Biomedical Engineering Reference
In-Depth Information
8 Summary of the Challenge of Antibiofilm Drug
Development
In summary, the challenges facing clinical medicine and the regulatory arena are
related to the comparatively recent scientific recognition of the role that biofilms
play in the majority of human infections and the urgent need to facilitate methods
for the development of antibacterials to address these ubiquitous microbial phe-
nomena. The challenges are primarily associated with the antimicrobial regulatory
approval process and insufficient financial incentives offered to pharmaceutical
developers. These substantial barriers to entry have been recognized by govern-
ments around the world and initial steps are being taken to both streamline the
development of antimicrobial drugs and to improve the financial incentives asso-
ciated with new antimicrobial development.
As a result of the expanding global crises relating to antimicrobial resistance and
chronic infectious diseases, there is now an extremely urgent need to rapidly
develop new drugs that have antibiofilm capabilities. To this end biofilm drug
developers must develop standardized protocols for evaluation of biofilm activity,
as well as rapid, effective biofilm diagnostic technologies. It is also imperative that
regulatory agencies exercise maximum flexibility in approving these innovative
new drugs. As was done in the early development of drugs to treat AIDS, regulatory
agencies need to encourage the development of new drugs targeting microbial
biofilms in recognition of the role the biofilms play in the majority of infectious
diseases. It is time for the biofilm research and product development communities
to make our voices heard, to connect the dots between antibiotic-resistant infections
and biofilms, and to bring attention to the fact that biofilm strategies may offer one
of the most timely and critically important answers to the global, expanding
infectious disease crisis.
References
ASTM International (2011) Standardization news. http://www.astm.org/standardization-news/
update/biofilm-ja11.html
Bjarnsholt T (2013) The role of bacterial biofilms in chronic infections. APMIS 121:1-58. doi: 10.
1111/apm.12099
CDC (2007 revised) HIV/AIDS surveillance report, cases of HIV infection and AIDS in the United
States and dependent areas, 2005. http://www.cdc.gov/hiv/pdf/statistics_2005_HIV_Surveil
lance_Report_vol_17.pdf . Accessed 29 Oct 2013
CDC (2013) Antibiotic resistance threats in the United States, 2013. http://www.cdc.gov/
drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf . Accessed 28 Oct 2013
Chan DM (2012) Antimicrobial resistance in the European Union and the world. In: Keynote
address at the conference on Combating antimicrobial resistance: time for action, Copenhagen,
Denmark, 14 March 2012
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