OR WAIT 15 SECS
Joanna Breitstein is a contributor to Pharmaceutical Executive.
From her start as a physician working in apartheid-era South Africa to the dramatic turnaround and takeover of Millennium, Deborah Dunsire has lived a life that has defied all expectations.
A handful of times in the span of a human life, there come moments that illuminate how the world could change. For some, it was Woodstock, or the resignation of Richard Nixon, or, more recently, the fall of the Berlin Wall. For Deborah Dunsire it came in 1990, in South Africa, the country she'd called home for most of her life, when the legendary anti-apartheid fighter Nelson Mandela was liberated after 27 years in prison. Like the rest of the country, Dunsire was transfixed by the broadcast image of the aging but unbowed hero of the country's downtrodden, as he told the throng that had gathered before Cape Town's old City Hall, "We have waited too long for our freedom. We can wait no longer."
"Watching it on TV, you got the sense that nothing was impossible," remembers Dunsire, "That ultimately things can change. There's never a need to accept something as a given."
Don't accept the given. It's an idea that resonates throughout Dunsire's life as well as her career. Born of parents lacking even high school education, Dunsire has used her own learning to traverse the world. She took an insignificant oncology unit at Novartis and built it into one of the company's crown jewels, along the way rewriting the story of cancer care for patients by leading the introduction of such important drugs as Gleevec. As CEO of Millennium Pharmaceuticals, her vision has been a game changer for the company, turning an underperforming biotech into a robust center of oncology excellence by way of a nearly $9 billion acquisition by Takeda.
Dunsire is one of the few female biotech CEOs (and almost certainly the only one who speaks fluent Afrikaans). Part of her success, say those who know her, is that she has always been governed by who she is—a physician who got her start treating the poor in Johannesburg, a mother and wife, and a deeply religious woman as well as a business leader.
"Deborah is warm and caring as well as strong and decisive," says Linda Heath, her executive assistant. "When she speaks, we clearly see that her head is that of a leader and her heart is that of a healer."
Her achievements have earned Dunsire the Healthcare Businesswoman's Association 2009 Woman of the Year Award, a prestigious recognition that has been bestowed on executives such as Charlotte Sibley, Meryl Zausner, and Susan Desmond-Hellman. This year's designation is made even more special given that the WOTY Award—which has helped recognize and advance women's leadership in the industry—is celebrating its 20th anniversary, while Dunsire also celebrates 20 years of career achievement.
Deborah Dunsire started her career by following a simple lesson that has only become more true as the years have passed: "You can't be too sure of the path you're on because you might shut down some side roads that are incredibly important."
Dunsire's parents were born in a small mining town in Scotland. Her father dropped out of school at age 13. He should have worked in the mines, but his mother wanted something better for him, so he became a carpenter. Life went along just fine until the 1940s and early 50s, when Scotland hit a building slump. Rather than stay there, he went looking for work in far-off places, first the Shetland Islands and then Africa. In the 1960s, he took Deborah's mother, whom he'd first me in elementary school, to Zimbabwe, where they married and Deborah was born.
Her parent's bold journey would color the rest of her life. "Nobody moved from that town—it just wasn't in the fabric of that society," says Dunsire. "Yet my father's initiative took him to another place. He's a person who never believed in boundaries and he passed that on to me."
Dunsire remembers a childhood of sunny afternoons spent swimming, riding bikes, and building forts in the forest. By the time she reached high school, her family had moved to South Africa, and Dunsire herself was solidly focused on academics. She performed brilliantly—she was named the top female student in her state, and selected as the national runner-up for a Rhodes Scholarship.
In 1980, Dunsire enrolled in the University of Witwatersrand in Johannesburg. At first, she studied occupational therapy, but she noticed she was getting better grades than the medical students in some of the classes she shared with them. She began to rethink her focus. "A therapist always works under the orders of a physician," says Dunsire. She tells a joke: "'What do they call the guy who came last in his class at graduation day? They call him doctor.' I remember thinking, 'I don't know that I want these boys telling me what I'm going to do with the patients.'"
Dunsire made the switch. She would soon experience up-close the major health disparities between black and white South Africans—and realize that she could make a difference. For a med school project, she worked in a rural maternity clinic, a desperate place that served poor women. "Women were coming with newspaper to cover the beds where they delivered," remembers Dunsire. "That wasn't acceptable to me. Through outreach efforts and advocacy we managed to change that for the clinic—to get more nursing staff, and also more facilities...even just sheets, pillows, blankets, and laundry services."
