1. The Advanced Therapies CRO The smart choice for biotechs and medtechs

2. 2 The large majority of the developments fail more or less prematurely (attrition rate in clinical studies: 90%) 86% of studies fail to enroll subjects in the contracted time 1 out of 4 patients drops out of a study after enrollment 15 to 40% of opened centres remain inactive Authorities’ requirements are more and more demanding: Clinical development, Risk Management Plan,… European administrative complexity and herogeneity are a source of important red tape and headaches … Reduce Time to Market and Control the Costs, But… The Advanced Therapies CRO The smart choice for biotechs and medtechs

3. 3 Fate? The Advanced Therapies CRO The smart choice for biotechs and medtechs

4. 4 As a long-established high-quality European CRO, Advanced Drug Development Services (ADDS) Group contributes to successfully bring as early, safely and cost effectively as possible your products to the market in a unique one-stop shop approach for Europe. ADDS helps you to: Conceive your complete development program and risk management plan Secure your administrative submissions Select the right investigator sites Shorten the recruitment time Improve the patient retention ratio Anticipate the risks and solve the issues Meet the Regulatory requirements ADDS offers European Qualified Person Representation for Pharmacovigilance ADDS mission The Advanced Therapies CRO The smart choice for biotechs and medtechs

5. 5 High level of repeat business Transparency and Anticipation Drafting of a Communication Management Plan for each project Key Performance Indicators (KPI) defined in accordance with the sponsor Study Web Portal Audits: SOPs, Systems, … Risk anticipation based on the « real-life » knowledge Respect of the commitments Timeline Services Budget Quality Improvement Periodical Learned Lessons Meetings with the sponsor Corrective actions Stable and dedicated project teams Our customers are our most valuable asset The Advanced Therapies CRO The smart choice for biotechs and medtechs

6. 6 A network of companies in drug & medical device development creating a virtual European company with an unequalled level of expertise and skills at each step One unique entry point to streamline all your development path Founding members: The Advanced Therapies CRO The smart choice for biotechs and medtechs Convergence, the unique «one-stop shop » initiative to access the European market

7. 7 Convergence, the unique «one-stop shop » initiative to accompany all your medicinal product life The Advanced Therapies CRO The smart choice for biotechs and medtechs

8. 8 R&D Biocompatibility Testing Clinical Phases CE Marking Pilot Pivotal Regulatory strategy Critical Data review → Risk Analysis IB/CTA Investigational Plan Instructions for Use Quality Management System (scale-up) Meeting NB Regulatory strategy Compilation of Investigational Studies Applications (IB/CTA) Critical Data review → Risk Management Plan Quality Management System Instructions for Use, Labels Design / technical file Meeting NB Regulatory Strategy Critical Data review → Risk Analysis Biocompatibility Studies Plan According to ISO 10993 Prototypes Manufacturing SOPs Regulatory strategy Design/Technical File Instructions For Use /Labels (translations) Audit NB Notification First Placing on the Market Convergence, the unique «one-stop shop » initiative to accompany all your medical device life The Advanced Therapies CRO The smart choice for biotechs and medtechs

9. 9 Development Strategy Consulting One team, One Project Manager Complete and audited SOPs and systems Special attention and methods for trial critical phases Feasibility Studies Centre Preselection Submission management Centre implementation FPI / centre Safety Query management: monitoring guide, data management documentation, last queries Data Base Lock Innovative design and solutions Adaptive studies eCRF, Web Portal ePRO (Digital Pen,...) The operational excellence to speed up your trials at the best quality/price ratio The Advanced Therapies CRO The smart choice for biotechs and medtechs

10. 10 Privileged access to investigators and patients in emerging countries Central Eastern Europe Maghreb, Egypt Site Support : Improvement of the ratio of active centres The investigators too are considered as customers Special attention to investigators ’ training Quality of human relationships between CRAs and Doctors Possible availability of study nurses to support the investigators Patient Supply Chain Lisibility tests of Patient Informed Consents Patient Support and Accompaniment: Web, Call Center, Home Patient recruitment and Patient retention Accelerator The Advanced Therapies CRO The smart choice for biotechs and medtechs

11. 11 Services in Vigilances & Risk Management Risk Management Pharmacovigilance Medical Device Vigilance Biovigilance Blood Safety OUTSOURCING STRATEGIC COUNSELING Approval dossier Safety Part Counseling QA/QC SOPs - Audit TrainingData base Regulatory Survey EUQPPV The Advanced Therapies CRO The smart choice for biotechs and medtechs

12. 12 ADDS Profile The Advanced Therapies CRO The smart choice for biotechs and medtechs

13. 13 Counseling in Clinical Development Medical writing Clinical Research operations Data Management & Biostatistics Post Marketing Studies Safety and Risk Management InSourcingInSourcing Regulatory Affairs Services The Advanced Therapies CRO The smart choice for biotechs and medtechs

14. 14 Quality Management System Quality Assurance Officer Internal and external audits (customer, independent) Customer Satisfaction Metrics Quality Management System The Advanced Therapies CRO The smart choice for biotechs and medtechs

15. Geographical coverage

16. 16 AllergyAllergy AnesthesiaAnesthesia Asthma and BPCOAsthma and BPCO CardiologyCardiology CNSCNS DermatologyDermatology DiabetesDiabetes Drug/Device Combination ProductsDrug/Device Combination Products EndocrinologyEndocrinology GynecologyGynecology HematologyHematology Infectious diseasesInfectious diseases Medical devicesMedical devices OncologyOncology PediatryPediatry PsychiatryPsychiatry RheumatologyRheumatology SurgerySurgery UrologyUrology AllergyAllergy AnesthesiaAnesthesia Asthma and BPCOAsthma and BPCO CardiologyCardiology CNSCNS DermatologyDermatology DiabetesDiabetes Drug/Device Combination ProductsDrug/Device Combination Products EndocrinologyEndocrinology GynecologyGynecology HematologyHematology Infectious diseasesInfectious diseases Medical devicesMedical devices OncologyOncology PediatryPediatry PsychiatryPsychiatry RheumatologyRheumatology SurgerySurgery UrologyUrology Fields of expertise The Advanced Therapies CRO The smart choice for biotechs and medtechs

17. 17 For any information, feel free to contact: Patrice Le Guen Senior Global Business Manager Advanced Drug Development Services SAS 56, Quai Alphonse le Gallo 92513 Boulogne-Billancourt Cedex – France Tel: +33 1 46 99 63 05 Mobile : +33 6 71 44 01 90 E-mail : pleguen@adds.compleguen@adds.com Web site : www.adds.comwww.adds.com The Advanced Therapies CRO The smart choice for biotechs and medtechs