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.
“There isn’t a day where I don’t find an email in my inbox where my investors are questioning the recent news they read, and how it will affect our future as a company, our certainty of getting our drugs approved,” Weiss said. “It’s a roller coaster.”
