Tag Archives: drug development

Expanding the Role of Patients in Drug Development

givingtuesday

Working alongside scientists, universities, and biotech companies, patients and patient organizations have the ability to play a critical role in the search for treatments and cures for chronic and deadly diseases.  As part of the 5th authorization of the Prescription Drug User Fee Act (PDUFA V), the Food and Drug Administration made a commitment to more systematically gather patients’ perspectives on their condition and the available therapies in order to incorporate these findings into their Read More >

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Time: How to Breathe New Life Into America’s Health-Care System

21st Century Cures Act

Last week, Rep. Fred Upton (R-MI) published an op-ed – How to Breathe New Life Into America’s Health-Care System – in Time Magazine on the potential of the 21st Century Cures Act to ‘help modernize the health-care innovation infrastructure, incorporate a patient perspective into the drug and device approval process, support advances in personalized medicine, streamline clinical trials, and provide more resources to support cutting-edge research and help young scientists.’ Rep. Upton points out that there are Read More >

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Biotech Could Miss a Multi-Billion Dollar Opportunity in Rare Disease

Give-RARE

Drug development is expensive.  Drug development is risky.  Drug development takes a long time. The key to changing this is leveraging the fact that no one is more motivated to eliminate rare disease than those who are directly affected by it. I know this because, as the founder of Give RARE, I have talked to parents of children with Tay Sachs disease who know their children will die within a few years unless something changes.  Read More >

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New Report Emphasizes the Role of Patent Protection in the Global Diffusion of New Drugs

medical_research

A new report from the National Bureau of Economic Research (NBER) has determined that strong patent protection accelerates the speed at which new drugs are launched in different countries. Providing affordable access is often challenged by the need to provide adequate incentives for developing new drugs, and ensuring affordable prices once they develop. Often neglected in the larger debate is that the speed at which drugs are launched and adopted in new countries is one Read More >

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Richard Pops: A Greater Patient Voice in Drug Development

ph-summit

In the October issue of MedNous, Alkermes’ CEO Richard Pops writes about the move toward increased engagement with patients in the development, review and delivery of new medicines, as well as the challenges and opportunities associated with access and reimbursement. Pops asserts that patients must organize to share data that can be used in regulatory decision-making. Furthermore, he writes that this input must be integrated through the process – from the early stages of development Read More >

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