Bloomberg Law
May 17, 2019, 7:02 PM UTC

Anxious Lawyers Hindering Cutting-Edge Drugs, Scientists Say

Jeannie Baumann
Jeannie Baumann
Reporter

A risk-averse culture at universities and cancer centers holds back a field of potentially life-saving cell transplantation therapies, scientists said.

“Patients are waiting. These therapies are curative. They’re important for the field,” Ellen V. Sigal, chairperson and founder of Friends of Cancer Research, said during a May 17 meeting on the future of cell therapies.

Universities and other research institutions require scientists to meet onerous commercial-grade drug manufacturing requirements in the first phase of human trials. Researchers say that’s unnecessary because they’re not developing commercial products. Upcoming Food and Drug Administration guidance could ease those concerns.

Cell-based therapies—treatments in which ...

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