CENTRAL LABORATORY SERVICES. Immune-Mediated Inflammatory Diseases

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1 CENTRAL LABORATORY SERVICES Immune-Mediated Inflammatory Diseases

2 Table of contents 01 Accelerating drug development starts here 02 Experience inspires innovation 03 Powerful results depend on reliable data 04 Uncover the full potential of your data 05 We put the whole world in your hands 06 Every patient counts

3 The IMID revolution is here: New targets for therapy Expanding markets for your products Accelerating drug development starts here Rigorous lab testing that produces consistent clinical data and drives the success of your clinical trial Immune-Mediated Inflammatory Diseases: IMIDs Among the most common of these "immune-mediated A new understanding, a new approach inflammatory diseases" (IMIDs) which affect thousands of people worldwide are asthma, chronic obstructive There has been a paradigm shift in our understanding pulmonary disease (COPD), psoriasis, rheumatoid of inflammatory disease and the immune arthritis system. (RA), In the inflammatory bowel disease (Crohn's not-too-distant past, drug developers focused disease on therapies and ulcerative colitis), and lupus. targeting specific organs and symptoms. Now, research has revealed the underlying immune system response mechanisms shared by some RAof these seemingly unrelated conditions. New opportunities for success COPD The revolutionary change in our understanding of immune-mediated inflammatory diseases (IMIDs) offers unique opportunities for pharmaceutical companies and their future R&D efforts. This approach may lead to: Psoriasis Future mechanistic applications vs. single disease state usage Enhanced value of your clinical portfolio Extended commercialization potential for existing therapies IBD The leader in IMID drug development Covance experience Asthma includes 14 of 15 top IMID drugs. Lupus

4 Over the past five years: 450+ IMID trials 75+ countries 18,000+ investigator sites 150,000+ patients Experience inspires innovation 42 studies Lupus: 30 studies Covance delivers excellence, so you can deliver Rheumatoid life-changing treatments Arthritis (RA): 169 studies New challenges and a partner with the experience Sites are located in convenient to help you overcome them areas with easy access to research Inflammatory Bowel Disease: institutions, study populations, and The choice of a central lab can have a significant impact transportation routes. on the success of your IMID drug development efforts. Covance CLS offers access to The lab you choose must: diverse study populations around Psoriasis: the world, including treatmentnaive potential sample study management subjects. 52 studies 3 Ensure high-quality end-to-end 3 Maintain tightly controlled, rigorous testing practices Asthma: 3 Produce globally consistent, reliable data 97 studies 3 Balance the demands of trial complexity with global patient populations and diverse assay requirements Chronic Obstructive Pulmonary Disease (COPD): 66 studies Covance Central Laboratory Services can help you overcome these challenges and achieve success and your patients always come first. Partner with Covance for assured data consistency every day, every trial, every site. We offer: Globally consistent testing platforms and SOPs Global automated kit production Customized training materials & tools based on the specific requirements of your protocol Dedicated oversight of your investigators and your trial sites In-house capabilities for more than 550 assays In-house capabilities for more than 550 assays Extensive assay validation capabilities Extensive assay validation capabilities

5 In-house capabilities: Medical and scientific consultation More than 550 assays CAP/CLIA assay validations Powerful results depend on reliable data Data consistency drives your success Rigorous SOPs enable better decisions Data consistency is critical to FDA approval and successful commercialization of your IMID drug. Achieving data consistency is a challenge in any clinical trial but especially when your trial is conducted globally, with constant pressures of tight budgets and short timeframes. To ensure that your study produces consistent data meeting all regulatory compliance requirements, you need a partner with proven methodologies and experienced technical staff. Our innovative laboratories process more clinical trial samples than any other central lab in the business. In-house capabilities: Key IMID assays Global in-house coverage with consistent SOPs Technicians with >5 years experience Delivering global data consistency Investigator site training meetings Endpoint dilution method provides Covance CLS offers unique in-house data certainty Multimedia delivery of best practices Validated in-house refrigerated ESR capabilities and dedicated support for training and testing Anti-Nuclear Antibody Indirect Multimedia delivery Erythrocyte of best Sedimentation practices Rate QuantiFERON -TB Gold Assay (QFT-G) a variety of key IMID assays to ensure Comprehensive investigator manuals Fluorescence Assay (ANA-IFA) training and testing (ESR) Focused investigator training and that you obtain consistent data and Lower cost, improved turnaround time, Consistent assays for improved patient project management support ensures help accelerate your clinical trial. unmatched data consistency. screening and better decision-making. site compliance and reportable results. MORE MORE MORE Fluorescent micrograph used with permission Bio-Rad Laboratories and the University of Washington

