J P Morgan healthcare conference Sanfran Cisco Jan 8 2019 FDA...

J P Morgan healthcare conference Sanfran Cisco Jan 8 2019
FDA creating innovative office to speed up drug development .... The FDA is creating an office of drug development science consisting of 51 operatives to cut the cost of bringing new medicines to patients ...FDA commisinor Scott Gottlieb revealed the new office at the JP Morgan conference ...Gottlieb thinks the FDA can leverage improved understandings 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 bio century " We believe the time has come to make the science of drug development a more formal process along with the components that it comprises " " Applications will be cloud based and instead of taking the sponsors charts and tables and evaluating their charts and tables we will be pulling down their bottom line data and formatting it through our own charts and tables to do the evaluation " Gottlieb said ...