For more: | FasterCures offers a guide to understanding user fee agreements | Hear from industry experts and R&D visionaries at Partnering for Cures
June 22, 2017
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New approach may pry open patient data silos
No single cancer research center has enough data to clearly understand all the genetic mutations and molecular abnormalities underlying cancer, but patient data remains locked away despite various initiatives to share it, write Kathy Giusti and Richard Hamermesh. They co-chair the Harvard Business School Kraft Precision Medicine Accelerator, where researchers are applying the Collective Impact framework to create a collaborative, direct-to-patient approach to precision medicine.
Harvard Business Review online (tiered subscription model) (6/21) 
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News from FasterCures
FasterCures offers a guide to understanding user fee agreements
FasterCures advocates for the timely reauthorization of the US Food and Drug Administration's (FDA) user fee agreements with industry, ensuring that FDA has the resources it needs to execute its important public health mission. These agreements include commitments to advance the science of patient input, while also providing resources to help address the FDA's persistent challenge of recruiting and maintaining a highly qualified workforce to implement those commitments. To dive deeper into the Prescription Drug User Fee Act VI and Medical Device User Fee Amendments IV, read FasterCures' position on each commitment letter.
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Hear from industry experts and R&D visionaries at Partnering for Cures
Why should you register to attend Partnering for Cures? This meeting brings together decision-makers from across diseases who are motivated by the same mission: to reduce the time and cost of getting new therapies from discovery to patients. Don't miss interactive discussions, hands-on problem solving, and meaningful collaborations at Partnering for Cures. The Boston meeting is less than a month away and spots are filling up fast! Register today to attend.
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Science and Technology
EHR-linked image database opens research opportunities
A centralized image warehouse at Mount Sinai Health Systems integrates clinical images with anonymized electronic health records for research. The system will provide opportunities for using integrated data for research, precision medicine and diagnosis in a variety of research areas, including mammography, cancer, neuro-degenerative diseases and genomics.
Health IT Analytics (6/20) 
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Rule-breaking cancers require novel research approaches
Brain cancer is among the most difficult to treat due in part to its complexity and the difficulty of breaching the blood-brain barrier, writes National Brain Tumor Society CEO David Arons, chair of the National Cancer Institute's Council of Research Advocates. Novel approaches, such as that being undertaken by the Defeat GBM Research Collaborative, are needed "to move the field beyond the simplistic tactic of repurposing -- sequencing individuals with glioblastoma and trying to match them to treatments developed for similar mutations in other cancers," Arons writes.
STAT (tiered subscription model) (6/22) 
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Flu vaccine grown in caterpillar cells more effective than egg-grown version
A DNA-based influenza vaccine grown in caterpillar cells was about 30% more effective than standard vaccines grown in chicken eggs, researchers reported in The New England Journal of Medicine, and the researchers say the vaccine can be made quickly and easily. To make the vaccine, one piece of human influenza virus is grafted onto an insect virus and grown in Spodoptera frugiperd cells, producing a less mutated version of antigen than other methods.
NBC News (6/21) 
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Viruses genetically modified to battle antibiotic-resistant bacteria
Viruses that have been genetically modified using the CRISPR-Cas9 gene-editing system have shown promise in defeating antibiotic-resistant bacteria, a presentation at CRISPR 2017 suggests. Several companies are studying bacteriophages and may be ready to start clinical trials next year.
Nature (free content) (6/21) 
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Study suggests Parkinson's disease may be autoimmune disorder
Parkinson's disease could be an autoimmune disorder, which would open up new avenues for treatment, according to findings published in Nature. The study suggests that antigens are displayed by neurons that produce dopamine in Parkinson's patients.
New Scientist (free content) (6/21) 
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Finance and Economics
Texas cancer, heart disease studies awarded total of $2.3M
The Max and Minnie Tomerlin Voelcker Fund has provided the University of Texas Health Science Center at San Antonio a total of over $2.3 million for a number of studies focusing on cancer and heart disease. In addition to five individual researchers who received $450,000 each via Young Investigator Awards, the center received $75,000 to study anticancer drugs.
San Antonio Express-News (tiered subscription model) (6/22) 
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Policy and Regulation
FDA commissioner aims to speed orphan reviews, nix REMS abuse
FDA Commissioner Scott Gottlieb told a Senate panel that he intends to eliminate the backlog of requests for orphan-drug designations within 90 days, set a 90-day review target for new requests and issue guidance for designing adaptive clinical trials, among other goals. Gottlieb also said he wants to set consistent policy for preventing abuse of the risk evaluation and mitigation strategy program.
Regulatory Focus (6/20) 
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Society and Ethics
Studying diseases in dogs could lead to faster cures for them and us
Studying diseases in dogs could lead to faster cures for them and us
Dogs develop cancers that are remarkably similar to human cancers; are susceptible to arthritis, diabetes, obesity and other conditions; have a similar microbiome as people and share the same living space, writes FasterCures Senior Fellow Bernard Munos. He suggests starting canine research initiatives similar to the NIH's All of Us study, and organizations and academic universities are beginning to do just that.
Forbes (6/19) 
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Preprint licensing divides researchers
Some researchers allow papers posted online before peer review to be freely redistributed and reused, and others set licensing terms that limit reuse and redistribution, which also limits the public good of posting preprints, says ASAPBio director Jessica Polka. ASAPBio has set up a task force that includes researchers, legal experts, funding agency officials and publishers to explore attitudes about preprint licensing.
Nature (free content) (6/16) 
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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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