CLINICAL DEVELOPMENT SERVICES. Immune-Mediated Inflammatory Diseases

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1 CLINICAL DEVELOPMENT SERVICES Immune-Mediated Inflammary Diseases

2 Table of contents 01 The new inflammation paradigm 02 Solutions for your success 03 An interconnected perspective 04 High-quality data for better answers, sooner 05 Your partner for a new IMID paradigm

3 Immune- Mediated Inflammary Diseases Global Impact: Asthma Psoriasis Rheumaid arthritis The new inflammation paradigm Growing markets, increasing opportunities IMIDs: Immune-Mediated Inflammary Diseases The tal annual cost of RA Global impact of IMIDs Growing markets, increasing opportunities Asthma affects 15% of thepsoriasis affects 2-5% of is estimated at 45 billion in A global new adult understing population. of inflammation the global population. Europe $54 billion in the has changed the IMIDs represent a significant escalating global threat United States. Source: World Health Organization. Source: World Psoriasis Day consortium. drug development lscape for several major diseases Source: Kobelt in terms G. in of Rheumaid morbidity, mortality, quality of life. affecting millions of people worldwide. These include: Arthritis (2009). This represents a growing opportunity develop new Asthma treatments designed modify these disease states; enter Chronic obstructive pulmonary disease 112 (COPD) IMID clinical trials new since markets; 2007 exp market share. 6,101 sites worldwide Psoriasis Covance has aligned our medical, scientific, operational 61,975 patients Rheumaid arthritis (RA) resources support your drug development needs under this new IMID paradigm. Systemic lupus erythemasus (Lupus) Inflammary bowel disease (IBD) (includes ulcerative colitis Crohn s disease) Covance global IMID experience Drug development has traditionally focused on treating the sympms of each disease separately, with limited integration of research clinical trial design. RA Asthma Today, the discovery that these conditions share a common underlying immune system response mechanism is driving a new, interconnected approach: targeting these immune-mediated inflammary diseases (IMIDs) as a unified area focused on mechanism-based disease modification. Psoriasis COPD Lupus IBD TOC

4 Solutions your IMID drug development challenges Solutions for your success Integrated capabilities aligned with your needs To gain competitive advantage in the IMID drug development market, you need overcome the operational challenges that can slow your progress reduce the possibilities for understing your compound's safety efficacy. Covance s integrated capabilities span the full range of services, resources, expertise you need conduct effective cost-efficient IMID studies that enable you make better decisions faster based on high-quality primary data. Placebo response rates Investigar interest Patient retention Patient compliance Site performance Objective endpoints PRO reporting Challenge: Challenge: If High Patient your placebo trial reported is conducted response outcomes rates play a low-performing observed a Challenge: crucial role IMID In in the site, highly trials differentiation it can (e.g., competitive have psoriasis a detrimental of new IMID effect 14-20%; products Challenge: clinical on trial your RA in the The arena where 30%; study crowded use ulcerative timelines, of objective IMID the colitis data dems market. endpoint quality, >30%) on can clinical mask treatment ROI. effects, putting the Improper measurements investigars Challenge: selection Because IMID are in high, IMID clinical of many PROs the clinical pool new trials can of trials are result subjects often in Covance success of solution: your drug Using risk. IMID missed (e.g., lengthy limited, radiographic therapies opportunities involve study are imaging injectable complex durations for differentiation, our (RA) procols, Xcellerate biologics, are often PRO platform, self-administration Covance label lesion long investigar making claims, phographs it we solution: difficult will provide accurate can interest High (psoriasis)) retain be cusmized placebo patient challenging may subjects can be assessment. response lacking for for recommendations patients, rates Covance enhance the entire difficult in IMID leading the solution: duration precision trials maintain. for noncompliance of Drawing are selecting the often study. accuracy related our moniring /or of combined the reduced "eligibility GHEOR your most data, drug appropriate but creep" a efficacy. they clinical often site, significant development require investigar, risk specialized experience in trials Covance solution: Covance will proactively provide location when assessment resources, disease deliver severity Covance patient is offers evaluated enrollment integrated using Covance cusmized techniques. "pressure solution: tests" recommendations each As procol your clinical for recruiting study trial helping subjective approach reduce self-reporting PRO the strategy drain on investigar your management. resources, partner, Covance retaining recommends we solution: ensure qualified a that cusmized Leveraging your investigars. study our mix subjects imaging of We are decrease assessment We help your indentify methods. trial timelines, PROs Covance which helps are enhance targeted properly experience have approaches the trained experience oncology ols needed monired studies, promote tailor Covance throughout yourcan your reduce at creating clinical placebo differentiation ROI. response With our rates robust through guide network our careful the perform study continued screening procol, a centralized study period sample participation. review size entire requirements, trial. analysis clients of of study through images investigar clinical evaluation, obtained the trial remuneration, PRO sites for investigar label your claim investigars, objective training, process. other endpoints we We also by can moniring offer elements reduce also PRO quickly data management investigar drive variability. deploy instrucr stby the engagement site clinical sites performance keep trials your using ensure throughout trial our translation Xcellerate your track, clinical even platform. epro when trial. unexpected readiness for any problems clinical trial arise. scenario. TOC

