Meet our Pharma Training experts

Michael Gamlen (Tableting and Stability Testing Expert)

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.


Graham Blakey (Pharmacokinetics, Drug Development)

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.


Mark Powell - Analytical Services (Dissolution Testing)

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.


Mark Cornell Manning (Proteins and Peptide Drugs)

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 (Analytical Services - HPLC, Stability)

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.


Susan Rocca (GMP Auditor Training)

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

Chris Penfold (Pharmaceutical Packaging)

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.


GRANULATION AND COMPRESSION Experts

Michael H. Rubinstein B.Pharm., Ph.D., M.R.Pharm.S., M.I.Chem.E., C.Eng., Q.P. (Course Director) Professor Rubinstein is Chairman and Co-Founder of Quay Pharmaceuticals Ltd., a contract pharmaceutical R & D and Clinical Trials Manufacturing company in North Wales. Previously he was Professor of Pharmaceutical Technology and Director of the School of Pharmacy and Chemistry at Liverpool John Moores University. His research interests include the examination of the granulation process and he has published and lectured widely in the field of tableting technology and the formulation of solid dosage forms. Professor Rubinstein has worked for AstraZeneca and GlaxoSmithKline in production technical support, pharmaceutical development and research. He has published over 200 research papers and articles in the area of solid dosage form technology and in particular in tablet compression. He lead one of the only academic research teams using a high speed Compaction Simulator to fundamentally characterise powder compression. Professor Rubinstein is both a Chemical Engineer and a Pharmacist with Q.P. Status, is the author of 5 books in pharmaceutical technology and two patents and is the series editor of the book series in Pharmaceutical Technology now published by Taylor & Francis Ltd. Professor Rubinstein is a consultant to a number of pharmaceutical companies and governments and is the Conference Co-Ordinator for the annual Pharmaceutical Technology Conferences.

Geert Verreck M.Eng., Ph.D.

Dr Verreck is a Scientist in the Pharmaceutical Sciences Department of Johnson and Johnson in Belgium. He is responsible for the evaluation of the solid dispersion approach for new active compounds, including hot melt extrusion and solubility techniques. He has published 37 papers and is the author of 6 patents in this area.

Ian Smales B.Sc.

Mr Smales is an Associate Scientist at Pfizer Central Research and has responsibilities for optimization, scale-up and technology transfer of pharmaceutical products. He has specialist expertise in wet and dry granulation and in particular roller compaction.

Paul Burton C.Chem, M.R.S.C.

Mr Burton has had extensive experience as a Formulation and Process Development Scientist with Beecham Products, Cyanamid UK and SmithKline Beecham Pharmaceuticals. He has been involved in new product introduction, scale-up of solid dosage forms and process validation. Currently he is Process Technology Manager for Glatt Protech where he has responsibility for applications of fluidised bed technology, high shear granulation and tablet coating technologies.

Terry Lewis

Mr Lewis is an independent Consultant and was formerly Operations Manager at I.Holland Ltd., UK. His is accountable for all technical activities of the company and has 28 years expertise in compression and tooling problems.

Harald Stahl Ph.D.

Dr Stahl is Senior Pharmaceutical Technologist with GEA Pharma Systems with world-wide process responsibility for the technologies supplied by GEA Pharma Systems. Previously he worked in the Pharmaceutical Development Division of Schering AG in Germany.

Jan Vogeleer B.Sc.

Mr Vogeleer is Managing Director of Courtoy N.V., manufacturers of tablet presses in Belgium. He has pioneered the design of new tablet machinery to enable tablets to be produced at faster speeds with minimal clean and down time and has a huge wealth of experience in novel design of compression machinery.

Ian Muir BSc., Ph.D.

Dr Muir is Vice-President of Zydis at Cardinal Health in the UK. He is responsible for product development for the fast dissolve Zydis technology. He has had previous experience in various aspects of product development from early compound selection to scale-up and commercialization.

Gordon Prudhoe BSc

Mr Prudhoe is Quality Assurance Technical Group Manager for Sanofi-Sythelabo. His responsibilities include technical support for production and co-ordination, planning and execution of all transfer activities both in and out of Sanofi-Sythelabo plants worldwide. Mr Prudhoe was previously Manager in charge of the formulation and analytical groups and has developed over 50 generic products. Mr Prudhoe has worked in the industry for over 20 years in a development/production support role.

Marina Levina MSc., Ph.D.

