Becca Hunt

Associate Director of Operations, Drug and Biological Products

Becca Hunt serves as Greenleaf Health’s Associate Director of Operations for the Drug and Biological Products Team. She oversees the progress of team projects to ensure efficient completion and that client expectations are met. She also manages team calendars to schedule meetings and conference calls with clients. 

Prior to joining Greenleaf, Becca worked in human resources, leading onboarding and organizing training for new employees. She also produced financial reports while employed as a personal assistant for a local family. 

Before working in administrative roles, Becca spent four years as an educator. While teaching, she was responsible for managing the effective use of classroom time to meet district requirements. She provided individualized support to students by continuously assessing their current progress and future goals. She ensured that safe and effective procedures were in place to provide stability and promote student independence. In addition to her classroom responsibilities, she served on committees to provide additional support to struggling students and to coordinate fundraising for the school. She also improved efficiency by developing systems to automate quarterly reporting for her grade levels.     

Becca received her undergraduate degree in elementary education from Brigham Young University-Idaho.  

Julia Barrett, M.D., M.P.H.

Executive Vice President, Drug and Biological Products

Dr. Julia Barrett joined Greenleaf Health with 23 years of biopharma consulting experience. An internist with a Master of Public Health (M.P.H.) and FDA expertise, Dr. Barrett has assisted clients worldwide with regulatory strategy and clinical development for a wide variety of biological products, drugs, and combination products across many indications. At Greenleaf, she applies the knowledge and unique perspective gained through this experience to her work as Executive VP, Drug and Biological Products. 

Julia is a strong clinical research professional who received her bachelor’s degree in biology from Smith College, an M.D. from Northwestern University, and an M.P.H. from George Washington University. She trained as a resident in internal medicine at the University of Minnesota and completed a fellowship in general internal medicine at George Washington University.

Julia began her 28-year career in biologics and drug development as a clinical reviewer in the Office of Vaccine Research and Review (OVRR) at the Center for Biologics Evaluation and Research (CBER). From 2004-2021 she was a Senior Clinical Consultant at Biologics Consulting Group, with a focus on clinical product development for U.S. licensure. Julia’s expertise spans a broad range of product classes, with particular expertise in biological products, including cell and gene therapy/regenerative medicine, protein therapeutics, allergy immunotherapy, vaccines, toxins, and microbiome-based products. Julia has extensive experience in the review and oversight of regulatory submissions, including the clinical sections of pre-INDs, INDs, BLAs/NDAs, FDA meeting packages, FT/BT/RMAT designation requests, orphan drug designation requests, clinical protocols, and statistical analysis plans. She provides in-depth clinical development plans and strategy, clinical/regulatory gap analyses, clinical protocol development, “FDA-style” clinical data review, and assistance with regulatory meetings. 

Julia’s product development experiences cover a wide range of clinical indications including infectious disease, neurology, gastroenterology, allergy, genitourinary, gynecology, orthopedics, rheumatology, dermatology, cardiopulmonary, ophthalmology, metabolic, and orphan diseases. 

Julia is a member of the Grants Working Group (GWG) of the California Institute for Regenerative Medicine (CIRM). The mission of CIRM is to accelerate stem cell and gene therapy treatments to patients with unmet medical needs. The GWG reviews the scientific merit of grant applications and is composed of subject matter experts from outside California and patient advocates. 

Chris Leptak, M.D., Ph.D.

Senior Vice President, Drug and Biological Products

Chris joined Greenleaf in 2021, bringing 14 years of FDA regulatory experience to his role as Senior Vice President of Drug and Biological Products. He specializes in the regulatory use of novel clinical endpoints, including surrogates for both traditional and accelerated marketing approval.

While at the FDA, Chris began as a medical officer in the gastroenterology division. With his immunology expertise, his primary focus was on immunomodulator drug and biologic product development. After joining OND’s Guidance and Policy team, he became OND’s first biomarker and companion diagnostic lead, responsible for developing guidance and evidence requirements to support regulatory acceptance. As CDER’s lead for implementation of the 21st Century Cures legislation for Section 3011 Drug Development Tools, he supervised staff responsible for Clinical Outcomes Assessments, biomarkers, and innovative drug development tools and approaches. As part of OND’s modernization effort, he led the creation of ODES, served on OND’s Senior Management Council, and supervised groups responsible for safety analytics as well as regulatory research in addition to the qualification programs. Chris served as the Chair of CDER’s Drug Development Tools Committee, the group of senior staff responsible for advice for novel surrogate endpoints and acceptance of DDT qualification submissions. He worked closely with all OND offices and divisions as well as CDER, CBER, and CDRH and founded and chaired an FDA-wide biomarker working group. Chris is frequently invited to speak and serve as a panelist at scientific conferences.

