Photo: Courtesy of Judith Vaitukaitis
Were it not for the National Institutes of Health's former policy that did not allow NIH researchers to patent their discoveries, "Vaitukaitis" would have been a household name, like Pasteur or Steinway. That's because reproductive endocrinologist Judith Vaitukaitis, now director of NIH's National Center for Research Resources (NCRR), discovered what became the first simple pregnancy test--the immunoassay for the presence of human chorionic gonadotrophin (hCG) in urine. She quips that her name isn't on the test because no one can spell it.
During her highly successful and productive clinical research career, which includes publication of more than 150 papers, she has had four publications selected as Citation Classics--including the paper on developing specific antisera (which led to the hCG immunoassay). "I think she's been an outstanding physician-scientist who has made many important contributions in the field of reproductive biology," says Aram Chobanian, dean of the Boston University School of Medicine. But as her research positions advanced, Vaitukaitis found that she was also very good and efficient at administrative tasks. Thus, 20 years after graduating from Boston University School of Medicine, she became an NIH administrator, first running the General Clinical Research Centers (GCRC) program under NCRR, then as NCRR director.
NCRR funds the underpinnings of biomedical research: technologies, instrumentation, infrastructure, animal models, biomaterials, genetic stocks, and clinical training. With regard to the diversity of activities she pursues, Vaitukaitis says, "It reminds me of being in a candy store." Her job is to "figure out ways of making it [biomedical research] happen." For example, NCRR supplied support for a beam line from a linear accelerator to study crystallographic structure. Using a linear accelerator was proving inefficient, and a means for speeding up the work had to be devised. One way, Vaitukaitis explained, was to use robotics to place the crystal on the beam line.
Researchers can use scalable computing--access to large supercomputers--to capture and analyze data. But they also need a means of communicating with each other. For that, they can now use Internet2, the new research Internet line that, says Vaitukaitis, "is more than 10 times faster than the regular Internet." It is operated by a consortium of universities and research centers headquartered at the University of Michigan at Ann Arbor.
NCRR programs support NIH's GCRCs at 80 sites nationwide--the heart of NIH-sponsored extramural clinical research. NCRR also aims to recruit more clinician-researchers (see "The Key to Translation ..." on page 22). One of the major problems facing clinical research today is the lack of trained medical professionals who also are clinical researchers. Vaitukaitis proudly states that NCRR is "a leading source of support" for training physicians and dentists to become clinical researchers.
In another project, she explains, the NCRR is cooperating with the San Diego Supercomputer Center and the National Science Foundation to build the Biomedical Informatics Research Network (BIRN), a fast, real-time, high-definition system that is being tested by neuroscience researchers. BIRN will allow multisite clinical trials of new techniques, allowing researchers to perform studies and interventions at one location with the patient at another location, such as stem cell implants to control Parkinson disease. This technology "allows multisite studies and accelerates research, and would allow participants from a wider geographic area," Vaitukaitis says.
Turning from technology development to human resources infrastructure, Vaitukaitis says a major issue with clinical studies now is that "the public is concerned about patient safety in participating in clinical research. It's really important that the fruits of research get back to the patient and do no harm." To do that, the system must contain safety mechanisms. To make both the public and the re-searchers more comfortable, NCRR has developed a research subject ombudsman program at each of its 80 GCRCs. The ombudsmen will work with the investigators to ensure that patients understand the research projects. If something untoward should occur during a project, the ombudsman will urge the researcher to take immediate action and report the event to the appropriate authorities.
NCRR also funds purchase of medical research equipment that would usually be too expensive for a clinical research center to afford. "Advanced research tools are absolutely needed for modern research, and the funds for them are very limited," notes Vaitukaitis. NCRR, she says, has "identified a backlog of a need for high-end equipment that costs a couple of million dollars." NCRR's total budget for the program this year is $10 million. The equipment costs between $750,000 and $2 million, which means that most of the 97 applicants this year will receive nothing; the NCRR can fund only 10 of the applications, although 30 of them should be funded. But here, Vaitukaitis' creativity, which was manifested in the laboratory, takes over. Options include pushing some projects over to the next fiscal year for funding, and working with other NIH institutes to see if they will fund some of the projects.
"Judy has worked extremely well to create research infrastructure, which this country really needs," notes her former NIH colleague Peter Kohler, who now is president of the Oregon Health and Science University in Portland. Michael Johns, vice president for health sciences at Emory University in Atlanta, sums up Vaitukaitis's achievements to date: "She is a woman of vision, integrity, and thoughtful enthusiasm for the unlimited possibilities of research that improves the health of all people."
Myrna E. Watanabe is a freelance science writer in Patterson, NY.