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908 catches a Trace

908 Devices a pioneer of purpose-built handheld and desktop mass spec devices for chemical and biomolecular analysis, announced that it has completed the acquisition of privately-held TRACE Analytics GmbH, based in Braunschweig, Germany, a provider of on-line analysis and sampling systems for biotech applications. 908 Devices expects the acquired technology to enable its mass spec devices as on-line bioprocess monitors.

Founded in 2003, Trace Analytics develops on-line aseptic sampling systems and novel biosensors for bioreactor monitoring and control. Their validated technology, in single-use and reusable configurations, is applied in mammalian cell culture and microbial fermentations at all levels of the bioprocess chain, from research and development to large scale production.

“The addition of TRACE Analytics enables us to take a measurable step forward in our goal to build a connected and comprehensive bioanalytics platform,” said Dr. Kevin J. Knopp, CEO and Co-founder of 908 Devices. “We are excited to have the TRACE Analytics team join us as we work together to meet the needs of our customers with on-line devices that provide actionable insights and enable Bioprocessing 4.0. Our focus has been to develop robust and easy to maintain devices for bioprocess monitoring and control,” said Dr. Wolfgang Künnecke, founder of TRACE Analytics. “We feel a strong affinity with 908 Devices, and we look forward to working together to develop innovative on-line analyzers.”

The purchase consideration includes an initial cash payment of $15.3 million and up to an additional $2.0 million of contingent cash consideration upon the achievement of certain milestones over the next two years.

SIGA Announces BARDA Exercise of Procurement Options Valued at Approximately $26 Million for IV TPOXX

SIGA Technologies, Inc., a commercial-stage pharmaceutical company, today announced the exercise of procurement options under its 75A50118C00019 (19C) contract with the U.S. Department of Health and Human Services for the delivery to the U.S. government of intravenous (IV) formulation of TPOXX treatment courses valued at approximately $26 million . These option exercises represent the first procurement option exercises for IV TPOXX under the 19C contract. Product deliveries of IV TPOXX in connection with these contract options are targeted for 2023. IV TPOXX is an important option for those who are unable to swallow.

“These option exercises for the procurement of IV formulation of TPOXX as well as the funding of a post-marketing field study for IV TPOXX highlight the growing importance of a broad-based response to the substantial risks posed by the orthopox family of viruses, including smallpox and monkeypox,” said Phil Gomez, CEO of SIGA. “The exercised options are among many procurement options under the 19C contract that remain to be exercised and, as such, we will continue to coordinate with the U.S. government toward future procurements of oral TPOXX and IV TPOXX.”

The procurement options, which were exercised by the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services, include the manufacture of bulk drug substance and the use of such substance to manufacture and deliver final drug product of IV TPOXX. 

Threat, Protection, Biological

US Nuclear disablement team trains at UK's Sellafield

DVIDs reported that American Soldiers from Nuclear Disablement Team 2 conducted nuclear counterproliferation training with personnel from the U.S. National Nuclear Security Administration and United Kingdom Ministry of Defense during an exercise in May. The exercise was the first time one of the U.S. Army Nuclear Disablement Teams have trained in the United Kingdom. Nuclear Disablement Team 2 is one of three NDTs from the 20th CBRNE Command, they directly contribute to the nation’s strategic deterrence by staying ready to exploit and disable nuclear and radiological Weapons of Mass Destruction infrastructure and components to deny near-term capability to adversaries and facilitate WMD elimination operations.

Maj. Neal J. Trump, a nuclear operations officer from NDT 2, said the Nuclear Disablement Team began planning for the exercise in 2020 but COVID-19 postponed it. In May 2022, the exercise took place at multiple locations in the United Kingdom. NDT 2 participated during the first half of the month at the Sellafield site in northwest England and at Weeton Barracks about an hour from Manchester, England. 

“The exercise as a whole validated the Department of Energy Mobile Packaging Teams in the receipt and processing of material collected from nuclear facilities and also integrated the participation of personnel from the DoE's Plutonium and Uranium Verification Teams,” said Trump, an Iraq veteran and former infantry officer from Lancaster, Pennsylvania, who has commanded Soldiers in the 82nd Airborne Division and 3rd U.S. Infantry Regiment (Old Guard).

