SPEAKER FOR THIS EVENT:
- Joel Morganroth, M.D., F.A.C.C., Chairman, Chief Scientist, eResearchTechnology, Inc.

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Recent years have seen a dramatic increase in focus on cardiac safety in new drug development. ICH E14 guidance was finalized in May 2005. An important component of the guidance is the requirement of the Thorough QT Trial (TQT) in the development of new drug candidates. eResearchTechnology, Inc. (eRT) has provided ECG Core Laboratory functions in support of approximately 90 TQTs since this concept was first introduced in writing in November 2002 in the FDA-Health Canada Points to Consider document. This significant experience provides insight into the evolutionary changes in TQT design, statistical analyses, power requirements, ECG measurement methods, and baseline treatments. The presentation will detail what has been learned in the first 90 TQTs, which may influence future study design and statistical approaches for such trials.

Dr. Joel Morganroth will provide "up-to-the-minute" insights into the ICH guidance and practical implications for implementation of the TQT. Comprehensive insight into emerging trends in TQT design, conduct and data analysis will be discussed in addition to the provision of an overview of the structure and function of the QTc Interdisciplinary Review Team of the FDA. Dr. Morganroth will also provide along with regulatory and business implications for later phase development. In particular, the role of TQT in driving later phase development will be discussed.

Pre-web Cast Questions

1. How does the ICH E14 guidance define which new drugs require a TQT before starting Phase III?
2. What has been learned about study design and analysis of Thorough QTc Trials over the past two years?
3. What technical and logistical requirements are required to conduct successful Thorough QTc Trials?

EVPs, VPs, Directors, Heads, Managers, Principal Scientists of:

• Clinical Pharmacology
• Clinical R&D
• Clinical Operations
• Regulatory Affairs
• Medical Affairs
• Outsourcing Management

eResearchTechnology (eRT) provides technology and services that enable life sciences industries to collect, interpret and distribute cardiac data accurately and efficiently. eRT is a leading provider of centralized electrocardiographic (ECG) services and supports the full-range of studies from single center to multi-center global trials across all therapeutic groups. eRT is an industry leader for Thorough QTc Trials (TQT), having completed significantly more than any other core lab.

EXPeRT® 2, eRT’s market leading analysis platform, provides secure and validated scalable capacity and efficient workflow processing. eRT offers best-practices digital collection, transmission and processing plus paper ECG processing and digital or paper rescue projects. eRT’s SOP-driven, cross-functional Project Assurance methodology encompasses pre-study planning, set-up, monitoring and close-out activities to ensure effective study conduct and drive superior performance metrics. eRT provides data access in a secure web platform plus flexible reporting options including XML waveforms.

eRT’s global experience includes thousands of studies and currently includes 24/7 customer care, logistics and site support to over 17,000 investigation sites. eRT’s cardiologists consult on medical and regulatory issues related to cardiac safety, including protocol design and medical report writing. eRT has formal partnerships across the clinical services spectrum and can facilitate assembly of best-in-class cross-functional solutions. www.ertECG.com

Joel Morganroth, M.D., F.A.C.C., Chairman, Chief Scientist, eResearchTechnology, Inc.

Joel Morganroth, M.D. has an international reputation as a cardiovascular drug development specialist. Dr. Morganroth's experience includes memberships on Data Safety and Monitoring Boards for the National Institutes of Health and the Veterans Administration research programs and several major Pharmaceutical trials. For ten years he was a Medical Review Officer/Expert for the Food and Drug Administration and has also served in a similar capacity for other regulatory agencies in Canada and has been an advisor in Europe. He is a member of major cardiology organizations and has served on the editorial boards of various cardiology journals. He has published over 300 articles and edited nearly two dozen books and is frequently invited to lecture on a variety of cardia c and clinical research regulatory issues at domestic and international meetings.