GREENLEAF - Key Persons

Job Titles:

• Principal, Regulatory Compliance

Job Titles:

• Principal, Medical Devices and Combination Products

Job Titles:

• Principal, Regulatory Compliance

Job Titles:

• Director of CDER 's Office of Compliance
• Executive Vice President, Regulatory Compliance

Don Ashley joined Greenleaf Health after a distinguished 25-year career at the Food and Drug Administration (FDA) and the Department of Justice (DOJ), including six years as Director of the Office of Compliance for the FDA's Center for Drug Evaluation and Research (CDER). As Director of CDER's Office of Compliance, Don led a staff of over 400 lawyers, scientists, consumer safety officers, pharmacists, and physicians. He oversaw development and implementation of the FDA's entire breadth of drug compliance and enforcement measures, including for manufacturing quality, current good manufacturing practice, good clinical practice, data integrity, clinical trial oversight, pharmacovigilance, drug supply chain security, compounding, over-the-counter monograph compliance, drug import and export, and unapproved drug compliance, among other areas. Don led all drug compliance actions taken by the FDA following inspection, as well as all grants of regulatory discretion in drug shortage cases. As an executive member of CDER's Drug Risk Management Board, Don helped guide the Agency's approach to some of most difficult drug safety issues over the last several years, including for nitrosamine and benzene impurities. In addition, Don served as one of a small group of senior agency officials who liaised with the generic drug industry to implement the Generic Drug User Fee Act program. Before joining the FDA, Don spent nearly two decades at DOJ in both the Civil and Criminal Divisions, prosecuting violations of the Food, Drug, and Cosmetic Act among other criminal statutes, as well as managing and directing investigations on both a national and international level. During his time with the Civil Division's Office of Consumer Litigation (now the Consumer Protection Branch), he prosecuted complex schemes to defraud consumers and/or federal agencies such as the FDA. Later, Don served in Asia as the senior DOJ official responsible for managing international law enforcement cooperation on behalf of the United States with several countries, including the Philippines, Singapore, and Indonesia. Don also represented DOJ in Italy as the senior official responsible for facilitating closer cooperation between Italy and the United States in criminal investigations and prosecutions. Previously, Don worked as a senior litigation associate with a major D.C. law firm, often representing clients under investigation for FDA-regulated activities. Don also served on active duty as an Army captain assigned to the Office of General Counsel, Department of the Army. Don earned his J.D. from Harvard Law School and an A.B., magna cum laude, from John Carroll University.

Job Titles:

• Principal, Drug and Biological Products

Dr. Karen Midthun joined 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 served as the Director of the FDA's Center for Biologics Evaluation and Research (CBER) from 2009 to 2016. 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, Bob Meyer, and Sandra Kweder. 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 products to prevent or treat infectious diseases, addressing ongoing public health needs for biologics, and advancing the growing field of cell and gene therapies. 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.

Job Titles:

• Senior Vice President, Regulatory Compliance

Liz brings more than ten years of regulatory experience and diverse knowledge of legal and public policy matters to her position as Senior Vice President of Regulatory Compliance. Liz 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 to address and remediate compliance matters. She advises clients on FDA communication, including 483 and warning letter responses, and offers guidance on agency expectations and regulatory policy. Liz has particular expertise in two of the FDA's newest regulated product categories, tobacco and cannabis-derived products. Liz advises clients navigating the regulatory landscape for tobacco products and assists with content and format of applications, interpretation of FDA regulation, engagement with the FDA, and policy development. Liz is well versed in the regulatory barriers facing the rapidly growing cannabis 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, Liz served as Director of Educational Programming for the Food and Drug Law Institute (FDLI) in Washington, D.C. While at FDLI, she gained extensive experience in all FDA-regulated product areas. Liz's role included regularly corresponding with FDA officials, as well as creating and supervising the development of curricula for an array of educational programs. She 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, Liz 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. Liz 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.

Job Titles:

• Senior Vice President, Regulatory Compliance

Grace joined Greenleaf Health after a 33-year career with the FDA. Through her many agency roles and experiences, Grace developed a broad understanding of the quality requirements and initiatives intended to assure that high-quality pharmaceuticals and devices are available to patients. For 13 years Grace served as an investigator for the Office of Regulatory Affairs (ORA) in the Philadelphia and Denver district offices, where she developed expertise in quality systems and current good manufacturing practice (cGMP) for pharmaceuticals and medical devices. She conducted drug and device inspections, both domestically and abroad. At Greenleaf, Grace provides strategic guidance and support to pharmaceutical and medical technology companies in areas including: strengthening corporate quality systems; developing compliance strategies; assisting industry clients and legal counsel in developing and communicating corrective action plans that meet FDA expectations and that achieve and sustain compliance; conducting audits and mock inspections; ensuring inspection readiness; and providing training, coaching, and mentoring. Grace communicates expert advice through presentations at industry conferences such as FDLI, FDANews, and ECA (European Compliance Academy) and through articles published in industry journals.

