Becky Upton, Pistoia Alliance president

Biotech-backed non­prof­it joins with FDA to stan­dard­ize process for sub­mit­ting in vit­ro phar­ma­col­o­gy da­ta

The biotech-backed non­prof­it Pis­toia Al­liance is putting to­geth­er a new work­ing group that will in­clude li­aisons from the FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search to de­vel­op a stan­dard­ized and shared tem­plate for in vit­ro phar­ma­col­o­gy (IVP) da­ta in reg­u­la­to­ry sub­mis­sions.

The work­ing group, which al­so will in­clude CRO and tech sup­pli­er reps, is meant to help con­sis­tent­ly align IVP da­ta sub­mis­sions to the FDA be­fore spon­sors take their in­ves­ti­ga­tion­al drugs in­to hu­man test­ing. Cur­rent reg­u­la­tions re­quire spon­sors to pro­vide a tox sum­ma­ry of a de­vel­op­ing drug in an­i­mals and in vit­ro, al­though the par­tic­u­lar stud­ies that need to be run de­pend on the com­pound and the phase of in­ves­ti­ga­tion, the FDA says.

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