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Genetic Alliance, PhRMA initiative for patient-focused drug development

Monday, November 11, 2013

Genetic Alliance, a nonprofit health advocacy organization, and the Pharmaceutical Research and Manufacturers of America (PhRMA) announced an initiative to explore the use of a technology-enabled, crowd-sourcing approach to patient engagement as a complement to ongoing patient-focused drug development efforts under the Prescription Drug User Fee Act (PDUFA V).

The FDA committed to gain the patient perspective on 20 disease areas in public meetings to be held between 2012 and 2017.

After issuing a Request for Proposals, Genetic Alliance chose advocacy organizations representing three disease areas to be the focus of FDA patient-focused drug development public meetings in 2014 and 2015. The patient communities in these three disease areas will pilot a crowd-sourcing, technology-enabled approach to gathering input from a diverse set of patients on key benefit-risk questions.

“Using the Platform for Engaging Everyone Responsibly (PEER), there is an opportunity to demonstrate the power of a secure, crowd-sourced approach to provide additional insight into patients’ experience with a disease or condition,” said Sharon Terry, president and CEO of Genetic Alliance. “The organizations we selected are expert at broad and diverse engagement from the very people that have a vested interest in patient-focused drug development.”

The following organizations were selected to engage the sickle cell disease community:

The Coalition for Pulmonary Fibrosis was chosen to engage the idiopathic pulmonary fibrosis community.

The Gastroparesis Patient Association for Cures and Treatments and Share and Care Cockayne Syndrome Network were selected to engage the irritable bowel syndrome, gastroparesis and gastroesophageal reflux community.

Genetic Alliance will provide the participating organizations with a customized version of the PEER system, through which they will engage in a systematic collection of affected individuals’ perspectives on a condition’s severity and current unmet medical needs.

Private Access is Genetic Alliance’s technology partner for this project. Private Access develops participant-centric access controls and privacy management systems. Private Access empowers each individual to set meaningful sharing and privacy preferences that reflect his or her needs and interests.

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