Register for "Paying for cures: Ensuring patient access and system sustainability" on Feb. 12! | Michael J. Fox Foundation, IBM to develop tech for Parkinson's | Allscripts, Microsoft aim to get more patients into clinical trials
January 15, 2019
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FDA could get funding increase for 2019
A budget bill that passed the House on Thursday includes a $159 million increase to the FDA's budget for fiscal 2019, which would bring its total budget to $2.96 billion. The agency would use the increase to streamline generics reviews, boost the transition to advancing manufacturing technologies and fund natural history databases to support development of rare disease treatments.
BioCentury (1/11) 
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News from FasterCures
Register for "Paying for cures: Ensuring patient access and system sustainability" on Feb. 12!
Register for "Paying for cures: Ensuring patient access and system sustainability" on Feb. 12!
On February 12 in Washington, D.C., FasterCures is co-sponsoring NEWDIG's event, "Paying for cures: Ensuring patient access and system sustainability." The conference will be an opportunity to share research and recommendations gathered over nearly three years in the NEWDIGS Consortium at MIT. Join other innovative leaders and national policymakers by registering for the event today.
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Science and Technology
Michael J. Fox Foundation, IBM to develop tech for Parkinson's
The Michael J. Fox Foundation will provide IBM with grants and data to develop new technology for tracking the various stages of Parkinson's disease, which is expected to affect almost a million people by 2020. "This partnership will help us to build a disease-progression model that will support our understanding of the disease, its progression, and how to improve the drug-discovery process," says IBM's Jianying Hu.
NBC News (1/9) 
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Allscripts, Microsoft aim to get more patients into clinical trials
Veradigm, Allscripts' payer and life sciences unit, will work with Microsoft to match patients with clinical trial participation opportunities through EHRs at the point of care.
Crain's Chicago Business (tiered subscription model) (1/9),  EHR Intelligence (1/7) 
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  • For more:
    Learn how patients and their health data have the power to transform the biomedical research and development world by visiting FasterCures' Health Data Basics site.
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Checkpoint inhibitors more effective in tumors with many DNA mutations
The higher the number of genetic mutations a tumor has, the more likely it is to respond to checkpoint inhibitors, but the number of mutations associated with a strong immune response varies depending on the type of cancer, according to a study published in Nature Genetics. The findings could improve patient selection for immunotherapy if researchers can develop methods for measuring the effects of mutation number and type in specific cancers, says biotechnology analyst Chris Shibutani.
Nature (free content) (1/14) 
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Finance and Economics
Crowdfunding for research projects popular with junior scientists
Junior scientists and students have been successful at raising funds for their research projects using crowdfunding, according to data collected by researchers at ESMT Berlin in Germany. However, researchers found that while crowdfunding scientists are successful at raising money, the amounts they are getting are less than what is typically gathered via traditional funding methods.
Nature (free content) (1/11) 
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$14B sought for response to AIDS, TB, malaria
The Global Fund to Fight AIDS, Tuberculosis and Malaria announced a three-year fundraising target of $14 billion to address AIDS, malaria and tuberculosis with the goal of preventing 16 million deaths. "We need to ... protect and build on the gains we have made, or we will see those achievements eroded, infections and deaths resurge, and the prospect of ending the epidemics disappear," said Peter Sands, the Global Fund's director.
Reuters (1/11) 
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Policy and Regulation
Drug development office proposed by FDA
The FDA has proposed creating an office focused on advancing innovation in drug development, with divisions focused on research and implementation of clinical outcome measures, biomarker development, safety analytics and biomedical informatics. "We believe the time has come to make the science of drug development a more formal scientific discipline within the new drug approval process, along with the components that it comprises," says FDA Commissioner Scott Gottlieb.
BioCentury (1/8) 
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FDA stretches resources during shutdown to protect public health
FDA Commissioner Scott Gottlieb said the agency has shifted funds to salaries and deferred internal operating charges so agency staff can continue activities necessary to identify and respond to threats to human safety during the partial government shutdown. The agency can continue ongoing product reviews until user fee funds are expended, Gottlieb said.
Regulatory Focus (1/14),  FiercePharma (1/16) 
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Society and Ethics
States seek novel models to cover cost of cures
Massachusetts is negotiating with Novartis's AveXis unit to allow health insurers to pay in installments for Zolgensma, a gene therapy for spinal muscular atrophy, which is expected to be priced at as much as $5 million for each one-time dose. In Louisiana, Medicaid officials proposed paying subscription fees to drugmakers in exchange for unlimited access to hepatitis C treatments, and Gov. John Bel Edwards asked drugmakers to submit contract proposals.
Business Insider (1/14),  The Washington Post (tiered subscription model) (1/10) 
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On the FastTrack
Make your voice heard by taking the Patient Focused Medicine Development's (PFMD) survey on "Compensation for Patient Experts at Fair Market Value"
PFMD is hoping to change the reality that there is currently no transparent system for financial compensation that reflects individual contributions and the expertise of patient partners. Do you have an opinion on this topic? PFMD is eager to hear from you. They have created a survey intended for all stakeholders who are relevant to patient engagement and involvement in medicines research, development, and delivery phases and lifecycle. Learn more about their efforts and access the survey today.
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FasterCures, a center of the Milken Institute, is driven by a singular goal: to save lives by speeding up and improving the medical research system. The Milken Institute is a nonprofit, non-partisan think tank determined to increase global prosperity by advancing collaborative solutions that widen access to capital, create jobs, and improve health.
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