Resolving the Paradox between Unmet Medical Need and Commercial Incentive
Author: Leslie A. Pray, PhD
The current crisis in antibiotic R&D is attributed to an industry pipeline with few late-stage candidates capable of combating the emergence and spread of novel, drug-resistant bacterial strains. This new report offers in-depth analysis of:
- Factors driving the field forward and opportunities for large and small pharma
- The key scientific challenges to antibiotic drug discovery
- The economic and regulatory realities of antibiotic R&D
- The broad range of antibacterial approaches being taken across the industry
- Select compounds in clinical development
Many experts consider the emergence and spread of antibiotic resistance to be a paramount public health threat of the 21st century. While most resistant microbes continue to emerge in the hospital setting, more resistance is being found outside of the hospital environment. Nonetheless, only 2 new classes of antibiotics have reached the market over the past 30 years. This report explores the interrelated factors leading to the current crisis.
The rapid emergence and spread of resistance is a challenge shared by no other type of drug—one that companies must consider from both a scientific and economic standpoint. The need for more regulatory clarity regarding drug approval standards is another great challenge that many antibiotic companies currently face, as is examined in this report.
Antibiotic R&D: Resolving the Paradox between Unmet Medical Need and Commercial Incentive explores the lucrative potential of antibiotic commercialization, despite the popular conception that antibiotic R&D is too great an economic risk to become involved in. As is described, dealing with the economic realities of antibiotic development and commercialization will require a shift away from the blockbuster model toward niche-market products.
From a scientific standpoint, combating resistance will require the discovery and development of new antibiotics with novel potential to inhibit bacterial growth, reproduction, and resistance. This report features some of the more promising late-stage products with novel mechanisms of action. Scientists and industry leaders are taking as many different approaches as there are companies. Among those described in this report:
- Entirely different antibacterial approaches, such as phage enzyme therapy and innate defense regulation
- Looking to the natural world for more complex bioactive molecules that would be less likely to induce resistance than small-molecule inhibitors
- Combinations of antibacterial/antibiotic agents
Antibiotic R&D: Resolving the Paradox between Unmet Medical Need and Commercial Incentive includes interviews with experts from companies engaged in both early and late-stage antibiotic R&D, including companies that have a marketed product. Additionally, it provides an analysis of results from a recent survey relating to the research, development, and commercialization of antibacterial agents.
About the Author:Leslie A. Pray, PhD, biologist and author, has written extensively on a range of biotech and pharmaceutical industry, public health policy, genetic and epigenetic, infectious disease, and higher education issues for The National Academy of Sciences, the American Association for the Advancement of Science, the American Chemical Society, the Immune Disease Institute,The Scientist, The Chronicle of Higher Education, and others. She also wrote Epigenetics: Technologies, Applications, and the Commercial Landscape, a previous Insight Pharma Report. She received her doctorate in population genetics from the University of Vermont. An elected member of Sigma Xi, she has been the recipient of numerous scientific research awards.