Category Archives: R&D

Doctors, Data, and Drug Development

It is estimated that applying big data strategies could potentially generate up to $100 billion in value annually across the US healthcare systems, specifically by optimizing innovation and improving the efficiency of research and clinical trials. With the advent of global CROs entering into the capital intensive sector of healthcare reimbursements, supporting pharmaceutical and biotech […]
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Ebola Crisis Could Spur Broader R&D Efforts

Up until a few months ago, there was little industry interest or public support for developing vaccines and treatments to combat the Ebola virus. Now the rush is on to launch clinical trials of therapies with some potential effectiveness against the disease. The situation has also encouraged FDA and regulatory authorities to facilitate these efforts […]
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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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