of its NCEs.

Graham Blakey

Graham Blakey is an advocate of creative and efficient clinical study design and has applied these principles across a range of global drug development projects in several therapeutic areas. In his current role he has provided support to large pharma and smaller biotech companies. This has involved evaluation of regulatory submissions concerning the biopharmaceutical aspects of re-formulated generic drugs and project management of the clinical pharmacology side of novel drug development. At AstraZeneca he was a principal scientist where he developed strategic drug-drug interaction thinking within the clinical function.

Graham holds a BSc (Hons) degree in Pharmacy and is a member of the Royal Pharmaceutical Society. He has an MSc in Clinical Pharmacology and a PhD from the University of Manchester.

Chris Penfold

Chris has over 25 years pharmaceutical & healthcare packaging development experience - developing, bringing to market and selling FMCG, OTC, Rx (prescription only) & GSL products as well as Medical Devices.

He has worked for a number of major "blue-chip" companies, including - Glaxo (GSK), Pitman Moore (now Schering Plough), Ciba (now Novartis), Boots Group Plc and Reckitt Benckiser. Chris also has 8 years consulting & strategic thinking experience - underpinned by an MBA completed in 2000.

He is a leading packaging professional within the European healthcare industry with numerous networked contacts.

Chris is also a Fellow of the Institute of Packaging, a Chartered Environmentalist and also a Charted Marketeer.

Chris Barnett

Chris is an independent GMP and compliance consultancy. Chris has a talent for coaching and explaining complex regulations in a straightforward manner. Chris is an expert 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.

Three roles in major multinationals over a ten-year period:

New Products Sourcing Project Manager

  • Responsible for liaison between early-stage Drug Development and Global Manufacturing and Supply for new chemical and biological entities being developed in Italy and the UK. Represented Global Manufacturing and Supply on the respective R&D Project Teams (Pre-Clinical, Ph 1, 2, 3) for the various NCE/NBEs.
  • Gained senior management agreement for the long-term manufacturing strategy for three new chemical / biological entities and line extension products.
  • Led the team developing the manufacturing strategy for a viral vaccine, working with Biologicals development and external contractors to develop a plan for capital investment leading to fully validated commercial primary production suite.

Project Manager, Product Introduction Planning Group

  • Led teams of technical, logistics and other staff to achieve validated, cost-effective and timely transfer of responsibility for new product supply from R&D (Ph 2, 3, 4) to the factories, leading to global product launch. Supervised the work of the respective technology transfer teams.
  • Member of the core R&D project team for the freeze-drying of a live viral vaccine, leading the R&D/Procurement/Manufacturing team to select a third-party contractor for freeze-drying a viral vaccine from the setting of initial selection criteria and market surveys, via tender document review, through to site visits and assessment audits.
  • Managed the team transferring a new fermentation process for a therapeutic protein from R&D to Commercial Production, including scale-up and validation, and preparation of the secondary production area for regulatory inspection.
  • Led the team assessing and selecting the packaging contractor for a highly-potent and toxic oral dosage form.
  • Brought eight products through regulatory submission and launch, and a further five through significant development milestones. This included the transfer of intellectual property and manufacturing technology as a divestment following a major corporate acquisition.

International Product Introduction Manager

  • Invited to establish a new role within the company, managing the transfer of new products from R&D into Production.
  • Joined R&D Development Project Teams from Ph 2 onwards, working closely with the Team Leaders and Planners, advising on the manufacturing/operational aspects of new product development.
  • Coordinated teams of technical, logistics and other staff in achieving validated, cost effective and timely transfer of responsibility for drug supply for three new chemical entities.

Mike Cliff

Mike is an independent training consultant specialising in the area of oral solid dosage manufacturing technology. Mike has been a regular presenter at courses and training events in his 34 year association with the process industries. An expert in oral solid dosage process technology, facility design, commissioning and start-up, Mike specialises in granulation and containment technology. Mike has a background as a chemical engineer with over 30 years experience in technology development and facility design roles, with the ICI, Zeneca and AstraZeneca. He has had experience of working on OSD facility projects in the UK, France, Germany, US, Sweden, Puerto Rico and Egypt. Mike has also been instrumental in introducing new technologies into the business such as microwave and continuous processing.

Mike graduated from Bradford with a degree in Chemical Engineering and a PhD on mixing technology.

Hussain Mulla

Hussain Mulla is a graduate of Pharmacy from the University of Portsmouth (1992), and Clinical Pharmacy from the University of Derby (1996). He was awarded a PhD in Clinical Pharmacokinetics from De Montfort University in Leicester (2003). He was a senior clinical pharmacist in adult and paediatric intensive care (1996 to 2003) at Glenfield Hospital in Leicester.

Following completion of his doctorate (2003), he took a position at AstraZeneca in the Department of Experimental Medicine and Clinical Pharmacology. In 2006 Hussain returned to Glenfield Hospital, Leicester as a senior research pharmacist in paediatric clinical pharmacology. His research interests span applications of population pharmacokinetic/pharmacodynamic modelling, formulation development, safety and tolerability of excipients and microanalytical methodologies for facilitating paediatric pharmacokinetic/pharmacodynamic studies. Hussain has been the recipient (principle investigator) of an NIHR RfPB grant to investigate the bioavailability of unlicensed formulations, as well as industry funded and investigator led PK studies and is currently a collaborator in an MRC funded European project (ESNEE) to investigate the kinetics of excipients in formulation administered to neonates.

