Regulatory clarity fromthoughttofinish

Engage with ELIQUENT:

Listen as former FDA senior officials share valuable perspectives and behind-the-scenes insights on the FDA’s transition to a new presidential administration. Hosts Kalah Auchincloss and Brian Mayhew combine real-life experiences with deep institutional knowledge to shed light on how agency transitions impact policies, people, and industry. This podcast is essential listening for anyone in the life sciences industry looking to understand how political shifts shape the regulatory landscape.


Meet the Hosts

With years of experience at the FDA and within regulated industry, our hosts bring a unique, insider perspective to the complex transitions shaping the agency. Having worked on regulatory policy, enforcement, and industry compliance, they’ve seen firsthand how leadership and regulatory shifts impact FDA priorities, approvals, and oversight. Their deep institutional knowledge, combined with real-world industry insights, allows them to break down these changes in a way that’s both informative and actionable for stakeholders navigating this evolving landscape.

Kalah leverages her experience at FDA, on Capitol Hill, and in the private sector to advise clients on regulatory policy, compliance, enforcement, and other actions.

Before joining ELIQUENT, Kalah spent six years at the FDA, where she served in several senior leadership roles across the agency, including: Deputy Chief of Staff; FDA Detailee to the Senate HELP Committee, working on the 21st Century Cures Act and other FDA-related legislation; Acting Director of FDA’s Center for Drug Evaluation and Research (CDER) Office of Unapproved Drugs and Labeling Compliance; and Regulatory Counsel in CDER’s Office of Regulatory Policy. Learn more about Kalah

Brian brings more than two decades of experience to his role at ELIQUENT Life Sciences where he leads the firm’s regulatory policy and intelligence function.

Brian’s in-depth knowledge of the regulatory landscape is rooted in a diverse career spanning roles in regulated industry and at the FDA, including: Policy analyst within FDA’s Office of the Commissioner; VP of Regulatory Policy at Alkermes; Executive Director of Global Regulatory & Development Policy at Novartis; and Associate Director, Regulatory Policy, at Merck. Brian is an active member of the FDA Alumni Association (FDAAA) and serves on the organization’s Board of Directors. Learn more about Brian

Regulatory Roadmap Podcast

The Regulatory Roadmap podcast series explores the profound changes occurring within the U.S. Food and Drug Administration (FDA) and the broader regulatory landscape during President Donald Trump’s second term.

Join us as we engage with former FDA senior officials, policy experts, and industry leaders to provide firsthand insights into how these transitions are reshaping the FDA and the industries it regulates.

Stay tuned for our upcoming episodes, where we bring you in-depth analyses and conversations on the critical issues at the intersection of politics, regulation, and public health.

Kalah and Brian kick-off the first podcast with a discussion of recent workforce reductions, Presidential Executive Orders, and the potential impact on public health. Listen as our experts address the challenges, implications, and strategies for navigating this evolving landscape.

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