WK07: Patient-focused endpoints: Developing and Analyzing PRO Endpoints with Considerations for Missing...

Libby is a Director of Biostatistics on the Quantitative Team at Clinical Outcomes Solutions, a global Health Economics and Outcomes Research strategic consulting group. Libby is a biostatistician with over 10 years of experience in patient reported outcomes research and clinical trials as an academic researcher and industry consultant. Much of her work has been in the development, interpretation, and analysis of patient reported outcomes with missing data, specifically when using responder analyses. She specializes in complex quantitative approaches for optimal interpretation and has extensive experience in psychometric analyses and mixed-methods research.

Stacie Hudgens, MA is the Chief Executive Officer and Strategic Lead, Regulatory & Access at Clinical Outcomes Solutions. She has over 20 years of combined clinical and outcomes research experience, specializing in research design and statistical and psychometric analysis with extensive US and European Regulatory submissions and presentations. She has held leadership positions in both consulting and pharmaceutical environments. In addition to being adjunct professor at two Universities, Stacie is also Co-Chair of the ISOQOL Psychometric Special Interest Group and member of the ISOQOL Industry Advisory Committee. She has previously developed webinars and symposiums including psychometric and statistical methodologies.
Harman Dhatt, MPH PhD Candidate is the Principal, Health Economics and Outcomes Research at Apex Health Solutions. She has over 13 years of combined experience leading and conducting research in clinical, academic, government agency, laboratory, pharmaceutical, and consulting environments. Over the last several years, she has lead research evaluating stakeholder, clinical, and economic outcomes as well as providing strategic value assessments for pharmaceutical products in various stages of the product life cycle. She has extensive experience in clinical outcomes assessments (COAs), including patient-, observer-, and clinician- reported/centered outcomes. Her relevant research has included qualitative COA development/modification, regulatory support and submissions including FDA and label claims, and psychometric analysis.