Dr. Freda Cooner is currently a Senior Director in Eli Lilly and Company. Prior to that, she is a Statistics Director in Amgen, leading the prostate cancer statistics program and exploration of innovative designs for several oncology and non-oncology products, including master protocols and seamless trials. Before joining Amgen late 2018, she was an associate director in Sanofi leading several diabetes products and studies. Prior to Sanofi, Dr. Cooner worked in FDA for over 10 years, where she reviewed hundreds of products in multiple therapeutic areas and led several working groups. She obtained her Ph.D. in Biostatistics from School of Public Health, University of Minnesota.

Jennifer Clark is a statistical reviewer for the FDA's Center for Drug Evaluation and Research. Her current work is in cardiology and nephrology with research interests in clinical outcome assessments and Bayesian methodology. Her past research interests include work in high dimensional data with applications in bioinformatics and epigenetics.