cardiovascular research

Transcription

2 PPD s Cardiovascular team: Optimizing Trials and Improving Outcomes Applying Experience, Innovation and Efficiency in the Fight Against Cardiovascular Disease PPD has extensive experience in planning and implementing Phase I IV programs for cardiovascular drug development, ranging from single-site dose exploration studies to multinational outcomes studies with hundreds of sites and thousands of patients. Meeting the Needs of Today s Clinical Trial Challenges Cardiovascular clinical trials are now larger and more complex than ever, presenting significant challenges in terms of time and cost. These studies often require both a global approach and deep medical and operational expertise in order to prove the therapeutic benefit of new treatments. As an experienced partner with cardiovascular expertise, operational capacity and global resources, PPD can provide the insight and access to help you develop an effective study protocol, overcome challenges and manage complex cardiovascular trials, regardless of size or scope. Helping You Explore New Strategies for Success PPD employs a highly consultative approach to understand fully the needs of your cardiovascular program. We apply broad strategic development expertise in cardiovascular research, significant global access and vetted feasibility processes to help you gain efficiencies by selecting the best countries and sites and the most suitable patient populations. Furthermore, we align your study protocol with marketing plans to ultimately help you realize your product s greatest value. As a leader in cardiovascular research, PPD provides you with: + + Comprehensive cardiovascular experience, with more than 100 trials conducted in the past five years + + Extensive cardiovascular outcomes experience and expertise + + A global team of nearly 1,900 scientific and operational experts led by cardiovascular physicians, as well as a global network of more than 5,000 experienced cardiovascular investigators + + Imaging solutions through our partnership with VirtualScopics, Inc.

3 PPD combines extensive experience and a global presence to optimize cardiovascular product development programs from early phase through post-approval. Cardiovascular trial experience (Past Five Years) Cardiovascular Outcomes Research Experience Cardiovascular outcomes research comes with significant risk in terms of cost and time delays to market. Our medical and operational experts can help you strategically design trials from single studies to full clinical programs, while our therapeutically aligned medical safety, scientific, project management and regulatory experts provide strategic planning, support and execution oversight at every stage to preserve efficiency, diminish risks and assure that program objectives are met. ++ Standard MedDRA queries specific for major adverse cardiac events (MACE) to ensure that no potential cardiovascular event is missed Phase I 6 Phase II 25 Phase III 51 Phase IV/Post-Approval 13 No Phase/Other Cardiovascular outcomes working group led by experienced cardiologists and clinical scientists with in-depth experience in Type 2 diabetes and other disorders that carry cardiovascular risks ++ Industry-leading analytics tool, which provides custom guidance and highlights potential risks ++ Experience with various academic research organization (ARO) partnership models Our comprehensive product development experience includes: ++ In-depth experience with key cardiovascular indications, such as acute coronary syndrome, lipid disorders, heart failure, venous thromboembolism and arrhythmias Comprehensive Experience that Spans the Development Process and the Globe PPD has conducted 11 cardiovascular outcomes studies in the past five years, involving more than 83,000 patients and 8,100 sites. Our experience includes cardiovascular outcomes research in support of therapies developed to treat key indications, such as: ++ Type 2 diabetes ++ Acute coronary syndrome ++ Significant cardiovascular stem cell research experience ++ Hyperlipidemia/dyslipidemia ++ Development of device and drug-device products ++ Obesity

4 An Integrated Approach Guides Programs Through Drug Discovery and Development PPD s worldwide team of experts includes physicians, project managers, clinical team managers and clinical research associates who have broad medical expertise and cardiovascular specialization. PPD Locations Backed by the resources of a leading global CRO, these experts apply their therapeutic experience, in-depth understanding of current standards of clinical practice and state-of-the-art approaches to plan and execute your cardiovascular study. PPD can help you anticipate and proactively overcome clinical and regulatory challenges across all areas of product development. This expertise saves valuable time and speeds informed go/no-go decision-making. Cardiovascular Project Team International Investigator Network PPD employs more than 1,900 professionals globally with experience conducting a broad range of cardiovascular studies. Achieving success in large, multi-national cardiovascular trials requires far-reaching clinical and operational resources. PPD has the expertise and resources to meet your needs through: ++ Led by experienced cardiovascular physicians who provide strategic guidance or protocol development and execution ++ Cross-functional project teams work efficiently to meet project timelines and achieve the highest quality standards within budget ++ Continuity in project teams and strong succession planning support your cardiovascular project throughout its entire life cycle, from strategy and feasibility, to study design and monitoring, to data analysis and reporting ++ A worldwide investigator network that includes more than 5,000 cardiologists with diverse specialties and experience in cardiovascular clinical trials ++ Extensive relationships with global study sites that enable efficient subject recruitment to help you reach target enrollments that represent patient populations and match study protocol requirements

