A biopharmaceutical company well-versed in small molecule manufacturing processes requested Greenleaf’s support in building out its cell and gene therapy (CGT) manufacturing facility processes. Specifically, Greenleaf was asked to assist in developing the company’s Quality Management System (QMS) for new modalities in order to understand its positioning for sustainability and expansion of operations. Greenleaf experts …
Karen Midthun, M.D.
Principal, Drug and Biological Products
Background:
28-year career in public service, including 22 years at FDA
Specialty:
Drug & Biological Products, Vaccines
Experience:
Former Director of FDA’s Center for Biologics
Dr. Karen Midthun joins 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 most recently served as the Director of the FDA’s Center for Biologics Evaluation and Research (CBER).
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 and Bob Meyer. 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 improved products to prevent the spread of infectious diseases, addressing ongoing public health needs for biologics, and advancing growing fields such as regenerative medicine.
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 and a member of the American College of Physicians.
Robert J. Meyer, M.D.
Principal, Drug and Biological Products
Background:
25 years of regulatory and academic leadership
Specialty:
Drugs and Biological Products
Experience:
Director of the Virginia Center for Translational and Regulatory Sciences at UVA; VP, Global Regulatory Strategy, Policy & Safety at Merck Research Laboratories; Director of the Office of Drug Evaluation II within CDER
As a Principal of Greenleaf’s Drug and Biologics group, Dr. Robert Meyer contributes a rich knowledge, gained through 25 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 will continue at UVA as an Associate Professor of Public Health Sciences while at Greenleaf.
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, Dr. Meyer 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 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 Pharmaceutical Research and Manufacturers of America (PhRMA). Dr. Meyer chaired the Regulatory Affairs Coordinating Committee for PhRMA and 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 served 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 was a longstanding member of the United Nations Environmental Program (UNEP) Technical Options Committee on Medical Aerosols.
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 program. He has also served as a volunteer staff physician in pulmonary and critical care medicine at the National Naval Medical Center in Bethesda, MD.
Kalah Auchincloss, J.D., M.P.H.
Executive Vice President, Regulatory Compliance and Deputy General Counsel
Specialty:
Regulatory Compliance
Experience:
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.
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.
David Elder
Principal, Regulatory Compliance
Background:
23 years with FDA
Specialty:
Corporate quality systems; compliance strategies; and inspection readiness
Experience:
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.
Cynthia Schnedar
Principal, Regulatory Compliance
Background:
Formerly Director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research (CDER)
Experience:
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.
John Taylor
President and Principal, Compliance and Regulatory Affairs
Background:
20 years in leadership roles at FDA
Specialty:
Specialist in regulatory policy, compliance, and enforcement
Experience:
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.
