Trends and Considerations in Global Infectious Disease Drug Dev | Page 2

Trends and Considerations in Global Infectious Disease Drug Development Throughout history, infectious diseases have had a devastating impact on humankind. They were the leading cause of death in the US until the 1920s.1 Today, despite remarkable advances in medical research and treatments Figure 1. Infectious Diseases Remain Major Reason for Mortality 1, 2 during the 20th century, infectious diseases remain a major reason for mortality, causing about one of every four deaths worldwide, including approximately two-thirds of all deaths among children younger than age five.2 Over the past several decades, it has become apparent that new infectious diseases will emerge, older threats will re-emerge, and microbes are increasingly prone to outsmart efforts to contain or eradicate them. Infectious diseases are acute or chronic conditions caused by pathogenic microbial agents -- such as bacteria, fungi, viruses, or protozoa. Within the human host, these infectious agents may cause initial acute symptomatic infection or asymptomatic infection -- only to become active at a later time when the host immunity wanes due to age or onset of immunosuppressive therapy. In this paper, Clinipace discusses the evolution of antimicrobial drug development, the uniqueness of antimicrobial trials, current challenges to successful drug development, and opportunities in the evaluation of new agents impacting this unique therapeutic area. Overview of Infectious Disease Occurrence ยป Although vaccines and treatments for some of the most important infectious diseases have been developed or improved, offering prevention and/or control of many of these diseases, new infectious diseases continue to emerge, such as the recent recognition of the first human cases caused by a novel avian influenza virus A (H7N9) in China, with 24 human cases and seven deaths as of April 8, 2013.3 Infectious diseases once considered treatable and under control, such as tuberculosis and malaria, have re-emerged due to resistance to available agents. Some potentially deadly pathogens, such as smallpox, anthrax and tularemia, are feared because of their potential use as agents of bioterrorism. clinipace.com 1