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Biography

Neervalur V Raghavan is an experienced leader of R&D organizations that have successfully developed novel formulations and implemented practical manufacturing solutions for drug entities that have poor solubility and limited shelf life. He has provided key leadership to drive strategic business initiatives, long term process optimization activities and the technical development of a scientifi c staff that is known throughout the industry. He is responsible for developing over 200 product presentations that include novel frozen drug formulations, inhalation therapy products, sterile, ready to use injectable antibiotic solutions and aseptic form fill seal injectable products. He has earned a PhD degree in Chemistry from University of Southern California, Los Angeles. After serving as a Postdoctoral fellow at Ohio State University, he joined University of Notre Dame focusing on radiation chemistry of low levels of aromatic aqueous solutions, utilizing HPLC and fast reaction kinetics. Then he joined Baxter Health Care Corporation and served there over thirty years, with increased responsibility, on sterile drug product development. He retired as VP of Pharmaceutical Product Development R&D. He had active membership with AAPS and ACS.

Abstract

The topic will cover fundamental aspects of development of aqueous injectable products ranging from small to large molecules. Emphasis will be placed on approaches to meet safety and stability to meet global regulatory considerations and market needs. In addition, particular challenges from formulation, analytical, and processing perspectives that are typically experienced in the development of drug device combo products and how to anticipate and to overcome them with carefully designed and systematic approaches during product development phase will also be discussed. A brief review of the challenges to the development of aqueous parental drug formulations will also be presented.

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