5 PPD offers a full spectrum of cardiovascular-focused services as part of a comprehensive clinical trial solution. Pharmacovigilance Regulatory Affairs ++ Experience in more than 30 global trials that have adjudicated clinical endpoints ++ Constant monitoring of the global regulatory environment related to cardiovascular products to enable better navigation of the regulatory process from preparation to submission ++ Access to a robust electronic adjudication system, which allows for remote event adjudication in real time ++ Dedicated adjudication group for clinical endpoint and committee management ++ Physicians and health care professionals around the world experienced in all aspects of drug development and drug safety and with extensive expertise across leading cardiovascular indications ++ More than 400 highly skilled medical and safety professionals with first-hand knowledge of regulatory requirements and therapeutic experience, providing safety coverage 24 hours per day, seven days per week ++ Global regulatory strategy development, supported by regulatory staff across North America, Europe, Latin America and Asia Pacific, provides expertise across a wide range of products Late Stage Research Clinical Data Management ++ More than 10 years experience developing and implementing late stage research, including patient registries and observational studies ++ Extensive data management experience for Phase I IV clinical cardiovascular trials ++ Comprehensive management that ensures long-term product value and market support ++ Global clinical data management staff with the knowledge to address local needs and the global reach to manage large, multi-national trials ++ Data management specialists actively involved from study start-up to database lock to ensure trials are closed quickly and with the highest level of quality Industry-leading endpoint-driven cardiovascular imaging capabilities through our partnership with VirtualScopics, Inc. Biostatistics ++ Global standardization of imaging acquisition study and data collection for large and complex trials ++ Accelerated decision-making through adaptive trial design, real-time analysis, and innovative, integrated technology and statistical solutions ++ Standardized data transfers with rolling reconciliation ++ Comprehensive analysis plans tailored to meet the needs of your project and optimize efficiencies throughout all phases, from initial dose titration through post-approval Cardiovascular-Focused Services that Assure Quality and Precision ++ Long-standing relationships with the U.S. Food & Drug Administration (FDA), European Medicines Agency (EMA) and national agencies help ensure timelines are met so you can get your product to market faster ++ Superior data quality via meticulous documentation, global audits and independent, senior-level review ++ Streamlined vendor management ++ Full spectrum of cardiovascular clinical and medical imaging services

6 Discovery and Laboratory Services that Provide Insight and Value From single-protocol studies to full compound development programs, PPD has the scientific expertise to help you successfully and swiftly make critical decisions for your cardiovascular discovery and development programs. Central Laboratories Strategically located in Belgium, China, Singapore and the United States, our laboratory facilities: ++ Follow global standard operating procedures (SOPs) and conduct weekly cross-validation of results among PPD facilities to ensure consistency and provide globally comparable and combinable data throughout each study ++ Provide integrated central laboratory services, including biomarker measurement services, to investigator sites in virtually every country of the world an important consideration when conducting a multi-national trial ++ Use a single, fully integrated, web-based database with no need to merge or harmonize data ++ Utilize PPD Clicks technology a secure website to view and analyze the most current lab results ++ Integrate CRO and central lab data through a proprietary, automated platform ++ Uniquely positioned to support your cardiovascular research, PPD s central labs have:»» More than 25 years of experience in lipids/ cardiovascular testing»» Provided unique HMG-CoA inhibition testing for every statin released to market»» An extensive menu of cardiac biomarkers»» A comprehensive offering of related renal, diabetes, inflammatory and hormonal biomarkers Discovery Services ++ End-to-end integrated services, from lead generation to pre-clinical candidacy to sponsorship ++ Resources include BioDuro, A PPD Company, a state-of-the-art, fully integrated life science research service provider, with a combined 180,000 square feet of laboratory space in Beijing and Shanghai and more than 600 researchers Bioanalytical Labs ++ Our bioanalytical laboratories in Richmond, Va., and Madison, Wis., provide comprehensive, state-of-theart assay development, transfer, validation and sample analysis capabilities with extensive experience in cardiovascular compounds cgmp Labs ++ PPD has been extensively involved in supporting the analysis of stents, stability and release testing from Phase II to market