Dr. James Vincent Lawler (born 1969)
Wikipedia 🌐 NONE
born - Nov 1969 ( See - https://www.truepeoplesearch.com/find/person/pn04lr86r60r6828r8n4 "James V Lawler Age 51 (Nov 1969)" as of July 2021)
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Middle name "vincent" (see https://www.truepeoplesearch.com/find/person/pn04lr86r60r6828r8n4 )
ASSOCIATIONS
Sina A Bavari (born 1959) ( Working peers while at USAMRIID; Note that Dr. Bavari also has a long-time relationship with UNMC, which is where Dr. Lawler has been working since 2017 ; Also research collaboration - such as ("Cynomolgus macaque as an animal model for severe acute respiratory syndrome" (DOI: 10.1371/journal.pmed.0030149 / https://pubmed.ncbi.nlm.nih.gov/16605302/ ) )
Dr. Peter B. Jahrling (born 1946) ( Shared research and papers .. 2006, 2011, 2012 )_
Dr. Bruce Edward Ivins (born 1946) ( 2006 research ... .)
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The "Red Dawn" Group ( ... )
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ASSORTED BIOGRAPHIES FOR Dr. James Lawler
Dr. James Lawler is an infectious disease physician trained in tropical medicine and public health whose career has focused on emerging infectious diseases, pandemic threats, and health system and public health preparedness. His contributions span applied science research, national and international policy, and field operations. Dr. Lawler currently serves as Executive Director for International Programs and Innovation for the Global Center for Health Security as well as the Deputy Medical Director for the Nebraska Biocontainment Unit at the University of Nebraska Medical Center (UNMC). Before joining the UNMC team in November 2017, he served 21 years in the US Navy Medical Corps.
Dr. Lawler has responded to multiple infectious disease emergencies, including Ebola and Marburg in Africa and COVID-19 domestically and abroad. He is a recognized authority on health system and field management of high-consequence infections and has consulted on the topic for multiple non-governmental organizations, national ministries of health, the World Health Organization, and the US Government. In 2014, he was the principal subject matter expert for the US military’s planning process for West Africa Ebola response (Operation United Assistance), briefing the Chairman, Joint Chiefs, and senior Pentagon officials. He subsequently led efforts standing up the Department of Defense (DoD) Ebola Medical Support Team and served as the team’s principal technical expert. His field medical experience also includes duty as a Marine infantry battalion surgeon, in disaster relief operations aboard the hospital ship USNS Comfort, and with the NATO Role 3 Hospital in Kandahar, Afghanistan.
As a junior investigator at the US Army Medical Research Institute for Infectious Diseases (USAMRIID), Dr. Lawler became one of the few uniformed physicians ever to become qualified in biosafety level-4 (BSL-4) laboratory operations, directing animal model research for highly dangerous pathogens while developing and teaching curricula in biological consequence management. He also assisted in initiating some of the first collaborative clinical research programs for DoD Cooperative Threat Reduction efforts in the Caucasus. He later helped establish BSL-3/4 laboratory safety systems and strategic research plans as Chief Medical Officer of the National Institute of Allergy and Infectious Disease Integrated Research Facility at Fort Detrick. During the last five years of his military career, Dr. Lawler founded and led the Austere Environments Consortium for Enhanced Sepsis Outcomes (ACESO), an international network developing practical solutions for management of severe infectious diseases in resource-limited settings.
Dr. Lawler served on the White House staff in the Homeland Security Council Biodefense Office during the George W. Bush administration and the National Security Council (NSC) Resilience Directorate under the Obama administration, where he led development and coordination of national policy related to medical and public health preparedness, pandemic and public health emergency response, medical countermeasure R&D, biosurveillance, and clinical care for domestic and international health threats. While at NSC, he co-led White House activities to coordinate national policy in response to the 2009-H1N1 influenza pandemic.
In response to the COVID-19 pandemic, Dr. Lawler has made a number of early contributions in research, training, and clinical operations. He assisted in leading a small team that deployed to Yokohama, Japan, to repatriate American citizens quarantined aboard the cruise ship Diamond Princess, coordinated quarantine and isolation care for some of the first cohorts of exposed/infected Americans returned from Wuhan and Yokohama, assisted in standing up the first hospital to conduct a randomized-controlled trial of remdesivir for COVID-19, and characterized environmental contamination related to the care of COVID-19 patients. Dr. Lawler advises local, state, and national leadership on COVID-19 response as well a variety of entities in the public and private sectors.
Dr. Lawler graduated from Georgetown University School of Medicine after receiving his undergraduate degree in biomedical engineering from Duke University. He resides on the outskirts of Omaha, Nebraska, with his wife, Meredith, their three children, and multiple animals, wild and domestic.
Experience
Director, International Programs and Innovation, Global Center for Health Security, at University of Nebraska Medical Center
Dates Employed : Nov 2017 – Present ( Employment Duration : 3 yrs 9 mos )
Location : Omaha, NE
Founder , 10 Water Street: health security solutions
Dates Employed : Jul 2017 – Present ( Employment Duration : 4 yrs 1 mo )
Location : Walkersville, MD
Health Security and Preparedness, Emerging Infectious Disease, and Global Health Consulting
ACESO Director and Chief, Clinical Research Department; BDRD/NMRC , Naval Medical Research Center - Frederick
Dates Employed : May 2012 – Jun 2017 ( Employment Duration : 5 yrs 2 mos )
Location : Fort Detrick, MD
Activities :
Conceived, developed, secured funding for, and directed a new $10M/year research program implementing multiple clinical research projects and coordinating government, non-government organization, and academic collaborators in 6 countries/3 continents; Supervised a primary team of 18 clinicians, scientists, and research support staff; Discovered novel approaches for host biomarker-based prediction of sepsis outcome in resource-limited settings; Enhanced severe disease surveillance and management capacity in strategic regions; Coordinated multi-agency international team to create first Department of Defense (DoD) outbreak response clinical trial capability.
Served as World Health Organization (WHO) clinical consultant in Conakry, Guinea during West Africa Ebola epidemic, assisting country team to improve clinical care across response and providing direct patient care in Donka Hospital Ebola Treatment Unit; Contributed in multiple working groups at WHO Geneva headquarters before and during outbreak to develop enhanced standards of care and effectively employ experimental therapeutics for treatment of Ebola virus disease.
