Furthering Public Health Security: Project Bioshield

House Committee on Energy and Commerce: Subcommittee on Health
Subcommittee on Emergency Preparedness and Response of the Committee on Homeland Security
March 27, 2003
09:30 AM
2123 Rayburn House Office Building

I am Dr. James Baker, a physician who is the Ruth Dow Doan Professor of Internal Medicine and Director of the Center for Biologic Nanotechnology at the University of Michigan. I am Director of Research at our institution's Bioterrorism Initiative, and Division Chief of Allergy and Clinical Immunology in the Medical School. I am a 14-year veteran of service in the U.S. Army, 12 of it on active duty, including service during Desert Storm. I have participated in and chaired committees in NIAID reviewing research into defense against biologic weapons. With support from the Defense Advance Research Projects Agency, the National Institutes of Health and NASA, my center is applying these technologies to a number of problems in biology including infectious disease therapy and microbial decontamination. I am also the CSO of two startup companies, one of which, NanoBio Corporation, is dedicated to commercializing new technologies for antimicrobial applications and decontamination. I have extensively studied the problems involved in preventing illness as a result of bio-terrorism or bio-warfare, and I am pleased to have been invited to testify before the committee this morning.

The Purpose of Project Bioshield Project Bioshield aims to rapidly transfer technology into products that can be used to protect individuals against biologic and chemical agents used as weapons of terrorism or mass destruction. The emphasis is on rapid introduction of new countermeasures into actual use, as many technologies currently under development need to be transitioned through regulatory approval or commercial development cycles. Unfortunately, Project Bioshield faces many challenges in attaining this goal. Some of these challenges are technical. The technologies that are currently available for commercialization are not adequate to meet the needs of our population. An excellent example is the current smallpox vaccine which is being produced in larger quantities but has medical issues that make it unacceptable for use by the current U.S. population. While new smallpox vaccines are in development, the time lag for approval of these is considerable and beyond the timeframe desired for Project Bioshield.

Other problems for Project Bioshield involve economic issues. Producing technologies solely for bioterrorism prevention is not economically viable for most companies. Since most products specifically targeted for defense against bioterrorism will hopefully never be used, small sales of these products would have to support massive development costs, even when aided by the government. Also, it is unlikely that established manufacturers will bid to produce products only for these applications since there would be no consistent, ongoing markets available to sustain product development and marketing costs. Finally, the cost of product liability may be an inherent issue in this process. Unlike products developed for the military, products directed towards civilian applications expose manufacturers to liability claims. A product, be it a detector, vaccine or therapeutic, will not be infallible and the risk of failure during a bioterrorism event would create liability issues great enough to prevent any established company from entering this market. This is apparent in many of the bioterrror initiatives the government has already launched.

The result of these many problems requires that most work supported by Project Bioshield will involve new technology developed by start-up companies who are willing to support the high-risk, high-reward nature of bioterrorism applications. In addition, this approach will also ensure that the American people get the best available technology, and leverage the investment in government-sponsored research from NIH, NSF and the EPA.

The Nation's Best, Largest Technology Incubator The nation's best and largest technology incubators are its' research universities. Most of the breakthrough technologies that have been incorporated into medical research and therapeutics have come from the nation's research university laboratories. These research advances cover the gamut of Project Bioshield needs from medical counter-measures, such as vaccines and therapeutics, through issues related to the psychological and economical impact of bioterrorism. The nation's universities produce new technologies very efficiently, given that they have a pre-installed technical base. The universities are also highly effective in technology transfer, being the source of much of the technology used by the nation's start-up biotechnology and pharmaceutical research companies. These start-up companies are most likely to respond to Project Bioshield given the fact they are willing to accept the risks involved in developing new technology for bioterrorism. This system is remarkably efficient; yielding new companies and new technologies rapidly and often without support from established companies. The focus also is on technology improvement to do a better job of protecting our citizens, rather than re-packaging current technologies.

My Personal Experiences Emblematic Of This System As a physician scientist I received funding from DARPA to develop new counter-measures for bioterrorism. This research quickly resulted in technology that was commercialized. NanoBio, a start-up company where I am Chief Scientific Officer, began work in March of 2001 and quickly responded to a request for decontamination materials during October 2001. Given our technology's unique application to skin decontamination, we have now moved towards FDA approval to use our material to decontaminate human beings and are initiating Phase I clinical trials this spring. This was accomplished despite the regulatory approach for bioterrorism approval being defined only 6 months ago. Thus, the head start given to our technology by university research and development was leveraged into a commercial product that will enter clinical trials less then two years after the company was created! It is this type of success that could be duplicated many times with academic support through Project Bioshield.

Proposal for Inclusion of Research University Components in Bioshield I would strongly urge you to include research university components in the Bioshield bill in order to support the transition and commercialization of university research. This will support and leverage funding to develop new technologies these universities have received from the NIH, NSF and EPA. It will also ensure that the newest and most effective forms of protection are made available to our population. Finally, given the economic and liability issues involved, it is likely that only start-up and small companies would accept the high-risk, high-reward endeavors entailed in Bioshield. By leveraging the government's investment in university research, the likelihood that these companies will be successful is increased for the betterment of all.

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