Experimental Therapeutics of Anti-Cancer Agents with Phase I Emphasis

Scope of Work – Subcontract on UM1 CA186712, “Experimental Therapeutics of Anti- Cancer Agents with Phase I Emphasis,” and a supplement, “UM1 Supplement for Early Therapeutic Trials with Phase 2 Intent.” Subawardee: University of Kentucky Research Foundation (UK Markey Cancer Center) The NCI designated UK Markey Cancer Center (UK MCC), including the MCC Clinical Research Network of multiple clinical facilities throughout the state of Kentucky, will serve as a consortium institution evaluating therapeutic agents for phase 1 and phase 2 evaluation. Dr. Robert DiPaola, PI of this subcontract and MPI of the UM1 grant along with Dr. Michael Grever at Ohio State University. Dr. DiPaola shares overall scientific and financial responsibility for the Phase I program, assists with oversight of the ETCTN clinical trials and patient accruals, has joint decision authority regarding selection of projects to pursue, assigns opportunities to investigators, and assists with development of concepts and submission of proposals for consideration to the IDB. Dr. DiPaola attends a monthly OSU meetings (by phone) and other teleconferences as needed, in collaboration with other consortium members. Dr. Susanne Arnold will serve on NCI’s IDB Steering Committee, review all portfolio trials and oversee work for projects involved in the UM1 at UK MCC site. Dr. Arnold will be part of an oversight committee with Drs. Carson and Grever, and consortium representatives and will assure proper regulatory and safety requirements for the clinical trials open under the UM1, as well as the ethical conduct of all clinical and laboratory research activities. Dr. Jill Kolesar, serves on the NCI’s Pharmacology Task force and is a co-investigator. She, along with Dr. Arnold, form the administrative and scientific oversight for the ETCTN trials at the UK MCC site, manage staffing, protocol selection, clinical monitoring and performance of the precision medicine team that is dedicated to early phase trials. Drs. Arnold and Kolesar attend monthly OSU meetings (by phone) and other teleconferences as needed, in collaboration with other consortium members. Additionally, Dr. Kolesar serves as the osimertinib translational scientist for studies 9903, 9898, 9910, performing all needed clinical pharmacology studies. She oversees analytical assay development, validation and performance, performs compartmental and population pharmacokinetic modeling and prepares all reports and manuscripts related to this work. The leadership team will meet in person with other UM1 investigators at a minimum twice annually.