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
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.