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Dr. Naomi Hunter

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Trump administration rolls out new coronavirus push, names HHS testing czar

“The changes have been made and testing will soon happen on a very large scale basis,” Trump said in a pair of tweets Friday morning.

The administration tapped Adm. Brett Giroir as a new “czar” housed at the Department of Health and Human Service. | Alex Wong/Getty Images



STATEMENT OF DR. BRETT P. GIROIR, M.D., INTERIM EXECUTIVE VICE PRESIDENT, TEXAS A&M HEALTH SCIENCE CENTER, TEXAS A&M UNIVERSITY Dr. GIROIR. Chairman Thornberry, Ranking Member Langevin, members of the committee, Congressman Flores, thank you for the opportunity to be here today. I am here as the principal investigator for the Texas A&M Center for Innovation in Advanced Development and Manufacturing, a public-private partnership with the Biomedical Advanced Research and Development Authority, also known as BARDA, of the U.S. Department of Health and Human Services.

This partnership is designed to enhance the Nation’s preparedness against pandemic influenza as well as chemical, biological, radiological, and nuclear threats. My previous experience includes Government service as the director of DARPA’s [Defense Advanced Research Projects Agency] science office and also as chair of the Chemical and Biological Defense Panel of the Threat Reduction Advisory Committee at Defense Threat Reduction Agency (DTRA).

At DARPA, we identified a critical national need for core bio-manufacturing facilities that would be low cost, flexible, adaptable, capable of simultaneously producing multiple products to support biodefense, while maintaining the ability to surge to a single product during a national emergency.

In 2008, when my assignment at DARPA was completed, I joined the Texas A&M system, secured a $50 million investment from the State of Texas to demonstrate those flexible manufacturing capabilities originally envisioned at DARPA. Beginning in 2009, Texas A&M designed, developed, constructed, and is now operating a revolutionary first in class, 150,000square 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.

This project, called the National Center for Therapeutics Manufacturing, is a primary infrastructure asset for the HHS [U.S. Department of Health and Human Services] center, which I will now describe. The Texas A&M Center for Innovation is one of three national centers competitively awarded by HHS in June of 2012 and is the only one led by an academic institution. It is found on an initial 51⁄2year base period contract consisting of $176 million in funding from HHS and a $109 million cost share by our center’s academic, commercial, and State of Texas partners.

The total potential duration of the contract is 25 years, with options for an additional $2.4 billion in readiness stipends and task orders. The high level objectives of our center are: first, to provide a national vaccine response against pandemic influenza, defined as 50 million doses delivered in 4 months, with initial doses available to the U.S. Government in 12 weeks; second, to perform what is called the advanced development and manufacturing of vaccines and medical countermeasures against chemical, biological, radiological, and nuclear threats as tasked by HHS; and, third, and very importantly, to train the future domestic U.S. workforce.

To achieve these objectives, Texas A&M is leading a multidisciplinary team with expertise spanning from research through clinical trials, including GlaxoSmithKline, or GSK, Vaccines, the world’s largest vaccine developer, with over 1.4 billion vaccine doses distributed worldwide annually and 11 vaccines in the United States. The center is also actively expanding domestic U.S. infrastructure. First, our preexisting facility is undergoing a capabilities upgrade that will be completed in March of 2014. Second, we are building a new, dedicated pandemic influenza vaccine facility to meet our 50milliondose requirements. Construction and facility commissioning will be completed in the third quarter of 2015.

Third, we are building a new live virus vaccine facility to produce vaccines up to the BSL–3 biosafety level. Construction and facility commissioning will also be completed in the third quarter of 2015. I would like to finish my remarks highlighting opportunities for collaboration with the Department of Defense. First, Texas A&M is highly motivated to continue our distinguished history of service to the Nation by supporting the DOD and supplying improved vaccines and countermeasures to the warfighter.

Of particular interest would be DOD partnerships to develop and manufacture products for their stockpile and special immunizations programs and, perhaps more importantly, to be the cornerstone for an emergency response to genetically modified, or chimeric organisms as well as other unexpected agents that we believe are a growing real threat to our national security and public health.

According to our contract with HHS, at least 50 percent of our center’s capabilities are available for non-HHS projects. Therefore, there is an immediate opportunity for the DOD to utilize our center’s capacity and expertise, which has already been funded by HHS. We believe such collaborations would not only reduce DOD operational risks but would also 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.


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Dr. Naomi Hunter

  • Awakened
  • **
  • 97
Grant for vaccine center gives A&M billion-dollar boost

By Eric Berger Published 7:25 pm CDT, Monday, June 18, 2012

The Texas A&M University System has won an immense federal contract to become a national hub of vaccine production and bioterror preparedness.

