Core D - Data Management, Analysis and Product Development Support (CIIG)

PROJECT SUMMARY/ABSTRACT The overall goal of Core D: Data Sharing, Analysis, and Product Development Support is to provide CIIG Center projects and cores scalable centralized platforms, tools, and expert support services to efficiently accelerate translation of Center-developed Neisseria gonorrhoeae (Ng) vaccine and therapeutic antibody products from laboratory to humans. To accomplish this goal, a team of experts in data sharing and collaboration platforms, study design and statistical analysis, and regulatory strategy and product development from Research Triangle Institute (RTI) International has joined this Center to provide a comprehensive portfolio of tools and support services in Core D. The Core D team will be led by Dr. Greg Sempowski, an immunologist, vaccine/countermeasure developer, and long-standing collaborator in Neisseria gonorrhoeae vaccine research and development of Drs. Jerse, Bash, Chackerian, Macintyre, and Criss. He will be joined by three co-investigators in delivery of core services: Dr. Sean Hanlon, a computer scientist with an established track record of using portal and dashboard technology solutions to support multi-disciplinary research initiatives; Dr. Nathan Vandergrift, a statistician with experience supporting study design and statistical analysis for non-clinical early phase research and development of infectious disease vaccines and therapeutics; and Dr. Mark Levi, a medicinal chemist with experience as a pharmacology/toxicology researcher and regulatory affairs specialist. Core D will support all CIIG projects and cores with three Specific Aims: 1) Develop and maintain a central resource and data sharing portal to accelerate Center collaboration and product development; 2) Provide study design, data analysis/statistical support to advance Center scientific rigor and data asset dissemination; and 3) Provide regulatory strategy and product development support to shorten the translational timeline for Center products to reach first in human trials. Through the successful delivery of services through these Aims, Core D will support and accelerate CIIG vaccine and antibody product development to combat Neisseria gonorrhoeae, a major antibiotic resistance public health concern.