Job Titles:

• President and Principal, Compliance and Regulatory Affairs

Job Titles:

• Deputy General Counsel

Katherine Mueller has more than a decade of legal experience in the private sector, most recently as First Vice President and Senior Counsel at SunTrust Banks, Inc., where she managed litigation nationally and advised default constituencies on risk mitigation. Prior to working at SunTrust, Katherine was a partner at an Am Law 200 firm, where she had both corporate and litigation practices. In her corporate practice, she focused on asset sales and acquisitions and corporate tax planning. Katherine also represented financial institutions in secured lending transactions, including loan workouts and corporate restructurings. She also managed a national Chapter 11 bankruptcy case, leading a team that resolved hundreds of preference actions and bankruptcy claims. Prior to law school, Katherine worked on Capitol Hill and at a government contracting firm where she was a technical writer and editor. Katherine received a B.A. in history, with honors, from Trinity College and a J.D. from William and Mary Law School.

Job Titles:

• Chief Operating Officer

Kathleen Sonntag serves as Chief Operating Officer at Greenleaf Health. 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. At Greenleaf, Kathleen is responsible for financial and operational aspects of the business. This includes oversight of accounting, financial reporting, human resources, and information technology. Before joining Greenleaf Health in 2011, Kathleen spent much of her career at The Capital Group, where she served as a liaison between sales organization and the technology team. Her work at the Capital Group included strategic planning, requirements and design, data modeling and data analytics. She was instrumental in the development of and strategic planning for key applications in the American Funds' portfolio, including enterprise-wide business intelligence, customer relationship management, and call center technologies. She also performed financial analysis for Sales and Marketing management, providing insights into sales territory restructuring, new product rollouts, and overall business measurement. Kathleen's additional business experience includes management of financial operations at a law firm, and an accounting analyst role at Merrill Lynch. Kathleen holds Bachelors of Science in Accounting and History from the University of Notre Dame. Kathleen has also completed coursework in Global Affairs at New York University.

Job Titles:

• Senior Vice President of Regulatory Compliance

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.

Job Titles:

• Director, Regulatory Affairs

Job Titles:

• Executive Vice President, Medical Devices and Combination Products & General Counsel

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 groups. More specifically, Maura's experience includes advising: Digital health companies on the FDA's evolving approach to digital health products; 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); 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; Trade associations and other public-health-focused organizations developing positions on various FDA policies, reports, proposed rules, and guidance documents; In vitro diagnostic (IVD) companies on product development, regulatory pathway questions, and premarket review issues; and A range of life sciences companies regarding regulation by and engagement with the FDA during the COVID-19 pandemic. 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.

Job Titles:

• CEO
• Vice Chair, Validant Group

Job Titles:

• Director of Operations
• Executive Director of Operations, Drug and Biological Products

Rhona Baniqued joined Greenleaf Health as Director of Operations, Drug and Biological Products in 2014, with more than 12 years' experience as a marketing professional with a successful track record managing complex agency, corporate, and nonprofit programs. At Greenleaf, Rhona is responsible for managing multiple processes, including contracting, client relationship and general operations management of Greenleaf's Drug and Biological Products Team. Before joining Greenleaf, Rhona served as a District Marketing Manager for the Microsoft Corporation, based in Washington, DC. In this position, Rhona brought specific products and solutions to customers by working with diverse sales, service, and partner organizations to build the "sales pipeline." She developed a marketing strategy focused on an application platform by identifying leads and revenue growth opportunities that accelerated sales while remaining sensitive to customer insights and business and competitive trends. Her efforts contributed to application pipeline sales in excess of $17M. In addition, Rhona directed the execution of the Executive Circle program, focused on building or strengthening relationships between Microsoft and corporate senior executives. Early in her career at Microsoft, Rhona administered the partner readiness program, in conjunction with corporate initiatives to train partners on Go-To-Market campaigns. Rhona's attendance ratios at these programs consistently ranked among those of the top 25 cities globally. Before her work at Microsoft, Rhona served as Senior Media Planner at Arnold Communications, developing and managing the implementation of long-term strategic media buys across print, radio, television, out-door, and on-line media for many Fortune 500 clients. Rhona began her career on Capitol Hill, working on legislative issues for Congressman Owen Pickett, D-Va. Rhona received her undergraduate degree from George Mason University.