The federal contract to create a Center for Innovation in Advanced Development and Manufacturing in College Station is likely worth at least $1.5 to $2 billion over the next 25 years.

"It's the biggest federal grant to come to Texas since NASA, quite frankly," Texas A&M University System Chancellor John Sharp said.

The contract, announced Monday by U.S. Department of Health and Human Services Secretary Kathleen Sebelius, is remarkable for several reasons.

Politically it comes during an election year, from a Democratic administration, to the alma mater of Gov. Rick Perry, who has made much political hay by pillorying President Barack Obama.

"They played it right straight down the middle and gave it to the people who were best qualified, even if it's from a state and university that's not considered very Democratic," Sharp said.

The economic implications for the College Station area are also significant. About 1,000 jobs will be created during a construction phase that will last about five year. After that there should be many more, said Dr. Brett Giroir, the Texas A&M scientist who led the university's bid. Additionally the development should attract drug companies to invest in or relocate to the area.

For the state's biotechnology industry, Monday's announcement is a game-changer, said Jacqueline Northcut, president and chief executive of BioHouston, which promotes life sciences commercialization in the Houston region.

"This is a major win for Texas and Houston," Northcut said. "This is one leg of the stool that was missing for Texas - the ability to manufacture biologics on a major scale. What A&M and College Station have assembled is the right cornerstone we need for industrial development of biotechnology in Texas."

Expanding its portfolio

The announcement also has implications for the Texas A&M system itself, which began as an institution devoted to agriculture and engineering, and had been searching for a way to expand its life sciences portfolio in an era that emphasizes human biology over all other research.

Other state institutions, primarily affiliated with the University of Texas system, excel at basic medical research and clinical trials. In between, however, there is a scarcity of resources and space for taking lab breakthroughs, conducting animal tests and making large, quality-controlled batches of new medicines for clinical trials.

A&M's veterinary school and engineering expertise will help ease and speed this "translational" phase of medicine development, Giroir said.

That's precisely what the federal government sought in awarding three large contracts, one to Texas A&M and the others to bids led by private contractors, Emergent BioSolutions and Novartis.

"Establishing these centers represents a dramatic step forward in ensuring that the United States can produce lifesaving countermeasures quickly and nimbly," Sebelius said Monday.

It took about eight months to make the H1N1 vaccine after the initial swine flu outbreak in 2009, by which time tens of millions of Americans already had been infected and experienced mild symptoms. That outbreak and concerns about the potential for bioterrorism prompted the federal government to create three new centers that would be capable of making 50 million doses of influenza vaccine within four months.

State investment

After coming to Texas A&M in 2008 from the U.S. Defense Advanced Research Projects Agency, Giroir urged state officials to consider investing in this area.

Giroir obtained a $50 million grant from Perry's Texas Emerging Technology Fund to build the National Center for Therapeutics Manufacturing, a large complex that provides educational opportunities for students, as well as modular space for developing, testing and manufacturing vaccines and other drugs. It opened last fall in College Station.

The federal grant provides $176 million over the first five years to build several other large facilities. The state will have to contribute an additional $55 million and private partners, including large vaccine maker GlaxoSmithKline, will provide approximately the same amount.

After construction, provided the federal government is satisfied with Texas A&M's efforts, the center will receive $432 million over the life of the contract to support and maintain the facilities, as well as up to $100 million a year in task orders.

If the center is used to manufacture a pandemic influenza vaccine, more money would flow.

Giroir noted that the A&M center is obligated to use the facilities for government work only 50 percent of the time.

"That's going to mean a huge economic impact for the state," he said. "It's an opportunity to leverage more of these companies to come to Texas, to work on global health and perhaps use the facility to produce seasonal influenza vaccines.

U.S. Officials Discuss Pandemic Policy Visions At Scowcroft Pandemic Forum
The 3rd Annual Pandemic & Biosecurity Forum in Washington D.C. drew an audience of elected officials and former federal agency leaders to take part in a sprawling dialogue on pandemic prevention and response.
By Sam Peshek, Texas A&M University Division of Marketing & Communications May 14, 2019

With the 100th anniversary of the 1918 flu pandemic that killed 50 million people worldwide as the backdrop, more than a dozen U.S. government officials and infectious disease experts gathered in Washington, D.C. for the Scowcroft Institute of International Affairs’ 3rd Annual Pandemic & Biosecurity Forum, where they discussed how to prevent future mass-casualty disease outbreaks.

The Scowcroft Institute, housed within the George H.W Bush School of Government & Public Service at Texas A&M University, also shared a white paper developed through research in 2018 by Bush School researchers and a team of eight interdisciplinary graduate students to more than 300 attendees at the National Press Club.