At Greenleaf, Chris draws on his expertise as a recognized expert on biomarkers and regulatory science to provide authoritative scientific advice and technical direction on critical aspects of drug development, particularly those that involve the broadest and most complex topics. His familiarity with regulatory precedent and policy enables him to formulate options and alternatives for novel ideas and approaches.

Chris completed a combined B.S./M.S. in Molecular Biophysics and Biochemistry from Yale University in 1990. His graduate work included an M.D. and Ph.D. in Microbiology/Immunology at the University of California, San Francisco in 1999. He completed his residency in Emergency Medicine at Harvard’s Brigham and Women’s Hospital and Massachusetts General Hospital in 2003.

In addition, Chris brings scientific and collaborative leadership experience from his roles on the Foundation for the National Institutes of Health Biomarkers Consortium Executive Committee and European Innovative Medicines Initiative TransBioLine Biomarker Development Scientific Advisory Board. 

Kate Cook

Principal, Regulatory Policy

Kate Cook joined Greenleaf following a distinguished career of more than 20 years with the U.S. Food and Drug Administration (FDA). During her FDA tenure, Kate provided crucial direction on strategic initiatives related to the regulation of drugs, biological products, and medical devices. Kate continues her commitment to public health at Greenleaf as Principal, Regulatory Policy, providing strategic consulting services and working with clients to bring innovative medical products to patients.

Kate’s FDA career began in the Office of the Chief Counsel, where she served for more than 15 years as a legal counsel on FDA issues related to biosimilars, gene therapy, vaccines, allergenics, human tissue and cellular products, blood products, medical devices, and combination products. She also provided guidance on human subject protection and advertising and promotion. Kate went on to serve as Associate Director for Regulations and Policy within the FDA’s Center for Devices and Radiological Health (CDRH), where she led strategic development and implementation of policies and regulations applicable to medical devices and radiation-emitting products. Later, as Senior Advisor in the FDA’s Center for Biologics Evaluation and Research (CBER), she played a pivotal role in the development and implementation of regulations and regulatory policy related to biological products, combination products, and medical devices regulated by CBER.

From 2016 to 2021, Kate was Executive Vice President with Greenleaf’s Drug and Biological Products Team. In 2021, she was enlisted to support the federal government’s pandemic response efforts. She returned to Greenleaf as Principal, Regulatory Policy, and now leads the firm’s services focused on supporting clients with expertise and guidance on FDA regulatory policies and programs.

Kate is the recipient of numerous FDA awards, including the FDA Award of Merit, the Secretary’s Award for Distinguished Service, the Commissioner’s Special Citation, and the CDRH Director’s Special Citation.

A graduate of Swarthmore College, Kate received her law degree from the New York University School of Law. 

Restarting a Stalled Development Program

Greenleaf Health worked with a multinational biopharmaceutical manufacturer to reinitiate their phase 3 program for a women’s health product, which had stalled after the FDA had voiced concerns with the design of the pivotal trial. The client needed a way to fulfill the Agency’s request for additional long-term outcomes data, which would require an expansion …

Leading a Client Through Dispute Resolution to Product Approval

Upon receiving a Complete Response Letter (CRL) for their lead product to manage mild to moderate pain, a mid-sized specialty pharmaceutical company engaged Greenleaf Health to assist them in addressing the deficiencies cited in the CRL and developing a strategy for resubmitting the new drug application (NDA).  Greenleaf’s regulatory experts, in conjunction with a partner …

Sean Hilscher

Vice President, Regulatory Policy

Sean Hilscher brings more than 10 years of experience as a consultant in the international and U.S. health care markets to his role as Vice President of Regulatory Policy at Greenleaf Health. Prior to joining Greenleaf, Sean served as a Director at the American College of Cardiology (ACC), where he managed a suite of real-world evidence platforms marketed to providers, payers, and life science companies. In the role, Sean provided objective analyses of markets, assessing the market impact of policy and regulatory changes.

Prior to his work at ACC, Sean was a manager on the Clinical Sourcing team at the Advisory Board Company. As a manager, Sean led data analysis efforts for operational and supply chain consulting engagements with provider organizations across the country.

Sean earned his MBA from the Georgetown University McDonough School of Business and an MA in Politics, Philosophy, and Economics from the University of Oxford.

Karen Midthun, M.D.

Principal, Drug and Biological Products

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

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 ozone-safe medical aerosols, Bob is also 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.

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