Greenleaf Health announces that Robert (Bob) Meyer, M.D. has joined the firm as Principal, Drug and Biological Products.

Dr. Meyer and Dr. John Jenkins, Principal, Drug and Biological Products, will serve as co-leads of the firm’s Drug and Biological Products Team, where they will provide strategic guidance and support to drug and biological product companies on the earliest stages of product development through post-approval commitments.

About Dr. Meyer

Dr. Meyer, a pulmonologist and critical care specialist, spent 13 years at the FDA (1994 – 2007), during which he served as the Director for the Office of Drug Evaluation II (ODE II) within the Center for Drug Evaluation and Research (CDER). In this role, Dr. Meyer was responsible for the evaluation of various drug products including pulmonary and allergy; metabolic and endocrine; analgesics; anesthetics; and rheumatologic drugs. Dr. Meyer was involved in several CDER initiatives, amongst them chairing the development of the Pre-Market Risk Assessment guidance. Additionally, he participated with the FDA negotiation team for the reauthorization of the Prescription Drug User Fee Act (PDUFA) III and IV.

Following his FDA service, Dr. Meyer joined Merck & Company (2007 – 2013) where he served as Global Head/VP of Strategy, Policy and Safety at Merck Research Laboratories (MRL). In this role, Dr. Meyer was responsible for all global regulatory strategy and operations, regulatory policy and intelligence, as well as product safety and pharmacovigilance for all Merck products. Dr. Meyer also co-chaired the Late Stage Development committee at MRL. Most recently, Dr. Meyer served as Director of the Virginia Center for Translational and Regulatory Sciences at the University of Virginia (UVA) School of Medicine. While at Greenleaf, Dr. Meyer will continue to serve as an Associate Professor of Public Health Sciences at UVA.

Externally, Dr. Meyer chaired the Regulatory Affairs Coordinating Committee for the Pharmaceutical Research and Manufacturers of America (PhRMA), and served as a key PhRMA negotiator on PDUFA V. He also served on the third expert panel for the National Heart, Lung and Blood Institute’s National Asthma Education and Prevention Program (NAEPP EPR3), as well as on the Board of Directors for the Reagan-Udall Foundation for the FDA. A Medical Science Trustee for the United States Pharmacopeia (USP) Board of Trustees, Dr. Meyer served on the USP expert panel making recommendations on Medicare Model Guidelines prior to his Board role.

Dr. Meyer began his career as an academic pulmonologist and critical care specialist at the Oregon Health and Science University, where he helped create the medical service in support of the Lung/Heart-Lung Transplantation program. Dr. Meyer graduated from Lehigh University cum laude with a Bachelor of Science and received his medical degree from the University of Connecticut School of Medicine, where he also served as Chief Medical Resident. He has published peer-reviewed articles in numerous journals, including the New England Journal of Medicine, the Journal of Clinical Pharmacology and Therapeutics and the Archives for Internal Medicine.

About the Drug & Biological Products Team

The Drug and Biological Products Team delivers a variety of services, including: monitoring and assessing the regulatory environment for emerging trends, analyzing the impact of agency actions on current developmental programs, and reviewing the competitive landscape for specific therapeutic areas.

Greenleaf experts specialize in clinical trial design, FDA submissions and the review process, as well as post-market requirements, including safety monitoring. The team’s approach, firmly grounded in established principles of public health practices, is guided by decades of regulatory experience in drug and biological product development, spanning all therapeutic areas.

About Greenleaf Health

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology and medical device companies developing and manufacturing innovative solutions to pressing global public health challenges. Greenleaf’s team of experts has more than 225 years of combined FDA experience, and as such provides a wealth of regulatory experience that is unmatched.

