Senior Scientist / Principal Scientist. Compounding Manager (Sterile and non-sterile specials) Senior Pharmaceutical Assessor

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1 Curriculum Vitae PERSONAL INFORMATION Andrew Twitchell WORK EXPERIENCE May 1987 September 1991 Senior Scientist / Principal Scientist 3M Health Care Ltd, (United Kingdom) Formulation, scale-up and manufacture of liquid and controlled-release products. September 1991 October 2004 Senior Lecturer / Principal lecturer / MPharm Programme Leader De Montfort University, (United Kingdom) Pharmaceutics / Pharmaceutical Technology teaching (MPharm and BSc Pharmaceutical Sciences courses) and research. Consultancy work. October 2004 November 2008 Compounding Manager (Sterile and non-sterile specials) Nova Laboratories Ltd, (United Kingdom) Responsible for managing all aspects of the formulation, manufacture and control of unlicensed sterile and non-sterile products (specials) including GMP compliance. Products included liquid and solid dosage forms manufactured individually for named patients, as batches or for clinical trials. November 2008 Present Senior Pharmaceutical Assessor MHRA, (United Kingdom) Assessment of the quality aspects of license applications and license variations for pharmaceutical products. Provision of scientific advice. EDUCATION AND TRAINING November 1983 April 1987 PhD Pharamceutical Technology Leicester Polytechnic, (United Kingdom) Pharmaceutical Technology Studies on the role of atomization in aqueous tablet film coating September 1979 July 1982 BSc Pharmacy Leicester Polytechnic, (United Kingdom) Pharmaceutics, Microbiology, Pharmaceutical Chemistry, Pharmacology, Pharmacy Practice ADDITIONAL INFORMATION Expertise Formulation, manufacture and testing of pharmaceutical dosage forms, particularly solid dosage forms. Powder mixing. Pharmacetical coating. Process validation. Pharamceutical specials. Publications Patent TWITCHELL A M and PORTER D United States Patent No Controlled Release Flecainide Acetate Formulation (1990) Refereed Papers and Books (1985) Factors affecting the atomisation of tablet coating solution. J. Pharm. Pharmacol., 37, 114P (1985) The Influence of Solution Properties and Atomisation Parameters on the Droplet Size of HPMC Film 28/11/14 European Union, Page 1 / 6

2 Coating Solutions. Proceedings of 4th Int. Conf. on Pharm. Tech., AGPI, V, 133 (1986) Estimated Surface Tensions of atomised Droplets in Aqueous Film Coating. J. Phar Pharmacol., 38, 75P (1986) The Effect of Atomisation Conditions on the Surface Roughness of Aqueous Film Coated Tablets. J.Pharm. Pharmacol., 39, 128P (1987) Contact angles formed by film coating formulations on uncoated and coated tablets. Proc. 12th Pharm. Tech. Conf., Solid Dosage Research Unit, Helsingor, Denmark, 1, (1993) The effect of additives and processing conditions on the rheological properties of films prepared from Eudragit NE 30D dispersions. Proc. 13th Pharm. Tech. Conf., Solid Dosage Research Unit, Strasbourg, France, 1, (1994) WEBSTER R, The effect of lactose and polyethylene glycol inclusions on the tensile properties of cast HPMC E15 films. Proc. 13th Pharm. Tech. Conf., Solid Dosage Research Unit, Strasbourg, France, 1, (1994) Assessment of the thickness variation and surface roughness of aqueous film coated tablets using a Light Section Microscope. Proc. 13th Pharm. Tech.Conf.,Solid Dosage Research Unit, Strasbourg, France, 1, (1994) The behaviour of film coating droplets on their impingement onto uncoated and coated tablets. S.T.P. Pharma Sciences, 5, (1995) Assessment of the thickness variation and surface roughness of aqueous film coated tablets using a Light-Section Microscope. Drug Dev. and Ind. Pharm., 21 (14), (1995) The effect of atomizing air pressure on the aqueous film coating process and on film coating quality. Proc. 1st World Meeting APGI/APV, Budapest, (1995) The mechanical properties of ethylacrylate methyl-methacrylate based films. J. Pharm. Pharmacol., 47, 1104 (1995) TWITCHELL A M AND Aulton ME Solution properties and atomization in film coating. Pharmaceutical Coating Technology, Ed: Cole, Hogan and Aulton. Taylor and Francis, UK, (1995) TWITCHELL A M AND Aulton ME Film Coat Quality. Pharmaceutical Coating Technology. Ed: Cole, Hogan and Aulton. Taylor and Francis, UK, (1995) The influence of atomization spray shape on the quality of HPMC film coats. Pharm. Res., (1995) The effect of additives and storage conditions on the water vapour permeability of poly(ethylacrylate methyl-ethacrylate)-based films. Proc. 15th Pharm. Tech. Conf., Oxford, UK, 1, (1996) LAFFERTY I, TWITCHELL A M AND Aulton ME The influence of crystallisation conditions on dextrose and the mechanical properties of its compacts. Proc. 15th Pharm. Tech. Conf., Oxford, UK, 3, (1996) The influence of application conditions and coat formulation on the release of theophylline from coated beadlets. Pharm. Res., 13 No.9, 184 (1996) 28/11/14 European Union, Page 2 / 6

