Canal Row Team Brings Recent FDA and Industry Experience Across Regulatory, Clinical, Compliance, and Policy Domains to Provide Clients – -- Principals include Michael Rogers, MS, Former FDA Associate Commissioner for Regulatory Affairs and Associate Commissioner for Inspections and Investigations, and Hilary Marston, MD, MPH, Former FDA Chief Medical Officer
BETHESDA, Md., Oct. 9, 2025 /PRNewswire-PRWeb/ -- Canal Row Advisors, a multidisciplinary team of former FDA and industry leaders with deep regulatory, clinical, compliance, and policy expertise, has officially launched. Bringing together regulatory experts with recent FDA and industry experience, Canal Row is exceptionally positioned to help leaders achieve clarity and foresight across the product lifecycle and advance public health.
"Today, life science leaders face distinct challenges in navigating a complex and evolving regulatory and policy landscape. Against this backdrop, leaders are seeking precise, strategic guidance to understand the landscape, make informed decisions, and prepare their organizations to meet future challenges," said Brian Corrigan, Co-Founder & Chief Executive Officer, Canal Row Advisors. "That is where Canal Row fills a gap – by leveraging our deep FDA and industry experience, our cross-functional team brings clarity and confidence to pivotal FDA decisions. We are uniquely positioned to guide leaders and their organizations with confidence, from first filings to final approvals and beyond, to advance public health through safe, effective therapies for patients."
Canal Row was founded by four recent FDA and industry leaders:
- Michael Rogers, MS: an international authority on FDA inspections, compliance and product quality. Spanning a 34-year career at the agency, Michael served as the FDA Associate Commissioner for Regulatory Affairs (ACRA) and later as Associate Commissioner for Inspections & Investigations (ACII), where he led approximately 4,000 staff across investigations, imports, and emergency response, guiding the agency's largest reorganization to create a more agile, quality-driven inspectorate.
- Hilary Marston, MD, MPH: a national public health leader with expertise in clinical and regulatory aspects of medical product and vaccine development. Over more than a decade in federal government, Hilary most recently served as the FDA's Chief Medical Officer, where she advised the Commissioner, led cross-center clinical policy, advanced rare disease product development, and directed responses to epidemics, product shortages, and other health crises. She previously served in senior roles at the White House, U.S. National Security Council, and NIH, and worked at McKinsey and the Bill & Melinda Gates Foundation.
- Brian Corrigan, JD: bringing more than 15 years of FDA regulatory strategy and policy experience across industry, government, and consulting, Brian most recently served as Senior Vice President, Regulatory & Quality Assurance at Lexicon Pharmaceuticals, leading all regulatory and quality initiatives. At Greenleaf Health (now ELIQUENT Life Sciences), he built and led the advisory services practice, guiding life science investors and companies through 150+ biopharmaceutical transactions. Earlier in his career, he directed federal policy strategy at Vertex Pharmaceuticals and established the U.S. federal policy and government affairs function at Astellas Pharma.
- Maura Norden, JD: a seasoned FDA regulatory advisor with nearly 20 years of experience guiding clients on regulation, policy, and compliance across the product lifecycle. Her expertise covers drugs (prescription and OTC), devices (including diagnostics), laboratory developed tests, digital health, dietary supplements, cosmetics, and product labeling and promotion. Most recently, she was General Counsel and Executive Vice President at Greenleaf Health (now ELIQUENT Life Sciences), where she helped clients interpret evolving regulations, supported investors with due diligence, co-managed the firm's litigation support practice, and led internal legal operations. Prior to that, Maura was a member of the Sidley Austin LLP food, drug, and medical device regulatory group.
Leveraging the team's experience, Canal Row provides a multidisciplinary approach to support drug and biologics sponsors across a range of therapeutic areas, patient populations, product types and technologies, all while maintaining a deep commitment to advancing public health:
- Regulatory & Clinical Strategy: With firsthand insight into the FDA's decision-making precedents and expectations, the team shapes strategies to advance products from pre-filing through approval and post market, including regulatory strategy, FDA engagement, and clinical development and trial design.
- Quality & Compliance: drawing on decades of FDA compliance and Good Practice (GxP) expertise, the team identifies opportunities to strengthen and reinforce practices that will reduce risk and instill a culture of quality and patient and consumer safety for companies, including process documentation and reporting, inspection readiness, audits, regulatory responses and corrective action plans.
- Regulatory Policy: Canal Row helps clients stay informed of and aligned with the latest developments in FDA regulation and policy to guide their actions. We provide thoughtful, up-to-date regulatory intelligence and assist with commenting on FDA guidance and regulation; In addition, we work with stakeholders seeking to shape the Agency's regulatory policies and priorities to advance public health.
- Advisory Services: Canal Row supplements the expertise of companies, investors, law firms, and other stakeholders with specialized regulatory insight and analysis, including regulatory diligence, competitive landscape analysis and litigation support.
To learn more, visit www.canalrow.com and follow Canal Row on LinkedIn for news and insights at Canal Row Advisors: Overview | LinkedIn.
About Canal Row Advisors
Canal Row Advisors supports life science leaders through pivotal FDA decisions with regulatory fluency, experienced foresight, and pressure-tested precision. Our cross-functional team of former FDA and industry leaders delivers full lifecycle guidance to navigate uncertainty, accelerate innovation, and uphold safety and public health at every stage.
To learn more, visit www.canalrow.com and follow Canal Row on LinkedIn for news and insights at Canal Row Advisors: Overview | LinkedIn.
Media Contact
Mark Marmur, Dept. 11, 1 (973) 906-1526, mark.marmur@dept-11.com
SOURCE Canal Row Advisors
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