Greenleaf Health assisted a mid-sized pharmaceutical company in developing a regulatory strategy to address safety and trial conduct issues in the phase 3 program for their lead compound for cardiovascular disease. During phase 3 trials, the client identified a consequential safety event and sought Greenleaf’s guidance on both addressing the safety event in the context …
Madeleine Giaquinto, J.D.
Director, Regulatory Affairs
Legal, Nonprofit, Government Affairs, and Public Health Policy Sectors
FDA Regulation of Drugs, Biologics, Medical Devices, Dietary Supplements, and Cannabidiol (CBD)
Regulatory Compliance Consulting
Madeleine Giaquinto offers a robust portfolio of regulatory compliance and federal healthcare advocacy experience, spanning legal, nonprofit, government affairs, and public health policy settings.
In her role as Director of Regulatory Affairs at Greenleaf Health, Madeleine provides clients with timely analysis of FDA regulations, policies, and guidance documents related to good practice standards for drugs, biologics, medical devices, dietary supplements, and CBD. In addition, she advises clients on strategic engagement with FDA regarding a range of compliance issues, such as remediating deficiencies identified in FDA Form 483 observations and FDA Warning Letters, as well as building cultures of quality within mature quality management systems.
She has published articles on topics ranging from the root causes of drug shortages along global supply chains, DOJ’s evaluation of corporate compliance programs in the context of FDA-regulated products, and FDA’s regulatory activities in response to COVID-19 and in future pandemic preparedness efforts.
Before joining Greenleaf Health, Madeleine gained legal and government relations experience at 340B Health, a membership organization of hospitals and health systems within the federal 340B drug pricing program. Her role involved researching and analyzing implications of 340B development and educating members on issues involving program compliance, implementation, and advocacy strategies. Madeleine also worked at Mintz Levin Strategies, where she tracked and analyzed development of various federal and state healthcare policies.
Before earning her law degree, Madeleine worked at MedStar Georgetown University Hospital managing the Department of Pediatrics’ compliance with healthcare provider credentialing requirements of various regulatory authorities.
Madeleine received a B.S. in Biology from Georgetown University and a J.D. from George Mason University School of Law.
Kristen C. Grumet
Senior Vice President, Regulatory Compliance
Medical Device Compliance
FDA Field Investigator Specializing in Medical Devices
Kristen is an expert in the field of medical device compliance, with 9 years of experience as an FDA Field Investigator specializing in medical devices and 23 years of quality systems compliance management and consulting for the industry. As a member of FDA’s Design Control Inspection Strategy (DCIS) Team and FDA’s Pacific Region Design Control Training Cadre, Kristen contributed to the development and implementation of the DCIS questionnaire for medical device inspections and trained companies in the use of the questionnaire. She was a Phase II-certified performance auditor in the area of medical devices at FDA and has the distinction of being part of the first cadre of certified medical device investigators in FDA history, conducting numerous inspections of European medical device facilities during her six-year tenure with the FDA foreign inspection cadre.
In her work with medical device companies, Kristen has managed successful Third-Party Certifications for companies under Consent Decree. She has led projects across the spectrum of quality assurance and regulatory compliance activities, including: compliance assessments; internal audits and investigations; quality systems and validation program development and implementation; corrective action planning and quality system remediation; and QSR and FDA inspection readiness training.
As Senior Vice President of Regulatory Compliance at Greenleaf Health, Kristen continues to provide medical technology clients with customized guidance and support in developing and implementing strong corporate quality systems and regulatory strategies for compliance.
Kristen has presented at FDA design control workshops and for a wide range of compliance-related seminars for the medical device industry and will continue to communicate expert advice through presentations and publications.
Kristen has a degree in Environmental Population and Organismal Biology from the University of Colorado, Boulder. She also has extensive FDA-sponsored training in areas such as performance and quality audits, design control and process validation requirements, and medical device quality management system requirements.
Kalah Auchincloss, J.D., M.P.H.
