PDA Letter Article

Cell and Gene Therapies Present Challenges, Promise

by Joshua Eaton, PDA

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Successful gene therapies are emerging from under the shadow of adverse outcomes from earlier gene therapy trials. Cell therapies also show increased promise. A growth in technological understanding and more advanced process control and verification strategies have improved the safety and efficacy of new treatments using cell and gene therapies.

But how will these new therapies be realized? Are these innovative products ready to move from the clinic to commercial production? And what do regulators think?

Members can read the full article in the April 2018 PDA Letter (PDF)