Watch the replay of the fireside chat “Bracing for Impact, Looking for Opportunity”

Summary: Fireside Chat at BiotechGate – Bracing for Impact, Looking for Opportunity

Cohesion Bureau hosted a fireside chat at BiotechGate Digital Partnering, moderated by Susan Schaeffer (Cohesion Bureau) and featuring Steve Usdin, Washington Editor at BioCentury. The discussion examined the implications of the new administration in Washington for the biopharma industry, regulatory agencies, public health policy, and science.

The session focused on how changes in leadership and policy across HHS, FDA, and NIH could affect drug development, approval processes, and innovation.

A major topic was the appointment of RFK Jr. as HHS Secretary and the expected confirmation of Marty Makary as FDA Commissioner. The conversation explored how political leadership influences agency direction, particularly in areas like drug approvals, vaccine regulation, and the future of user fees.

The discussion also covered the effects of staff reductions and restructuring at the FDA, highlighting the firing of personnel at the Center for Devices and Radiological Health (CDRH) and the potential impact on device reviews. Funding constraints and policy shifts at NIH were another key point, including concerns over the future of basic science funding and opportunities for positive changes in peer review and grant distribution.

Finally, the upcoming PDUFA renegotiation was examined as a critical moment for the industry, with potential opportunity for reforms in how the FDA is funded and how it interacts with industry and other stakeholders

While the policy landscape remains uncertain, industry engagement and strategic advocacy will be critical in shaping the future of biotech and healthcare regulation.