Showing posts with label Drug Development. Show all posts
Showing posts with label Drug Development. Show all posts

Top-Five Global Pharmaceutical Company Names NewCardio as its Provider of Automated Thorough QT Solution

SANTA CLARA, Calif., - NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiac diagnostic and services company, today announced that a top-five pharmaceutical company has named NewCardio's QTinno(TM) software suite, NewCardio's first commercial product, as the technology that will be used in all of its fully automated Thorough QT (TQT) studies.

The pharmaceutical company evaluated several automated cardiac safety solutions before choosing QTinno(TM) as its automated solution moving forward. As part of this evaluation, a blinded TQT dataset was provided for processing by the automated solutions. The automated results were then un-blinded by the pharmaceutical company and compared to the original core lab results. The pharmaceutical company determined that NewCardio's solution demonstrated the highest consistency and lowest variability in relation to the original core lab results. After reviewing NewCardio's underlying platform technology, the pharmaceutical company determined that QTinno(TM) was the solution it will utilize to begin replacing the semi-automated methodology currently utilized by its preferred ECG core labs. At recent industry conferences, a number of pharmaceutical companies have expressed a strong desire to transition to fully automated methods in an effort to reduce human error, minimize intrinsic variability and increase efficiency.

Going forward, all TQT study requests for proposals (RFPs) issued by the pharmaceutical company that will require a fully automated component will require the use of NewCardio's QTinno(TM) by its preferred ECG core labs. It is anticipated that this pharmaceutical company will conduct its first clinical trial using fully automated readings by the end of the year and will increasingly utilize fully automated results in its TQT studies.

"NewCardio is excited to work with a major pharmaceutical company and we believe this is the clearest signal yet of the impending transition to fully automated cardiac testing in drug development as sponsors look for ways to improve quality while simultaneously reducing expenses," said Vincent Renz, NewCardio's President and Chief Operating Officer. "This global pharmaceutical leader is an early adopter, and this announcement demonstrates their commitment to quality, safety and the use of new technologies to drive innovation."

NewCardio's innovative 3D ECG platform technology dramatically improves the accuracy and significantly increases the diagnostic value of the standard 12-lead electrocardiogram (ECG). NewCardio's lead product is QTinno(TM), a software suite that provides an automated, comprehensive analysis of QT intervals and other ECG-based cardiac safety for the pharmaceutical industry and drug regulators. The Company believes that its QTinno(TM), software-based, analytical technology is the industry's first solution for the reliable automated analysis of ECGs used to determine cardiac toxicity during drug development.

Heath-Care Providers Pledge to Help Cut Health Costs

WASHINGTON -- Health-care providers said they would help cut up to $1.7 trillion in health costs over the next decade by improving care for chronic diseases, streamlining administrative tasks and reducing unnecessary care.

Proposals by the major industry groups on Monday offer the first detailed glimpse into how hospitals, doctors, pharmaceutical companies, health insurers, medical-device makers and a big labor union plan to make good on the cost-cutting promise they made to President Barack Obama last month. The groups have pledged to help reduce the annual growth rate of health-care spending by 1.5 percentage points over 10 years. The savings are key to helping fund the Obama administration's ambitious plan to fix the nation's broken health system and provide health insurance coverage for every American.

There are big hurdles to achieving the proposed cost savings. Many of the changes couldn't be enacted unless Congress passes legislation that would allow for increased government oversight of the nation's health system. Other changes would require years of testing before they could be expanded widely enough to achieve meaningful savings.

"To bend the cost curve, you really have to change the whole system in a substantial way," said David Nexon, senior executive vice president at the Advanced Medical Technology Association, which represents medical-device makers. "That's not an easy exercise to go through."

Under the groups' proposals, certain types of care could see cutbacks, potentially sparking concerns among consumers. For example, the American Medical Association, which represents doctors, is proposing to "reduce unnecessary utilization" in areas including Caesarean sections, back-pain management, antibiotic prescriptions for sinusitis and diagnostic imaging tests.

The groups involved include the Advanced Medical Technology Association, America's Health Insurance Plans, the American Hospital Association, the American Medical Association, the Pharmaceutical Research and Manufacturers of America and the Service Employees International Union.

These groups estimate that, over a decade, improving chronic care management would save between $350 billion and $850 billion; administrative streamlining would save $500 billion to $700 billion; and improving the "utilization" of care would save $150 billion to $180 billion. Their proposals include pledges to try and reduce medical errors, switch to common insurance forms, improve measurements of physician performance, reduce the number of patients readmitted to hospitals, improve the efficiency of drug development and expand in-home care for patients with long-term illnesses.

Some of the proposed changes could help improve companies' revenues. Pharmaceutical Research and Manufacturers of America, a prescription drug lobbying group, cites "poor adherence to needed medicine" as a factor that drives up medical costs. Its proposal to the Obama administration noted that improving such adherence could save "tens of billions of dollars in the health-care system."

Some lawmakers expressed wariness on Monday about the cost-savings pledged. "I'm skeptical that these proposals will add up to anywhere near $2 trillion," Iowa Sen. Chuck Grassley, a top Republican involved in crafting the health legislation, said in a statement.

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