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

Expression of interest database Approval Pathway Expression of interest database Screening 14 Days Study Placement Agreement Final Protocol Ethics Submission Ethics Approval Study Commencement 14 Days CTA Submission CTA Approval Set dates for Screening & Dosing Time

Key Expertise Women’s Health Dermatology & Transdermals 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 us 1. MHRA Supplementary Accreditation 2. 14 day approval timeline 3. Trial design expertise 4. Extended capability (in-house & outpatient) 5. Database of 17,000 volunteers 6. 100% QC on all source data 7. Long serving senior staff 8. Strategic alliances for comprehensive solutions 9. Training unit for Faculty of Pharmaceutical Medicine 10. We make our clients happy!