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Bridging the Gap
From Medical Biochemistry to Clinical Trials
Steve Coney – Manufacturing ScientistPharmaceutical Profiles Ltd12 March 2009
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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
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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
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The Enterion Capsule
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What do we do?
ImagingEnterion TM
Manufacturing Clinical
ImagingEnterion
GCP Facility, 30 bedsPhase 0 microdosingIV PK & MetabolismPhase IPhase IIa POC
PharmacoscintigraphyFormulation validation Gastric emptying/motilityLung / nasal deposition
GMP FacilityFormulation R&DAnalytical R&DRadiolabellingCT manufacture
Remote controlledTargeted within GIMultiple dosage forms
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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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What can we do?
• Enterion capsules
• Tablets
• Capsules
• Solutions
• Aseptic manipulations
• Ointments & creams
• Neutron Activation
•Radiolabelled egg
•Radiolabelled drink
•Nasal sprays
•pMDIs
•Powder inhalers
•Nebulised doses
•14C-microdoses
•Encapsulation
Routes of administration
• Oral• Intravenous• Inhaled• Intranasal• Rectal• Intravaginal• Dermal
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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”
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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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About Me
• Graduated 2006 BSc(hons) Medical Biochemistry
• June 2006-April 2007 UHL Nursing Auxilliary
• Joined PP April 2007
• Married June 2007
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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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How do you get into Clinical Trials?
• Apply for jobs
• Gain experience in the Pharmaceutical/Food Industry
• Many roles requiring Bioscience graduates
• Volunteer!!
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Any Questions?