WILMINGTON, N.C.--(BUSINESS WIRE)--Pharmaceutical Product Development, LLC (PPD), a leading global contract research organization (CRO), today announced the creation of a dedicated unit combining its medical affairs research operations (MARO) team and Evidera, the provider of evidence-based solutions to demonstrate the real-world effectiveness, safety and value of biopharmaceutical and biotechnology products. PPD acquired Evidera last year, uniting two best-in-class research companies to create transformative opportunities for biopharmaceutical clients.
The new dedicated unit, retaining the Evidera name, will provide customers with global comprehensive and integrated solutions, including modeling and simulation, interventional studies (including expanded access/compassionate use and extended access), observational studies (including registries), health economics, outcomes research, market access, epidemiology, real-world evidence, safety and risk management.
“Our clients are seeking better evidence to satisfy the requirements of both regulators and payers, and we have a tremendous opportunity to meet that need by delivering real-world evidence that bridges the gaps between efficacy, safety and value,” said William Sharbaugh, chief operating officer of PPD. “Through this new business unit we will be able to help our clients seamlessly integrate and align regulatory and peri- and post-approval research efforts, improving their ability to meet the evidence demands of both regulators and payers.”
The new business unit will retain the executive and scientific leadership of both the Evidera and MARO organizations. Jon Williams, who has served as president and CEO of Evidera since 2013, will lead the new unit.
“Bringing together Evidera’s scientific and consulting expertise with PPD’s global operations infrastructure creates an unparalleled ability to partner with and serve our clients in optimizing their product value and market access,” Williams said.
Experts from the new unit will be present at the annual meetings of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) in Boston in May, and the Drug Information Association (DIA) in Chicago in June, where they will contribute more than 50 research presentations, posters, short courses and other research activities.
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 19,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. For more information, visit www.ppdi.com.
Any statements made in this news release that are not statements of historical fact, including statements about the combination of PPD’s medical affairs research operations and Evidera, are forward-looking statements that involve a number of risks and uncertainties. These statements often include words such as “anticipate,” “expect,” “suggests,” “plan,” “believe,” “intend,” “estimates,” “targets,” “projects,” “should,” “could,” “would,” “may,” “might,” “will,” “forecast” and other similar expressions. The forward-looking statements contained in this news release are subject to and involve risks, uncertainties and assumptions, and therefore you should not place undue reliance on them. Although PPD believes these forward-looking statements are based on reasonable assumptions at the time they are made, many factors are beyond PPD’s ability to control or predict and could affect the outcome of the subject matter of this news release and our actual financial results, and therefore the outcome and results might differ materially from those expressed in the forward-looking statements.
Additional factors that might materially affect the forward-looking statements include, but are not limited to: the competitive nature of the drug development services industry; changes in trends in the biopharmaceutical industry; our ability to recruit, retain and motivate key personnel; rapid technological changes that make our services less competitive or obsolete; the impacts of political, economic and/or regulatory changes on the health care industry; the fact that our backlog may not accurately predict or convert into service revenue; the termination, delay or change in scope of our contracts; industry, customer or therapeutic concentration; the pricing of and cost management of customer contracts; information and communication systems failures; contractual failures; regulatory and ethical standards failures; our ability to attract investigators and enroll patients in clinical trials; violations of laws governing privacy, conduct of clinical trials and/or other pharmaceutical research; competition between existing and potential customers; management of business restructurings and acquisitions; risk relating to the performance of drug development services and our insurance coverages, if any, for such risks; U.S. or international economic, currency, political and other risks; changes in existing or interpretations of tax laws; factors impacting the value of our goodwill and intangible assets; and other factors.
PPD assumes no obligation and expressly disclaims any duty to revise or update any forward-looking statements, or make any new forward-looking statement, whether as a result of new information, future events or otherwise, except as required by applicable law. PPD is not responsible for updating the information contained in this news release beyond the published date, or for changes made to this news release by wire services or internet service providers or any other party.