Goal is to establish new quality, cost and speed benchmarks for creating real-world clinical and economic evidence
WILMINGTON, N.C. and WILMINGTON, DEL. (June 15, 2015) – Pharmaceutical Product Development, LLC (PPD) and HealthCore, Inc., have established a collaboration that will enable both companies to further expand their services in the pre- and post-approval research market with the aim of helping biopharmaceutical clients demonstrate more quickly and cost effectively how their products will perform and benefit patients in the real world.
The collaboration brings together two well-respected organizations and aligns complementary strengths to address the need for real-world evidence, one of the faster-growing aspects of clinical research. It combines PPD’s clinical trial design, health economics and outcomes research (HEOR), medical affairs research and epidemiology services with HealthCore’s strengths in HEOR, innovative real-world research designs and its robust research-enabled electronic health care data environment.
“The goals of optimizing reimbursement and increasing payer and patient value are becoming more dependent on biopharmaceutical companies’ ability to provide high-quality evidence of how products will perform for patients in a real-world setting,” said Michael Pollock, vice president of real-world outcomes at PPD. “With the collaborative expertise of PPD and HealthCore, particularly in planning, designing and implementing pragmatic clinical trials, we hope to set a new standard for the quality, cost and speed of real-world evidence generation that can help optimize patient outcomes and enable our clients to better demonstrate the true value of their products and the return on their investments in new product development.”
The collaboration allows life sciences companies to engage in one contract with combined services from PPD and HealthCore that has the potential to cover product research in both pre- and post- approval settings. Both PPD and HealthCore will be able to provide biopharmaceutical companies analyses of medical claims data and electronic health records necessary to understand the utilization and impact of their products and to design appropriate pragmatic clinical trials that address payers’ needs.
“By combining clinical and economic information and leveraging our access to large health care provider networks, we will have a much more robust view of how patients use and react to different therapies,” said Marcus Wilson, president of HealthCore. “This gives us an opportunity to produce relevant information that can facilitate decisions and speed to market those products that provide the most value to patients, payers and life sciences companies alike.”
The majority of post-approval pharmaceutical research includes HEOR, as life sciences companies seek to generate real-world outcomes as part of their cost-effectiveness analyses. Payers are requesting more real-world evidence to help them analyze product safety and effectiveness. As a result, companies are undertaking more pragmatic clinical trials and other Phase IV studies to meet the payer need for real-world outcomes data and to support appropriate reimbursement.
“There’s a certain level of efficiency and understanding that the two companies will gain from working together on research designs at an earlier point in the development process,” said Mark Cziraky, vice president of research for HealthCore. “This approach allows us to evolve the evidence while operationally offering seamless, one-stop research shopping to life sciences companies.”
PPD is a leading global contract research organization providing drug discovery, development, lifecycle management and laboratory services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 14,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit www.ppdi.com.
HealthCore, Inc., is the clinical outcomes research subsidiary of Anthem, Inc. HealthCore uses real-world data, including claims data, to provide clinical and other scientific expertise and research services to the pharmaceutical, biotechnology and device industries, in the conduct of industry-sponsored safety, health economic outcomes, comparative effectiveness, epidemiological and late stage research projects. HealthCore’s capabilities include retrospective database design and analysis, prospective observational research design and analysis, safety and epidemiologic research services, post authorization safety study (PASS), health services research, patient and/or provider survey development and implementation, and general research consultation. To find out more about HealthCore, go to www.healthcore.com.
PPD Forward-Looking Statement
Except for historical information, all of the statements, expectations and assumptions, including statements, expectations and assumptions about the collaboration with HealthCore and the establishment of new quality, cost and speed benchmarks, contained in this news release are forward-looking statements that involve a number of risks and uncertainties. Although PPD attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based and could cause actual results to differ materially from the forward-looking statements. Other important factors that could cause future results to differ materially include the following: risks associated with and dependence on strategic relationships; risks associated with acquisitions and investments; the ability to attract, integrate, retain and train key personnel; competition in the outsourcing industry; rapid technological advances that make our services or capabilities less competitive; PPD’s ability to win new business; overall global economic conditions; economic conditions, research and development spending, and outsourcing trends in the pharmaceutical, biotechnology and government-sponsored research sectors; changes in the regulation of the drug development process; consolidation in the pharmaceutical and biotechnology industries; loss, delay or modification of large contracts; higher-than-expected cancellation rates; the rate of conversion of backlog into revenue; actual operating performance; compliance with drug development regulations; and the ability to control SG&A spending. PPD assumes no obligation and expressly disclaims any duty to update these forward-looking statements in the future, except as required by applicable law. These forward-looking statements should not be relied upon as representing PPD’s estimates or views as of any date subsequent to the date hereof.
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