Drug Development Support for Cancer Therapy Evaluation Program (CTEP)

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE. Title: Drug Development Support for Cancer Therapy Evaluation Program (CTEP) The Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is responsible for the administration and coordination of most of the extramural therapeutic clinical trials supported by the DCTD. CTEP, DCTD has sponsored from 100 to 200 active Investigational New Drug Applications (INDs) with the Food and Drug Administration (FDA) at one time. The current CTEP portfolio encompasses the development of approximately 65 investigational agents on which the Division sponsors approximately 120 active INDs. The sources of investigational agents are typically internally developed NCI agents and those co-developed with pharmaceutical industry collaborators. There are currently approximately 600 clinical studies conducted under these INDs that run the gamut from pilot studies through licensing studies. In addition to single-agent trials, CTEP sponsors multi-agent trials, with either combinations of investigational drugs or biomarker-driven strata of unique agents. Oftentimes, CTEP-sponsored studies contain supporting investigational in vitro diagnostic assays or investigational imaging agents. CTEP-sponsored studies span the purview of Office of Cell and Gene Therapy (CBER), Office of Hematology and Oncology Products (CDER), and Office of In Vitro Diagnostics and Radiological Health (CDRH), requiring expertise in investigational drugs, biologics and assays. The Organization shall provide support to the Cancer Therapy Evaluation Program (CTEP) Regulatory Affairs Branch (RAB) and Investigational Drug Branch (IDB) for a wide range of services including: 1) Providing support for the preparation, tracking, submission and distribution of CTEP drug development related documents and FDA submissions; 2) Monitoring and supporting Adverse Event Reports; 3) Tracking information regarding investigational anti-cancer agents; 4) Providing general technical and administrative support for investigational agent development and regulatory activities and 5) Maintaining a Quality Control Program. The Contractor will also provide similar support for the Cancer Imaging Program, Division of Cancer Treatment and Diagnosis (DCTD) under this Contract. The Contractor shall furnish services, qualified personnel, material, equipment, including secure computers, high speed-high capacity data link to NCI servers, computer support, and facilities not otherwise provided by the Government under the terms of this contract, including maintenance of appropriate software and licenses as needed to perform the clinical research support tasks set forth below. All of the aspects of this in-depth tracking of investigational agent information shall require frequent face-to-face, one-on-one meetings to discuss strategies and tasks and to review and analyze data. The world is currently being conducted under contract HHSN261200800006C held by Technical Resources International. The NCI seeks continuation of services to be acquired through full and open competitive procedures under NAICS 541990. It is anticipated that a cost-reimbursement, completion-type contract with a base period of one year and six one year option periods may be awarded beginning on or about April 1, 2015. The RFP will be available electronically at a later date and may be accessed through the FedBizOpps at www.fbo.gov. WE ENCOURAGE ALL RESPONSIBLE SOURCES, PARTICULARLY SMALL BUSINESSES, TO SUBMIT A PROPOSAL WHICH WILL BE CONSIDERED BY THE AGENCY. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted. IT IS THE OFFERORS RESPONSIBILITY TO MONITOR THE ABOVE MENTIONED SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS.