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Mark Kramer

Executive Vice President, Medical Devices and Combination Products
  • Background:
    • 17-year FDA career that included leading interdisciplinary review teams in CDRH and directing the Office of Combination Products; M.S., Biomedical Engineering
  • Specialty:
    • FDA regulation of combination products and medical devices
  • Experience:
    • Founding Director of the FDA's Office of Combination Products; 13 years as a strategic regulatory consultant for medical device, combination product, drug, and biological product clients

Mark Kramer is Greenleaf’s primary expert on combination products, providing clients with unique insight from his experience establishing and leading the FDA’s Office of Combination Products (OCP). As Director of OCP from 2002 to 2007, Mark oversaw the development of significant regulations, policies, and practices currently in effect for combination products, including the primary mode of action rule, the cGMP rule, the adverse event reporting rule, numerous guidance documents clarifying the regulation of combination products, and the intercenter consultation process. Mark also has a firsthand understanding, through his management of the FDA’s Product Jurisdiction Program, of how the Agency assigns combination products to Centers for review and determines the regulatory identity of drugs, devices, and biological products for which jurisdiction is unclear or in dispute.

Mark’s work is informed by his training as a biomedical engineer and a 35-year career in medical product regulation that has united technical, front-line regulatory skills with strategic advising and leadership. He ran an independent consulting practice for over 13 years (2009-2022), advising approximately 200 clients from across the globe, including sponsors of medical devices, combination products, drugs, and biological products, as well as breakthrough and orphan products. In addition to helping clients develop and refine their regulatory strategies, Mark supported sponsors’ regulatory submissions and FDA interactions at all stages of the regulatory process: authoring, strengthening, and submitting initial submissions; developing and critically reviewing responses to FDA-identified deficiencies; preparing for Agency and advisory panel meetings; and advising on cGMPs and adverse event reporting. Clients further benefitted from his knowledge of FDA expectations for key device concerns, such as biocompatibility, electrical safety, electromagnetic compatibility, as well as his biomedical engineering background, which enhanced his reviews of design control documentation for devices and combination products. Mark has also served as an expert witness, testifying in depositions and trials, in a variety of litigation matters and provided regulatory expertise for due diligence activities.

During his 17 years at the FDA, Mark also gained extensive hands-on experience in device evaluation as a lead reviewer and supervisor for a broad range of products: cardiovascular, anesthesiology/respiratory, urology, gastroenterology, surgical, and dental. He managed interdisciplinary review teams as Chief of the Urology and Lithotripsy Devices Branch and as Chief of the Anesthesiology and Defibrillator Devices Branch of CDRH’s Office of Device Evaluation and directed the Center’s education and training programs for staff and industry. Beyond his deep experience at the Agency, Mark spent three years in industry as Chief Regulatory Strategist for GE Healthcare’s medical device business, with executive responsibility for regulatory strategies, processes, and decisions throughout the U.S., Canada, and Latin America.

Mark has served as a board member of the Regulatory Affairs Professionals Society (RAPS), and in 2021 was awarded the RAPS Founders Award. He is also a longstanding adjunct faculty member with the Regulatory Affairs Master’s Program at St. Cloud State University (Minnesota). He earned an M.S. in biomedical engineering from Rensselaer Polytechnic Institute in New York and a B.A. in mathematics from Rutgers College of Rutgers University. 

Conducting Due Diligence to Guide a Corporate Acquisition Decision

Greenleaf Health was engaged by a global medical device company to assist in conducting due diligence for the potential acquisition of another device company. Greenleaf’s Advisory Services Team evaluated the target company’s FDA compliance history and regulatory status, as well as their promotional and advertising materials, in order to assess the regulatory risk that would …

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.

Taryn Fritz Walpole

Chief of Staff
Executive Vice President, Regulatory Affairs
  • Background:
    • More than 20 years of regulatory, legislative, policy and communications experience, including role as FDA’s Deputy Chief of Staff.
  • Specialty:
    • Specialist in regulatory affairs, strategic planning and communications-engagement campaigns.
  • Experience:
    • Provides regulatory affairs, compliance and communications experience from previous roles at the FDA, Capitol Hill and industry.

Taryn Fritz Walpole is a strategic regulatory advisor and senior communications executive who brings to Greenleaf 20+ years of leadership on Capitol Hill and at the Food and Drug Administration (FDA). She uses her expertise in managing complex regulatory and health policy issues to help Greenleaf clients achieve their business objectives.

Taryn joined Greenleaf after serving at FDA from 2005–2009, most recently in the role of Deputy Chief of Staff. In this capacity, Taryn planned and executed FDA’s priority announcements and medical product crisis actions on a wide variety of issues. She directed dozens of high-profile public health actions, from the Food Protection Plan and the Heparin® recall to the historic opening of FDA’s first international offices and, most recently, communications outreach for the H1N1 Flu Pandemic.

Taryn’s leadership role in developing and coordinating communications and outreach required frequent interaction with the agency’s many internal and external stakeholders, including scientific experts, senior leadership, the White House, news media, consumer groups, legislators, local governments, and regulatory counterparts around the world.

Prior to being named Deputy Chief of Staff, Taryn served as the Senior Advisor to the Chief of Staff. In addition to guiding the reorganization of the Office of the Commissioner while in this role, she spearheaded the creation and implementation of FDA’s first process plans for coordinating public announcements, including message platforms, communications and outreach strategies, and tactical activities.

