Medical Countermeasures - Presentation - An Integrated Approach
Author:
Robert V. House, M.S.P.H., Ph.D.Summary:
Successful development of medical countermeasures for biological, chemical and radiological threats is a complex process with much associated risk. Mitigation of this risk requires flexibility at all stages of development, and this flexibility is best addressed in a virtual, systems integration approach.
Presented at the 2007 Systems Integration in Biodefense conference, this presentation details how a systems integration approach has been successfully employed to bring a range of products through advanced development, including FDA licensure.
The process is described, along with an explanation of how integration is achieved from early stage (discovery) through manufacturing/testing, animal model development, and human clinical trials. The importance of a strong foundation in regulatory strategy, quality management, and programmatics is also detailed. Finally, the crucial element of data management and tracking, including the nascent use of bioinformatics in the process, is described.
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