Provided critical leadership and subject matter expertise for the DoD Ebola response, directly supporting Joint Staff planning for Operation United Assistance and briefing Chairman and Joint Chiefs on risks and opportunities associated with response; Led curriculum development and implementation of training and served as lead technical expert for DoD Medical Response Team for Ebola, which was created as a national resource in Oct-Nov 2014.
Deputy Director , U.S. Central Command Joint Combat Casualty Research Team
Dates Employed : Jul 2013 – Dec 2013 ( Employment Duration : 6 mos )
Location : Kandahar Airfield, Kandahar, Afghanistan
Managed day-to-day operations of a 7-person team of military clinical/scientific staff in 3 separate locations overseeing implementation and regulatory compliance of all human subjects research in the Afghanistan Theater of Operations; Responsible for more than 20 clinical research protocols
Chief Medical Officer , Integrated Research Facility/NIAID/NIH
Dates Employed : May 2008 – May 2012 ( Employment Duration : 4 yrs 1 mo )
Location : Ft Detrick, MD
Activities : Led strategy process, development, and implementation of research, operational, and administrative programs standing up the Federal Government’s newest high containment (Biosafety Level-4) research laboratory; Collaborated with leading industry and academic elements to promote progress in imaging science application to infectious disease research; Coordinated working group to stand up NIH Center for Infectious Disease Imaging; Developed and hosted several symposia and workshops on infectious disease imaging science; Engaged and facilitated consulting partner to implement new BSL-4 safety program modeled on aviation safety and operations programs; Worked with WHO and international experts to develop research and clinical management standards for outbreak response.
Director for Medical Preparedness Policy , National Security Staff, The White House
Dates Employed : Apr 2009 – Oct 2010 ( Employment Duration : 1 yr 7 mos )
Activities : By-name requested to lead national interagency policy process for response to the 2009 H1N1 influenza pandemic; Facilitated integration of national, state, local, private sector, and international efforts for accelerated production and distribution of H1N1 vaccine; Improved domestic and international public health surveillance; Expanded hospital and clinical care capacity; Enhanced anti-viral drug and medical consumables supply chains, nationwide public health messaging campaign, and novel international vaccine donation program; Produced semi-weekly pandemic updates for the President of the United States; Spearheaded follow-up assessment of national countermeasure enterprise, working with government, private sector, and academic to redesign drug, vaccine, and diagnostics discovery and development for public health emergencies – this resulted in new Department of Health and Human Services Public Health Emergency Medical Countermeasure Enterprise strategy influencing $ billions of Federal Government investments.
Director for Biodefense Policy , Homeland Security Council, The White House
Dates Employed : 2006 – 2008 ( Employment Duration : 2 yrs )
Activities :
Coordinated national policy process for defense against bioterrorism, pandemics, emerging infectious diseases, and other public health emergencies; Led 1-year interagency working group developing Homeland Security Presidential Directive #21 (“Medical and Public Health Preparedness”); Engaged all levels of government, private sector, non- governmental organizations, and academic institutions to set Federal Government priorities for transforming national capabilities in biosurveillance, medical countermeasure distribution and dispensing, mass-casualty healthcare response, and public health disaster science and education; Key member of team overseeing execution in the Federal Government of the National Strategy for Pandemic Influenza Implementation Plan (2006).
Hand-chosen by Homeland Security Advisor to occupy interim position as Acting Senior Director for Biodefense, the President’s principal advisor for biological defense, pandemic preparedness, and public health emergency response; Managed White House Homeland Security Biodefense Office of 5 Director and 1 Deputy Director-level staff; Led Federal Policy Coordinating Committee and sub-committees in refinement of national biological incident response planning and accountability for Pandemic Influenza Implementation Plan; Oversaw final approval process for HSPD-22 (“Domestic Chemical Defense”).
Principal Investigator , US Army Medical Research Institute of Infectious Diseases
Dates Employed : Aug 2004 – May 2006 ( Employment Duration : 1 yr 10 mos )
Location : Ft Detrick, MD
Developed, directed, and collaborated on animal model research on biological threat agents including Ebola, SARS- CoV, orthopoxviruses, B. anthracis; Served as Principle Investigator for DoD Investigational New Drug (IND) clinical trial of F. tularensis vaccine and Medical Expert for DoD IND of IV Vaccinia Immune Globulin; Developed instruction and course materials for DoD Medical Management of Chemical and Biological Casualties Course and created curriculum and instruction for new Hospital Management of Chemical and Biological Incidents Course; Led development and implementation of initial clinician training program and collaborative research efforts for DoD Cooperative Threat Reductions Thread Agent Detection and Response Program in the Republic of Georgia.
Fellow , National Naval Medical Center/Walter Reed Army Medical Center
Dates Employed : Aug 2001 – Jul 2004 ( Employment Duration : 3 yrs )
Location : Bethesda, MD
Infectious Disease Fellow
Resident , National Naval Medical Center
Dates Employed : Aug 1999 – Aug 2001 ( Employment Duration : 2 yrs 1 mo )
Location : Bethesda, MD
Internal Medicine Resident
Battalion Surgeon , Second Marine Division
Dates Employed : Jul 1997 – Aug 1999 ( Employment Duration : 2 yrs 2 mos )
Location : Camp Lejeune, NC
Primary medical officer for 1000-Marine infantry battalion (2nd Battalion, 8th Marines). Responsible for operation of battalion aid station and 45 US Navy Hospital Corpsmen.
