Agreement between the Food and Drug Administration and the THEW
FDA and University of Rochester signed a collaborative agreement.
Visit the FDA website for Public Private Partnerships (PPP)
May 27th 2008, Dr. Janet Woodcock (Director of the Center for Drug Evaluation and Research, FDA) and Dr. Norman Stockbridge (Acting Director of the Division of Cardiovascular and Renal Products, CDER FDA) signed a Letter of Agreement with University of Rochester (UR) for the Telemetric and Holter ECG Warehouse Initiative. This 3-year agreement is accompanied by a fully executed confidentiality disclosure agreement.
This UR-FDA partnership aims at promoting cross-fertilization of scientific knowledge, resources and ideas that will advance the field of quantitative electrocardiography, the THEW will strive to:
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Develop specific projects to implement and to grow the repository of ECG information in the THEW;
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Facilitate scientific projects toward the development, testing and validation of ECG-related technologies and platforms;
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Leverage expertise and resources toward the implementation of collaborative projects among FDA, UR, and other public and private stakeholders;
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Identify, develop and evaluate new electrocardiographic markers of cardiovascular risk related to management of patient care and evaluation of new molecular entities;
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As appropriate, incorporate scientific findings from the THEW into the premarket evaluation process for electrocardiographic devices and associated methodologies, and into the total product life cycle.
The U.S. Food and Drug Administration is interested in the development of improved technologies to evaluate drug safety and efficacy. This interest has been officially expressed in the Critical Path Initiative which is the Agency’s attempt "to stimulate and facilitate a national effort to modernize the scientific process through which a potential human drug, biological product, or medical device is transformed from a discovery or a "proof of concept" into a medical product”. In the field of drug safety, one approach is to assess the cardiac safety of a new compound by investigating its delaying effect on the QT interval from the surface electrocardiogram (ECG). Today drug-induced QT prolongation is used as a surrogate marker of drug cardiotoxicity, yet the scientific community has strongly questioned its validity and there is a consensus on the need for novel technologies that would improve the current safety guidelines.
[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...