Administrative Core

PROJECT SUMMARY / ABSTRACT: Administrative Core The goal of the Administrative Core is to promote an environment of communication and collaboration among Penn State TCORS investigators, across TCORS, and with CASEL and FDA and NIH staff. To accomplish this, the Core will work closely with our TCORS components to establish the governance procedures, prioritization, interaction, feedback and communication within the TCORS including its affiliate University of Texas MD Anderson Cancer Center. The Administrative Core will oversee the fiduciary, ethical and legal responsibilities of the TCORS and its members. The Core will manage and assume responsibility for responding to the prioritizations of the FDA, NIH and the TCORS funding opportunity announcement. This includes the conduct of scientific studies within the scientific domains of the RFA, forming an External Advisory Board (EAB) and arranging for annual meetings with NIH officials and the EAB. The Core will assume the responsibility for the Center’s rapid response capability, and adhering to recommendations and requests from the EAB, the Internal Advisory Board, CASEL, national TCORS working groups and initiatives. The Administrative Core will work to be at the forefront of FDA tobacco regulatory law, utilizing its EAB and Admin Core experts in regulatory law and tobacco regulatory science to guide our activities. The Core will encourage TCORS members to assume leadership positions in the national TCORS initiatives on working groups, webinars and other venues. The TCORS will be supported by the Penn State College of Medicine Center for Research on Tobacco and Health, which facilitates and coordinates tobacco research across the Departments and Graduate training programs in the College of Medicine The Steering Committee includes faculty members who have collaborated for many years on tobacco control and interdisciplinary tobacco research. The Steering Committee will meet at least weekly to insure that the Center adheres to state of-the-art science, its integrative theme, and make recommendations for changes in direction if necessary. The Core will insure that all activities, including career development, pilot projects, major projects, and collaboration with other TCORS are responsive to FDA regulatory needs and its authority. Based on the Penn State TCORS (2014-2019), which included many of the same PIs and Co-Is, we have had significant experience in the administration of a TCORS both locally and nationally. A key component of the Core is overseeing the Career Enhancement and Training Core. Our previous TCORS had over 20 trainees, many of which have received their own funding including NIH training grants, are now fully employed at the FDA Center for Tobacco Products, or have attained faculty positions at Penn State or elsewhere. The Career Enhancement Training Program is led by two former trainees, who are now faculty, and well positioned to continue the training and career development of the next generation of tobacco regulatory scientists.