Panelists in this morning’s opening session outlined strategies for the FDA to better engage the patient community to guide the drug development process.
“Patients should be providing input and guidance throughout the entire drug review process,” said Marc Boutin, Executive VP and COO of the National Health Council.
Boutin highlighted the improvements made through PDUFA V to open up and enhance the Agency’s interaction and engagement with patients. “Integrating our perspective into how drugs are developed will increase the value and quality of products for chronic conditions,” said Boutin.
Annie Kennedy of the Muscular Dystrophy Association emphasized the importance of working with the FDA to create flexible trial design and better stratify trials according to patient sub populations.
“It’s critical to gather data on patients that can be used to better inform drug development and review,” said Kennedy. “The surveys we have conducted have been enormously helpful in understanding patients’ experience and being able to communicate this perspective to decision makers.”
Kimberly McCleary asserted that ‘there are as many patient perspectives as there are patients.’ McCleary goes on to emphasize that it is important to ask open ended questions but, as a caveat, added that it is also important to never underestimate the task of analyzing the data.
BIO’s Andy Womack, PhD, moderated the session and closed by encouraging continued engagement between the patient community and FDA.