Nancy Bradish Myers, JD
Nancy Bradish Myers, JD, CEO of Catalyst Healthcare Consulting, Inc., is a Washington-based attorney with deep expertise in health care law and regulation, policy development and government relations. She has been closely involved in cutting edge drug, biotechnology and medtech regulatory issues from a range of vantage points over the past two and a half decades.
Ms. Myers advises clients from the Board room, to executive leadership teams, to Regulatory Affairs groups on regulatory and health policy matters, ranging from crisis management to long-term strategy development.
Her clients include innovators, investors, patient advocacy organizations and trade associations.
She is both an author and a sought-after speaker, frequently invited to speak at national and international regulatory conferences.
She is an expert on FDA user fees and served as co-editor of the book PDUFA and the Expansion of FDA User Fees: Lessons from Negotiators published by the Food and Drug Law Institute.
Her leadership positions have spanned the federal government, drug and biotechnology industry associations, health insurance and the equity research/investment world. Her range and depth of experience arm her with unique insight into complex regulatory and policy issues and the key stakeholders involved.
At FDA, she served in a number of roles, most recently as special assistant and senior strategic advisor in FDA’s Office of the Commissioner. Within the private sector, she served as special counsel for science policy for the Pharmaceutical Research and Manufacturers of America (PhRMA), vice presidential-level political healthcare analyst for Lehman Brothers, reimbursement counsel and director of government affairs for the Biotechnology Industry Organization (BIO), senior lobbyist for the Blue Cross Blue Shield Association/BCBS of NJ, and a stint on Capitol Hill. Ms. Myers uses her unique 360-degree stakeholder view to assist organizations in achieving regulatory, reimbursement, and policy goals.
Ms. Myers has actively held leadership positions on not-for-profit Boards for the past 15 years. Currently, she serves on the executive committee and as chair of the FDA Alumni Association International Committee. She served as Chair of the Board of Directors of the FDA Alumni Association (FDAAA) for years where she actively drove the organization to expand membership, broaden its footprint into international arenas, and generate value-added programming, such as FDA mentor programs, that directly support the agency’s mission.
She is a founding board member, current nominations committee chair and past-President of the Alliance for a Stronger FDA, a 200+ member coalition of former regulators, patient and consumer advocates and industry leaders.
Ms. Myers was awarded the John C. Villforth FDAAA Founders Award in 2019 and FDA’s Distinguished Alumni Award in 2012 for outstanding contributions in advancing FDA’s mission, creating a strong coalition to advocate for FDA resources, and establishing enduring connections between FDA alumni and staff.
She received her BS from Duke University and her juris doctor degree from Temple University School of Law.
NANCY BRADISH MYERS, JD
Ms. Myers received her BS from Duke University and her juris doctor degree from Temple University School of Law.
Ms. Myers has run Catalyst for the past decade; she has helped clients with everything from Regulatory Intelligence, to strategic product development, to submitting Breakthrough Therapy designation requests. She advises small start-ups, large biopharma companies and many in between.
One of her favorite things is helping innovators find pathways through the FDA, where there are none that fit the precise technology. Ms. Myers brings a 360-degree view of the healthcare regulatory landscape; she’s held senior positions at FDA, the two top industry trade associations, an insurance association, and an investment banking firm.