5 Integrated in-house IMID capabilities Central Laborary Services Market Access & GHEOR Early Clinical Services Our integrated global in-house An interconnected perspective IMID capabilities in central Covance IMID drug development advantages: Covance IMID drug development Covance IMID advantages: drug development advantages: laborary services, market Proven access IMID clinical trial experience: Market Covance access is the strategy: global leader Our Recruitment: with market access We offer global a strong health global economics Phase I presence with Integrated capabilities services across HEOR more IMIDs strategies, than 450 IMID studies involving over 150,000 outcomes patients research since (GHEOR) five clinical teams research provide units, comprehensive, a capacity of more targeted, than 350 beds, early clinical services We (including have been involved with the development empirically of 14 of 15 guided p IMID strategies drugs. the for experience bringing products ability market. recruit patients with a full range of drug development biomarkers) allow you High-quality services leverage data: Our laboraries in Geneva, Burden of Singapore, illness: We Shanghai, can inflammation integrate our diseases. comprehensive retrospective our diverse strengths across all Like you, Covance targets IMIDs as stages an interconnected Tokyo, of your IMID area clinical that requires Indianapolis an deliver globally consistent prospective data through burden of unified Design illness study conduct services of early ensure unit-based skilled project IMID clinical studies: equipment platforms SOPs. management for your site interconnected approach commercially, trials medically, optimize your operationally. drug We selection can evaluate maintenance. your product in a relevant patient population very development program. Global clinical trial sites: We have worked Patient-reported with more than outcomes 18,000 early (PROs): in your Our clinical experience development with several program. Our unique integrated approach offers valuable opportunities investigar leverage sites in more than 75 countries, IMIDs with access virtually many all well-regarded Proof-of-concept PRO (PoC) instruments IMID across studies: the Our IMID experience in smaller our medical operational experience across related diseases, difficult--recruit enabling you populations. spectrum enables us capture scientifically the voice of focused the patient multicenter minimize PoC inflammation studies benefit from our strategic insight obtain faster, high-quality results. variability associated with Tightly controlled end--end sample management, with the ability helps the use drive of PRO your Phase instruments. IIb or III trial design. Our broad range of integrated Phase I-IV drug development services includes: perform assay validations in-house: Our Health unique economic capabilities modeling: Scientific dedicated We offer insights: development As your of partner, cost-effectiveness our strong capabilities Clinical trial moniring project management support for a variety of key IMID assays ensure budget consistent impact data. models, in analysis inflammation of secondary biomarkers, databases translational populate medicine, these models, integration with patient studies underst the Site services Aumated lab processes: We deliver maximum consistency scalability pharmacokinetic/pharmacodynamics (PK/PD) modeling, health outcomes that impact a disease state related costs. while minimizing costs. combined with our expertise in early clinical studies, enable Data management Value message development you & create dossiers: a successful Covance Phase provides III empirically trial. Global aumated kit production: With the largest, highest capacity, most based, readily testable, differentiating value messages, as well as Biometrics medical writing aumated clinical trial kit production facility in the world, we can deliver dossiers (e.g., global value, AMCP) for global, regional, country-specific, economy of scale global consistency. Central laborary services or market-specific purposes. Expert scientific & medical consultation: Our experience provides you Quality assurance control Registration studies: Our clinical, operational, GHEOR experts with unique insights in study design testing methodologies assess provide fast results on clinical, economic, patient-reported outcomes, Patient safety your drug's safety efficacy. ensuring that registries are conducted seamlessly from design through implementation support. Regulary submissions TOC

6 Xcellerate : optimizing your clinical trials High-quality data for better answers, sooner Enhance site selection, reduce waste, improve ROI You depend on high-quality, reproducible data get the answers you need early in the drug development process so you can make the right decisions about what steps take what opportunities pursue. Xcellerate is Covance s unique, proprietary approach forecasting, investigar site selection, clinical trial management. We will help you: Efficiently evaluate each potential study. Engage investigars likely help you meet patient enrollment goals from the start. Obtain faster clinical outcomes, less waste, more consistent predictable on-budget studies. As your IMID partner, we will also help you avoid scope creep cost overruns while proactively preventing resource waste. The Covance Xcellerate platform harnesses the power of the industry s largest clinical trial knowledge base, developed through our view in more than 30 percent of all clinical trials through our Central Laborary Services group. The Covance clinical trial knowledge base the industry's largest is the result of our unique ability index a large volume of data in the public space identify useful patterns/trends for our clients. For you, the powerful combination of our feasibility site selection processes, drug development expertise, available investigar data enhances your ability select appropriate trial sites plan design IMID trials based on matched trial design disease characteristics. TOC

7 Our approach: aligned with your perspective your needs Targeting IMIDs as a cohesive area Faster decisionmaking results Increased clinical ROI Reduced risk Global studies Your partner for a new IMID paradigm IMID drug developers need a partner As your with partner, Covance can enable Covance can help you avoid IMID studies are Drug associated developers with face significant challenges a unique combination of area expertise, faster decision-making, reduce the scope creep proactively specific operational when challenges conducting (such late-phase clinical studies. global clinical trial capabilities, risk of errors flawed data, ensure that your resources as are high placebo response rates cusmer-focused service. keep your clinical trial on time used most cost-effectively. low enrollment Covance retention). offers scalable, targeted, cost-effective global reach a network on budget. Creative, cusmized solutions Covance perceives, operationalizes, Covance understs of global how resources so reduce you can be assured targets inflammation as a cohesive area these risks produce of appropriate robust, study participants, rapid your IMID clinical trial needs our experts underst how support high-quality data enrollment, support trial consistent processes your development of targeted mechanismbased our treatments. goal is provide results regulary high-quality submissions. data sets across global sites. As your IMID drug development partner, creative, cusmized solutions your clinical trial needs. You will benefit from our deep broad expertise of IMIDs related diseases. We are medically, scientifically, operationally aligned with the new IMID paradigm your drug development goals requirements. For more information, contact your account executive or visit us online at Covance is an independent, publicly held company with headquarters in Princen, New Jersey, USA. Covance is the marketing name for Covance Inc. its subsidiaries around the world. THE AMERICAS COVANCE ( ) EUROPE/AFRICA ASIA PACIFIC Copyright 2013, Covance Inc. BROCDS TOC