The Texas A&M Center for Innovation In Advanced Development And Manufacturing (CIADM) has been awarded new funding as a public-private partnership by the Departments of Defense and Health and Human Services to enhance America’s preparedness to respond to infectious disease pandemics and biological, chemical, radiological and nuclear threats.
The HHS Texas A&M CIADM was established partly a response to pandemics such as the 2009-2010 H1N1 flu — for which traditional biomanufacturing methods took 26 weeks to produce initial vaccine doses – and the future threat of biological attacks and other public health emergencies. According to expert witnesses testifying here Oct. 11 before the House Armed Services Committee’s subcommittee on intelligence, emerging threats and capabilities, some kinds of advances in biomanufacturing processes and DNA technologies have lowered the bar for states, and even individuals, who seek to produce biological weapons.
One of the subcommittee’s witnesses was physician-scientist and biodefense expert Dr. Brett P. Giroir, M.D., principal investigator at the Texas A&M Center for Innovation, and interim vice president and chief executive officer of the Texas A&M Health Sciences Center. Dr. Giroir is vice chancellor for strategic initiatives for The Texas A&M University System, and is responsible for leading the Center for Innovation In Advanced Development And Manufacturing, and is a former director of the Defense Sciences Office at the Defense Advanced Research Projects Agency (DARPA), and chair of the Chemical and Biological Defense Panel for the Threat Reduction Advisory Committee (TRAC) for the U.S. Department of Defense.
Dr. Giroir is vice chancellor for strategic initiatives for The Texas A&M University System and is responsible for leading 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, including pandemic influenza, and chemical, biological, radiological and nuclear threats. He is a former director of the Defense Sciences Office at the Defense Advanced Research Projects Agency (DARPA), and chair of the Chemical and Biological Defense Panel for the Threat Reduction Advisory Committee (TRAC) for the U.S. Department of Defense.
“Literally, what once took weeks during medical school to produce in a multimillion-dollar laboratory can be done [today] in an afternoon on a benchtop by someone with a relatively less degree of scientific training,” he is cited in an American Forces Press Service release telling the panel, “So the barriers to entry have decreased.”
The Texas A&M Center for Innovation in Advance Development and Manufacturing is one of three centers established in June, 2012 as a public-private partnership with the U.S. Department of Health and Human Services (HHS) to enhance the nation’s emergency preparedness against emerging infectious diseases, including pandemic influenza, and chemical, biological, radiological and nuclear threats. The Center was founded on an initial $285.6 million investment, including a $176.6 million contribution from the HHS, with the remainder cost-shared by commercial and academic proposal partners, and will perform research and advanced development to accelerate vaccines and other medical products through pre-clinical and clinical development and produce these products in cases of pandemics or other national emergencies. Through these activities, the CIADM will address a recognized shortcoming in preparedness and response to known and unknown threats, and will improve America’s ability to protect the health of its citizens in emergency situations
The need for this advanced public health and biosecurity capability was identified following a comprehensive review of federal public health emergency medical countermeasures called for by President Barack Obama in his 2010 State of the Union address, in which he noted: “We are launching a new initiative that will give us the capacity to respond faster and more effectively to bioterrorism or an infectious disease – a plan that will counter threats at home, and strengthen public health abroad.” The president’s charge prompted a comprehensive assessment of the public health and emergency preparedness enterprise published in August 2010.
DHHS Secretary Kathleen Sebelius has noted that “Our nation must have a system that is nimble and flexible enough to produce medical countermeasures quickly in the face of an attack or threat.”
Dr. Giroir’s work at the Texas A&M Center for Innovation began in 2008 after nine years at the DARPA, which was established in 1958 to prevent strategic surprises from negatively impacting U.S. national security and to create strategic surprise for U.S. adversaries by maintaining the technological superiority of the U.S. military. To fulfill its mission, the DARPA relies on diverse performers to apply multi-disciplinary approaches to both advance knowledge through basic research and create innovative technologies that address current practical problems through applied research. DARPA’s scientific investigations span the gamut from laboratory efforts to the creation of full-scale technology demonstrations in the fields of biology, medicine, computer science, chemistry, physics, engineering, mathematics, material sciences, social sciences, neurosciences and more. As the DoD’s primary innovation engine, DARPA undertakes projects that are finite in duration but that create lasting revolutionary change.
During his first five years at DARPA, Dr. Brett Giroir was a member of the Defense Sciences Research Council, for which he chaired or co-chaired intensive studies on chemical, biological, radiological and nuclear security and countermeasures, decontamination and warfighter performance under extreme conditions. Subsequently, as deputy director and later director of the DARPA Defense Sciences Office, Dr. Giroir and a team of scientists, physicians and engineers developed a platform of research initiatives called Accelerating Critical Therapeutics, or ACT, which was was designed to provide new, highly effective medical countermeasures and an unprecedented, flexible and rapid response to address the growing threat of genetically modified or chimeric organisms — single organisms with two or more sets of genetically distinct cells — for which no vaccines or countermeasures existed.