Taryn began her FDA career after 8 years as a senior staffer for Capitol Hill lawmakers. From 2000–2006, she was the Senior Advisor and Communications Director for US Rep. Henry Bonilla (Texas-23rd District) and Deputy Press Secretary for US Sen. Kay Bailey Hutchison (Texas) from 1998–2000.

Before joining Sen. Hutchison’s staff, Taryn was a public affairs specialist at the National Association for Home Care, a Washington, DC, trade association representing the home healthcare industry.

Taryn received a B.A. from Southern Methodist University, with a dual major in Communications/Journalism and Political Science.

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.

Daniel Schultz, M.D., F.A.C.S.

Principal, Medical Devices and Combination Products
  • Background:
    • 20 years as a practicing physician/surgeon, 15 years at CDRH FDA regulating medical devices in the US and over a decade as Principal for Medical Devices and Combination Products at Greenleaf Health
  • Specialty:
    • Specialist in medical devices and combination products
  • Experience:
    • Patient care, device regulation at multiple levels within CDRH, consulting for industry on medical device regulation in the US

Dr. Daniel Schultz joined Greenleaf following a distinguished 35-year career devoted to supporting and advancing Americans’ public health as a physician, teacher, Food and Drug Administration (FDA) official, and member of the US Public Health Service (USPHS). He has been recognized many times for his contributions and dedication to public health.

Dan continues his commitment to public health at Greenleaf as Principal of Medical Devices & Combination Products, where he provides strategic consulting services and works with Greenleaf clients to bring safe and innovative devices to patients.

As Director of the Center for Devices and Radiological Health (CDRH) at FDA from 2004–2009, Dan was responsible for seven FDA offices and more than 1,000 agency employees. He led the development, implementation, and evaluation of regulatory policies concerning medical devices and radiation-emitting products.

Dan began his 15-year FDA career in 1994 as a Medical Officer in the General Surgery Devices branch of the CDRH’s Office of Device Evaluation. In 1995, he advanced to Chief Medical Officer in the Office of Device Evaluation in the division of Reproductive, Abdominal, ENT, and Radiological Devices. He served as Division Director from 1998–2001. Dan became Deputy Director for Clinical and Review Policy in the Office of Device Evaluation in 2001 and Director of the Office of Device Evaluation the following year.

During his time at FDA, Dan took advantage of his medical knowledge and experience as Assistant Professor of Surgery at the Uniformed Services University of the Health Sciences and as a member of the Surgical Staff at the National Naval Medical Center in Bethesda, MD.

Before joining FDA, Dan served as a member of USPHS. During postings at Indian Health Service hospitals in Arizona and New Mexico, he provided medical care for people living in the Navajo Nation and Indian Pueblos. Dan received multiple awards for his service, including the Public Health Service Outstanding Medal.

A New York City native, Dan is a graduate of the City College of New York. He received his M.D. from the University of Pittsburgh and is board certified in Surgery and Family Practice.

Maura M. Norden, J.D.

Executive Vice President, Medical Devices and Combination Products and General Counsel
  • Background:
    • Nearly 15 years advising FDA-regulated entities, investors, and public health organizations on a broad range of FDA regulatory matters
  • Specialty:
    • FDA statutes, regulations, and policy
  • Experience:
    • Joined Greenleaf after almost a decade of professional experience working in the food, drug, and medical device practice group at a large, multinational law firm

Maura Norden joined Greenleaf from the law firm Sidley Austin LLP in January 2015, following nearly a decade advising leading medical device and drug companies and investors on a broad range of FDA regulatory matters.

Maura uses her comprehensive and in-depth understanding of the FDA’s statutory jurisdiction, regulatory requirements, and regulatory processes to provide strategic advice to FDA-regulated companies throughout the product lifecycle, from development to FDA premarket review and postmarket regulation. Maura advises a broad range of clients, including early-stage companies, large, multinational industry leaders, trade associations, and public health organizations.

More specifically, Maura’s experience includes advising:

  • A range of life sciences companies regarding regulation by and engagement with the FDA during the COVID-19 pandemic;
  • In vitro diagnostic (IVD) companies on product development, regulatory pathway questions, and premarket review issues;
  • Consumer technology companies with respect to potential FDA regulation under the medical device provisions of the Federal Food, Drug, and Cosmetic Act;
  • Clinical laboratory clients regarding the FDA’s historical and current policies related to laboratory-developed tests (LDTs); 
  • Digital health companies on the FDA’s evolving approach to digital health products;
  • FDA-regulated firms on compliance with FDA promotional requirements, drawing on experience gained during temporary assignments to multinational pharmaceutical companies, where she sat on copy review committees;
  • Cosmetics companies with respect to permissible claims for cosmetic products; 
  • Investors by providing strategic advice and conducting regulatory assessments in connection with due diligence for transactions and working with investors post-acquisition on integration activities; and
  • Trade associations and other public-health-focused organizations developing positions on various FDA policies, reports, proposed rules, and guidance documents.

Maura received her J.D., with honors, from the George Washington University Law School where she was an associate of The George Washington International Law Review. She received her B.A. from the University of Virginia where she was a Jefferson Scholar.

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