While 2001 saw many U.S. industries in an economic holding action, medical technology could look to the federal government for new sources of funding for a variety of discovery efforts. The new funding possibilities have been fueled on two fronts: on the one hand, the increasing threat of bioterrorism and, on the other, a growing recognition that biotechnology often does not fit neatly into many of the standard categories.In response to Sept. 11 and its aftermath, the Department of Health and Human Services (Washington) rolled out seven new initiatives to accelerate research focused on the organisms that might be used in bioterror attacks. "People's concerns are heightened, and as a result of that, we have been able to identify a lot of what we don't know about a lot of these organisms," said Carole Heilman, director of the division of microbiology and infectious diseases at the National Institute of Allergy and Infectious Diseases (NIAID; Bethesda, Maryland). "A lot of people who are working on, for example, complementary systems, could contribute to understanding of these organisms."
And she said that the NIAID was fielding calls from companies and academics interested in being a part of the various initiatives. "We can give you some general guidelines about the NIH [National Institutes of Health] process if you're new to it. We can help explain a little bit more about what some things may indeed mean. Or if there is something that you're looking for in terms of a potential collaboration, we can help lead you to somebody that may be a good marriage."
The federal government is not shy about funding these programs. During FY01, $47 million was allocated to the NIH for bioterrorism research, with $36 million of that used by the NIAID. In the proposed FY02 budget, submitted before Sept. 11, President George Bush stepped up those figures to $93 million to the NIH for bioterrorism research, $81.6 million of it earmarked for the NIAID. The final budget has yet to be approved. The initiatives will fund research on what the Centers for Disease Control and Prevention (CDC; Atlanta, Georgia) defines as Category A biological diseases, including anthrax, botulism, plague, smallpox, tularemia and viral hemorrhagic fevers.
The new grant program areas include:
The Anthrax Vaccine Contract, designed to accelerate development of new vaccines. "The current anthrax vaccine that is available has a regimen that requires six vaccine doses over an 18-month period," Heilman said. "That works perfectly if you are in a very confined arena and you know you were going into a situation in which the threat of bioterrorism may be real. So [in] a military situation, that works. But in the situations that we have seen recently, it would have been nice to be able to have had an alternative strategy to broad-based use of antibiotics. And it would have perhaps given a little bit more comfort to people who are on the periphery of concern with respect to potential for anthrax infection."
The Rapid Response Grant Program on Bioterrorism-Related Research will evaluate and fund new applications in five to six months after receipt, rather than the usual nine or 10 months. This program is aimed at new prevention strategies and treatments infected, as well as improved diagnostics. It will also fund basic research that provides a better understanding of the disease-causing organisms, particularly information taken from the genomes of these organisms.
The Partnerships for Novel Therapeutic, Diagnostic and Vector Control Strategies in Infectious Diseases is for work on new drug development and better diagnostics through partnerships among government, academia, and the biotechnology and pharmaceutical industries.
A set of Exploratory and Developmental Grants will apply the latest genetic, imaging and computer technology to currently funded research on infectious diseases, especially those caused by Category A agents of bioterrorism. With these grants, investigators can purchase new equipment or collaborate with researchers in possession of needed equipment and expertise.
The Small Business Program on Bioterrorism-Related Research is a one-time solicitation of applications for research on bioterror agents. This program is part of the already established small business grant program, but the administrative and review process will be streamlined.
The U.S.-based Collaboration in Emerging Viral and Prion Diseases is designed to establish multidisciplinary research units that will investigate viral and viral-like diseases. These units will quickly study threats from emerging and re-emerging viruses and provide needed information about them.
The NIAID Investigator-Initiated Small Re-search Grants will fund specific, well-defined projects that can be completed in two years or less. This program allows individual investigators to take advantage of unexpected research opportunities and to follow promising new leads.
Other new funding sources offered by the NIH were described in late November by Donna Dean, PhD, at the 87th annual meeting of the Radiological Society of North America (Oak Brook, Illinois) in Chicago. Dean, senior scientific advisor in the office of the NIH director, is the acting head of the new National Institute of Biomedical Imaging and Bioengineering (NIBIB). Formed in December 2000 as the newest NIH institute, the NIBIB will focus on stimulating "those areas for which investigators have not been able to find a home at NIH," Dean said. While acknowledging the NIBIB as the "youngest kid on the block," Dean said it would be "by no means the least ambitious" of those kids and that it was positioning itself to hand out between $25 million and $30 million in new research grants in the areas of biomedical engineering and imaging.
