Personalised Healthcare Solutions (PHCS) Excellence for your Biomarker-driven Strategies

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1 Personalised Healthcare Solutions (PHCS) Excellence for your Biomarker-driven Strategies

2 The value of In Vitro Diagnostics The value of diagnostics as an integral part in the healthcare value chain Diagnostics are about gathering medical data to be transformed into actionable information. Condition Data Information Action Sample Test Result Evaluation Treatment Desicion Transforming clinical samples into informed therapeutic action is key in the healthcare value chain. IVD testing has long been a silent champion of healthcare, influencing over 60 % of clinical decision-making, while accounting for only about 2 % of total healthcare spending. IVD accounts for ~2 % of worldwide healthcare spending 1,2 IVD influences >60 % of clinical decision-making 1,2 IVDs provide excellent healthcare value. 1 European Diagnostic Manufacturers Association (EDMA), 2009; based on: The Lewin Group, commissioned by Advamed, The Value of Diagnostics, The Lewin Group, The Value of Diagnostics Innovation, Adoption, and Diffusion in Healthcare (2005).

3 Roche Diagnostics are an integral part in the healthcare value chain Healthy Asymptomatic/Symptomatic disease Chronic disease Diagnostics Prevention Screening Diagnosis Prognosis Stratification Treatment Monitoring Pharmaceuticals Today, IVDs are an integral part of decision-making along the entire continuum of a patient s health or disease, enabling physicians to make full use of IVDs along the healthcare value chain.

4 Roche Leadership in Diagnostics 3 Roche Diagnostics areas of expertise Roche Diagnostics covers all IVD segments in all major healthcare areas. Performed on blood, tissue or other patient samples IVDs are a critical source of objective information for improved disease management and patient care. Roche Diagnostics offers the industry s broadest range of diagnostic tests. Our pioneering technologies and solutions not only help ensure an accurate diagnosis, they can detect the risk of disease, predict how a disease may progress, and enable the right treatment decision at the outset. We help patients gain control over chronic conditions by enabling both physicians and patients to monitor treatment progress. And, through our successful collaboration with laboratories, we provide the fast and reliable results needed for lifechanging decisions. Roche Diagnostics serves customers spanning the entire healthcare spectrum from research institutions, hospitals, and commercial laboratories to physicians and patients. Main Focus Areas Cardiology Infectiology Oncology Women s Health CNS

5 7,000 Installed systems 29,000 Installed systems 1,500 Installed systems 7,000 Installed systems 18,000 Installed systems Roche Diagnostics commitment Providing innovation and excellence today and tomorrow Roche offers a pioneering partnership to make the maximum contribution to patient care. As a leader in IVD solutions, 3 we are your dedicated partner supporting you through our immunoassay technologies for centralised and decentralised settings, in molecular and tissue testing, as well as automation and IT solutions. In a pioneering partnership, we provide products that increase testing efficiency and deliver medical value, whilst supporting you every step of the way with our global and local expertise; dedicated service and support teams are available in over 130 countries. Our commitment and rich pipeline of differentiated solutions and technologies will facilitate your provision of improved patient care today and also tomorrow. 20 years of innovation and experience with Elecsys For two decades now, Roche has been continuously investing in the development of Elecsys assays, delivering fast and reliable testing solutions for laboratories all over the world. ElectroChemiLuminescence (ECL) technology is Roche s highly innovative detection technology for heterogeneous immunoassays. Since the launch of the first Elecsys 2010 analyser for small to mid-range laboratories in 1996, the extraordinary success story of the Elecsys platform and ECL technology has continued to set the standard in immunochemistry. More than 35,000 instruments* testify to the outstanding success of Elecsys systems, assays and the ECL technology. Every second, 60 results are reported in laboratories all over the world, amounting to more than 1.9 billion tests in Roche Diagnostics professional IVD analysers combine innovative technologies with accurate, precise and reliable patient results that contribute to better patient care. 3 Source: Roche Annual Report January * Status 2016

6 Personalised Healthcare (PHC) What is PHC all about? PHC is about providing the right treatment for the right group of patients. Roche s strengths in pharmaceuticals and diagnostics along with advances in science and technology have made fitting treatments to patients possible. Did you know that previously, only half of all patients, on average, actually benefited from their treatment? Today, up to 80 % of patients respond to their targeted therapies. Before PHC After PHC From better disease understanding to supporting regulatory approvals.

