Vinod P. Shah
Dr. Shah is a pharmaceutical consultant. He retired from the US FDA (Food and Drug Administration) after serving for 30 years. While at the FDA, he developed several Regulatory Guidances for the Pharmaceutical Industry in the area of biopharmaceutics, including a guidance on the dissolution of IR and ER products. He is the author/co-author of over 290 scientific papers and co-editor of three books. He is a recipient of the FDA Award of Merit, FIP Lifetime Achievement Award in Pharmaceutical Sciences and has an Honorary Doctorate from Semmelweis University (Budapest, Hungary).
Sanjaykumar Patel is Principal Scientist at Merck & Co., Inc. in Rahway, NJ. He has 18 years of experience in pharmaceuticals industry. His experience includes working on novel drug delivery formulations such as self-emulsifying drug delivery systems, amorphous solid dispersion, controlled release and gastro retentive, and parental formulation. His research interest is focused on developing predictive bio-relevant in-vitro methodologies to understand in-vivo performance of oral and parental formulations. He has co-authored several scientific papers. He is an active member of AAPS and a part of the IVRDT (In Vitro Release and Dissolution Testing) focus group steering committee. He is involved in cross-organization consortium, OrBiTo, in the area focusing on a development and improvement of in-vitro analytical tools.
Dr. Xujin Lu is a Research Fellow at Bristol-Myers Squibb Company in the department of Drug Product Development, Global Product Development and Supply. With 30 years of experience in research and development in pharmaceutical industry, Dr. Lu currently focuses on in-vitro biopharmaceutics drug release and biorelevant dissolution for product development. Dr. Lu is active members of AAPS, ACS, and SAS, and a past Chair of the In Vitro Release and Dissolution Testing (IVRDT) Focus Group of AAPS. Dr. Lu also serves on the USP Expert Panel on New Advancements in Product Performance Testing, USP Expert Committee of Dosage Forms, and the Editorial Advisory Board of Dissolution Technologies journal.
Dr. James E. Polli is Professor of Pharmaceutical Sciences and Ralph F. Shangraw/Noxell Endowed Professor in Industrial Pharmacy and Pharmaceutics at U of Maryland. He received a B.S. in Pharmacy (Philadelphia College of Pharmacy and Science) and a Ph.D. in pharmaceutics (U of Michigan). His research interest is oral drug absorption. His two main research interests are 1) maximizing oral bioavailability through formulation and chemical approaches and 2) developing public quality standards for oral dosage forms. Dr. Polli has an active laboratory and clinical research program, with clinical pharmacokinetic studies in patients and healthy volunteers. He has served as advisor to 20 Ph.D. graduates. He is co-Director of the U of Maryland Center of Excellence in Regulatory Science and Innovation (CERSI), and FDA-funded collaborative agreement with the Agency. He is Director of the online MS in Regulatory Science program (www.pharmacy.umaryland.edu/regulatoryscience). He is an Editor of Pharmaceutical Research. He is a member of the University of Maryland General Clinical Research Center Advisory Committee. Dr Polli is a member of the University of Maryland institutional review board (IRB). He is a member of the Scientific Advisory Board of Simulations Plus.
Dr. Sperry is a Sr. Research Advisor in Small Molecule Drug Development at Lilly Research Laboratories. He obtained a B.S. degree in chemistry from Indiana University, Bloomington, IN and a Ph.D. degree in chemistry from the University of Rochester, Rochester, NY. After receiving his degree, he took a postdoctoral research scientist position at Pharmacia & Upjohn where he developed an Artificial Stomach Duodenum model and studied its utility in drug development. Shortly thereafter, he accepted a research scientist position at Pharmacia (later Pfizer), working in the area of in vitro methods and biopharmaceutics. He then moved to Bausch and Lomb where he developed commercial ophthalmic formulations for late stage molecules. In 2007, Dr. Sperry joined Lilly Research Laboratories, where he created a group focusing on in vitro drug product performance techniques and predictions of in vivo performance. In 2013, Dr. Sperry joined a computational modeling group at Lilly. He now supports product development by using existing and creating new models to predict product performance and oral absorption of small molecule drug formulations.
Deanna Mudie, Ph.D., is a Principal Scientist in Research and Development at Lonza. Her focus is on enabling bioavailability enhancing amorphous solid dispersions by developing dosage form platforms and in vitro dissolution methodologies to predict bioperformance. Deanna earned her Ph.D. in Pharmaceutical Sciences and B.S.E. in Chemical Engineering from the University of Michigan. She has seven years of pre-doctoral experience at two large pharmaceutical companies developing and manufacturing oral dosage forms from pre-clinical to commercial scale.
Dr Arvind Kumar Bansal is currently Professor and Head, department of Pharmaceutics at National Institute of Pharmaceutical Education and Research (NIPER) – SAS Nagar, Punjab, India. He earned his M Pharm (Pharmaceutics) (1988) and Ph.D. (1993) from University of Delhi, India. Prof Bansal worked as Senior Scientist and Group Leader in JK Pharmaceuticals and Ranbaxy Research Laboratories, for 8 years. Therein he conceptualized, evolved formulation strategies, developed and transferred the technology to production shop floor, for NCEs and generic drug products. Prof Bansal joined NIPER in 2000 and developed expertise in areas of pre-formulation and formulation development encompassing characterization and stabilization of the amorphous form, polymorphism, pseudo-polymorphism, particle engineering, screening salt forms, improvement of oral bioavailability and lyophilization. His research group works with the mission statement – ‘developing science based industrially viable pharmaceutical technologies’ and works closely with pharmaceutical industry to create opportunities for commercial exploitation of the products. Dr Bansal was conferred prestigious Fellow of American Association of Pharmaceutical Sciences in 2016. He has won prestigious awards like AAiPS Distinguished Educator and Researcher Award, Innocentive Award, OPPI Award and IPA-ACG Scitech Innovation Award 2018 for Best Innovative Development of Solid Dosage Form. Prof Bansal’s research group has completed more than 550 industry-sponsored projects, granted 11 patents, filed 27 patents, and published 170 research articles and 27 review articles. He has total citations of 8011, with h-index of 47, in Google Scholar. He is an editorial board member of ‘Journal of Excipients and Food Chemicals’, ‘Drug Development Research’ and ‘Pharmaceutics’. He is also an Advisor to the editorial board of ‘Journal of Pharmaceutical Science’ and ‘Molecular Pharmaceutics’. Recently his lab has out-licensed a platform technology on “Nano crystalline solid dispersions – NanoCrySP”.
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. An immigrant to the US himself, he particularly enjoyed working with and developing solutions for immigrant scientists from the Indian subcontinent and elsewhere through his tenure at SOTAX.