Intern , National Naval Medical Center
Dates Employed : Jun 1996 – Jul 1997 ( Employment Duration : 1 yr 2 mos )
Location : Bethesda, MD
Categorical Internal Medicine
EVIDENCE TIMELINE
2002 (April) - First reserch paper...
https://pubmed.ncbi.nlm.nih.gov/12198756/
When biotoxins are tools of terror
Early recognition of intentional poisoning can attenuate effects
LCDR David L. Blazes , MC, USNR,LT James V. Lawler , MC, USNR &CAPT Angeline A. Lazarus , MC, USN
Pages 89-98 | Published online: 30 Jun 2015
Capable of causing disease as well as being therapeutic, toxins have been both a curse and a blessing for millennia. Now, the threat of rogue countries or terrorist organizations using toxins as weapons of war is very real. In this article, Drs Blazes, Lawler, and Lazarus review the clinical and epidemiologic features of the toxin-mediated diseases most likely to occur as a result of a biological warfare event.
download the PDF : https://sci-hub.se/10.3810/pgm.2002.08.1278
Angeline Lazarus - https://www.dcmilitary.com/journal/features/walter-reed-doctor-earns-national-teaching-award/article_21fc8466-3366-552a-8b9b-cdb6c988e9c9.html
David Blazes - "David Blazes
Deputy Director, Vaccine Development & Surveillance – Modelling and Pathogen Genomic Sequencing" ... B+M Gates foundation .. https://www.gatesfoundation.org/about/leadership/david-blazes
May 2006 - COllaboration with Jahrling and Baric ...
https://pubmed.ncbi.nlm.nih.gov/16605302/
Cynomolgus macaque as an animal model for severe acute respiratory syndrome
James V Lawler 1, Timothy P Endy, Lisa E Hensley, Aura Garrison, Elizabeth A Fritz, May Lesar, Ralph S Baric, David A Kulesh, David A Norwood, Leonard P Wasieloski, Melanie P Ulrich, Tom R Slezak, Elizabeth Vitalis, John W Huggins, Peter B Jahrling, Jason Paragas
Affiliations expand
PMID: 16605302
PMCID: PMC1435788
Free PMC article
Abstract
Background: The emergence of severe acute respiratory syndrome (SARS) in 2002 and 2003 affected global health and caused major economic disruption. Adequate animal models are required to study the underlying pathogenesis of SARS-associated coronavirus (SARS-CoV) infection and to develop effective vaccines and therapeutics. We report the first findings of measurable clinical disease in nonhuman primates (NHPs) infected with SARS-CoV.
Methods and findings: In order to characterize clinically relevant parameters of SARS-CoV infection in NHPs, we infected cynomolgus macaques with SARS-CoV in three groups: Group I was infected in the nares and bronchus, group II in the nares and conjunctiva, and group III intravenously. Nonhuman primates in groups I and II developed mild to moderate symptomatic illness. All NHPs demonstrated evidence of viral replication and developed neutralizing antibodies. Chest radiographs from several animals in groups I and II revealed unifocal or multifocal pneumonia that peaked between days 8 and 10 postinfection. Clinical laboratory tests were not significantly changed. Overall, inoculation by a mucosal route produced more prominent disease than did intravenous inoculation. Half of the group I animals were infected with a recombinant infectious clone SARS-CoV derived from the SARS-CoV Urbani strain. This infectious clone produced disease indistinguishable from wild-type Urbani strain.
Conclusions: SARS-CoV infection of cynomolgus macaques did not reproduce the severe illness seen in the majority of adult human cases of SARS; however, our results suggest similarities to the milder syndrome of SARS-CoV infection characteristically seen in young children.
Conflict of interest statement
Competing Interests: The authors have declared that no competing interests exist.
2006 (June) ... "Short-course postexposure antibiotic prophylaxis combined with vaccination protects against experimental inhalation anthrax" - IVINS and LAWLER
Research ... with Dr. James Vincent Lawler (born 1969) ....
June 2006
Proceedings of the National Academy of Sciences 103(20):7813-6
Source
Authors:
Leffel Consulting Group, LLC
University of Florida Research Academic Center, Orlando, United Sates
DOWNLOADED - https://sci-hub.se/10.1073/pnas.0602748103
SPONSORED BY NIAID ... UNUSUAL FOR IVINS ??
2006 (June) - Change of job ...
"Director for Biodefense Policy , Homeland Security Council, The White House
Dates Employed : 2006 – 2008 ( Employment Duration : 2 yrs )"
2011
J Infect Dis
. 2011 May 15;203(10):1348-59. doi: 10.1093/infdis/jir038. Epub 2011 Mar 21.
Molecular imaging of influenza and other emerging respiratory viral infections
Mike Bray 1, James Lawler, Jason Paragas, Peter B Jahrling, Daniel J Mollura
Affiliations expand
PMID: 21422476
PMCID: PMC3080905
Free PMC article
Abstract
Research on the pathogenesis and therapy of influenza and other emerging respiratory viral infections would be aided by methods that directly visualize pathophysiologic processes in patients and laboratory animals. At present, imaging of diseases, such as swine-origin H1N1 influenza, is largely restricted to chest radiograph and computed tomography (CT), which can detect pulmonary structural changes in severely ill patients but are more limited in characterizing the early stages of illness, differentiating inflammation from infection or tracking immune responses. In contrast, imaging modalities, such as positron emission tomography, single photon emission CT, magnetic resonance imaging, and bioluminescence imaging, which have become useful tools for investigating the pathogenesis of a range of disease processes, could be used to advance in vivo studies of respiratory viral infections in patients and animals. Molecular techniques might also be used to identify novel biomarkers of disease progression and to evaluate new therapies.
2012
Viruses
. 2012 Sep;4(9):1668-86. doi: 10.3390/v4091668. Epub 2012 Sep 21.
Clinical management of filovirus-infected patients
Danielle V Clark 1, Peter B Jahrling, James V Lawler
Affiliations expand
PMID: 23170178
PMCID: PMC3499825
DOI: 10.3390/v4091668
Free PMC article
Abstract
Filovirus infection presents many unique challenges to patient management. Currently no approved treatments are available, and the recommendations for supportive care are not evidence based. The austere clinical settings in which patients often present and the sporadic and at times explosive nature of filovirus outbreaks have effectively limited the information available to evaluate potential management strategies. This review will summarize the management approaches used in filovirus outbreaks and provide recommendations for collecting the information necessary for evaluating and potentially improving patient outcomes in the future.
Keywords: Clinical management; Ebola; Filoviruses; Marburg; Outbreak; Treatment.
