New modality deep dive; plus Sharpless speaks & Five Prime scores: a BioCentury podcast

On the latest BioCentury This Week podcast, BioCentury’s editors discuss take-homes from a discussion with NCI Director Ned Sharpless, who talked to BioCentury  about how he thinks FDA could expedite reviews of cancer and rare disease. The team also surveys how regulatory breakthroughs and deep late-stage pipeline of new modality drugs indicate that these therapies are at last poised to create a heavy footprint in drug development, plus Five Prime’s deal with Amgen.

One of Sharpless’ major takeaways from his 2019 stint as acting FDA commissioner was FDA’s lack of regulatory frameworks for N-of-1 medicines, according to Senior Editor Karen Tkach Tuzman. In their conversation, 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...