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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
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