1989; B.Sc (1st Hons), Pharmacy and Pharmaceutics, University of Strathclyde
1994; Ph.D., Pure and Applied Chemistry – Crystallography, University of Strathclyde
Preformulation and Materials Science
• PhD in the Crystallography of molecular crystals through research into a combination of high resolution X-Ray diffraction and molecular modelling techniques.
• Established a Materials Assessment Laboratory for the characterisation of powder specimens and compacts with a view to accelerating the development of Phase 1
• Established polymorph screening and regular pre-formulation screening within the Quintiles Edinburgh facility and established collaborations for the provision of further data from third parties.
Formulation, process development and scale up
• Actively involved in the development, scale up and manufacture of clinical and commercial dosage forms since 1989.
• Involved in the introduction of, and continued support of, new products into a commercial, sterile manufacturing operation through provision of technical support in respect of IV and ophthalmic products at the Wellcome Foundation.
• Responsible at Pfizer Research and Development for a group of development scientists charged with the development of solid oral dosage forms for Phase 1 and Phase 2 clinical studies.
• Responsible for the scale up and transfer of solid dosage forms from the Pfizer Research laboratories to US commercial manufacturing site.
• At Quintiles, developed projects on multiple dosage forms (solid oral, sustained release, topical, IV etc) managing internal project demands on behalf of third parties.
• Senior Director of Quintiles operational groups charged with the development of multiple formulations for clinical and commercial use with associated analytical support. Further responsibility to ensure transfer of a range of products and methods into commercial manufacturing facility to ensure supply into multiple territories.
Clinical supplies manufacture and testing
• Involved with the manufacture and supply of multiple dosage forms from Pfizer Central Research for clinical studies supporting Phase I through to Phase III.
• Senior Director of operational groups charged with the supply of materials for clinical (Phase I-III) and commercial use with associated analytical support.
• Involved in the preparation of dossiers for the support of clinical development programmes and new product introductions in Europe and the US.
Methods development and stability testing.
• Responsibility for managing a team of analysts at Pfizer Central Research involved in the development of methods and early stability studies in support of volunteer studies.
• Senior Director of operational groups charged with the development of analytical methods to support products from Preclinical Testing through to commercial use.
• Complete understanding of the Regulatory expectations around method development and validation for each of the development phases and of ICH expectation in establishing and executing stability trials appropriate for development and pre and post registration.
• An ab initio approach to crystal structure determination using high resolution powder diffraction and computational chemistry techniques Fagan, P. G., Hammond, R. B., Roberts, K. J., Docherty, R., Edmondson, M. Cryst. Growth Org. Mater., Proc. Conf. (1996) 22-27
• Comparative study of the mechanical behaviour of alpha-lactose from measurements on compacted beam specimens, controlled powder compression and single crystals. Fagan, P.G., Harding, V.D., Norman, G.T., Arteaga, P. and Ghadiri, M. AIChemE Conference Proceedings, 5th World Congress of Chemical Engineers, San Diego 1996. AIChemE.
• A work hardening mechanism for pharmaceutical powders. Sinko, C. M., Carlson, G. T., Oksanen, Fagan, P.G., Harding, V. D. and Norman, G.T. Pharm Res., 13 (1996), 9S
• Determining the crystal structures of organic solids using X-ray powder diffraction together with molecular and solid state modeling techniques. Hammond, R.B., Jones M. J., Murphy, S.A., Roberts, K.J., Smith, E.D.L., Klapper H., Kutzke, H., Docherty, R. Cherryman, J., Roberts, R. J. and Fagan, P. G.
Molecular Crystals and Liquid Crystals, 356 (2001) 389-405
• Author of two expert reports on Chemistry, Manufacturing and Controls of EMEA new product submissions.
• In addition to publications in these areas, speaker at industry and opinion forming forums in US and EU on all experiences described above.