THEW Events
January 16th, 2008 -1st Telemetric and Holter ECG Warehouse Event Location: FDA Campus, Springfield, MD The first meeting related to the THEW project was a successful event with 44 registrants from for-profit and not-for-profit organizations. The meeting included a presentation of the THEW project and a session for scientific presentations during which various companies such as Mortara Instrument, GE-Health Care and others presented the latest technologies for analysis of the QT interval from Holter and continuous ECG signals. Download the documentation and presentations:
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The Telemetric and
Holter Warehouse Project - JP Couderc (URMC)
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Interest of Using Holter Technologies in Cardiac Safety Studies
Continuous
12-lead ECG Recording in Clinical Trials - Justin Mortara (Mortara
Instrument)
Holter Technology
in Drug Safety: A Technical Point of View - Fabio Badilini (AMPS
LLC)
Advantages of 12-lead
Holter Technology in TQT Studies - Marek Malik (on behalf of GE
Health Care Inc.)
ECG Restitution
of the Beat-to-beat QT-TQ Intervals in Humans -Anthony Fossa (Pfizer
Inc.)
Holter-Based Methods
for Improved Cardiac Safety Assessment - Mikael Totterman (iCardiac
Technologies Inc.)
CSRC: Involvement and Update - P. Kligfield
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[12/16/2009]: The Director of the THEW interviewed by Technology Review published by the MIT: here.
[11/11/2009]: New Research Center to Focus on Cardiac Safety and Innovation in Pharmaceutical Industry Today: here.
[6/11/2009]: University of of Rochester and FDA Partner for ECG Database, Drug Discovery & Development Magazine. More info here
[5/6/2009] FDA website Existing Partnerships FDA’s Public-Private Partnership Program: THEW
[03/28/2009] Public and Private part- nership to help determine Clinical Biomarker Utility in Applied Clinical Trials online.com.>here
[7/26/2010] Members: Angel Medical System Inc. has joined the THEW initiative. Angel Medical Systems develops and markets cardiac devices that provide heart monitoring, alerting, and data collection. Their AngelMed Guardian system is an iimplantable cardiac monitoring and alerting system that is designed to warn cardiac patients of potentially life-threatening heart conditions.
[7/12/2010] The THEW quoted in a recent issue of the Journal of the American College of Cardiology. In a reply to a correspondence from Dr. Verrier and Nieminen on the role of T-wave alternans in hospital monitoring for torsades de pointes, Dr. Drew quoted the THEW as " a less expensive (than prospective clinical trials) and immediate available research strategy ... to validate ECG monitoring algorithms." JACC Vol. 56, No 3., 23010, 238-42.
[1/13/2010] Members: The Oxford University Computing Laboratory is the first new member for year 2010. At the heart of computing and related interdisciplinary activity at Oxford, this centre focuses on research in computer science, numerical analysis, computational biology, quantum computation, computational linguistics, and information systems. The Computational Biology Group also plays a key role in interdisciplinary initiatives across the University, including the EU FP7 projects euHeart and PreDiCT.
[05/27/2008]: "THEW Beyond QT working Group" releases an ECG marker submission form designed in collaboration with the FDA.
[12/13/2009]:The University of Rochester and the NHLBI enabled the creation of a "Center for Quantitative Electrocardiography and Cardiac Safety" (CES). Read more...
[05/27/2008] FDA: Dr. J. Woodcock (Director, CDER-FDA) and Dr. Norman Stockbridge (Director for the Division of Cardiovascular and Renal Products, CDER-FDA) signed a Letter of Agreement officially starting the partnership between the FDA and University of Rochester for the THEW initiative. More...