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Anxious Lawyers Hindering Cutting-Edge Drugs, Scientists Say

  • Commercial-grade manufacturing requirements from institutions holding back cell therapies
  • Draft guidance from FDA in the works

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 stem cells are modified into the specific cell type required to repair damaged or destroyed cells or tissues—have the potential to treat diseases ranging from autoimmune diseases to cancer.

Richard Klausner, a former National Cancer Institute director and the current chief executive of Lyell Immunopharma, called cell therapies the third great modality of science-based medicine, following small molecules that created the pharmaceutical industry and recombinant DNA discoveries that spurred the biotechnology industry.

Novartis broke open the cutting-edge CAR T-cell market in 2017 with Kymriah, which treats a type of leukemia by training a patient’s T-cells to fight off cancer cells. But Sigal said challenges lie ahead in the manufacturing, accessibility, and affordability that could hold back these therapies.

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