National Cancer Institute, Research Contracts Branch, TCS, 6120 Executive Blvd, EPS/RM 603 Bethesda, MD 20892-7220

R -- DRUG DEVELOPMENT SUPPORT FOR THE CANCER THERAPY EVALUATION PROGRAM SOL N01-CM-77019-08 DUE 071996 POC Todd C. Cole, Contract Specialist, (301) 496-8620 or FAX (301) 402- 6699. One five-year incrementally funded contract is expected to be awarded in order to assist the Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment, Diagnosis and Centers (DCTDC), National Cancer Institute (NCI). The Government's requirement is 27 FTEs per year totaling 135 FTEs over the five-year period of performance. The Cancer Therapy Evaluation Program is responsible for administration and coordination of most of the extramural clinical trials supported by the DCTDC. It is also responsible for the development of more than 200 agents on which the Division has filed more than 200 Investigational New Drug Applications (INDs) with the Food and Drug Administration (FDA). The CTEP must prepare and file INDs for the agents it sponsors in clinical trials. As the sponsor of these agents, DCTDC must design a plan for the efficient evaluation and development of these agents and monitor the safety, efficacy and drug distribution of the agents in the trials it sponsors, tracking the progress of the studies both administratively and scientifically, report adverse event reactions in a timely manner and prepare IND annual reports for submission to the Food and Drug Administration (FDA), and other special reports and manuscripts. CTEP must also submit amendments to the INDs it sponsors including new protocols, protocol amendments, adverse event reaction reports, updated chemistry and manufacturing information, compassionate exemptions and responses to FDA communications. The Contractor shall provide support for a wide range of services related to these responsibilities. To help the Investigational Drug Branch (IDB) of the Cancer Therapy Evaluation Program fulfill its responsibilities as an IND Drug Sponsor, the Contractor shall provide support for investigational agent development and clinical research information management. The Contractor shall be responsible for informaton and data collection/compilation, maintenance and retrieval, technical report and manuscript preparation, monitoring of clinical activities, administrative coordination, and general logistical support, particularly in the area of investigational agents. The Contractor shall maintain up to date project plans and maintain databases relating to various aspects of drug development. To assist the Regulatory Affairs Branch (RAB) of the Cancer Therapy Evaluation Program in fulfilling its responsibilities as an IND sponsor, the Contractor shall provide assistance in writing and organizing Investigational New Drug Applications (INDs) (approximately 25-35 per year) from data provided by RAB. The Contractor shall make copies of all IND submissions and deliver them to the FDA. The Contractor shall maintain existing databases for Adverse Event Reports ( AER reports) for both commercial and investigational agents. The Contractor shall maintain additional databases for FDA communications tracking, Cooperative Research and Development Agreements (CRADAs) and Clinical Trials Agreements (CTAs) as well as IND status. The proposed contract is 100 percent set-aside for small business concerns with a SIC code of 7375 ($14.5M). NO collect calls will be accepted See Numbered Notes(s): 1. (0180)

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