Sean Hilscher

Vice President, Regulatory Policy

As Vice President of Regulatory Policy at Greenleaf Health, Sean Hilscher brings 15+ years of experience in health care, having worked with a broad array of stakeholders including life science companies, data companies, providers, and international health organizations. Sean helps Greenleaf clients navigate the evolving regulatory policy landscape, conducting in-depth analyses of legislation, regulations, and regulatory initiatives and their impact on clients’ products.

Previously, 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. Sean has experience in strategy and operation consulting from his time at the Advisory Board Company. As a manger in the sourcing and operations practice, 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.

Karen Midthun, M.D.

Principal, Drug and Biological Products

Dr. Karen Midthun joined Greenleaf Health following a distinguished 28-year career in public service, of which 22 years were dedicated to the FDA. An infectious disease physician by training, Dr. Midthun served as the Director of the FDA’s Center for Biologics Evaluation and Research (CBER) from 2009 to 2016.

At Greenleaf, Dr. Midthun serves as Principal, Drug and Biological Products, co-leading the firm’s Drug and Biological Products Team with fellow principals Drs. John Jenkins, Bob Meyer, and Sandra Kweder. Dr. Midthun contributes specialized insight — informed by her regulatory, research, and clinical experience — to the strategic and technical guidance that Greenleaf provides to FDA-regulated entities developing products to prevent or treat infectious diseases, addressing ongoing public health needs for biologics, and advancing the growing field of cell and gene therapies.

During her FDA tenure, Dr. Midthun played a critical role in facilitating policy and technology development in the areas of blood products, vaccines, and cell, tissue, and gene therapies. Under her leadership, the FDA approved several vaccines that have had a significant public health impact, including vaccines for pneumococcal disease, meningococcal disease, and human papilloma virus. Dr. Midthun received praise for her work responding to the 2009 influenza pandemic; developing a framework for the regulation of human cell and tissue products; and, in collaboration with the Center for Drug Evaluation and Research (CDER), developing a policy for the regulation of biosimilar products.

Prior to her role as Center Director, Dr. Midthun served as the Deputy Director of CBER and the Director of the Office of Vaccines Research and Review within CBER. Before joining the FDA in 1993, Dr. Midthun was on the faculty of the Department of International Health at the Johns Hopkins Bloomberg School of Public Health, where she was involved in the clinical development of investigational vaccines and was an attending physician at the Johns Hopkins Hospital.

Dr. Midthun received her bachelor’s degree from the Massachusetts Institute of Technology (MIT) and her medical degree from the George Washington University School of Medicine. She trained as a resident in internal medicine at Johns Hopkins Hospital and as a fellow in infectious diseases at Johns Hopkins Hospital and the National Institute of Allergy and Infectious Diseases (NIAID). She is a fellow of the Infectious Diseases Society of America.

Robert J. Meyer, M.D.

Principal, Drug and Biological Products

As a Principal of Greenleaf’s Drug and Biologics group, Dr. Robert Meyer contributes a rich knowledge, gained through 30 years of regulatory and academic leadership, of the important issues facing the pharmaceutical sector today. Bob was previously the Director of the Virginia Center for Translational and Regulatory Sciences (VCTRS) at the University of Virginia (UVA) School of Medicine and continues as an Associate Professor of Public Health Sciences at UVA.

At the VCTRS, Bob led the development of a new regulatory science curriculum and served as a faculty expert in drug/biologic regulation, clinical development and study design, and commercial discovery and development, providing insight to support the regulatory success of medical research with transformational potential. Before joining UVA in 2013, Bob headed worldwide regulatory and pharmacovigilance activities at Merck Research Laboratories (MRL), most recently as Vice President, Global Regulatory Strategy, Policy, and Safety. He was also a member of MRL’s Early Stage and Late Stage Development Review Committees and Safety Review Committee. Bob serves currently as a non-executive Director on the Board of Chimerix Inc., and did so for Translate BIO until its acquisition by Sanofi.

Prior to his academic and corporate experience, Bob had a notable career at the U.S. Food and Drug Administration (FDA), including five years (2002-2007) as the Director of the Office of Drug Evaluation II within the Center for Drug Evaluation and Research (CDER), with oversight of pulmonary and allergy, metabolic and endocrine, analgesic and anesthetic, and rheumatologic drug products. The rest of his tenure at the FDA was spent in CDER’s Division of Pulmonary and Allergy Drug Products, which he directed from 1999 to 2002 after positions as a medical reviewer and team leader. He chaired the Pre-Market Risk Assessment guidance development for CDER and participated in several Prescription Drug User Fee Act (PDUFA) negotiations on behalf of both the FDA and the Pharmaceutical Research and Manufacturers of America (PhRMA).

