Tag Archives: clinical trials

Stretching Your Dollar: Methods and Tools for Increasing the Productivity of Clinical Trials


Recent Tufts data show clinical trials typically take nearly twice as long to complete enrollment as predicted at launch and 48% of trial sites miss enrollment targets.  Delays in trials shrink the returns from patent exclusivity and increase R&D costs.  New methods such as adaptive and batch trial designs, as well as explosive growth in digital tools, such as Apple’s ResearchKit, have transformed the trial design choices available.  These innovations, and others, provide new levers Read More >

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Coalition Offers a Remedy for Stagnated Clinical Trials


Promising new clinical trial data offers fresh hope for the families of Alzheimer’s patients.  A new medication seems to be slowing the disease’s progress, limiting the cognitive decline that characterizes this “long goodbye.” Wouldn’t it be wonderful for patients suffering other diseases to have equally encouraging prospects? But many do not. Part of the problem lies with clinical trials.  For a new medication to receive FDA approval, it must undergo comprehensive testing on actual patients.  Read More >

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New Target for Alzheimer’s Disease


Biotechnologists have developed a drug candidate that blocks production of diseasecausing neurotoxins in mouse models Reducing the concentration of cathepsin B using an enzyme inhibitor prevents the creation of the neurotoxic peptide, pyroglutamate-AB (pGlu-AB), which has been linked to the development of Alzheimer’s disease (AD). The candidate inhibitor drug, a cysteine protease inhibitor named E64d, was developed by scientists from the University of California, San Diego School of Medicine, the Medical University of South Carolina and Read More >

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Syringes for Clinical Trials


Today’s pharmaceutical and biotechnology companies are under pressure to remain competitive. To do so, they require innovative approaches to manage drug development, particularly early development work. Any competitive advantage in the development process is highly prized – and one approach is to begin the development of the compound in a prefilled syringe earlier in the process, rather than later. Traditionally, biopharmaceutical companies have almost exclusively used vials in drug development. There are good reasons for Read More >

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New Type of Prospective Survey Initiative

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Our industry is on the cutting-edge of science aimed at developing new therapies for devastating and life-threatening diseases. To help advance innovation and promote the development of the next generation of treatments and cures, we must acknowledge that the scientific method does not operate in a vacuum. Robust, interactive FDA-Sponsor communication is a key element of modern drug development. However, in order to improve the drug development enterprise and the FDA review process further, the Read More >

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