Sarah McGarry, M.D.

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.

Wilson W. Bryan, M.D.

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. 

Sandra L. Kweder, M.D.

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.

Sandy recently served for six years as Deputy Director of the FDA’s Europe Office and Liaison to the European Medicines Agency (EMA), first in London and later in Amsterdam, working to strengthen international collaboration across all areas of FDA regulation, especially medical products. She launched new engagements with the EMA in areas including labeling and study of drugs in pregnancy, patient engagement strategy, rare disease product development, and an invigorated parallel scientific advice program. Upon returning to the U.S., she provided strategic direction and subject matter expertise to FDA leadership as Senior Medical and Regulatory Advisor in the Office of Global Strategy and Policy.

Prior to her work in Europe, Sandy spent nearly 14 years as Deputy Director of the Office of New Drugs (OND) in the FDA’s Center for Drug Evaluation and Research (CDER). She guided OND through a phase of substantial maturation between 2002 and 2016, as the prescription drug user fee program (PDUFA) grew and CDER strengthened review standards and practices to incorporate scientific innovation and emerging drug development approaches such as patient-reported outcomes in clinical trials. Among other initiatives, Sandy led the taskforce responsible for developing the 2014 Pregnancy and Lactation Labeling Rule that updated the regulations on labeling prescription drugs for use in pregnant and lactating patients and helped to modernize the FDA’s policies on conducting research in these populations.

Sandy joined the FDA in 1988 as a medical officer in the Division of Antiviral Drug Products, newly established to address the urgent need for treatments for HIV/AIDS. She became Acting Director of the Division of Epidemiology and Surveillance, then, after a two-year clinical fellowship, Deputy Director of the Office of Drug Evaluation IV, responsible for regulating antiviral and antimicrobial drug products. While at the FDA, she was a delegate to the American Board of Medical Examiners and a Fellow of the Drug Information Association (DIA). Sandy was often called upon to communicate complex medical and regulatory information to audiences ranging from patients and clinicians to intragovernmental and global partners. In 2022, Sandy was honored with an FDA Reward of Merit for her work to advance the Agency’s mission, particularly on the global front.

For 33 years Sandy served in the U.S. Public Health Service (PHS), rising to the rank of Rear Admiral and receiving numerous PHS awards before retiring from the service in 2013.

Sandy trained in medicine at the Uniformed Services University in Bethesda, MD, and performed her two-year clinical teaching fellowship in obstetrics and consultative medicine at Brown University School of Medicine. She remains on the faculty at USUHS and continued to teach medical students and residents while at the FDA, and is known for her strong commitment to mentoring the next generation of clinicians and FDA professionals. 

Tanvi Mehta

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. 

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.  

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

Executive Vice President, Drug and Biological Products

Chris joined Greenleaf in 2021, bringing 14 years of FDA regulatory experience to his role as Executive 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. 

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

As Vice President of Regulatory Policy at Greenleaf Health, Sean Hilscher brings 15+ years of experience in health care, having worked with a broad array of stakeholders including life science companies, data companies, providers, and international health organizations. Sean helps Greenleaf clients navigate the evolving regulatory policy landscape, conducting in-depth analyses of legislation, regulations, and regulatory initiatives and their impact on clients’ products.

Previously, 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. Sean has experience in strategy and operation consulting from his time at the Advisory Board Company. As a manger in the sourcing and operations practice, 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.

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