Manufacturing Scientist
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A presentation on working as a manufacturing scientist in a company specialising in provision of clinical trials (c) Pharmaceutical Profiles and Steve Coney, 2009
Manufacturing Scientist
- 1. Bridging the Gap From Medical Biochemistry to Clinical Trials Steve Coney – Manufacturing Scientist Pharmaceutical Profiles Ltd 12 March 2009 03/12/09 Pharmaceutical Profiles 1
- 2. Who are Pharmaceutical Profiles? • Nottingham University spin out – 1990, School of Pharmaceutical Sciences • Unique and differentiated technology • Approximately 100 people – 20,000 ft2 Ruddington, Nottingham • >30 clinical studies per year – Global customer base – 65% USA, 25% Europe, 10% Japan 03/12/09 Pharmaceutical Profiles
- 3. How do we make our money? Clinical investigation of bioavailability issues • Application of novel technologies and methodologies to understand how to build an optimal drug formulation for man – EnterionTM, iv MicroTracer PK, pharmacoscintigraphy Rapid evaluation of new formulations in man • Integrated manufacturing and clinical evaluation to enable rapid evaluation and validation of test formulations – Oral, inhaled, intravenous, and intranasal routes of delivery 03/12/09 Pharmaceutical Profiles
- 4. The Enterion Capsule 03/12/09 Pharmaceutical Profiles
- 5. What do we do? Manufacturing Clinical GCP Facility, 30 beds GMP Facility Phase 0 microdosing Formulation R&D IV PK & Metabolism Analytical R&D Phase I Radiolabelling Phase IIa POC CT manufacture Pharmacoscintigraphy Remote controlled Formulation validation Targeted within GI Gastric emptying/motility Multiple dosage forms Lung / nasal deposition Imaging Enterion TM Enterion Imaging 03/12/09 Pharmaceutical Profiles
- 6. Who do we work for? • Worked with the majority of top 30 pharma companies • Over 250 biotechnology companies • Greater than 30 marketed oral drugs • >50 oral drugs currently in development • 16 of the top 100 selling drugs 03/12/09 Pharmaceutical Profiles
- 7. What can we do? •Radiolabelled egg Enterion capsules • Routes of administration •Radiolabelled drink Tablets • • Oral •Nasal sprays Capsules • Intravenous • • Inhaled •pMDIs • Intranasal Solutions • • Rectal •Powder inhalers • Intravaginal Aseptic manipulations • • Dermal •Nebulised doses Ointments & creams • •14C-microdoses Neutron Activation • •Encapsulation 03/12/09 Pharmaceutical Profiles
- 8. Clinical Trials – an Overview • Four main stages: – Phase I Initial human testing - safety – Phase II Dose finalisation – Phase III Therapeutic trials – Phase IV Post-marketing safety monitoring • Also one further stage: – Phase 0 “microdosing” 03/12/09 Pharmaceutical Profiles
- 9. Where does PP fit in? • Mainly Phases 0, I and II (although some III) • Market leader in Phase 0 IV 14C-microdosing 03/12/09 Pharmaceutical Profiles
- 10. About Me • Graduated 2006 BSc(hons) Medical Biochemistry • June 2006-April 2007 UHL Nursing Auxilliary • Joined PP April 2007 • Married June 2007 03/12/09 Pharmaceutical Profiles
- 11. What do I do? • Manufacturing Scientist • Prepare Investigational Medicinal Products (IMPs) • Manage supplies • Perform in vitro experiments • Trained to handle radioactive materials 03/12/09 Pharmaceutical Profiles
- 12. How do you get into Clinical Trials? • Apply for jobs • Gain experience in the Pharmaceutical/Food Industry • Many roles requiring Bioscience graduates • Volunteer!! 03/12/09 Pharmaceutical Profiles
- 13. Any Questions? 03/12/09 Pharmaceutical Profiles 13