Project Summary/Abstract - Regulatory Science Core Establishing early a regulatory-enabling research framework is essential for the successful translation of promising target biomedical discoveries especially targeted to the next “Disease X” and respond to the 100 Days Mission (100DM) as well as ASPR Next of the US government. For vaccines and therapeutics, such a framework would accelerate the technology transfer of novel and promising candidates into the manufacturing and toxicology testing stages and would ensure robust preclinical data packages used in the compilation of regulatory dossiers to initiate the clinical testing. A Consortium-wide Regulatory Science Core, aligned and integrated with the other cores, especially the Data Management Core, will be created to prepare, guide, assess and ensure that all research and development (R&D) efforts of the consortium projects are embedded in a regulatory- enabling and Total Quality Management System (TQMS) environment supporting the rapid translation and readiness of new vaccine candidates towards their suitability for technology transfer to GMP pilot manufacturers, GLP toxicology testing and prepare a smooth adaptation to seek regulatory approval for their entry into clinical trials. The expectation is that having access to such a core, the grant R&D efforts will result in high-quality vaccine prototypes with robust preclinical data packages leading to efficient and rapid transitions into manufacturing and toxicology testing and accelerating regulatory approvals for the entry into the clinic. The Regulatory Science Core will have the following aims: 1) Establish a consortium-wide regulatory-enabling TQMS adapted to the needs of the consortium to accelerate the development timelines of the novel vaccine prototypes. Briefly, an initial landscape assessment will give insights of the levels of regulatory-enabling and quality processes and tools used by consortium members. Subsequently, a set of standardized and harmonized templates and tools will be generated for consortium use and lastly a digital cloud-based document control system to centralize and archive documents will be created; and 2) Monitor and evaluate consortium-wide quality improvements by establishing a plan for continuous monitoring and evaluation of the TQMS and strengthen the consortium performance, time management and pre-investigational new drug (pre-IND) Go/NoGo decision points and be more efficient in achieving the project milestones. A continuous and sustainable quality learning environment will build self-reliance and self-sufficiency thus become better prepared for any emerging pandemic. Overall, including a regulatory science core in this proposal is the generation of a comprehensive system that enables and is aligned with regulatory requirements such that the novel vaccine candidates emerging from this consortium can be ready to advance into the critical phases of development if an emerging pandemic caused by one of these ...