ry covalence; former Medical Officer & Dep. Director at FDA) • Paul Flyer, PhD, Dinka( Stan sacs 135• years of statistical experience - FDA, Amgen, Biogen Ides. ICOS) • Solomon Tse, PhD, Chemistry, Manufacturing, & Controls (30• years OMC experience- MJ) • Dan Szeto, PhD, OA/QC pa years QC/QA/GMP/GLP ope