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FOR IMMEDIATE RELEASE ::  May 15, 2020 Contact: HHS Press Office : 202-690-6343 :: media@hhs.gov

 Trump Administration Announces Framework and Leadership for 'Operation Warp Speed'

On Friday (CIRCA May 15, 2020 )  , the "Trump Administration" announced the appointment of Moncef Slaoui as chief advisor and General Gustave F. Perna as chief operating officer of Operation Warp Speed (OWS), the [TRUMP]  administration's national program to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (medical countermeasures).

 Moncef Slaoui as chief advisor Operation Warp Speed (OWS) < GOOGLE 
  [ https://www.politico.com/news/2021/01/06/moncef-slaoui-warp-speed-biden-administration-455470 ] 

  [ SOURCE: https://www.politico.com/news/2020/12/03/zients-murthy-biden-coronavirus-team-442609  ] 

 "...  (IMAGE) Jeff Zients speaks. ... Jeff Zients speaks during a news briefing at Eisenhower Executive Office Building in Washington, D.C. | Alex Wong/Getty Images

By ALICE MIRANDA OLLSTEIN and TYLER PAGER ... 12/03/2020 12:14 PM EST ...Updated: 12/03/2020 01:58 PM EST 

... former Obama administration official Jeff Zients is set to serve as the White House’s Covid-19 coordinator and Vivek Murthy, the former U.S. surgeon general under Obama, will return to that role, but with a broader portfolio that will include acting as the top medical expert and public face of the effort.
... Marcella Nunez-Smith, a co-chair of Biden’s Covid-19 advisory board, will also take a key role in the administration’s response, focused on health disparities. ... modeled on the one that now-Biden chief of staff Ron Klain played during the Ebola outbreak in 2014, when Klain coordinated the Obama administration’s national response. In the new Covid position, ... Zients, a business executive with a range of management experience, will be tasked with working across government agencies to curtail the coronavirus outbreak that has killed almost 275,000 Americans. 

... POLITICO’s Sam Mintz breaks down ... he ( Zients ?) founded Doctors for America, a nonprofit group advocating for improved healthcare access.

 (IMAGE) Vivek Murthy speaks. Former U.S. Surgeon General Vivek Murthy speaks during the 2020 Democratic National Convention. | Democratic National Convention via AP ... “It will be like an amplified, [Surgeon General] on steroids plus,” the source close to Biden said, adding that Murthy will have a “broader portfolio” that covers both the immediate pandemic crisis and, once it ends, more systemic health care issues including substance abuse, mental health and racial disparities in health care. ... Murthy, who has been deeply involved in the formulation of Biden’s Covid-19 plans and has been briefing the president-elect multiple times a week since the early months of the pandemic, had been a leading candidate to run the Department of Health and Human Services, but concerns arose over his lack of experience running a large agency with tens of thousands of employees and a budget in the billions. ... Nunez-Smith, an associate professor of medicine at Yale, is an expert on health care inequality and will take the lead on the administration’s plans to address the racial inequalities of the virus’ impact. The rates of hospitalization and death are two to four times higher than they are for white people, according to the Centers for Disease Control and Prevention. ... “We’re thinking about [health care inequality] across all policy domains and all policy areas,” Nunez-Smith said in an interview with POLITICO last month. “I’m not the only voice at the table centering us in that way. That’s exactly what we need to be doing.”... 

... The selection of Zients, Murthy and Nunez-Smith follows Biden’s pattern of filling senior positions with people who have a long history of working with him and a proven record in their field. In the "Obama administration" , Zients served as the director of the National Economic Council, acting director of  "the Office of Management and Budget and the chief performance officer", a position created by Obama that focused on the federal budget and government reform. But Zients won particular praise in the Obama years for his work salvaging the glitch-plagued Healthcare.gov website during the launch of the Affordable Care Act in 2013.

... Kathleen Sebelius, who ran the Department of Health and Human Services at the time, praised Zients as the “quarterback” of the last-ditch, high stakes, eight-week effort that saved Obamacare’s enrollment portal.

“We knew we had just one more bite at this apple, and if we announced a date and rolled out a second product that was less than workable, that was it,” she recalled in an interview, referring to the relaunch of Healthcare.gov. “It was a real make-or-break moment and a pretty scary bet. But Jeff exceeded all of my expectations.”

... Zients’ past work in business and government prepared him to bring people together in a way that was “unique in times of high crisis” and his background outside the medical world was an asset rather than a liability.

[ Sebelius] said. “It was a logistical challenge and identification of where the experts were who understood each piece of the puzzle and making sure they had a seat at the table. The same can be said of a pandemic response.”

... Zients’ background running an investment fund, sitting on Facebook’s board and serving as the bridge between the Obama administration and corporate America.

... said Jeff Hauser, the director of the "Revolving Door Project" at the Center for Economic and Policy Research, noting that much of the pandemic coordination role will be “purely logistical.”

... But Hauser and others say they’re concerned the job will allow him to advance a "corporate-friendly" agenda when it comes to matters like using the "Defense Production Act" to spur more manufacturing of masks and swabs and wrangling with pharmaceutical companies on patents for Covid-19 vaccines and therapeutics. In a 13-page document "the group" [ "Revolving Door Project" ] compiled on Zients’ background, they flagged in particular ### his investment firm Cranemere’s purchase of a majority stake in an anesthesia company that engaged in so-called balance billing  ### — in which patients receive unexpected large bills after seeing a provider thought to be in their insurance network. ... “Our basic take is that the less Zients is in a position to assess the prospects for wealthy people and corporations to become more wealthy, the better,” he [ Hauser  ] said. “I’m not saying he’s without skill, but I think you can have people in government - who don’t see "surprise medical billing" as a profit center.”  ..."


Dr. Slaoui is a venture capitalist and, formerly, Chairman of Global Research and Development and Chairman of Global Vaccines at GlaxoSmithKline, where he led the development of five major novel vaccines. [ https://investors.modernatx.com/news-releases/news-release-details/moncef-m-slaoui-phd-joins-modernas-board-directors ]

As the four-star general in charge of the U.S. Army Materiel Command, General Perna oversees the global supply chain and installation and materiel readiness for the U.S. Army, including more than 190,000 military, civilian, and contract employees.

Among its other objectives, Operation Warp Speed aims to have substantial quantities of a safe and effective vaccine available for Americans by January 2021.

"President Trump's vision for a vaccine by January 2021 will be one of the greatest scientific and humanitarian accomplishments in history, and this is the team that can get it done," said HHS Secretary Alex Azar. 

"Dr. Slaoui and General Perna are ideal leaders for this unprecedented effort to get vaccines, therapeutics, and diagnostics to American patients much faster than ever before. 

Since January, America's scientists and innovators have been working day and night on this national effort. 
... President Trump has refused to accept business-as-usual timelines for vaccines and other essential tools, and instead has insisted that America, and the world, needs answers faster. 
... Under the President's leadership, his administration and American industry will squeeze every last inefficiency out of the process and pour every resource we can into this effort."

"In addition to deploying 62,000 military service members in direct support of fighting COVID-19 on frontlines across the globe, the Department of Defense is racing towards a vaccine," 
... said Defense Secretary Mark T. Esper. "Through our research and development labs such as DARPA and the Defense Health Agency, and our massive logistical knowledge and capacity, we are committed to achieving the goal of Operation Warp Speed for the American people. I am confident that, as with any mission our military undertakes, we will adapt and overcome all obstacles in our path." 

Elements of Operation Warp Speed

Operation Warp Speed is a public-private partnership to facilitate, at an unprecedented pace, the development, manufacturing, and distribution of COVID-19 countermeasures, between components of HHS, including CDC, FDA, NIH, and the Biomedical Advanced Research and Development Authority (BARDA); the Department of Defense; private firms; and other federal agencies, including the Department of Agriculture, the Department of Energy, and the Department of Veterans Affairs. It will coordinate existing HHS-wide efforts, including the NIH's ACTIV partnership for vaccine and therapeutic development, NIH's RADx initiative for diagnostic development, and work by BARDA. [ Rick Bright : https://en.wikipedia.org/wiki/Rick_Bright ]

Leadership: In addition to the expertise of Dr. Slaoui and General Perna, each countermeasure area will be overseen by a highly qualified and accomplished career HHS scientist:

Vaccines: Peter Marks, M.D., Ph.D., Director of the FDA's Center for Biologics Evaluation and Research.

