G. K. Raju, Ph.D.

Executive Director, Pharmaceutical Manufacturing Initiative (PHARMI),
Program on the Pharmaceutical Industry (POPI),
Massachusetts Institute of Technology;
& Chairman & CEO, Light Pharma Incorporated.

"PAT and the Manufacturing Science Opportunity"

Abstract

In this presentation, the speaker will describe the PAT and Manufacturing Science opportunity. A “PAT and Manufacturing Science” perspective will be used as an overall theme to:

•  Highlight the strategic role of pharmaceutical manufacturing

•  Describe its current state (“Here”)

•  Envision its desired future state (“There”)

•  Identify real and perceived barriers in getting from “Here” to “There”

•  Identify how PAT can help overcome some of these barriers

Examples of how PAT technologies (such as LIF) together with a "science” perspective can fundamentally transform the way medicine is made will be described.

Some of the current momentum towards capturing this rare window of opportunity will be described in some detail.

Biography

G.K. is Chairman and CEO of Light Pharma Incorporated - a consulting and technology company that is focused on pharmaceutical manufacturing. He is Executive Director of the Pharmaceutical Manufacturing Initiative (PHARMI) within the Program on the Pharmaceutical Industry (POPI) at MIT. He is also Adjunct Professor of Industrial Pharmacy at Purdue University . In addition, GK is the Executive Director of the Consortium for the Advancement of Manufacturing of Pharmaceuticals (CAMP). He is also a Special Government Employee (SGE) of the U.S. Food and Drug Administration and a member of the Process Analytical Technology (PAT) and Manufacturing Subcommittees for the FDA Pharmaceutical Science Advisory Committee. GK obtained his M.S. in Chemical Engineering from MIT in 1989, his MBA from the MIT Sloan School of Management in 1994 and Ph.D. in Chemical Engineering from MIT in 1998.

G.K. has worked with or consulted for most of the top pharmaceutical and biotechnology companies. His expertise is in defining the strategic role of pharmaceutical development and manufacturing and enabling its performance with the pharmaceutical and biotechnology industry. He has benchmarked the pharmaceutical and biotechnology industry's manufacturing practices for a large number of years and has been involved in multiple organizational transformation efforts. His work focuses on pharmaceutical process innovation and addresses issues of regulatory compliance, six sigma, systems dynamics, organizational learning, process analytical technology, on-line sensors, economic modeling, data analysis, pattern recognition and knowledge based systems. GK's work makes extensive use of simulation. He is the author of several publications and book chapters.