Last week, DCFR hosted Texas A&M Vice Chancellor of Strategic Initiatives, Brett Giroir. He is a foremost expert on biosecurity and biodefense. His remarks at DCFR coincided with major news in the days that followed—that the U.S. is building biodefense, bioterror and pandemic prevention capabilities.
Over the past several years, the area surrounding Texas A&M, College Station was envisioned as becoming a ‘third coast’ of pharma manufacturing by Dr. Brett Giroir. His big idea has now turned into a reality and then some. Yesterday, on Monday, June 18th, Texas A&M System was awarded a contract to develop one of three U.S. Department of Health and Human Services Centers for Innovation in Advanced Development and Manufacturing. The $285.6 million contract includes an initial investment of $176.6 million from the U.S. government, with the remainder cost-shared by commercial and academic proposal partners. The goal is to enhance the nation’s biosecurity preparedness.
“Our approach has been to try to build something that is absent in the state and complimentary to the other major centers, ” says Dr. Giroir. Dallas and Houston are both phenomenal at basic biomedical research with UT Southwestern and Texas Medical Center; they also are very good at clinical trials. “But what is missing from the state, and I would argue nationally, is a real commitment to the non-glamorous part, which takes about 75% of the time and the money. About 75% of the cost for new complex biological drugs is R&D for manufacturing —how to make them and how to make them consistently. These are engineering disciplines.” By focusing on those aspects of product development, the research centers add to Texas’s commercial success by filling the biopharmaceutical manufacturing gap but also fill the ‘very big gap’ in biosecurity nationally, which has been limited by a lack of capabilities.
Giroir explains the challenges, “One cannot simply manufacture new vaccines and new molecules. They cannot be made by the new chemistry. They have to be made by programming a living organism to actually make it for you. They are very, very complex. This requires vast technical challenges that span the intersection between biochemistry, genetics, and engineering. And one needs to industrialize the end product under an FDA regulatory umbrella. This is partly why we are stuck with very old technology. We grow flu vaccines in chicken embryos, which is 60-65 year old technology. That did not meet up with the needs of H1N1 or for any future pandemic.”
The state-of-the-art project, The National Center for Therapeutics Manufacturing at Texas A&M, structurally changed what was once billion-dollar, single-use facilities to very modular, flexible facilities, creating an architecture to produce many products to work through the pipeline instead of one. A second project works on next generation vaccines in a plant-based facility, GreenVax, or nationally called the Blue Angel Program. It was a partnership between A&M and a private company. It’s now a private fully-integrated biopharmaceutical company working on plant-made products on the Texas A&M campus.
Giroir likens the Texas A&M centers to the national energy labs like Los Alamos or Oak Ridge. “There’s no way you can say that the national labs have not been a great success for the U.S.,” Giroir suggests. “The country keenly understands that the next 100 years are going to be the years of biological threats. We need medical responses to chemical, nuclear, and radiological agents because if someone dropped a dirty bomb in the middle of Dallas, you can’t go to Parkland and get the antidotes. This is a strategic national stockpile capability. Together, the three centers chosen by the U.S. government will have 150 million vaccines doses, which will be enough to protect the U.S. against pandemic.”
The H1N1 outbreak proved that our technology was not able to respond fast enough, and there was no domestic U.S. production to counter it. Giroir comments, “Other countries basically nationalized their own vaccine facilities, so the U.S. was caught with no assurance of biosecurity. We can’t have that.”
With Dr. Giroir’s healthcare background, he became very concerned about the U.S.’s position against naturally emerging diseases such as H5N1 and SARS. But the bioterrorist and terrorist campaigns also troubled him. While at Defense Advanced Research Projects Agency (DARPA) from 2004-2008, Dr. Giroir worked to outline a strategy about what needed to be done. Subsequently, landing back in Texas, he had the opportunity to start implementing the strategy, and not wait for the federal government. Texas A&M had the engineering prowess and related disciplines to initiate the new centers needed for 21st century challenges.
The Centers for Innovation in Advanced Development and Manufacturing will utilize rapid, nimble and flexible approaches to:
(1) develop and manufacture vaccines to protect against pandemic influenza;
(2) provide therapies in the event of chemical, biological, radiological, and nuclear threats;
(3) perform advanced development, accelerate vaccines and other biosecurity products and,
(4) train the next generation of professionals in areas required to sustain this national capability.
“This is a definitive opportunity to leverage our resources and infrastructure to build a biopharmaceutical industry, including the many firms desiring to set up shop in Texas,” Giroir enthusiastically remarks. The building of this industry will bring high-quality jobs and new skill sets to Texans, Texas firms, and ultimately provide Americans a more biosecure, pandemic-savvy country.