Dr. Sneha Dhapare currently serves as a Pharmacologist in the Division of Therapeutic Performance (DTP) in the Office of Research and Standards (ORS) within the Office of Generic Drugs (OGD) in Center of Drug Evaluation and Research (CDER) at the FDA. In this role, Sneha is involved in the review and assessment of complex generic products, including inhalation and nasal products. This work includes making recommendations for the approach to establish bioequivalence in the product-specific guidances (PSGs) using more advanced in vitro and in silico approaches. To inform the guidance development, Sneha is actively involved in the GDUFA-funded research and serves as a Project Officer for research contracts with the academia and industry driving the science and research required to assist in regulatory decision making, with the goal of introducing more affordable and safer inhaled products.
In the past, Sneha has worked in research supported by the National Institutes of Health (NIH) focusing on development of novel inhalation devices and formulations and in vitro and in vivo evaluation with an emphasis on lung delivery. Sneha has published several peer-reviewed manuscripts and abstracts related to aerosol formulation and lung delivery. Sneha has served as an editorial board member and scientific reviewer for high impact factor journals in the areas of aerosol science and pharmaceutics.
She holds a Bachelor of Pharmacy degree (2011) from the University of Mumbai, India, a Master of Science degree (2013) in Pharmaceutical Sciences from Creighton University, Omaha, NE and a Ph.D. in Pharmaceutical Sciences from Virginia Commonwealth University (2017).