I have 26 years of clinical research and practice, program development, and administrative experience in pediatrics, infectious disease, international health, and emergency medicine. I have been PI on 5 clinical studies, and have written or contributed to 30 peer-reviewed publications, including 2 invited editorials. I led development of the fellowship training program in pediatric emergency medicine at Johns Hopkins, developing my organizational and administrative skills, which were further honed by my work as Director, Division of Pediatric Emergency Medicine, at the University of Rochester School of Medicine and Dentistry. My earliest scientific work involved the management of childhood diarrhea with oral rehydration therapy, which was followed by participation in development of the first clinically proven childhood vaccine against Haemophilus influenzae B infections, a therapy that has subsequently saved thousands of lives (1, 2). This work, in the context of my emergency medicine activities, led to an interest in simple technological solutions to complex medical problems, including social justice issues and development of a community health worker-based intervention program in urban Baltimore, where I developed skills in qualitative research. After retiring from clinical practice in 2004, I developed expertise in nutritional approaches to chronic disease, with a focus on irritable bowel syndrome through my consulting work with Genova Diagnostics, Inc., where I produced comprehensive White Papers on diagnostic biomarkers in IBS and the role of the gut microbiome, while contributing to development of new IBS-related biomarker panels and their utility in managing IBS (8,9). In 2017 I founded Scaled Microbiomics, LLC (SMB), to explore and capitalize on the unique properties of avian antibodies (IgY) as therapeutic modulators of microbial-human signaling pathways and pathogenic event cascades, with particular application to disrupted (dysbiotic) microbial ecosystems (microbiomes). To date SMB has successfully developed three IgY-based therapeutic candidates targeting human enteric pathogens (Human Norovirus and ETEC) as well as SARS-CoV-2.
I am the inventor of “SYSTEMS AND METHODS FOR ALTERING MICROBIOME TO REDUCE DISEASE RISK AND MANIFESTATIONS OF DISEASE,” filed as a PCT patent (16/253,392) with USPTO on August 27, 2017 and assigned to Scaled Microbiomics, LLC. I have spearheaded the development of Scaled Microbiomics to date, including developing a research team, equipping a laboratory, designing the experiments that produced supporting data on use of IgY in microbiome applications, and interpreting the results. This work has resulted in five additional patent filings: “Formulations for Altering Microbiome to Reduce Risks of Familial Adenomatous Polyposis and Colorectal Cancers” (PCT/US20/33952), and “TREATING OR PREVENTING TRAVELERS DIARRHEA” (63/009,509).
In August 2022, Scaled Microbiomics, in partnership with Magic Medical Solutions, LLC formed a new venture called Evimero, where I am currently Chief Science Officer.
My clinical and research experience, as well as my administrative and entrepreneurial skills, are excellent qualifications to serve as Principal Investigator for this STTR Phase I proposal entitled “Feasibility of Immunotherapeutic Formulations to Prevent Opioid Use Disorder in First-Time Users.”