Rare Trials Summit
August 10, 2026
Join Elizabeth Duke as she helps attendees navigate the complexities of global regulatory interactions through a mock advisory meeting workshop.
At Canal Row Advisors, insight runs deeper than information. With cross-functional FDA fluency and years of pattern recognition, our team anticipates complexity before it appears. Strategies are built to withstand pressure, sharpened by a rare understanding of how the FDA thinks and acts.
Collaboration defines our work. Canal Row partners closely with clients, listening, aligning priorities, and designing strategies built for impact. Every recommendation is grounded in credibility and principled judgment, delivering regulatory guidance that holds firm in the most demanding environments.
Purpose drives our culture. Every engagement reflects a commitment to protecting lives, promoting health, and advancing public trust. Canal Row operates with intelligence, integrity, and respect for the responsibility clients carry, delivering solutions that serve both the mission at hand and the greater good.
We are former FDA leaders, industry veterans, and strategic minds who’ve been in the room when decisions mattered most.
We’ve spent decades shaping policy, guiding complex operations, and driving high-stakes outcomes.
Kalah is an expert in FDA regulation, policy, and compliance who has led major regulatory modernization initiatives and enforcement activities at the agency.
Rhona has 18+ years of experience building strong client relationships and operational processes for life science and technology companies.
With 15+ years in life sciences, Brian brings regulatory expertise to guide business decisions.
Matt is a public health and regulatory affairs expert with over a decade of experience at the FDA translating scientific, medical, and regulatory priorities into actionable initiatives to advance drug development.
Elizabeth is a practicing physician and former clinical reviewer at FDA’s CDER Office of Oncologic Diseases with cross-center experience through the Oncology Center of Excellence.
Dionna is an expert in pediatric and rare disease drug development and regulation, informed by 15+ years as a senior FDA leader and CDER reviewer.
Hilary has held senior government positions, including Chief Medical Officer at FDA, and is a national authority on drug development and regulatory and clinical policy.
For 20 years, Maura has guided clients on regulation, policy, and compliance for FDA products.
Liz brings 10+ years as an industry and policy leader advancing regulatory and legislative strategies to support medical product innovation and FDA modernization.
Donna guides the regulatory use of real-world evidence and AI, drawing on nearly 15 years of leadership at FDA and the National Cancer Institute.
Michael is an international regulatory leader with 34 years at the FDA advancing inspections and safety.
Tammy is a former senior FDA administrative leader with 36+ years leading budget, talent, and organizational programs across the Office of the Commissioner and CDER.
John is a former FDA CDER Division Director with extensive regulatory experience in clinical development of drugs and therapeutic biologics for obesity, diabetes, and lipid indications.
Douglas Stearn is an expert in food and drug regulatory compliance and policy who has served in many senior positions across FDA and litigated cases involving FDA.
Juli is an authority on regulatory decision making with over 13 years of FDA experience as a former Deputy Division Director and reviewer in CDER.
Andy leverages extensive experience leading cross-functional initiatives to shape corporate strategy, support drug development, and advance regulatory policy priorities.
Join Elizabeth Duke as she helps attendees navigate the complexities of global regulatory interactions through a mock advisory meeting workshop.
Michael Rogers and Douglas Stearn will join industry leaders at the 30th Annual GMP By The Sea Conference, sharing insights on the evolving quality, compliance, and regulatory challenges facing the pharmaceutical and biotechnology industries.
Kalah Auchincloss will join industry leaders to discuss the evolving legal, privacy, and cybersecurity considerations surrounding the use of health data in AI-enabled research and innovation.
Hilary Marston featured in Pink Sheet discussing FDA’s Commissioner’s National Priority Voucher (CNPV) pilot and the importance of balancing accelerated review with regulatory predictability.
