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

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

Ferring Controlled Therapeutics Overview 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

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

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

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

How does it work?

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

Milestones in the Process Compound discovered and patent application made Submission of registration dossier to regulatory authorities Beginning of Human Trials Publication in Scientific Journal Trials in Patients Registration Research and Discovery Launch and Manufacture Early Development Full Development Pre-Market Activity 5 8 12 15 Years 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.

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

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

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

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 13

Culture of Excellence 2003 – Queen’s Award for Innovation 2004 – Manufacturer of the year – Glasgow 2006 – Lanarkshire Business Excellence Awards – Innovation and Creativity 2007/2008 – National Council for Work Experience 2009/2010 – Sunday Times Best Companies ‘One to Watch’ 2010 – Queen’s Award for Enterprise (International Trade) 2010 – Best Factory Awards UK (Cranfield School of Management) Nominated in 6 out of 10 categories Best SME – Highly Commended (Runner up) People Management and Skills Development – Highly Commended (Runner Up) 2011 – Scottish Engineering – Presidents award for Outstanding Achievement Glasgow Business Awards – Innovation through Technology Category (Shortlisted) Confidential

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

Varied tasks Science Regulatory knowledge HR skills Fun!