US Food & Drug Administration – Public meeting on Patient-Focused Drug Development Initiative for Autism and workshop
Lynn Durham, CEO & Founder, is participating in patient focused Drug Development meeting organized by FDA being held May 4, 2017.
Take away for all:
- Targeting communication impairments means more to the community than offering repetitive behavior endpoints.
- Endpoints should be individualized for each patient with quantifiable endpoints individually defined within core impairments.
- Consensus with all stakeholders that drugs are urgently needed by a highly underserved community.
Drug developer take away:
- Repetitive behavior endpoints might no longer be the best choice in seeking FDA approval for ASD drug
- Know your patients
- Don’t give up: personalize