Abstract
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.
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