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Patient Advocacy 3.0: Outreach Stretches to First Stages of Regulatory Development

 
• By Cole Werble

FDA is ready to bring patient voices and perspectives into the drug approval framework. Practically, that means that drug sponsors will have to develop new skills and structures for working with a familiar stakeholder group at an unfamiliar point in the drug development process. The new challenge was a major theme at PhRMA’s 2012 Annual Meeting.

Think of pharma’s new outreach to patient groups as Patient Advocacy 3.0 – a new set of relationships designed to impact the early stages of drug development by defining the targets and criteria for drug review and approval by the Food & Drug Administration.

Patient Advocacy 1.0 stretches back about twenty five years to the early push for accelerated approval approaches for HIV treatments, expanded to put more pressure on FDA to meet timelines...

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