Bill Gates’ $25 million gift to aid vaccine research
Foundation will support innovative approaches
Sequella Global TB Foundation will take a $25 million gift bestowed by Microsoft mogul Bill Gates and use it to start preparing for clinical trials of TB vaccine candidates. In addition, the foundation will subsidize innovative projects in vaccine development that otherwise might be passed over, says Larry Geiter, PhD, who is the sole employee of founder and director Carol A. Nacy, PhD.
The plucky, two-person shop in Bethesda, MD, along with an equally tiny sibling, a for-profit company called Sequella Inc., specializes in what’s known as "translational research." Simply put, that’s the knack for picking potential hits from an array of existing bench-science technology and discoveries and then figuring out what clinical studies or other refinements are needed to make the discovery appealing to industry.
Nacy says she’s still getting used to the transforming effect of a gift that rivals the giant National Institutes of Health’s (NIH) entire budget for TB research. "It’s like, wow, we do exist! We’re a real program!" she says. "We’re still a little bit in shock. I’m not certain if Larry’s gotten up off the floor."
Once he does, the first order of business will be to assemble a panel of core scientists who will direct basic research. A second panel of TB experts will begin developing criteria for site selection and characterization for the clinical trials.
In Capetown, South Africa, a Sequella-supported trial of BCG, which compares the efficacy of two methods for administering the TB vaccine, is almost ready to begin. "We’ve already established close ties with our colleagues in Capetown," says Geiter.
Along with providing some information that should prove helpful to South Africa, the Cape-town work will serve as a warm-up exercise for the foundation as well.
Finally, the "innovative grants program" will target TB vaccine research that’s promising yet so innovative it might not get a fair shake in more traditional quarters.
Supporting TB vaccine research was the next logical step in the path set out by the Bill and Melinda Gates Foundation, says Nacy. "They’d done malaria; they’d done children’s vaccines; and they’d done HIV," she notes. "TB was the next logical disease for them to wrap their arms around."
For Gates, vaccine development holds the same fascination it does for the more esoteric world of TB researchers, says Jack Farris, a foundation spokesman.
"Vaccines are the single most powerful way to make significant gains in health on a global basis," he says. "The idea of being able to leverage our current knowledge to fight this terrible scourge is extremely appealing."
For Nacy, the fascination with TB vaccines arrived in a more roundabout way. After a stint as an immunologist at Walter Reed Army Medical Center in Washington, DC, she decided to test the waters of capitalism and helped found a biotech company. Called EntreMed, that company made headlines with researcher Judah Folkman’s purported anti-cancer discoveries, endostatin and angiostatin, neither of which seems to have lived up to the media hype.
These stats were awful!’
Nacy left EntreMed and was tapped to serve on a panel of experts asked to review the past five years’ worth of work at the NIH’s extramural TB program. The experience proved an epiphany, she says. "Here I was, someone who’d been an academician and an immunologist all my life, and I simply could not believe the TB statistics I was hearing. I kept wondering where I’d been all my life. These stats were awful!"
Just as strange, it seemed to her, there was plenty of good research being done on the problem; the trouble, as a long line of experts attested, was a total lack of interest from industry.
"That just didn’t make any sense," Nacy says. She left the NIH review determined, as she puts it, "to find a way to help the TB research community."
The upshot was Sequella Inc., which Nacy started in 1997 along with Leo Einch, PhD, who now serves as president. A bit later, Nacy started Sequella Foundation; the intent was to use the foundation’s resources to give an extra push to new technology or research that, though promising, wasn’t as close to being ready for prime time as some other work might be.
Thanks to her track record at EntreMed, Nacy brought more than just good intentions to her self-appointed task. "She’s someone who — how does the saying go? — can walk the walk and talk the talk, on both the industry and the science side of the street," says Geiter. "That’s a pretty unusual combination of qualities. Working with Carol, I’ve really learned a lot. She knows how to talk about marketability, and she knows what buttons to push."
That means looking at something from the standpoint of industry and then being able to see how to fill in the gaps. "We work with the investigator to see what needs to be done to provide so-called proof of principle’ — the de facto evidence that you have something that will actually work in people," Nacy says. "Scientists get wrapped up in finding the answer to whatever mystery they’re trying to solve," she adds. "These aren’t usually the kinds of things they typically think about."
Sequella offers other services as well. There’s a Bio-Safety-Level-3 laboratory, and Nacy and Einch are savvy about technology transfer issues and intellectual property rights. Nacy has a keen eye for what makes a proposal look good to an industry type, as opposed to a grant reader.
The foundation director’s enthusiasm is contagious. She refuses to buy into the gloomy conventional wisdom that TB is a disease afflicting mainly countries that are much too poor to pay for a cure.
"The World Health Organization, among others, has done a very good job of positioning TB as a charity case," she says. "The truth is that $4 billion is spent each year on TB therapeutics and diagnostics — and two-thirds of that is spent in developed countries."
That’s a no-brainer, by Nacy’s reckoning. Given a good product that costs about $10 a pop, why wouldn’t the entire United States, Western Europe, and Japan — where treating an uncomplicated case of TB runs to $20,000 — snatch up a new vaccine? As for developing countries, conventional marketing and distribution strategies don’t apply; instead, she explains, the World Bank makes a big loan, and a developing country buys what it likes from the authorized procurement list.
This reminds her of another point: Recently, the Institute of Medicine (IOM) published a list of the top 30 diseases for which finding a good vaccine would substantially shrink U.S. health care costs. Guess what supposedly third-world-only pathogen landed in the No. 15 spot?
Thinking and working creatively is easier if you’re small, Geiter and Nacy agree. "I think it helps that we’re not the government, and so we’re not bound by a lot of restraints," Geiter says. Adds Nacy with a laugh: "I always tell Larry, Let us think good thoughts.’"
Geiter, with his background in public health, brings a different set of strengths to the table, adds Nacy. The onetime chief of the TB research branch of the Division for Tuberculosis Elim ination at the Centers for Disease Control and Prevention, Geiter has worked as freelance consultant to the WHO and the International Union Against Tuberculosis and Lung Disease, among others.
After Nacy hired him, with no money in the foundation’s bank account, she "loaned" her new employee to the IOM, where he’s spent the last year leading that august body’s look at TB programs in the United States.
The IOM stint has honed Geiter’s already keen sense of what TB programs need, Nacy says. "Larry’s got a genuinely human touch," she adds. "He’s also brought a wealth of experience in public health that’s made a huge difference."
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