Platform designations: FDA’s new cell and gene therapy super office director sees potential

FDA’s Nicole Ver­dun has high ex­pec­ta­tions for a new des­ig­na­tion that could be cru­cial for cell and gene ther­a­py spon­sors.

There’s “a lot of op­por­tu­ni­ty” for what will be known as a plat­form des­ig­na­tion. Ver­dun, head of the FDA’s new­ly cre­at­ed su­per of­fice, known as the Of­fice of Ther­a­peu­tic Prod­ucts, said at the Amer­i­can So­ci­ety of Cell and Gene Ther­a­py’s pol­i­cy con­fer­ence on Mon­day that it could be specif­i­cal­ly ben­e­fi­cial to gene ther­a­pies that might use the same AAV back­bone and be from the same spon­sor, al­low­ing the agency to move more than one ther­a­py for­ward with­in a short­ened pe­ri­od of time.

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