Executive Vice President, Regulatory Compliance and Deputy General Counsel
More than a decade of food and drug legal, policy, and regulatory experience at the FDA, on Capitol Hill, and in the private sector
Kalah has 15 years of food and drug legal, policy, and regulatory experience at the FDA, on Capitol Hill, and in the private sector. Kalah spent six years at the FDA, including as Deputy Chief of Staff for two FDA Commissioners, Dr. Robert Califf and Dr. Scott Gottlieb. As Deputy Chief of Staff, Kalah worked with senior FDA leadership to manage crises, develop policy decisions, implement communications strategies, and liaise with the Department of Health and Human Services, the White House, and other agencies. Kalah was also a primary point of contact in the immediate Office of the Commissioner for the six FDA Centers and other components of the Commissioner’s Office.
Prior to that role, Kalah spent time on Capitol Hill as the FDA detailee to the Senate Committee on Health, Education, Labor, and Pensions, working on the 21st Century Cures Act and other FDA-related legislation. She has also served in the FDA’s Center for Drug Evaluation and Research (CDER) as a regulatory counsel in the Office of Regulatory Policy, and as Director of CDER’s Office of Unapproved Drugs and Labeling Compliance in the Office of Compliance, leading a team of more than 50 staff working on pharmacy compounding, unapproved drugs, over-the-counter drugs, and other enforcement issues.
Before joining the FDA, Kalah was an associate at the law firm Foley Hoag LLP in the firm’s health care practice group.
As an Executive Vice President at Greenleaf, Kalah is continuing her commitment to public health by providing strategic counsel to clients on compliance, enforcement, and policy matters.
Kalah holds a B.A. with honors from Williams College, a J.D. with honors from Georgetown University Law Center, and an M.P.H. from Harvard University.
Executive Director of Operations, Regulatory Compliance
Program facilitation and management
More than 10 years operational and administrative experience
Laura Bartee serves as Greenleaf Health’s Executive Director of Operations, Regulatory Compliance, bringing with her more than ten years of experience as an administrative professional and demonstrated success in managing office operations, corporate events, and customer experiences.
Prior to joining Greenleaf, Laura served as Legal Personnel Coordinator in the Washington, DC office of Cleary Gottlieb Steen and Hamilton LLP (“Cleary”). Laura spearheaded the onboarding and training of new associates and worked with the recruiting team to plan the Summer Associate Program. She also played a significant role in executing the firm’s professional and social events.
Prior to her work at Cleary, Laura served as Utilization Coordinator for the Northeastern Region of Tennessee for Enterprise Rent-A-Car, facilitating the distribution of new cars throughout the region, as well as the removal of used cars from the fleet. Laura also managed the region’s team of drivers, efficiently allocating them to add and remove cars from the region’s rental offices. Laura began her career at Enterprise Rent-A-Car as an Assistant Branch Manager in various rental branches throughout the region.
Laura received her undergraduate degree, with Honors, from King University (formerly King College) in Bristol, Tennessee.
Principal, Regulatory Compliance
23 years with FDA
Corporate quality systems; compliance strategies; and inspection readiness
Senior FDA Regulatory Official and retired Captain in U.S. Public Health Service
David Elder brings more than 32-years of extensive regulatory experience to his role as Principal, Regulatory Compliance at Greenleaf Health.
A 23-year veteran of the U.S. Food and Drug Administration (FDA) and U.S. Public Health Service (USPHS), David served as a senior FDA official with prominent roles in domestic and foreign inspections; recalls and emergencies; and compliance actions involving hundreds of situations. He has testified in federal court and before Congress, initiated and approved enforcement actions, and represented the FDA during national media events. Additionally, David has received numerous honors, including the Distinguished Service Medal.
David began his FDA career as an Investigator in the Boston District Office where he conducted domestic and foreign inspections and investigations in various program areas. He was selected as a Compliance Officer and later as the Director of the Compliance Branch with responsibility for assessment of inspection reports, initiation of compliance actions and evaluation of compliance action effectiveness.
David transferred to FDA headquarters when he was selected as the Director of the FDA Office of Enforcement in 2003, a position he held for the next six years. In this Senior Executive Service position, David led the Office with responsibility for agency enforcement policy, agency recall policy and operations, and enforcement strategy and case review. In 2009, David transferred from the Office of Enforcement to the Office of Regional Operations where he led the Office with responsibility for policy and operations related to foreign inspections, domestic inspections, import operations and field science. In both roles, David served as a principal advisor to FDA’s Associate Commissioner of Regulatory Affairs.