Paul Butler

Paul is an independent consultant specialising in Facility Design, Validation, and GMP Compliance for the manufacturing sectors of the pharmaceutical and consumer healthcare industry. He has over 40 years experience working in and with the pharmaceutical industry, the last 24 as a consultant. He has a BSc in Medicinal Chemistry.

He has extensive experience in the design and specification of international regulatory compliant secondary production plants, including a number of very large non-sterile and sterile facilities, assessment and improvement of GMP systems, auditing - both API and Secondary facilities, hands-on GMP training, and inspection preparation. He has worked with most of the worlds multinationals, as well as many smaller companies around the world, working in almost all European countries, the Middle East, Africa, the Indian sub-continent, and the Far East.

Before becoming a consultant in 1988, Paul had 15 years experience as a production/works manager, working with small to medium sized companies mostly involved in the production of oral solid dosage and liquid products. His experience also included 2 years working with a homoeopathic products manufacturer

Paul Cummings

Paul is a Pharmaceutical Consultant with nearly 30 years experience in Pharmaceutical R&D specializing in sterile / parenteral product development including product formulation development, development plans, contamination control, strategic assessments, due diligence activities, specialist auditing of parenteral facilities to cGMP, troubleshooting, microbial contamination and design of parenteral manufacturing facilities.

He spent 24 years at GSK in various technical roles including Director Pharmaceutical Development. Paul is a Chartered Biologist and a Fellow of the Society of Biology and is an expert in pharmaceutical radiation safety, ADME study design and implementation. He has vast regulatory experience with European and FDA agencies and authorship of numerous regulatory submissions including INDs, NDAs, aNDAs, MAAs and CTXs. A proven track record for teaching, mentoring and coaching with many years managerial experience at all levels.

John Faulkes

John is Director of Team Communications Development, and is an expert in organisation and team development, specialising particularly in cross-function working /matrix organisations. He has over 15 years experience working with the pharma/biotech sectors as well as in general manufacturing, sales and the public sector.

Hedley Rees

Hedley has had many years in the pharma and biotech industry working with high profile biotech and emerging specialty pharmaceutical companies to bring new 'molecular' entities and re-profiled compounds through development stages into full scale commercial launch. He has been a key contributor to trial progression and commercial launch across all phases of development in multiple territories and global markets.

Hedley was responsible for managing global supply chains in big pharma companies such as Bayer and Johnson & Johnson. Here, he built a wide competency base in all the disciplines of supply chain management, implementing and using state-of-the-art information systems enablement. He holds an Executive Master's in Business Administration from Cranfield University School of Management, a degree in production and industrial engineering from the University of Wales and is a full corporate member of the Chartered Institute of Purchasing and Supply (CIPS). Hedley sits on the Bioindustry Association's Manufacturing Advisory Committee and has previously lectured strategic supply chain management for the CIPS professional stage examinations.

Ralph White

Ralph is a specialist in learning and development work for the pharmaceutical/biotechnology industries. Ralph has over 25 years experience in the industry as a scientist, project manager and learning & development specialist.

Wilfried Niessen

Wilfried has almost 30 years of experience as a researcher and project manager in the field of analytical mass spectrometry, and especially liquid chromatography mass spectrometry. Since 1996, he has worked as an independent consultant, providing expert consultancy and (advanced) courses in analytical mass spectrometry. In 2002, he was appointed (part-time) extraordinary professor in bioanalytical mass spectrometry at the Faculty of Science of the VU University in Amsterdam, where he is currently interim Head of the Division BioMolecular Analysis.

Wilfried has been involved in many different consultancy projects within industry, governmental institutes and other laboratories in the Netherlands, Belgium, Italy, Germany, Denmark, Sweden, United Kingdom, Switzerland, Slovenia, Israel, Hong Kong China, India, and Canada. In addition, in the past 14 years he provided more than 320 courses with in total more than 3400 participants. He is (co)author of more than 160 refereed papers in the field of LC-MS. The third edition of his book Liquid Chromatography - Mass Spectrometry was published in October 2006. He co-edited several special volumes of Journal of Chromatography A (794, 970, 974, 1058, 1067, and 1159) on "Mass Spectrometry: Innovation and Application". He is the editor of Volume 8: Hyphenated Methods of the Encyclopaedia of Mass Spectrometry, published in 2006 by Elsevier.

William van Dongen

William holds a PhD (1996) in peptide and protein mass spectrometry. He has worked as an industrial researcher, project manager and laboratory manager in the field of bioanalytical mass spectrometry and liquid chromatography - mass spectrometry. He was responsible for setting up the bioanalytical LC-MS facility of Pharma Bio-Research (currently PRA International), one of the first contract laboratories offering commercial LC-MS services to the pharma industry. He has almost ten years experience as study director of bioanalytical LC-MS studies. He started up the mass spectrometry facilities for the generic pharmaceutical company Synthon and for his current employer PROXY, a pharma contract laboratory.

He is (co-) author of 25 refereed papers in the field of protein and peptide mass spectrometry and bioanalytical LC-MS.