Get the latest from FasterCures | Young adults with Alzheimer's disease gene help drugmakers | ResearchKit draws more than 75,000 into medical studies
July 30, 2015
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Voices of patient advocates grow stronger
Patients are assuming an increasingly strong role in drug development and regulation, and the trend is likely to continue with the 21st Century Cures bill's focus on patient input, write John Clerici and Philip Bradley. The Parent Project Muscular Dystrophy recently helped the FDA develop guidance for Duchenne muscular dystrophy drug development, amyotrophic lateral sclerosis groups are working on a similar project, and Alzheimer's disease groups have met with the FDA's neurology review division. Obstacles to including patient perspectives in drug development include a disconnect between researchers and patients, and a lack of regulatory predictability on the use of patient-derived data, panelists at a recent meeting said. (7/23)
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Science and Technology
Young adults with Alzheimer's disease gene help drugmakers
The DIAN Trials Unit project is allowing young people with early signs of Alzheimer's disease to participate in clinical trials. The project was founded by the Dominantly Inherited Alzheimer Network, created for people who carry a genetic mutation responsible for early Alzheimer's disease, and it enables drugmakers to conduct human trials of drugs to prevent or treat Alzheimer's disease. National Public Radio (7/23)
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ResearchKit draws more than 75,000 into medical studies
More than 75,000 people are participating in the ResearchKit program, logging data into iPhone applications for studies of diabetes, heart disease, Parkinson's, asthma and breast cancer. Stanford University cardiologist Michael McConnell, who is part of the heart disease study, said a smartphone is a great research platform because people have it with them every day. The Herald (Rock Hill, S.C.)/The Associated Press (7/29)
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Wildlife diseases offer chance to prevent zoonotic disease outbreaks
Studying pathogens that pass from wildlife to livestock can help predict and prevent zoonotic disease outbreaks in humans, according to research published in the Proceedings of the National Academy of Sciences. Researchers found that half of all diseases transmitted from wildlife to livestock over the past century were caused by 10 pathogens -- mostly viruses, followed by bacteria, then parasites. "Oftentimes we don't prioritize animal health until it impacts on human health, which means we miss the opportunity to manage diseases at the source," said Siobhan Mor of the University of Sydney's veterinary science department. Healio (free registration) (7/28)
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Finance and Economics
Nonprofits play a major role in fight against childhood cancer
Nonprofit agencies are playing an integral role in the fight against childhood cancer, as the lion's share of medical industry attention and federal funding go to adult treatments. Solving Kids Cancer and St. Baldrick's Foundation are among the nonprofits working to find a cure and support development of new treatments. Newsweek (7/20), (7/27)
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HIV/AIDS research group awards $2M to support latent HIV antibodies
The Foundation for AIDS Research has awarded researchers with Beth Israel Deaconess Medical Center a four-year grant worth $2 million to support the development of two antibodies for latent HIV. Two universities also received funding from the organization. American City Business Journals/Boston (7/30)
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Stem cell researchers receive $7.4 million grant
The California Institute for Regenerative Medicine has awarded a $7.4 million grant to researchers with the University of California at Los Angeles' Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research. The funding will support a Phase I/II clinical trial of a stem cell gene therapy for X-linked chronic granulomatous disease. Daily Bruin (UCLA) (7/28)
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Policy and Regulation
More funding is needed for BARDA pandemic flu program, BIO CEO says
The development of vaccines and other medical countermeasures for pandemic flu, including highly pathogenic avian influenza, relies on funding through the Biomedical Advanced Research and Development Authority's pandemic influenza program, but money allocated for the program has declined significantly in recent years, Biotechnology Industry Organization President and CEO Jim Greenwood writes. To ensure the nation's preparedness against possible disease outbreaks, the government should increase funding for BARDA's pan flu program, commit to long-term funding and boost the transparency of future budget allocations, he writes. The Hill (7/29)
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Innovation box proposal is unveiled
Rep. Charles Boustany, R-La., and Rep. Richard Neal, D-Mass., proposed an "innovation box" as a key aspect of the House's larger tax reform measure. The idea is to lower taxes on income generated by patents and other intellectual property. The idea has generated support from both parties. The Hill (7/29)
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On the FastTrack
How patients can advance research through the regulatory process
Patients with rare diseases often face few options for treatment, in part because small populations present unique study design challenges. A case study in the Orphanet Journal of Rare Diseases illustrates how patient and advocacy groups can advance research by developing regulatory guidance on drug development. The Parent Project Muscular Dystrophy did just that in a sweeping collaboration bringing together the Duchenne muscular dystrophy community and the FDA, and the approach should serve as a model for other groups. Read more.
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