Dr. Helen Schiltz has more than 25 years of experience in biotech industry and US government in development and management of therapeutic, diagnostic and vaccine products against a wide range of bacterial and viral biodefense and emerging infectious pathogens.
As a formal program officer in the Office of Biodefense Research, Resources and Translational Research (OBRRTR) within National Institute of Allergy and Infectious Diseases (NIAID), Helen was instrumental in building a successful BEI Resources Reagents and Repository Program for NIAID that supports US and international research and development efforts for diagnostics, vaccines, and therapeutics products. She managed the critical reagent programs to support immunoassay development programs of multiple vaccine products for anthrax, plague, tularemia, and smallpox that have eventually licensed. Furthermore, she was a founding member and acting chief of the Drug Development Section of OBRRTR where she employed broad agency announcement mechanism and applied that into NIAID’s R&D contract funding streams and established in house procedures for contract technical oversight. She has made significant contribution to the overall strategic implementation of NIAID’s biodefense research and development agenda in building a robust therapeutic portfolio targeting a wide selection of high priority bacterial and viral pathogens and spanning from preclinical to early clinical (Phase I and II) development stages. She has worked with a variety of technologies and innovative approaches for products, including biologics (recombinant protein and antibodies) and small molecules (siRNA, peptides, and other chemical entities) for inhaled, oral, and parenteral administrations. Over 16 years in NIAID, she has overseen more than 20 IND submissions and multiple clinical phase I and II trials, and is a leading expert in development of products that are licensed under the Animal Rule. Most notably, these therapeutics include products for smallpox, influenza, dengue, yellow fever, Ebola, Marburg, chikungunya, COVID-19, Zika, anthrax, plague, and other multi-drug resistant bacterial pathogens. Helen was also a key member of the US PHEMCE (Public Health Emergence Medical Countermeasure Enterprise) integrated product teams, leading multiple interagency portfolio management teams in the therapeutic area, to evaluate and stratify products for smallpox and filovirus diseases. She collaborated and advised multiple US government agencies’ biomedical research programs. She is a recipient of multiple NIH Director Awards and NIAID Merit Awards for her outstanding contribution to the Ebola outbreak response, Zika outbreak response, and determined efforts to promote advanced development of biodefense antivirals and transition to BARDA.
Prior to joining OncoImmune, she held senior director of R&D position in Sabin Vaccine Institute. Before joining NIAID, she has held manager and director positions for R&D in Qiagen (formally Digene) and Metrigenix, where she developed HIV, HBV, Parvo B19 quantitative detection assays and HPV genotyping assays, and multiplex genomic and proteomic arrays for biomarkers of diseases.
Helen received her Master of Science degree from Sun Yat-sen University in Guangzhou China, and her doctoral degree in biochemistry from Louisiana State University.