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. 

Lisa Parks

Senior Vice President, Regulatory Policy

Lisa joined Greenleaf Health after serving for eight years as the Vice President of Sciences and Regulatory Affairs at the Association for Accessible Medicines (AAM), a leading generic and biosimilars trade association in Washington, D.C. In this role, she developed and promoted regulatory and scientific affairs initiatives, internal and external communications and relations, and training/knowledge-sharing opportunities for member companies. She was AAM’s primary liaison with the FDA and facilitated discussions and efforts with the FDA, lawmakers, and industry stakeholders on numerous topics that impacted the generic and biosimilar industry. Lisa served as the industry lead negotiator for the Generic Drug User Fee Amendment (GDUFA) II and III negotiations with the FDA and co-lead for the Biosimilars User Fee Act (BsUFA) II and III negotiations for AAM’s Biosimilars Council. She also led the implementation phase of both the GDUFA II and BsUFA II user fee programs for AAM.

Lisa’s career with the FDA’s Office of Generic Drugs (OGD) began in 2008 in the regulatory affairs division. Her keen ability to facilitate discussions and build consensus around intricate regulatory policy issues was quickly recognized by senior CDER leadership, and she was appointed to lead the implementation of GDUFA I for the OGD. Due to her accomplishments, CDER leadership appointed her for further work in planning for and standing up the Office of Pharmaceutical Quality and other modernization initiatives.

In 2022, Lisa launched Daedal Regulatory Strategies, LLC to assist entities in better interpreting and navigating discussions with the FDA on complex regulatory and policy issues. In August 2022, Lisa joined Greenleaf as the Senior Vice President of Regulatory Policy in order to work alongside fellow experts and former FDA colleagues in helping clients advance their interactions and dialogue with the Agency.

Lisa holds a pharmacy degree from the Massachusetts College of Pharmacy in Boston, MA. 

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.

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

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.

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