Net Effect - Pharmaceutical Executive

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Net Effect


Pharmaceutical Executive


This year or maybe next, if all goes as planned, a GlaxoSmithKline scientist named Ripley Ballou may finally win approval for a vaccine he started testing as an army physician more than 25 years ago—an advance that could mark the beginning of a whole new phase in the battle against one of the world's great killers: malaria.

Ballou hadn't plan on going into research. He grew up an army brat, entered West Point in the late '60s, and proved himself a model cadet. But then one day, while standing sentry duty, a Vietnam War protester slipped a flower into the barrel of his rifle. Rip had a change of heart, and traded West Point for Georgia Tech, where he studied biology and envisioned a career in medicine.


To be effective, malaria efforts must reach the poor in remote villages. Social marketing events, like the one Novartis sponsored in Ifakara
The army is tough to escape, though. Upon college graduation, Ballou couldn't afford med school, so he accepted a military scholarship and the four years of service that came with it. His internship led him to Walter Reed Army Institute of Research in Washington, DC. There, in 1981, his lab chief assigned him to the world's first recombinant malaria vaccine study.

"At the time, there was this overexuberant expectation that we were going to very quickly develop a vaccine," says Ballou, now 53.


Tanzania highlight the importance of using bed nets.
As the primary investigator, Ballou gathered his army research pals and persuaded them to join him in participating in the study—as subjects. They all received the vaccine candidate dubbed RTS,S and let malaria-infected mosquitoes settle in for a blood meal. Before long Ballou and company showed the familiar symptoms—raging fever, shivers, and massive headaches—all except one volunteer, for whom the vaccine apparently worked. Ballou had hoped for a higher success rate, but he took this promise as proof: A malaria vaccine was possible.

Today, Ballou is still chasing that dream. In 2008, GSK will deploy the first-ever multicenter Phase III vaccine trial conducted with GCP standards in sub-Saharan Africa. Its subject: the latest iteration of RTS,S. Ballou hopes that, after many years spent improving it, the vaccine will offer hope to the 300 million people infected by the microscopic parasites.

The World Health Organization (WHO) reports that 90 percent of the 1 million-plus annual global malaria deaths occur in sub-Saharan Africa, where the disease is the leading killer of children under five. It also disproportionately affects pregnant women, whose immune response is lowered. Until recently, the global health community had all but given up in the fight against the deadly disease. But in the past two years, efforts signal a renewed commitment:

Malaria is stepping out of the shadows with events like the Presidential Malaria Initiative (PMI), chaired by First Lady Laura Bush in December, after two decades that saw the explosion of the HIV epidemic.

WHO has issued its first new treatment guidelines in 20 years, calling for countries to switch to newer, more effective antimalarials.

There is growing support to deploy all the weapons in the malaria arsenal, including drugs, diagnostics, vaccines, bed nets and—after WHO reversed a 30-year-old policy against the pesticide DDT last year—insecticides.

Researchers are creating programs to better understand drug resistance, so health officials can try to prevent it.

New funding incentives to engage pharma companies—including major grants from the Bill and Melinda Gates Foundation—signal a pathway through which industry can become more involved with malaria research.

Taken together, these events point the way forward for a new era in the fight against malaria. "The fact that malaria could be eradicated is a concept that is now getting back on the agenda," says Christopher Hentschel, CEO of the Medicines for Malaria Venture (MMV), a key nonprofit drug developer.

But ask Rip Ballou, and he'd say progress has been a long time coming.


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