Dr Levina is a Lead Product Owner, OSD at GlaxoSmithKline responsible for Global Supply Oncology products. Previously, she worked as a Global Technical Manager, Excipients and Modified Release at Colorcon Ltd. Dr Levina has experience in the production of tablets by conventional and by ultrasound assisted compaction and with the development of various solid oral dose formulations for both immediate release and modified release applications. She has published over 70 research papers and communications in the area of Pharmaceutical Technology, including book chapters, peer-reviewed articles and poster abstracts presented at more than 20 national and international conferences and seminars. She is an Editorial Advisory Board member and reviewer for international pharmaceutical journals.


PARENTERAL PRODUCTS Experts

Peter Cameron (Course Director)

Mr Cameron has worked for the last 20 years as a Pharmaceutical and Healthcare Consultant, originally within the Pharmaceutical Division of Bovis Lend Lease and more recently with his own company, 3CP. He specialises in parenteral production operations, regulatory issues and validation. He has been associated with the production of sterile products for over 40 years, during which time he worked for Parke Davis as a Technologist with special responsibility for parenteral validation and process development and CAMR, managing the production of clinical trial material. Mr Cameron is a member of the Pharmaceutical and Healthcare Sciences Society of Great Britain, freeze drying special interest group and been closely involved in the production of many of the society"s monographs. He has edited and contributed to a book on Good Pharmaceutical Freeze Drying Practice.

Joanne Broadhead B.Pharm., Ph.D.

Dr Joanne Broadhead is an Independent Consultant specialising in parenteral product development and manufacture. Prior to forming her own consultancy company in 2011, she worked for many years in the Product Development group at AstraZeneca. Within AstraZeneca she led both formulation and manufacturing teams and from 2006-2011 managed the pilot scale parenteral manufacturing facility at the company"s Charnwood site. Joanne is a registered Pharmacist and co-chair of the Parenteral's Focus Group of the Academy of Pharmaceutical Sciences. In her current role, Joanne works with client companies on various parenteral product development projects. She also works part time with the DeMontfort University Quality by Design team in a business development capacity and as a Lecturer on their postgraduate MSc programme.

Keith Wickert B.Sc (Hons)

Mr Wickert is Technical Manager for Amazon Filters Limited. He is responsible for managing new product development and technical support, including supporting internal and customer validation projects. He has served on various Pharmaceutical Industry committees including the PDA, IMechE Pharmaceutical Group and Parenteral Society and presented at numerous international conferences. Keith has worked with the Pharmaceutical industry for over 40 years and before he joined Amazon Filters held a variety of Management positions in Production of Pharmaceutical Products, supply of critical equipment and Compliance Consultancy.

Andy Donnelly Ph.D.

Andy Donnelly has 20 years of experience working within the field of parenteral science and joined Bespak"s Innovation Group in September 2013 as an Innovation Manager, helping to develop next generation delivery devices to meet the ever increasing requirements of the pharmaceutical and biotech industry. Previously Andy was based in the USA where he established and subsequently led MedImmune"s drug delivery and device development group, responsible for evaluation and development of innovative device and formulation drug delivery technologies. Prior to this, Andy spent over 12 years working in AstraZeneca"s formulation development groups in both Sweden and the UK, work that included both small and large molecules. Andy has a degree in Pharmacy and a Ph.D. in drug delivery from the Welsh School of Pharmacy UK

Eddie J French Ph.D.

Eddie French of TEKH Consulting Ltd, is an independent pharmaceutical consultant who specializes in therapeutic product design and development. Eddie has 25 years experience in the pharmaceutical industry. The majority of this time was spent with Pfizer as a director within Pharmaceutical Sciences, focusing on drug delivery and drug product development. This included 9 years leading a global team formulating proteins, peptides and nucleic acids. Eddie has a PhD in drug delivery from the University of Bath where he was also a lecturer in pharmaceutics, prior to his industrial career. Eddie is a previous chair and is currently on the advisory board of the Academy of Pharmaceutical Sciences of Great Britain. He is an honorary professor in biopharmaceutical development at the University of Bath and the special professor of formulation at the university of Nottingham


PHARMACEUTICAL AEROSOLS, DRY POWDER INHALATION SYSTEMS AND NASAL DELIVERY DEVICES Experts

Michael H. Rubinstein B.Pharm., Ph.D., M.R.Pharm.S., M.I.Chem.E., C.Eng., Q.P. (Course Director)

