Bioanalytics
Jad Zoghbi, MS
Scientific Director
Biogen
Cambridge, Massachusetts
Catherine Vrentas, PhD
Principal Scientist
PPD, A ThermoFisher Company
Richmond
Bioanalysis is essential in the development of a new therapeutic and without appropriate evaluation, the review and approval process may be jeopardized causing delays and additional costs. As companies embark on a new drug development, a clinical development plan is established that includes an extremely critical bioanalytical strategy. Throughout the development, bioanalysis allows for a thorough study evaluation via data analysis at various intervals to help speed up the development or potentially stop it from proceeding, thus allowing for a potential change in strategy, if necessary. The bioanalytical program can evolve throughout the development cycle; however, it is important to be proactive with an appropriate plan to allow for an early feasibility assessment and timely implementation. The presentation will highlight some of the aspects of the bioanalytical program with considerations around immunogenicity and biomarker methods.