Building Vaccine Consensus

BIOBUSINESS When Klaus Stöhr left the World Health Organization to take a job at the Swiss drug giant Novartis in February, there were some who questioned whether the most prominent figure in the global fight against avian influenza had forsaken public health for profit margins. "I don't see why this should be good news," wrote one blogger with the moniker "gsgs" on a site devoted to pandemic flu soon after the news broke. "It's a signal that he considers the [pandemic flu] threat as less important than Novartis research." Sitting in August at a hotel restaurant at Frankfurt, where he's in the middle of two days of strategy sessions with 40 colleagues in the influenza business at Novartis Vaccines and Diagnostics, Stöhr says he'd anticipated that kind of criticism, but that it stems from a misunderstanding. "Honestly, it's human that people think that, [but] they do not know what industry really is," he says. He finds his new job invigorating, he says: "Everything that I'm doing today is new to me." Smiling, Stöhr offers a little arithmetic to illustrate his satisfaction level with his new role in the pharmaceutical industry. Most people spend 20% of their time doing things they love, 30% on things they're OK with, and the remaining 50% on "other stuff," he says. "Now, what I'm doing is 80% things I absolutely enjoy. Every day." From pigeons to microbes Stöhr, 48, didn't have an insider's view of industry until this year. His entire career had been in public health, for the past 15 years at WHO, and before that in his native East Germany. He was born in Leipzig, his father a recruitment officer for the military and his mother the director of a state kindergarten. In high school, Stöhr spent much of his spare time helping out a local veterinarian, who often told his young assistant about his dream of working in Africa. "He was fascinated by tropical veterinary medicine," Stöhr remembers. "But he never had a chance to do it." Stöhr was inspired, too, and set about convincing a lecturer in tropical veterinary medicine to teach him and a few others privately, every Saturday at the academic's villa outside Leipzig. The man would bring a bag full of random disease slides and use them as the starting point for the lesson. "Part of the objective [in recruiting Stöhr] was not to hire your average pharmaceutical developer. We didn't want to follow the traditional models." --Eric Altoff He eventually went on to study veterinary medicine at university in Leipzig. For his PhD, which he earned in 1987, he used a parasitic infection that was affecting the hundreds of thousands of racing pigeons in Germany as a model for creating procedures for investigating outbreaks of unknown diseases. His first job was running a rabies vaccine development program at the National Institute for Epidemiology and Infectious Disease Control in Animals. After that, he took a job at the WHO, where he worked again on rabies and then food-borne diseases. Later, he played a critical role in establishing a global surveillance system for antimicrobial resistance in humans and in animals. "I like complex challenges," he says. Communicating SARS David Heymann, assistant director-general for communicable diseases at WHO, began working with Stöhr in 1996. "Very soon, I saw he was someone who understood issues clearly and was able to move forward to solutions," he says. In 1997, for example, Stöhr was assigned to work with Hong Kong authorities on the outbreak of avian influenza and made his mark with his ability to gather information from disparate sources and act on it, Heymann says. "He's a very good networker who maintains good links with people." Those links became crucial in late 2002, when SARS first emerged in Hong Kong, triggering widespread panic. By this time, Stöhr had been made head of the WHO influenza program, and Heymann remembers that the German quickly reconnected with the network of virologists he had during the earlier flu outbreak to gather data on this new threat. Stöhr established a kind of "virtual laboratory" on the Web, allowing influenza virologists, as well as some of his contacts from the zoonosis field, to communicate quickly. "He was very focused and kept the momentum going in terms of getting people to communicate and share information," says John Mackenzie, a professor of infectious diseases at Curtin University in Perth, Australia. "There was a need to know what was going on with SARS, and Klaus did that very well." Dutch virologist Albert Osterhaus says that coordinating this response to SARS was Stöhr's biggest contribution while at WHO. "He managed to bring together a number of competitive scientists who agreed for the sake of public health to work together for more than a month," he says. "I think people trusted him." Klaus Stöhr at a WHO press conference. Courtesy of Klaus Stöhr Mackenzie has worked with Stöhr on several occasions since 2001, including during and after the SARS outbreak. "There's no doubt he's driven... and ambitious," Mackenzie says, adding that that dynamism earned Stöhr some fans in the influenza world, but may have concerned others who were partial to the gentler approach of his predecessors as the head of the WHO flu program. During SARS and the ongoing avian influenza situation, Stöhr also became a