Prior to joining Greenleaf, David served as Vice President with PAREXEL International. During this time, he traveled to client locations across the U.S. and in 14 foreign countries, conducting audits and mock inspections; providing training, coaching and mentoring; advising clients with the development and communication of corrective actions that meet FDA expectations and that achieve and sustain compliance.
At Greenleaf, David continues to provide strategic guidance and support to pharmaceutical and medical technology companies in areas including: strengthening corporate quality systems, developing compliance strategies, ensuring inspection readiness, assisting industry clients and legal counsel in developing and communicating corrective actions plans in response to compliance issues, and performing due diligence activities. David also continues to communicate expert advice through presentations at FDA and industry conferences and through articles published in industry journals.
David received a B.S. degree in Electrical Engineering from Boston University and attended executive management courses at Harvard University.
Senior Vice President, Regulatory Compliance
Legal, Public Policy, and Non-Profit Sector
8+ years of FDA regulatory experience. Previously served as Director of Educational Programming for the Food and Drug Law Institute (FDLI) in Washington, DC
Elizabeth brings more than eight years of regulatory experience and a diverse background of legal, public policy, and non-profit sector knowledge to her position as Senior Vice President of Regulatory Compliance.
As a consultant, Elizabeth provides strategic guidance on premarket and postmarket issues, specifically related to regulatory compliance. She works with pharmaceutical and medical device clients to prepare for FDA inspection and remediate compliance matters through 483 and warning letter responses. She offers guidance on quality system management and how to build a culture of quality. Elizabeth also advises clients navigating the regulatory landscape for tobacco products and assists with content and format of applications, interpretation of FDA regulation, communication with the FDA, and analysis of proposed rules.
Additionally, Elizabeth is well versed in the regulatory barriers facing the rapidly growing CBD industry. She offers strategic guidance and risk-based strategies to CBD manufacturers and distributors as the FDA contemplates how to regulate the product category.
Prior to joining Greenleaf Health, Elizabeth served as Director of Educational Programming for the Food and Drug Law Institute (FDLI) in Washington, DC. While at FDLI, she gained extensive experience in all FDA-regulated product areas. Elizabeth’s role included regularly corresponding with FDA officials, as well as creating and supervising the development of curricula for an array of educational programs. Elizabeth led FDLI’s committees responsible for monitoring regulatory developments in the tobacco and pharmaceutical industries and served as Editor-in-Chief of the Food and Drug Law Journal.
Before earning her law degree, Elizabeth worked as a government relations professional for the Society of Chemical Manufacturers and Affiliates (SOCMA), where she directed a grassroots network of more than 100 member companies. Elizabeth earned a B.S. in Political Science from the University of Arizona and a J.D. from the University of the District of Columbia’s David A. Clarke School of Law.
Principal, Regulatory Compliance
Formerly Director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research (CDER)
30 years of experience as an expert in compliance issues
With more than 30 years of experience as an expert in compliance issues – including more than 20 years in leadership positions in the government – Cynthia adds to Greenleaf Health’s prestige as Principal, Regulatory Compliance.
Cynthia was formerly Director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research (CDER), where she led a staff of more than 300 doctors, scientists, manufacturing experts, pharmacologists, attorneys, and administrative staff. During her time at FDA, she spearheaded efforts to protect the American public from unsafe and ineffective drug products by ensuring that companies comply with federal standards for quality and safety. Among her many duties, Cynthia advised the FDA Commissioner, the CDER Director, and other senior FDA officials on significant enforcement issues.
Before joining FDA in 2014, Cynthia spent more than two decades at the Department of Justice (DOJ), where she specialized in compliance and enforcement issues. Her most recent position at DOJ was as Deputy Inspector General and Acting Inspector General, where she led a nationwide staff in investigating allegations of corruption and misconduct concerning DOJ’s employees and in conducting independent audits of the Department’s operations and programs. She communicated significant findings from the investigations and reviews to the Attorney General and to Congress.
