SRI International, the Menlo Park, CA-based nonprofit contract research giant, is counting on its Michigan office to play a crucial role in the development of a new vaccine.
SRI has been awarded two contracts worth $4.7 million by the U.S. Army’s Joint Vaccine Acquisition Program to test and manufacture a potential new vaccine against Venezuelan equine encephalitis (VEE), a potentially serious viral infection for which there is currently no vaccine that is commercially available.
Housed inside the state-owned Michigan Life Science Innovation Center (MLSIC), SRI’s Plymouth office will conduct clinical testing for the new vaccine. We called Jon Mirsalis, managing director and head of translational development for SRI’s biotech operation, to discuss vaccines, pandemics, bioterrorism, America’s general preparedness for a major infectious disease outbreak, and the role Michigan plays in vaccine development.
SRI was originally established by Stanford University in 1946 to further innovation and economic development in California, but formally separated from the university in 1970. (SRI originally stood for Stanford Research Institute.) A number of “life-changing” technologies have been invented at SRI, Mirsalis says, including Siri and the computer mouse. SRI also got the first U.S. contract to develop treatments for AIDS in 1991.
Today, SRI does contract research across a number of tech sectors for a variety of clients, including those in private industry and government. Mirsalis says he specializes in advancing medical trials for infectious disease treatments.
Although it might not provoke the same bleeding-from-every-orifice horror that Ebola inspires, VEE is “very debilitating,” Mirsalis says. “It makes you really sick and can lead to encephalitis.”
A VEE vaccine does technically exist, but Mirsalis says it’s not effective. The Army is interested in a the vaccine to protect its soldiers from getting sick, whether as a result of biowarfare or managing a civilian outbreak.
SRI opened its Plymouth facility in 2014, and Mirsalis says the company recently hired its sixteenth employee there. SRI chose to set up shop at MLSIC thanks to a cooperative agreement with the Michigan Economic Development Corporation, which operates the building. According to Mirsalis, SRI chose Michigan partly because of the resources devoted to biotech research at the University of Michigan.
“U-M is one of the top recipients of National Institutes of Health funding,” he says. “They’re a major player in biomedical research.”
Mirsalis says the U.S. is better prepared for a pandemic than it was 15 years ago, but there are still challenges to overcome. Big pharma has largely abandoned infectious disease research because there’s not a lot of money to be made compared to, say, cholesterol or erectile dysfunction pills.
“How many people died of Ebola in the West? Not many. So if you were a drug company, would you invest in Ebola or would you invest in hypertension, Botox, and erectile dysfunction? Small to medium-sized companies are still playing in the market, but not big pharma.”
That leaves development of vaccines to the government and nonprofits. The Bill and Melinda Gates Foundation, he says, has spent billions on infectious disease research and vaccine development.
“We collaborate on a lot of this research—we’re very well known in this space,” Mirsalis says. “You kind of have to go through SRI if you want to develop treatments for infectious diseases in the U.S.”
Mirsalis recalls a particularly notable collaboration. When the Ebola breakout occurred in 2014, the U.S. had the world’s supply of the Z-Map vaccine because SRI was working on it with the NIH and the Biomedical Advanced Research and Development Authority (BARDA) “at a leisurely pace,” thanks to a recent cut in government funding.
The outbreak was scary enough to cause people to come together and help. “We changed the study’s design, rounded up all the drug samples, and there was just enough to treat the nine people in the U.S. who were infected,” Mirsalis says.
It’s hard to predict how emergency preparedness will work under a new presidential administration, but Mirsalis doesn’t anticipate huge changes right away.
“I don’t think we’ll have major changes in our biodefense programs because they have wide, bipartisan support,” he says. “Congress just approved a budget that actually added to NIH. We might see some shifts, but politically, I don’t see significant near-term changes. The stability of funding is important, and I think they get that. Many levers move support, and public interest is still a strong lever.”
Mirsalis says that while pandemics and bioterrorism are always a concern, he sees an arguably more pressing threat on the horizon with drug-resistant bacteria, rendering antibiotics ineffective. SRI is already hard at work on a $20 million drug-resistant bacteria project.
“These diseases affect so many people,” he says. “The drugs we use to treat them are