manufacturing scientist

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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?