Cardiocore

Cardiocore CEO and VP, Medical Operations to Present at Central Labs West

vpalacios — Mon, 01 Feb 2010 18:06:30 +0000

Cardiocore CEO and VP, Medical Operations to Present at Central Labs West

vpalacios — Mon, 01 Feb 2010 18:01:49 +0000

Core Lab Leaders Discuss Current and Future Trends in Cardiac Testing


Washington, DC and San Francisco, CA— Cardiocore, a premier centralized cardiac testing lab, announced today that its Chief Executive Officer, Jennifer Cotteleer and Vice President of Medical Operations, Polina Voloshko, MD, will present at Central Labs West on February 4-5, 2010. This conference will be hosted in San Francisco, California, where Cardiocore maintains a full-service core lab location supporting the local biotech community. On Thursday, February 4th at 4:00pm (PST), Ms. Cotteleer will lead a roundtable discussion of biotech and pharmaceutical representatives sharing best practices in outsourcing and operations for cardiac and other imaging modalities. All interested conference attendees are invited to participate in this interactive session. The following morning, at 11:00am (PST), Ms. Cotteleer will present Cardiac Safety Industry Trends. Applying her vast experience in cardiac studies and clinical data management, she will help attending conference delegates and speakers envision the future shape of cardiac testing in clinical trials. Additionally, on Thursday, February 4th at 2:45pm, Dr. Voloshko will present Cardiac Safety Evaluation for Oncology Compounds. This session will examine the benefits of both electrocardiographic (ECG) and echocardiographic (ECHO) biomarkers. It will feature a case study demonstrating how a large pharmaceutical company used echocardiography to successfully identify reversible drug-induced cardiomyopathy in cancer patients. More details about this key industry conference may be accessed through Cardiocore’s web site at http://www.cardiocore.com/news/events.

About Cardiocore: Cardiocore has provided superior centralized cardiac testing services to the pharmaceutical industry for 16 years. Services include centralized electrocardiography (ECG), Holter, echocardiography (ECHO), multigated acquisition scans (MUGA), and consulting services such as protocol development, scientific reporting and statistical analyses. The company is experienced in the design and the implementation of cardiac safety and efficacy testing in Phase I-IV and Thorough QT clinical trials. These services are supported by the company’s advanced data management system featuring the proprietary HolterGateway™ and CardioPortal™. Cardiocore’s U.S. headquarters is located in Bethesda, Maryland, its West Coast office is located in San Francisco, California, and its European subsidiary, Cardiocore Limited, is located in London, England. www.cardiocore.com

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Cardiocore CMO to Chair the 2010 CBI Cardiac Safety Assessment Summit

vpalacios — Mon, 04 Jan 2010 15:12:48 +0000

Cardiocore CMO to Chair the 2010 CBI Cardiac Safety Assessment Summit

vpalacios — Mon, 04 Jan 2010 15:07:41 +0000


Washington, DC— Cardiocore, a premier centralized cardiac testing lab, announced today that its chief medical officer, Lawrence Satin, MD, FACC, will co-chair the 4th Annual CBI Cardiac Safety Assessment Summit on January 12-13, 2009 in Washington, DC. Dr. Satin, one of the world’s leading research cardiologists and a pioneer in cardiac safety testing for clinical trials, will co-chair the conference with Daniel Bloomfield, MD, a senior scientific leader in cardiovascular research for Merck. Both Dr. Satin and Dr. Bloomfield are founding members of the Cardiac Safety Research Consortium, an organization of key regulatory and biopharmaceutical research constituents who apply the principals of the FDA’s Critical Path Initiative to optimize cardiac safety evaluation in drug development. At the summit, Dr. Satin will present Cardiac Safety Strategies in Early Clinical Development. This session will review the benefits continuous electrocardiographic analyses (Holter monitoring) within first-in-human, and ascending dose studies. Details about this important scientific conference may be accessed through Cardiocore’s web site at http://www.cardiocore.com/news/events.