2014 - WHO, Ebola experts
https://www.who.int/mediacentre/events/meetings/2014/lop-ebola-consultation.pdf
Lawler and Bavari both are experts
2019 - Lawler and Bavari
Pre-positioned Outbreak Research: The Joint Medical Emerging Diseases Intervention Clinical Capability Experience in Uganda
Karen A. Martins, Rodgers R. Ayebare, Nahid Bhadelia, Francis Kiweewa, Peter Waitt, Derrick Mimbe, Stephen Okello, Prossy Naluyima, David M. Brett-Major, James V. Lawler, Monica Millard, Richard Walwema, Anthony P. Cardile, Chi Ritchie, Antonia Kwiecien, Helen Badu, Benjamin J. Espinosa, Charmagne Beckett, Sina Bavari, Saima ZamanShow lessGeorge Christopher, Danielle V. Clark, Mohammed Lamorde, Hannah Kibuuka
Research output: Contribution to journal › Article › peer-review
Access to Document
Abstract
The West Africa Ebola virus disease outbreak of 2014-2016 demonstrated that responses to viral hemorrhagic fever epidemics must go beyond emergency stopgap measures and should incorporate high-quality medical care and clinical research. Optimal patient management is essential to improving outcomes, and it must be implemented regardless of geographical location or patient socioeconomic status. Coupling clinical research with improved care has a significant added benefit: Improved data quality and management can guide the development of more effective supportive care algorithms and can support regulatory approvals of investigational medical countermeasures (MCMs), which can alter the cycle of emergency response to reemerging pathogens. However, executing clinical research during outbreaks of high-consequence pathogens is complicated and comes with ethical and research regulatory challenges. Aggressive care and excellent quality control must be balanced by the requirements of an appropriate infection prevention and control posture for healthcare workers and by overcoming the resource limitations inherent in many outbreak settings. The Joint Mobile Emerging Disease Intervention Clinical Capability was established in 2015 to develop a high-quality clinical trial capability in Uganda to support rigorous evaluation of MCMs targeting high-consequence pathogens like Ebola virus. This capability assembles clinicians, laboratorians, clinical researchers, logisticians, and regulatory professionals trained in infection prevention and control and in good clinical and good clinical laboratory practices. The resulting team is prepared to provide high-quality medical care and clinical research during high-consequence outbreaks.
Original language : English (US)
Pages (from-to) : 114-124
Number of pages : 11
Journal : Health Security
Volume : 18
Issue number : 2
State : Published - Mar 1 2020
2020 (Feb 14) - Wired Magazine : "Darpa Cranks Up Antibody Research to Stall Coronavirus"
Subtitle : It's not the same as a vaccine. But a shorter-lived antibody treatment may shield health workers and family members during the early days of an outbreak.
Article saved as PDF : [HP00DY][GDrive]
Mentioned (or implied) : AbCellera Biologics Inc. / ADEPT program (DARPA) / Dr. Amy Lynn (Haas) Jenkins (born 1979) / Dr. James Vincent Lawler (born 1969) /
SOMETIME IN THE next day or two, a medical courier will deliver a styrofoam cooler to the offices of [AbCellera Biologics Inc.], a biotech firm headquartered in downtown Vancouver, British Columbia. Inside the box, packed in dry ice, will be a vial of blood prepared by researchers at the US National Institutes of Health, who drew it from a patient infected with the Covid-19 coronavirus.
The blood sample will be taken to AbCellera’s laboratory and placed in a microfluidic chip the size of a credit card that will isolate millions of white blood cells and put each one into a tiny chamber. Then the device will record images of each cell every hour, searching for the antibodies each one produces to fight the coronavirus.
“We can check every single cell within hours that it comes out of the patient,” says [AbCellera Biologics Inc.]’s CEO, Carl Hansen. “Now with a single patient sample we can generate 400 antibodies in a single day of screening.”
Antibodies are proteins that the immune system creates to remove viruses and other foreign objects from the body. Vaccines work by stimulating the body’s own immune system to produce antibodies against an invading virus. This immunity remains, should the virus attack again in the future. Vaccines provide protection for years, but they also take a long time to develop. Currently, there is no vaccine that can be used against the virus that causes Covid-19, although drug companies like Johnson & Johnson and Cambridge-based Moderna are working on developing them. So researchers are instead investigating whether an infusion of antibodies alone can be used as a short-lived—but immediately available—treatment to protect doctors and hospital workers, as well as family members of infected patients who need it right away.
The Pentagon’s Defense Advanced Research Projects Agency, or Darpa, launched its Pandemic Prevention Platform program two years ago with the goal of isolating and reproducing antibodies to deadly new viruses within 60 days. It enlisted researchers at Duke and Vanderbilt medical schools, as well as [AbCellera Biologics Inc.] and pharmaceutical giant AstraZeneca.
In preparation for an outbreak like the coronavirus now gripping China, scientists with the program made test runs using viruses responsible for severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). Both are members of the coronavirus family and closely related to Covid-19.
After isolating these antibodies, the researchers then capture their genetic code, using it as a blueprint to mass produce them. Their goal is to create an antibody treatment that can be injected directly into a patient, giving them an instant boost against the invading coronavirus.
“We are going to take the patient’s blood, identify the antibodies, and do it very rapidly,” said [Dr. Amy Lynn (Haas) Jenkins (born 1979)], program manager at Darpa’s biological technologies office, which is supporting [AbCellera Biologics Inc.]’s work with a four-year, $35 million grant. “Once we have the antibodies isolated, then we can give them back to people who are not yet sick. It’s similar to a vaccine and will prevent infection. The difference is that vaccines will last a long time. Our approach is immediate immunity and doesn’t last as long.”
If all goes well, [Dr. Amy Lynn (Haas) Jenkins (born 1979)] said, the antibody countermeasure would last several months rather than the several years that vaccines are effective. That said, the researchers still need to test the safety and efficacy of this antibody protein in animal and human clinical trials.
Of course, developing a treatment using antibodies isn’t simple. First, only one of the 15 US patients struck by Covid-19 has so far agreed to donate blood. (China has thousands of infected patients, but US researchers haven’t been able to get their blood for research here.) That means that [AbCellera Biologics Inc.] is on the waiting list to get a few drops of that valuable sample, along with several other companies and academic institutions that are partnering with Darpa and the CDC to develop treatments. “We have mobilized our team and are getting in place as soon as it arrives,” says Ester Falconer, AbCellera’s head of research and development. “We are raring to go.”
