PHILADELPHIA - A number of government agencies issued calls for further industry collaboration on biodefense research and development during Monday's opening sessions of the BIO 2005 conference.
"All of a sudden now, we're doing a lot more together," Charles Schable, the director of the Office of Terrorism Preparedness and Emergency Response at the Centers for Disease Control and Prevention, said of an increasing coordination between various federal agencies to collectively oversee early research, later-stage development and eventual product procurement. "The federal government is doing a pretty good job."
A variety of agencies play a range of roles in such a continuum.
Within the National Institutes of Heath, the National Institute of Allergies and Infectious Diseases continues to work toward facilitating research in biothreats classified as bioterrorism, emerging diseases and re-emerging diseases.
"Our plans are based on research for Category A, B and C agents," said Gregory Milman, the director of the Office of Innovation at the NIAID. He added that industry should be interested in researching vaccines, therapeutics, adjuvants and diagnostics, and noted the NIH's role in funding a portion of such investigations.
For example, the NIAID has a $45 million budget for the current fiscal year for dispersal of Small Business Innovation Research grants, with Phase I awards topping out at $500,000 and Phase II grants worth up to $2 million. Also, a small grants program awards companies and academic institutes up to $50,000 "for those things that you want to do a pilot project on," Milman said, adding that early grants might serve as bridges that "could get you preliminary data to get you much more money."
He also noted that though the NIH has been criticized for increasing biodefense funding at the expense of basic research funding, "it hasn't taken any money away from our institute," indicating that both have increased over the past five years.
Lastly, Milman pointed to collaborative efforts between industry and NIH scientists, such as Cooperative Research and Development Agreements. "In addition to getting money from us," he said, "you can get technology from us."
While the idea of government collaboration with industry is not new, such a relationship has taken on added attention in the years since the 2001 anthrax attacks. And since Project BioShield was signed into law a year ago, yet another mechanism for such cooperation is in place.
Designed for federal procurement of FDA-licensed countermeasure products, the program considers only applications that have met a range of criteria: data from studies of toxicology, Phase I, pharmacokinetics or immunogenicity, animal efficacy and demonstrations of manufacturing capability. Already, a dozen packages of stockpiled drugs, housed at confidential locations around the country, can be shipped anywhere in the U.S. within 12 hours.
Beyond the acquisition and stockpile aspects of BioShield, it also allows for added NIH funding flexibility for research and development grants, as well as quicker approvals through the FDA's Emergency Use Authority.
According to Karen Midthun at the FDA, other ways to speed the approval process for bioterrorism countermeasures include early and frequent dialogues between product developers and the agency, as well as use of the animal efficacy exception for cases in which human efficacy testing is not feasible. She added that "most countermeasure products would be eligible for priority review."
While she noted that the FDA is not in the business of funding product development, the CDC's Schable said his agency maintains a budget to support the research and development of countermeasures. Recent funding included $142 million for extramural and intramural use, as well as $863 million for state and local health departments that can disperse their awards to industry.
During a related session, representatives from the Department of Defense also encouraged continued industry interaction through government collaborations. "DoD is not good at biology," admitted Klaus Schafer, the deputy assistant secretary of defense chemical and biological defense within the DoD. "We never have been." But in stressing that research activities under way within DoD impact all public health agencies, he added that "we are all now partners in this business."
Also discussed were non-therapeutic biotech applications such as biofuels, camouflage and concealment, combat identification and foods. Research in such areas is carried out in part through the Institute for Collaborative Biotechnologies, established three years ago at the University of California at Santa Barbara. "We're seeing some of the basic research we've funded begin to bear fruit," said Joseph Zarzycki, the technical director of the U.S. Army's Edgewood Chemical Biological Center