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DoD Biorisk Program, Ebola mAbs Therapeutics, Measles Outbreak in PacNW

See what we’re reading this week at Global Biodefense on topics including the DoD Biorisk Program, monoclonal antibody treatments for Ebola, botulinum neurotoxin poisoning, and a measles outbreak in the Pacific Northwest.

Quick Index

POLICY + PRACTICES

DoD Biological Select Agents and Toxins (BSAT) Biosafety and Biosecurity Program

Effective 25 Jan, this directive designates the Secretary of the Army as the DoD Executive Agent for the DoD BSAT Biorisk Program and outlines responsibilities including coordination of Federal Select Agent Program inspections and reporting to CDC and APHIS, establishment of a government-only scientific peer-review board to conduct biorisk assessments, and development of a comprehensive inspection program. DOD DIRECTIVE 5101.20E .pdf

Vaccine Skeptics on MN Autism Council Touch Off Debate

Autism activists are concerned that the appointment of vaccine skeptics to a newly formed state council gives credibility to views the state has struggled to dispel. Anti-vaccination groups have focused on Minnesota’s Somali-American community in the past as they tried to perpetuate the hoax that vaccines cause autism, contributing to a drop in vaccinations and the largest measles outbreak in the state’s recent history in 2017. Star Tribune

The Doomsday Clock is Stuck at 2 Minutes to Midnight

The Bulletin of the Atomic Scientists is keeping the  Doomsday Clock set at 11:58, citing nuclear weapons and climate change as two existential risks that leave the world dangerously close to an apocalypse. “These major threats—nuclear weapons and climate change—were exacerbated this past year by the increased use of information warfare to undermine democracy around the world, amplifying risk from these and other threats and putting the future of civilization in extraordinary danger…” CBRNE Central

MEDICAL COUNTERMEASURES

Toxic at Best – Development of a Botulinum Toxin Medical Countermeasure

A botulinum toxin medical countermeasure under development by the DoD is being used as the establishment product for its Adamant-based manufacturing process at the DOD ADM facility. The standardised manufacturing process is being set up at the 500 litre (132 gallon) bioreactor scale. Maintaining this production scale throughout the development stages eliminates the need for costly and lengthy scale up efforts and reduces significant risks. Each drug product manufacturing batch is expected to provide monoclonal antibodies sufficient to support 8,000 to 16,000 doses. This product is expected to receive FDA approval in 2025, which is already much faster than traditional medical product development. After a second medical product is run through the platform validation process, development time is expected to be even shorter. Joint Program Executive Office for Chemical Biological Defense

Flu Science Points To Another Culprit When Vaccines Fail — Us

A growing body of evidence suggests that sometimes our immune systems simply don’t follow the instructions a vaccine tries to give them — that is, make antibodies to fight a particular H3N2 or H1N1 virus. The reason? We all have flu baggage that shapes the way our immune systems respond to both infections and vaccines. STAT

Investigational Monoclonal Antibody to Treat Ebola Is Safe in Adults

The investigational Ebola treatment mAb114 is safe, well-tolerated, and easy to administer, according to findings from an early-stage clinical trial published in The Lancet. Eighteen healthy adults received the monoclonal antibody as part of a Phase 1 clinical trial that began in May 2018 at the NIH Clinical Center in Bethesda, Maryland. NIAID

FDA Approval Expands Fluzone Quadrivalent Indication for Youngest Kids

The FDA’s approval was based on a phase 4 safety and immunogenicity study in nearly 2,000 children that suggested one or two 0.5 mL doses of children ages 6 through 35 months had a safety profile that was similar to the smaller dose, with no new safety concerns and with a robust immune response.  Sanofi Pasteur leadership noted that the expanded indication will streamline immunization efforts for pediatricians by allowing the same 0.5-mL dose for the youngest children as for other children. CIDRAP

OUTBREAK NEWS + THREAT SURVEILLANCE

Deadly Ebola Virus is Found in Liberian Bat, Researchers Say

For the first time, the type of deadly Ebola virus responsible for recent epidemics has been found in a bat in West Africa, Liberian health officials announced on Thursday. Only 20 percent of the bat’s genome has been studied, and research on it is continuing. “It’s an incomplete study, a work in progress,” said Simon J. Anthony, a virologist at Columbia University who has performed genetic analyses on samples from the infected bat. “It feels premature scientifically, but on the other hand, you have the public health aspect. We do have enough data to suggest to me that it is Ebola Zaire in this bat. We agree with our Liberian government partners that this information should be shared.” NY Times

Measles Sickens 21 in Washington State

A person infected with measles attended a Portland Trail Blazers home game in Oregon last week amid an outbreak that has left at least 21 people ill this month in neighboring Washington state. Contagious people also went to Portland International Airport, as well as to hospitals, schools, stores, churches and restaurants across Washington’s Clark County and the two-state region, county officials said. CNN