7 Ferring Pharmaceuticals and Roche collaborate to develop personalised infertility treatment As a leader in personalised healthcare we are expanding this approach to ever more areas of unmet medical need such as infertility and women s health. In collaboration with Ferring, we are excited to play a pioneering role in individualising fertility management while continuing to invest in medically differentiated tests. Jean-Claude Gottraux, Head of Centralised and Point of Care Solutions

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9 Excellence for your Biomarker-driven Strategies The integral process to support drug development with CDx At Roche we combine technical competence with therapeutic insight. Development of a successful targeted therapy involves both diagnostic and pharmaceutical (clinical) concurrent co-development of the drug and the IVD CDx test. From a regulatory standpoint, the identification of the biomarker and development of the IVD CDx test require extensive testing, validation and approval in parallel with the clinical development of the therapeutic product. The Food and Drug Administration (FDA) states that, ideally, a therapeutic product and its corresponding IVD CDx device should be developed contemporaneously, with the clinical performance and clinical significance of the IVD CDx device established using data from the clinical development program of the c orresponding therapeutic product. 4 Roche provides the strong partnership required for development of the therapy and the CDx test, ensuring a smooth and organized development process, in order to achieve timely regulatory marketing authorisations. FDA definition of CDx 4 An IVD CDx device is an IVD device that provides information that is essential for the safe and effective use of a corresponding therapeutic product. The use of an IVD CDx device with a therapeutic product is stipulated in the instructions for use in the labelling of both the diagnostic device and the corresponding therapeutic product, including the labelling of any generic equivalents of the therapeutic product. Roche the partner of choice for PHC Solutions Knowledge is leading to a dramatic increase in the identification of biological targets to fight many diseases. In collaboration with large and small pharmaceutical companies, we identify and develop innovative CDx to target those patients who are likely to respond to specific therapies. Because we recognize the tremendous potential for these solutions, we continue to focus on addressing unmet medical needs by developing the cutting-edge tools you need. In-house Skills Know-how PHC Tools Structure Roche offers all the necessary components to meet complex challenges that make PHC a reality. 4 Food and Drug Administration. August 6, Accessed Aug 2016.

10 Delivering the promise of biomarker-driven strategies Partnership throughout the drug development process In the early stages of discovery, biomarkers can provide insights on the causes or pathophysiology of the disease biology and the mode of action of a therapeutic molecule. During these early phases of a project, the biomarker and diagnostics teams work together with the ultimate goal of developing a reliable biomarker-based test the CDx test, which will help predict which patients will respond to targeted therapies. This is central to the concept of PHC. A multitude of potential biomarkers have been identified that can be used to evaluate disease processes, understand disease diversity, identify drug targets and recognize differences between individual patients. Once a biomarker is found, a standardized diagnostic test can be developed and prepared for regulatory approval alongside a drug. Using biomarkers early can avoid exposing study participants to excessive doses of the drug compound in development and related potential side effects. The future of sustainable healthcare depends on diagnostics. Pharmaceuticals Research and early development Clinical development Commercialisation Target section Lead generation Phase 0 Phase I Phase II Phase III Filing Market Phase IV Discovery phase Exploratory phase Proof of concept Confirmatory phase Biomarker development Target identification Companion diagnostic feasibility and utility Patient selection Dx launch/post-launch assessment Tailored prescribing and monitoring Diagnostics Roche provides the strong partnership required to achieve timely regulatory approvals for therapeutic products and their CDx tests.

11 We bring over 200 biomarker projects with over 55 pharma partners with strong track records reliably on time and on budget We reduce biotech companies development and commercialization risks We offer a differentiated, broad instrument and reagent portfolio Ventana Medical Systems

12 For more information please contact Published by Roche Diagnostics International Ltd Forrenstrasse Rotkreuz, Switzerland 2016 All trademarks mentioned enjoy legal protection.