FasterCures responds to senators' Innovation report | PCORI announces $64M in new grants for comparative studies | Prizes could spur antibiotic development and save money
 
February 26, 2015
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NIH funds basket study of cancer genes
Memorial Sloan Kettering Cancer Center is among the institutions participating in a federally funded national program to sequence cancer tumor genes in thousands of cancer patients to identify mutations that will respond to new drugs. The studies have no control groups, are not randomized and are smaller than typical studies; participants are difficult to identify; and the effects must be significant and unmistakable to show they are not due to chance. The National Cancer Institute's Match study is considered a "a basket of basket studies," in which tumor samples from at least 3,000 patients will be sent to central labs for analysis, and patients with certain mutations can enroll in clinical studies. The New York Times (tiered subscription model) (2/25)
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News from FasterCures
FasterCures responds to senators' Innovation report
FasterCures has submitted comments to the Senate Health, Education, Labor and Pensions Committee about its recently released report, "Innovation for Healthier Americans: Identifying Opportunities for Meaningful Reform to Our Nation's Medical Product Discovery and Development." Our comments focus on three areas in which we believe more tightly coordinated action could lead to substantial improvements in the biomedical ecosystem:
  1. Transitioning the FDA's traditional model of patient engagement with designated patient representatives to an evidence-based model that can effectively integrate the whole patient experience -- including unmet medical needs, risk tolerance and outcome preferences -- into regulatory decision-making.
  2. Applying learnings from FasterCures' analysis of nearly 400 consortia through our "Consortia-pedia" program to enhance the many important public-private partnerships in which federal agencies, particularly the Food and Drug Admistration (FDA) and the National Institutes of Health (NIH), are involved to increase their effectiveness and output.
  3. Strengthening mechanisms to foster inter-agency collaboration between the NIH and the FDA in developing regulatory science tools, such as biomarkers and clinical outcome assessments, with the appropriate regulatory standards from the earliest stage of research.
Read the full comments.
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Science and Technology
PCORI announces $64M in new grants for comparative studies
The Patient-Centered Outcomes Research Institute announced funding for five studies, including a comparison of individualized screening models for breast cancer, transitional and at-home care for stroke patients, and surveillance for patients with small growths in their lungs. The studies will be conducted in real-world settings, and the goal is to engage payers and other stakeholders in the research design and implementation, PCORI executive director Dr. Joe Selby said. Modern Healthcare (tiered subscription model) (2/24), Health IT Analytics (2/26)
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Finance and Economics
Prizes could spur antibiotic development and save money
At least 2 million people are infected each year with a bacteria for which there is no effective antibiotic -- 23,000 of whom die -- and the cost to the health care system is up to $20 billion, according to CDC data. The high cost of drug development discourages many drugmakers from trying to develop new antibiotics, leaving the task to small biotech companies, writes Ezekiel Emanuel, vice provost at the University of Pennsylvania. Developed nations could band together to offer prizes to companies or academic institutions that develop new, approved antibiotics, Emanuel suggests. The New York Times (tiered subscription model)/Opinion (2/24)
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BIO report: Funding dwindles for new drugs to treat common diseases
Venture capital is plentiful for orphan diseases and rare ailments, while funding for novel treatments designed for more prevalent diseases is falling short. And according to a new report from the Biotechnology Industry Organization, in 2013, the number of first-time Series A rounds was almost a third lower than the 2006 peak. American City Business Journals/Biotech SF blog/San Francisco (2/25)
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Parkinson's disease drug developer gets $20M funding boost
A recent equity funding round pulled in $20 million for Cambridge, Mass.-based biotech firm Lysosomal Therapeutics to move its Parkinson's disease drug into clinical trials and expand its biology platform. Investors include the venture arms of Sanofi-Genzyme, Roche Holding and Eli Lilly and Co., as well as Atlas Venture, Hatteras Venture Partners, Partners Innovation Fund and several angel investors. American City Business Journals/Boston/Health Care Inc. blog (2/23)
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NYC struggles to build a biotech startup community
New York City has had a hard time becoming a major center for biotech innovation, despite having nine of the nation's top medical centers. But the movement toward virtualization in life sciences and government support for affordable wet lab space could give the city's biotech sector a lift. Fast Company online (2/24)
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NIH backs development of microbial molecular Dx test
The NIH has given a $5 million grant to Accelerate Diagnostics and Denver Health Medical Center to fund the development of a blood test for identifying common bacteria and antibiotic resistance in fewer than three hours. The study will make use of Accelerate's ID/AST system, which combines fast phenotypic susceptibility and rapid genomic identification. GenomeWeb Daily News (free registration) (2/23)
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Policy and Regulation
Review of suspended virology studies moving forward
The NIH is quietly moving forward on a review of research practices on a series of government-funded virology studies that were deemed so risky the government suspended them. The NIH is expected to contract Gryphon Scientific to conduct a risk-benefit analysis of the studies, but some scientists say the review is being rushed. The review is the result of research begun in 2011 that made a flu virus spread more easily plus several accidents that occurred at federal research labs last year. ScienceMag.org (2/25)
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Society and Ethics
Poll: 78% of Americans support mandatory immunizations
Data from a Reuters/Ipsos survey showed 78% of respondents agreed that all children should receive mandatory immunizations unless the vaccines pose adverse health risks. Data also show 71% of those surveyed support school suspensions for unvaccinated children during a disease outbreak. Reuters (2/24)
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Merck permits low-cost sale of pediatric HIV drug in poor countries
Merck signed a licensing agreement with the Medicines Patent Pool allowing the low-cost sale of its pediatric HIV drug raltegravir in poor countries with the highest burden of disease. The agreement means that generic manufacturers and other companies can produce low-cost pediatric versions of the drug. Reuters (2/24)
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