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CTTI: Use of Central IRBs in Multi-Center Trials to Streamline Clinical Research

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Multi-center clinical trials can provide high-quality, statistically-sound evidence to answer medical questions. Earlier this year, the Clinical Trials Transformation Initiative (CTTI) launched a new tool and provided recommendations to improve the efficiency and quality of multi-center clinical trials. Typically, each participating center submits the study protocol to its institutional review board (IRB). Thus in a multi-center trial, the same protocol is submitted to as many IRBs as there are sites. The process of multiple reviews Read More >

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E&Y Study: 3 Tax Tweaks that Could Spur Job Growth

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A new report from Ernst & Young illustrates the economic impact of three tax proposals intended to help small businesses spur innovative research and development. The report indicates that the three tax revisions, if enacted together, could drive up research and development investments by more than $20 billion and create an estimated 623,000 new jobs at new and small firms. The report outlines the potential impact of the three proposals, which include: The R&D partnership Read More >

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New PhRMA Report: Nearly 300 Vaccines Currently in Development

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Today, the Pharmaceutical Research and Manufacturers of America released a report, Medicines in Development: Vaccines – A Report on the Prevention and Treatment of Disease Through Vaccines. The report shows that U.S. biopharma companies are currently developing 271 vaccines to prevent and treat numerous conditions, including infectious diseases and various forms of cancer and neurological disorders. Vaccines have successfully prevented devastating infectious diseases such as smallpox, measles and polio. According to data from the Centers Read More >

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Prosensa’s IPO and the Value of the BIO Investor Forum

Hans Schikan

Prosensa (NASDAQ: RNA) is a Dutch biotechnology company engaged in the discovery and development of RNA-modulating therapeutics for the treatment of genetic disorders. Our primary focus is on rare neuromuscular and neurodegenerative disorders with a large unmet medical need, including Duchenne muscular dystrophy, myotonic dystrophy and Huntington’s disease. We completed an IPO onto NASDAQ in June of this year. Prior to last year’s BIO Investor Forum in San Francisco, we were still in the very Read More >

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NCATS R&D Day Aimed At Linking Investors to Preclinical Drug Development Projects

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On behalf of the National Center for Advancing Translational Sciences (NCATS), I invite BIO stakeholders to join us for our inaugural “Research & Development Day” September 12 in Cambridge, Mass. Novartis Institutes for Biomedical Research will host the event at which researchers will showcase therapeutic candidates for indications such as sickle cell disease, hereditary inclusion body myopathy, Duchenne muscular dystrophy and cryptococcal meningitis to potential partners. To register and view the agenda, visit https://events-support.com/events/NCATS_RandD_Day. The Read More >

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