BioWales 2015 Pharmaceutical Supply Chain Showcase. 04 March 2015

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1 BioWales 2015 Pharmaceutical Supply Chain Showcase 04 March 2015

2 SIMBEC RESEARCH 40 YEARS EXPERIENCE IN EARLY STAGE CLINICAL DRUG DEVELOPMENT BACKGROUND Over 1,200 clinical studies safely and successfully completed ~40% First-in-Human NCE/biologics including multi-part / umbrella protocols OPERATIONAL 58 bed clinical pharmacology unit Central laboratory services γ-scintigraphy imaging services Integrated Data Management and Statistics, Project Management & Medical Writing Pharmacy and Qualified Person (QP) QA Unit MEDICAL 4 full time Physicians and 1 part-time screening Physician All Physicians, Research Nurses, Physiologists and Technicians, ILS or ALS trained Study specific Risk Management Plan is prepared for every study Emergency Scenario Training including first response rapid resuscitation kit and agreements with local Welsh Ambulance Service Trust & Prince Charles Hospital

3 MAY MARCH 2014 BACK FROM THE BRINK Simbec Research was on the brink of collapse the business had been sold to an owner which wanted to undertake cheap, low cost, bioequivalence studies 100 Welsh jobs were at risk Through the determination of Howard Jenkins and Dr Trevor Tanner the business was saved Prof Sir Chris Evans with his team at Arthurian Life Sciences recapitalise the business through the Wales Life Sciences Fund Prof Trevor Jones agreed to become Chairman In the next 10 months the business got back on track growing 30% in one year and stopped losing money But, where should it go from there

4 MARCH 2014 MARCH 2015 AND WHAT A YEAR IT S BEEN! In a private room at BioWales 2014 Simbec s board held a meeting we agreed to back the acquisition of Orion Clinical Services, and agreed succession planning for the board In June 2014 the merger of Simbec Research and Orion Clinical was agreed, backed by the Wales Life Sciences Fund & HSBC The merger created a Welsh HQ d, international, full service CRO Integration was completed rapidly and we now have an international team Today we have depth, specialty and the power to meet our clients needs

5 FULL SERVICE CRO FROM THE FIRST DOSE IN MAN TO THE LAST DOSE PRE-REGISTRATION PHASE I I V DATA MANAGEMENT & STATISTICS MEDICAL MONITORING IMP MANAGEMENT drug labeling, release, tracking recall, accountability, QP PHARMACOVIGILANCE Clinical trials & post-marketing REGULATORY AFFAIRS & TECHNICAL WRITING QUALITY ASSURANCE CENTRAL LABS Bioanalytic & Pathology

6 GLOBAL RESOURCES WE HAVE THE REACH TO DELIVER FOR ANY CLIENT >30 COUNTRIES CLINICAL MONITORING SERVICES OFFICES MONITORS

7 THERAPEUTIC FOCUS CONCENTRATE ON OUR AREAS OF EXCELLENCE ONCOLOGY RARE & ORPHAN RESPIRATORY DERMATOLOGY INFECTIOUS DISEASE TRANSLATIONAL MEDICINE

8 A YEAR IN REVIEW WE ARE GRATEFUL FOR Winning Phase I healthy volunteer studies from Orion-pre merger clients Winning two major international Phase III studies in Non-Small Cell Lung Cancer and Systemic Lupus Erythematosus (SLE) Executed the first two partnership agreements taking equity in our clients Secured major Central Lab business via our Phase II, III and IV business Created our IMP Management Group from Simbec s Pharmacy to be capable of handling for international Phase II, III and IV studies internationally No staff are now employed below Living Wage and we have a commitment to improve standards further We have consolidated our administrative operations in Wales taking advantage of the talent pool available We are attracting new talent to the Group: recruiting World class scientific talent back to Merthyr Tydfil and securing senior leadership internationally We now compete with businesses multiple times our physical size So what s next?

9 ETHOS OUR CLIENTS ARE OUR PARTNERS We have a simple principle - while we provide outsourced service We Think Like Drug Developers

10 SIMBEC-ORION A HERITAGE OF CLINICAL RESEARCH 1976 ESTABLISHED one of the oldest clinical research service provider in the world 40 YEARS EXPERIENCE AND EXPERTISE PHASE I- IV FULL CONTINUUM OF PHASE 1 - IV SERVICES to follow your molecule from early phase to post-marketing >1,500 (phase I-IIa) >500 (phase I-IV) NICHE EXPERTISE FULL SUITE OF SERVICES PLANNED AND CONDUCTED more than 1,500 Early Phase (Phase 1-11a) studies SUCCESSFUL DELIVERY more than 500 Phase II-IV studies IN A SERIES OF HIGHLY FOCUSED AREAS Oncology, Rare & Orphan, Respiratory, Dermatology, Infectious disease, and Translational Medicine PV, IMP, DM, STATS, MED Wr, REG AFFAIRS QA, CENT LABS,