Chair: Dr. Alice Chen, National Cancer Institute

Dr. Chen directs the Developmental Therapeutics Clinic (DTC) at the National Cancer Institute since 2014. Within the DTC, NCI facilitates the discovery and development of new anticancer drugs and drug targets agents on a national and international basis. She works closely with her statisticians at the Biometric Research Program to develop novel clinical trial designs that best fit the agent in development. She led a trial of atezolizumab in Alveolar Soft Part Sarcoma that had led to approval of atezolizumab in this histology and first approval for pediatrics and reported in the NEJM. She is also one of the PI for the NCI MATCH and ComboMATCH, both are national precision medicine trials. She will be presenting an international trial of selumetinib in NF1 patients with plexiform neurofibromatosis at ASCO this year. She is the director the Advance Developmental Therapeutic Training Program which trains medical oncologists in early phase drug development. She has authored over 180 manuscripts and made presentations by invitation to major oncology meetings internationally on early phase clinical trials, precision medicine, and rare tumor.

Panelist: Laura Esserman, University of California, San Francisco (UCSF)

Laura Esserman, MD, MBA is Professor of Surgery and Radiology at the University of California, San Francisco (UCSF) and director of the UCSF Breast Care Center. Her work in breast cancer spans the spectrum from basic science to public policy issues, and the impact of both on the delivery of clinical care. Dr. Esserman is recognized as a thought leader in cancer screening and over-diagnosis, as well as innovative clinical trial design. She led the creation of the University of California-wide Athena Breast Health Network, a learning system designed to integrate clinical care and research as it follows 150,000 women from screening through treatment and outcomes. The Athena Network launched the PCORI-funded WISDOM Study, which tests a personalized approach to breast cancer screening in 100,000 women. She is also a leader of the innovative I-SPY TRIAL model, designed to accelerate the identification and approval of effective new agents for women with high risk breast cancers. In 2020 she got FDA approval for an I-SPY COVID trial, designed to rapidly screen and confirm high impact treatments to reduce mortality and time on ventilators.

Panelist: Dr. J. Jack Lee, University of Texas MD Anderson Cancer Center

J. Jack Lee, Ph.D., M.S., D.D.S. is Professor of Biostatistics and Kenedy Foundation Chair in Cancer Research at the University of Texas MD Anderson Cancer Center. His areas of expertise include design and analysis of cancer clinical trials, Bayesian adaptive designs, statistical computation/graphics, drug combination studies, biomarkers identification and validation, and statistical methods for precision medicine. In over 30 years of service at MD Anderson, Dr. Lee has been working with many multidisciplinary research teams and providing biostatistical support to clinical, translational, and basic science studies. He is an elected Fellow of American Statistical Association, Society for Clinical Trials, and American Association for the Advancement of Science. He has published extensively in statistical and medical journals. He co-authored two books entitled: “Bayesian Adaptive Methods for Clinical Trials” and “Model-Assisted Bayesian Designs for Dose Finding and Optimization: Methods and Applications.”

Dr. Lee received his D.D.S. from National Taiwan University in 1982 and M.S. and Ph.D. in Biostatistics from University of California, Los Angeles in 1984 and 1989, respectively.