A presentation on working as a manufacturing scientist in a company specialising in provision of clinical trials
(c) Pharmaceutical Profiles and Steve Coney, 2009
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Manufacturing Scientist
1. Bridging the Gap
From Medical Biochemistry to Clinical Trials
Steve Coney â Manufacturing Scientist
Pharmaceutical Profiles Ltd
12 March 2009
03/12/09 Pharmaceutical Profiles
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2. Who are Pharmaceutical Profiles?
⢠Nottingham University spin out
â 1990, School of Pharmaceutical Sciences
⢠Unique and differentiated technology
⢠Approximately 100 people
â 20,000 ft2 Ruddington, Nottingham
⢠>30 clinical studies per year
â Global customer base
â 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
â 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
â Oral, inhaled, intravenous, and intranasal routes of delivery
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
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8. Clinical Trials â an Overview
⢠Four main stages:
â Phase I Initial human testing - safety
â Phase II Dose finalisation
â Phase III Therapeutic trials
â Phase IV Post-marketing safety monitoring
⢠Also one further stage:
â Phase 0 âmicrodosingâ
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9. Where does PP fit in?
⢠Mainly Phases 0, I and II (although some III)
⢠Market leader in Phase 0 IV 14C-microdosing
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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
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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