title: Systems integration: an effective and innovative response to emerging biological threats.
abstract: A rapid and effective development of vaccines and other prophylactics, as well as novel therapeutics, against emerging threats requires the development and implementation of novel strategies. One such strategy is the integrator approach. This approach utilizes an integrated development team comprising expertise in program management, scientific management, clinical research, preclinical/nonclinical development, manufacturing, testing, risk management, quality assurance, and regulatory strategy and compliance. Key to the success of this approach is the successful management of subcontracted work, as well as the seamless integration of multiple systems and data inputs into a coherent development plan.
authors.affiliation: DynPort Vaccine Company LLC, 64 Thomas Johnson Drive, Frederick, MD 21702, United States. rhouse2@csc.com
authors.forename: Robert V
authors.initials: RV
authors.lastname: House
mesh_terms: D023482:Bioterrorism / Q000517:prevention & control; D003140:Communicable Disease Control; D004189:Disaster Planning / Q000379:methods; D006302:Health Services Research / Q000458:organization & administration*; D006801:Humans; D011634:Public Health; D012107:Research Design / Q000592:standards*; D013597:Systems Analysis; D018511:Systems Integration