After graduation, Dunsire became a general practitioner in Johannesburg. There, she was expected to make house calls. The phone would ring in the middle of the night, and Dunsire would get in her car and visit the ill. It was a chaotic career, but an extraordinary learning experience. In South Africa, a physician treated not just the ailments of Western society, such as diabetes, hypertension, and heart disease, but also the diseases of the Third World—malaria, tuberculosis, and malnutrition.
At one point, feeling that she needed better balance, Dunsire applied for and won a fellowship in ophthalmic surgery. The program didn't start for nine months, though. In the meantime, young Dr. Dunsire found herself in the unusual circumstance of having time on her hands.
An ad in the newspaper pointed her in a new direction. Sandoz needed someone to implement Phase III studies for specialty drugs. At the time, it was just what she needed: a paycheck to tide her over until the fellowship began and a chance to learn something new—plus a company car.
Working in the pharma industry wasn't, at first, a pleasant experience. Dunsire felt like she was just biding time; she really missed working with patients. "A GP sees a different patient every 10 to 14 minutes; it's intensely interactive and personal," says Dunsire. "I remember sitting in the office and wondering, 'Doesn't anybody ever talk to you in here? What am I doing?'"
But as the days went on, the big picture clicked into focus. "I finally understood that by bringing new medicines forward, you can touch so many more lives than you can in a practice, where you're more personally engaged with patients but your universe is much smaller," says Dunsire.
The starting date for the ophthalmology fellowship arrived, but Dunsire decided to stay at Sandoz. By that time, she was working in transplantation, Sandoz' largest division and a place where it was possible to see new drugs make dramatic improvements in patient's lives—something that would always stick with Dunsire.
She took on sales and marketing responsibilities, and directed commercial development for all specialty products, determining which data packages and clinical studies would optimize the drug's market share. She was successful, accountable for 35 percent of corporate sales and 68 percent of the profitability of the local affiliate.
Dunsire's success opened doors. The company invited her and her husband to work in their headquarters in Switzerland and three years later, in their North American offices in New Jersey. Dunsire was put in charge of portfolio management of oncology drugs, though the company's portfolio wasn't much to speak of. "At the time, Sandoz was a real 'wannabe,'" says Dunsire. "We really wanted to be an oncology company, but we weren't quite there."
Then, in 1996, Sandoz merged with Ciba-Geigy, at the time the largest corporate merger in history, forming Novartis. Dunsire saw opportunity in the chaos. There were stronger oncology companies than Ciba-Geigy, but it did have Aredia (pamidronate), which helped build bone, particularly in patients with multiple myeloma. The drug made a big difference in patients' lives, and it was enough to give Novartis a real platform in oncology. Dunsire teamed up with David Epstein, Greg Burke, Alex Matter, and others to make a case for the importance of investing in oncology—for patients and the company alike. The team proposed a global business unit, where the decision-makers would be close to the business, science, and thought leaders. "At the time, it was a really different way of thinking for Novartis," says Dunsire. "But Daniel Vasella saw what it was doing for patients and the fact that it was good for business, so we got more support."
In 2000, Dunsire was named senior vice president and head of North American oncology. "I was really fired up about it, and I couldn't do any harm because it wasn't big business for the company."
There, Dunsire helped craft the business from the ground up. She led teams through six new product/indication launches, including Femara (letrozole), Gleevec (imatinib), and Zometa (zoledronic). Over the span of a decade, the unit grew from $50 million in sales to $2.1 billion—and Novartis became one of the most important oncology companies on the planet. (Novartis also nominated Dunsire for the WOTY Award, the first time a woman was backed by two companies.)
Dunsire could see just how much she'd learned at Novartis. But she was getting comfortable. So when opportunity knocked in 2005, in the form of an offer to become CEO at Millennium, she answered, realizing it was time once again to push her boundaries. "One always has to grow," she says.
Millennium was founded in 1993 in Cambridge, MA; by May 2003, after a decade of sophisticated science and intense deal-making, it had its first marketed product: Velcade (bortezomib).
