Chairman Thornberry, Ranking Member Langevin, and members of the committee, thank you for the opportunity to be here today. I appreciate the opportunity to discuss government efforts and opportunities for collaboration to address our nation's biodefense priorities.
I am currently the Interim Executive Vice President and CEO of the Texas A&M Health Science Center and Principal Investigator for the Texas A&M Center for Innovation in Advanced Development and Manufacturing, a public-private partnership with the U.S. Department of Health and Human Services designed to enhance the nation's emergency preparedness against emerging infectious diseases.
My pathway to this position includes a career as an academic physician scientist, focusing on life threatening infectious diseases, particularly those diseases affecting adolescents and young adults. As a result of work in this field, I was invited to serve on one of DARPA's non-governmental science and technology assessment panels, the Defense Sciences Research Council (DSRC), which was responsible for developing concepts that could potentially lead to DARPA initiatives and "game-changing" capabilities benefitting national security. In this role, I chaired or co-chaired numerous intensive studies on chemical, biological, radiological, and nuclear (CBRN) security and countermeasures, decontamination, and warfighter performance under extreme conditions.
After five years on the DSRC, I was privileged to serve as Deputy Director, and then Director, of the Defense Sciences Office at DARPA, and honored to be the first medical doctor to become an office director in the 50 year history of that agency. In my role as Director, working with a multidisciplinary team of the nation's finest scientists, physicians, and engineers, and with the budgetary opportunities provided to us by Congress, we developed and implemented an integrated platform of research initiatives, named Accelerating Critical Therapeutics (ACT), designed not only to provide new, highly effective medical countermeasure capabilities, but also to provide an unprecedented, flexible, adaptable, and rapid response to address and defeat the pervasive and growing threat of highly genetically modified or chimeric organisms for which the nation had no pre-existing vaccines, countermeasures, or technical approaches. Many DARPA programs begun at that time are now operational and have made an enormous impact on our public health preparedness and response.
One aspect of the portfolio that was extraordinarily challenging, even by DARPA standards, was the ability to develop low cost, highly flexible and adaptable manufacturing technologies capable of providing tens of millions of doses of vaccines or medical countermeasures (such as monoclonal antibodies or antidotes to chemical weapons) within weeks of notification. Such a capability did not exist in the civilian or military experience, and there were profound technical barriers to overcome. Among these barriers were traditional manufacturing facility architectures that were generally single use, and cost $1 billion or more. In addition, production platforms such as fertilized chicken eggs necessitated an enormous logistics tail, and therefore had very limited rapid response capabilities, even when heroic efforts were made by the U.S. Government and industry, as demonstrated in the 2009 H1N1 pandemic.