Janet Woodcock, AP Images

The FDA's Janet Wood­cock talks about some big changes she's push­ing for in drug de­vel­op­ment, and agency re­views

Janet Wood­cock is per­haps the most in­flu­en­tial reg­u­la­tor at the FDA. And when the head of CDER talks about the changes be­ing made at the agency when it comes to clin­i­cal tri­al de­signs, or the need to re­or­ga­nize for a spe­cif­ic dis­ease are­na, an as­sess­ment of the ex­pan­sion of gene ther­a­py or I/O, com­mon de­vel­op­ment mis­takes, and so on, you can be sure the in­dus­try pays at­ten­tion to every word.

So it was with some ea­ger­ness that I opened up Ge­of­frey Porges’ sum­ma­ry of their re­cent con­ver­sa­tion about the FDA. And I wasn’t dis­ap­point­ed. In a wide-rang­ing ex­change with the SVB Leerink an­a­lyst, Wood­cock dis­cussed the grow­ing im­por­tance of pa­tient-re­port­ed out­comes in clin­i­cal tri­als, a cam­paign un­der­way now to see if CROs would help spur more bas­ket stud­ies to com­pare drugs head-to-head, and much, much more.

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