Author Archives: Guest Blogger

Risking It All? Risk-Based Monitoring at Cancer Research UK

“Only those who risk going too far can possibly find out how far they can go,” said T.S. Elliot. Cancer Research UK (CRUK) followed this advice when it decided to have its Center for Drug Development (CDD) adopt a risk-based monitoring (RBM) approach across its entire portfolio of clinical trials. This decision has revealed how risk-adjusted approaches […]
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The Year of Living Openly: Europe and Transparency 2015

The past year has brought significant changes not only in regulatory mandates and guidances but also regarding a broader overall emphasis on coordination of information and processes. The regulators have prioritized transparency and harmonization for some time but underscored them to an even greater degree in 2014; 2015 is likely to see the trend intensify.
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‘Warehousing’ and the Future of HCV Treatment

The battle against hepatitis C (HCV) is a relatively new, and highly dynamic, one.  The viral disease was only discovered in the 1980’s and, according to WHO estimates, some 3% of the world’s population are now infected with HCV and there are more than 170 million chronic carriers. So what does the HCV treatment landscape look […]
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Tufts Figures on Drug Development Spark Debate

By Agnes Shanley, Pharmaceutical Technology. The Tufts University Center for the Study of Drug Development (CSDD) released its latest research on the costs and timeframes required for launching a new drug. Although the study acknowledges that it still takes about 10 years to launch a new brand-name pharmaceutical, this year, the costs required were estimated at $2.6 […]
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FDA "Stymies Competition in Drug Industry", Says PCMA

By Randi Hernandez. The Pharmaceutical Care Management Association (PCMA), an organization that represents the nation’s leading pharmacy benefit managers (PBMs), which administer prescription drug plans for over 210 million Americans, released a new white paper investigating FDA’s influence on drug prices and competition in the pharmaceutical marketplace. The PCMA argues that competition within branded drugs […]
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