One aspect of the DARPA portfolio that was extremely challenging, even for DARPA, Dr. Girois notes in the American Forces Press Service release, was the ability to develop low-cost, highly flexible and adaptable biomanufacturing technologies that could provide tens of millions of doses of vaccines or medical countermeasures such as chemical-weapon antidotes within weeks of notification. Such a capability didn’t exist in the civilian or military experience, he notes, and profound technical and financial barriers kept the problem unsolved for several years.
“In 2008, when my assignment at DARPA was completed, I joined the Texas A&M system [and] secured a $50 million investment from the state of Texas to demonstrate those flexible manufacturing capabilities originally envisioned at DARPA,” Giroir told the panel. “Beginning in 2009, Texas A&M designed, developed, constructed and is now operating a revolutionary first-in-class, 150,000-square-foot facility that has pioneered highly flexible, adaptable and even mobile manufacturing platforms at a capital cost of about 80 percent less than the current state of the art.”
The facility is called the National Center for Therapeutics, or NCTM, a key feature there being the use of modular and mobile stand-alone biopharmaceutical clean rooms, called modular clear rooms, or MCRs. The initial MCR concept was funded by DOD through DARPA and the Army Research Office, Dr. Giroir said, adding that NCTM is the core facility and main site for developing and manufacturing medical countermeasures and vaccines against chemical, biological, radiological and nuclear threats for the Texas A&M Center for Innovation, and is a first-of-its-kind, multi-disciplinary workforce education institution and biopharmaceutical manufacturing center, located at Texas A&M University in College Station, Texas. The NCTM, whose workforce development mission is to provide education, training, and outreach programs to produce a highly skilled workforce for the vital U.S. and global pharmaceutical industry, offers 152,000 square feet of workforce development and contract manufacturing space. The academic wing provides nearly 50,000 square feet of educational facilities with well-appointed wet labs, cell culture facility, spacious lecture and conference halls, software training laboratory, and fully-equipped mock current Good Manufacturing Practice (cGMP) training suite that simulates pharmaceutical manufacturing environments.
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Another part of the Center for Innovation’s biomanufacturing infrastructure is the Caliber Biotherapeutics Facility, also at College Station, a fully-integrated biopharmaceutical company, developed and built through Texas A&M and G-CON Manufacturing, with funding from the DARPA Blue Angel Program. In April, 2010, Caliber Biotherapeutics opened the world’s largest plant-made pharmaceutical manufacturing facility at Bryan, Texas, with the capability of producing 10-100 million doses of infectious vaccines per month, and hundreds of thousands of doses of protein biotherapeutics such as monoclonal antibodies. In addition to its plant-based facility, Caliber is tasked with developing a proprietary product pipeline for cancer and infectious diseases utilizing cell and microbial-based production system to provide more effective and affordable vaccines and biotherapeutics for patients delivered in a time frame in which they are needed.
Led by Dr. Giroir and Barry Holtz, Ph.D., an internationally recognized pioneer in plant-made pharmaceuticals, Caliber Biotherapeutics represents a fundamentally different approach to vaccine and drug development. In May 2009, DARPA initiated the Blue Angel effort to identify ongoing programs to assist in the Government-wide response to the H1N1 pandemic. The Blue Angel program is an accelerated and integrated effort to deliver effective interventions for pandemic influenza. Blue Angel brings together the following technologies to form a comprehensive approach in response to a pandemic influenza or manmade outbreak: Predicting Health and Disease (PHD), a program to predict and diagnose individuals exposed to influenza before they are symptomatic; Modular Immune In vitro Constructs (MIMIC), a program to identify safe and effective treatments in a test tube; and Accelerated Manufacture of Pharmaceuticals (AMP), a capability for rapidly mass producing low-cost, vaccine-grade recombinant protein that has the potential for scale up to tens of millions of doses per month. In response to the 2009 H1N1 swine flu pandemic, Blue Angel programs are currently in a “live-fire test” to demonstrate a flexible and agile capability for the Defense Department to rapidly react and neutralize any natural or intentional pandemic disease, predict disease propagation, and appropriate early treatment of infected individuals.
The Texas A&M Center for Innovation has partnered with Caliber Biotherapeutics to make Caliber’s plant-made pharmaceutical facility available for HHS task orders, including vaccines, Dr. Giroir told the panel, noting that: “The facility has the capability to produce up to 20 kilograms of purified protein per month through its highly automated, Nicotiana benthamiana, a close relative of tobacco, plant-based production system,” adding that “We consider this program to be the most responsive, secure and capable plant-made vaccine program currently available worldwide.”
Dr. Giroir also is cited noting in his remarks to the panel that the Center for Innovation’s high-level objectives are:
• To provide a national vaccine response against pandemic flu, defined as 50 million doses delivered in 4 months, with initial doses available to the federal government in 12 weeks;
• To perform what’s called advanced development — the final steps — in manufacturing vaccines and medical countermeasures against chemical, biological, radiological and nuclear threats as tasked by HHS; and
• To train the future domestic U.S. workforce.
