In vitro and In Silico Predictions of Orally Inhaled Drug Product In Vivo Performance

Dr Shah is a Pharmaceutical Consultant. He is International Chairman of Society of Pharmaceutical Dissolution Science (SPDS) (2012 – Present) and founder President of SPDS-US chapter. He received his Pharmacy degree with Gold Medal distinction from Madras University, India and Ph.D. in Pharmaceutical Chemistry from University of California, San Francisco (UCSF). Dr Shah served US Food and Drug Administration (FDA) in different capacities in the Centre for Drug Evaluation and Research. His regulatory research interest was to develop in vitro and in vivo methodology for various pharmaceutical dosage forms. He has developed many Regulatory Guidances for the Industry. He is a recipient of several FDA Awards, including Award of Merit. He retired from FDA as a Senior Research Scientist after over 30 years of service. He is author/co-author of over 340 scientific papers and is a co-editor of four books. Dr Shah was the President of American Association of Pharmaceutical Scientists (AAPS) in 2003. He is a Fellow of AAPS and of International Pharmaceutical Federation (FIP). Dr Shah is a recipient of AAPS Distinguished Service Award; IDMA Eminent Pharmaceutical Analyst Award; FIP Lifetime Achievement Award in Pharmaceutical Sciences; Honorary Doctorate from Semmelweis University, Budapest, Hungary and from University of Medicine and Pharmacy Carol Davila Bucharest, Romania; SPDS Award of Excellence; American Association of Indian Pharmaceutical Scientists (AAiPS) Lifetime achievement award; AAPS Distinguished Pharmaceutical Scientist Award; AAPS Global Leader Award and FIP Host Madsen Medal Award.

Dr. Deanna Mudie is a leader in oral drug formulation and PBPK modeling with over 20 years of experience across academia, pharmaceutical companies, and CDMOs. She is a recognized expert in the development of amorphous solid dispersion (ASD) formulations for improving the performance of poorly soluble compounds. As a Senior Principal Scientist at Simulations Plus, Dr. Mudie develops modeling solutions that enhance drug innovation and streamline regulatory approvals. With a PhD in Pharmaceutical Sciences and a BSE in Chemical Engineering from the University of Michigan, she combines her background in formulation design with simulation technology to advance pharmaceutical research.

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.

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.

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.