“Our new center of excellence builds on PPD’s longstanding expertise and experience to address the special drug development considerations of rare diseases and pediatrics,” said Karen Kaucic, M.D., PPD senior vice president and head of the center of excellence. “With a great majority of rare diseases touching children, we believe our approach will enable us to be a more connected and active partner. Our clients can depend on us for the latest trial design innovations, the ability to navigate complex trial logistics and our keen understanding of customized patient access strategies in low-prevalence, widely dispersed patient populations. We felt today was an appropriate time to introduce this new venture, as we join with the drug development community in recognizing Rare Disease Day.”
Dr. Kaucic will leverage her experience in rare diseases and pediatrics to drive the implementation of PPD’s CoE, leading a dedicated team with a wealth of expertise in rare disease trial design and execution in such disciplines as product development, clinical operations, commercial strategy and early engagement.
This team has been assembled to support clinical trial services in areas such as feasibility strategy, clinical information, biostatistics, pharmacovigilance, lab operations and business analytics.
PPD has conducted more than 220 studies in rare diseases with more than 50,000 patients over the past five years. The company leverages a pediatric investigator network to help provide clients with faster trial startup, more predictable patient enrollment and higher-quality data.