Biotech execs, academic expert lament impact of FDA turnover on rare disease drug development

‘It’s a roller coaster,’ one CEO said of investors’ reaction to the leadership chaos

Mahzi Therapeutics CEO Yael Weiss, left, and Ted Love, the former chairman of BIO, spoke at the STAT Breakthrough Summit West in San Francisco.Jack Simpson for STAT

Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health. Confidential tips can be sent on Signal at lizzylaw.53.

SAN FRANCISCO — Drug industry executives and an academic expert agreed Wednesday that the ouster of key officials at the Food and Drug Administration has created tremendous anxiety and uncertainty for the developers of rare disease drugs, and debated how much flexibility the agency should allow in designing clinical trials.

At the STAT Breakthrough Summit West, Mahzi Therapeutics CEO Yael Weiss said she has faced constant, nervous questions from investors about how personnel chaos at the FDA will impact her company’s future.

Biotech execs, academic expert lament impact of FDA turnover on rare disease drug development

Other newsrooms on this story

Related reading

Drugmakers guard IP more tightly amid China competition

FDA’s leadership void leaves biotech with renewed ‘uncertainty’

Astellas treatment offers new hope to a devastated rare disease community

Biotech leaders campaign for Pazdur; Takeda to lay off 4,500 workers

At a time of tumult at FDA, a former commissioner is hopeful it’s on a better…

Pharma leaders hope next FDA head calms waters