Drug Development Support for the Cancer Therapy Evaluation Program (CTEP)

The Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute's (NCI) Division of Cancer Treatment and Diagnosis (DCTD) has a continuing requirement for providing support to the Investigational Drug Branch (IDB) and Regulatory Affairs Branch (RAB), CTEP. Specifically, the support required encompasses a wide range of services, including: 1) providing assistance with Investigational New Drug Applications (INDs); 2) information management; 3) assessment of Adverse Events (AEs); and 4) logistical and clerical support. In addition, the Contractor shall furnish all services, qualified personnel, material, equipment (including secure computers and computer support) and facilities not otherwise provided by the Government under the terms of the contract, including maintenance of appropriate software licenses, as needed, to perform the clinical research support tasks required by the contract. Major tasks required of the Contractor include the following: A. Provide support for investigational agent development, clinical research information management, adverse event reporting and assistance in writing and organizing INDs and Master Files (MFs), which includes the following subtasks: 1) Assist in the preparation of approximately ten to twenty (10-20) INDs and MFs per year; 2) Assist in the preparation and submission of up to five (5) Investigational Device Exemptions (IDEs) with the Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA) per year; 3) Maintain Investigational New Drug (IND) files; 4) Update NCI MFs from data provided by RAB (e.g., clinical protocols, preclinical toxicology, chemistry and manufacturing information); 5)Monitor and maintain collaborative research agreement records; 6) Prepare, for IDB staff on a quarterly basis, or in some cases on an as needed basis, summary tables from information in the CTEP informatics databases updating clinical trial status, accrual, response results and AEs; 7) Prepare and edit IND FDA Annual Reports for each active IND for submission to the FDA in accordance with FDA requirements; 8) Prepare approximately five (5) Investigator's Informational Packets per year--from information provided in the INDs, the CTEP enterprise systems including the Clinical Data Update System (CDUS), appropriate literature and other sources--when the IND does not have a CTEP or pharmaceutical collaborator; 9) Attend scientific meetings, meetings with pharmaceutical collaborators and/or meet periodically with Clinical Investigators and Data Managers involved in the conduct of CTEP-sponsored clinical trials to organize and discuss study results and data retrieval; 10) Draft written responses--for IDB physicians to investigators who have submitted protocols or Letters of Intent (LOIs)--reflecting the discussions of the Protocol Review Committee regarding the protocols and LOIs; B. Monitor and Support Adverse Event Reporting, which includes the following subtasks: 1) Provide telephone answering services on the CTEP AE reporting telephone line (called AdEERsMD) Monday through Friday from 7am-8pm (except for holidays); 2) Receive, prioritize and direct all incoming queries from clinical investigators regarding AE reporting and use of Adverse Event Expedited Reporting System (AdEERS) to appropriate CTEP or Contractor staff during business hours; 3) Receive, analyze, organize and prepare AE reports from information received via AdEERS in accordance with IDB Senior Investigator instructions and FDA requirements. 4) Enter and maintain AE data in appropriate computerized databases; 5) Set up an electronic mail (e-mail) mailbox to receive adverse event reports from pharmaceutical collaborators and review/share with appropriate IDB drug monitor; 6) Provide written review of the adverse event reporting section of clinical protocols submitted to the Protocol Review Committee (PRC), CTEP; C. Track information regarding investigational anti-cancer agents, which includes the following subtasks: 1) Maintain IDB drug development plans and prepare quarterly/annual reports for project planning; 2) Maintain the Informatics Project for Agents and Diseases (iPAD) database and enter information into iPAD regarding pivotal non-NCI studies performed by pharmaceutical collaborators; 3) Maintain project plans for each investigational agent in development; 4) Maintain an up-to-date Drug-Disease Matrix which tracks investigational agents available for study in standard diseases; 5) Survey, retrieve and assemble clinical and supportive data on each IND agent; 6) Establish and maintain comprehensive reference databases of articles pertinent to the investigational agent and monitor published literature relevant to investigational agents, including as necessary, conducting literature searches or obtaining copies of scientific articles as requested by Program Staff; 7) Prepare quarterly/annual reports regarding agent and disease development plans using data in the CTEP enterprise system; D. Provide general administrative support for investigational agent development and regulatory activities, which includes the following subtasks: 1) Distribute (electronically) relevant investigational agent development information to investigators; 2) Prepare slides for presentations from data made available to the Contractor; 3) Organize and maintain supplemental investigational agent information files by investigational agent; 4) Maintain, store and provide to CTEP, Investigator's Brochures, Annual Reports, active and inactive INDs, including all amendments to the IND and other archived material; 5) Store electronic copies of IND Annual Reports, prepared in mandated electronic formats (read-only MS Word or PDF) and provide electronic delivery of these reports within 1 hour upon request; and E. Establish, implement and maintain a Quality Control Program, which includes the following subtasks: 1) Establish and put into place written procedures to allow the effective continuation of work in the event of personnel changes/absences; 2) Establish Standard Operating Procedures (SOPs) for performing the tasks outlined in the Statement of Work and utilize those SOPs as part of a comprehensive plan to demonstrate the Contractor's compliance with FDA regulations and CTEP requirements. In addition to the above, all eligible offerors must document the ability of their staff to meet frequently/or on short notice (within the workday), face-to-face with CTEP Program Staff. This is a recompetition of a previous requirement and the Government anticipates that one (1) contract will be awarded on an incrementally funded basis for a period of seven (7) years. The Government's estimated requirement is 71,136 labor hours per year, for a total of 497,952 labor hours over the total 7 year period. Additionally, the Government anticipates including the following options for additional labor hours, as follows: Option # 1 is estimated at 7,280 labor hours per year, for a total of 50,960 labor hours over the total 7 year period; and Option # 2 is estimated at 8,320 labor hours per year, for a total of 58,240 labor hours over the total 7 year period. RFP No. N02-CM-81000-48 will be issued on or about November 19, 2007 with a due date for proposal receipt on or about December 19, 2007. The RFP will be available at the website of the Office of Acquisitions (OA), NCI, at the following url: http://rcb.cancer.gov/rcb-internet/ . The NAICS Code is 541990. Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. No Collect Calls will be accepted.