Therapeutics: Janet Woodcock, M.D., Director of the FDA's Center for Drug Evaluation and Research.

Diagnostics: Bruce Tromberg, Ph.D., Director of the NIH's National Institute of Biomedical Imaging and Bioengineering.

The Department of the Defense (DoD) has identified subject matter experts to lead DoD support for five areas, including:

1. Diagnostics: Major General Lee Payne, Assistant Director for Combat Support at the Defense Health Agency (DHA).

2. Therapeutics: Sean Biggerstaff, Ph.D., Acting Director for Research and Development at DHA.

3. Vaccines: Matt Hepburn, M.D., Joint Project Lead CBRN Defense Enabling Biotechnologies.
Production and Distribution: Stacy Cummings, Principal Deputy Assistant Secretary of Defense for Acquisition Enablers.

4. Security and Assistance: Andrew Kilianski, Chief Intelligence Officer for CBRN Defense.
Three focus areas: There are three core areas where the effort will accelerate the timeframe for countermeasures, including a vaccine, reaching the American public: 1) development, 2) manufacturing, and 3) distribution.

5. Commitment to affordability: The Trump Administration is committed to making these countermeasures affordable for the American people. As a condition of receiving support from Operation Warp Speed, companies will provide a donated allocation of countermeasures developed, including an eventual vaccine.

6. Financial resources: Congress has directed almost $10 billion to this effort through supplemental funding, including the CARES Act, and Congress has appropriated other flexible funding. Over $6.5 billion has been designated by Congress for countermeasure development through BARDA, along with $3 billion for NIH research.

7. Planned updates: Public updates on each step of Operation Warp Speed will depend on certain scientific milestones, which depend on the results of clinical trials (e.g., trials are sometimes halted before completion due to clear results).


Operation Warp Speed will select the 

8. most promising #### countermeasure candidates ### and provide coordinated government support to support their development.

9. Protocols for the demonstration of safety and efficacy will be aligned, which will allow the trials to proceed more quickly.

10. The protocols for the trials will be overseen and set by the federal government, as opposed to traditional public-private partnerships, in which pharmaceutical companies decide on their own protocols.

For example, this process has proceeded for vaccines in the following manner:
A. Fourteen promising candidates have been chosen from the 100+ vaccine candidates currently in development—some of them already in clinical trials with U.S. government support.
B. The 14 vaccine candidates are being winnowed down to about eight candidates, which will go through further testing in early stage small clinical trials.
C. Large-scale randomized trials for the demonstration of safety and efficacy will proceed for three to five of the candidates.
D. Additional non-clinical testing will be done in parallel to the extent possible. 
E. For instance, multiple animal models may be used to assess vaccine safety and efficacy in order to support the clinical development program. 

 11. Manufacturing : The federal government is making investments in manufacturing and distribution at its own risk much earlier than usual, giving firms confidence that they can invest aggressively in development of countermeasures.

12. Manufacturing capacity for selected candidates, including the three to five selected vaccines, will be advanced while they are still in development, rather than scaled up after approval or authorization, as is the case with traditional development timelines.

13. The manufacturing capacity developed will be used, to the extent practicable, for whatever vaccine is eventually successful, regardless of which firms have developed the capacity.

14. Before the countermeasures are approved or authorized, the program will build the necessary plans and infrastructure for distributing them, especially the unprecedented effort that will be necessary to deliver a vaccine to hundreds of millions of Americans in a timely manner.

15. OWS will also focus on expanding the supplies of specialized materials and resources, such as cold-chain storage, glass vials, and other materials, that can be necessary for distribution of countermeasures.

16. Once a product such as a vaccine is ready, the Department of Defense's involvement will enable faster distribution and administration than would have otherwise been possible using wholly private medical infrastructure.

