Category Archives: R&D

Latest Developments in Alzheimer’s R&D

With drug-development efforts in Alzheimer’s disease continuing to produce underwhelming results—as clinicians have long battled the inherent diagnosis and translational research challenges associated with the disorder—it’s no secret that there is increased clinical focus now on the prevention and early detection of Alzheimer’s. Those were two areas of emphasis at the recent Alzheimer’s Association International […]
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NIH Begins Human Safety Study of Ebola Candidate Vaccine

Initial human testing on a vaccine to prevent Ebola virus co-developed by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and GlaxoSmithKline (GSK) has begun. The study is the first of several Phase 1 clinical trials that will examine the investigational NIAID/GSK Ebola vaccine and an experimental […]
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Major Changes to EU Clinical Trials Regulation

Earlier this year, the newly approved EU Clinical Trials regulation (No 536/2014) was published in the Official Journal of the EU (OJEU).  The European Commission (EC) estimates that all the changes could save researchers €800 million (over $1 billion) a year. It replaces the existing EU Clinical Trials Directive (2001/20/EC), which was intended to simplify […]
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mHealth Set to Transform Clinical Trials

The health sciences industry received some important and encouraging news from the US Food and Drug Administration (FDA) in late June—an announcement that may, ultimately, help to transform the way data is collected in clinical trials and lead to safer studies and faster time to market. The FDA issued new draft guidance that stated its […]
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The Future of Oncology is Now

Applied Clinical Trials’ Lisa Henderson speaks to Novella Clinical CEO Richard Staub. Last August, Quintiles announced its intention to purchase Novella Clinical, specifically for its focus on small and mid-sized oncology biopharma clients, as well as medical device and diagnostics companies. We checked in with Novella President Richard Staub to discuss post-acquisition life, outsourcing, and […]
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