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Dr. Dimitrios Zarkadas, Merck & Co, USA

Dr. Dimitrios Zarkadas has 20 years of experience in API development, commercialization and lifecycle management. He is currently leading API lifecycle management and development activities for the Merck Animal Health worldwide CMO network and also leading the API Innovation program, a portfolio of projects that created over $30MM in value for the company in the last 3 years. A subject matter expert in drug substance development, lifecycle management and compliance, he has also led over the years several cross-functional initiatives such as the regulatory starting material best practice, the NCE development roadmap and most recently the development of CTD templates for drug substance master files.

Dimitrios has spent his first ten years at Merck in API development in Human Health and has led the efforts for the commercialization of of two Hepatitis-C drug substances, boceprevir and grazoprevir. In 2015, Dimitrios moved to Merck Animal Health, where he was responsible for the API R&D portfolio and a number of commercial projects. He later managed the Mature Products portfolio in Regulatory Affairs-CMC in Human Heath, prior to assuming his current role in 2020. Dimitrios has a PhD in Chemical Engineer from New Jersey Institute of Technology and a BS in Chemical Engineering from Aristotle University of Thessaloniki, Greece. He is the author of several publications, presentations and patents in the areas of API development and crystallization. He is also a certified Project Management Professional from 2012.
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