3 The influence of spray-gun design on the quality of HPMC-based film coats. Pharm. Res., 13, No.9, 185 (1996) Physical properties of HPMC solutions and their role in the film coating process and the quality of the coated product. In: Aqueous polymeric coatings for pharmaceutical dosage forms, Ed J.W. McGinity, (1997), Marcel Dekker The effect of coating conditions on drug release from coated theophylline beadlets. Proc. 2nd World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology (APGI/APV), Paris, (1998) WEBSTER R, The effect of lactose and polyethylene glycol inclusion on the adherance of hydroxypropyl methylcellulose films to waxy tablet cores. Proc. 2nd World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology (APGI/APV), Paris (1998) BONE A, MINCHOM C and TWITCHELL A M Survey of Industrial Pharmacists, The industrial Pharmacist, 1, No.6, ISSN (1998) The contribution of excipients and processing to surface free energy values, J. Pharm. Pharmacol., 51, Suppl., 272 (1999) Spreading during film coating of tablets a surface free energy approach, J. Pharm. Pharmacol., 51, Suppl., 290 (1999) Spreading of film-coating formulations on lactose and dibasic calcium phosphate-based tablets a surface free energy approach, AAPS Pharm. Sci. Suppl., 1, issue 4, 2308 (1999) Effect of magnesium stearate concentration on spreading coefficients of aqueous coating solutions on tablets and film coat adhesion, Proceedings of the Millennial World Congress of Pharmaceuticals Sciences, , p112 (2000) LAFFERTY I, TWITCHELL A M AND Aulton ME Effect of crystallisation temperature on the mechanical and powder properties of dextrose crystals, Proceedings of the Millennial World Congress of Pharmaceuticals Sciences, , p121 (2000) TWITCHELL AM and BONE A Industrial Pharmacists Group Salary Survey 2000 The Pharmaceutical Journal, Vol 266 No 7129 p9 (2001) TWITCHELL AM and BONE A Survey of industrial pharmacists, Industrial Pharmacist 19:4 5 (2001) LAFFERTY I, TWITCHELL A M AND Aulton ME Effect of crystallisation conditions on the growth and properties of dextrose crystals, Proceedings of the Pharmaceutical Congress of the Americas, AAPS, 2111 (2001) TWITCHELL AM Mixing. In: Pharmaceutics - The Science of Dosage Form Design (2nd edition). Ed: Aulton, ME, Churchill Livingstone, UK, (2002) Clarification. In: Pharmaceutics - The Science of Dosage Form Design (2nd edition). Ed: Aulton, ME, Churchill Livingstone, UK, (2002) Heat transfer and the properties and use of steam. In: Pharmaceutics - The Science of Dosage Form Design (2nd edition). Ed: Aulton, ME, Churchill Livingstone, UK, (2002) AULTON ME and TWITCHELL AM Pharmaceutical plant design. In: Pharmaceutics - The Science of Dosage Form Design (2nd edition). Ed: Aulton, ME, Churchill Livingstone, UK, (2002) 28/11/14 European Union, Page 3 / 6

