The PWS Clinical Trial Consortium has recently been granted the unique chance to have a Critical Path Innovation Meeting with representatives of the FDA. The meeting will take place in November in Silver Spring, Maryland. This is a unique opportunity for the consortium and the PWS community to engage in discussions with the FDA on the progress made in the last three years by the consortium to overcome clinical trial challenges in PWS.
The PWS Clinical Trial Consortium recently requested a Critical Path Innovation Meeting with the FDA in order to share its work with the agency and get their input and guidance on the consortium's ongoing and future work. Several topics will be discussed during a 90-minute, in-person meeting, including new questionnaires developed in collaboration with the consortium by the Dykens group to capture the strategies caregivers use to control their child`s food environment, new rigidity measures developed by the Taylor and Hollander groups, and new anxiety and distress measure developed by Levo, as well as the latest studies on PWS caregiver burden and caregiver preferences for emerging treatments in PWS.
Three years after its creation, the PWS Clinical Trial Consortium is delivering its first results as a unique collaboration between experts from industry, academia and patient representatives. This has led to a growing interest from industry partners, academic and patient organizations to join the consortium. The upcoming Critical Path Innovation Meeting is a great opportunity for the different stakeholders of the consortium to come together to dialog with FDA and explore ways to leverage its work and ultimately benefit the entire PWS community.
Critical Path Innovation Meetings can be requested by stakeholders external to FDA, including industry, academia, patient advocacy groups, or consortia. Stakeholders can use these meetings to discuss methodology, technology or — more broadly — challenges or strategies in drug development with FDA outside of the context of review for any particular product or application. The meetings are a venue to get FDA`s perspective as well as advice on opportunities or issues to consider in pursuing their work.