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

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 Beginning of Human Trials Publication in Scientific Journal Trials in Patients Submission of registration dossier to regulatory authorities Registration Research and Discovery Early Development Full Development Pre-Market Activity Launch and Manufacture 0 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

Novel Polymer Technology

Pre Clinical Work

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

Culture of Excellence 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!