A team of Chinese scientists announced on January 31 that they had found an antibody which binds to the surface of the coronavirus and appears to neutralize it. Their research paper, which appeared as a preprint on the site BioXArchiv, hasn’t been peer reviewed by other scientists. And it is not clear how effective the antibody would be once it is mass produced and then tested in animals or humans.
Should antibody treatments work, there’s also the question of who would get them first, whether its first-line responders in specific hospitals where Covid-19 patients are being treated, or perhaps people at home with family members who test positive. (The antibody supply will likely be distributed by federal public health officials.)
Another potential looming issue is a bottleneck for scaling up antibody mass production. Medical experts say it's unlikely that pharmaceutical makers can make enough to protect everyone who needs them. “The constraint is production capacity,” says [Dr. James Vincent Lawler (born 1969)], an emerging disease specialist at the University of Nebraska Medical Center who is not involved in the Darpa program. “We are getting pretty good at finding appropriate antibody preparations. But the problem we still have is: How do we produce those rapidly enough to have an impact in a global epidemic?”
To protect the doctors, nurses, and health care workers at the more than 5,500 hospitals and medical centers in the US would take more than 1 million doses of treatment, according to [Dr. James Vincent Lawler (born 1969)]. “Scaling to a million doses of antibody product is a heavy lift to do in a few months,” he says. “We don’t have scaling capacity for therapeutics or prophylaxis in that time frame. In two years, we could get to that point.”
Despite those obstacles, medical researchers involved in the Darpa program say they are ready to fire up sophisticated tools for cellular screening and imaging that have been boosted in recent years by advances in machine learning and pattern recognition. [AbCellera Biologics Inc.]’s machine is trained to look through millions of images to find the perfect one of an antibody binding to the surface of the virus.
At Vanderbilt University’s School of Medicine, Robert Carnahan is also waiting for the blood from that first US patient sample to run through Vanderbilt’s own antibody screening technology. Carnahan and his colleagues at the Vanderbilt Vaccine Center used their method last year to find new antibodies against the Zika virus. Their initial test resulted in 800 antibodies that were narrowed down to 20 for animal testing, and finally one that stopped the virus from spreading. That entire process only took 78 days, Carnahan said.
“We need the most potent antibodies,” Carnahan said. “That requires a lot of work. Most of the work in our lab during the Zika trial was to take a small subset into these more detailed studies. In the midst of a pandemic, you don’t have that luxury.”
Carnahan said he expects to receive the US coronavirus blood sample any day now. Given the lack of US patients, his colleagues are also trying to get them from infected patients living outside of China. But acquiring the samples requires working directly with hospital administrators and public health officials in each country, because no international body is yet coordinating a sharing program.
“Everyone’s anxious,” Carnahan said about the researchers on his team at Vanderbilt. “When the human samples become available, things will progress quickly. And it’s probably OK from a safety perspective that these samples aren’t flying all around the country.”
2020 (Mar 13) -
See [Ira Mann Longini, Jr. (born 1948)] ..
See Ira Longini page... Lawlor in NY times providing worst-case estimates ...
2020 (Mar 13) - NYTimes : "Worst-Case Estimates for U.S. Coronavirus Deaths; Projections
based on C.D.C. scenarios show a potentially vast toll. But those numbers don’t account for
interventions now underway."
By Sheri Fink / Published March 13, 2020 / Updated Sept. 9, 2021
https://www.nytimes.com/2020/03/13/us/coronavirus-deaths-estimate.html?searchResultPosition=5
2020-03-13-nytimes-coronavirus-deaths-estimate.pdf
2020-03-13-nytimes-coronavirus-deaths-estimate-img-1.jpg
2020 (July 28) - ABC News - "'American Catastrophe: How Did We Get Here? 5 key takeaways"
By Lucien Bruggeman and Soo Rin Kim / July 28, 2020, 7:02 AM / Source : [HM0020][GDrive]
Tens of thousands dead. Millions more infected. An economy crippled. How did we get here?
When an outbreak of the novel coronavirus emerged late last year in Wuhan, China, few could have imagined the depth of its devastation. The virus crossed borders and oceans, eventually spreading throughout the United States and forever reshaping the lives of those left in its wake.
Now, months later, a wide-ranging ABC News investigation examines the evolution of the global pandemic through extensive interviews with current and former public health and national security officials.
Their collective voice tells the story of a viral infection that exposed gaps in leadership that left millions of Americans vulnerable.
Here are five key takeaways from the ABC News investigation:
1) 'Red Dawn': A collection of former officials sounded an alarm. Were they heard?
In January and February, as the nascent coronavirus grew from outbreak to epidemic to pandemic, a group of former public health and national security officials, some of whom had helped craft a set of so-called "pandemic playbooks" to help guide a unified federal response, privately encouraged officials across the Trump administration to heed warnings of an impending disaster.
Dr. James Lawler, a former National Security Council (NSC) official during both the Bush and Obama administrations who worked specifically on pandemic preparedness, said this was "a serious group," with "many folks who had thought for a long time about pandemics."
To them, at least, the seriousness of the threat was clear.
"Our various groups that look at these things were giving each other the play-by-play on what we were hearing and what we were seeing," Lawler told ABC News. "It was obvious very early on, in January, that this had the potential to be a serious global event."
They exchanged concerns and ideas in a lengthy email thread, which they called "Red Dawn Rising" – a reference to the Cold War-era film by the same name in which a band of Americans work to repel Soviet invaders. In hindsight, the concerns they raised seem prophetic.
Frustrated with a president who seemed intent on downplaying the disease's threat, this band of experts – six of whom spoke with ABC News, many for the first time publicly – offered their unvarnished thoughts to senior administration officials, including top medical advisors in the departments of Defense, Homeland Security, Veterans Affairs, and Health and Human Services.
"The president began to say that nobody could imagine that something like this could actually occur," Dr. Dan Hanfling, a biosecurity and disaster response expert in Virginia, told ABC News. "The truth is that there was a group of us that had been trying to raise the alarm."
2) On the eve of crisis, a pandemic preparedness office scrapped
The White House National Security Council once featured a pandemic preparedness desk that monitored for biological threats to the security of the United States.
