It’s been almost a decade since the release of the first stunning data on a cell therapy that battled blood cancer by genetically altering a patient’s own white blood cells to attack it. Many years and billions of dollars in mergers and acquisitions later, CAR-T is still used mostly as a last resort. Could new clinical trials that are about to report out in full change that?

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Panel Discussion sponsored by Precision ADVANCE

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Assays that measure neutralizing antibodies (NAb) have become an essential part of the development process for many gene therapeutics. When these NAb assays are used to determine eligibility for treatment, there are heightened regulatory concerns.

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There is no doubt that the advanced therapies sector is growing at an exponential rate. According to a recently published 2021 Report by ARM (Alliance for Regenerative Medicine), the sector has raised $14.1B in financing in the first half of 2021 which is already 71% of what was raised in all of 2020. In addition, there are over 2,600 advance therapy clinical trials being conducted with 264 of those trails being Phase 3 trials and another 1,500 being Phase 2 trials.

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Cell and gene therapies present tremendous clinical and humanistic opportunity to change the course of disease but also present several unique aspects that differ from more traditional therapies. These differences will impact how innovators develop evidence and manufacture and distribute products. Payers also need to adapt how they assess value, make coverage decisions, and manage reimbursement.

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