A Businesslike Approach
Nonprofit Aeras Has Developed a Drug 'Pipeline' to Try to End TB Scourge

By Justin Gillis
Washington Post Staff Writer
Thursday, March 23, 2006

A man named Jerald Sadoff rushes from room to room down a corridor sealed by air locks from the outside world, pointing toward elegant contrivances of pipes and valves and vessels. Afternoon sun filters through thick plate windows, and stainless-steel surfaces gleam.

"A little jewel," Sadoff declares.

On first glance, this new drug-production line in Rockville looks like the ones built by many of the biotechnology companies lining the Interstate 270 corridor. But Sadoff is no corporate chieftain, and the organization he heads is not out to make millions. Instead, it is a prime example of a group of charitable outfits trying to develop a new approach to the world's biggest medical problems.

In a few years, Sadoff's shiny drug factory could well be the focus of a fresh global assault on tuberculosis, one of humanity's great scourges.

The Aeras Global TB Vaccine Foundation has set out to give the world its first new tuberculosis vaccine since 1921, a product that public health doctors hope will cut the staggering annual toll from tuberculosis. Though nearly forgotten in rich countries such as the United States, the lung ailment sickens many millions of people every year and kills nearly 2 million of them.

The 1921 vaccine, to this day the most widely used vaccine in the world, protects babies from the worst forms of TB but doesn't do much to cut the toll in adults. Backed by tens of millions of dollars from the Bill and Melinda Gates Foundation, Aeras is working on an improved vaccine that might finally banish the disease.

Gates money has been used to set up numerous charitable enterprises devoted to tackling AIDS, malaria and a slew of other problems that afflict poor countries. With encouragement from the Gates Foundation, these organizations have been stealing ideas from the business world.

They have set themselves up like small drug companies, investing in multiple drugs or vaccines at once in hopes that at least some will survive rigorous human tests and prove useful. Drug companies call this a "pipeline," and it's an explicit hedge against failure -- an acknowledgment that the usual fate for a new drug or vaccine is to eat up millions in development costs and then crash in the final stages of human tests.

It's an expensive approach, and rarely have health-care charities had the money to try it on a grand scale. That is changing fast as the Gates Foundation, the world's largest charity, pours billions of dollars into global public health campaigns. (Melinda Gates is a board member of The Washington Post Co.)

Aeras, with $108 million in Gates money, has gone further than any of the other Gates-funded groups. Not only has it set up a pipeline, but it has now built a $10 million drug factory that will allow it to produce any vaccine that emerges from the far end of that pipe. Except for its nonprofit charter and its financing, Aeras is hard to distinguish from a small drug company.

Maryland Gov. Robert L. Ehrlich Jr. (R) is scheduled to dedicate the new facility this morning, with help from African diplomats who hope it's a step toward ending the TB scourge in their countries.

With government funding, scientists around the world have been making headway in recent years in understanding the biology of tuberculosis and creating potential new vaccines. But there's little or no market for those vaccines in wealthy countries, which long ago brought the disease under control by tracking down people with TB and treating them aggressively with drugs.

With little hope of profits, drug firms haven't been willing to take the vaccines that university scientists created and spend the enormous sums required to test them in humans, produce them at commercial scale and deliver them at low cost to the poor countries that need them. That is the problem Aeras has set out to solve.

"Before Aeras came along, these vaccines basically sat in a freezer," said Marcus Horwitz, a researcher at the University of California at Los Angeles who invented one of the vaccines in Aeras's pipeline. "Aeras has provided an opportunity for these vaccines to be developed. That's a sea change."

Sadoff calculates that the earliest a vaccine can be readied for wide use might be 2012 or 2013. But it's necessary to build a production line now, he said, to make large amounts of vaccine for the tests, which will take place in human volunteers in Africa and Asia. If a new vaccine proves to work better than the 1921 product, the world could well need 150 million or more doses every year, a quantity the new Rockville facility could supply.

"If we don't do this now, we wouldn't have a facility ready and rolling when the time comes," Sadoff said.

Sadoff has built not just a drug factory but a research laboratory where Aeras scientists can tweak tuberculosis vaccines -- and possibly work on vaccines for other diseases. That actually worries Horwitz, who is eager to see a TB vaccine developed as rapidly as possible and is concerned that Aeras could lose focus. "I think it's reasonable to have a pipeline, but I think the pipeline should come from laboratories that specialize in making vaccines," he said.

Sadoff replied that Aeras would not let extraneous projects slow the main goal. "I agree with him -- we don't want to lose focus," Sadoff said.

Even if Aeras develops a vaccine, there's no guarantee that governments and charities in the wealthy countries will spend the money needed to get it to poor people. But, with Gates backing, the once-stagnant field of TB research is hopping, leading to optimism in many quarters.

"It would have been unheard of 10 years ago to have a pipeline" of tuberculosis vaccines, said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, which has funded much of the academic research Aeras is poised to exploit. "All of a sudden there's a keen interest in diseases that we knew about, we kind of accepted as being terrible, but the developed world didn't feel we needed to do anything about."