Its dissolution – less than a year before the novel coronavirus first emerged in China – has become fodder for the president's critics.
The office traced its roots back to 2015, when Ron Klain, who had been brought on to coordinate the Obama administration's Ebola response, suggested leaving a permanent position in place at the NSC to deal with pandemic preparedness. Obama agreed, and the White House's National Security Council Directorate for Global Health Security and Biodefense was born.
Then John Bolton took the helm as President Trump's third national security advisor. Eager to shake up the national security bureaucracy and downsize the staff, Bolton disbanded the office in 2018.
"It is my understanding that they were trying to reduce the size of the National Security Council, and there are a lot of arguments for why that is a good thing," said Elizabeth Neumann, who until recently served as the Trump administration's assistant homeland security secretary for threat prevention and security policy. "That said, the National Security Council plays a really critical role when it comes to crises and inter-agency coordination."
A senior administration official rejected claims that Bolton and Trump disbanded the office, telling ABC News that its work was absorbed elsewhere within the NSC to "optimize responsiveness to challenges in largely overlapping fields." The official added that "no positions related to pandemic preparedness were eliminated" in the re-shuffling.
Bolton echoed the administration official's denial, insisting the office's dissolution amounted to nothing more than a "streamlining" of the NSC, but critics feel strongly that Bolton's decision impeded the federal government's ability to react effectively to the novel coronavirus by removing a coordinating office and signaling that pandemic preparedness was not a priority.
"I play music," Hanfling told ABC News. "It's pretty helpful to have somebody leading, somebody who is actually signaling the changes and counting the time and so on, and I think that's what that office would have provided."
"In retrospect," he said, "not such a great move.
3) Lost time: After early action, opportunities squandered
Experts say that a delayed response from the federal government and a lack of cooperation from foreign counterparts hampered the nation's ability to prepare for the pandemic.
Robert Redfield, director of the Centers for Disease Control and Prevention, said the Chinese central government's resistance to help from the U.S., despite the CDC's offers, was a missed opportunity for American scientists to learn about the virus early in the crisis.
"I think that was unfortunate," Redfield told ABC News. "If we could've gotten in to assist China in the first weeks of January, I think there would be a different situation today. … We had literally 20, 30 people ready to go in and assist, and then to be sorta told, 'Stand down.' Yeah, it's frustrating."
Dr. Anthony Fauci, the nation's top infectious-disease expert, told ABC News the Chinese government's refusal to provide a sample of the actual virus to American scientists caused another significant delay in understanding that speed at which it the virus was spreading from person to person. By the time the outbreak in Washington state made it clear the virus was spreading through human contact, Fauci said, community spread had already progressed significantly.
"It isn't something where you know everything that you're going to know from day one," Fauci told ABC News. "The insidious aspect about community spread is that … you don't know who is infecting who. Once that happens, that is the big red flag that we have a real serious problem. And that's when we first started realizing the first community spread that was not related to an identifiable source. Now we see an explosion of that. That's exactly what went on in New York, went on in Chicago and New Orleans, and what is currently now, as you and I are speaking, which is going on in several of the southern states."
Once public health officials identified the potentially catastrophic nature of the contagion, the challenge was to act immediately and get leadership and the public on the same page, said Elizabeth Neumann, who until April served as assistant homeland security secretary for threat prevention and security policy.
"When you're an emergency management professional, you're constantly balancing not wanting to be Chicken Little," Neumann told ABC News. "'The sky is falling, the sky is falling.' Then nothing happens, and the next time you have to say the sky is falling, nobody believes you."
"So there's always a tension there," Neumann said, "in trying to clearly communicate to the public, clearly communicate to leadership, what the concerns might be, what the likelihood of a potential disaster could be."
Tom Bossert, former homeland security adviser to President Trump and an ABC News contributor, said sticking with containment efforts until there was hard evidence of community spread was a "sequential mistake" made during those critical early months as symptomatic and asymptomatic infectious people were "walking around in any community at any given time, unbeknownst to not only the public health authorities, but to the people that were sick."
"Once there's 1% or more prevalence," Bossert said, "it becomes very difficult for human, non-pharmaceutical interventions to contain it."
4) Inadequate testing blinds leaders
Until April, the United States lagged far behind numerous other countries on testing even as community spread was actively occurring across the country and around the world.
"Like any threat, you can't fight it if you don't know where it is," Klain told ABC News.
Assistant Secretary of Health Adm. Brett Giroir, the nation's top health official tapped by President Trump to oversee coronavirus testing, told ABC News the government was not prepared to ramp up its testing efforts early in the pandemic because testing supplies were not part of the national stockpile.
"When I looked to see what was there, there was nothing there," Giroir told ABC News. "We didn't know what industries were involved. We needed these strange things called swabs. Who makes swabs?"
According to CDC Director Redfield, companies were slow to jump into testing early on in the coronavirus crisis because of their past experience with SARS and MERS. Because those ailments never spread widely, private labs saw tests go unused, he said.
"By the time they developed the test there was no market for the test," Redfield told ABC News.
But the president's critics say the administration should have quickly used the Defense Production Act to boost testing efforts early on -- an effort that's now being implemented as several states and private labs are once again faced with testing shortages, supply issues and a significant lag in turnaround time for test results nearly half a year into the pandemic even after the federal government and states across the country have significantly ramped up testing efforts.
FDA Commissioner and White House Coronavirus Task Force member Stephen Hahn attributes the current testing shortage to an increase in demand as tests open up to asymptomatic people.
"I think it's a reasonable public health strategy that we've done that," Hahn told ABC News. "Our job at FDA is to say, 'Okay, where's the next generation of tests so that we can scale up by tens of millions per month?' Fortunately, that's happening."
But several states, including California, have recently reverted to prioritizing symptomatic patients. Former New York City Health Commissioner Dr. Mary Bassett told ABC News the lag in turnaround time for testing results -- which is as long as a week in some places -- are "not acceptable."
"It makes a complete mess of all public health prevention strategies of a communicable disease," said Bassett, who oversaw New York City's Ebola response. "You have to have rapid turnaround."
5) Mixed messages undermine a public's confidence in response
In 2005, when President George W. Bush dispatched his top public health officials to craft a pandemic preparedness plan, a top priority was to convey a clear, unified message to the American people about the federal government's response.
