Payal Agarwal, Ph. D is currently a Biopharmaceutics assessor in the Division of Product Quality Assessment VI, in the Office of Pharmaceutical Quality (OPQ), CDER. Her responsibilities include biopharmaceutics assessment of NDAs (original and supplement), ANDAs (original and supplement), INDs, and Pre-ANDAs. Before joining the FDA, Dr. Agarwal served as a Senior Manager Advisory Services, Research Scientist I at Avalere Health. In this role she applied her comprehensive blend of expertise on multiple regulatory policy and strategy projects for diverse group of clients. She was engaged in providing regulatory policy advice and guidance based on legislative trends to Avalere’s internal and external stakeholders. Prior to Avalere Health, Dr. Agarwal was a tenured faculty and worked as an Associate Professor of Pharmaceutics and Biopharmaceutics in the Department of Pharmaceutical Sciences at the School of Pharmacy, Notre Dame of Maryland University for 12 years. Due to her exceptional dedication, knowledge and skills, and service to students, in addition to her caring and compassionate personality, Dr. Agarwal was awarded as the Teacher of the Year. Along with teaching, research, and mentorship roles, she held several leadership positions at the institution. She has been actively involved with many scientific organizations, served as an editorial board member and as a scientific reviewer for various peer reviewed journals, meetings abstract, and book chapters. She authored and edited the textbook “Pharmaceutical Calculations” for the PharmD curriculum. She has executed, managed, and led multiple scientific and regulatory projects.
Dr. Agarwal has made significant contributions in the areas of oral delivery of proteins and peptide-based drugs. The novelty and significance of her research has been recognized and awarded by several scientific communities. Dr. Agarwal received her Ph.D. in Industrial Pharmacy from St. John’s University, NY, MS in Pharmacometrics from University of Maryland, Baltimore, MS in Pharmaceutics and Bachelor of Pharmacy from Dr. H.S. Gour University, India.
Elizabeth Bielski, M.S., Ph.D. is a Senior Pharmacologist working at Division of Therapeutic Performance-I (DTP-I), Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center of Drug Evaluation and Research (CDER) at the FDA since October 2022. Prior to her role as a Senior Pharmacologist, she served as a Pharmacologist (October 2020-October 2022) and as a Chemist (January 2020 t-October 2020) within DTP-I. Her areas of expertise involve orally inhaled and nasal drug products (OINDPs) and drug-device combination products (DDCPs). She is actively involved in developing general and product-specific guidances, addressing controlled correspondences, pre-ANDA meeting requests, citizen petitions, internal consults, and collaborating on current research projects to promote generic drug development of OINDPs and DDCPs. Prior to joining the FDA, she served as an ORISE Fellow at FDA within DTP from August 2018-December 2019. Elizabeth completed her Ph.D. in Chemical Engineering from Wayne State University (Detroit, MI, USA) in July 2018 encompassing work also conducted at Department of Chemistry at the University of São Paulo (São Paulo, Brazil) and Department of Pharmaceutics at Virginia Commonwealth University (Richmond, VA, USA) related to novel inhaled drug delivery strategies for treatment of lung cancer and lung metastases. Prior to receiving her doctorate, she received her Bachelor of Science in Biomedical Physics Honors with University Honors in 2011, and her Master of Science in Biomedical Engineering in 2012 from Wayne State University.
James Mullin is a Senior Principal Scientist at Simulations Plus, Inc. and has a graduate degree in Chemical Engineering. In his role at Simulations Plus, he contributes to modeling and simulation development and consulting activities across multiple programs including GastroPlus, MembranePlus, and DDDPlus. Most recently, James is participating in an FDA grant project to extend the capability of Gastroplus to predict local tissue concentrations by enhancing the model structure. Additionally, he has developed models to predict partitioning in pulmonary tissues and simulate inhalation of vapors for purposes of toxicological modeling and assessments. James has 19 years’ experience in PBPK modeling, computational fluid dynamics, and mathematical modeling.
Dr. Ross Walenga joined the FDA in 2015 as an Oak Ridge Institute for Science and Education (ORISE) Fellow. He is currently a Chemical Engineer at the Division of Quantitative Methods and Modeling at the Office of Research and Standards. He began his career at Virginia Polytechnic Institute and State University (Virginia Tech), where he earned a Bachelor Science in Aerospace Engineering. He later earned his Ph.D. in Engineering (mechanical track) from Virginia Commonwealth University in 2014, where he also spent seven months as a postdoctoral fellow prior to joining the FDA. His research interests include computational fluid dynamics modeling of orally inhaled, nasal, ophthalmic, and dermal drug products to answer questions pertaining to bioequivalence.
Dr. Vaka is a Director of Formulation R & D, specialty product division at Amneal Pharmaceuticals. He obtained his Ph.D in Pharmaceutics & Drug Delivery from the University of Mississippi. After graduating, he worked at Kashiv Pharmaceuticals LLC., for about 8 years in R & D, focusing on 505(b)(2) programs. He developed GRANDE® (advanced gastric retention system) and KRONOTEC® (advanced osmotic oral drug delivery system) proprietary technology platforms for controlled drug delivery of challenging compounds that significantly improve efficacy, tolerability and compliance. He has authored 25+ research articles in peer-reviewed international journals, 2 book chapters and is an inventor on over 15 patents.
Nilay Patel is a Director of Pre-Formulation & Analytical R&D for the Specialty & complex generics product division at Amneal Pharmaceuticals. He holds a Master’s degree in Pharmaceutical Sciences from Stevens Institute of Technology. Nilay joined Amneal in 2010 as a scientist in the Analytical R&D department and has since progressed through a series of leadership positions within the company. Throughout his tenure at Amneal, Nilay has gained extensive experience working with a wide range of dosage forms, including oral, semisolid, ophthalmic, otic, implants, transdermal, nasal, and inhalation formulations. He has played a pivotal role in suggesting in-vitro alternatives to clinical testing for complex generic products. Currently, he is actively involved in supporting 505(b)(2) programs, focusing on establishing in-vitro models for proprietary gastro-retentive oral dosage forms using multiple approaches.
Patrick serves as Vice President and Deputy of the CEO of the Aesch, BL, Switzerland headquartered SOTAX Group. Raised in Switzerland and educated at ETH Zurich, he moved to Pennsylvania in 2005 and Massachusetts in 2009 to develop the presence of SOTAX in the United States. Today he oversees all activities of SOTAX in North- and South America, including Production, Product Development and Application Laboratories at SOTAX in Westborough, MA. A Chemist by training, his research interests prior to joying SOTAX were in the areas of Medicinal and Computational Chemistry.