March 21, 2008 — The Drug Information Association (DIA) will host an educational forum in conjunction with the FDA and the Heart Rhythm Society entitled 'QT and Arrhythmia Issues in Drug Development' from April 7-8, in Bethesda, MD, to focus on the new direction in the development of pharmaceutical agents for cardiac repolarization.
Specific areas of concentration will include:
• QT study design and analyses;
• the use of new methodologies including concentration-effect modeling;
• approaches to QT evaluation in Phase 3 when there is a QT signal;
• QT assessment in patient populations when healthy volunteers cannot be studies;
• QT assessment of biologic compounds;
• regulatory implications; and
• a special session on the science and clinical ramifications of QT shortening.
“The FDA is, of course, keenly interested in safety standards, and their involvement with this workshop means participants will gain first-hand knowledge of regulatory expectations such as how new preclinical or clinical biomarkers can gain regulatory acceptance,” said Program Chair Philip T. Sager, M.D., chief medical officer, CardioDX Inc.
Workshop content will be relevant to a variety of disciplines in drug development, including academic scientists, industry management, clinical project physicians, quality assurance directors, preclinical/discovery scientists, ECG safety data managers, ECG lab and equipment vendors, regulatory specialists and safety assessment personnel.
In addition to the two-day conference, a pre-event tutorial: An Introduction to QT Issues in Drug Development will be offered on April 6. The tutorial will provide attendees with the resources and information necessary to understand relevant concepts in the collection, analysis and interpretation of ECG parameters in their own clinical trials and to learn of the most recent developments in clinical interpretation of QT/QTc prolongation.
For more information: www.diahome.org