Lessons for the future: a review of sepsis past and present.

Sepsis continues to intrigue and challenge drug developers because of the high unmet need for this illness. The large market potential for sepsis is counterbalanced by the historical failure of multiple drug candidates for this indication that have not demonstrated clinical benefit. The failure of successful drug candidates can be attributed in part to a rudimentary under-standing of complex sepsis pathophysiology, unsophisticated and poor clinical trial design, and an over-reliance on preclinical models for proof-of-concept.

High unmet-need infectious disease opportunities.

Despite advances in pharmaceutical science, considerable unmet medical needs exist in the field of anti-infective therapies. While pharmaceutical companies have focused research efforts on a few selected areas of the field, new microbial diseases have steadily increased in prevalence. Three emerging areas in the field of anti-infectives now represent large commercial opportunities: Gram-negative infections, community-acquired methicillin-resistant Staphylococcus aureus, and Clostridium difficile-associated diarrhea.