MENLO PARK, Calif.-SRI International announced in mid-November a $15.5 million seven-year contract renewal from the National Institute of Allergy and Infectious Diseases (NIAID), of the National Institutes of Health (NIH). SRI will continue providing preclinical services for development of drugs and therapeutic vaccines for treating HIV and infections related to HIV and AIDS.
"The program started in 1991, and this is actually the fourth contract we've had," says Jon Mirsalis, Ph.D., managing director of SRI's Biosciences Division and principal investigator for the program. "It's basically all of the biological services to take a drug candidate all the way to an IND application." SRI has two other current contracts with NIAID covering programs for other infectious diseases and biodefense.
Mirsalis says work under the HIV/AIDS program breaks down into three areas: pharmacology, toxicology, and developing new assessment models. The last category encompasses varied projects, and he cites as one example cytokine assays to determine irritation from vaginal microbicides that block HIV transmission. Another: "Developing better predictive in vitro models for assessing what we call the drugability of compounds," says Mirsalis, adding that developing new technologies "makes this a particularly fun contract, by the way."
Michael Ussery, Ph.D., chief, Drug Development and Clinical Science Branch Division of AIDS at NIAID, said the AIDS-related contract is one of a package of contracts in his branch that meet pharmacology and toxicology needs of academic investigators and businesses, usually small companies. The relatively small contract amount means "there are only a half dozen to a dozen studies that we can do in one year." Ussery considers single- and multiple-dose toxicity work with dogs, rodents, and nonhuman primates "the bread and butter of this."
Although NIAID has renewed SRI's AIDS program contract multiple times, Eileen Webster-Cissel, AIDS Research Contracts Branch, Office of Acquisitions, Division of Extramural Activities at NIAID, emphasizes that the program looks at competitive solicitations. "We negotiate and we make a contract award for the best value to the government," says Webster-Cissel.
Value includes more than drawing maximum biological services from contractors. "We just want to see more treatments available for patients," says Ussery, so SRI and NIAID also facilitate relationships for companies, leveraging connections with the NIH and the FDA. Pre-IND meetings, says Ussery, help reduce wasted time for busy companies that aren't always sure how to prepare documentation.
SRI's broad experience with basic research, drug discovery, and contract services spans three areas-neuroscience, cancer, and infection-that complement each other and provide further connections for small companies receiving services under NIAID contracts.
Mirsalis says SRI's activity in infectious disease is particularly gratifying because it covers illnesses that kill people around the world but aren't of much interest to the pharmaceutical industry because they don't affect many Americans.