Prior Dengue Infection Protects Children against Zika Symptoms

A Nicaraguan study supports the idea preexisting dengue immunity may affect susceptibility to Zika. The science exploring the relationship between dengue and Zika may provide valuable data that can be used in the development of an effective vaccine. The results support the hypothesis that an immunological interaction exists between dengue and Zika, which belong to the same Flavivirus genus. Scientific American

RESEARCH + TECH

Errors in Long-read Assemblies Can Critically Affect Protein Prediction

Even after multiple rounds of correction, long-read assemblies can contain errors in protein coding regions that can substantially alter, and often truncate, protein predictions. This article discusses improving assembly quality by inclusion of data from multiple technologies, incorporating multiple rounds of assembly polishing into downstream analyses, and performing additional checks for remaining indels and errors. These additional checks should include alignment of known proteins and cDNA or mRNA sequences against the genome to check for genic indels, manual inspection of genomic alignments and, where necessary, manual fixing of errors that the correction algorithms miss. Nature

Clinical Research Networks and Assessing Pandemic Severity

Through the International Forum for Acute Care Trialists and the International Severe Acute Respiratory and Emerging Infection Consortium, we have established a global network of critical care units dedicated to rapid data collection and sharing in future outbreaks. This work builds on the work of the Canadian Critical Care Trials Group and the Australia New Zealand Intensive Care Society Clinical Trials Group, who did observational research during the 2009 pandemic. Currently, using approved observational protocols for severe acute respiratory infection, we collect periodic data annually to determine baseline severity and to identify problems with the existing research infrastructure. The Lancet

Opinion: Disease Prediction by Bat Virus Surveys Is a Waste

Costly virus hunts are ineffective in protecting public health and have unfairly harmed the historically excellent safety record of bats as beneficial neighbors. New viruses can be found wherever we look, and most are innocuous. Finding more in the most frequently searched animals isn’t surprising or necessarily indicative of risk. Promoters of virus hunting too often exaggerate even remote risks, making them seem imminent and extreme. Because few people understand viruses or bats the combination is ideal for manipulation to justify large grants. The Scientist

OPPORTUNITIES

PNNL Seeks Biodefense Senior Biomedical/Biochemical Scientist

PNNL aims to develop the science of using multi-omics methods for the threat-agnostic identification of pathogens that are problematic for human health, and of interest in the national security realm. In particular, PNNL is interested in broadening the understanding of basic pathogen functions and host-pathogen interactions so that future threats to national security can be rapidly identified as such based on their functional characteristics and public health implications, rather than by comparison to lists of known threat agents.  The incumbent will develop and direct a collaborative research program and interface with external clients (i.e., DOE and national security sponsors including the Departments of Defense and Homeland Security) to generate new and repeat business and to grow PNNL’s technical capabilities. Pacific Northwest National Laboratory

Collaborative Research and Licensing Opportunity: Middle East Respiratory Syndrome Coronavirus Antibodies

Inventors at the Vaccine Research Center of the NIAID have identified and developed neutralizing monoclonal antibodies (nMAbs) against the MERS-CoV. This invention describes antibodies that target the Spike (S) glycoprotein on the coronavirus surface, which mediates viral entry into host cells. These novel antibodies target different regions of the S protein, and when administered in combination, reduce the possibility of viral escape. In preclinical testing, these nMAbs have demonstrated potent protective effects, preventing death, viral replication in the lower airways and severe disease in challenge studies with mice. In addition, these nMAbs have potential application for use in assays for detecting MERS-CoV S protein in infected patients or animals. This technology is available for licensing for commercial development as well as for further development and evaluation under a research collaboration. National Institute of Allergy and Infectious Diseases

DTRA Seeks Interdisciplinary Microbiologist/Physical Scientist

GS-13/14 employment opportunity with the Defense Threat Reduction Agency. Using national security strategies, defense planning guidance, and Combatant Command (CCMD) strategies and plans to support the Research and Development mission in the identification of opportunities for international cooperative counter-CBRNE science and technology (S&T) activities. USAJobs Closes Feb 5

DTRA Intelligence Operations Specialist – WMD Department, Intelligence and Plans Directorate

Serving as a Defense Threat Reduction Agency nuclear/radiological subject-matter expert and technical authority with a focus on current/near-term events, plans, developments and trends pertaining to the proliferation of WMD and nuclear/radiological events; issues impacting nuclear weapons security; force protection; and force operability and survivability against a broad spectrum of nuclear, biological, chemical and other WMD events. Initiating projects, and planning, organizing, directing, and/or conducting analysis of broadly defined and interrelated areas of intelligence and technical issues pertaining to WMD threats to US and allied nations. USAJobs  Closes Feb 4

