Contact:
Rosemary S. L. Wong, Ph.D.
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard
EPN6015A, MSC 7440
Bethesda, MD 20892-7440
Telephone: (301) 496-9360
E-mail: rw26f@nih.gov
Objective of Project:
The small business community has been very active in the innovative development and production of a variety of commercializable biomedical research and technology products since the inception of the SBIR/STTR programs in 1982 and 1992. There are certain types of biomedical research that require clinical evaluation and Federal regulatory approvals before the Phase III part of the small business research pathway to commercialization can ever be realized. However, the progress made by the SBIR/STTR businesses in translating their new discoveries and technologies into clinical benefit for the cancer patient has been hampered by the lengthy research and development (R & D) process and costs required before commercialization. As a way to alleviate some of these extramural funding issues and also to better utilize the SBIR/STTR set-aside funds more effectively, this initiative will provide competing continuation funds for up to 3 additional years to qualified Phase II grantees that have developed promising anticancer agents or biologics, new devices, biomarkers or assays intended to understand, diagnose, prevent or treat human health disorders. These funds will enable businesses to complete: 1) the necessary preclinical research and development needed for pre-IND or IDE filing or 2) other processes needed to meet the requirements and expectations of Federal regulatory agencies including clinical evaluation for safety, toxicity and effectiveness. The products may include, but are not limited to: drugs, vaccines, radioligands, biomarkers, medical implants, imaging protocols proposed for clinical use, instrumentation software, medical devices, etc.
Description of Project:
The competing continuation Phase II SBIR/STTR applications would represent a logical continuation of support for research and development of the previous work funded by the original Phase II grant. It is expected that promising results from a previous SBIR/STTR Phase I and Phase II grant will indicate the merit of further research and development. Clinical investigations and Federal regulatory approvals will ultimately be required to realize the potential of the product being researched and developed for translation into the clinic.
Activities supported by a competing continuation of a Phase II SBIR/STTR grant may include an extension and expansion of preclinical research and development, clinical testing, and other scientific research and development activities needed to meet the requirements and expectations of Federal regulatory processes.
These competing continuation applications will compete with all SBIR/STTR applications, be reviewed according to the customary peer review procedures for SBIR and STTR mechanisms and be funded from the appropriate set-aside programs.