The exercise offered a unique training opportunity for NDT 2 to characterize an industrial-scale reprocessing facility and to recognize the equipment and materials used there, said Trump. In addition to seven soldiers from NDT 2, four soldiers from the other NDTs were able to participate in the exercise.

“This exercise presented a truly unique training experience for NDT 2 that will pay dividends for a long time to come,” said Trump. “Since there are currently no commercial reprocessing facilities for spent nuclear fuel operating in the United States, conducting training at Sellafield exposed team members to a portion of the nuclear full cycle that we rarely have the opportunity to work in and at a scale that nobody had witnessed before.”

Trump said the NDT Soldiers were able to conduct a reconnaissance and characterization of the Thermal Oxide Reprocessing Plant (THORP), as well as perform sampling operations of highly accurate simulants from large negative pressure gloveboxes.“The most enduring effect of the exercise, however, will likely be the excellent relationships we developed with Sellafield personnel that we hope to leverage for further training opportunities in the future,” said Trump.

During the exercise, NDT Soldiers refined procedures for detecting nuclear material and collecting gamma ray spectra, as well as packaging simulated samples of nuclear material to transfer to the NNSA's Mobile Plutonium Facility.
At Sellafield, representatives from the NNSA’s Uranium Verification Team and Plutonium Verification Team not only observed the training but also participated in discussions about how both organizations can better support one another in the counterproliferation fight. NDT 2 Soldiers also used the U.S. Department of Energy’s reach-back process while in the United Kingdom to send requests for information to a U.S.-based team of subject matter experts who were able to provide technical guidance in support of the NDT characterization of the Thermal Oxide Reprocessing Plant.

“At the conclusion of our training, NDT 2 prepared and presented an exploitation brief to senior members of the 20th CBRNE Command and leadership of the NNSA’s Nuclear Compliance Verification and Mobile Packaging programs,” said Trump. “This interaction further served to demonstrate the capabilities of the NDTs to key interagency partners and acted as a relationship-building venue between key DoE professionals and NDT personnel.”

Jonathan P. Spencer, a manager at the Sellafield site, said joint training exercises give his site invaluable opportunities to share knowledge and learn from the other participants.

“While Sellafield's challenges are different in many ways to the challenges faced by the NDT, there are some similarities,” said Spencer. “Seeing how other teams approach tasks like characterization, sampling and radiation and contamination control is very instructive. There are many learning points from the exercise which will help inform our work in the future. Finally, Sellafield recognizes the important role the NDT performs and takes pride in being able to play a small role in the NDT training and exercise program.”

Spencer, who has worked at Sellafield Ltd for 12 years, credited the success of the exercise to advanced planning done by NDT 2 Team Chief Lt. Col. Ronald C. Lenker and Maj. Neal Trump with his Sellafield team, including Astelle Batty and Gareth Bawden. “It was evident that the attention to detail resulted in the successful running of the exercise,” said Spencer. “Due to the nature of work on the Sellafield deployments, such as this exercise while on paper may appear simple in reality are not straightforward.”

The exercise was the first at the Sellafield site’s new Glove Box Training Facility. “It was a great pleasure and honor for Sellafield Ltd to host this visit within THORP and our Glovebox Training Facility,” said Spencer. “It was a particular highlight to see NDT members calmly, methodically and professionally tackle the very challenging scenarios we created for them in this new facility.”

Newly Identified Compound Binds to Shiga Toxin to Reduce its Toxicity

Infection from the enterohemorrhagic E. coli (EHEC) can cause bloody diarrhea and severe abdominal cramps in humans. This is due to the presence of a deadly toxin called “Shiga toxin” (Stx) produced by EHEC. Researchers from Japan have now discovered a compound that binds to and selectively inhibits Stx2a, a particularly lethal and virulent subtype of Stx. This finding could open doors to a potential therapeutic agent against EHEC infections.

