Challenges In Development And Testing of Complex Drug Products

Sanjaykumar Patel is Sr. Principal Scientist at Merck & Co., Inc. in Rahway, NJ. He has more than 22 years of experience in the pharmaceutical industry. His experience includes working on novel drug delivery formulations such as self-emulsifying drug delivery systems, amorphous solid dispersion, controlled release and gastroretentive, and parental formulation. His research interest is focused on developing predictive bio-relevant in-vitro methodologies to understand the in-vivo performance of oral and parental formulations. He has co-authored 18 scientific papers. He is an active member of AAPS and an immediate past Chair of the IVRDT (In Vitro Release and Dissolution Testing) community. He is a board member of the Society of Pharmaceutical Sciences-US Chapter in the area focusing on dissolution.

Navnit H. Shah is SVP and scientific advisor at Amneal. Prior to joining Amneal he was President and CSO of Kashiv Pharma, in Bridgewater, NJ. Navnit was a Distinguished Scientist in the Pharmaceutical R&D Department at Hoffmann-La Roche Inc. Nutley, N.J. and was heading dosage form development group prior to joining Kashiv Pharma in 2012. He received his Ph.D from St John’s university , New York, has over 40- years of experience and published and presented over 100 papers and 120 abstracts in drug delivery area covering improving dissolution and bioavailability of poorly water soluble molecules, Lipid delivery and controlled release. He is an inventor and co-inventor of 35 issued patents and 20 patent applications and has recently published extensively on Amorphous Solid Dispersion Technologies for poorly soluble drugs. He has received numerous awards: AAPS fellow in 1998, Thomas Alva Edison Patent Award in 2005, distinguished Alumni award in 2008, Research Leadership award from New Jersey Bio Medical Research in 2010, and New Jersey Inventor of the year award by New Jersey Inventor Hall of fame (NJIHoF) for the drug delivery technologies in October 2011. He was adjunct professor at University of Rhode Island , responsible for mentoring many graduate students for their thesis.

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.