James M. Burke

Dr. James Burke is a University of California, San Francisco trained hematologist and oncologist who has led clinical development of gene therapy and oncolytic viruses for cancer for over 15 years including first in human through Phase 3 studies. Most recently, Dr Burke served as Chief Medical Officer of Sillajen (previously Jennerex) leading Phase 1-3 global development of a vaccinia virus platform for multiple cancers including HCC, RCC, and CRC.

The global Phase 3 registration trial targeting advanced HCC represents one of the largest oncolytic studies conducted to date spanning four continents including North America, Europe, Australia, and Asia. This Phase 3 study was the first oncolytic virus study conducted by a foreign biotech in China and one of only a few OV trials to ever be conducted in mainland China. Aside from Sillajen, Dr Burke led initial Phase 1-2 clinical development of Turnstone’s maraba virus prime-boost oncolytic virus program as CMO through initial studies and fund raising.

Dr Burke started his career at Cell Genesys spearheading early gene and immunotherapy studies including oncolytic adenovirus, lentivirus, AAV, and tumor vaccine programs. In addition to his biotechnology experience, Dr Burke directed studies as a clinical scientist including first in human studies in oncolytic viruses, tumor vaccines, as well as other cancer therapeutics in Phase 1-3 development.

Throughout his career he has had extensive interaction with global regulatory authorities and key academicians, led clinical development of numerous agents, built expert research teams, presented his research findings in key scientific journals and symposia, and led medical discussions and negotiations with external financing entities including venture capital and pharma.