View the summary of webinar on FDA's Patient-Focused Drug Development | Partnership will study sequencing-based monitoring of myeloma patients | Compare DNA of cancerous, normal tissue to avoid false positives, researchers say
April 16, 2015
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Consortium aims to boost patient involvement in drug development
A forthcoming public-private consortium to focus on fully integrating patients in the drug development process will improve patient-centered drug development and reduce uncertainty in patient-drugmaker communications, planning group members said at a recent forum. Many patient advocacy groups lack the capacity to work with multiple drugmakers in multiple disease areas, said FasterCures Director of Strategic Initiatives Kim McCleary. The FDA also plans to compile and release a compendium of patient-reported outcomes to develop a baseline for new PROs. BioCentury (4/13)
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News from FasterCures
View the summary of webinar on FDA's Patient-Focused Drug Development
Traditionally, the opportunities to infuse patient input into regulatory decision-making have been very limited and relegated to the late stage of the new drug application review process, noted Kim McCleary, FasterCures' director of strategic initiatives, at the beginning of FasterCures' April 7 webinar. During the hour-long discussion, "FDA's Patient-Focused Drug Development: The view from the other side of the table," hundreds of attendees tuned in to hear insights from patient groups engaged in the FDA's Patient-Focused Drug Development initiative -- a commitment under the fifth authorization of the Prescription Drug User Fee Act to hold at least 20 disease-specific meetings to better understand patients' experiences with symptoms, impacts on daily living and available therapies. Read the summary and view the archive.
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Science and Technology
Partnership will study sequencing-based monitoring of myeloma patients
The Multiple Myeloma Research Foundation has agreed to work with Adaptive Biotechnologies and the University of Torino to evaluate sequencing-based monitoring of minimal residual disease in multiple myeloma patients. A clinical trial of the technology will involve 400 patients. GenomeWeb Daily News (free registration) (4/14)
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Compare DNA of cancerous, normal tissue to avoid false positives, researchers say
Genetic tests on cancerous tissue should be compared with genetic tests on healthy tissue to avoid mistaking normal genetic variation as a potential target, according to a study published in the journal Science Translational Medicine. Researchers comparing genetic analyses of patients' cancerous and normal tissue found that about two-thirds of mutations "were a part of the patient's normal inherited genetic variation," said the study's senior author, Victor Velculescu, co-director of the Cancer Biology Program at Johns Hopkins University School of Medicine. HealthDay News (4/15), MedPage Today (free registration) (4/15)
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Practice Fusion to develop clinical trial database with ePatientFinder
A partnership was formed between Practice Fusion and ePatientFinder to enhance patients' and physicians' awareness of clinical trial opportunities. The companies aim to develop a database that could be accessed through Practice Fusion's EHR platform. (4/15)
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Experimental drug appears to benefit damaged myelin
A drug being developed by Biogen Idec may have repaired damaged myelin in a midstage trial involving 82 people with acute optic neuritis, which can be a precursor to multiple sclerosis. Study results will be presented at the American Academy of Neurology's annual meeting this month. "Finding ways to restore myelin holds significant promise as a strategy to restore the function that multiple sclerosis has taken from people and reducing or stopping multiple sclerosis progression," said Bruce Bebo, the National Multiple Sclerosis Society's executive vice president for research. HealthDay News (4/14)
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Finance and Economics
Calif. invests $3M in personalized medicine initiative
The state of California is investing $3 million in the California Initiative to Advance Precision Medicine, a public-private program that seeks to develop targeted therapies by integrating patient information, clinical data and scientific knowledge. Data from patients across the University of California health care system will be cross-referenced with genomic information, clinical trial data, and environmental, socioeconomic and health patterns. American City Business Journals/San Francisco/BiotechSF blog (4/14)
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Innocrin attracts strong investment
Fred Eshelman joined Hatteras Venture Partners, Lilly Ventures, Novartis Venture Fund, Intersouth Partners and A&B Equity Holdings as an investor in Innocrin Pharmaceuticals, which is developing a treatment for advanced breast and prostate cancers. The company, a spinoff of Viamet Pharmaceuticals, has raised $28 million in this Series D funding round. American City Business Journals/Raleigh/Durham, N.C. (4/16), Xconomy (4/15)
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Policy and Regulation
FDA seeks nominees for advisory committees
The FDA has asked drugmakers to nominate candidates for 18 committees that advise the Center for Drug Evaluation and Research. Self-nomination is allowed, and industry groups will choose from the candidates. Regulatory Focus (4/15)
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Society and Ethics
Survey: Patients want to OK study participation
Between 75% and 80% of patients said they wanted to be asked for permission before being included in research involving a medical record review or studies comparing medication outcomes, survey data showed. The report found most people said a verbal permission or general notification would be acceptable if the process of gaining written permission would halt the study. Medscape (free registration) (4/14)
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WHO calls for greater transparency in clinical trials
The World Health Organization issued a statement on Tuesday seeking public disclosure of results of clinical trials for all medical devices, drugs and vaccines. Failure to report clinical trial outcomes "creates indirect costs for public and private entities, including patients themselves, who pay for sub-optimal or harmful treatments," WHO Assistant Director-General Marie-Paule Kieny said. Reuters (4/14)
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