6 Data quality control and assurance: Leverage clinical trial best practices Access diverse study populations worldwide In-house assays minimize risk and cost Automation reduces TAT and ensures consistency Uncover the full potential of your data Data quality that exceeds your expectations and yields enhanced results Covance offers the highest level of data quality control and assurance, with: The most IMID clinical trial experience The greatest number of global clinical trial sites The most tightly controlled, end-to-end sample management, with the ability to perform assay validations in-house Automated lab processes to maximize consistency and scalability while minimizing costs 14 of 15 top IMID drugs developed with Covance data quality Automated The greatest most tightly IMID lab number processes clinical controlled, of trial global to end-to-end experience clinical trial sites maximize sample Covance CLS delivers management, has the consistency five reassurance central labs of worldwide: more with and than Indianapolis, 25 scalability the years ability of experience U.S.; to Geneva, in while perform Switzerland; conducting minimizing and Shanghai, assay delivering China; validations clinical costs Tokyo, trials Japan; and drug and in-house Singapore. development We programs. provide testing services In the years for clinical since 2008 trials we've at more conducted than 18,000 more investigator than 450 IMID sites studies in 75 countries world- Covance CLS has offers automated high-quality many end-to-end lab processes sample for maximum management data services to ensure across wide more the globe more than any other than central any other laboratory. central We ve laboratory also in been the involved world. Our withglobal consistency, sample stability, scalability, data consistency, and cost-effectiveness. and valid results. This approach Your trial ensures will benefit that from our reach the development gives you unparalleled of 14 of 15 access top IMID to many drugs. difficult-to-recruit Our testing methods, populations, end-to-end so you we highly can experienced optimize the technicians, volume of samples global in-house processed coverage, at each of and our consistent labs and SOPs. can sample avoid management the time and services, expense and of investigator launching additional training tools standalone have been studies. refined Our provide you with reduced turnaround time and a lower cost per sample. We centralized and understand optimized global based that data your on management the IMID knowledge trial capabilities may and have expertise specific ensure we've testing that developed your needs study not as produces a covered by consistent result previously of that data extensive validated you can global assays. rely on. experience. Covance offers extensive in-house assay validation capabilities to minimize the expense, risk, and uncertainty of sending your samples Because Covance we approaches have strong IMID relationships research the with same couriers, way you referral do: as labs, one storage interconnected facilities, to a referral lab. In 2012 our labs validated more than 50 assays in immunology and area other of diseases partners sharing all common the regions underlying which immune we operate, system we can response maintain mechanisms. This and makes assure it you possible of consistent, for us to timely, leverage cost-efficient best practices service across across a range all your of sample alone. We also provide unique capabilities and dedicated support for a variety of stability key IMID assays to ensure that you obtain consistent data. trial diseases sites. and assays. As your central laboratory partner, we'll put our exceptional Covance s experience in-house to work for capabilities you ensuring can help that you your reduce study costs produces and accelerate consistent your data clinical and yields trial. maximum value.

7 Global capabilities and partners: 5Central Labs Multiple layers of contingency planning We put the whole world in your hands Worry-free, cost-effective global logistics and Shanghai, operations China Global solutions for IMID clinical trials Indianapolis, Indiana Geneva, Switzerland Five central labs with the ability to transfer samples for specific assays quickly to preserve the stability of your samples Singapore Expanded facilities in Shanghai, China, offering an extensive population of treatment-naive potential Strong, long term relationships with couriers and referral labs deliver consistent service and flexibility for your clinical trials Tokyo, Japan Samples Delivered Within Stability Japan Earthquake: > 99% Superstorm Sandy: > 99% Russian Embargo: > 95% Hurricane Katrina: > 99% Volcanic Ash Cloud: > 92% Weathering the storm and delivering sample stability Data consistency during a natural disaster Learn more about how Covance CLS responded to Superstorm Sandy MORE

8 Our commitment to you and your patients: Partnering with you to promote healthier lives Enabling you to alleviate pain Supporting your patients in managing their symptoms Helping you bring new hope to people everywhere Every patient counts Empowering you to change people's lives We handle the samples, so you can help the patients We understand that developing a new IMID drug is more than a market decision. It represents your commitment to helping people live healthier lives. As your partner, Covance provides the support and resources you need to develop critical treatments that can alleviate patients pain, manage their symptoms, and give them new hope. Covance recognizes the value and dignity of every patient, and the significant contributions made by every person enrolled in your clinical trials. We conduct and manage every trial with this in mind, ensuring that our practices maintain your patients as the priority. Covance is here to serve all your clinical trial needs and we will always put the needs of your patients first. Covance is an independent, publicly held company with headquarters in Princeton, New Jersey, USA. Covance is the marketing name for Covance Inc. and its subsidiaries around the world. THE AMERICAS COVANCE ( ) EUROPE/AFRICA ASIA PACIFIC Copyright 2013, Covance Inc. BROCLS