Using Quality by Design (QbD) and Systems Thinking in the Development, Commercialization

Healthcare solution providers developing innovative medicines work within a complex ecosystem of pharmaceuticals and biologics technologies, shifting political, economic and regulatory trends, and a multitude of stakeholders that includes patients, physicians, nurses, payers, partners and competitors. What is at stake is nothing short of collectively bending the course of global human health towards improved wellness for all humanity. In this extremely complex environment, there is one strategic certainty: systems thinking is essential. This presentation will highlight implementation challenges and successes of the Quality by Design (QbD) paradigm in the arena of medicinal and vaccine development, commercialization, and supply. It will demonstrate that QbD is the true embodiment of systems thinking in the drug development space by discussing advantages and challenges of adopting associated mindsets, methodologies, and tools. About the Speaker Anando A. Chowdhury, SDM ’09, works at Merck/MSD in Whitehouse Station, NJ leading the organizational strategy, management and operations function for Merck’s Global Science, Technology and Commercialization organization. His organization enables Merck to meet its promise to the patient/customer through the development, commercialization, launch and manufacturing technical support of all pharmaceutical, biologic, vaccine and consumer products and associated packaging. Chowdhury is currently a Fellow in MIT’s System Design and Management Program. He holds a B.S. and M.S. in Chemical Engineering and Biomedical Engineering from the University of Rochester, is a Six Sigma Black Belt and a graduate of Merck’s Business Leadership Program through Duke University.