During his tenure at Merck, Bob chaired the Regulatory Affairs Coordinating Committee for PhRMA. While at the FDA, he served on the third expert panel for the National Heart, Lung, and Blood Institute’s National Asthma Education and Prevention Program (NAEPP EPR3). Bob also served on the Board of Directors for the Reagan-Udall Foundation and an elected term as a Medical Science Trustee for the United States Pharmacopeia Board (2015-2020). A recognized expert on environmental impacts of medical aerosols, Bob has contributed his expertise to the United Nations Environmental Program (UNEP) Technical Options Committee on Medical Aerosols beginning in 1998.

Bob received his medical degree from the University of Connecticut School of Medicine and completed his residency with the University of Connecticut School of Medicine at the VA Medical Center in Newington, CT, serving as Chief Medical Resident from 1987-88. At the Oregon Health Sciences University in Portland (1991-94), he was an academic pulmonologist and critical care specialist, helping to establish the medical service for the Lung/Heart-Lung Transplantation team. He has also served as a volunteer staff physician in pulmonary medicine at the National Naval Medical Center in Bethesda, MD.

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.

Joseph Griffin

Executive Vice President, Drug and Biological Products

Joe Griffin brings more than 20 years of service at the Food and Drug Administration (FDA) to his role at Greenleaf. Joe uses his extensive institutional knowledge to provide valuable insights and guidance to Greenleaf clients in his role as Executive Vice President of Drug and Biological Products.

Widely known for his extensive experience in policy development and comprehensive knowledge of the regulatory environment, Joe’s career has given him particular expertise in expedited drug development mechanisms, biosimilars, investigational new drug applications, prescription drug promotion and labeling, good clinical practices, human subject protection, and expanded access to investigational drugs.

Joe’s career includes several roles within FDA’s Center for Drug Evaluation and Research (CDER). Most recently, he served as Associate Director for Policy Development in CDER’s Office of Medical Policy. In this position, Joe focused on developing policy on a broad range of clinical and regulatory matters.

Joe began his FDA career in 1991 as a Regulatory Review Officer and went on to become Special Assistant to the Director/Regulatory Counsel in the Division of Drug Marketing, Advertising, and Communication (now the Office of Prescription Drug Promotion). In 1995, Joe was promoted to Special Assistant to the Center Director, where he developed policy on complex clinical and regulatory issues, focusing on rulemaking and guidance to implement the FDA Modernization Act (FDAMA) of 1997 and improve prescription drug labeling. Joe continued in this role until moving to CDER’s Office of Medical Policy in 1999.

Joe has received numerous FDA honors, including CDER’s Center Director’s Special Citation. He has also co-authored several publications on a number of drug regulatory matters, including observational research, development of combination therapies, biosimilars, and drug promotion.

Joe received his J.D. from Northeastern University Law School and holds a B.S. in Pharmacy from Northeastern University.

Brian Corrigan

Executive Vice President, Regulatory Policy

Brian Corrigan joined Greenleaf in August 2014, following more than a decade of professional experience in the biopharmaceutical industry. Brian uses his in-depth understanding of the U.S. healthcare system and the Food and Drug Administration (FDA) regulatory process to provide strategic and technical guidance to Greenleaf clients.

At Greenleaf, Brian has advised numerous clients in the drug and biologics space on interpreting FDA clinical expectations, navigating regulatory hurdles, and executing formal meetings with the FDA, while providing strategic support through the application review process toward product approval.

Brian also leads Greenleaf’s Advisory Services practice area, working with life science investors to evaluate potential issues and regulatory risks during the due diligence stage of transactions.

Before joining Greenleaf, Brian was a key member of the Government Affairs and Public Policy team at Vertex Pharmaceuticals. Brian led the development of Vertex’s regulatory policy strategies and worked closely with the company’s leadership to incorporate these strategies into business planning and clinical development initiatives. Brian also represented the company on industry trade association committees.

Brian joined Vertex Pharmaceuticals from Astellas Pharma U.S., where he worked on federal policy and governmental affairs issues.

Brian graduated magna cum laude from the George Mason University School of Law. He received his B.A. from Boston College, where he graduated magna cum laude and Phi Beta Kappa.

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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