public figure, talking regularly to reporters and becoming one of the prime media sources of quotes about the risk of a human pandemic. "I felt the responsibility that whatever we were saying was right and appropriate," he says. Things didn't always go according to plan, however, and the ramifications of one mistake still trouble him. "One situation I regret was when H5N1 started spreading to humans. We said at the beginning that the pandemic will begin when we see human-to-human transmission." In reality, what was needed was sustained and widespread transmission between humans, he says, not just small clusters. "There will always be clusters, but we haven't been able to get this idea out of the heads of journalists," Stöhr says. Seeking a deliverable Stöhr's move to industry had its genesis in a meeting with Novartis Vaccines executives during a conference last year in the Italian city of Sienna. He had already been made a generous offer by another major drug firm, which he declined to name, and had been offered a teaching post at the Harvard School of Public Health. But the job as director of the influenza vaccine franchises at Novartis Vaccines and Diagnostics trumped both. "What I felt was different about Novartis was that there was space to shape things," he says, "or to be a part of those changes." Stöhr says he left WHO in search of an environment where the results of his efforts were more tangible: "a deliverable." He is particularly enthusiastic about the role that cell culture-based production processes will play in the future. "To me, it's a very, very exciting time ... we have taken a leap ahead." The company recently broke ground on construction of a plant in Holly Springs, NC, to manufacture cell culture-derived vaccines, which is expected to have an annual capacity of up to 50 million doses of seasonal cell culture-vaccine by 2011. At Novartis, Stöhr runs project teams from all the company's functional areas (research, business development, marketing, etc.) to develop an overarching strategy for R&D within its influenza franchise. This covers both the seasonal influenza vaccine and the potential need for a pandemic vaccine. His role involves bringing in resources from throughout the company, including R&D, technical operations, strategic global marketing, commercial operations, and regulatory affairs. The endpoints of his role will be the launch of new products. Building a consensus So why did Novartis hire Stöhr, a person with no drug company experience, for such a high-profile position? He says the company wanted his public-health approach. "Part of the objective [in recruiting Stöhr] was not to hire your average pharmaceutical developer," agrees Eric Altoff, the company's director of communications. "We didn't want to follow the traditional models." Someone once told Stöhr that if anyone from the public-health world could survive in the drug company environment, it would be him. He describes his working style as "enthusiastic ... perhaps impatient. When I believe something can be done, I keep at it until I really believe it can't be achieved." The Novartis philosophy is to strive for consensus, he says, and that's something he aims for too, "but I don't shy away from making decisions." Ian Barr, deputy director of the WHO influenza center in Melbourne, Australia, remembers this side of Stöhr's personality from annual influenza vaccine formulation meetings, during which experts gather to decide the composition of the flu vaccines for the coming year. "They're torrid affairs. It's always a rush and you don't always have a full set of data in front of you," Barr says. But Stöhr was firmly of the opinion that the meetings needed to end with a consensus to ensure there was no delay in delivering the vaccine. For example, around the time of the 2003 meeting, Barr recalls, there were hints of a new influenza strain emerging, and opinion among the experts was divided as to whether it would become important on a global scale. Stöhr was central to achieving a speedy resolution, says Barr. The experts decided that the vaccine would not include the new strain, and that decision was a good one because the strain did not end up being a major pathogen. "He was very proactive in arriving at an outcome that wouldn't cause delays. Klaus has this approach where it's work, work, work and bulldoze your way through." (Gauging how well this approach is appreciated among his Novartis colleagues is difficult, as the company wasn't able to find anyone available to speak before deadline.) Consensus building will be important when the next flu pandemic arrives - something Stöhr and his colleagues haven't been perfect at predicting. "We have been saying it's coming for the past five years," he says. "But we have possibly underestimated the time such a virus of pandemic potential can take to cross species efficiently." When it does come, will Stöhr's job be to make sure that Novartis is in a position to deliver vaccine to as many people as possible? His answer goes beyond his own company. "I would hope that as many companies as possible will be able to deliver as much vaccine to as many people as possible," he says. "The role of competition will be different during a pandemic."

Building Vaccine Consensus

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