RECOVERY - ACTNOW "Early Therapeutics Development with Phase II Emphasis"

This contract amendment provides additional funding for the ACTNOW Clinical Trial 8376, focusing on Phase 2 and early clinical trials of National Cancer Institute (NCI)-sponsored agents. The goal is to investigate the biological effects of these agents on molecular targets, explore promising combination therapies, and determine clinically relevant outcomes and correlates. The work emphasizes rapid initiation, completion, and data reporting of high-priority studies critical for drug development. Payment is structured based on patient accrual, with a fixed price paid for each patient enrolled, alongside cost reimbursement for non-patient care expenses. This arrangement addresses the uncertainty in predicting patient enrollment, making a cost reimbursement contract more appropriate than a fixed-price model. The contract supports early therapeutic research through pilot protocols and pivotal studies, facilitating the evaluation of NCI agents’ clinical efficacy. The solicitation, titled "RECOVERY - ACTNOW 'Early Therapeutics Development with Phase II Emphasis,'" was posted in September 2009 under solicitation number N01-CM-62204. Key contacts for the contract include Contract Specialist Michael P. Marino and Contracting Officer Richard L. Hartmann, who oversee contract administration and coordination. The contract is categorized under NAICS code 541711, which pertains to research and development in biotechnology.