In efforts to improve the clinical development process for rare disease drug development, the EveryLife Foundation is hosting a full day forum today in Washington, DC. This annual scientific workshop is about why incorporating the patient perspective into the various phases of developing drugs and associated programs is vital to new treatment success. A few years ago the Food & Drug Administration (FDA) brought stakeholders from industry, government and advocacy organizations together to discuss how patients are the missing link in successful drug development.
Patient centricity is a buzz word these days, and the FDA opened the gates to a flood of information back in 2012 when the Patient-Focused Drug Development Initiative was mandated under law, PDUFA-V. Over the next few years, twenty-four conditions were chosen for this focused attention and various meetings were scheduled between 2013-2017; 14 have been since held.
The workshop reports, “Voice of the Patient Report” can be viewed publicly here. The question has become how really can patient experiences influence agency and industry decisions to regulate availability of new treatments? How can patient input be translated into systematic and quantitative data? Will the FDA even use the gathered information?
Patient Worthy is onsite today at the Everyday Life Foundations’ Workshop and we are eager to report back from experts and officials from Patient Organizations and small and large drug sponsors alike.
