National Institutes of Health: Innovative Toxicology Models for Drug Evaluation
December 1, 2000
Funding News
National Institutes of Health: Innovative Toxicology Models for Drug Evaluation
The National Institutes of Health (NIH) recently issued a program announcement for the development of models for rapid efficacy and toxicology evaluations of novel drugs. This initiative is intended to encourage the small business community to develop, standardize, and validate new and innovative assays to determine or predict specific organ toxicity.
This program would be available through the National Cancer Institute as well as other branches of the NIH such as the National Institute of Diabetes, Digestive and Kidney Diseases, and the National Institute of Drug Abuse. The NIH is looking to further recent advances in the field that have allowed the rapid synthesis of new chemical compounds as well as the identification and characterization of their protein targets.
Currently, studies normally are performed on intact experimental animals of two species in order to satisfy the requirements of the Food and Drug Administration for an investigational new drug application (determination of the maximum tolerated dose, dose-limiting toxicities, scheduled dependency of toxicity, reversibility, and safe clinical starting dose). The development of high throughput screening may allow the identification of hundreds or thousands of agents that would be considered for serious clinical evaluation, decreasing the cost and length of the development process of these potentially useful therapeutic agents.
The mechanism of support through this program is a set-aside program administered through R41, R43, R42, and R44 mechanisms or through the FAST TRACK option. Applications are open to any small business, independently owned by a U.S. citizen or permanent resident and located within the United States. Phase I and Phase II trials must be performed within the United States. Deadlines for applications are Jan. 11, 2001, and Nov. 14, 2001. For more information on award amounts for each mechanism and application requirements, please visit http://grants.nih.gov/grants/guide/pa-files/PAR-01-004.html.
National Cancer Institute and National Institute of Dental and Craniofacial Research: Molecular Epidemiology of HIV-Associated Cancers
The National Cancer Institute and the National Institute of Dental and Craniofacial Research have invited grant applications for interdisciplinary studies of molecular epidemiology and the role of cofactors in the development of pre-neoplastic and neoplastic conditions occurring among persons infected with HIV.
Of particular interest are those cancers associated with DNA viruses such as the human papilloma virus, Epstein Barr virus, and the human herpes virus 8. Important cofactors of interest would include genetic susceptibility and phenotype, age, and other factors affecting the host’s immune response.
Grants awarded through this program will be issued through the "modular grant" and "just-in-time" mechanisms. The total requested period of support will be five years or less, and applications are open to both domestic and foreign researchers at for-profit, not-for-profit, public, and private institutions. This program announcement is intended to encourage research on the molecular and social epidemiology of pre-neoplastic conditions among HIV-infected persons. Emphasis is placed on an interdisciplinary approach, linking the expertise of basic scientists with epidemiologists, clinicians, and behavioral scientists. Because this program announcement utilizes the modular grant concept, only limited budgetary information is required in the application. Modular grant applications may request direct costs in $25,000 modules up to a total direct cost request of $250,000 per year. Applications are made on the standard form PHS 398. Further information on the "modular grant" in time mechanisms is available at http:\\grants.nih.gov\grants\funding\modular\modular.htm. For specific information on the molecular epidemiology of HIV-associated cancers program announcement, please visit http://grants.nih.gov/grants/guide/pa-files/PA-00-086.html.
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