Professor Rubinstein is C.E.O of Quay Pharmaceuticals Ltd., a contract pharmaceutical R & D and Clinical Trials Manufacturing company in North Wales. Previously he was Professor of Pharmaceutical Technology and Director of the School of Pharmacy and Chemistry at Liverpool John Moores University. Professor Rubinstein has worked for AstraZeneca and GlaxoSmithKline in production technical support, pharmaceutical development and research. He has published over 200 research papers and articles in the area of solid dosage form technology. Professor Rubinstein is both a Chemical Engineer and a Pharmacist with Q.P. Status, is the author of 5 books in pharmaceutical technology and two patents and is the series editor of the book series in Pharmaceutical Technology now published by Taylor & Francis Ltd. Professor Rubinstein is a consultant to a number of pharmaceutical companies and governments and is the Conference Co-Ordinator for the annual Pharmaceutical Technology Conferences.

Julia Mottishaw BSc QP

Ms Mottishaw is Qualified Person at Teva in the UK. Previously she was Head of Microbiology at Sanofi-Aventis with responsibilities for quality of the company"s inhalation systems.

Martyn Ticehurst PhD., B.Sc

Dr Ticehurst is an Associate Research Fellow, Materials Sciences at Pfizer Global R & D. He has many years experience of material science and powder technology aspects of dry powder inhalation systems and has pioneered the development of these devices at Pfizer.

Joseph Lim B.Pharm. Ph.D.

Dr Lim is a Pharmaceutical Assessor at the Medicines and Healthcare Products Regulatory Agency (MHRA) in London. He is responsible for assessing the chemical and pharmaceutical data in relation to abridged applications (national and incoming MR) and has been involved in the assessment of applications for new inhaled products, including dry powder inhalers and MDI"s (CFC free). Previously Dr Lim was Section Manager for over 10 years at Sanofi-Aventis and has specialist expertise in the pharmaceutical and process development of inhalation products, regulatory advice and has been involved in formulating and developing the Guidelines for inhalation products.

Robert Clayborough Ph.D., B.Sc., MBA, Cchem, MRSC, CPhys, MInstP

Dr Clayborough is an OINDP independent Consultant and CEO of Alchemy PharmaTech. Previously he was Principal Consultant with Sagenta UK, VP of Product Development at Akela Pharma based in Austin, Texas and CEO of LAB Pharma in Finland. Prior to joining LAB Pharma, Dr Clayborough spent 4 years at 3M Health Care heading up the pMDI Inhalation Formulation & Device Development Group. Before joining 3M Health Care he worked in a variety of increasingly senior positions within the Respiratory Technology Group at Aventis Pharma.

Gary R. Pitcairn Ph.D., B.Sc., C.Chem., M.R.S.C.

Dr Gary Pitcairn is Head of Portfolio Management for Respiratory, Inflammatory and Autoimmune Diseases at AstraZeneca. Previously he was Senior Director of Respiratory Drug Delivery in the Global Respiratory Group at Mylan Pharmaceuticals UK Ltd. Dr Pitcairn spent a number of years working at Pharmaceutical Profiles, evaluating drug delivery from a wide range of pulmonary and nasal drug delivery devices in both in vitro studies and Phase I and II studies. Whilst at Pfizer R&D, he was responsible for helping to select and progress new inhaled drug candidates from discovery through to First in Human studies, and on to Proof of Concept studies in patients. During this time, he was also responsible for developing patient focused testing and incorporating this approach into the development process for new inhaled products. Dr Pitcairn has published over 40 peer reviewed papers and is a frequent speaker at international meetings. He is the chair of the organizing committee for Drug Delivery to the Lungs (DDL), which delivers a successful international conference each year. He is also part of the organizing committee for the "Drugs to the Lung Network", which runs small annual meetings (via the Academy of Pharmaceutical Scientists), focusing on particular topics of interest to the inhaled aerosol community.

Tol S. Purewal Ph.D., M.R.Pharm.S.

Dr Purewal is an independent consultant and was formerly Head of Pulmonary R & D at Bespak Europe Ltd. Previously he was Manager of Inhalation Development at 3M Health Care in Loughborough. Dr Purewal began his industrial career with Merck, Sharpe and Dohme and later became leader in aerosol development at GlaxoSmithKline Research.

Paul Sullivan B.Sc.

Mr Sullivan is Managing Director of D & H Industries, who supply a variety of aerosol filling equipment to both the pharmaceutical and cosmetic industries.

Gerallt Williams PhD., B.Sc.

Dr Williams is Director of Scientific Affairs at Aptar in France.

He is responsible for all new development initiatives in Nasal Delivery and has published very widely in the area of nasal drug delivery.


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


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 (Supply Chain Expert)

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.


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