|
 |
European Pharmaceutical Contractor
|
| In the face of the sensitive variables that constitute the cardiac safety challenge, promising new technologies may offer important solutions, state Susan Boyle of Spacelabs Healthcare and Sasha Latypova of iCardiac Technologies, Inc
For pharmaceutical companies seeking to improve the productivity of their development pipelines, cardiac safety presents both an obstacle and an opportunity. Most drug developers are familiar with the difficulty of establishing a definitive cardiac safety profile for a compound in development. They may not know, however, that emerging technologies offer a way to significantly reduce uncertainty and curtail the time and cost associated with cardiac safety testing. By providing a solution for what has become a significant hurdle, these new technologies offer the opportunity to accelerate development, reduce false-positive and false-negative results and significantly reduce costs.
THE CARDIAC SAFETY CHALLENGE
That many drugs – whether in development or on the market – have the potential to cause a life-threatening arrhythmia, known as torsades de pointes (TdP), is a significant safety concern. It has been estimated that as many as 86 per cent of all new chemical entities tested in pharmaceutical development may show human ether-a-go-go related gene (hERG) inhibitory activity, and thus have a potential to affect the potassium ion channel (Ikr) and to prolong the heart’s ventricular repolarisation process – the brief period between two heart beats which is known to be a vulnerable point for arrhythmia induction. This prolongation can trigger TdP, which can lead to sudden cardiac death (1). |
Read full article >>
|
|
 |
|
| Rate this article |
You must be a member of the site to make a vote. |
|
Average rating: |
0 |
| | | | | |
|
|
Alexandra (Sasha) Latypova, is Executive Vice President, at iCardiac Technologies, Inc. She is a co-founder of iCardiac Technologies, a branch of the University of Rochester Medical Center, engaged in the development of advanced ECG biomarkers and technologies for drug cardiac safety assessment. Prior to iCardiac Technologies, Sasha headed sales and business development at VirtualScopics, Inc. Before that, she was a Manager in healthcare practice at Analysis Group, Inc, where she advised pharmaceutical clients on a wide range of issues concerning product development, as well as providing economic analyses and expertise in pharmaceutical litigation cases. Sasha holds a Masters of Business Administration degree from the Amos Tuck School at Dartmouth College.
Susan Boyle is Director of Business Development, Spacelabs Healthcare Clinical Trial Services. She has over two decades of experience in operations and business development in the clinical research industry, specialising in centralised cardiovascular diagnostic services in both domestic and international markets. Susan established many of the first programmes at the company’s inception in 1985, and has held a range of operations and business development management positions. She has a degree in Nursing with a strong emphasis on cardiovascular disease. |
|
|
|
|
|
 |
Industry Events |
 |
4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
More info >> |
|
 |
News and Press Releases |
 |
New PFA SonicLine® ultrasonic flowmeters
Flow measurement with ultrasound fast, precise, free from contamination The new PFA SonicLine® ultrasonic flowmeters assure precise measurement and control of chemical consumption and management of chemical stocks with high reliability. SonicLine® is also ideally suited for accurate batch and dosing processes with high reproducibility.
More info >> |
|
 |
