Flexible system to advance innovative research for cancer drug discovery by small businesses. (Fellowships, Grants, & Awards).

Discovery and development of new drugs and biologicals for cancer treatment, including gene therapy and drug delivery approaches, normally involves lengthy and costly projects. The multiple components of the overall process including discovery, efficacy testing, development of lead agents, toxicology and pharmacology, investigational new drug application filing, and clinical evaluation may require years and several million dollars. The small business community is an active participant in the cancer therapy discovery effort. Thus it is important that their innovative ideas be supported. The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs were developed to support innovative research with a commercial intent by small businesses. This program announcement (PA) provides a flexible system within the SBIR and STTR programs to accommodate the special needs of the complex discovery and development process, at least partially, from basic discovery through proof-of-principle demonstration in clinical trials. It is hoped that this initiative will stimulate drug discovery research efforts in the small business community.

This PA must be read in conjunction with the 2001 omnibus solicitation for the NIH SBIR and STTR grant applications, found online at http:// grants.nih.gov/grants/funding/sbirsttr/index.pdf. All of the instructions within the omnibus solicitation apply with the following exceptions: 1) special receipt dates, 2) initial review convened by the Division of Extramural Activities, National Cancer Institute, 3) additional review considerations, 4) more flexible time and budget specifications, and 5) no modular format. Instructions for detailed budgets will be followed.

This PA provides a flexible funding mechanism with regard to budgets and time of award to support the research activities necessary for small businesses to bring their efforts for drug discovery and development to clinical validation. Projects submitted in response to this PA should focus on discovery and development of a specific agent or class of agents. Applications devoted to topics relating more generally to drug discovery such as technology and model development without direct relevance to development of a specific agent are not appropriate.

Flexibility within the PA allows for projects to be presented at all stages of the drug discovery and development process. Projects will be evaluated on overall innovation, strength of the drug discovery approach, and probability of clinical success, with less emphasis on the nature of the specific stage proposed in the application. This latter aspect is especially important if applications are focused on later stages of the drug discovery and evaluation process that may be more routine and often considered less innovative as stand-alone projects.

The deadlines for letters of intent are 8 October 2001 and 6 March 2002, with final applications due I0 April 2002 and 12 November 2002. Institute policy requires that all applicants requesting greater than $500,000 direct costs in any one year must obtain approval from program staff prior to submission of the application. If more than $500,000 per year is requested, this fact must be clearly stated and approval requested in the letter of intent.

Contact: George S. Johnson, Division of Cancer Treatment and Diagnosis, NCI, Executive Plaza North, Room 8152, MSC 7456, 6130 Executive Boulevard, Bethesda, MD 20892-7456 USA, 301496-8783, fax: [phone], e-mail: johnsong@ exchange.nih.gov. Reference: PA No. PA-01-091