Ex-FDA Leaders Launch Canal Row Advisors, Offer Insights on Agency’s Challenges and Direction

Canal Row Advisors, a new consultancy, was founded by former senior FDA leaders including Michael Rogers (former FDA Associate Commissioner for Regulatory Affairs) and Hilary Marston (former FDA Chief Medical Officer)1.

The advisory team brings expertise in regulatory, clinical, compliance, and policy aspects from their experience at the FDA and related organizations, positioning them to guide clients in the life sciences through the complex regulatory landscape1.

Michael Rogers led the FDA’s largest reorganization, managing inspections, imports, and emergency response, aiming for a more agile and quality-driven inspectorate1.

Hilary Marston has been pivotal in cross-agency clinical policy, rare disease product development, and health crisis response; her federal experience includes roles at the White House and NIH1.

Ex-FDA leaders, including those unaffiliated with Canal Row, have recently spoken publicly about the need for significant updates to FDA regulatory frameworks, particularly in response to advances in rare disease therapies and new clinical trial technologies3.

There is a consensus among former FDA officials that the agency must rethink drug review processes and adapt to innovations like personalized medicine, advanced data tools, and more flexible approaches to clinical evidence, especially for rare diseases and breakthrough treatments3.

Sources:

1. https://www.prweb.com/releases/former-fda-industry-leaders-launch-canal-row-advisors-to-provide-clients-with-strategic-insight-and-actionable-guidance-in-an-increasingly-complex-regulatory-landscape-302579789.html

3. https://schaeffer.usc.edu/research/fda-innovation-reform-rare-disease-gottlieb-woodcock/