- April 09, 2019
FDA Commissioner Scott Gottlieb, M.D., was due to reveal the new office in early January 2019 via videolink at the J.P. Morgan Healthcare Conference. In creating the office, Gottlieb thinks the FDA can leverage improved understanding of biomarkers and other advances to build tools that take some of the risks and costs out of drug development. “The whole reason for the cost of drug development is high is that the science of prediction is costly and uncertain,” Gottlieb told BioCentury. “We believe the time has come to make the science of drug development a more formal scientific discipline within the new drug approval process, along with the components that it comprises.”
In practice, that belief will manifest in 51-person Office of Drug Evaluation Science made up of groups focused on clinical outcome assessments, biomedical informatics and safety analytics and biomarker development.
Around one-fifth of the office’s workforce will focus on creating more structured approaches to the evaluation of biomarkers, which Gottlieb thinks are ready to play a “much more formal” role in drug development and review. One strand of the biomarker unit’s activities will seek to develop standards in collaboration with drug developers, academics and other stakeholders.
Another third of the office’s 51 employees will work on biomedical informatics and safety analytics. Gottlieb said these staff will build “a standardized tool for capturing and formatting safety data” to make the agency’s reviews of safety data more structured and consistent.
If the initiative advances as hoped, it will serve as a stepping-stone to a new way of managing drug application reviews. The new approach foreseen by Gottlieb will build on advances in data handling and cloud computing to give the FDA a more active role in how the information underpinning filings is presented and evaluated. “Applications will be cloud based and instead of taking the sponsors’ charts and tables and evaluating their charts and tables, we’ll be pulling down their bottom line data and formatting it through our own assessment tools and creating our own charts and tables to do the evaluation,” Gottlieb said.
REFERENCE: Fierce BioTech; 08 JAN 2019; Nick Paul Taylor