Biomedical Engineering Reference
In-Depth Information
Clinical and Regulatory Development
of Antibiofilm Drugs: The Need,
the Potential, and the Challenges
Brett Baker, Patricia A. McKernan, and Fred Marsik
Abstract
Escalating rates of mortality and morbidity associated with chronic,
recurrent, persistent, and increasingly antibiotic-resistant bacterial infections have
generated an extremely urgent unmet need for new antibiotics, particularly those
with new mechanisms and targets of action. Over 80 % of all infections are
associated with biofilms, a growth condition that not only increases their resistance
to currently available antibiotics but also enhances their capability for evading
many host defenses. Targeting biofilms may therefore be one of the most important
new strategies available for the development of novel antibacterials. In spite of this,
biofilms remain underappreciated as targets by the current global healthcare sys-
tem. Deterrents to their clinical development are primarily associated with the
antimicrobial regulatory approval process and insufficient financial incentives
offered to pharmaceutical developers—issues which are just now becoming recog-
nized by governments and professional health associations around the world. To
facilitate the development of antibiofilm drugs, it is critical that infectious disease
stakeholders engage in an ongoing dialog with regulatory agencies to develop
standardized methods with respect to (a) the rapid, effective diagnostic assessment
of biofilm-related infections and (b) the clinical assessment of antibiofilm drug
efficacy. It is also imperative that regulatory agencies are willing to exercise
maximum flexibility in approving these innovative and much needed new drugs.
B. Baker (
*
) • P.A. McKernan
Microbion Corporation, 1102 West Babcock, Suite B, Bozeman, MT 59715, USA
F. Marsik
Microbiology Consultant, formerly Microbiology Team Leader, FDA, Division of
Antiinfective Products, New Freedom, PA 17349, USA
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