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Ferring Controlled Therapeutics R&D in The Pharma Industry Dr Janet Halliday BSc, FRPharmS, PhD.

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Presentation on theme: "Ferring Controlled Therapeutics R&D in The Pharma Industry Dr Janet Halliday BSc, FRPharmS, PhD."— Presentation transcript:

1 Ferring Controlled Therapeutics R&D in The Pharma Industry Dr Janet Halliday BSc, FRPharmS, PhD

2 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

3 Ferring 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

4 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

5 R&D staff have qualifications in Chemistry Biochemistry Biology Pharmacy Chemical Engineering Level of qualifications PhD, MSc, MBA, BSc, HND, HNC

6 Ferring Controlled Therapeutics 30 22£13 million 30 Countries, 22 partners, over £13 million sales 2011 Developing the technology Committed to female healthcare New technology on the way Highly specialised manufacturing

7 How does it work?

8 Propess® and Cervidil® Vaginal Insert 30 22£13 million 30 Countries, 22 partners, ca.£13 million sales in the world Largest obstetrics brands in the world –Our direct competitors are Novartis and Pfizer

9 Milestones in the Process 0 581215 Years Research and Discovery Compound discovered and patent application made Publication in Scientific Journal Beginning of Human Trials Registration Submission of registration dossier to regulatory authorities Trials in Patients Early Development Full Development 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

10 New Polymers Toxicology for new polymer for drug delivery Medical device guidelines

11 Pre Clinical Work Discuss project plan for study in sheep Vaginal pH Body Temperature Stage of Oestrus SE grant funding Patents Novel Polymer Technology

12 Intellectual Property Preliminary examination report for vaginal applicator patent On line databases, translations

13 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

14 Confidential Culture of Excellence

15 We recognise, reward and celebrate success Company Values What is success? HR, admin, QC, manufacturing, R & D

16 Varied tasks Science Regulatory knowledge HR skills Fun!


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