- Leadership Biographies:

Moncef Slaoui - Dr. Slaoui is, most recently, a Partner at Medicxi Venture Capital and serves as the Chairman of the Board at Galvani, a bioelectronics R&D company company jointly owned by GlaxoSmithKine (GSK) and Verily Life Sciences. As Chairman of GSK R&D, Dr. Slaoui led a restructuring to improve focus on innovation and productivity. As Chairman of Global Vaccines, Dr. Slaoui was directly involved in the company's vaccine pipeline, which led the industry during his time, with the broadest portfolio of vaccines of any company—48—and the creation of 14 new vaccines in ten years. Dr. Slaoui led the development of a number of novel vaccines, including Cervarix, to prevent cervical cancer; Mosquirix, a candidate to prevent malaria; Rotarix, to prevent rotavirus gastroenteritis; Shingrix, to prevent shingles; and Synflorix, to prevent pneumococcal disease. ... Among other honors, in 2016, Dr. Slaoui was recognized as one of Fortune's 50 Greatest World Leaders for his work in under-researched diseases common in the developing world, served on the Advisory Committee to the Director of the NIH from 2011 to 2016, and has advised U.S. President's Council of Advisors on Science and Technology. ... Dr. Slaoui holds a Ph.D. in Molecular Biology and Immunology from the Université Libre de Bruxelles, in Belgium; completed postdoctoral studies at Harvard Medical School and Tufts University School of Medicine; and has been a professor of Immunology at the University of Mons, Belgium. 

General Gustave F. Perna - General Gustave F. Perna - ...  assumed duties as the 19th Commander of the U.S. Army Materiel Command (AMC) 30 September 2016. General Perna served for two years as the Army's Deputy Chief of Staff, G-4 in his previous assignment. He oversaw policies and procedures used by all Army logisticians throughout the world. Prior to joining the Army staff he served for two years as Deputy Chief of Staff, G-3/4, U.S. Army Materiel Command, one of the Army's largest commands with 190,000 military, civilian and contractor employees, impacting all 50 states and 152 countries. ... The General's other command assignments include: Commander, Joint Munitions Command and Joint Munitions and Lethality Lifecycle Management Command, responsible for the lifecycle management of $40 billion of conventional ammunition; Commander, Defense Supply Center Philadelphia, Defense Logistics Agency, responsible for the procurement of more than $14.5 billion worth of food, clothing, textiles, medicines, medical supplies, construction and equipment items for America's Warfighters and other customers worldwide; Commander, 4th Sustainment Brigade, where he deployed the brigade to combat operations during OIF 05-07; Commander, 64th Forward Support Battalion,3rd Brigade, 4th Infantry Division, Fort Carson, Colorado, where he deployed the battalion to combat operations during OIF I; Deputy Commanding Officer, 64th Corps Support Group, 13th Corps Support Command, Fort Hood, Texas; and Commander, B Company, 143rd Ordnance Battalion, Aberdeen Proving Ground, Maryland. ... General Perna's key staff assignments include: 
 - Director of Logistics, J4, U.S. Forces-Iraq, responsible for sustainment plans and policies for strategic and operational logistics to sustain coalition and joint forces; 
 - Executive Officer to the Director of the Defense Logistics Agency, supporting the Director's mission of providing Army, Navy, Air Force, Marine Corps and other federal agencies with logistics, acquisitions and technical services support; 
 - Ordnance Branch Chief, Human Resources Command; DISCOM Executive Officer and G4, 1st Cavalry Division, where he deployed to Bosnia; 
 - 544th Maintenance Battalion Support Operations Officer and Battalion Executive Officer, 13th COSCOM; 
 - and G4 Maintenance Officer, 13th COSCOM, where he deployed to Somalia as a member of Joint Task Force Support Command.

He [ PERNA ] graduated from Valley Forge Military Academy with an Associate's degree in Business Administration. Graduating as a Distinguished Military Graduate, he was commissioned as a Second Lieutenant, Infantry Officer. He earned a Bachelor's degree in Business Management from the University of Maryland and a Master's degree in Logistics Management from Florida Institute of Technology.

His [ PERNA ] awards and decorations include: Distinguished Service Medal with two Oak Leaf Clusters, Defense Superior Service Medal with Oak Leaf Cluster, Legion of Merit, Bronze Star Medal with Oak Leaf Cluster, Defense Meritorious Service Medal, Meritorious Service Medal with four Oak Leaf Clusters, and the Parachutist and Air Assault Badges.

Note: All HHS press releases, fact sheets and other news materials are available at https://www.hhs.gov/news.

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 Last revised: May 15, 2020 - Sign Up for News Release Updates [SUSAN DONE DID 2-6-2021 ]



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