Register for Dec. 2 webinar on university-foundation relations | View videos and summaries from Partnering for Cures | How IT is powering precision medicine
November 24, 2015
FasterCures SmartBrief
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FDA committees to consider Duchenne MD drug candidates
An FDA advisory panel is considering whether to recommend approval of two drugs to treat Duchenne muscular dystrophy, a condition caused by a gene mutation that affects young boys. Both drug candidates are based on exon skipping technology, which restores the faulty gene's ability to produce dystrophin. The Washington Post (tiered subscription model) (11/21)
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News from FasterCures
Register for Dec. 2 webinar on university-foundation relations
Academic research institutions and patient foundations have long been important partners in the effort to advance science and innovation, and the relationship has evolved. While this evolution has the potential to create more productive partnerships, it has also created new challenges. Shifting priorities and a move toward more outcomes-driven philanthropy have prompted a re-examination of the traditional partnership model. Over the past year, FasterCures has been working with a variety of stakeholders to identify and implement strategies for strengthening these relationships. Tune in to this webinar to hear from leaders in the field about the concrete steps foundations and universities can take to foster more efficient, fruitful collaborations, and learn how to craft agreements that best serve the needs and interests of all parties. This free webinar is part of FasterCures' webinar series designed to spotlight innovative approaches to disease research. Learn more.
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View videos and summaries from Partnering for Cures
Cori Lathan
Catch up on the discussions from this month's Partnering for Cures meeting, including "Breaking Down Information Silos," "Redefining Discovery for the 21st Century" and "Gimme My %^&* Data." And be sure to take 20 minutes to view a Time=Lives Talk, which featured inspiring stories from Deb Lappin on resiliency, Ben Schwartz on creativity and Cori Lathan on purpose. View the sessions.
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Science and Technology
How IT is powering precision medicine
Information technology advancements such as mobile devices, cloud platforms, faster computers and Big Data analytics are propelling medical knowledge forward. The Precision Medicine Initiative Cohort Program will merge health record and genomic data to better understand risk and treatment of disease, NCI-Match seeks to provide new treatment options for cancer by looking at the molecular makeup of tumors to determine the appropriate course of treatment, and the Wisdom Study is looking at better ways to detect breast cancer. InformationWeek (11/12)
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AstraZeneca and Sanofi will exchange thousands of compounds
Sanofi and AstraZeneca announced they will exchange 210,000 compounds to help speed drug discovery. The unusual arrangement, which could take several years to yield drug candidates, involves no payments. Reuters (11/20), PharmaTimes (U.K.) (11/20)
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Family history may be unreliable predictor of pediatric cancer, study finds
Hereditary genetic mutations were found in 8.5% of pediatric cancers studied, but only 40% of the children with the mutations had a family history of cancer, researchers working on the Pediatric Cancer Genome Project reported in the New England Journal of Medicine. Mutations could be inherited from a parent who has not developed cancer or could develop spontaneously shortly after conception, the researchers said. The findings suggest that both normal and tumor tissue be sequenced in children with cancer, senior author James Downing said. The Wall Street Journal (tiered subscription model) (11/18)
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Finance and Economics
Crucial projects often struggle to get funding
New funding mechanisms are flourishing, but some observers say important areas of innovation -- including research into Alzheimer's and infectious diseases -- are being overlooked. "The best ideas don't always get financed," said Ramana Nanda of Harvard Business School. MIT Technology Review online (11/23)
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Donation surprises charity
Seattle businessman Donald Sirkin left the bulk of his estate -- $125 million -- to LightHouse for the Blind and Visually Impaired, despite never having contacted the charity or previously donating to it. National Public Radio/KQED (11/23)
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UK creates $1.5 billion fund for malaria prevention
The UK is establishing a $1.5 billion initiative with the goal of eliminating malaria and other infectious diseases. About $174 million will be allocated for the discovery of novel drugs, diagnostics and insecticides to prevent infectious diseases such as malaria and tuberculosis, while about $285 million will be provided to support the improvements of biodefense and rapid response systems for epidemics. The Bill & Melinda Gates Foundation will work with the UK government to administer the Ross Fund, which is named after 1902 Nobel Prize winner Sir Ronald Ross, who discovered that mosquitoes transmit malaria. BBC (11/22)
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Policy and Regulation
Researchers urge FDA to close loopholes in orphan drug policy
Some drugmakers are skirting the intent of the Orphan Drug Act and should not receive incentives for products with strong economic potential or that could treat more than 200,000 patients, researchers at Johns Hopkins University wrote in the American Journal of Clinical Oncology. Suggested reforms include increased scrutiny of approval submissions, a tiered incentive system, shortened exclusivity periods after benchmark profits are attained and more transparent pricing. Regulatory Focus (11/20)
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Society and Ethics
NIH phases out chimp research program
The NIH is winding down its chimpanzee research program, with its remaining animals being moved to sanctuaries and no new funding for invasive research involving chimps. The agency retired many of its chimps two years ago but has kept a small population for certain research of high public health importance, and observers warn eliminating that resource could have serious implications. However, NIH Director Francis Collins said invasive research on chimpanzees is no longer considered essential. Nature (free content) (11/18), The New York Times (free-article access for SmartBrief readers) (11/19)
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Bristol-Myers enters generic hepatitis C drug manufacturing agreement
Bristol-Myers Squibb signed an agreement with United Nations-backed organization Medicines Patent Pool for the commercialization of generic Daklinza, or daclatasvir, in 112 low- and middle-income countries. The deal gives other drug developers permission to develop generic versions of the hepatitis C drug on the condition that it will be marketed in the targeted countries. Reuters (11/23), Seeking Alpha (free registration) (11/23)
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On the FastTrack
NCATS seeks input on strategic plan
The National Center for Advancing Translational Sciences is creating a five-year plan to set goals and priorities. Stakeholders are invited to provide input. The deadline is Jan. 8.
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Editor's Note
FasterCures SmartBrief will not publish Thursday
In observance of the Thanksgiving holiday in the US, FasterCures SmartBrief will not publish Thursday, Nov. 26. Publication will resume Tuesday, Dec. 1.
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FasterCures is an action tank that works across sectors and diseases to improve the effectiveness and efficiency of the medical research enterprise. FasterCures, a center of the Milken Institute, is nonpartisan and independent of interest groups.
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