A Love of Science and a Vision to Save Millions of Lives Make Her Day

Today is one of only seven days this month that Victoria Hale is in her office, and she has a lot to do. She is trying to save the lives of half a million people.

It is an especially busy time for the 45-year-old founder and chief executive of the Institute for OneWorld Health, a nonprofit organization whose tagline sounds like an oxymoron: “a nonprofit pharmaceutical company.”

The mission of Ms. Hale’s six-year-old group is to find drugs to quash diseases that disproportionately affect the world’s poor. It is working to develop drugs whose patents have expired or whose for-profit creators are not manufacturing them because the profitability of drugs for the world’s poorest poor is low.

To accomplish her goals, she travels constantly. Tomorrow she begins a 10-day trip, but an important deadline looms. Ms. Hale is overseeing the preparation of the regulatory paperwork — to be filed in India in May — for the institute’s first drug.

A lot hinges on the Indian government’s approval of paromomycin, an antibiotic that treats the parasitic disease visceral leishmaniasis, also known as VL. The ailment infects half a million people annually worldwide, according to the World Health Organization, and can be fatal if left untreated. Countries that see high rates of the disease include Bangladesh, Brazil, India, Nepal, and Sudan.

“Think about it,” says Ms. Hale. “If our first project, the first thing we set out to do fails, who would fund us again? People will say, ‘You see, it can’t be done.’ We have to have a winner.”

The money for developing the regulatory paperwork and the paromomycin clinical trial data it contains was provided through grants totaling $17.25-million from the Bill & Melinda Gates Foundation, in Seattle. The foundation also gave the institute a new $30-million grant in December to develop effective strategies for distributing the drug to patients, if it is approved, and to begin conducting clinical trials of paromomycin in children.

“Victoria’s strength,” says Regina Rabinovich, director of the infectious-diseases program at the Gates Foundation, “is leveraging philanthropic dollars toward drug-development work. Victoria has a vision of how to meld the two. The proof of that will be in the pudding. Paromomycin will be the first product out, and it will be a key milestone for this organization.”

A Drug’s Long History

After several morning meetings with staff members to discuss personnel issues and the materials she needs for a forthcoming presentation — and several “I just need you for five minutes; it’s urgent” interruptions — Ms. Hale has a 10:15 a.m. conference call with a medical writer who is working on the regulatory paperwork. She explains to the writer how to find a long history of studies on the drug, whose patent expired in the 1970s, meaning that it is available to be manufactured by other drug makers.

OneWorld Health conducted a clinical trial on the drug in India in 2004 in collaboration with the World Health Organization and a nonprofit group from the Netherlands. As soon as Ms. Hale ends the call with the writer, she joins an hourlong conference call with two researchers who are volunteering their time to OneWorld to help it analyze data from the clinical trial.

During both calls, Ms. Hale’s scientific and pharmacological background is evident — she holds a Ph.D. in pharmaceutical chemistry from the University of California at San Francisco, and spent four years reviewing new drug applications at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research. She speaks easily of drug toxicities, methodological issues in research, and efficacious doses. She and the two researchers, a professor of clinical pharmacology and his graduate student, discuss paromomycin’s effectiveness in fighting VL, and the professor talks about the changes in patients who have received the drug.

“Yes, yes,” Ms. Hale says excitedly and gazes out her window, “the change.”

Delayed Gratification

The need for change drives Ms. Hale, who grew up in Baltimore and has always loved science. Even as a child, she says, “I always wanted to make medicines.”

She considered becoming a doctor but realized she could help more people by developing drugs. “I don’t know the names of individual patients. That’s not what making medicines is about,” she says. “It’s about saving millions of lives, curing millions of people, not healing one at a time. I’m a long-term-vision kind of person. Delayed gratification is fine for me. I’m willing to knock myself out for years because I know it’s benefiting large numbers of people.”

After working at the Food and Drug Administration, Ms. Hale joined the biotechnology firm Genentech in 1995. Three years later, she wrote a strategic plan for the nonprofit company she envisioned, but set it aside. She then left to start her own regulatory consulting business. At the same time, she searched for a project that could serve as OneWorld’s first test case.

