Dr. Ruth Ellis | Senior Consultant
Biologics Consulting Group Inc

Ruth D. Ellis, MD MPH joined Biologics Consulting in February 2015. Ruth received a B.A. in Chemistry from Knox College, an MD from the University of Illinois, and an MPH from the University of Colorado Health Sciences Center. She completed a residency in Family Medicine and was Board Certified in 1992. At Biologics Consulting she works on a broad range of products and indications, including vaccines and biologics targeting infectious diseases, cellular and gene therapy, pediatrics, and rare diseases.

Ruth came to Biologics Consulting with over 11 years of experience in clinical research, including 9 years in development of vaccines. Prior to joining Biologics Consulting she was Director of Clinical Development at Aeras, where she led multidisciplinary product teams in development of vaccines to prevent tuberculosis. Working in collaboration with large industry and small biotech partners, Ruth was responsible for creation and maintenance of clinical sections of target product profiles and product development plans, design and development of study protocols, investigator brochures, study reports, and other study-related documents, coordination of primary analyses and interpretation, and dissemination of results to partners and the tuberculosis vaccine community. Ruth was the team lead on field optimization and use of interferon gamma release assays as endpoints in novel prevention of infection proof of concept clinical trials, and took the prevention of infection model from concept to first subject dosing within 12 months.

Prior to joining Aeras, Ruth was head of the Clinical Group at the Laboratory of Malaria Immunology and Vaccinology at the National Institute of Allergy and Infectious Disease, National Institutes of Health. At NIAID she was responsible for the design and conduct of early phase trials of malaria vaccine candidates targeting three phases of the plasmodium life cycle. Trials were conducted in the US and overseas in resource-limited settings. Ruth took the lead on innovative clinical trial designs using novel endpoints to assess biologic impact of vaccination to support progress towards licensure. She also served as member and vice chair of the NIAID Institutional Review Board, and as a chair or member of several safety monitoring committees and advisory committees.

In addition to her product development and consulting experience, Ruth has a variety of primary care and management/evaluation experience in resource-limited settings in the US, Africa, and Asia.