Featured speakers who received the report included U.S. Sen. Richard Burr (R-NC), Department of Health and Human Services Assistant Secretary for Health Admiral Brett P. Giroir, U.S. Rep. Michael C. Burgess (TX-26) and U.S. Rep. Bill Flores (TX-17).

Giroir, who served as executive vice president and CEO of Texas A&M’s Health Science Center from 2013-2015, hailed the report titled “Community Resilience, Centralized Leadership & Multi-Sectoral Collaboration In Pandemic Preparedness & Response” as a pivotal and urgent document.

“I think it is absolutely a critical, seminal piece of work that will serve as a guidepost both nationally and internationally,” Giroir said during the event.
Facilitating innovation

Burr, who serves as chairman of the Senate Select Intelligence Committee, said during his keynote remarks that the U.S. government often fails to develop and deliver technological innovations in a timely manner. He noted

“A system that restrains the deployment of technology on one side and incentivizes the innovation of technology on the other has to come together to figure out how to make these two mesh,” Burr said.

He pointed to the success of public-private partnerships like BARDA and open source software company Red Hat to encourage further collaboration between the National Institutes of Health (NIH), university researchers and private companies.

“This is the model I think we will try to replicate, whether it’s at Texas A&M, whether it’s in Massachusetts somewhere, whether it’s in Silicon Valley, because we now understand that without all three partners at the table in the same room with the same charge, we may come up short,” Burr said. “Don’t be scared to put government, academia and the private sector in the same room with a common challenge working on the same solution.”

He also warned that if the U.S. fails to become more agile and flexible when it comes to vaccine development, than the country could be “100 percent reliant on what someone else develops and tells us is a solution. I’m not sure I want to trust the Russian Ebola vaccine.”
Pandemic response at the community level

Burgess, who is a ranking member on the House Energy and Commerce Subcommittee on Health, invoked an iconic saying from former House Speaker Tip O’Neill by saying all politics is local, “and you know what, public health is local also, and executed on the ground by our hospitals, by our health departments and by our emergency responders who are in fact the front lines in addressing infectious diseases, disasters and threats.”

Burgess’s remarks were tied to the Scowcroft Institute white paper’s fourth recommendation, which calls the government to “financially and technically capacitate diverse community actors to carry-out their detection and response goals when emergency strikes.”

The second half of the day-long forum featured a series of three panel discussions featuring researchers and public and private sector infectious disease experts, who drilled down into the importance of pandemic preparedness at the community level.

Steve Davis, president and CEO of Seattle-based health nonprofit Program for Appropriate Technology in Health (PATH), underscored the importance of not just funding “magic bullet” projects during his panel discussion on the Ebola outbreak in the Democratic Republic of the Congo.

“Complexity needs sustained funding,” Davis said. “I’d move to follow up these big global policy commitments to make sure there’s ongoing funding so we’re not lurching from one magic bullet funding this year to nothing the next year.”
‘At a delicate period’

Panelists who took part in the global health security leadership discussion emphasized that building trust between doctors and patients in communities could help combat online misinformation that is fueling the spread of measles in the U.S.

Former CDC Principal Deputy Director Anne Schuchat said there needs to be a restoration of trust between families and physicians.

“I think it’s really important for people know that here in the united states, most parents make sure their kids get vaccinated against all the things that are recommended,” she said. “We’re not in crisis mode everywhere across the country with everybody opting out of the system, but I think we’re at a really delicate period in terms of trust, which I think is really local.”

During the final panel of the afternoon, Ron Klain, who served as the White House Ebola Response Coordinator from 2014 to 2015 and as Chief of Staff to Vice Presidents Al Gore and Joe Biden, urged attendees to not take the current pandemic response infrastructure for granted and to keep striving for improvements.

He recalled the 2009-2010 H1N1 flu pandemic, which recorded an estimated 60 million cases and 12,000 deaths, as an example.

“It’s purely a fortuity that this wasn’t one of the great mass casualty events in American history,” Klain said. “It had nothing to do with us doing anything right, it just had to do with luck. If anyone thinks this can’t happen again they don’t have to go back to 1918, they just have to go back to 2009-2010.”

Gerald Parker, Texas A&M associate dean of Global One Health and Former HHS Principal Deputy Assistant Secretary for Preparedness & Response, encouraged attendees to turn ideas into action during his closing remarks.

“We have learned a lot, but unfortunately some of these issues are not new issues,” he said. “We have simply got to find a way to turn some of these longstanding lessons observed into lessons learned. Our nation and international community deserves it.”

Last Edit by Gladstone


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