Greenleaf is guided by experts with a combined total of more than 225 years of FDA experience. Dr. Meyer joins several former FDA officials at Greenleaf, including Patrick Ronan, former FDA Chief of Staff; John Taylor, former FDA Counselor to the Commissioner and Principal Deputy Commissioner; Dr. John Jenkins, former Director of the Office of New Drugs for FDA’s Center for Drug Evaluation and Research (CDER); Dr. Daniel Schultz, former Director of FDA’s Center for Devices and Radiological Health (CDRH); and Michael Chappell, former Associate Commissioner for Regulatory Affairs. Greenleaf’s blend of former FDA officials and industry experts provide a unique set of capabilities when advising entities regulated by the FDA.

For more information on Dr. Meyer and Greenleaf Health, visit greenleafhealth.com

Greenleaf Health announces that Kalah Auchincloss, JD, MPH, has joined the firm as Senior Vice President, Regulatory Compliance and Deputy General Counsel.

Kalah Auchincloss

Kalah brings more than a decade of food and drug legal, policy, and regulatory experience to her roles at Greenleaf.  Most recently, Kalah spent six years at FDA 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 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.

Kalah’s experience also includes time as an associate at the law firm Foley Hoag LLP, in the firm’s healthcare practice group.  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.  Kalah will provide regulatory advice to Greenleaf clients in her role as Senior Vice President, and will also be part of the team managing Greenleaf’s legal affairs in her role as Deputy General Counsel.

New Roles

In addition to Kalah’s arrival at Greenleaf, the firm is also pleased to announce that two employees will assume new roles.  Maura Norden, J.D., currently Senior Vice President, Medical Devices and Combination Products, has been named General Counsel and will now also manage Greenleaf’s legal affairs.  Maura joined Greenleaf in 2015 from the law firm Sidley Austin LLP, following nearly a decade of experience advising leading medical device and drug companies on a broad range of FDA regulatory matters.  Maura will continue to provide regulatory guidance to Greenleaf’s clients.

Also assuming a new role, Kathleen Sonntag has been promoted to Chief Operating Officer (COO) for Greenleaf.  Kathleen joined the firm in 2011 and most recently served as Greenleaf’s Chief Financial Officer (CFO).  Kathleen’s broad career experience spans financial services and the legal profession, with an emphasis on information technology and data analysis. This unique blend brings strong analytical, technical and business skills to her role at Greenleaf.

About Greenleaf Health

Greenleaf Health is a leading FDA regulatory consulting firm that provides strategic and technical guidance to pharmaceutical and medical device companies developing and manufacturing innovative solutions to pressing global public health challenges. With a team of experts with more than 200 years of FDA experience, Greenleaf provides a wealth of experience that is unmatched.

For more information on Kalah Auchincloss, Maura Norden, Kathleen Sonntag and Greenleaf Health, visit greenleafhealth.com

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Greenleaf Health announces that John Jenkins, M.D., has joined the firm as Principal, Drug and Biological Products.

A 25-year veteran of the U.S. Food and Drug Administration (FDA), Jenkins will lead a team of experts to assist clients with their drug development programs from the early stages of product development through to regulatory submission and post-approval requirements. Jenkins most recently was Director, Office of New Drugs (OND) within the FDA’s Center for Drug Evaluation and Research (CDER) where he oversaw the review of thousands of new drug applications and biological licensing applications.

“No one is more qualified than John to provide our clients strategic and technical guidance on FDA’s regulatory process for drug and biological product development,” said Patrick Ronan, CEO of Greenleaf Health. “Our experts at Greenleaf, who have a combined total of more than 200 years of FDA experience, help our clients navigate complex regulatory challenges. John’s knowledge and experience in this area are unrivaled, and he makes a great addition to our team.”

Jenkins started his FDA career as a medical officer in the Division of Oncology and Pulmonary Drug Products and he held several leadership positions including director of the Division of Pulmonary Drug Products and director of the Office of Drug Evaluation II. He was a critical figure in the development and implementation of programs under the Prescription Drug User Fee Act (PDUFA) and played a leading role in implementing CDER’s biosimilar biologics program.

Board certified in internal medicine and pulmonary diseases, Jenkins started his career as a staff physician at Hunter Holms McGuire VA Medical Center in Richmond, Va., and was assistant professor of pulmonary and critical care medicine at the Medical College of Virginia (MCV).

