Enriching Drug Development through Insightful Trial Design

BioKinetic – who we are?

European focus

One of the few remaining

independent, owner-managed Phase I/II CROs in the UK &

Ireland

Committed to providing a fast and

flexible service to our clients

Long-term staff dedicated to

providing excellent clinical research

A trusted advisor!

What we do

• Clinical trial design – FIM to PoC• Protocol development/review• Regulatory affairs• Clinical conduct – Phase I-III• Project Management• Pharmacy & QP Services• Medical Writing• DM&SA and Bioanalysis (through strategic

alliance partners)

Broad Experience in Phase 1

– Over 100 studies in current unit

• PK/PD – Proof of concept studies• Bioequivalence studies• NCE programmes• Interaction studies• HRT studies• Skin assessments• Vaccines• TQTc studies• Biosimilars

Broad Experience In Other Phases

– Phase IIa, IIb & III studies• Diabetes

• Impaired Glucose Tolerance

• Women’s Health

• Arthritis and Pain

• Vaccine

• Transdermal

• Dermatology

• Asthma/COPD

• Access to Network of Specialist Consultants

Clinic Information• MHRA Phase I Supplementary and

Standard Accreditation• GCP and GMP Compliant Facility• Access-controlled 30-bed unit, located

on one-floor to maximise volunteer monitoring and safety

• Access-controlled 8-bed unit for intensive monitoring studies

• Access-controlled separate outpatient and screening rooms

• Designated dosing, phlebotomy and processing areas

• Recreation and dining areas

Current Volunteer Database– Over 17,000 volunteers

• 7,300 healthy M / F , 18-65years• 181 healthy m / f volunteers, over

65• Obese volunteers: 756• T1DM : 106• T2DM diet : 44• T2DM Ins : 34• T2DM Oral : 276• Hypertension : 133• Healthy smokers : 1,813• Skin conditions : 28• Asthma/COPD : 1651/572• Arthritis : 234• RA: 297• Post-menopausal women : 699

Figures at 18NOV2013

Our Location: Belfast, NI

Belfast City Centre• Easy access via Belfast

and Dublin airports

• Population of Greater Belfast – 500,000

• Easy access for clients and volunteers

Unique Operating Environment

• 14 days for Phase I CTA/14 days for REC approvals

• Recruitment capability of whole of Ireland• Cross-border links with Intertrade Ireland &

Enterprise Ireland• Not competing for volunteer or patient

populations

StudyPlacementAgreement

Expression of interest database

FinalProtocol

EthicsSubmission

Time

EthicsApproval

CTASubmission

14Days

Set dates for

Screening&

Dosing

CTAApproval

StudyCommencement

Screening

Approval Pathway

14Days

Key Expertise

1• Women’s Health

2• Dermatology & Transdermals

3• Pain Management & Arthritis

4 • TQTc & Cardiology

5• Vaccines

6• Diabetes & Prediabetes

10 Reasons why Clients Work with us1. MHRA Supplementary Accreditation2. 14 day approval timeline3. Trial design expertise4. Extended capability (in-house & outpatient)5. Database of 17,000 volunteers

6. 100% QC on all source data7. Long serving senior staff8. Strategic alliances for comprehensive solutions 9. Training unit for Faculty of Pharmaceutical Medicine 10. We make our clients happy!