WILMINGTON, N.C., (May 9, 2011) -- 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.