"It was interesting to go back and reread the pandemic plan from 2005," said Dr. Julie Gerberding, who directed the Centers for Disease and Control from 2002 to 2009 and helped convince Congress to adopt the Bush strategy. "If you go down the list, it included … communication capability development with trustworthy spokespeople."
Public health officials say President Trump's rhetoric has set back efforts to convey a unified message to Americans.
Both supporters and critics of the president have accused him of downplaying the threat of the pandemic.
"As I watched a lot of this evolve from January through February and March, I was worried about a number of mistakes that, it appeared to me from the outside, were being made, or at least in communication with the public were being made," said Tom Bossert, a former homeland security advisor to Trump who was also a security aide to Bush when the 2005 pandemic plan was enacted. "I mean, this is the part that's so hard for me. Yes, of course, there's bad leadership right now. It's so self-evident that you don't need me to say."
The president and his close political advisors often offered messages in direct conflict with his public health experts. The friction between the two factions came to a head earlier this month when the president's trade advisor, Peter Navarro, penned an op-ed in USA Today critical of Fauci, the administration's top infectious disease expert.
"What are people supposed to think when the federal government has a plan for reopening and the president is telling people to ignore his experts' own plan for reopening?" asked Klain. "That confuses everyone. It leads to politics, division, divisiveness. It leads to some of these protests you were seeing."
President Trump imposed a travel ban from Europe, which he has cited as an important early response. But some health experts say it also drove a massive number of people back to the U.S. at a time when social distancing was needed.
"He said he was banning everyone, and that led to a panic," Klain said. "It led to thousands and thousands of people coming back from Europe who didn't need to come back. It led to people being jammed up in U.S. airports and probably a lot of coronavirus was brought to this country and spread once in this country."
"The implementation of that could have gone much -- needed to have gone better, because people ended up in those crowded hallways for a long period of time," Neumann said. "And many were exposed, and reportedly have passed because of their exposure waiting to clear customs."
Public health experts haven't been immune from criticism for their mistakes. In early March, for example, Fauci characterized the risk of Americans contracting the illness as "really relatively low" while the surgeon general discouraged the use of masks.
Adm. Brett Giroir, the Trump administration's testing coordinator, described how conflicting messages erode public trust in the government's response – and the challenges of being the bearer of bad news.
"I can tell you I've tried – and all my colleagues have tried, to the best of our ability – to be completely transparent and open with the American people. I've been accused of being the person who's more negative," Giroir said. "I've tried to be right down the middle of the fairway. Because I believe it's important for the American people … to know that this is very serious."
This report was featured in the Tuesday, July 28, 2020, episode of “Start Here,” ABC News’ daily news podcast.
2021 (Jan 28) - "Doctor who correctly predicted COVID-19 death toll in US reflects on pandemic"
A grim coronavirus prediction, 1 year later. One infectious disease specialist was able to predict the grim outcome.
Source : [HM001Z][GDrive] / By Haley Yamada,Lauren Pearle, and Lindsey Griswold January 28, 2021, 9:09 AM
One year ago, not many could have predicted the toll the novel coronavirus would take on human life. As much of the world remained ignorant to the looming reality of the virus, one infectious disease specialist was able to predict the grim outcome.
Dr. James Lawler, who served in the Obama and Bush administrations, and a group of current and former health officials, quickly reacted amongst themselves to the Trump administration officials' early messages that the mysterious virus in China was not a serious concern.
"This was my somewhat tongue-in-cheek response to that ... I describe Napoleon's retreat from Moscow [as] 'just a little stroll gone bad,'" Lawler said. "Pompeii [was] 'a bit of a dust storm' and Wuhan -- 'just a bad flu season,'" said Lawler.
In a series of email chains called Red Dawn, Lawler and his group closely monitored early outbreaks, such as the one on the Diamond Princess cruise ship in early February 2020.
"Despite these pretty aggressive infection control measures that passengers were taking, they were continuing to get sick. That really brought home to us the potentially explosive transmission that could occur," said Lawler.
While former President Donald Trump downplayed the threat of the virus early on -- saying it was was "under control" and was a "problem that's going to go away" -- Lawler did the math. In a private webinar with the American Hospital Association in February 2020, he estimated 480,000 people in the U.S. could die.
Unfortunately, 11 months later, he has been proven right. This week, the U.S. reached the milestone of 425,000 COVID-19 deaths and the Centers for Disease Control warned the toll could reach 465,000 to 508,000 by Feb. 13. Lawler said it reflects how the country is handling the pandemic.
"I think this reflects the fact that we really have not done a great job of mitigating the impact of the pandemic," Lawler told ABC News Wednesday, close to a year after he made his first grim prediction.
"I had thought that after a while we would be able to act with more uniformity and more purpose and to do the things that are necessary to reduce community transmission. Unfortunately, that's not been the case and now we're seeing the impact of that," he added.
In December, U.K. health officials announced a more contagious COVID-19 variant that has since spread across the U.S. Officials are also tracking potentially other variants from South Africa and Brazil.
"Well [variants] do make it harder to predict, and we're learning more every day," Lawler told ABC News. "I think it's also true that they seem to presage the arrival of other variants, that we may not have recognized yet."
Despite the variants, Lawler said he believes the current vaccines will still be effective. Moderna and Pfizer, the two companies whose vaccines are authorized in the U.S., have said it believes the same.
"I think it's highly likely that these vaccines that we have right now, will be sufficient to create herd immunity," he said.
Lawler said that after a year of confusion and disinformation, he's glad to see the Biden administration focus national attention toward the pandemic. He said the key to fighting the virus is a coherent strategy for the country.
"I think messaging has to be one of the top priorities. So much has been lost in the messaging, so far in the last year," he said. "If we could have had consistent messaging from the White House, I think that would have made a significant impact."
Although Lawler called the vaccines "a light at the end of the tunnel," he said the country will unfortunately still suffer the effects of the virus in the near future.
"It's clear that we're going to see deaths from COVID-19 for a long time in this country, even after the vaccine is fully rolled out," he said. "We could have done a lot differently and we would have been in a much better position if we had taken actions early on and focused nationally."
