Critical Path for Parkinson’s 3DT initiative: Early regulatory engagement to optimize paths for efficient

Hoffman-La Roche Ltd Kirsten Taylor Janice Hitchcock Ole Graff Roche Critical Path Institute GSK Derek Hill Michael Lawton Luis Garcia-Gancedo Critical Path Institute Critical Path Institute GSK Robert Alexander Joseph Scheeren H. [...] Sengoku Takeda Critical Path Institute UCB Yijia Luo Klaus Romero Babak Boroojerdi Takeda Critical Path Institute UCB Rob Rubens Michael Minchik Glenn Stebbins Takeda Critical Path Institute Rush University Neta Zach Beatrice Yang Marjan Meinders Takeda Lundbeck Radboud University Medical Center Josh Cosman Susi Lee Bastiaan R. [...] Schwarzschild, Massachusetts Michele Hu, Oxford Univ General Hospital Derek Hill, University College London John Seibyl, Institute for Neurodegenerative Karl Kieburtz, University of Rochester Disorders Eric Macklin, Massachusetts General Ira Shoulson, Georgetown University Hospital Tanya Simuni, Northwestern University Ken Marek, Institute for Glenn Stebbins, Rush University Neur. [...] Disorders API for Mood Trailmaking Gait continuous tremor Fatigue Digit Symbol Substitution (DSST) Balance monitoring Cognition Visual Working Memory Tremor Tremor Alternate Finger Tapping Bradykinesia Fine Motor Speech How is WATCHPD unique as compared to other PD digital studies? Target population is focused on early PD, de novo patients to align with current and em. [...] Not all requests are accepted Meetings are informal and advice is non-binding CPIM Participation from FDA (May, 2019) Well attended by wide range of FDA staff from across the agency Office of Medical Policy (OMP) Division of Neurology Products (DNP) 36 FDA participants Clinical Outcomes Assessments (COA) in person,18 remote Office of Biostatistics (OB) Office of Science Policy (OSP).