Karen Joy Shaw is President of Hearts Consulting Group, providing consulting services for antibacterial and antifungal drug discovery and development programs. Most recently she was Chief Scientific Officer at Amplyx Pharmaceuticals, where she was responsible for the preclinical development of fosmanogepix, a first-in-class broad spectrum agent currently in Phase 2 clinical trials for the treatment of invasive fungal infections. With her team at Amplyx, she discovered APX2039, which inhibits the same Gwt1 protein target, but demonstrates remarkable in vitro and in vivo activity against Cryptococcus. This molecule is currently in late stage discovery.
Karen was previously Senior Vice President of Biology at Trius Therapeutics (acquired by Cubist Pharmaceuticals). At Trius, she led the microbiology development of the antibiotic tedizolid (Sivextro) and presented the drug’s microbiology and pharmacology to the US Food & Drug Administration advisory board in March 2014. In addition, her work at Trius led to the discovery of the novel, broad-spectrum class of inhibitors which target DNA Gyrase/topoisomerase IV (TriBE inhibitors).
Before joining Trius, she was Team Leader of Infectious Diseases at Johnson & Johnson Pharmaceutical Research & Development. There she developed bacterial microarray technology for E. coli and S. aureus, as well as a novel bacterial RNA amplification technology. The combination enabled the first simultaneous microarray analysis of host and pathogen interactions during an in vivo infection.
Early in her career as a research fellow at Schering-Plough Research Institute, she initiated the use of genomic approaches to discover novel antibacterial and antifungal agents and led global epidemiology studies on aminoglycoside resistance.
Karen has significant experience in obtaining contracts and grants to support research with non-dilutive funding. Her consulting activities have included antibacterial and antifungal drug discovery and development, in-licensing diligence (preclinical evaluation), natural product drug discovery, antibiotic resistance, and microbial physiology.
Karen has published over 90 articles on bacterial genetics and physiology, epidemiology of aminoglycoside resistance, microarray analysis of bacterial gene expression, oxazolidinone resistance and antibacterial drug discovery. She holds several patents on antibacterial and antifungal targets and assays.