Understanding tradeoffs: A benefit-risk bloggersation | NIH unveils website to streamline access to global clinical studies | Google X seeks to develop diagnostic nanoparticles and device
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October 30, 2014
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Anderson: We need to advance change in medical research
Our biomedical and health care systems are experiencing dramatic changes, including the debate over the cost of a drug from Gilead that promises to cure hepatitis C, and many stakeholders are struggling to keep up and find their place in the new environment, FasterCures Executive Director Margaret Anderson writes. As FasterCures prepares for its Partnering for Cures meeting next month, Anderson encourages stakeholders to celebrate the changes in medical research and work on the many things that need to be done to advance change. In this blog post, she imagines a stronger environment for medical research, including a patient-focused research culture built on partnerships, predictable and ongoing funding from NIH, and a strong infrastructure for essential health systems. The Huffington Post (10/29)
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News from FasterCures
Understanding tradeoffs: A benefit-risk bloggersation
Assessing benefits and risks is core to medical product development, regulation and health care decision-making. FasterCures is working to expand ways for patient perspectives to be better heard and integrated in the benefit-risk conversation. We have invited three of our Benefit-Risk Advisory Council members -- Patricia Furlong of Parent Project Muscular Dystrophy, Bennett Levitan of Janssen Pharmaceutical R&D and Robert Meyer of the University of Virginia School of Medicine -- to break down some of the key issues in this first installment of our Benefit-Risk Bloggersation.
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Science and Technology
NIH unveils website to streamline access to global clinical studies
The NIH website ClinRegs was launched last month to facilitate compliance with clinical trial regulations worldwide. Side-by-side comparisons of regulatory information are available for 12 nations, including the U.S., South Africa, Brazil, India and China, and more countries will be added. Regulatory Focus (10/29)
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Google X seeks to develop diagnostic nanoparticles and device
The Google X lab is developing what it calls a Nanoparticle Platform, technology that combines nanoparticles and a wearable device for disease detection. The idea involves magnetic nanoparticles bearing antibodies or proteins that circulate in the bloodstream to zero in on signs of disease, which would be detected by a wearable sensor. The goal is diagnosis long before symptoms appear, but there are hurdles to developing and deploying such technology, including regulatory and privacy issues. Wired.com (10/28), The Wall Street Journal (tiered subscription model) (10/29), BBC (10/28), The New Zealand Herald/Agence France-Presse (10/29)
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Private-academia partnership to tackle proteins linked to many diseases
Amgen, Sanofi and Ono Pharmaceutical have entered into a research collaboration with the Shanghai Institute of Materia Medica, ShanghaiTech University's iHuman Institute and the University of Southern California. The research project will focus on G-protein coupled receptors, a super-family of proteins linked to many disease processes including cancer. Improved understanding of GPCRs' structure could lead to development of new drugs, the research partners said. Reuters (10/28)
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Partnership aims to support development of new blood cancer drugs
Cancer Research UK has partnered with Leukaemia & Lymphoma Research to finance early-phase clinical trials of experimental blood cancer drugs. Under the five-year deal, in addition to providing funding for development and clinical trials, LLR will provide access to therapies that its scientists are studying. Pharmaceutical Business Review Online (10/28)
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Finance and Economics
Acquisitions remain a critical biotech exit path
The window for more biotech exits via initial public offerings is still open. But what often is overlooked "is the important -- and more frequent -- role of the M&A exit in driving liquidity in biotech," writes Bruce Booth. Forbes (10/27)
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Venture funds dividing into narrowly focused firms
Venture funds specializing in IT and health care might be gaining an advantage over other funds as limited partners get pickier about investments. Some diversified firms are splitting into specialist funds with a narrow focus. Xconomy (10/22)
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Policy and Regulation
Bill to expedite Ebola drug approval planned by 2 senators
Senate Health Committee leaders Sens. Lamar Alexander, R-Tenn., and Tom Harkin, D-Iowa, plan to introduce legislation to provide incentives for the development of Ebola treatments under the FDA's neglected tropical disease program. The bill would make Ebola drug developers eligible for the priority review program as well as for bonus vouchers allowing priority review for an additional drug. The Hill (10/28)
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FDA seeks input on improving communication during clinical trials
The FDA is asking for comments from the public, industry and other groups on how to improve communication during drug development with sponsors of investigational new drug applications. The goal is to collaboratively develop guidance that includes best practices, the agency said. Regulatory Focus (10/28)
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Society and Ethics
Report: Pakistan is biggest obstacle to eradicating polio
Pakistan is the biggest stumbling block to eradicating polio worldwide by the end of the year, according to a report by the Global Polio Eradication Initiative. Pakistan has reported 220 cases this year so far, the highest number in 14 years. The Wall Street Journal (tiered subscription model) (10/27)
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