A presentation on working as a manufacturing scientist in a company specialising in provision of clinical trials
(c) Pharmaceutical Profiles and Steve Coney, 2009
Contemporary Economic Issues Facing the Filipino Entrepreneur (1).pptx
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
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
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