Programs To Support Drug Development In Infectious Disease

By Kevin Barber, Ph.D. Vice President, Regulatory Strategy and Submissions, and Joseph Watson, Ph.D. Senior Research Scientist

According to the Centers for Disease Control and Prevention (CDC), more than 2.8 million people a year are sickened by antibiotic-resistant infections, and more than 35,000 people die as a result. Antibiotic resistance is on the rise as bacteria continue to grow impervious to currently available antibiotics. Antibiotic-resistant microbes can spread quickly across communities, the food supply, and healthcare facilities and can share their ability to become resistant with other microbes that have not been exposed to antibiotics. When microbes are resistant to antibiotics, not only does this limit the ability to fight routine infections but it also erodes the ability to provide treatments that may immunocompromised patients, such as cancer treatments or organ transplants, and to safely perform more routine procedures that require a certain level of sterility, such as joint replacements.

It is critical for drugmakers to develop treatments for antibiotic-resistant infections. However, it is difficult to identify patients with highly resistant bacterial infections and to enroll them in sufficient numbers for traditional, large-scale clinical trials. Historically, there was also little incentive to develop new antibiotics because these drugs tend to generate smaller revenue compared with “blockbuster” drugs such as those for high blood pressure treatment, which are taken by many more people daily.

Now more than ever, as global pandemics such as COVID-19 and other infectious diseases threaten people’s lives across the globe, demanding an adaptable CRO partner with an insider’s understanding of regulatory programs to support drug development in infectious disease and a proven track record of drug development success from program strategy through clinical trials and marketing applications isn’t just important—it’s critical.