QT Issues in Drug Development the evolving science, practical issues, and regulatory implications

Date(s) And Time(s):
Apr 11 2007 8:00AM - Apr 13 2007 5:00PM

Location:
Washington Marriott Hotel
1221 22nd Street NW
Washington, DC 20037-1294

Download the conference program
http://www.biopharmnet.com/doc/DIA_FDA_QT_Symposium2007.doc

Interest Area(s):
Clinical Research and Development, RA/Policy/Drug or Device Approval/GRP, Non-clinical Safety&Efficacy/Toxicology, Clinical Safety/Pharmacovigilance, Clinical Laboratory Data, Devices

Overview:
Co-sponsored by FDA
Heart Rhythm Society

Call for Abstracts and First Announcement

This program will bring together a faculty of regulatory, industry, and scientific leaders in the field to explore and discuss the evolving science surrounding drug development and cardiac repolarization. The meeting will focus on the current state of the art, new directions that can meaningfully impact the development of pharmaceutical agents, and practical challenges and possible solutions. 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
• special session on the science and clinical ramifications of QT shortening

There will be ample time for audience discussion, participation, and interaction with faculty.

Suggested Abstract Topics
The following areas are solicited for oral abstract presentation.

Evolving Science of QT Assessment
• The use of preclinical data to predict clinical QT effects – experience from well defined data bases
• QT measurement methodology
• Automatic QT measurement compared to manual or semi-automatic approaches
• Studies examining non-pharmacologic active controls
• QT concentration-effect modeling
• QA/QC issues in QT measurement
• Statistical issues to analyzing QT data
• Isolated heart rate effects on QTc assessment

Clinical assessment of proarrhythmia risk:
• Post-marketing assessment of proarrhythmia risk
• Epidemiologic approaches to measuring proarrhythmia risk
• Advanced techniques to assess postmarketing proarrhythmia risk
• Assessment of the background incidence of non-drug induced torsade de pointes
• QT assessment in patients
• New ECG methodologies/markers for assessing proarrhythmia risk

In lieu of the standard 300 word abstract, 4-5 draft PowerPoint slides of the key points and supporting data should be sent by email to Rachel.Villareal@diahome.org by February 15, 2007 in order to be considered for presentation. All presenters will be listed in the final program.

Learning Objectives:
• Discuss how preclinical data can be used to assist in internal clinical decision making
• Describe the practical challenges in assessing QT prolongation in specific situations
• Learn the preclinical mechanisms and clinical ramifications of QT Interval Shortening
• Identify the statistical approaches to QT assessment
• Explain the regulatory implications of the ICH E4 Guidance
• Describe the Critical Pathway and Cardiac Safety Consortium efforts

Target Audience:
This program will benefit the following individuals:
• Academic scientists
• Industry management
• Clinical project physicians
• Quality assurance directors
• Preclinical/discovery scientists
• Managers dealing with electrocardiographic safety data
• ECG lab and equipment vendors
• Regulatory specialists
• Operational personnel responsible for safety assessment

Event Code:
07009

Contact Information:
For further information, contact
Rachel Villareal, Program Developer
Phone +1.215.442.6131
Fax +1.215.293.5904
Rachel.Villareal@diahome.org