Brian Johnson has over 40 years’ experience of drug discovery, pharmaceutical development, regulatory affairs, clinical supplies and GMP facilities/systems. His experience includes 12 years as a Formulation Section Head for Upjohn Ltd., 11 years as Head of Research Product Formulation and Clinical Supplies for Boots Pharmaceuticals and Knoll, 2 years as Head of Pharmaceutical Development for Knoll and Abbott Laboratories and 13 years as Owner and Managing Director of Brian Johnson Consulting Ltd (Brian Johnson Associates Ltd. until September 2013). In these roles, he has developed new medicines for several therapeutic areas including antibiotics, narcotics, anti-inflammatory, anti-obesity, psychosis, cardiovascular, pain, diabetes and drug induced nausea and vomiting. Brian Johnson developed and contributed significantly to the scale up and worldwide launch of a novel prostaglandin gel for induction of labour, several immediate release and controlled release oral dosage forms, several topical preparations and several transdermal dosage forms. His expertise ranges from development for phase 1 to phase 3-4, preparation of CMC sections for regulatory submissions on a global level, manufacture and packaging of clinical supplies for complex multi-national clinical studies, design and construction of development and GMP facilities and installation, maintenance and audit of GMP systems.
Brian Johnson is experienced with working with companies, facilities and clients on a worldwide basis, including Europe, USA, Japan, Latin America, The Far East and particularly India. He has authored or co-authored several scientific publications and is an inventor of several development patents.
Dr Alan Smith has forty years of experience in the industry across the entire spectrum of pharmaceutical development activities, ranging from the introduction of new drugs emerging from discovery to the design and marketing approval of highly innovative products. Alan graduated from London School of Pharmacy and completed research studies for his PhD at the University of Aston in Birmingham. Subsequently he has held supervisory / management positions at Glaxo (4 years), Boots Pharmaceuticals where he was Head of Formulation Research (15 years), Knoll Pharmaceuticals (4 years), West Pharmaceutical Services (7 years) and as Vice President R&D at Archimedes Pharma (10 years). In these roles his responsibilities have ranged across pre-formulation, analytical development, formulation, preclinical and clinical development, GMP manufacture and drug delivery technologies. Alan has worked across the breadth of therapeutic areas and dosage forms (including vaccines and biologicals); notably he developed and contributed significantly to European and US approval/launch of a potent opiate-based product which required an onerous level of risk-management to be incorporated into its design. Expertise includes the preparation of preclinical and CMC sections for regulatory submissions and Alan has eligibility to act as a Qualified Person (QP). He has been the industrial supervisor to numerous PhD students, has authored or co-authored around 90 scientific papers, acted as an editorial adviser/referee for a number of periodicals and has several patents granted in the fields of drug delivery and pharmaceutics.
Alan presented at many international symposia and conferences and has acted as consultant/expert advisor to numerous bodies including the Association of the British Pharmaceutical Industry (ABPI), the Chemical Industries Association, Royal Society of Chemistry, European Commission, several regulatory authorities and many pharmaceutical Companies.