Vaccine helps show value of partnerships
WASHINGTON -- The Food and Drug Administration is expected to approve a vaccine this week that could revolutionize how girls, women, and their doctors reduce the risk of cervical cancer.
Development of the vaccine, Gardasil, depended on a kind of public-private partnership that is revolutionizing the way scientific discoveries are brought to market.
Federal researchers uncovered the basic science that underpins Gardasil and another, similar experimental vaccine awaiting FDA approval. But private dollars -- from Merck & Co. for Gardasil and from GlaxoSmithKline for Cervarix -- will commercialize them.
Such public-private partnerships are not new, but in recent years they have yielded a string of successes, spurring more such collaborations.
The logic is simple:
Federal dollars underwrite the massive expenses of early research. Private companies sell the products using existing marketing and manufacturing infrastructure. The public research institutions involved in the work receive a percentage of the revenue after the product goes to market.
Other high-profile public-private projects have included the process for making the cancer drug taxol , a test that spots early prostate cancer, and an electronic hearing aid.
Another sweeping public-private project now in its infancy is a Mayo Clinic discovery that could provide a universal template from which drug companies could create vaccines to combat smallpox, monkeypox, and avian flu.
The National Cancer Institute researcher who co-invented the Gardasil vaccine said scientists doing basic research there are constantly reminded to think about the real-world impact of their discoveries, which helps keep their work grounded.
``We at NCI think if an ordinary researcher like me can be involved in something like this, lots of people can do it," said Doug Lowy , deputy director of the Center for Cancer Research. ``We really think about that: How can I make a difference, in terms of having an impact on clinical disease? [Gardasil] is a real success story, in terms of going from understanding how the cancer comes about to then devising ways of intervening."
Just 25 years ago, scientists had little idea what caused cervical cancer. They now know that virtually all cases of cervical cancer are caused by persistent infection with high-risk strains of the human papillomavirus . Routine screening has dramatically lowered American women's risks, but cervical cancer remains a leading cause of death for women in developing countries.
Gardasil's pending approval by the FDA gives a boost to researchers working on a next-generation vaccine that could include high-risk human papillomavirus strains more prevalent in developing nations.
The virus types currently represented in the vaccine are more prevalent in the United States and Europe than the developing world, said Dr. Sharmila Makhija .
``I'm sure there will be somebody who now will try to develop the vaccine against more strains," said Makhija, a gynecologic oncologist at the University of Alabama-Birmingham who has led clinical trials for the Merck and Glaxo vaccines.
The success of the vaccine commercialization also is expected to spur researchers working in other areas to develop their discoveries for market.
Marjorie Hunter , director of the Office of Technology Transfer at the University of Rochester Medical Center , has already gotten more e-mails from researchers there who are tracking Gardasil's progress toward commercialization. Hunter expects to soon see a spike in invention disclosures.
``They say, `I think I have something. I've done something that I think is a breakthrough. I see its potential commercial applications,' " Hunter said.
The university seeks patent protection on roughly 35 percent of the 100 invention disclosures that come from its medical center each year. Last year, the medical center earned $35 million in royalties and revenue from such research, including discoveries that led to Wyeth Pharmaceuticals' commercialization of Prevnar , a vaccine that protects infants and toddlers from life-threatening meningitis and blood infections .
Gardasil's ripple effects have been felt across the nation.
A Mayo Clinic vaccine guru, Gregory Poland, has a patent application for a discovery that he hopes will attract the interest of private industry to the same degree that Gardasil has.
Poland's vaccine research group discovered and patented a surface protein that the body recognizes as malicious and knows to mount an immune response to protect against. When they tested cells drawn from former members of the military who had been vaccinated against smallpox , the cells recognized the smallpox threat and knew how to ward it off.
As it turns out, that same protein is found in strains of smallpox, camelpox, and monkeypox. That means a single protein could provide a universal building block for vaccines that protect against a wide range of infectious diseases.
``We've just been celebrating," Poland said of the discovery. ``We are now applying this to avian influenza. Next, we're going to go for West Nile virus."
The lab discovery is years and millions of dollars in research away from being a vaccine. But the promise of such breakthroughs is what drives daily e-mails from job seekers wanting to join the lab.
``I think what attracts them is our passion about what we do," Poland said. ``In vaccine research, it's one of the few areas when you discover something, it affects millions of people."
Diedtra Henderson can be reached at dhenderson@globe.com. 