In the process, she visited the World Health Organization, in Switzerland, and learned of a promising program to treat VL that had been discontinued in the 1990s for lack of money. The drug at the center of the program, paromomycin, had been shelved before undergoing Phase III clinical trials, a step necessary for approval by Indian, and other countries’, regulatory agencies. In contrast to other treatments that are expensive and can induce severe side effects, paromomycin was expected to yield the same results with fewer side effects, at a lower cost.

Ms. Hale flew to India to visit a doctor who was an expert in the disease, which can cause fever, anemia, an enlarged liver and spleen, and, if untreated, death.

“The horrendous poverty, the empty eyes of women in their 20s and 30s who looked so much older because of hunger and overwork — that visit convinced me to complete the trial,” she says.

Visceral leishmaniasis is one of several diseases that are endemic to poverty-stricken parts of the world. Malaria, Chagas disease, diarrheal diseases, leprosy, river blindness, sleeping sickness, and others all take their toll among populations that can’t afford preventive measures or cures. Given her industry background, Ms. Hale knew that formulations for effective drugs were available to treat many of them, but drug companies didn’t necessarily invest the money to develop these medicines. The drugs’ lack of profitability is the chief obstacle, she says.

‘No Precedent’

People in developing countries, who make up about 80 percent of the world’s population, represent only about 20 percent of worldwide medicine sales, according to a 2001 report by Doctors Without Borders. In the 25 years that preceded the report’s publication, the organization found that only 13 new drugs were designed to treat tropical diseases, which primarily affect poor people. By contrast, 179 drugs were developed for cardiovascular diseases, which have nearly the same impact as tropical diseases.

It was hard for Ms. Hale to get others to see her vision at first. It took 10 months of discussions with the Internal Revenue Service to get charity status for the institute.

“There was no precedent for them to comprehend the concept of a nonprofit pharmaceutical company until we offered the analogy of public versus commercial television,” says Ms. Hale, “which serve different audiences, provide different products, and are funded differently.”

She also had to counter the skepticism of drug-company executives. “We weren’t seen as a threat per se because we’re small, but there was much confusion early on as to what we would do and how,” she says. “Today we’re in discussions with most major pharmaceutical companies about how they can engage in global-health projects with us.”

In addition to paromomycin, other projects are under way. OneWorld’s staff also works on promising therapies to treat pediatric diarrheal diseases. In addition, the organization’s employees lead a collaboration with the University of California at Berkeley and a biotechnology firm to create a synthetic lower-cost supply of an anti-malaria drug currently in short supply. A $42.6-million grant from the Gates Foundation, given in 2004, supports the joint project.

A Hectic Pace

Ms. Hale and the institute’s work have received wide attention from news-media outlets such as Newsweek, The Economist, USA Today, National Public Radio, trade publications, and others. She has been invited to speak several times at the World Economic Forum, an international nonprofit group that engages leaders in efforts to improve the state of the globe, and OneWorld’s scientists routinely attend and present at international clinical and scientific conferences.

But the pace Ms. Hale has had to keep to engage so many parties since she started the organization in 2000 isn’t sustainable, she acknowledges.

The staff numbers 50 employees but, until recently, when the organization hired two vice presidents, Ms. Hale and her husband, Ahvie Herskowitz, the institute’s chief operating officer and chief medical officer, worked “six and a half days a week,” she says.

Their jobs, she acknowledges, have often pulled the couple away from their children, ages 13 and 6. “Our two boys can look at our faces and tell whether we’re present and with them or whether our minds are on work,” she says. “We’ve given them permission to tell us when we’re not present, and they do.”

Thanks to a $615,000 Skoll Foundation Award for Social Entrepreneurship, Ms. Hale and Dr. Herskowitz are now searching for a new chief operations officer and a senior vice president for research and development. Dr. Herskowitz would remain chief medical officer.

Ms. Hale says concerns have been raised by OneWorld’s staff members and trustees about her being “such a big founder, and they wonder what would happen if I were to get sick or die in a plane crash.”

