ICPD Invited to Present at FDA Workshop on the Design of Clinical Trials for Antibacterial Drugs for Hospital-Acquired and Ventilator-Associated Pneumonia

Albany, NY, March 5, 2009 – The Institute for Clinical Pharmacodynamics (ICPD) today announced that its director, Dr. Paul G. Ambrose, Pharm.D., FIDSA, has been invited to join other industry experts in presenting at a workshop designed to provide a forum for discussion of key issues in the design, implementation, and analysis of clinical trials to evaluate antimicrobial drugs for the treatment of patients with Hospital-Acquired Pneumonia (HAP) and Ventilator-Associated Pneumonia (VAP). The workshop is co-sponsored by the Infectious Diseases Society of America (IDSA), the American Thoracic Society (ATS), the Society of Critical Care Medicine (SCCM), the American College of Chest Physicians (ACCP), and the U.S. Food and Drug Administration (FDA). The two-day workshop will take place March 31 and April 1, 2009 in Silver Spring, MD.

The occurrence of HAP and VAP has continued to increase in recent years. Both are difficult-to-treat infections with high rates of morbidity and mortality. Those patients who are critically ill and are immunocompromised are at the highest risk, particularly when infected by multidrug-resistant pathogens.

Dr. Ambrose’s presentation will focus on the specific relevance of pharmacologic considerations for HAP/VAP trials. “The challenges surrounding the design and performance of HAP and VAP clinical trials are growing. Pathogens continue to develop more complex resistance patterns,” explains Dr. Ambrose. “The need for our industry to develop new antimicrobial agents is as critical as ever. Patients are depending on us to make safe and effective drugs available. It is our responsibility to develop successful clinical trials so that we can better serve the public.”
Dr. Ambrose’s presentation will address dose selection, key parameters to be evaluated during clinical trials, and strategies to reduce drug resistance.

“ICPD is committed to serving the public’s need in resolving the current drug resistance crisis,” comments Dr. Ambrose. “Workshops of this type are an important component in that goal, as they provide a platform for knowledge leaders in the field to come together, contribute to the discussion, and collaborate with colleagues toward a solution.”

About ICPD

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.com