Streamlining data management in drug product commercialization and manufacturing
Author(s)Anderson, Spencer C. (Spencer Clark)
Leaders for Global Operations Program.
Roy E. Welsch and Daniel D. Frey.
MetadataShow full item record
Effective execution and alignment of data management across development and manufacturing teams is essential for Amgen's Drug Product Technology group to realize its main goals of shortening the development timeline and ensuring robust commercial manufacturing. The right data management strategy can help address these goals by accelerating development work and regulatory filing as well as improving commercial manufacturing efficiency. In the face of challenges associated with rapid growth and an expanding product pipeline, Amgen's commitment to standardizing development work and digitizing both clinical and commercial manufacturing has introduced many opportunities for new data management initiatives, improvements, and a revamped overall data management strategy. We identify a framework for the development of a data management strategy for the Drug Product Technology group to enable greater efficiency and alignment across development and manufacturing teams. The primary steps in data management and objectives at each step were determined. While a full data management strategy has been recommended to the Drug Product Technology group as a set of current and future projects, this thesis focuses on three specific case study projects within the overall strategy: (1) data generation and collection in drug product manufacturing, (2) real-time multivariate statistical process monitoring of lyophilization in clinical manufacturing, and (3) integration of development study data through electronic lab notebook software. Based on insights from these case studies, we make specific recommendations for further improvements in data management.
Thesis: M.B.A., Massachusetts Institute of Technology, Sloan School of Management, 2014. In conjunction with the Leaders for Global Operations Program at MIT.Thesis: S.M., Massachusetts Institute of Technology, Department of Mechanical Engineering, 2014. In conjunction with the Leaders for Global Operations Program at MIT.Cataloged from PDF version of thesis.Includes bibliographical references (pages 68-69).
DepartmentSloan School of Management.; Massachusetts Institute of Technology. Department of Mechanical Engineering.; Leaders for Global Operations Program.
Massachusetts Institute of Technology
Sloan School of Management., Mechanical Engineering., Leaders for Global Operations Program.