publication date: Mar. 29, 2019

Cancer is a model for drug development, FDA-bound Sharpless says to NCI advisors

By Paul Goldberg

Decades of basic research in oncology are paying off, resulting in an unprecedented number of drug approvals, said Ned Sharpless, the NCI director who is set to become FDA acting commissioner.

“I think that the research engine—that effort funded by the National Cancer Institute and the industry—has really started to pay off, and one way of showing that is bewildering number of approvals in 2018,” Sharpless, who is about to decamp for FDA in the near future, said to the Board of Scientific Advisors March 25.

Sharpless’s next job will place him in charge of a massive agency with a vast regulatory and law enforcement portfolio that covers drugs as well as food, cosmetics and tobacco products. His talk at BSA focused on the area he knows best—development of cancer drugs.

Showing a slide illustrating that cancer drugs make up a big share of therapeutic agents in late stages of development, Sharpless noted that oncology is booming in spite of the fact that cancer drugs are difficult to develop.

“It’s an interesting question why this happens, but I would argue that it largely reflects that the basic biologic understanding of cancer has improved substantially over the last decades that now allows pharmaceuticals executives to think that this is a good use of resources, that if you invest in this area, you are likely to get a therapeutic that would work, as opposed to other areas—certainly not because cancer drugs are easy to make,” Sharpless said.

During his 18 months at NCI, Sharpless has demonstrated deep understanding of the cancer field. It’s not publicly known what … Continue reading Cancer is a model for drug development, FDA-bound Sharpless says to NCI advisors

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