About Cardiocore: Cardiocore has provided superior centralized cardiac testing services to the pharmaceutical industry for 16 years. Services include centralized electrocardiography (ECG), Holter, echocardiography (ECHO), multigated acquisition scans (MUGA), and consulting services such as protocol development, scientific reporting and statistical analyses. The company is experienced in the design and the implementation of cardiac safety and efficacy testing in Phase I-IV and Thorough QT clinical trials. These services are supported by the company’s advanced data management system featuring the proprietary HolterGateway™ and CardioPortal™. Cardiocore’s U.S. headquarters is located in Bethesda, Maryland, its West Coast office is located in San Francisco, California, and its European subsidiary, Cardiocore Limited, is located in London, England. www.cardiocore.com

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Oncology-focused Biotech Selects Cardiocore as Preferred Provider

vpalacios — Fri, 06 Nov 2009 19:33:32 +0000

Oncology-focused Biotech Selects Cardiocore as Preferred Provider

vpalacios — Fri, 06 Nov 2009 19:33:06 +0000

Leading Core Lab to Provide ECG, ECHO and Scientific Consulting Services


Washington, DC— Cardiocore, a premier centralized cardiac testing lab, announced today that it has been selected as a preferred provider by a growing West Coast biotechnology organization with a robust oncology treatment pipeline. During their selection process, this drug developer reviewed the scientific expertise, global logistics capabilities and data management systems of the major cardiac core lab vendors. Key considerations included Cardiocore’s deep experience in the design and conduct of oncology clinical trials, and its broad range of cardiac safety services including electrocardiography (ECG), echocardiography (ECHO) and multigated acquisition scanning (MUGA). To serve this sponsor’s data management needs, Cardiocore will customize all data outputs per the sponsor’s unique specifications, and will deliver data through the CardioPortal™ system. Cardiocore’s advanced web service presents comprehensive cardiac safety reports to the sponsor and investigative sites, in real time. As part of the preferred provider relationship, Cardiocore’s scientific and operational leaders have begun a series of cardiac safety training seminars for the client’s translational medicine and clinical teams. These sessions provide strategic planning, operational and clinical development support across all therapeutic groups in the sponsor organization. Cardiocore Chief Executive Officer, Jennifer Cotteleer said, “We are proud to earn this preferred provider award from another leading biotechnology organization.” She added, “We appreciate this client’s interest in expertise and innovation, and we look forward to many years of providing them the best quality scientific consulting, global cardiac testing services and customized data management.”

About Cardiocore: Cardiocore has provided superior centralized cardiac testing services to the pharmaceutical industry for 16 years. Services include centralized electrocardiography (ECG), Holter, echocardiography (ECHO), multigated acquisition scans (MUGA), and consulting services such as protocol development, scientific reporting and statistical analyses. The company is experienced in the design and the implementation of cardiac safety and efficacy testing in Phase I-IV and Thorough QT clinical trials. These services are supported by the company’s advanced data management system featuring the proprietary HolterGateway™ and CardioPortal™. Cardiocore’s U.S. headquarters is located in Bethesda, Maryland, its West Coast office is located in San Francisco, California, and its European subsidiary, Cardiocore Limited, is located in London, England. www.cardiocore.com

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Cardiocore’s Thorough QT Performance Factors in FDA’s Approval of Livalo

vpalacios — Tue, 03 Nov 2009 20:53:38 +0000

Cardiocore’s Thorough QT Performance Factors in FDA’s Approval of Livalo

vpalacios — Tue, 03 Nov 2009 20:51:58 +0000

Cardiac Safety Profile Established in First Statin Thorough QT Study

Washington, DC— Cardiocore, a premier centralized cardiac testing lab, announced today that a Thorough QT study it performed for Kowa Pharmaceuticals contributed to the Japan-based drug developer’s successful regulatory approval of pitavastatin which will be marketed under the name LIVALO®.

In a joint presentation by Cardiocore and Kowa scientists, the Thorough QT (TQT) results for LIVALO were initially introduced at the quadrennial World Conference on Clinical Pharmacology and Therapeutics, held in 2008. The Food and Drug Administration (FDA) announced the drug’s approval for treatment of hypercholesterolemia on August 3, 2009.

