Mark Pegram is the Suzy Yuan-Huey Hung Endowed Professor of Medical Oncology at the Stanford Comprehensive Cancer Institute, Associate Dean for Clinical Research Quality, and Medical Director of the Clinical Translational Research Unit — the premier first-in-human phase I clinical trial venue in the Stanford University School of Medicine. Dr. Pegram has extensive (30 years) experience in early-phase clinical/translational research/oncology drug development. Under the mentorship of Dr. Dennis Slamon at UCLA, Pegram played a significant role in the pre-clinical, early clinical, and pivotal registrational clinical development of trastuzumab (Herceptin®) for the treatment of HER2-positive breast cancer. Since that time, over 2.5 million women have been treated with Herceptin® globally, and Herceptin® is on the WHO list of essential medicines. Dr. Pegram has participated as PI or co-PI in numerous early-phase clinical trials, including (but not limited to): lead author on the first publication of a combination of trasutuzmab + chemotherapy in human subjects – which became the standard of care in HER2+ disease; HER2 MAb pertuzumab, HER2 antibody-drug conjugate T-DM1; HER2 kinase inhibitors lapatinib, tucatinib and neratinib; humanized anti-muc-1 MAb AS1402; thymidylate synthase-activated prodrug NB1011; recombinant p53 adenovirus SCH58500; Fc-engineered HER2 MAb MGAH22 (margetuximab); hypoxia-activated prodrug PR- 104; bispecific HER2 antibody-drug conjugate MEDI4276; trastuzumab biosimilars, and was Medical Director for the first-in-class, first-in-human phase 1 pharmacokinetic and pharmacodynamic study of Hu5F9-G4, an anti-CD47 monoclonal antibody (magrolimab), for patients with advanced solid tumors [J Clin Oncol. 2019 Apr 20;37(12):946-953. PMCID: PMC7186585]. A number of these trials were investigator-initiated and/or first in human clinical trials. Dr. Pegram was lead author on the paper describing pre-clinical synergy between multiple chemotherapeutics and trastuzumab; senior author of the pivotal trial of letrozole plus lapatinib – leading to FDA approval [J Clin Oncol. 2009; 27: 5538-46]; and co-author on the pivotal trials of trastuzumab plus chemotherapy, and T-DM1, published in the New England Journal of Medicine, and leading to FDA approvals [Slamon, et al., N Engl J Med. 2001;344(11):783-92, and Verma, et al., N Engl J Med 2012;367(19):1783– 1791. PMCID: PMC5125250]. Recently, Dr. Pegram was the lead author on the pivotal, registrational phase III clinical trial or PF-05280014 (a trastuzumab biosimilar) which won FDA approval in 2019. Dr. Pegram is also coauthor of the recently published phase III registrational clinical trial of tucatinib, winning regulatory approval in April, 2020. Finally, Dr. Pegram is co-author of the pivotal registrational phase III clinical trial of Margetuximab – an Fc-engineered HER2 antibody with enhanced immune effector function, which won FDA approval in December, 2020. Based upon this experience, Dr. Pegram has become expert at pre-clinical and early-clinical development of oncologic therapeutics, with a focus on breast cancer, particularly HER2+ breast cancers.