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 TherapeuticsFerring 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

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

3030 Countries, 2222 partners, over £13 million£13 million sales 2011

Developing the technology

Committed to female healthcare

New technology on the way

Highly specialised manufacturing

How does it work?

30 30 Countries, 2222 partners, ca.£13 million£13 million salesLargest obstetrics brands in the worldin the world

–Our direct competitors are Novartis and Pfizer

Milestones in the Process

0 5 8 12 15Years

Research and

Discovery

Compound discovered and patent application

made

Publication in

Scientific Journal

Beginning of

Human Trials

Registration

Submission of

registration

dossier to regulator

y authoritie

s

Trials in Patients

Early Developme

nt

Full Developme

nt

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

New Polymers

Toxicology for new polymer for drug delivery

Medical device guidelines

Pre Clinical Work

Discuss project plan for study in sheepVaginal pHBody TemperatureStage of Oestrus

SE grant funding

Patents

Novel Polymer Technology

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

Confidential

Culture of Excellence

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!