Our Speaker Faculty

Michael is Managing Director of Pharmaceutical Development Services Ltd, a Guildford (UK) -based technical consultancy.  Dr Michael Gamlen 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 Ltd 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 and his courses are highly rated, exceeding the expectation of the participants in many case.

Michael continually updates the content of his courses with the latest guidance and extracts of

up-to-the minute scientific papers.  He provides a substantial body of relevant literature to all course participants as well as a copy of all notes and guidance used.  He is very popular presenter.

Dr David Inglis

David is a consultant specialising in GMP/Quality Assurance for the manufacturing sectors of the pharmaceutical and consumer healthcare industry.  He has extensive experience in assessment and improvement of QA/GMP systems, auditing, GMP training, inspection preparation and plant cleaning / decontamination, especially in bulk intermediates and APIs.  He has a Ph.D. degree in enzyme chemistry (affinity chromatography).

During more than 29 years in Quality Assurance in the pharmaceutical industry, Dr Inglis has gained extensive experience of Quality Management, through roles in QA laboratories, GMP compliance and regulatory compliance.  He successfully pioneered automated HPLC methods, then managed all aspects of QC laboratories before spending the following 11 years managing and developing Quality Assurance, including documentation, control of change, auditing and routine regulatory compliance to cGMP. He is a Qualified Person under EU Regulations, formerly for bulk sterile antibiotics and now for bulk product intermediates for use in clinical trials.

Dr Inglis is an experienced international auditor of suppliers and contractors and has successfully prepared several sites for FDA/MHRA inspections, including FDA “Systems” based inspections. He has extensive experience of being the lead spokesman during major regulatory audits.

Dr Inglis is a specialist in cGMP training and QA system improvement.  His flagship improvement package details a system of secure GMP compliance at competitive cost.  For conceiving and developing this package, Dr Inglis received the highest level of recognition for excellence from a global pharmaceutical manufacturing company.

Dr Pauline McGregor

Twenty years in the pharmaceutical industry has included working for pharmaceutical companies and Contract Testing Laboratories in Canada and the UK.

Pauline completed her honours degree in Scotland on a part time basis while employed full time. She left the industry to pursue her PhD in photo organic chemistry where she also taught analytical techniques to undergraduate students. On completing her PhD in 1995, she travelled to UWO in London, Ontario, Canada to complete her post doctoral studies. She is an experienced trainer and has been delivering cGMP and validation training for the past 15 years.  She is a very highly rated presenter.

Since then she has worked as a validation specialist at Pfizer, Manager of Research, Development and Validation at SGS Life Sciences, a consultant to the pharmaceutical industry and has taught analytical R& D, method validation, GMP and related Quality Systems courses across Canada, in the US and China .

Throughout her career, Pauline has identified a lack of shared knowledge between Manufacturing, Quality Control, R & D and Quality Assurance sectors in the Healthcare Industries. She believes there is a need for cross education and training to allow the different disciplines to communicate with each other so that realistic objectives can be met by all in a timely manner with a harmonised understanding.

Pauline is also a member of The Royal Society of Chemistry, UK and listed on the RSC Directory of Consultants.

Mr 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.

Previously 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).  Currently, Hedley sits on the Bioindustry Association's Manufacturing Advisory Committee and has previously lectured strategic supply chain management for the CIPS professional stage examinations.

Dr Roland Colicott

Dr Roland Collicott 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 founding the ChalPharm Consultancy 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.

Mr Chris Barnett

An independent GMP and compliance consultancy. 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.
Chris is an expert in quality management, technology transfer and new product introduction and 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.

Dr Steve Carleysmith

Steve is a Chartered Scientist and Engineer and Lean Sigma Black Belt and with more than 30 years experience of the pharmaceutical industry across R&D, development and manufacturing.  Steve has trained many staff in methods for continuous improvement, and is director of Reo Process Improvement Ltd.

Dr Steve Rees

A consultant who offers senior level drug development and project management services to the pharma and biotech industries.  He has over 20 years R&D experience gained in nonclinical, clinical, regulatory, manufacturing and project management roles in small, medium and multinational companies.  Steve has held Global Project Director positions in big pharma, and has been the deputy R&D Director, member of the R&D Board and a member of the Scientific Advisory Board for a publicly listed biotech company. 

Steve has a particular interest in biotechnology development programmes and has consulted for companies on many biotechnology programmes globally.  He has worked in the areas of gene therapy, vaccines, therapeutic proteins and antibody development programmes for both brand name and emerging biotech companies.  Steve lectures widely within the healthcare industry and on a number of university MSc courses in the biological sciences.  Steve has a PhD in Medical Biochemistry and an MBA with distinction from the Manchester Business School.

Andy Langler

Andy Langler has worn several “hats” in his professional life and has more than 20 years experience in the pharmaceutical, agrochemical, not for profit and publishing environments. This includes a number of formal and informal training and developments roles. Throughout this time he has worked with many people from all levels of organisations to help them reach their maximum potential.

Andy has led, been involved with and written programmes for many types of development initiatives from board level change management to shop floor communication skills. His range of training skills covers a wide range of areas including: interpersonal & communications skills; management development; change management; IT strategy and getting the most out of IT.

Dr Ralph White
An experienced consultant who provides interim project management as well as learning and development work for the pharmaceutical/biotechnology industries. has over 25 years experience in the industry as a scientist, project manager and learning & development specialist.

Paul Titley

Paul has  over 30 years of experience in  the  development  of  pharmaceuticals.  Originally with Wellcome,  GlaxoWellcome and  later  into  the  contract sector with  Quintiles  and  then Encap (General Manager). He specializes in process development and validation and has lectured on these subjects since 1983.    R5 Pharmaceuticals  is a  new  contract  pharmaceutical development company based at BioCity, Nottingham, UK. R5 has been set up by a team of individuals with many years experience in the science and management of the contract development and manufacture of clinical trial materials. R5 will develop and manufacture clinical materials including tablets, capsules and injectables from its new facilities.