Since starting my drug development journey as quality assurance manager in a laboratory that would later become part of Covance to now serving as the CEO, I’ve witnessed our industry’s notable shift to support more nimble drug development. From improved trial design to companion diagnostics and more predictive insights fueled by advanced informatics, it’s exciting to see bold ideas enable smarter decisions and speed the introduction of groundbreaking therapies.
Progress is evident in many areas—starting at early phases through market access—but one factor remains constant throughout the years: our hard-working employees continue to advance innovation. They are the reason we can deliver unique perspectives that shape new solutions and carry out the vision of a healthier future. Continue reading
The Importance of Clinical Research Associate Training to Support Effective Trials
The clinical trial landscape is witnessing an increase in Phase III trials that average more than 3,500 patients. As more of these large trials continue to emerge, many contract research organizations (CROs) and sponsors are struggling to recruit qualified clinical research associates (CRAs) to support the influx of work.
Lack of experienced talent represents one of the main challenges facing the market, impacting sponsors and CROs alike with increased costs and extended timelines. Yet the urgent need for qualified CRAs will continue given that the demand in the field is projected to grow by 36.4% from 2012 to 2022 in the US, an issue also reflected worldwide.
Incorporating technologies such as biomarkers into the development of inflammation therapies can improve the development and delivery of the right therapy, at the right dose, to the right patient. Nonetheless, there are numerous risk factors inherent in inflammation studies and drug development overall. It’s crucial to identify these risks early on in your development plan and develop mitigation strategies that will help decrease your chances for failure. Continue reading
As the biopharmaceutical industry increasingly turns its focus to discovering and delivering targeted, personalized medications, the companion diagnostics field is rapidly advancing. By 2015, the worldwide companion diagnostics market will be worth $3.45 billion, according to London-based market research firm Visiongain. The involvement of central laboratories in the companion diagnostics space is also growing, as they increasingly play a role as partners with, and facilitators between, biopharma and diagnostic companies. Continue reading
In recent years there has been renewed interest in the Dried Blood Spot technique for determining drug levels in blood samples. The advantages it offers – including less blood per sample, easier logistics due to longer shelf life, non-hazardous samples, storage at ambient temperature, and reduced costs – are helping Dried Blood Spot gain momentum as a popular alternative to the traditional plasma/serum blood sampling technique.
Although Dried Blood Spot has been in existence for almost 50 years, it had not been widely utilized within the drug discovery and development process due to limitations of the method. In the past, analytical technologies were not sensitive enough to obtain reliable, quantitative data from such tiny blood samples. However, recent advancements – mainly ultra-high performance liquid chromatography and mass spectrometry (LC-MS/MS) – have overcome this limitation, enabling Dried Blood Spot to not only screen for the presence or absence of a particular molecule, but also to quantitatively determine the extent to which a molecule is present. Continue reading
Landmark study links overall clinical trial investigator satisfaction with sponsors’ choice of Central Laboratory.
Recruiting productive and experienced clinical trial investigators is a critical component of the drug development process. In fact, as sponsors face growing pressure from contracting study timelines, increasingly “experienced” patient populations, and competition for top-performing investigators, the value and importance of the investigator to the sponsor will only continue to grow.
That being said, sponsors could greatly benefit from a better understanding of what drives investigator satisfaction and an intimate understanding of the pressing issues these individuals face.