Ferring Controlled Therapeutics R&D in The Pharma Industry Dr Janet Halliday BSc, FRPharmS, PhD.
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Transcript of Ferring Controlled Therapeutics R&D in The Pharma Industry Dr Janet Halliday BSc, FRPharmS, PhD.
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Ferring Controlled Therapeutics
R&D in The Pharma Industry
Dr Janet Halliday
BSc, FRPharmS, PhD
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Janet Halliday
Pharmacy Degree Heriot Watt
Pre Registration period in hospital and industry
Sterling Winthrop
PhD University of Strathclyde – Glaxo sponsored
Controlled Therapeutics as Formulation Scientist 1988
Formulation Manager
Director of R &D
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Ferring Controlled TherapeuticsFerring Controlled Therapeutics
Pharmaceutical drug delivery company based in East Kilbride 68 people
Development, Manufacturing, Regulatory, Admin
Spin out of University of Strathclyde
Polymer controlled drug release technology
Founded 1986, on US market 1995
Acquired October 2012 by Ferring Pharmaceuticals
4,000 employees worldwide
Overview
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R&D at Ferring Controlled Therapeutics, Scotland
Employees: 26 Three Platform Technologies
Cross Linked Polyurethane Hydrogel Propess ® marketed product, Misopess® Phase III
Linear Polyurethane Vaginal Ring - animal data
Biodegradable Polyurethane: very early, PhD project Patents for Misopess, C-Vad, linear polymer platform, biodegradable platform Early stage Development Late stage Development GMP facilities: Phase 1, 2 and 3 supply capabilities
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R&D staff have qualifications in
Chemistry
Biochemistry
Biology
Pharmacy
Chemical Engineering
Level of qualifications
PhD, MSc, MBA, BSc, HND, HNC
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Ferring Controlled Therapeutics
3030 Countries, 2222 partners, over £13 million£13 million sales 2011
Developing the technology
Committed to female healthcare
New technology on the way
Highly specialised manufacturing
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How does it work?
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30 30 Countries, 2222 partners, ca.£13 million£13 million salesLargest obstetrics brands in the worldin the world
–Our direct competitors are Novartis and Pfizer
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Milestones in the Process
0 5 8 12 15Years
Research and
Discovery
Compound discovered and patent application
made
Publication in
Scientific Journal
Beginning of
Human Trials
Registration
Submission of
registration
dossier to regulator
y authoritie
s
Trials in Patients
Early Developme
nt
Full Developme
nt
Pre-Market Activity
The above shows a general representation of the development of a new medicine. Various processes may differ from country to country and between different compounds.
Launch
and
Manufacture
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New Polymers
Toxicology for new polymer for drug delivery
Medical device guidelines
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Pre Clinical Work
Discuss project plan for study in sheepVaginal pHBody TemperatureStage of Oestrus
SE grant funding
Patents
Novel Polymer Technology
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Intellectual Property
Preliminary examination report for vaginal applicator patent On line databases, translations
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Clinical trial supply
Process scale up In relation to marketed product Source of API
Analytical validation
Stability Pack design – foils, closures, patient profile
Location of study CTA/IND
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Confidential
Culture of Excellence
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We recognise, reward and celebrate success
Company Values What is success? HR, admin, QC, manufacturing, R & D
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Varied tasks Science Regulatory knowledge HR skills
Fun!