Cynthia’s other positions at DOJ also provided her with an extensive background in criminal and civil enforcement work. They included Counselor to the Inspector General, Deputy Chief of the Sex Offense and Domestic Violence Section in the U. S. Attorney’s Office for the District of Columbia, Assistant U. S. Attorney, and Trial Attorney in the Civil Fraud Section of the Civil Division.
Previously, Cynthia clerked for a federal judge on the Ninth Circuit and worked as a television reporter in New Mexico and Texas.
Cynthia earned a B.A., with distinction, from the University of New Mexico and a J.D., with honors, from the University of Texas School of Law.
President and Principal, Compliance and Regulatory Affairs
20 years in leadership roles at FDA
Specialist in regulatory policy, compliance, and enforcement
Previous experience with the medical devices, biotech, and pharmaceutical industries
John Taylor joined Greenleaf following a distinguished career of more than 20 years at the Food and Drug Administration (FDA). During John’s time at the agency, he led several of its priority initiatives. At Greenleaf, John continues his commitment to healthcare innovation as the firm’s President and Principal of Compliance & Regulatory Affairs, providing strategic consultation to FDA-regulated clients on enforcement and compliance matters.
From 2009–2014, John held three high-profile positions at FDA: Counselor to the Commissioner, Acting Deputy Principal Commissioner, and Acting Deputy Commissioner for Global Regulatory Operations and Policy.
As Counselor to the Commissioner, John served as the principal advisor to Commissioner Margaret Hamburg on issues that affected the agency’s programs, policymaking, management, budget, and administration. In his role as Acting Deputy Commissioner for Global Regulatory Operations and Policy, John provided leadership and direction to more than 4,000 employees in FDA’s Office of Regulatory Affairs and Office of International Programs.
John began as an attorney within FDA’s Office of the Chief Counsel in 1991. During this time, John was responsible for all phases of criminal and civil litigation related to violations of the Federal Food, Drug, and Cosmetic Act and other federal laws. In 1997, John was promoted to Senior Advisor for Regulatory Operations and Policy within FDA’s Office of the Commissioner. He was later named Director of the Center for Drug Evaluation and Research’s Office of Compliance. In 2000, John accepted the position of Director of ORA’s Office of Enforcement. Two years later, John was promoted to Associate Commissioner for Regulatory Affairs.
In 2005, John left FDA to spend 4 years working in industry, first as Divisional Vice President for Federal Government Affairs at Abbott; then, in 2007, as Executive Vice President for Health at the Biotechnology Industry Organization.
John received his J.D. from the College of William and Mary and is a graduate of Pennsylvania State University with a B.A. in History.
Executive Director of Operations, Regulatory Compliance
9 plus years experience in pharmaceutical marketing, communications, and event planning
Specialist in operations and project management
Brittany Milby joined Greenleaf in 2010 with more than nine years of professional experience in pharmaceutical marketing and event planning. Brittany began her career at Greenleaf providing administrative support to the Medical Device team and then transitioned to Director of Operations, Compliance where her responsibilities included managing the schedules, meetings, and travel for the team, as well as overseeing contract negotiations, time tracking, and client deliverables.
As Executive Director of Operations, Compliance, Brittany now spearheads multiple operations, including the organization and management of the Greenleaf Independent Contractor Network where she serves as the direct point of contact for contracting, logistics, work product deliverables, and communications between Greenleaf’s Independent Contractor Network and clients. Through her work, Brittany supports Greenleaf’s commitment to serving clients’ needs by providing extensive expertise and strategic insight in a manner that supports the availability of safe, effective, and high-quality drugs, biologics and medical devices.
Prior to joining Greenleaf, Brittany served as an Executive Pharmaceutical Sales Representative for GlaxoSmithKline (GSK), where she was responsible for developing and implementing strategic business plans to analyze territorial trends in order to grow market share more efficiently and effectively. Brittany organized and implemented several educational speaker series, dinner programs, and educational forums for specialists and primary care physicians in the Washington, DC market. Through the use of corporate and Food and Drug Administration approved sales aids and clinical studies, Brittany educated physicians, nurses, office staff, and pharmacists while maintaining selling structure integrity. Brittany remained a leading sales representative throughout her tenure at GSK.
Brittany graduated cum laude from The George Washington University in Washington, DC and received her Project Management Professional Certificate through the Georgetown University professional development program.