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
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

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 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 Countries, 22 partners, ca.£13 million sales
Largest obstetrics brands in the world
Our direct competitors are Novartis and Pfizer

9. 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.

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

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

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 13

14. 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

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!