Executives and an academic expert told a biotech forum that recent turmoil and personnel changes at the FDA are raising anxiety among rare-disease drug developers. At the STAT Breakthrough Summit West, Mahzi Therapeutics CEO Yael Weiss described ongoing investor questions about how the agency’s staffing uncertainty could affect approval timelines and trial design confidence. The discussion centered on whether developers can expect sufficient stability and flexibility while building rare-disease programs under evolving FDA leadership. The exchange underscored how personnel continuity at regulators can translate into real operational risk for companies with fewer margins for trial missteps. Separately, another report on the day said the CDC’s ACIP panel is being “re-established” after prior changes were withdrawn, reflecting the policy-level uncertainty that can ripple into clinical trial endpoints and evidence planning.