Nancy Bradish Myers, President/Founder

Nancy Bradish Myers, President 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 drug, biotechnology and medtech regulatory issues from a range of vantage points over the past two decades.

Ms. Myers currently advises select clients on regulatory and health policy matters.

Her clients include manufacturers, trade associations, investors and patient advocacy organizations.

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.

She is also 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 in 2011.

She is a founding board member and past-President of the Alliance for a Stronger FDA. This group is a 200+ member coalition of former regulators, patient and consumer advocates and industry leaders working to increase federal funding of the FDA.

She is Chair of the Board of Directors, of the FDA Alumni Association and is actively involved in the Food and Drug Law Institute (FDLI) and the Drug Information Association (DIA). She is currently Co-Chair of DIA’s Public Policy/Health Care Compliance/Law track and has served in this position since 2014.

She received 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.

Ms. Myers received her BS from Duke University and her juris doctor degree from Temple University School of Law.

Nancy Bradish Myers

President/Founder

About Nancy

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.

E nancy@catalysthcc.com
T 703-448-7448
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Anne McNickle, Vice President, Communications and Research

Anne McNickle, Vice President, Communications and Research at Catalyst Healthcare Consulting, Inc., specializes in regulatory strategy and communications. She is a health policy analyst and communications professional over 20 years of experience.

During her tenure at Amgen’s headquarters (Thousand Oaks, CA), she served on the media relations team as an official corporate spokesperson; she was responsible for strategic communications supporting academic and corporate collaborations, mergers and acquisitions and general corporate initiatives. Her areas of specialty include corporate public relations, media relations, internal and external communications, and partnership relationship management.

She also brings a wealth of knowledge in regulatory, health policy, and reimbursement issues. She has provided strategic advice on the impact of changes in Medicare, Medicaid and private insurance both in-house (at Amgen) and for biopharma clients (at consulting firms Avalere Health and Parexel).

Ms. McNickle began her career in health care journalism with F-D-C Reports in Chevy Chase, MD, focusing on the interaction between the biopharma industry and the federal government (including FDA, CMS, NIH and Congress). Over the course of eight years, she served as Managing Editor of Health News Daily, covered Capitol Hill for The Pink Sheet, reported on NIH and biomedical research issues for The Blue Sheet, and held a range of other editorial and staff management positions.

She received her BA from the College of William and Mary.

Anne McNickle

Vice President, Communications and Research

About Anne

She received her BA from the College of William and Mary.
Ms. McNickle has spent her career digging into complex regulatory and health policy issues, finding answers, and conveying them clearly and concisely in order to inform decision making. Her work ensures Catalyst’s advice to clients is well-grounded in high-quality research. She brings biopharma industry experience from Amgen, policy and reimbursement consulting experience from several DC-area firms, and reporting and editing experience from The Pink Sheet and Health News Daily.
E annemcnickle@catalysthcc.com
T 323.868.5827

Jill Hartzler Warner, JD, Vice President, Regulatory Policy

Jill Hartzler Warner, Vice President, Regulatory Policy, is an expert in strategic regulatory positioning, legal analysis, policy development, and problem solving in the context of international regulatory standards. From her 30-plus-year career at FDA, she brings her depth and breadth of experience and understanding of agency approaches gleaned from her many leadership roles at the agency, including Associate Commissioner, Senior Advisor, and Associate Chief Counsel.

During her vast and diverse career at FDA, Ms. Warner was responsible for executive oversight of the agency’s offices of orphan products development, combination products, pediatric therapeutics, good clinical practice, and advisory committee oversight and management. She provided key input on significant FDA legislation, including the 21st Century Cures Act, FDA Safety and Innovation Act, and FDA Modernization Act. As lead architect and author of FDA’s approach to cell and tissue product regulation, she brings significant expertise in regulation of regenerative medicine.

Ms. Warner successfully 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. 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 received both her JD and BA from the University of Virginia.

Jill Hartzler Warner, JD

Vice President, Regulatory Policy

About Jill

She received both her JD and BA from the University of Virginia.
Ms. Warner is a former FDA Associate Commissioner, Senior Advisor, and Associate Chief Counsel.  She brings a depth and breadth of experience and understanding of agency approaches based on many leadership roles over 30+ years at FDA. During her time at the agency, she was responsible for executive oversight of the agencys offices of orphan products development, combination products, pediatric therapeutics, good clinical practice, and advisory committee oversight and management. She provided key input on significant FDA legislation, including the 21st Century Cures Act, FDA Safety and Innovation Act, and FDA Modernization Act.  She also brings significant expertise in regulation of regenerative medicine as lead architect and author of FDAs approach to cell and tissue product regulation.
E jillhw@catalysthcc.com
703-869-0504

Barbara Brophy

Barbara Brophy is a recent college graduate with several years’ experience in professional writing and editing, public relations, and research. As Catalyst Healthcare Consulting’s Research Associate, she gathers information on FDA regulations and industry actions, analyzes issues, writes memos on findings, and attends political meetings in Washington on behalf of clients. Ms. Brophy received her BA from George Mason University.

Barbara Brophy

Ginny Hanlon, Executive Assistant

Ms. Hanlon, an Executive Assistant at Catalyst Healthcare Consulting, Inc., brings an extensive background in business administration. For ten years, she worked as Senior Administrative Assistant at Eli Lilly and Company in the US Regulatory Division, and prior to that she worked for the President of NABI Biomedical Research, Rockville, MD.

She also served as Executive Assistant to the SVP of Strategic Marketing at Phillips Publishing Company in Rockville, MD, and for 25 years as VP and Secretary of Hanlon Construction, Inc. in Ashton, MD.

Ms. Hanlon received her Associates Arts Degree in Business Administration from Strayer University in Washington, DC.

Ginny Hanlon

Executive Assistant

About Ginny

For 15 years, Ms. Hanlon ran Regulatory Affairs offices for large pharma companies, aggregating complex regulatory information and effectively distributing regulatory intelligence across divisions in concise, user-friendly formats. She is Catalyst’s early warning system; when things are happening and issues are developing quickly, she captures and conveys the information through efficient, actionable tools. Ms. Hanlon has served as Executive Assistant to SVP and Presidential-level executives throughout her career.
ginny@catalysthcc.com

Additional experts

In addition, Catalyst has in place a set of alliances with external advisors to ensure clients get the level of expertise needed for each policy goal.

These experts include:
· Former FDA decision makers
· Other regulatory experts
· Scientific experts
· Leaders in patient advocacy

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