THEW NewsLetter and Expert Opinions:
The purpose of this THEW electronic Newsletter is to keep you inform about the recent developments and the various opportunities that may be of interest to your organization.
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| Release date | Issue | Title |
|---|---|---|
| 08/09/2008 | 1 |
University of Rochester and FDA signed a collaborative agreement. |
| 09/02/2008 | 2 |
The THEW Executive Committee is formed. |
| 01/05/2009 | 3 |
Opening of the THEW: The Telemetric and Holter ECG Warehouse is up and running. |
| 05/19/2009 | 4 |
Alliance between the Telemetric and Holter ECG Warehouse (THEW) and the NYSTAR High Performance Computing Consortium (HPC2) |
| 09/18/2009 | 5 |
THEW announces NHLBI award |
| New HTML format for the Newsletter | ||
| 01/05/2010 | 6 |
THEW celebrates its first anniversary |
| 02/15/2010 | 7 |
Cardiac Safety and "torsade(s) de pointes" |
| 05/24/2010 | 8 |
Thorough Holter QT studies, LQTS database and NHLBI Cooperation |
| 05/24/2010 | 9 |
QT/QTc evaluation for drugs with autonomic effects |
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EXPERT OPINIONS
Contributions from international experts to our electronic newsletter can be found in the following table:
| Release Date | Expert Opinions |
|---|---|
| 02/05/2010 | ICH E14 Update by Borje Darpo, MD, PhD |
| 02/15/2010 | Hospital providers should be aware of rare, life-threatening heart rhythm by B. Drew RN, PhD,FAH |
| 06/15/2010 | The dynamic beat-to-beat method by Dr. A. Fossa, PhD |
| 06/30/2010 | Holter bin Analysis by Dr. F. Badilini, PhD |
[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.
NHLBI Support[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...
Agreement[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...