4 MACLEOD GS and TWITCHELL AM Comparison of the tensile and adhesion properties of different film coating systems, J. Pharm. Pharmacol., 55, Sept. Suppl., 78 (2003) TWITCHELL AM Mixing. In: Pharmaceutics - The Design and manufacture of medicines (3rd edition). Ed: Aulton, ME, Churchill Livingstone, UK, (2007) Clarification. In: Pharmaceutics - The Design and manufacture of medicines (3rd edition). Ed: Aulton, ME, Churchill Livingstone, UK, (2007) Heat transfer and the properties and use of steam. In: Pharmaceutics - The Design and manufacture of medicines (3rd edition). Ed: Aulton, ME, Churchill Livingstone, UK, (2007) AULTON ME and TWITCHELL AM Pharmaceutical plant design. In: Pharmaceutics - The Design and manufacture of medicines (3rd edition). Ed: Aulton, ME, Churchill Livingstone, UK, (2007) TWITCHELL AM Mixing. In: Pharmaceutics - The Design and manufacture of medicines (4th edition). Ed: Aulton, ME and TAYLOR KMG, Churchill Livingstone, UK, (2013) Clarification. In: Pharmaceutics - The Design and manufacture of medicines (4th edition). Ed: Aulton, ME and TAYLOR KMG, Churchill Livingstone, UK, (2013) Projects External Examinerships MSc Pharmaceutical Sciences / MSc Industrial Pharmaceutical Studies, University of Greenwich, UK MPharm, University of Sunderland, UK MSC Pharmaceutical Industrial Advanced Training (PIAT), University of Manchester, UK Number of successful PhD students supervised - 6 MSc / PhD vivas carried out at De Montfort University, Greenwich University, University of Manchester and Liverpool University Reviewer of papers for the following pharmaceutical journals (while working at De Montfort University): Pharmaceutical Technology Europe, International Journal of Pharmaceutics and Pharmaceutical Development and Technology Memberships Member of the Royal Pharmaceutical Society of Great Britain Presentations / invited lectures Controlled Release Drug Delivery Using Tablets and Multi-Particulate Systems. School of Medicine, University of Nottingham (1990) Unit processes in Pharmaceutics: Two day theoretical/practical course presented to Scherer DDS. (1993) Powder Mixing, Particle Size Measurement Techniques, Powder Flow Presented as part of a Powder Technology Course to Fisons plc (1996) Modified Drug Release: Processing considerations Coating Pans and Coating Columns European Continuing Education College course on Pharmaceutical Coating Technology (1998) Film Coating Equipment - Pfizer Film Coating Symposium (1999) Coating of solid dosage forms, Coating equipment (1999) Coating of Pharmaceutical Dosage Forms (1999) Coating of Pharmaceutical Dosage Forms 28/11/14 European Union, Page 4 / 6

5 Sanofi Winthrop in-house course on Principles of Tablet and Capsule Formulation (1999) Modified Drug Release: Processing Conditions for Multiparticulates, Film Coating Processes 2 Equipment, Issues that Relate to the Design of the Substrate European Continuing Education College course on Pharmaceutical Coating Technology (2000) The Coating of Tablets, Tablet Coating Equipment (2000) Introduction to the Coating of Solid Dosage Forms (2000) Issues that Relate to the Design of the Core Manesty Film Coating Seminar: Recent advances in film coating technology (2000) (2001) Mathematical Ability of Students Entering the MPharm Course at De Montfort University - Miscalculations can lead to dispensing errors, Academic Pharmacy Group of RPSGB (2001) Application of Surface Energies in Film Coating Film Coating Focus Group meeting: Advances in Film Coating Science, Technology and Application, London (2002) (2002) Recent Developments in Film Coating Presented to 139th British Pharmaceutical Conference, Film Coating Focus Group session, Manchester, UK (2002) (2002) (2003) (2003) (2004) (2004) Modified Drug Release: Processing Conditions for Multiparticulates, Film Coating Processes 2 Equipment, Issues that Relate to the Design of the Substrate, Application of Surface Energies in Film Coating European Continuing Education College course on Pharmaceutical Coating Technology (2004). (2005) (2005) 28/11/14 European Union, Page 5 / 6

6 (2006) Other Relevant Information 28/11/14 European Union, Page 6 / 6

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