WASHINGTON, D.C.  – Greenleaf Health, a leading Food and Drug Administration (FDA) regulatory consulting firm, today announces that the firm has expanded its compliance and manufacturing portfolio to include Good Clinical Practice (GCP) services.

Greenleaf’s in-depth knowledge and understanding of the FDA enables the firm to provide unmatched guidance to companies developing products for the U.S. market. Greenleaf experts work with companies to build GCPs that will align a client’s approach with the FDA’s quality, safety, and compliance expectations.

STRATEGIC & TECHNICAL CAPABILITIES

Greenleaf’s expanded GCP services build-on the firm’s already robust compliance portfolio by working with life science entities to evaluate and strengthen clinical quality systems. Greenleaf’s team of regulatory experts use a risk-based methodology to provide strategic and technical guidance to companies designing and executing clinical trials. Because there is no one-size-fits-all approach to GCP compliance, each solution is built to fit the targeted needs of the client, with an eye toward mitigating risks, optimizing processes, and creating a culture of compliance.

Members of Greenleaf’s Product Quality, Manufacturing, and Compliance Team offer a rare blend of perspective developed as leaders in both the public and private sectors. The firm’s wealth of experience enables experts to deliver valuable regulatory and real-world insight. Greenleaf’s tailored GCP services include: complete quality and compliance system assessments; inspection readiness, including mock inspections; comprehensive auditing services; compliance remediation; quality system and inspection readiness training; FDA communications, including analysis of and responses to enforcement letters and facility and supply chain audit reports; and the complete spectrum of compliance and regulatory consultation and guidance.

EXPERT TEAMS

Greenleaf’s team is comprised of experts with a combined total of more than 250 years of FDA experience. With decades of experience in senior positions at the FDA and throughout industry, Greenleaf’s team of respected professionals understand firsthand the importance of accurate and reliable clinical data.

The collective knowledge and extensive experience of the Greenleaf team is enhanced by Greenleaf’s network of specialized technical experts who can be deployed to provide on-site services at entities that manufacture FDA-regulated products.

FULL-SERVICE SUPPORT

Greenleaf professionals work as teams specializing in product quality, manufacturing, and compliance; medical devices and combination products; and drug and biological products. The firm’s comprehensive approach provides a full-service engagement that ensures clients can count on expert direction as they encounter complex regulatory challenges.

Additional services provided by Greenleaf experts include:

• Real World Evidence (RWE): Greenleaf has partnered with Trio Health to provide a cutting-edge combination of technology and regulatory insight via Trio Health’s innovative RWE technology platform.
• Cell & Gene Therapy: Greenleaf assists sponsors of cell and gene therapies by optimizing FDA interactions and submissions to support development, manufacturing, quality, and regulatory review.
• Advisory Services: Greenleaf understands the complex environment within which life sciences transactions take place and frequently advises investors to evaluate potential issues and regulatory risks that may be identified during such transactions.

ABOUT GREENLEAF

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges.

The firm includes former leaders and regulatory professionals from the FDA, Capitol Hill, top global pharmaceutical and medical device companies, leading law firms, and the top U.S. biotechnology trade organization. Greenleaf’s blend of former FDA officials and industry experts provides a unique set of capabilities when advising entities regulated by the FDA.

For more information on GCP services and Greenleaf Health, visit greenleafhealth.com.

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Firm Announces Dr. Midthun as Principal, Drug and Biological Products

WASHINGTON, D.C. – Greenleaf Health, Inc. (Greenleaf), a leading Food and Drug Administration (FDA or agency) regulatory consulting firm, today announces that Karen Midthun, M.D., has joined the firm as Principal, Drug and Biological Products.

Dr. Midthun joins fellow principals Drs. John Jenkins and Bob Meyer to co-lead the firm’s Drug and Biological Products Team. In this role, Dr. Midthun will contribute 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.

About Dr. Midthun

Dr. Midthun joins Greenleaf 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). 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. 

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.

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.

