Would you take a drug that could kill you? Understanding benefit-risk assessment in pharmaceutical products | Calling all cross-sector research collaborators | PCORI-funded project to use data-sharing program to study Phelan-McDermid syndrome
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July 22, 2014
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NCATS collaboration yields potential treatment for sickle cell disease
A collaborative model created by the NIH's National Center for Advancing Translational Sciences under its Therapeutics for Rare and Neglected Diseases program has brought a possible treatment for sickle cell disease from the "valley of death" into development. NCATS and TRND worked with AesRx on development and early clinical testing of Aes-103, an experimental, small-molecule, oral drug for sickle cell disease, reducing the financial risk for AesRx to develop the treatment. Early success allowed the company and its drug to be acquired by Baxter International, which will continue to develop Aes-103. PharmExec.com/PharmExecBlog (7/17)
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News from FasterCures
Would you take a drug that could kill you? Understanding benefit-risk assessment in pharmaceutical products
Register now for a FasterCures webinar on Tuesday, July 29, at 1 p.m. Eastern, to learn about how benefit-risk drives decision-making and emerging efforts to factor patients' preferences into these assessments. Speakers include Patricia Furlong of Parent Project Muscular Dystrophy, Bennett Levitan of Johnson & Johnson, Robert Meyer of the Virginia Center for Translational and Regulatory Sciences, and Kim McCleary of FasterCures. Register now.
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Calling all cross-sector research collaborators
Are you a part of a cross-sector research collaboration or consortium working to speed up and improve the medical research system or the process of getting new therapies to patients? If so, consider applying for an Innovator Presentation slot at this year's Partnering for Cures. The deadline to apply is Aug. 22. Find out more.
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Science and Technology
PCORI-funded project to use data-sharing program to study Phelan-McDermid syndrome
The TranSmart Foundation announced that the Phelan-McDermid Syndrome Foundation and the Harvard Medical School's Center of Biomedical Informatics will use its cTAKES data-sharing and data-analysis system in a research project that will expand insights on Phelan-McDermid syndrome. The project, which is being funded by the Patient-Centered Outcomes Research Institute, will leverage the platform's i2b2 features to consolidate patient data from EHRs and the Phelan-McDermid Syndrome International Registry and advance knowledge about the condition that can affect the development of the brain. GenomeWeb Daily News (free registration) (7/21)
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National Pancreas Foundation to electronically collect data on pancreatic diseases
A national patient registry is being developed by the National Pancreas Foundation with software vendor Remedy Informatics to collect data contributed by physicians and patients related to all pancreatic diseases. The database will analyze data using Remedy's Mosaic Platform, which can be easily modified as research needs change. Health Data Management (7/18)
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U.K. academia gains access to pharma's abandoned compounds
U.K. Business Secretary Vince Cable announced a partnership between seven major drugmakers and the Medical Research Council, which shows the strengthening ties between external scientists and the industry. Researchers will have access to a range of abandoned experimental drugs, which have been dropped from development but may still be useful for other conditions. The drugmakers are UCB, Takeda, Pfizer, Eli Lilly, Johnson & Johnson, GlaxoSmithKline and AstraZeneca. Reuters (7/21)
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Finance and Economics
Broad Institute gets $650M donation for psychiatric research
The Stanley Family Foundation recently donated $650 million to the Broad Institute for psychiatric research, just as the largest analysis to-date on the genetics of schizophrenia was published in the journal Nature. When Jonathan Stanley, now 48, developed bipolar disorder at 19, his father Ted created the foundation to support psychiatric research. The Broad Institute participates in a research consortium that pools data for research that resulted in the Nature study. The New York Times (tiered subscription model) (7/22)
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Foundation awards $4.7M for prostate cancer test development
The Movember Foundation has awarded $4.7 million to a team of Canadian scientists to support the development of molecular diagnostic tests that could be used to guide the treatment of prostate cancer. Specifically, the team will design an assay that could pinpoint men who are at risk for aggressive prostate cancer and formulate customized treatments for early cancers. GenomeWeb Daily News (free registration) (7/17)
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Clemson medical research program wins $11M grant from NIH
The National Institutes of Health has awarded an $11 million grant to Clemson University for its study of regenerative medicine. "The high-impact medical technology they are developing could lead to therapies and cures that help patients around the world," said College of Engineering and Science Dean Anand Gramopadhye. The Greenville News (S.C.) (tiered subscription model) (7/16)
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Maine scientists receive $839,000 to study cancer
Seven researchers in Maine will receive a total of $839,000 from the Maine Cancer Foundation to study the origins and possible cures for various forms of cancer. Studies will examine lung, brain, kidney and breast cancer as well as leukemia and will involve the Jackson Laboratory, the Maine Medical Center Research Institute and the University of Maine. The News & Observer (Raleigh, N.C.)/The Associated Press (7/19)
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Policy and Regulation
FDA creates educational program to spur medtech development
The FDA has developed a program to educate students and entrepreneurs about the agency's process for evaluating medical devices. The National Medical Device Curriculum will initially include learning tools in four areas, including medtech regulatory pathways as well as risk management and safety-assurance planning. The program is a step forward in the FDA's initiatives to foster the development of advanced medical devices, drugs and biologics, writes Francis Kalush, a senior adviser at the FDA Center for Devices and Radiological Health. MassDevice.com (Boston)/MassDevice blog (7/18)
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Society and Ethics
U.K.'s Cameron signals renewed focus on life sciences
U.K. Prime Minister David Cameron has named George Freeman to a new position in an effort to provide stronger oversight over the life sciences sector. The U.K. has sought to encourage greater investment in health care and medicine through tax changes, but wants to ensure that acquiring companies honor their promises. British firms have become a target for a number of U.S. drug companies seeking lower corporate taxes. Financial Times (tiered subscription model) (7/16)
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