Former FDA Associate Commissioner Jill Hartzler Warner Joins Catalyst Team, Expanding the Firm’s Expertise in Regenerative Medicine, Rare Disease Drug Development and Combination Product Regulation

Press release

Washington, DC – Catalyst Healthcare Consulting is pleased to announce that Jill Hartzler Warner, JD, has joined the firm as Vice President, Regulatory Policy. She will advise clients in strategic regulatory positioning, legal analysis and policy development.

Ms. Warner brings a depth and breadth of experience and understanding of agency approaches gleaned from her many leadership roles over her 30+ years at the agency, including Associate Commissioner, Senior Advisor, and Associate Chief Counsel.

“Jill’s expertise across a range of cutting edge areas of innovation will enhance our services for clients engaged in development of orphan drugs, Combination Products, and pediatric therapies,” Catalyst President Nancy Bradish Myers said. “And as lead architect and author of FDA’s approach to cell and tissue product regulation, Jill is ideally poised to help our clients navigate FDA’s regulation of regenerative medicine.”

During her vast and diverse career at FDA, she worked across FDA Centers and Divisions to craft solutions and pathways for innovative products. She served on many agency-wide working groups, and her experience spans diverse areas of the agency, including the Office of the Commissioner, Office of the Chief Counsel, Office of Medical Products and Tobacco, and the Center for Biologics and Evaluation and Research.

She also provided key input on significant FDA legislation, including the 21st Century Cures Act, FDA Safety and Innovation Act, and FDA Modernization Act.

Her work as FDA’s representative to the World Health Association and the Institute of Medicine fostered collaborative partnerships in tackling issues such as cell and tissue regulation and addressing conflicts of interest in medical product development.

She received numerous awards during her FDA career, including: the HHS Secretary’s Award for Distinguished Service for outstanding performance in developing and finalizing a major rulemaking to implement a comprehensive regulatory approach for enhanced safety of human cells, tissues, and cellular and tissue-based products; and the FDA Commissioner’s Special Citation for helping to bring about the successful passage of the FDA Safety and Innovation Act in 2012.

Ms. Warner earned both her JD and undergraduate degrees from the University of Virginia.

About Catalyst

Catalyst Healthcare Consulting, Inc. is a boutique regulatory affairs advisory firm.

We work closely with our clients to anticipate and shape complex healthcare issues that can affect their business, and to address the FDA regulatory hurdles that can arise during the product development and approval process. We create engagement strategies to find win-win solutions that benefit the patient, client and regulators.

Serving as a catalyst is what we do best. With strategic vision, expertise, and energy, we help clients generate and advance meaningful opportunities and solutions while sidestepping unnecessary challenges.

Our clients include biopharma, medical device, combination product, digital health and genomics companies, as well as patient advocacy organizations, venture capitalists launching new companies, and nonprofits. We specialize in helping cutting-edge companies identify the best pathways forward. And for those with regulatory policy agendas, we help to advance them.