About Greenleaf’s Drug and Biological Products Team

Greenleaf’s 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 development programs; and reviewing the competitive landscape for specific therapeutic areas.

Greenleaf experts specialize in clinical trial design, FDA submissions and the review process, and postmarket 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 knowledge that is unmatched.

Dr. Midthun 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); Dr. Bob Meyer, former Director of the Office of Drug Evaluation II within CDER; and Michael Chappell, former Associate Commissioner for Regulatory Affairs. Greenleaf’s blend of former FDA officials and industry experts provides a unique set of capabilities when advising entities regulated by the FDA.

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

Greenleaf Health announces that Kristen Grumet has joined the firm as Senior Vice President, Regulatory Compliance.  The addition of Grumet to Greenleaf’s team of experts further enhances the firm’s expanded portfolio of comprehensive compliance services, which now include inspection readiness, on-site compliance assessments, and remediation.

About Grumet

Kristen Grumet is an expert in the field of medical device compliance.  In addition to almost a decade of experience as an FDA field investigator, Grumet’s professional background includes 16-years of quality systems compliance management and consulting within the medical device industry.

A Phase II-certified medical device performance auditor, Kristen has the distinction of being among the first cadre of certified medical device investigators in FDA history. During her service at the FDA, Grumet inspected both domestic and International medical device manufacturers to ensure compliance with Quality System Regulations (QSRs).  Grumet was responsible for documenting and developing numerous regulatory cases, including warning letters, seizures and corporate-wide injunctions.

Grumet’s 20+ years of industry experience includes positions at NSF Health Sciences; Intuitive Surgical, Inc.; Quintiles Consulting; and LifeScan, Inc.  Her work with medical device companies provided experience leading projects across the spectrum of quality assurance and regulatory compliance activities, including compliance assessments; internal audits and investigations; quality systems development and implementation; corrective action planning and quality system remediation; and QSR and FDA inspection readiness training.  Grumet’s impressive portfolio also includes numerous FDA and industry presentations and publications.

At Greenleaf, Grumet joins the firm’s Product Quality, Manufacturing & Compliance team, where she will serve as Senior Vice President, Regulatory Compliance.  In this role, Grumet will continue to provide medical technology clients with customized guidance and support in developing and implementing strong corporate quality systems and regulatory strategies for compliance.

Greenleaf’s Expanded Compliance Services

Greenleaf’s Product Quality, Manufacturing, and Compliance Team has a proven track record of providing excellent services to life science companies seeking strategic and technical expertise to strengthen their quality management systems and guide them through challenging quality and compliance matters.  In addition to Greenleaf’s core regulatory consulting services, the firm recently expanded its compliance service portfolio to include expanded remediation, auditing, and compliance services.  Greenleaf’s compliance capabilities now include:

• Inspection Readiness:  Greenleaf experts strengthen clients’ readiness for FDA pre-approval and surveillance inspections through training, mentoring, audits and mock inspections.
• Compliance Assessments: Greenleaf works with life science firms to evaluate and strengthen compliance functions with an eye towards optimizing processes, mitigating risks, and creating a culture of compliance.  The Greenleaf team performs objective audits and assessments of a clients’ operations to identify strengths and areas of needed improvement, while continuing to meet business objectives.
• Compliance Remediation:  Greenleaf’s experts bring an unmatched level of experience and insight when guiding companies along the remediation pathway.Greenleaf’s services address the complete scope of remediation, from acute enforcement actions, to strategic development and implementation of remediation plans.

By expanding Greenleaf’s compliance service portfolio, the firm is now capable of providing a full-service experience for companies navigating today’s evolving FDA regulatory environment.

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 draws on a combined total of more than 200 years of FDA experience. Members of the firm’s Product Quality, Manufacturing, and Compliance Team include former leaders and regulatory experts from the FDA, Capitol Hill, top global pharmaceutical companies, leading law firms and the top U.S. biotechnology trade organization. Greenleaf’s robust blend of regulatory expertise and FDA institutional knowledge allows the firm to provide unmatched regulatory guidance.

For more information on Kristen Grumet visit her bio.

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.