Citation

House RV. Vaccine 2007; 25(16): 3170-3174.

Affiliation

DynPort Vaccine Company LLC, 64 Thomas Johnson Drive, Frederick, MD 21702, United States. rhouse2@csc.com

Copyright

(Copyright © 2007, Elsevier Publishing)

DOI

10.1016/j.vaccine.2007.01.027

PMID

17270323

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.

Language: en