Grazyna (a.k.a. Gracie) Lieberman is a Biostatistician with 30+ years of experience in drug development. For the first twenty years of her drug development career, Gracie worked in the Biostatistics Department and the last ten years in Regulatory Policy. The regulatory policy focus areas were adoption and acceptance of innovative clinical trials, and Real-World Evidence in drug development and regulatory decision-making. While at Genentech, Gracie has gained experience in all phases of drug development, from pre-IND to post-marketing, drug/diagnostic co-development, and collection/evaluation of Patient Reported Outcomes (PROs). Gracie served on review and oversight committees, advising molecule development teams. She participated in select strategic initiatives such as 2 New Molecular Entities Development Considerations and led a Biostatistics Initiative on Drug/Diagnostic Co-Development. Gracie was also a panelist at a clinical conference organized by Friends of Cancer Research and Brookings Institute. The recommendations developed by the specific panel were key to the establishment of the Breakthrough Therapy Designation. Between 2020 and 2022 Gracie was co-leading a TransCelerate Initiative to develop recommendations for a checklist supporting RWD audit readiness and was a Lead Investigator in an FDA funded project to develop recommendations for study designs that reliably and rigorously combine data from different sources (e.g., a randomized clinical trial and RWD) and generate evidence that could be used to support regulatory decision-making. Gracie played a key role in initiating both projects.