Rajesh N. Davé, Ph.D., Fellow of the American Institute of Chemical Engineers (AIChE), American Association of Pharmaceutical Scientists (AAPS), and National Academy of Inventors (NAI) is a Distinguished Professor of Chemical and Materials Engineering at New Jersey Institute of Technology.
Prof. Davé has made significant contributions to QbD of Drug Product Development and Manufacturing through multi-university research center leadership and fundamental research promoting mechanistic understanding of materials, formulations, and processing. His grant-funded ($23M+ as his share from $76M+ as PI/Co-PI) translational research (~190 journal papers, 13,600+/9,400+ Google/Scopus citations, H-index 62/53, 21 issued patents), resulted in numerous international keynote/invited presentations, awards and recognitions, commercialization of technology, and work-force development by graduating 35 doctoral students (eleven females), including seven as faculty in the US Universities. He has made substantial impact to particle technology and pharmaceutical sciences through grant funded research for improved understanding of particle formation and processing, and cost-efficient manufacturing while developing patient compliant technologies including taste-masking. His trend-setting contributions include predictive understanding of the effect of surface modification of drug or excipient particles, thin polymeric films embedded with poorly water-soluble drug as a patient compliant platform technology for precision medicine along with regulatory science, and an understanding of drug particle milling from surface energetics perspective. High-impact QbD contributions include: (1) Model-based, PAT-enabled regulatory science for thin polymeric films, (2) Predictive property enhancements through dry coating for high and low drug loaded direct compression formulations, (3) Nano and micro powder mixing, fluidization, and film coating, (4) Enhancement of bioavailability through creation of size/form stable nano/micro drug particles composites, and (5) Modeling including DEM and PBM of particulate processes, and scale-up. Such work has led to numerous national awards, including 2015 American Institute of Chemical Engineering, Particle Technology Forum Fluidization Lectureship, 2016 Thomas Alva Edison Patent Award, and New Jersey Inventors Hall of Fame 2015 Innovators Award.
Prof. Davé’s most impactful contributions come from establishing and managing multi-disciplinary multi-university Centers, and his roles within AIChE, as past-Chair of the Particle Technology Forum, and as a Chair of tracks 3a and 3d through which he promoted material science and engineering of pharmaceutical products. He is the founding Director of the R&D Excellence Center, New Jersey Center for Engineered Particulates (NJCEP, funded from 15+ industry awards), was a founding Co-PI of the former NSF-ERC (30+ industry members) for which he played major roles as NJIT Site-Leader, Thrust Leader and a Test-bed Leader, and most recently, launched a pharma industry-driven, Center for Integrated Materials Science and Engineering of Pharmaceutical Products (CIMSEPP, an NSF-IUCRC, 13 members, including B-I, Biogen, BMS, Catalent, Genentech, GSK, Merck, Novartis).