Precision Medicine Initiative Aims High But Must Surmount Technical, Practical Hurdles
Executive Summary
White House proposal for a longitudinal cohort encompassing one million people seeks to leverage ongoing studies. But bringing all that data together under one roof, and ensuring it is useful and participants’ privacy is adequately protected, promises to be a significant task.
You may also be interested in...
‘Precision Medicine’ Gets R&D Funding Push In President’s Speech
President Obama highlights potential for personalized medicine in his State of the Union address and will seek a “major increase” in research and development funding.
Lung-MAP Patient Screening Should Translate To Cost-Savings
Sponsors say the large number of biomarkers that will be searched for in candidates for the lung cancer trial should allow researchers to find patients much faster, and will offer cost-savings over traditional drug development.
US FDA Urged To Improve Messaging To Professional Societies On Accelerated Approval Withdrawals
Lengthy withdrawal process creates an opening for the FDA to better convey its concerns about a medicine’s benefit-risk profile in a way that impacts prescribing guidelines, Johns Hopkins’ Joshua Sharfstein says; CDER’s Jacqueline Corrigan-Curay says new expedited withdrawal procedures under omnibus law appear more ‘streamlined’ than those followed for Makena.