Job Titles:

• Principal, Drug and Biological Products

Job Titles:

• Internal Medicine Expert
• Principal, Drug and Biological Products

Dr. Sandra Kweder is an internal medicine expert with more than 30 years of experience in U.S. and international medical products regulation and policy. As Principal, Drug and Biological Products, with Greenleaf Health, she offers broad expertise accrued through multiple senior leadership roles at the FDA, where she oversaw significant regulatory developments during periods of transformation in the landscape of science policy and public health.

Job Titles:

• Senior Vice President, Drug and Biological Products

Sarah McGarry joined Greenleaf Health after an 18-year career with the FDA. Through her different agency roles and experiences, Sarah developed a broad understanding of the FDA regulatory review process, which she uses to advise drug and biologics clients on how to navigate this process and work effectively with the Agency. At the FDA, Sarah began as a medical officer in the antivirals division in the Center for Drug Evaluation and Research (CDER), where she was the primary reviewer on the application leading to the approval of a first-in-class HIV treatment (raltegravir) and team leader on the review leading to approval of a first-in-class hepatitis C treatment (sofosbuvir). She later became Acting Deputy Division Director in the epidemiology division of the Center for Biologics Evaluation and Research (CBER), where she provided leadership and management of postmarket surveillance and adverse biologic reactions. Sarah rejoined CDER's antivirals division as an Associate Director of Bioinformatics and served as a subject matter expert in medical science and drug regulatory review processes. In that capacity, she led a team responsible for modernizing the FDA's review of marketing applications. Sarah obtained FDA guidance and policy experience as a member of the clinical advisors team in the Office of New Drugs (OND) policy group before returning to the antivirals division during the COVID-19 pandemic. As a team leader, she played a significant role in anti-SARS-CoV-2 monoclonal antibody and small molecule emergency use authorizations as well as in the approval of Paxlovid (nirmatrelvir co-packaged with ritonavir). At Greenleaf, Sarah draws upon her expertise to provide scientific advice and technical direction on critical aspects of drug development. Her familiarity with regulatory precedent, complex regulatory issues, and policy enables her to formulate options for advancing novel ideas and alternative approaches. With her substantial experience on the review teams for novel products requiring advisory committee meetings, Sarah is able to guide clients through the FDA advisory committee process and help prepare them for the questions and concerns that might arise during a meeting. Sarah completed a B.S. in biology at Dartmouth College in 1993 and her M.D. at Georgetown University Medical School in 1997. She completed her residency in internal medicine and fellowship in infectious diseases at Duke University in 2003.

Job Titles:

• Vice President of Regulatory Policy

Job Titles:

• Manager, Regulatory Affairs and Policy

Tanvi Mehta came to Greenleaf with a background in finance and professional services and an understanding of the business of health care, which she applies to her work in regulatory affairs and policy. Prior to Greenleaf, she was responsible for client relations and financial reporting at Morgan Stanley and Invesco. Most recently, she worked for Arc Initiatives in Washington D.C., where she supported rollouts of various national campaigns with in-depth policy analysis, strategic communications, and regulatory assessments. Tanvi's financial experience allows her to effectively address regulatory challenges with an analytical approach. Throughout her education, Tanvi gained significant exposure to public health and policy. She received her business graduate degree with a focus on health care. During her MBA program, she served on the board of the Healthcare Business Association and participated in DC-based public policy initiatives. Tanvi earned her MBA from Georgetown University's McDonough School of Business and her B.A. in public health and economics from Agnes Scott College.

Job Titles:

