Transcript Janet Halliday

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
Research
and
Discovery
Submission
of
registration
dossier to
regulatory
authorities
Trials in Patients
Early
Development
Full
Development
Registration
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!