WILMINGTON, N.C.--(BUSINESS WIRE)--PPD, Inc. (Nasdaq: PPDI) today announced it has established four practice areas through PPD® Consulting—biosimilars, adaptive trial design, China regulatory strategy and cardiovascular outcomes studies—strengthening the company’s ability to help clients meet unique product development challenges across multiple disciplines.
PPD Consulting offers clients a strong team of industry experts with first-hand knowledge in applying clinical, regulatory and commercial program strategies to a range of development programs for small molecules, vaccines, biologics, biosimilars, diagnostics and devices. Biopharmaceutical and medical device companies can engage PPD Consulting to address gaps in their strategic resourcing, to take advantage of PPD’s experience with regulatory agencies, and to seek strategic insight for long-term development and planning activities.
“PPD has a strong team of physicians, regulatory experts, scientists and biostatisticians with extensive experience in creating and implementing product development plans from preclinical through post-approval on global and local levels,” said Christine Dingivan, M.D., chief medical officer of PPD. “We have aligned our consulting practice to the areas where we continue to see a strong need for our services to help our clients address significant regulatory and market challenges.”
Biosimilar development is an example of a new but quickly evolving area. Biopharmaceutical companies can benefit from PPD’s consulting services to select appropriate endpoints, design more efficient clinical trials and develop effective regulatory strategies. Adaptive trial design is also an area where PPD’s biostatistics and therapeutic area experts can assist in the design of approaches, which decrease cycle times and facilitate more efficient, less costly development.
The four practice areas expand PPD’s already deep expertise in regulatory, biostatistics and clinical development consulting across a wide range of product development issues in all major therapeutic areas, including oncology, cardiovascular disease and critical care, neurology and psychiatry, infectious diseases and metabolic diseases.
About PPD
PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 44 countries and more than 11,000 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.
Except for historical information, all of the statements, expectations and assumptions, including expectations and assumptions about product development consulting services offered through PPD Consulting, 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 which could cause future results to differ materially include the following: the ability to attract, integrate and retain key personnel, including a new CEO; competition in the outsourcing industry; research and development spending and outsourcing trends in the pharmaceutical, biotechnology and government-sponsored research sectors; compliance with drug development regulations; changes in the regulation of the drug development process; risks associated with and dependence on strategic relationships; rapid technological advances that make our services less competitive; PPD’s ability to win new business; and risks associated with acquisitions and investments, such as impairments and integration. These and other PPD risk factors are set forth in more detail from time to time in our SEC filings, copies of which are available free of charge upon request from PPD’s investor relations department. PPD assumes no obligation and expressly disclaims any duty to update these forward-looking statements in the future, except as required by applicable securities laws. 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.