Dr. Trent serves as Director, Scientific and Regulatory Affairs in the Office of Nonclinical Regulated Studies (ONcRS). The ONcRS's primary responsibility is to work with academic researchers who are doing product-oriented research and to help them design and conduct their studies to meet regulatory requirements by assuring regulatory compliance, quality assurance and data management. This requires development and implementation of data management and quality control/systems and procedures. Statistical design and analysis is implemented for each activity conducted in the product development plan. Conduct of human trials and licensure of products for human use requires strict adherence to FDA regulations and guidance, including conduct of animal studies and assays under Good Laboratory Practice (GLP) guidelines and the manufacture of the product under cGMP and quality assurance documentation to support adherence in these areas. The ONcRS will provide assistance in the implementation of regulatory requirements through workshops, classes and hands-on instruction to the scientific community.
His laboratory will focus on the development of Dengue (DEN) virus vaccines that are more immunogenic and safer than what is currently available. The antigenic structure of the DEN virus envelope (E) protein and identification of CD4 T cell epitopes will be investigated to identify conserved peptides involved in stimulation of DEN virus (protective type) specific antibodies. The immunological impact of the DEN subtype-specific CD4 T epitopes expressed in both DNA and virus-like particle DEN vaccines to stimulate production of protective type specific antibodies will be determined. His lab will also examine different prime – boost strategies using live attenuated and DNA vaccines to reshape the long-term immune landscape with engineered DNA vaccines so that subsequent exposure to either wild type virus or vaccine boost will stimulate a safe and protective immunity profile.