To achieve these objectives, Texas A&M leads a multidisciplinary team with expertise that spans research to clinical trials, including GlaxoSmithKline (GSK), or GSK Vaccines, the world’s largest vaccine developer, Dr. Giroir observed. GSK Vaccines produces 30 vaccines worldwide, eleven of which are licensed by the FDA. In 2012, GSK provided more than 20 million flu shots for the U.S. market and recently became the first major U.S. vaccines provider to gain FDA-approval for a broader-protection, four-strain (quadrivalent) influenza vaccine shot that will be available in time for the 2013-14 flu season. The partnership with GSK was founded on a long, collaborative relationship between Texas A&M and the Wallonia Region of Belgium.
On March 26, 2013 GlaxoSmithKline and The Texas A&M University System announced that the U.S. Department of Health and Human Services (DHHS) had approved establishment of a $91 million influenza-vaccines manufacturing facility as the anchor of the Center for Innovation in Advanced Development and Manufacturing in Bryan-College Station, Texas. Upon the announcement at the Texas State Capitol, which was attended by Texas A&M System Chancellor John Sharp, Dr. Robin Robinson, DHHS Deputy Assistant Secretary and Director of the Biomedical Advanced Research and Development Authority (BARDA), and Antoon Loomans, Senior Vice President, GSK Vaccines Governor Rick Perry stated: “Today’s announcement is a huge win for Texas and for the nation. The Texas A&M Center, anchored by this facility, is expected to bring more than $41 billion in expenditures within the State of Texas over the next 25 years, and will add more than 6,800 direct and related jobs to Texas.”
One of only three CIADMs to be developed in the U.S., the Texas A&M Center is at the vanguard of U.S. pandemic-preparedness efforts and represents unprecedented public-health collaboration among state and federal governments, academia and private industry, able to supply 50 million doses of pandemic influenza vaccine within four months of an outbreak. BARDA conceived the public-private formula to assure a strong biosecurity product development and manufacturing base on U.S. soil, ensuring that the nation would have rapid access to vaccines and therapeutics in the advent of influenza pandemics, or chemical, biological, radiological, and nuclear attacks.
“GSK’s decision to partner with Texas A&M and bring their vaccine manufacturing to our state is a testament to the investments that the A&M System and the State of Texas have made in the people, infrastructure and technologies, much of which came from critical state programs such as the Emerging Technology Fund,” Dr. Giroir commented. “GSK brings unequaled influenza vaccine development, manufacturing, and regulatory expertise to our Center. Equally important, GSK brings its cell based influenza vaccine development program, which we have assessed to be the most promising near term influenza vaccine technology to improve upon current egg based vaccines.”
The Texas A&M Center for Innovation is lead by Dr. Giroir and a core team of A&M experts in biotechnology, infectious diseases, facilities planning and construction, federal acquisitions/contracting, and government affairs.
“GSK’s decision to partner with Texas A&M and bring their vaccine manufacturing to our state is a testament to the investments that the A&M System and the State of Texas have made in the people, infrastructure and technologies, much of which came from critical state programs such as the Emerging Technology Fund,” Dr. Giroir said. “GSK brings unequaled influenza vaccine development, manufacturing, and regulatory expertise to our Center. Equally important, GSK brings its cell based influenza vaccine development program, which we have assessed to be the most promising near term influenza vaccine technology to improve upon current egg based vaccines.”
The Texas A&M Center for Innovation represents the largest commitment of a global biopharmaceutical company to partner within Texas, and will be an important catalyst to the future growth of this industry within the State, expanding domestic U.S. infrastructure with a new, dedicated pandemic flu vaccine facility to meet its 50-million-dose requirements, and a new live-virus vaccine facility at biosafety level 3, designed specifically for research with hazardous biological agents. Dr. Giroir is cited noting that Texas A&M is highly motivated to continue its history of service to the nation by supporting DOD and supplying improved vaccines and countermeasures to the warfighter, explaining that “Of particular interest would be DOD partnerships to develop and manufacture products for their stockpile and special immunizations programs,” he added, “and perhaps more importantly, to be the cornerstone for an emergency response to genetically modified or chimeric organisms [and] other unexpected agents that we believe are a growing, real threat to our national security and public health…. Because the center’s contract with HHS indicates that 50 percent of its capabilities are available for non-HHS projects, there is an immediate opportunity for DOD to use center capacity and expertise already funded by HHS, he added. We believe such collaborations would not only reduce DOD operational risks, but would reduce DOD expenditures, potentially by hundreds of millions of dollars, that could then be reallocated to provide additional vaccines, countermeasures and capabilities to our warfighters.”
Dr. Brett P. Giroir received his undergraduate education at Harvard University and his medical training at the University of Texas Southwestern Medical Center. He is a frequently published basic science and clinical investigator, and currently holds professor appointments at the Texas A&M Colleges of Medicine and Engineering and adjunct professor appointments at the Texas A&M University Bush School of Government and Public Service and the Baylor College of Medicine. He is the recipient of the Texas A&M System Award for Innovation and the U.S. Secretary of Defense Medal for Outstanding Public Service.
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