The Need for Manufacturing Execution Systems (MES) in Cell and Gene Therapy
Date: Tuesday, July 21, 2020
Time: 10:00am PDT / 1:00pm EDT

The presentation will provide an understanding why manufacturing execution systems (MES) should be considered early in the development of cell and gene therapy products. Typically, this type of information system is deployed with commercial products but the demand of early phase and clinical manufacturing will also take advantage of MES. Business drivers and technical considerations will be reviewed as well as special requirements of cell and gene product manufacturing. Finally, how does MES fit into a digitization strategy will be discussed.

Speaker:

Robert Lechich
Principal Manufacturing and Supply Chain Consultant
Company: Global OT/IT – Quality Services

Robert currently is a Manufacturing and Supply Chain Consultant with Global OT/IT Quality Services specializing in Regenerative Medicine including Cell and Gene Therapy and Tissue Engineering with leading organizations. He has a diversified background in pharmaceutical and biotechnology with companies such as Pfizer, Merck and Hoffmann La Roche. His operational and project work experiences include manufacturing, supply chain, engineering and technical services, operational excellence, automation and information systems. He is certified as a Master Black Belt in Lean Six Sigma, PMP, CPIM, CPIP and CSCP. He has degrees in chemical engineering, technology management, pharmaceutical science and quality assurance/regulatory affairs. He is also an adjunct professor at NJIT in the Chemical Engineering department teaching pharmaceutical engineering.