Gracie Lieberman

Senior Director Regulatory Policy Genentech

Gracie Lieberman is a Biostatistician with 30+ years of experience in oncology clinical trials. Gracie is a Senior Director of Regulatory Policy at Genentech and her focus areas are adoption and acceptance of innovative clinical trials and Real World Evidence in drug development and regulatory decision-making. For the past 25+ years 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 and guiding molecule development teams. She participates in select strategic initiatives such as 2NME Development Considerations and in the past led a Biostatistics Initiative on Drug/Diagnostic Co-Development. She was also a panelist, representing Genentech 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.