Recognising the need for ‘real-world’ data to underpin product value and for a seamless transition from clinical development to product commercialisation, US-based biopharmaceutical services organisation Parexel has made a number of executive appointments to its global Peri-Approval Clinical Group (PACE).
The PACE team’s capabilities include Phase IIIb and Phase IV clinical trials, observational research, post-approval safety surveillance programmes and case processing, and health economics and outcomes research services.
The new appointments include:
• Peggy Schrammel, vice president and global head portfolio management, PACE. Schrammel has previously held senior-level positions at clinical research organisations such as United BioSource, PharmaNet and Quintiles, where she designed and managed late-phase programmes including patient registries, clinical-experience trials, pharmacoeconomic studies and managed care-based effectiveness trials.
• Neal Mantick, senior director, global observational research. Mantick was previously an executive director at Abt Bio-Pharma Solutions, where he led the Observational Studies/Registries Business Unit. Before that, he was responsible for the ongoing management of four global registries for rare diseases at Genzyme.
• David Brown, vice president, epidemiology. Dr. Brown was most recently senior director of epidemiology at King Pharmaceuticals, which was acquired by Pfizer. Before that, he held senior positions in epidemiology and global safety surveillance at Wyeth Research.
• Deborah Lubeck, vice president, health economics and outcomes research. Dr. Lubeck was previously vice president of scientific services at Icon Clinical Research, as well as associate director, health economics at Genentech and director, global health economics and outcomes research at Amgen.
“Observational research has become increasingly important as a means to demonstrate product value in a real world clinical setting,” noted Carol Collins, corporate vice president and worldwide head of PACE at Parexel.“These appointments to the Parexel PACE global team of late-phase experts add extensive expertise to help clients optimise the design and execution of their late-phase and observational research programmes to seamlessly move products from clinical development through commercialisation.”