About Greenleaf Health

Greenleaf Health is a leading FDA regulatory consulting firm that provides strategic and technical guidance to pharmaceutical and medical device companies developing and manufacturing innovation solutions to pressing global public health challenges. With a team of experts with more than 200 years of FDA experience, Greenleaf provides a wealth of experience that is unmatched.

David Elder, Kate Cook Add to Greenleaf’s Extensive Institutional Knowledge

Greenleaf Health, Inc. today announced that David Elder and Kate Cook, former senior officials at the U.S. Food and Drug Administration (FDA) have joined the firm. The addition of Elder and Cook to Greenleaf’s team of experts expands the firm’s unmatched regulatory expertise.

Greenleaf is guided by experts with a combined total of more than 200 years of FDA experience. Elder and Cook join several former FDA officials at Greenleaf, including Patrick Ronan, former FDA Chief of Staff; John Taylor, former FDA Counselor to the Commissioner and Principal Deputy Commissioner; Dr. Daniel Schultz, former Director of FDA’s Center for Devices and Radiological Health (CDRH); Michael Chappell, former Associate Commissioner for Regulatory Affairs; Heather Rosecrans, former Director of CDRH’s 510(k) staff; Joe Griffin, former Associate Director of Policy Development for FDA’s Center for Drug Evaluation and Research (CDER); Linda Carter, former Associate Director of CDER’s Office of Evaluation I; Cynthia Schnedar, former Director of CDER’s Office of Compliance; Taryn Fritz Walpole, former FDA Deputy Chief of Staff; and Stephen Mason, former Assistant Commissioner for Legislation. Greenleaf’s blend of former FDA officials and industry experts provide a unique set of capabilities when advising entities regulated by the FDA.

David Elder, Executive Vice President, Regulatory Compliance

A 23-year veteran of FDA and the U.S. Public Health Service, David Elder served as a senior FDA official with prominent roles in domestic and foreign inspections, recalls and emergencies and compliance actions.

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. In 2003, David was selected as the Director of FDA’s Office of Enforcement, a position he held for the next six years. In this senior position, David led the Office with responsibility for agency enforcement policy, agency recall policy, operations and enforcement strategy, and case review. In 2009, David transferred to the Office of Regional Operations where he was responsible 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.

At Greenleaf, David joins the firm’s Product Quality, Manufacturing & Compliance group, where he provides strategic guidance and support to pharmaceutical and medical technology companies in areas including: strengthening corporate quality systems, developing compliance strategies, ensuring inspection readiness and assisting industry clients and legal counsel in developing and communicating corrective action plans and performing due diligence activities.

Kate Cook, Executive Vice President, Drug and Biological Products

Kate Cook joins Greenleaf following a distinguished career of more than 20 years at the FDA. During her FDA tenure, Kate provided direction on strategic initiatives related to the regulation of drugs, biological products and medical devices.

Kate’s FDA career began in the Office of Chief Counsel, where she served for more than 15 years as a legal counsel on FDA issues related to such medical products as biosimilars, vaccines, allergenics, human tissue and cellular products, blood products, medical devices and combination products. She also provided legal guidance on issues related to human subject protection and advertising and promotion.

Kate’s FDA experience included roles as Associate Director for Regulations and Policy within CDRH and Senior Advisor in FDA’s Center for Biologics Evaluation and Research (CBER). In both roles, Kate played a pivotal role in the development and implementation of policies and regulations applicable to biological products, drugs, combination products and medical devices.

At Greenleaf, Kate joins the firm’s Drug & Biological Products group, where she continues her commitment to public health by providing strategic consulting services and working with clients to bring innovative medical products to patients.

About Greenleaf Health

Greenleaf Health is a full service regulatory consulting firm that provides strategic and technical guidance to pharmaceutical and medical device companies developing and manufacturing innovative solutions to pressing global public health challenges.

Click here for more information on David Elder and Kate Cook.