MaryAnn Morgan-Cox is a Sr Director and Leader of the Immunology Design Hub at Eli Lilly and Company, where she focuses on innovative approaches to drug development, clinical research, commercialization, and portfolio management.

Dr. Buxton is CEO of Global Coalition for Adaptive Research (GCAR), a nonprofit organization founded to expedite the discovery and development of treatments for patients with rare and deadly diseases, and home of several Phase II/III adaptive platform trials for drug registration. Dr. Buxton has been involved in clinical research and drug development for over 20 years. She has been instrumental in the establishment of numerous innovative clinical research programs, with extensive experience in building and running master protocols. Focused on efficient approaches to the design and execution of clinical trials, Dr. Buxton brings expertise in scientific and operational implementation, regulatory strategy, and partnership development.

Mitzi Allred, PhD, is Director of Clinical Operations at MSD with more than 20 years of experience in Regulatory Affairs, Clinical Operations, and digital transformation. At MSD, she advances protocol digitization, study design standardization, the one SOA framework and metadata-driven initiatives that enhance quality, efficiency, and traceability across clinical development. Mitzi is an active contributor to ICH and CDISC, collaborating with regulators, industry partners, and technology to advance digital clinical research. She serves on the ICH M11 Expert Working Group and participates in CDISC USDM Governance. Prior to joining the biopharmaceutical industry, she earned a PhD in Engineering and spent 15 years in aerospace.

Karen received her Ph.D. in Statistics from Baylor University in 2001, and joined Eli Lilly and Company at that time. She is currently Research Fellow at Eli Lilly and Company where she leads the Statistical Innovation Center, a team that focuses on innovative design and analysis of clinical trials. In 2011, Karen helped form and led the DIA Bayesian Scientific Working Group and currently serves as past-chair. This group includes members in Industry, Regulatory, and Academia. Her research interests include Bayesian design and analysis of clinical trials and master protocols. In 2016, Karen was elected a Fellow of the American Statistical Association.