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0305 Sharpless Q&A
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Regulation

Flexible platform: how NCI’s Sharpless thinks COVID variants could boost personalized therapies

Platform-based vaccine regulation could answer questions for cancer neoantigens and rare diseases

Platform-based vaccine regulation could answer questions for cancer neoantigens and rare diseases.

Mar 5, 2021 | 8:11 PM GMT

As regulators embrace platform technologies to rapidly update COVID-19 vaccines, they are laying the groundwork for personalized cancer and rare disease therapies, according to NCI Director Ned Sharpless.

FDA’s lack of regulatory frameworks for n-of-one medicines was one of Sharpless’ major take-homes from his seven-month stint as acting FDA commissioner between April and November in 2019. Sharpless has since returned to his role leading NIH’s National Cancer Institute, which he has held since 2017.

Ned Sharpless, NCI

In a conversation with BioCentury, Sharpless outlined how the streamlined clinical development paths FDA is piloting for vaccines and therapies to address SARS-CoV-2 variants could fill that gap, particularly for platform technologies that make it possible to rapidly change a compound’s target while holding the rest of the molecule constant.

Sharpless views the flexible expedited review pathways that helped create massive industry investment in oncology and

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