Download the Presentations from the 2009 THEW meeting sponsored by the FDA

April 29th, 2009 - FDA Headquater, Silver Spring , MD

The second THEW meeting was a success with participants from pharmaceutical companies, CROs and ECG equipment companies. Held at the FDA headquarter (White Oak Campus) in Silver Spring (MD, this THEW meeting was a great opportunity to meet with regulators and discuss current issues related to cardiac safety. You can download the presentations from the 2009 THEW Meeting by clikcing the links below:

Author (organization)	Slides
Dr. Christine Garnett (Silver Spring, CDER, FDA)	CSRC White Paper: QT/QTc evaluation for drugs with autonomic effects
Dr. Mark Haigney (Uniform Services University Health, MD):	QT variability and drug safety
Dr. Marek Malik (London University, UK):	QT measurements and heart rate corrections
Dr. Richard Verrier (Harvard University, MA)	T-wave alternans and Drug Safety
Dr. Wojciech Zareba (University of Rochester, NY):	Repolarization Morphology and Cardiac Safety
Dr. Fabio Badilini (AMPS, NY, USA)	Optimized ECG extractions in clinical trials
Dr. Anthony Fossa (iCardiac Technologies, NY, USA)	Prospective Evaluation of advanced ECG/Holter markers to differentially assess the QT Interval with drugs that affect autonomic state vs. impair repolarization
Dr. Adel Nada (Abbott, IL, USA)	Thew Initiative: A valuable resource to large pharmaceutical company in managing cardiac safety in clinical development
Dr. Jeremy Rice (IBM, NY, USA)	Combination in vitro and in silico methodology for risk assessment of Long QT type 1 patients
Dr. Larry Satin (Cardiocore, MD, USA)	The Value of Holter Arrhythmia Analysis in Thorough QT Trials
Dr. JP Couderc (THEW)	2009 THEW Update

About the THEW: On January 15th, 2009, the THEW was open and fully operational : ECG signals and their associated clinical information can be accessed from our server hosted at the University of Rochester Medical Center, NY. The Warehouse has received several databases from which millions of 12-lead standard ECG recordings and hundreds of Holter recordings can be downloaded. This data has been shared by pharmaceutical companies and research organization from all over the world.

The current list of dataset available in the warehouse is growing rapidely and we are updating the list of studies periodically .. More....

To learn more about the tool to access the data from the warehouse, you can request for a demo. version of the THEW Client Application which provides access to a database containing a couple of Holter ECGs. More...

The THEW members are entitled to: (1) a license to the THEW Client Application (CA), software for review and extraction of Holter and standard 12-lead ECG signals and their associated clinical information, (2) a username and password to access to a database including 24-hour Holter recordings from 206 healthy individuals (and associated clinical characteristics), (3) an access to the THEW Translational Research Group, a group gathering the THEW partners in order to develop collaborative projects between the FDA, the THEW and other public and private stakeholders.

The Executive Committee (EC) of the Telemetric and Holter ECG Warehouse (THEW) has been formed during the second quarter 2008, the seven individuals in the EC are from the Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, the Commissioner Office of the Food and Drug Administration (FDA) and the University of Rochester Medical Center, More…

The Telemetric and Holter ECG Warehouse (THEW) project was started the 15th of March 2008. The THEW website was created to provide information about our mission, infrastructure, partners, and the development of this project. More ...