2021 (April 02) - Omaha.com : "UNMC pandemic expert says Trump's COVID response cost thousands of lives"
Henry Cordes / Jan 22, 2021 Updated Apr 2, 2021 / Source : [HW0069][GDrive]
A pandemic expert from the University of Nebraska Medical Center welcomed a chance to reset the nation’s COVID-19 response under new President Joe Biden and sharply criticized Donald Trump, saying the outgoing president undermined public health guidance and cost thousands of lives.
Dr. James Lawler, a manager at UNMC’s Global Center for Health Security, particularly faulted the messages Trump sent by politicizing masks, downplaying the severity of the pandemic and holding large rallies.
It all suggested to the public, Lawler said, that the pandemic was overblown and that social distancing measures designed to control the virus amounted to unnecessary infringements on people’s lives.
“The result of that is we have 400,000 dead Americans,” Lawler said in an interview with The World-Herald. “It didn’t need to be this way.”
If the president had instead used his voice and the presidential bully pulpit to urge Americans to heed public health advice, Lawler said, it could have made “a huge difference.”
Just before leaving for Florida on Wednesday, Trump praised his administration’s efforts to control what he called “the China virus,” particularly noting Operation Warp Speed, the drive to accelerate vaccine development.
Striking tones he rarely has during the pandemic, Trump also cautioned Americans to be “very, very careful” of the virus and expressed sympathy for virus victims and their families.
“We want to pay great love, great love to all of the people that have suffered, including families who have suffered so gravely,” he said.
The former administration had previously said that Trump’s actions significantly reduced U.S. deaths from an early forecast under one model of as many as 2.2 million.
Lawler, a Navy veteran whose military career included White House assignments dealing with biodefense, pandemic response and health preparedness, lauded the federal effort to speed the development of vaccines. He said those vaccines, whether developed privately or with federal assistance, are showing “fantastic” efficacy in fighting COVID-19.
But Lawler faulted the Trump administration for not having a more robust plan to get the vaccine into the arms of Americans.
The administration largely left it to state and local public health officials to solve a major logistical challenge, one that they are not trained for, Lawler said.
He said the U.S. military has significant logistical expertise that could have been brought to bear, and he thinks that other strategies could be explored to speed vaccinations.
“We’ve given this task to a group of professionals who don’t have the skill set to execute it,” he said. “I wouldn’t look to myself to repair a car, and I wouldn’t look to my public health colleagues to solve a complex logistical problem. We need professional logisticians to solve this problem.”
It’s not too late for Biden to change America’s course on vaccination efforts, Lawler said, as there is still a long way to go.
As of Wednesday, some 17 million shots had been administered. It’s estimated that it will take 250 million Americans getting two shots — half a billion total shots — before the nation can achieve “herd immunity,” halting the wide spread of the virus.
Since taking over on Wednesday, Biden has pledged a “full-scale, wartime” response to the pandemic.
The president has set a goal of vaccinating 100 million Americans in his administration’s first 100 days. Since vaccinations began, the nation has been averaging about 450,000 a day, though recent figures have been higher than that. Exactly how Biden expects to ramp up the vaccination effort is unclear.
The beefed-up COVID-19 response includes an effort to change the messaging.
With no legal authority to impose a national mask mandate, Biden instead issued a “100 Days Masking Challenge” — asking Americans to wear masks for 100 days to slow the spread of the virus. He also issued an order requiring the wearing of masks in federal buildings and by federal employees.
Lawler said he would like to see more advocacy from the new administration on the safety of the vaccine, so that fewer people refuse to take it. He’s also hopeful that Biden will let science and health experts guide the national response in a way that’s unfettered by politics.
The U.S. has recorded more coronavirus deaths than any nation in the world, almost twice as many as No. 2 Brazil. It ranks near the top among developed nations in deaths per capita, trailing only Belgium, Italy and the United Kingdom. Neighboring Canada’s death rate is less than half that of the U.S.
In late February, before the pandemic had come to Nebraska, Lawler gave Omaha-area school superintendents a briefing on the deadly virus that was spreading across Europe. Based on what was known at the time, Lawler predicted that 480,000 Americans would lose their lives within a year.
Now with over 400,000 deaths and roughly 4,000 more dying each day, the U.S. is on pace to exceed that figure. He said his forecast had assumed “a relatively unmitigated epidemic.”
“Unfortunately, that’s what we’ve got,” he said. “I had hoped that we would be able to respond with much more unity of action. Unfortunately, the U.S. has recorded the most deaths of any country precisely because we were unable to approach the response with unity of effort and with a coherent strategy.”
Lawler said he will never understand why Trump often chose to downplay the virus and to politicize masks and other “nonpharmaceutical interventions” such as avoiding crowds and close contact.
Trump often appeared in public without wearing a mask and held campaign events with thousands of supporters, many of them maskless.
In October, the president himself became infected and was hospitalized with the virus. After spending three nights in the hospital, Trump compared COVID-19 to the flu, saying Americans would learn to live with the new virus.
“All of these things were verbal or visual cues that indicated that the public health interventions that we had been preaching were not important or were unnecessary,” Lawler said. “It fueled this conspiracy theory that the pandemic was intentionally overblown and that this information was designed to control people’s lives.”
Wearing masks became an ideological issue, which Lawler called “one of the tragedies” of the pandemic.
After Trump lost his reelection bid in November, he made few pronouncements relative to the pandemic at all.
“He obviously had kind of checked out of the pandemic business a long time ago,” Lawler said. “But silence was an improvement over what was essentially constantly undermining public health.”
Family / Parent research info
Parent's wedding (1957)
(frank p. polard - Masonry contractor.. https://www.newspapers.com/image/652954571/?article=a08025d2-15fa-4692-9447-4e6590efb4de )
Lester V. Lawler - Passed 1979 - https://www.newspapers.com/image/654159460/?terms=%22lester%20lawler%22&match=1
Dr. Donald Lawler - English professor, East Carolina Univ. - https://www.newspapers.com/image/655989506/?terms=%22donald%20lawler%22&match=1
"d Dr. Donald Lawler, chaired a seminar on Kurt Vonnegut at the Modern Languages Association's national convention in San Francisco. "