Specializing in helping early-stage biotechs identify and develop microbiome-directed therapeutics with experience in :-Early stage discovery-Live microbe manufacturing-Regulatory strategy (IND vs. GRAS)-Biomarker identification-Clinical design

As Pareto's first employee, I have made major contributions to every facet of company development, consistently producing results ahead of schedule and under budget in a quest to treat food allergies in children.After establishing and outfitting our research laboratory, I developed and implemented a vision for our scientific platform. To realize this vision, I defined and implemented protocols for all microbiology and molecular biology activities and hired, trained, and supervised research associates who executed large-scale screenings of bacterial isolates for safety and multi-dimensional functional outputs. Ultimately, I oversaw the selection of Pareto's first candidate product, a bacterial consortium designed to promote immune tolerance. The therapeutic potential of this consortium was supported by work from our lab (with the help of a CRO) demonstrating efficacy in the gold-standard animal model of disease. With the efficacy of our lead product confirmed, I led efforts to manufacture and formulate it for maximum potency alongside our CDMO partner. This has so far resulted in the successful production of drug substance for all of our (strictly anaerobic) strains. Along the way I developed novel manufacturing protocols that have led to IP filings.While driving development of our product candidate, I have authored critical sections of FDA filings and contributed to the design of our first in human clinical trials, in part by identifying appropriate biomarkers.

Led research team that identified KB195, our lead compound for treating hyperammonemia associated with urea cycle disorders via the gut microbiome• Coordinated and executed early-stage discovery efforts• Contributed to writing of regulatory filings with the FDA and met face-to-face with regulators to discuss developmental path for KB195 Resulted in Kaleido’s first successful IND.

• Met with known opinion leaders (KOLs) as part of advisory boards in the U.S. and Europe• Contributed to IP filings• Initiated and managed relationships with contract research organizations (CROs)• Managed Masters-level scientist and mentored several others• Actively contributed to company culture by organizing scientific talks for non-scientists, mentoring young scientists in critical skills, creating KaleidOlympics, organizing coat drive, etc.

My work in the Beckwith lab focused on understanding how the periplasmic disulfide bond (DSB) formation pathway in E. coli contributes to the growth and virulence of this organism under low oxygen conditions. We employed a high-throughput approach to identify small molecule inhibitors of this DSB system, and I characterized several of these small molecules to elucidate their mechanism of action and to identify mutations that render E. coli (and other Gram-negatives) resistant to such compounds.

As a graduate student my work focused on the molecular mechanisms underlying strict anaerobiosis in bacteria. Specifically, I sought to answer the question, "What makes an anaerobe an anaerobe?"I worked extensively with bacteria associated with the human gut microbiome (like Bacteroides and Clostridia) to understand how the metabolic networks of these strict anaerobes responded to oxygen. I identified and characterized mutations that allowed these organisms to grow in 40-times more oxygen than they were normally capable of tolerating, and investigated numerous metabolic pathways to determine the extent of oxidative damage. Much of my work focused on amino sugar utilization by Bacteroides fragilis, as this pathway appeared to be a critical interface between oxygen tolerance and growth in the gut.