• Senior Vice President, Regulatory Compliance

Tom Berry brings more than 20 years of extensive regulatory experience to his role as Senior Vice President, Regulatory Compliance at Greenleaf Health. Tom is a retired Captain with 23 years in the U.S. Public Health Service (USPHS) and six years as an Army Pharmacy Officer. He was assigned to multiple positions over his 20 years with the FDA, most recently as a Pharmaceutical Program Expert in the Office of Regulatory Affairs (ORA), responsible for providing guidance to ORA field components, drafting FDA policy, reviewing proposed guidance and legislation, and representing ORA on FDA committees. He also trained "new hire" investigators and was a cadre member for courses in Food and Drug Law, Evidence and Development, and New Hire Fundamentals. Tom was an original author of "FMD-153 Investigations of Facilities engaged in the Manufacturing, Packaging, Labeling, and Testing of Medical Products that may be subject to an Emergency Use Authorization (EUA)." As the past Director of Compliance, Denver District and member of the FDA Cannabis Product Council, he is familiar with FDA cannabis oversight operations and cannabis regulatory history to include "Brownie Mary," Charlotte Figi, Colorado Amendment 64, and the 2018 Farm Bill. Tom began his FDA career as an investigator for eight years in the Raleigh, NC resident post, where he was a domestic and international drug, bioresearch monitoring (BIMO), and pharmacovigilance investigator. He was selected as a Compliance Officer in Denver and subsequently as the Director of the Compliance Branch, with responsibility for assessment of inspection reports, initiation of compliance actions, and evaluation of compliance action effectiveness. After ORA Program Alignment in May 2017, Tom conducted a 180-day detail to establish the BIMO Program West Division responsible for the oversight of BIMO operations in the Western 27 States. He subsequently assumed his permanent position as Director of Compliance, Office of Pharmaceutical Quality Operations IV, with oversight of the pharmaceutical operations in the Western 13 States and global inspection regulatory assessments. At Greenleaf, Tom provides strategic guidance and support to pharmaceutical, pharmacovigilance, and cannabis companies, including: developing compliance strategies; performing due diligence activities; ensuring inspection readiness; assisting industry clients and legal counsel in developing and communicating corrective action plans that meet FDA expectations and that achieve and sustain compliance; conducting audits and mock inspections; and providing training, coaching, and mentoring. Tom continues to communicate expert advice through presentations at FDA and industry conferences and articles published in industry journals. Tom received a B.S. in pharmacy and a Pharm.D. from Creighton University and completed an ASHP-certified residency at Fitzsimons Army Medical Center.

Job Titles:

• Executive Vice President, Drug and Biological Products

Wilson joined Greenleaf Health in 2023, following a 19-year career at the FDA that culminated in his leadership of the Office of Tissues and Advanced Therapies in the Center for Biologics Evaluation and Research (CBER). A neurologist and neuromuscular specialist, Wilson was a clinician and clinical researcher for over a decade prior to his work at the Agency. Wilson began his regulatory career as a medical officer in CBER, where he served as primary reviewer for Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs). He subsequently served two years as a clinical team leader in the Division of Neurology Products within the Center for Drug Evaluation and Research (CDER), with a focus on neuromuscular disorders, bioterrorism, and sleep disorders. Wilson then worked for three years as a regulatory consultant with the Biologics Consulting Group. Wilson returned to CBER in 2009 as Chief of the Clinical Evaluation Branch in the Office of Cellular, Tissue, and Gene Therapies (OCTGT), and was later promoted to Director of the Division of Clinical Evaluation and Pharmacology/Toxicology. In 2016, Wilson became Director of the newly formed Office of Tissues and Advanced Therapies (OTAT). OTAT was responsible for the regulation of gene therapies, cellular therapies, genetically-modified cells (e.g., chimeric antigen receptor T cells), tissue-engineered products, plasma protein therapeutics (e.g., immunoglobulins; coagulation factors), selected medical devices, and xenotransplantation. OTAT-regulated products covered a full range of medical indications, including oncology, hematology, neurology, cardiology, endocrinology (e.g., diabetes), pulmonary, nephrology, dermatology, and a variety of surgical indications. Of the thousands of applications in the OTAT portfolio, approximately 50% were for the treatment of rare diseases. OTAT also developed processes and standards for the new Regenerative Medicine Advanced Therapy (RMAT) designation. Wilson retired from the FDA when OTAT was reorganized into the Office of Therapeutic Products (OTP) in 2023. His work at Greenleaf is informed by the experience of overseeing the FDA's regulation of cellular and gene therapies, along with other advanced technologies, during a transformative period in which the foundation was laid for today's development and approval processes. Before joining the FDA in 2000, Wilson was on the faculty of the Department of Neurology of the University of Texas Southwestern (UTSW) Medical School for 13 years. At UTSW, he served as a neuromuscular specialist and was an investigator for clinical trials in neuromuscular disorders, particularly amyotrophic lateral sclerosis (ALS), and in cerebrovascular disease. Wilson received his bachelor's degree from the University of South Carolina and his medical degree from the University of Chicago Pritzker School of Medicine. He completed an internal medicine internship at Grady Memorial / Emory University Hospitals, a neurology residency at Parkland Memorial Hospital / University of Texas Southwestern Medical School, and a neuromuscular / neurophysiology fellowship at Tufts University / New England Medical Center.