ICPD Announces Initiative to Address US Food and Drug Administration Challenge Regarding Trial Design for Community-Acquired Respiratory Tract Infections

Albany, New York, 3 March 2008 – The Institute for Clinical Pharmacodynamics (ICPD) today announced the launch of an initiative to answer the challenge of identifying the treatment effect of antimicrobial agents used to treat community-acquired respiratory tract infections. The novel approach, which was presented on 18 January 2008 by Dr. Paul G. Ambrose at an Infectious Disease Society of America (IDSA) co-sponsored public workshop with the Food and Drug Administration (FDA), will involve applying pharmacokinetic-pharmacodynamic (PK-PD) analysis to existing clinical trial databases to determine treatment effect and calculate non-inferiority margins for future clinical trials.

According to Dr. Ambrose, Director of ICPD, “the data presented provided clear evidence of a drug benefit in patients with community-acquired respiratory tract infections, including pneumonia”. Dr. Glenn Tillotson, Executive Director of Scientific Affairs, Replidyne Inc. added “the use of PK-PD analyses could provide a paradigm for determining the magnitude of treatment effect without resorting to alternative study designs, such as placebo-controlled studies, or those utilizing suboptimal doses of comparator regimen”.

However, Dr. Ambrose added “ICPD cannot accomplish this alone. It will take a collaborative effort to gather clinical trial data and obtain funding but the benefit will be profound for the drug development of these agents in the future”.

ICPD is actively looking to collaborate with pharmaceutical and biotechnology companies with appropriate data, as well as those companies and individuals interested in providing funding support for this novel and important initiative to drug development and public health.

About ICPD, Ordway Research Institute

The ICPD serves as a center for translational science collaboration to the world. We help pharmaceutical and biotechnology companies develop more effective and safer drugs through advanced methods of pharmacokinetic and pharmacodynamic system analysis. Our general contact information is as follows:

Telephone: (518) 429-2600
Info-ICPD@OrdwayResearch.org