The FDA Division of Oncology Initiative with the NCI SBIR/ STTR Programs

Abstract

3173 Small businesses normally do not have a complete range of expertise and resources necessary to bring products to market from initial discovery through the expensive development phases. The NCI and other federal institutions support the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs to help fill this need. The SBIR and STTR programs are granting programs for small business and provide a mechanism for small business to collaborate with research institutions to engage in federally funded research and development. The goal of these programs is to provide resources for innovative research for discovery and early-stage development to ensure that interested commercial partners will continue product development and, ultimately, bring a new product to market. The CDER Division of Oncology Drug Products (DODP) has collaborated with the NCI to establish educational and training resources for the NIH SBIR/STTR program grantees. Grantees’ lack of regulatory knowledge necessary to file Investigational New Drug Applications (INDs), for product development may lead to inefficient use of resources, lost opportunities, and potentially to premature termination of development. The DODP team has been working with the NCI SBIR/STTR program managers to identify specific issues leading to these inefficiencies and to develop novel solutions. DODP reviewers presented an overview of the regulatory requirements for submitting INDs for oncology drug products at the annual NIH SBIR/STTR conference (http://grants.nih.gov/grants/funding/SBIRConf2004/presentations.htm). We will present an overview of the DODP-SBIR/STTR interaction and discuss the chemistry, pharmacology/ toxicology, and clinical regulatory requirements for submitting an IND. No significant financial relationships to disclose.