Innovations In Clinical Neuroscience

Hot Topics in Drug Development Apr 2016

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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Click * at the end of each synopsis to access the full article online. SETTING THE RECORD STRAIGHT ON INNOVATION AND DRUG DEVELOPMENT In this concisely written BiotechNow opinion piece, the author describes the impact that the modern biotechnology industry is now having on drug development, stating "the entrepreneurs, researchers, and investors working in this field have firmly established themselves at the forefront of medical innovation and the search for new cures and therapies for previously untreatable diseases." The author asks the readers not to let the questionable ethics of a few CEOs in the pharmaceutical industry overshadow the commitment the biotechnology industry as a whole has to alleviating human suffering and disease through their innovative medical research. * Read more here: http://www.biotech- now.org/health/2015/10/setting-the- record-straight-on-innovation-and-drug- development. WHERE DO YOU START WHEN DEVELOPING A NEW MEDICINE? A public-private research initiative between GSK, the European Bioinformatics Institute (EMBL-EBI), and the Wellcome Trust Sanger Institute will utilize "big data" and genome sequencing to improve the success rate for discovering new medicines. In this article from Drug Discovery Today, the author describes the new Centre for Therapeutic Target Validation (CTTV) initiative and how it aims, through collaboration, to address a wide range of human diseases, which includes sharing its data openly in the interests of accelerating drug discovery. * Read more here: http://www.drugdiscoverytoday.com/view/ 37649/where-do-you-start-when- developing-a-new-medicine/ THE FDA DRUG APPROVAL PROCESS SIMPLY EXPLAINED If you are new to the drug development process, terminology such as "Phase 2 clinical trials" or "filing of an IND application"can be quite confusing. In this article posted on Nanalyze.com, the authors define specific phases that a new drug needs to go through in order to receive approval to be marketed and sold to consumers. * Read more here: http://www.nanalyze.com/2014/09/the-fda- drug-approval-process-simply-explained/ HOW DRUGS ARE DEVELOPED AND APPROVED Straight from the horse's mouth, so to speak. In this article, the FDA provides an overview of the process of drug discovery, development, and approval, from their perspective, using a case example. Their site provides some other articles on the drug approval process you might find informative. * Read more here: http://www.fda.gov/Drugs/DevelopmentAp provalProcess/HowDrugsareDevelopedand Approved/ THE FDA'S DRUG REVIEW PROCESS: ENSURING DRUGS ARE SAFE AND EFFECTIVE Here, the FDA presents a nice little overview of the stages of drug development and review. They even jazzed it up a bit with some graphics. * Read more here: http://www.fda.gov/Drugs/ResourcesForYo u/Consumers/ucm143534.htm CLSA REPORT: TRACKING FDA DRUG REVIEW PERFORMANCE The FDA has an important and difficult job: Ensuring timely and efficient drug review processes while maintaining rigorous scientific and safety standards. Overall, agency performance has improved markedly, a reflection of the work by FDA leadership, industry, Congress and other stakeholders. Still, there are wide variations across therapeutic areas. * Read more here: http://califesciences.org/2016FDADrugRep ort/?utm_content=bufferd4cbe&utm_medi um=social&utm_source=twitter.com&utm _campaign=buffer Hot Topics in Drug Development [April 2016] 5 Sorted and summarized for you. Current Trends and Future Predictions in Drug Development

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