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03/12/09 Pharmaceutical Profiles 03/12/09 Pharmaceutical Profiles 1 Bridging the Gap From Medical Biochemistry to Clinical Trials Steve Coney – Manufacturing Scientist Pharmaceutical Profiles Ltd 12 March 2009

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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

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Page 1: Manufacturing Scientist

03/12/09 Pharmaceutical Profiles03/12/09 Pharmaceutical Profiles 1

Bridging the Gap

From Medical Biochemistry to Clinical Trials

Steve Coney – Manufacturing ScientistPharmaceutical Profiles Ltd12 March 2009

Page 2: Manufacturing Scientist

03/12/09 Pharmaceutical Profiles03/12/09 Pharmaceutical Profiles

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

Page 3: Manufacturing Scientist

03/12/09 Pharmaceutical Profiles

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

Page 4: Manufacturing Scientist

03/12/09 Pharmaceutical Profiles

The Enterion Capsule

Page 5: Manufacturing Scientist

03/12/09 Pharmaceutical Profiles

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

Page 6: Manufacturing Scientist

03/12/09 Pharmaceutical Profiles

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

Page 7: Manufacturing Scientist

03/12/09 Pharmaceutical Profiles

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

Page 8: Manufacturing Scientist

03/12/09 Pharmaceutical Profiles

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”

Page 9: Manufacturing Scientist

03/12/09 Pharmaceutical Profiles

Where does PP fit in?

• Mainly Phases 0, I and II (although some III)

• Market leader in Phase 0 IV 14C-microdosing

Page 10: Manufacturing Scientist

03/12/09 Pharmaceutical Profiles

About Me

• Graduated 2006 BSc(hons) Medical Biochemistry

• June 2006-April 2007 UHL Nursing Auxilliary

• Joined PP April 2007

• Married June 2007

Page 11: Manufacturing Scientist

03/12/09 Pharmaceutical Profiles

What do I do?

• Manufacturing Scientist

• Prepare Investigational Medicinal Products (IMPs)

• Manage supplies

• Perform in vitro experiments

• Trained to handle radioactive materials

Page 12: Manufacturing Scientist

03/12/09 Pharmaceutical Profiles

How do you get into Clinical Trials?

• Apply for jobs

• Gain experience in the Pharmaceutical/Food Industry

• Many roles requiring Bioscience graduates

• Volunteer!!

Page 13: Manufacturing Scientist

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Any Questions?