Drug & Biological Products Team - Greenleaf Health

John K. Jenkins, M.D.

Principal, Drug and Biological Products

Background:
- 25 years at FDA, member of senior leadership in CDER for 15 years
Specialty:
- Drug and Biological Products
Experience:
- Oversight of drug regulation across all therapeutic areas within CDER

Dr. John Jenkins joins Greenleaf Health as Principal, Drug and Biological Products, following a distinguished 25-year career at the Food and Drug Administration (FDA). John received numerous awards from the FDA and external groups for his work on behalf of patients and his contributions to public health.

As Director of the Office of New Drugs (OND) at FDA’s Center for Drug Evaluation and Research (CDER) from 2002 to 2017, John was responsible for more than 1,000 agency employees and 19 product review divisions. During that time, he oversaw the review of thousands of new drug applications and biological licensing applications as well as the approval of more than 400 new molecular entities. John was a critical figure in the development and implementation of programs under the Prescription Drug User Fee Act and implementation of the statutes and regulations that guide innovative drug development and regulation. John also played a leading role in implementing the biosimilar biologics program in CDER under the Biologics Price Competition and Innovation Act and the Biosimilars User Fee Act, including approval of four biosimilar applications.

John began his FDA career in 1992, where he was a medical officer in the Division of Oncology and Pulmonary Drug Products. He subsequently served as Pulmonary Medical Group Leader and Acting Division Director before being appointed as Director of the Division of Pulmonary Drug Products in 1995. He became the Director of the Office of Drug Evaluation II in 1999 and remained in that position until he was appointed Director of OND in 2002.

John received his undergraduate degree in biology from East Tennessee State University in 1979 and his medical degree from the University of Tennessee at Memphis in 1983. He completed his postgraduate medical training in internal medicine, pulmonary disease, and critical care medicine at Virginia Commonwealth University/Medical College of Virginia (MCV) from 1983 until 1988.

John is Board Certified in internal medicine and pulmonary diseases by the American Board of Internal Medicine. Following completion of his medical training, John joined the faculty of MCV as an Assistant Professor of Pulmonary and Critical Care Medicine and as a Staff Physician at the Hunter Holmes McGuire VA Medical Center in Richmond, Virginia.

Stephen Mason

Executive Vice President, Regulatory Policy

Background:
- 20+ years of regulatory, legislative, and policy expertise
Specialty:
- Specialist in regulatory and legislative policy development and analysis
Experience:
- Brings experience from FDA, Capitol Hill, and within the innovator and generic pharmaceutical industries

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

Background:
- 20 plus years with FDA
Specialty:
- Drug and biologics regulations and policy
Experience:
- Previous experience 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 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

Background:
- 15 years in the pharmaceutical industry
Specialty:
- Strategic regulatory guidance and analysis of FDA premarket processes
Experience:
- Previous industry experience in regulatory policy development

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 US healthcare system and the Food and Drug Administration’s (FDA) regulatory process to provide strategic and technical guidance to Greenleaf clients.

Before joining Greenleaf, Brian was a key member of the Government Affairs and Public Policy team at Vertex Pharmaceuticals. While at Vertex, Brian led the development of federal policy strategies and worked closely with the company’s leadership to incorporate these strategies into the business planning and forecasting process. Brian also represented the company on industry trade association committees and was responsible for translating industry developments into actionable corporate initiatives.

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

Specialty:
- Operations and project management
Experience:
- More than 18 years of marketing and project management experience

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.

15 records

John K. Jenkins, M.D.

Principal, Drug and Biological Products

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Specialty:

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Stephen Mason

Executive Vice President, Regulatory Policy

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Joseph Griffin

Executive Vice President, Drug and Biological Products

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Brian Corrigan

Executive Vice President, Regulatory Policy

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Rhona Baniqued

Executive Director of Operations, Drug and Biological Products

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