Velcade looked like a winner: It was the first FDA-approved proteasome inhibitor, the first approved treatment for multiple myeloma in more than a decade (it is also approved for second line treatment of mantle cell lymphoma), and the second fastest drug approval (at 10 weeks) in history.
In Velcade's first seven months on the market, its sales reached $60 million, doubling the initial guidance. In 2004, sales more than doubled to $143.1 million. But by the time Dunsire joined Millennium in July 2005, growth was leveling out. Then, at the end of the year, Celgene launched Revlimid (lenalidomide), a competing drug for multiple myeloma. As a once-a-day pill, Revlimid soon outsold injectable Velcade.
This was bad news for Millennium. Velcade was the company's only marketed product; promising candidates such as MLN-0002 for ulcerative colitis and Crohn's disease lagged many years behind it in the pipeline. "The $2 billion oncology division at Novartis is less than 10 percent of the whole," says Dunsire. "But at Millennium, the success of the company and the ability to invest in your portfolio, to achieve your mission and vision is totally dependent on that one product."
In other words, for Millennium, Velcade had to work.
Many were doubtful that it could. "[Dunsire] stepped in at a time when competitive threats were heightening, and people wondered if Velcade could compete against an emerging competitor," says Christine Poon, the new dean of Ohio State University's Fisher School of Business, and former vice chairman of Johnson & Johnson, Millennium's partner in Velcade. "There was doubt about whether she could position the product and the company to make people believe that it could grow, and that the pipeline was something to be excited about." Headlines echoed the sentiment: "The Future Millennium Isn't So Exciting," opined investment Web site The Motley Fool.
But Dunsire had a vision for how to get Velcade—and Millennium—to achieve their potential. First, she addressed what she called the "burning fire" (there was no commercial head) by hiring Christophe Bianchi, a seasoned oncology exec who had previously run Sanofi-Aventis' $2 billion cancer business. Together, they brought Big Pharma sales and marketing know-how to the table, doubling the size of the sales force.
They also simplified the drug's selling points. "Velcade is a great drug, and there is a gold mine of things you can say about it," says Christophe Bianchi. "But at the end of the day, the customer will only remember a couple of them, not 20. You have to choose what to say—and also what not to say."
Velcade sales started to grow again. In 2006, a 20 percent increase for Velcade put Millennium in the black with a net profit of $8.3 million. But what really changed the trajectory of the drug was the expanded FDA approval to use Velcade in first line multiple myeloma patients in 2008. (It was originally approved in 2003 as a third line therapy, then in 2005 as second line.) By November 2008, Velcade was a blockbuster.
Certainly, the drugs will continue to jockey for position. Revlimid also became a blockbuster in 2008, bringing in $1.3 billion. There's also evidence that the drugs work well in combination. "I can see two winners in this game," says Howard Liang, an analyst for Leerink Swann. "There is room for both drugs to increase penetration of the first line setting, and then eventually combine and continue to grow."
Revlimid never swept the market the way many expected, thanks largely to Velcade's promotional response. Baird analyst Chris Raymond predicts that sales of Revlimid are likely to disappoint in 2009 due to strong competition from Velcade.
Meanwhile, Dunsire saw another problem—sweeping R&D spend, without much to show for it. "I tend to simplify things, as opposed to looking for complexity," she says. "I remember saying, 'The arithmetic doesn't add up. The R&D budget's wildly bigger than the revenue, and we just have to fix that.'"
Under founding CEO Mark Levin, Millennium started out as a genomic-based company, but it expanded to include efforts in inflammation as well as oncology. Dunsire worked with the R&D team—Joe Bolen, Nancy Simonian, and Pete Smith—to decide where to scale back. "It's not just a resource or scale issue, it's also about where your skills are," says Dunsire. Ultimately, the team decided to focus exclusively on oncology. The decision was a hard one, mostly because it meant laying off workers. Ultimately, though, the move to focus the company promised to be the key to its future success.
"When Deborah came into the company, she certainly spent a lot of time on the commercial side. Given her background, that was natural," says Christine Poon. "But what impressed us is how much time she spent with her R&D organization—looking at the pipeline and where to allocate resources, and making the tough decisions on where to focus."
"She got us focused on what was important," says Mark Levin, now a partner at Third Rock Ventures, who remembers meeting Dunsire and getting excited about her commitment to doing great things. "When you bring a product to market, especially in a small company, it's a long haul. We got part of the way, but Deborah came on board and took our capability to market and sell up by an order of magnitude."
