The overall objectives and scope of this contract is to advance the development of human monoclonal antibody (mAbs) products for treatment of Influenza A viral infections. The scope of work for this contract includes nonclinical, preclinical, and clinical development activities to: (1) perform studies to characterize and validate lead mAbs using in vitro and in vivo approaches;(2) develop manufacturing and formulation processes and analytical testing procedures for lead Flu mAb candidates and manufacture GMP clinical materials;(3) perform enabling activities to file the Investigational New Drug (IND) applications with the Food and Drug Administration (FDA);and (4) perform clinical trials to evaluate the safety, tolerability, pharmacokinetics, and the proof of efficacy in humans of the candidate drug products.
