According to a series of articles published this month in PLOS Medicine, data sharing in medical research could soon become the norm. The papers represent authors from the World Health Organization, the pharmaceutical corporation GlaxoSmithKline, the US National Library of Medicine and the International Committee of Medical Journal Editors. In an accompanying editorial by the PLOS Medicine editors, recent progress toward acceptance of data sharing, in particular for research related to public health emergencies and for reports from clinical trials, is summarized. The editors also outline remaining challenges, including “the need to ensure that researchers who share data receive appropriate recognition.” They note that “even in morally straightforward cases, data sharing can encounter roadblocks.” This is discussed in a recent Policy Forum by Vasee Moorthy and colleagues at the World Health Organization.1 WHO convened a consultation in September, inviting scientists, medical journal editors, representatives of industry, funding organizations and government. “Specifically, the consultation sought to prevent the kind of delays in data sharing that may have impeded resolution of the 2014-2015 Ebola crisis. Editors attending the consultation — representing BMJ, Nature journals, New England Journal of Medicine and the PLOS journals — were called on to address a concern that data sharing in an emergency could lead to subsequent rejection of research by journals, on the grounds of prior publication.” After considering issues of particular relevance to clinical trials, including topics presented in the Institute of Medicine report of January 2015,5 editors of the 14 International Committee of Medical Journal Editors (ICMJE) member journals have jointly published a proposed plan. If adopted following public comment, the plan will require data sharing for all clinical trials that will be published in the many journals that endorse ICMJE recommendations.6 “The plan would provide a major impetus for sharing data, reminiscent of the 2004 ICMJE requirement for registration of clinical trials.7 Implementation would mean that researchers wishing to publish clinical trials in any of the large number of participating journals, including some of the most influential venues for clinical trial reports, would need to work with their institutional ethics committees to ensure that, going forward, informed consent language permits sharing of deidentified individual participant data (IPD).” Beyond the efforts of journal editors, the editorial points out that medical research funders and industry sponsors also have instituted advances in data sharing. “For example, The Bill & Melinda Gates Foundation launched an open access policy in January 2015 including a requirement that data underlying their grantees’ published research be made accessible and open.8 During a 2-year transition period, this policy has permitted a 12-month embargo, but as of January 2017 immediate sharing will take effect.” Also highlighted is a “progressive data sharing policy” that GlaxoSmithKline (GSK) has implemented for its clinical trials. The policy has been joined by several other companies that now provide access to study data.9 The editors go on to outline substantial challenges to data sharing that still remain to be addressed. These include They go on to state that “not the least among challenges will be ensuring due credit for analyses of shared data, so that groups with greater speed or resources for conducting analyses do not gain unduly in reputation at the expense of researchers who share data that they have dedicated their own resources to obtain. While this theme recurs throughout these recent articles, none proposes a specific answer, perhaps because any viable solution necessarily requires action by the clinical research community as a whole.” They conclude on a positive note that “large and complex organizations and the structures that support them have started changing in order to reduce barriers to data sharing in medical research. The pieces are falling into place with such rapidity that opposing the sharing of data may soon find as little overt support within the research community as opposing the theory of gravity.”
Seeing monoclonal antibodies rank among the top-selling pharmaceuticals, major drug companies are investing in the next generation of engineered antibodies and antibody-drug conjugates (ADCs). In under a week, AbbVie, GlaxoSmithKline (GSK), and Takeda Pharmaceutical signed deals with small technology firms that together could be worth more than $2 billion. AbbVie will pay $40 million up front and up to $645 million in milestone payments to help Argenx develop its . . .
News Article | April 8, 2016
The mood stabilizer Lithium is commonly prescribed to treat depression, but new research indicates that the drug may hold an intriguing anti-aging secret. Publishing in the journal Cell Reports, a study led by researchers from University College London found that low doses of lithium was able to prolong a fruit fly’s lifespan by an average of 16 percent. The team tested different doses of lithium on 160 different flies. High doses had ended up reducing the lifespan of these insects whereas the low doses led to an average 16-18 percent extension. Lithium had also shown benefits as a, “transient and one-off treatment,” according to the announcement. UCL scientists administered the chemical as a one-off near the end of fruit flies’ lives and provided low doses to younger insects for 15 days before switching to a placebo. Both forms of these insects were able to live longer without any adverse events. The key was that the drug simultaneously blocked a molecule called glycogen synthase kinase-3 (GSK-3) and activated another labelled NRF-2. Humans, worms, flies, and other mammals carry this gene as a defense against cellular damage. Essentially, this research shows that GSK-3 could serve as a potential drug target. However, the BBC writes that the way lithium works on the brain is still not fully understood. Still, study leader Professor Linda Partridge of the UCL Institute of Healthy Ageing told the website that the discovery was “encouraging” and they’re looking at targeting GSK-3 in more complex animals. Establish your company as a technology leader! For more than 50 years, the R&D 100 Awards have showcased new products of technological significance. You can join this exclusive community! Learn more.
GlaxoSmithKline has joined with Verily Life Sciences to setup Galvani Bioelectronics, which will focus on treating chronic illnesses by controlling electrical impulses in the body. GSK and Verily, the former Google Life Sciences business, will initially invest up to $718 million over seven years to support R&D at Galvani. Having made a concerted push into the bioelectronics area in 2012, GSK will now put its in-house efforts into Galvani for a . . .
News Article | April 7, 2016
Fruit flies live 16 percent longer than average when given low doses of the mood stabilizer lithium, according to a study. How lithium stabilizes mood is poorly understood but when the scientists investigated how it prolongs the lives of flies, they discovered a new drug target that could slow aging -- a molecule called glycogen synthase kinase-3 (GSK-3).