Testing new antibiotics to treat highly resistant bacterial infections is especially difficult, since only a small number of patients contract such infections or meet the requirements to participate in clinical trials. Following are examples of hard-to-treat pathogens that present the greatest unmet needs today, and the types of drugs that are most likely to address them.More info
Reviving the Pipeline of Life-Saving Antibiotics
Exploring Solutions to Spur Innovation
Antibiotic-resistant infections are a growing public health threat. At the same time, antibiotic innovation is waning. Howard Florey, the co-discoverer of penicillin, lived to see 13 new classes of these drugs make it through the pipeline. Since his death in 1968, however, there have been just two.
The Pew Health Group (Pew), the Infectious Diseases Society of America (IDSA), and the Pharmaceutical Research and Manufacturers of America (PhRMA) hosted a one-day conference, Reviving the Pipeline of Life-Saving Antibiotics: Exploring Solutions to Spur Innovation, at the offices of The Pew Charitable Trusts in Washington, DC, on September 22, 2011. About 100 attendees, including infectious diseases physicians, pharmacists, economists, pharmaceutical industry representatives, and government officials, explored ways to overcome the challenges that hinder the development of new antibiotics (drugs designed specifically to kill disease-causing bacteria, as opposed to viruses, fungi, and other pathogens).
The conference, moderated by Allan Coukell, director of medical programs at Pew, was divided into three sessions. During the first session, panelists identified the greatest unmet health needs requiring new antibiotics. The second session was aimed at addressing the current regulatory and scientific challenges that hinder antibiotic development. Throughout the third session, speakers and panelists examined economic incentives that could spur greater innovation.
Although the conference was not designed to generate consensus, some common themes emerged:
- Several factors make antibiotic research and development challenging, including drug resistance and the low return on investment compared with other therapeutic areas.
- The greatest immediate public health need is for antibiotics designed to treat infections caused by multidrug-resistant, Gram-negative bacteria, such as Escherichia coli, Pseudomonas aeruginosa, and Klebsiella pneumoniae.
- The U.S. Food and Drug Administration (FDA) should provide clearer guidance to industry about conducting antibiotic clinical trials (i.e., testing in humans), including feasible study designs.
- Faster diagnostic tests are needed to identify suitable patients for enrollment in antibiotic trials. New diagnostics can also guide proper usage of these drugs in clinical practice.
- Drug companies require better financial incentives to develop antibiotics, and a variety of potential policy solutions exist. Panelists emphasized that no single incentive is sufficient to address the multiple challenges impeding research and development.
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- Date added:
- Apr 12, 2012
The President’s Council of Advisors on Science and Technology held a public meeting on April 4 to discuss the issue of antimicrobial resistance. Drug safety and innovation director Elizabeth Jungman testified on the need to spur the development of new antibacterial drugs.More info
Allan Coukell, senior director of drugs and medical devices, testified before the U.S.-China Economic and Security Review Commission on the global pharmaceutical supply chain security and the importance of the newly passed Drug Quality and Security Act.More info
Drug-resistant bacteria, or superbugs, present a serious and worsening threat to human health. According to a Centers for Disease Control and Prevention report, 2 million Americans acquire serious infections caused by antibiotic-resistant bacteria each year, and 23,000 of them die. Doctors routinely encounter patients with infections that do not respond to available treatment, and when new drugs come to market, bacteria quickly develop resistance. To ensure that the supply of new antibiotics keeps pace with these evolving pathogens, it is necessary to have a robust pipeline of new drugs and innovative pathways to get this medicine to the patients who need it the mostMore info