Others see Dunsire's value not only in the skills she brought to the company, but also in her ability to lead. "Few CEOs have stepped into more challenging situations," says Marsha Fanucci, Millennium's former CFO. "She inherited the legacy of an audacious company vision, a great but under exploited product, and an operating infrastructure that was by any measure suboptimal. Perhaps most important, she followed a CEO who was an inspirational leader loved by all. So many ways to fail, yet through her leadership she unlocked the potential of the product, and even more important, the people."
"Sometimes the price of success is that you get acquired," says Dunsire. Indeed, by all accounts, Millennium has been a success. Last spring, Takeda, Japan's largest drug manufacturer, plunked down $8.8 billion (roughly 13 times Millennium's revenue) for the biotech—the largest deal ever for a Japanese company. The price translated to $25 a share, a 53 percent premium over the price of Millennium shares the preceding day. Takeda got what it was after: a sleek, focused oncology outpost, and a blockbuster with room still left to grow. The biotech, with its single marketed product, made its exit with the eighth largest market value in that industry—roughly twice as much as the next ones in line, Cephalon, ImClone, and Vertex, according to the In Vivo blog.
Nearly a year after the deal was announced, there are but a few signs at Millennium of its new parent company. A clock displaying Tokyo time hangs in the lobby. Pamphlets are on the way, explains a PR person, to explain the new structure. Dunsire says she's learning to speak Japanese.
Rather than slash-and-burn M&A tactics, the Takeda/Millennium deal is expected to bring new drugs (and jobs) to the company. Takeda wants Millennium to become a center of excellence for oncology, keeping its name and assets, and taking on the job of developing Takeda's other cancer drugs as well. Millennium now has a pipeline of 14 oncology compounds in early to late development—previously it had five.
With everything it took to turn around Millennium, Dunsire says getting acquired wasn't part of the plan. Indeed, her original discussions with Takeda centered on building a relationship from which the two companies could form licensing agreements. Dunsire originally visited the company in July 2007; she was surprised a year later when Takeda made an offer.
For now, both she and her management team have agreed to stay on. Still, the merger has changed things somewhat. "The pressure is less because you don't see yourself as being the final line of defense on a decision," says Dunsire. "At the same time, as the CEO you have established your mindset, you can never go back to think about just one component of the company."
And after a career in oncology, there remains one boundary Dunsire is determined to cross, the "big, hairy, audacious goal" of curing cancer rather than just treating it. "We know we haven't done it yet, and it will take a long time," says Dunsire. "But unless you set your sights beyond what's traditionally possible, you're never going to get there."
Dunsire regularly inspires and challenges employees with that vision—and they have responded. "The true sign of a leader is not simply his or her achievements, but in the strength of personal character that continually draws others toward a shared vision," says Kenneth Weg, chairman of Clearview Projects and chairman of Millennium's board of directors.
Dunsire uses her vision to push not only Millennium, but the industry past its boundaries. Frank Baldino, CEO of Cephalon, serves with Dunsire on the PhRMA board of directors. He says, "Deborah immediately made an impact on the board, providing insight from the vantage point of a leader of an emerging biopharmaceutical company, and with the pedigree of an established pharmaceutical executive."
Dunsire also sits on other boards, where she is often the youngest, and the only woman. Still, says Allergan CEO David Pyott, "When Deborah asks a question everyone listens."
To help her focus, says Dunsire, she prays.
"You've got to have sources of restoration. Mine comes from faith," she says.
Restoration also comes from spending time with her family—her husband, Dr. Michael Hall, and two boys, age 9 and 11. "Having children makes you realize that you can't sweat the small stuff," says Dunsire. She can often be seen dropping them off at school in the morning, or the soccer fields on the weekend.
Says Heidi Wyle, a family friend and CEO of CB Corporation, "She never leaves my house without jumping from the table, grabbing my gloves, and washing the dishes—including the pots."
Dunsire has achieved success on her own terms: as a physician in apartheid-segregated hospitals in South Africa, a mother, a vibrant member of her community, and a warrior against cancer. It wasn't the way she thought would turn out—but that's okay with her. "My mother always says, 'I've been so many places and I've done so many things that I could never have imagined,'" says Dunsire. "But in a sense, that only happens to people who don't put boundaries around what could happen and who don't limit themselves."