HISTORICAL REFLECTIONS

Death in the Air: Revisiting the 2001 Anthrax Mailings and the Amerithrax Investigation

Although advances in the life sciences are improving the tools available for bioforensics, Amerithrax also demonstrates the limitations of such innovations. Admittedly, bioforensics was in its infancy at the outset of the investigation. A 2017 Government Accounting Office report cites experts as stating that bioforensics at the time of Amerithrax was incapable of detailed characterization and comparative analyses, and whether the scientific findings would have withstood critical scrutiny in the courts is uncertain. War on the Rocks

WEBCAST EVENTS THIS WEEK

Committee to Review Long-term Health Effects of Antimalarial Drugs

28 Jan: The National Academies of Sciences, Engineering, and Medicine Committee to Review Long-Term Effects of Antimalarial Drugs will be having a public session as part of its information gathering activities. The public session will be held on Monday, January 28, 2019, from 1:00 PM to 5:00 PM ET. The session will be accessible to the public via live webcast. Eventbrite

NAS Public Meeting on Safeguarding the Bioeconomy

Jan 28: Open session of committee members convened by the National Academies of Sciences, Engineering, and Medicine to review the U.S. bioeconomy, assess opportunities, and consider strategies to protect its intangible assets (such as data and intellectual property), while sustaining innovation. Global Biodefense Calendar

Fighting Ebola in DRC: New Tools and New Challenges

Jan 29: Join Doctors Without Borders for a live webcast panel discussion on January 29 from 12:30 PM – 2:00 PM EST on efforts to contain the current Ebola epidemic in Democratic Republic of Congo (DRC). Global Biodefense Calendar

New Preparedness Risk Assessment Toolkit

Jan 29: The Department of Health and Human Services’ Office of the Assistant Secretary of Preparedness and Response will host a Jan. 29 webinar on its new Healthcare and Public Health (HPH) Risk Identification and Site Criticality (RISC) Toolkit to help health care organizations identify threats and hazards to inform preparedness activities and investments. HHS

2018-2019 Influenza Season and CDC Recommendations for Clinicians

Jan 29: During this Clinician Outreach and Communication Activity (COCA) call, clinicians will learn about 2018 – 2019 influenza activity and hear an overview of CDC’s recommendations for health care providers regarding flu vaccination and the use of antiviral medications this season, including a new antiviral medication approved by the FDA in October 2018. CDC

HHS Virtual Listening Session on Updates to National HIV and Viral Hepatitis Plans

Jan 29: The U.S. Department of Health & Human Services Office of HIV/AIDS and Infectious Disease Policy (OHAIDP) hosts this listening session to continue gathering public input for updates to the National HIV/AIDS Strategy (NHAS) and the National Viral Hepatitis Action Plan (NVHAP). Both national plans currently expire in 2020. HHS/HIV.gov

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

Jan 29-30: The need for effective cybersecurity to assure medical device functionality and safety has become more important with the increasing use of wireless, Internet- and network- connected devices, and the frequent electronic exchange of medical device-related health information. In addition, cybersecurity threats to the healthcare sector have become more frequent, more severe, and more clinically impactful.  FDA

Innovative Attachment Systems for Improved Performance of Prosthetics & Exoskeletons

Jan 30: Traditional approaches to attaching prosthetics, orthopedic devices or exoskeletons use a simple capture approach, which has little regard for skeletal biomechanics, leaving the wearer without full control. Similarly, the standard approach in the exoskeleton and bionics market is to capture the limb, with little regard to natural limb movement. This webinar discusses a non-surgical technique that utilizes soft tissue compression and release which offers an alternative to other more-invasive methods. DoD Homeland Defense & Security Information Analysis Center

From Dose Response Curve to Formulation

Jan 31: Dose response curves have been an integral part of drug discovery and development for centuries. Multi-dimensional data on proteins, compounds generated using modern techniques still relies on insights coming from the dose response curves. Learn how to add dose response curve to formulation data and leverage TIBCO Spotfire® X for experimental data. Perkin Elmer

Leveraging Single-Cell Genomics to Identify Drivers of Enhanced Immunity

Jan 31: In this webinar, Alex K. Shalek of the Massachusetts Institute of Technology (MIT) will discuss his work using single-cell genomic approaches — in particular, single-cell RNA-seq — to explore the functional diversity among immune cells within and across individuals. This project aims to uncover distinct cell types and states associated with improved immunity from the molecular level. Roche/GenomeWeb

Ebola virus

Ebola Spreads to High-Risk Area of Congo

North Korea’s Bioweapons Program, Eradicating Viral Hepatitis, Working in BSL-2 Plus