DIA, FDA and The C-Path Institute to Sponsor Workshop on Community-acquired Pneumonia

Drug Information Association

The Drug Information Association (DIA), FDA and The C-Path Institute will sponsor Conference on Issues in Design and Analysis of Trials in Community-acquired Pneumonia (CAP) from November 16-17 at the University of Arizona in Tucson.

The workshop will feature an interactive discussion about the major obstacles in developing therapies for CAP. It will also highlight the Critical Path Initiative that can address these limitations. The Critical Path Initiative is supported by The C-Path Institute, a non-profit organization that creates innovative programs in education and research that enable the safe acceleration of medical product development.

This meeting will include three sessions that will focus on CAP. The first session will define the importance of studies in CAP and will include the views of the clinician, a large pharmaceutical company and a biotechnology company. The second will focus on considerations of current methodologies including clinical, radiological and microbiological diagnosis, trial designs for drug development and the importance of defining the etiologic agent for drug development. The third session will consider innovative approaches to CAP drug evaluation, such as: current technologies for detecting biomarkers, clinical trials in CAP, adaptive design in clinical trials and patient reported outcomes in clinical trials.

Participants of this workshop will be able to define the major hurdles to improving clinical development of therapies for CAP, and compare and evaluate CAP diagnostic methodology for enrollment of patients in clinical trials. They will also be capable of assessing and utilizing various study designs to accelerate clinical development of therapies to treat CAP.

The program will be most beneficial for academic, government and industry professionals. Clinical researchers (especially those involved in designing clinical trials for new drugs), drug development decision-makers and project managers, biostatisticians and scientists who specialize in biomarkers, imaging, devices or microbial signatures are encouraged to attend.

For more information, contact Jessica.Kusma@diahome.org or register online at http://www.diahome.org/docs/events/events_search_detail.cfm?EventID=05021. To download the brochure, visit http://www.diahome.org/content/events/05021.pdf.

HORSHAM, Pa. October X, 2005

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