“I’ve read about founder syndrome, I’ve brought in consultants, and I keep coming back with, ‘Let’s have the funding,’” she says, meaning that more money is needed to hire other staff to take on some of the chores she performs. “Not everyone is going to come in and work without taking a salary.” (Ms. Hale did not draw a salary during the institute’s first two years; instead, she and her husband lived on their savings and obtained bank loans against their assets.)

Securing money for operations has been a challenge. OneWorld’s annual budget hovers close to $30-million, she says, all of it from grants from foundations — primarily the Gates Foundation — and donations from individuals. And nearly all of it has been earmarked for specific projects, though that’s beginning to change. Ms. Hale says the group is embarking on a new effort to find funds to help cover its general operating expenses.

Grant makers like the institute’s approach, she says, but she believes the cost of its programs puts many off. Drug development is expensive, despite OneWorld’s efforts to keep costs down. And the focus of its work is outside the United States, which might also deter grant makers. “We deliberately chose neglected diseases that others were not working on — VL, diarrhea, and Chagas. There has been little research done on these diseases, and limited money for research or development. We don’t choose projects because money is available, we choose projects and then we go find funding.”

‘Make Them for Pennies’

At noon, Ms. Hale is back on the phone with an interviewer from Ashoka, an international nonprofit organization that supports social entrepreneurship, or the application of innovative techniques to solve social ills. She has been nominated for an Ashoka fellowship and is going through the selection process. She takes a few bites of the lunch her husband snuck in earlier as she fields questions about revenue, sustainability, and her organization’s business model.

“If you look at antibiotics, even generics sell for tens of times their cost,” she says. “We can make them for pennies.”

Because the group starts with off-patent drugs, or drugs whose patents have expired, as it did in the case of paromomycin, or licensing rights donated by pharmaceutical companies, it saves some research-and-development costs. Without the need to turn a profit, it is not long before production costs can be recouped, Ms. Hale says.

And, she notes, perhaps by producing drugs that treat malaria and other diseases that affect more than just the poorest poor, OneWorld can generate some revenue through tiered pricing.

When she hangs up, she says her head is spinning. She is flushed and hoarse, too.

That level of enthusiasm serves her well, says Barbara Kibbe, vice president of program and effectiveness at the Skoll Foundation, in Palo Alto, Calif. Ms. Hale is “articulate, passionate, charismatic, intelligent, and experienced in the field in which she’s trying to make change. She has deep experience in the pharmaceutical industry and tremendous credibility” in talking to big drug companies, says Ms. Kibbe. “They’re impressed by her commitment — she took a risk and stepped out of a lucrative career.”

Distribution Challenges

Following her noon conference call, Ms. Hale immediately begins another with an executive from one such company. They discuss how his firm might donate some much-coveted research documents supporting a OneWorld project.

OneWorld Health will rely on partnerships with government and private entities for the distribution of drugs too, not just their development. “We don’t want to expand into distribution,” Ms. Hale says during one of her many conference calls. “Our core skills are R&D.”

Distribution may present a hurdle, says Ms. Kibbe. “Once a drug is developed and solutions are tested, the next challenge is to make sure it gets in the hands of those that need it. A distribution network is something Victoria and her team think and worry about and are addressing.”

To build a network in India, Ms. Hale says, OneWorld Health is negotiating with nonprofit groups and government agencies whose identities she says she is not yet able to disclose. When and how the drug will be available to patients in India — and eventually in other countries with VL — will depend on the arrangements they finalize.

Ms. Hale sounds confident the hurdles can be overcome. In the car going home with her husband and a newly hired consultant they have invited for dinner, she talks about eradicating visceral leishmaniasis. And she does so consistently using the word “when,” not “if.”

But no matter how immersed she becomes in reducing diseases among the poor, she also wonders, rhetorically, how one can truly know global poverty as an American. “In some villages, people are lucky if a well has been dug,” she says. “But once you’ve seen it and you know that you can do something, how can you ignore it and say, ‘Let’s go shopping’?”

“You can’t take care of all two billion of the world’s poorest poor at one time,” she adds. “But you can go disease by disease and determine which you can succeed with.”