Executive Director
Critical Path Institute
Diane Stephenson is a neuroscientist by training with 30 years combined experience in academic neuroscience and drug discovery. Dr. Stephenson received her undergraduate degree in Biochemistry at University of California, Santa Barbara and her Ph.D. in Medical Neurobiology from Indiana University. Her research over the years in industry has focused on target identification, validation and prioritization of novel candidates and biomarkers across many CNS diseases. Despite advancing more than >40 different targets over many years through various stages of development, none were approved to reach patients in urgent need of therapies. Dr Stephenson joined the nonprofit organization Critical Path Institute in 2011 and led the Coalition Against Major Diseases (CAMD) with focus on Alzheimer’s disease, achieving regulatory milestones based on model informed drug development and data science. As an ambassador for public-private partnerships, Dr Stephenson has initiated numerous external academic collaborations including worldwide alliances and strategies that require multistakeholder consensus to solving problems. At present, she leads Critical Path for Parkinson’s (CPP), a multinational consortium advancing drug development tools with focus on early intervention. The CPP digital drug development tool 3DT initiative has provided a unique data-driven framework for multiple sponsors who have agreed to collaborate on optimizing the use of digital health technololgies in clinical trials. The approach being taken in this initiative has been under advisement of FDA and EMA from its inception in the spirit of collaboration and open science and is unique in that the strategy is fully aligned with patient focused drug development and FDA guidance in the use of digital health technologies in clinical trials.
Disclosure(s): No financial relationships to disclose
Thursday, March 28, 2024
1:30 PM – 3:00 PM MDT