Dean specifically pointed to research in molecular engineering as "a very rich area of opportunity . . . because it will take us from the level of tissues and organs — historically, the path of imaging — to the sub-cellular level." And she called that area one "where the research radiologist and the bioengineer can find common ground." Dean said that NIBIB funding would go not only to primary research areas, but also to efforts in product commercialization. In the future, she said, NIBIB "will have to begin to grapple" even more with the issue of commercial spin-off and "what is appropriate for projects for profit and appropriate for the government to be stimulating commercialization." Dean said she expected the first grants to be awarded early this year.
She said that the NIBIB will be seeking grant applications that will pursue novel imaging or bioengineering technologies that are not organ- or disease-specific. Toward that goal, the institute is co-sponsoring the International Symposium on Biomedical Imaging: Macro to Nano, July 7-10, at the Ritz Carlton Hotel in Washington.
Aventis II closed with $400 million
While various forces are acting to push new med-tech funding, the subsiding of an alternate technology — the dot-com wave — may also serve to funnel new monies toward medical devices and pharmaceuticals. That is the view of Ross Jaffe, MD, managing director of Versant Ventures (Menlo Park, California), which last month closed a new round of $400 million in venture capital, called Versant II. Over the past two years, the dot-com/telecommunications boom "was sucking the oxygen out of the business fires in other areas," he said, adding that with that trend abated, health care again offers a strong investment environment.
The new $400 million Versant Venture Capital II fund will bring the company's capital under management to $670 million. Like the company's first fund of $250 million, Versant II will be "pretty balanced across the health care sector" — about 40% in devices, 40% in biotech and pharmaceuticals and 20% in health care services and IT, Jaffe said. Versant is not tuned into one particular disease or health care sector but is looking for those companies with promise but needing early-stage seeding and care. And in 2001, that strategy paid off well for Versant, Jaffe said.
"The past year has really been good for us," he noted. Its successes during that period have included seeing the sale of three companies it has invested in and a fourth going public. The three sales involved Atrionix (Palo Alto, California), an electrophysiology cardiology firm, to Johnson & Johnson's (New Brunswick, New Jersey) Cordis unit for $62.8 million; IntraTherapeutics (St. Paul, Minnesota), focused on interventional vascular radiology, to Sulzer Medica (Winterthur, Switzerland) for $145 million; and most recently, Pro-Duct Health (Menlo Park, California), developing technology to assist in detecting breast cancer, to CyTyc (Boxborough, Massachusetts) in a $38.5 million deal. Going public was glucose monitoring specialist TheraSense (Alameda, California), with an IPO offering that raised $131 million.
For venture capital, Jaffe said, the health winds "are blowing in our favor — the aging of the population, relatively good economic status of the baby boomer generation, a clear willingness to pay for health care." Plus, "Science keeps marching on. There's continued innovation in health care, both in the medical device field and innovations in service delivery and information in health care." And Jaffe, formerly a practicing internist, adds one more layer as icing on the cake: "The other benefit, hopefully, is that we're producing products that really help people — that benefit society."
Got anthrax? Find out with CT
With the coming of flu season, health care providers are likely to be hit with an avalanche of requests for antibiotics to ward off suspected cases of anthrax. But how to separate — and do it quickly — the many thousands of bad cases of the flu from those very few cases of inhaled anthrax (hopefully, very, very few) or none at all? The fastest, most reliable method is not a traditional bacteria culture assay but rather, computed tomography (CT) imaging. That was the primary message delivered by three radiologists at the aforementioned Radiological Society of North America meeting.
In three cases of individuals with inhaled anthrax, CT scans were used as a follow-up to chest X-rays which indicated a very serious but unknown problem, with the follow-up assessment of anthrax via CT coming too late to prevent one death. The radiologists acknowledged that there is still a great deal to learn concerning when inhaled anthrax first appears on a CT scan, plus many public health issues to be resolved concerning when to use this diagnostic system.