Preparing for pivotal: solving challenges in scale for cell and gene therapy clinical trials

Published: 5 August 2021
Innovator Insight
Subbu Viswanathan,
Richard Gaeto,
Erin Goodhue Meyer,
Chris Greenberg,
Jim Wise

Advanced therapies – such as cell therapies, gene therapies, and personalized cancer vaccines – emerge from uniquely advanced science. The clinical studies behind these therapeutics are some of the most complex in the history of medicine, and must overcome the operational challenges inherent in their patient-centric paradigm. In addition, the transformative nature of these treatments means that a promising early result often leads to accelerated status and pressure to scale rapidly.

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