Why CAR-T policymaking is broken, and why we need to fix it

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The initial reports of the near-miraculous benefits of CAR-T in pediatric acute lymphoblastic leukemia generated tremendous excitement—there was a Lazarus-like quality to these stories.

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Michael Kolodziej
Vice president and chief innovation officer, ADVI Health
Louis Jacques
Chief clinical officer and senior vice president, ADVI Health; Former director of the Coverage and Analysis Group, Centers for Medicare and Medicaid Services
Marc Samuels
Chief executive officer, ADVI Health
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In his first sit-down interview since beginning his role as FDA commissioner 17 days earlier, Marty Makary, a former Johns Hopkins surgeon and the only Trump pick for HHS whose confirmation received Democratic support, said he would speed up approvals for rare-disease treatments by reducing reliance on animal testing and shifting towards organoids and computational models. 
Michael Kolodziej
Vice president and chief innovation officer, ADVI Health
Louis Jacques
Chief clinical officer and senior vice president, ADVI Health; Former director of the Coverage and Analysis Group, Centers for Medicare and Medicaid Services
Marc Samuels
Chief executive officer, ADVI Health

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