Kate Cook

Principal, Regulatory Policy

Kate Cook joined Greenleaf following a distinguished career of more than 20 years with the U.S. Food and Drug Administration (FDA). During her FDA tenure, Kate provided crucial direction on strategic initiatives related to the regulation of drugs, biological products, and medical devices. Kate continues her commitment to public health at Greenleaf as Principal, Regulatory Policy, providing strategic consulting services and working with clients to bring innovative medical products to patients.

Kate’s FDA career began in the Office of the Chief Counsel, where she served for more than 15 years as a legal counsel on FDA issues related to biosimilars, gene therapy, vaccines, allergenics, human tissue and cellular products, blood products, medical devices, and combination products. She also provided guidance on human subject protection and advertising and promotion. Kate went on to serve as Associate Director for Regulations and Policy within the FDA’s Center for Devices and Radiological Health (CDRH), where she led strategic development and implementation of policies and regulations applicable to medical devices and radiation-emitting products. Later, as Senior Advisor in the FDA’s Center for Biologics Evaluation and Research (CBER), she played a pivotal role in the development and implementation of regulations and regulatory policy related to biological products, combination products, and medical devices regulated by CBER.

From 2016 to 2021, Kate was Executive Vice President with Greenleaf’s Drug and Biological Products Team. In 2021, she was enlisted to support the federal government’s pandemic response efforts. She returned to Greenleaf as Principal, Regulatory Policy, and now leads the firm’s services focused on supporting clients with expertise and guidance on FDA regulatory policies and programs.

Kate is the recipient of numerous FDA awards, including the FDA Award of Merit, the Secretary’s Award for Distinguished Service, the Commissioner’s Special Citation, and the CDRH Director’s Special Citation.

A graduate of Swarthmore College, Kate received her law degree from the New York University School of Law. 

Sean Hilscher

Vice President, Regulatory Policy

Sean Hilscher brings more than 10 years of experience as a consultant in the international and U.S. health care markets to his role as Vice President of Regulatory Policy at Greenleaf Health. Prior to joining Greenleaf, Sean served as a Director at the American College of Cardiology (ACC), where he managed a suite of real-world evidence platforms marketed to providers, payers, and life science companies. In the role, Sean provided objective analyses of markets, assessing the market impact of policy and regulatory changes.

Prior to his work at ACC, Sean was a manager on the Clinical Sourcing team at the Advisory Board Company. As a manager, Sean led data analysis efforts for operational and supply chain consulting engagements with provider organizations across the country.

Sean earned his MBA from the Georgetown University McDonough School of Business and an MA in Politics, Philosophy, and Economics from the University of Oxford.

Stephen Mason

Executive Vice President, Regulatory Policy

Stephen Mason came to Greenleaf following an accomplished and diverse career that includes time in regulated industry, at the Food and Drug Administration (FDA), and on Capitol Hill.

Before joining Greenleaf, Stephen served as Director of Regulatory Affairs for Amgen. In this role, Stephen led the company’s US regulatory policy function, which included developing and implementing strategies for corporate engagement with regional and global regulatory agencies.

Stephen joined Amgen following 3 years as Assistant Commissioner of Legislation at FDA, where he managed all legislative and policy activities affecting the agency and Congress, including congressional oversight activities. Additionally, Stephen served as the primary liaison for FDA in its interactions with Congress, the White House, other federal departments, and state governments.

Stephen’s career also includes a role as Director of Government Relations at the Generic Pharmaceutical Association (GPhA). While serving at GPhA, Stephen was a leader in advocating for the association’s priorities in Congress and the Administration. He was instrumental in the development of generic drug policy issues, as well as in organizing coalition and outreach efforts surrounding federal policy issues.

Before joining GPhA, Stephen held several other positions, including Legislative Aide to Congressman John Ensign (R-NV). In this position, he directed legislative issue management and fostered policy development on an array of issues, including healthcare.

Stephen earned a B.A. in Business Administration-Finance at Oakland University in Rochester, MI.

Rhona Baniqued

Executive Director of Operations, Drug and Biological Products

Rhona Baniqued joined Greenleaf Health as Director of Operations, Drug and Biological Products in 2014, with more than 12 years’ experience as a marketing professional with a successful track record managing complex agency, corporate, and nonprofit programs. At Greenleaf, Rhona is responsible for managing multiple processes, including contracting, client relationship and general operations management of Greenleaf’s Drug and Biological Products Team.

Before joining Greenleaf, Rhona served as a District Marketing Manager for the Microsoft Corporation, based in Washington, DC. In this position, Rhona brought specific products and solutions to customers by working with diverse sales, service, and partner organizations to build the “sales pipeline.” She developed a marketing strategy focused on an application platform by identifying leads and revenue growth opportunities that accelerated sales while remaining sensitive to customer insights and business and competitive trends. Her efforts contributed to application pipeline sales in excess of $17M. In addition, Rhona directed the execution of the Executive Circle program, focused on building or strengthening relationships between Microsoft and corporate senior executives. Early in her career at Microsoft, Rhona administered the partner readiness program, in conjunction with corporate initiatives to train partners on Go-To-Market campaigns. Rhona’s attendance ratios at these programs consistently ranked among those of the top 25 cities globally.

Before her work at Microsoft, Rhona served as Senior Media Planner at Arnold Communications, developing and managing the implementation of long-term strategic media buys across print, radio, television, out-door, and on-line media for many Fortune 500 clients.

Rhona began her career on Capitol Hill, working on legislative issues for Congressman Owen Pickett, D-Va.

Rhona received her undergraduate degree from George Mason University.

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