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.

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. 

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.