LIVALO is the first statin to seek marketing approval after publication of the FDA/ICH Guidance for Industry, E14: Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. As a result, it is also first statin to undergo Thorough QT testing. The TQT results were negative, and no signals of cardiotoxicity appeared in other trials of LIVALO.

Using the TQT data analyzed by Cardiocore, Kowa’s clinical development team provided regulators a clean and thorough cardiac safety profile that factored into the approval of LIVALO. According to the FDA’s announcement, “LIVALO was approved on the basis of five clinical trials comparing its efficacy and safety to that of three currently marketed statins.”

Kowa Chief Medical Officer, Roger Morgan, MD, FACS said, “This Thorough QT study is part of a successful, collaborative partnership we enjoy with Cardiocore. As we achieve this important milestone, I’d like to thank Cardiocore for their valuable contributions along the way.”

Cardiocore Chief Medical Officer, Lawrence Satin, MD, FACC added, “We are delighted by the approval of LIVALO, and proud to have supported Kowa in this endeavor. Most importantly, we are glad that clinicians will now have another means to mitigate the risks of heart disease and stroke associated with elevated cholesterol.”

About Cardiocore: Cardiocore has provided superior centralized cardiac testing services to the pharmaceutical industry for 16 years. Services include centralized electrocardiography (ECG), Holter, echocardiography (ECHO), multigated acquisition scans (MUGA), and consulting services such as protocol development, scientific reporting and statistical analyses. The company is experienced in the design and the implementation of cardiac safety and efficacy testing in Phase I-IV and Thorough QT clinical trials. These services are supported by the company’s advanced data management system featuring the proprietary HolterGateway™ and CardioPortal™. Cardiocore’s U.S. headquarters is located in Bethesda, Maryland, its West Coast office is located in San Francisco, California, and its European subsidiary, Cardiocore Limited, is located in London, England. www.cardiocore.com

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Cardiocore CMO to Present at the 2009 CSRC Annual Meeting

vpalacios — Tue, 27 Oct 2009 20:57:45 +0000

Cardiocore CMO to Present at the 2009 CSRC Annual Meeting

vpalacios — Tue, 27 Oct 2009 20:47:14 +0000

Washington, DC— Cardiocore, a premier centralized cardiac testing lab, announced today that its Chief Medical Officer, Lawrence Satin, MD, FACC, will present at the Cardiac Safety Research Consortium (CSRC) Annual Meeting on October 29-30, 2009 in Bethesda, MD.

Dr. Satin will moderate a discussion entitled Cardiac Safety in Medical Product Development in Pediatrics, and will be a contributing panelist on the topic of Late Phase & Post-marketing Assessment of Cardiac Safety. He is the sole cardiac core lab scientist included on the agenda, along with seven FDA officials and other industry leaders.

Cardiocore was a founding member of the Cardiac Safety Research Consortium whose mission is to advance scientific knowledge on cardiac safety for medical products by building a collaborative environment based on the FDA’s Critical Path Initiative principles. Other CSRC founding members include pharmaceutical organizations such as AstraZeneca, Daiichi-Sankyo, Eli Lilly, GSK, J&J, Pfizer, Merck, and Roche.

Details about this Cardiac Safety Research Consortium meeting may be accessed through Cardiocore’s web site at http://www.cardiocore.com/news/events.

About Cardiocore: Cardiocore has provided superior centralized cardiac testing services to the pharmaceutical industry for 16 years. Services include centralized electrocardiography (ECG), Holter, echocardiography (ECHO), multigated acquisition scans (MUGA), and consulting services such as protocol development, scientific reporting and statistical analyses. The company is experienced in the design and the implementation of cardiac safety and efficacy testing in Phase I-IV and Thorough QT clinical trials. These services are supported by the company’s advanced data management system featuring the proprietary HolterGateway™ and CardioPortal™. Cardiocore’s U.S. headquarters is located in Bethesda, Maryland, its West Coast office is located in San Francisco, California, and its European subsidiary, Cardiocore Limited, is located in London, England. www.cardiocore.com

Download as a PDF file.