A strain of E. coli bacteria called enterohemorrhagic E. coli (EHEC) is known to cause several gastrointestinal disorders, which include bloody diarrhea and abdominal cramps, by damaging the intestinal lining. When accompanied with fatal systemic complications, it can even cause acute renal failure in children. The EHEC exerts these deadly effects by producing the Shiga toxin (Stx), of which the Stx2a subtype is particularly virulent and deadly. Compounds that can inhibit these toxins are, therefore, desirable as potential therapeutics against EHEC infections.

To this end, a group of scientists from Japan led by Professor Kiyotaka Nishikawa from Doshisha University has recently discovered a molecule that inhibits Stx2a toxicity by binding to its “A-subunit” - the part of the toxin responsible for its lethality.

The catalytic A-subunit of Stx2a toxin inhibits protein synthesis and its inhibition could be crucial for slowing EHEC pathogenesis,” says Prof. Nishikawa, explaining their motivation behind the study, which was published in Scientific Reports. The same group had earlier developed an inhibitory molecule that can bind to the B-subunit of Shiga toxin and reduce its toxicity.

Professor Nishikawa and his colleagues, including Assistant Professor Miho Watanabe-Takahashi of Doshisha University, Dr. Miki Senda and Dr. Toshiya Senda of the Institute of Materials Structure Science at High Energy Accelerator Research Organization (KEK), and Dr. Kentaro Shimizu of the University of Tokyo, among others, identified the potent compound from a database with over 7,400,000 molecules.

To do this, the researchers had to first identify the basic 3D arrangement of molecules (the peptide motif) that can occupy the catalytic cavity in the A-subunit. In a stroke of luck, they stumbled upon a synthetic molecule with a high affinity for A-subunit. This molecule, a peptide called “MMβA-mono,” helped identify the compound that could bind to the A-subunit of Shiga toxin by serving as a template.

The researchers next outlined the molecular and electronic structure that a possible inhibitory compound must have using structural analysis and X-ray crystallography. These features of a potential inhibitor, known as a “pharmacophore,” was then confirmed using molecular dynamics simulations.

Finally, they screened a chemical database for compounds that resembled the pharmacophore and identified nine candidates using docking simulations. Of these, a compound identified as “compound #6” showed effective binding to the A-subunit of Stx2a.

Further, in vitro cytotoxicity assays using Vero cells showed that compound #6 significantly reduced the destruction of cells caused by Stx2a. Additionally, mice models treated with a lethal dose of Stx2a and compound #6 survived longer than those injected with only Stx2a.

Prof. Nishikawa is optimistic about the future applications of this study. On being asked how the compound might work in the infected cells, he explains, “The hydrophobicity of compound #6 may facilitate penetration through the cell envelope, allowing it to inhibit the toxin present in the cells. We believe that it holds promise as a novel therapeutic agent for treating EHEC infections.

The team has even suggested that their studied pharmacophore could help design more inhibitors for similar toxins, such as the bioterrorism agent ricin, whose catalytic region has a structure similar to that of Stx.

We can certainly expect some new developments in the treatment of intestinal diseases caused by bacteria!

Reference
Title of original paper: A unique peptide-based pharmacophore identifies an inhibitory compound against the A-subunit of Shiga toxin
Journal: Scientific Reports
DOI: https://doi.org/10.1038/s41598-022-15316-1

About Assistant Professor Miho Watanabe-Takahashi from Doshisha University, Japan

Dr. Miho Watanabe-Takahashi is an Assistant Professor at the Faculty of Life and Medical Sciences in the Department of Medical Life Systems at Doshisha University. She received her Ph.D. from Hoshi University, Japan, in 2006. She works primarily in Life Sciences and Pharmacology with a focus on health and biochemistry. She has 24 peer-reviewed publications in reputed journals and holds several industrial property rights. Her major research interests include Shiga toxin, Endoplasmic Reticulum, Golgi Complex and Pleckstrin Homology Domain.

About Professor Kiyotaka Nishikawa from Doshisha University, Japan

Dr. Kiyotaka Nishikawa is a Professor at the Faculty of Life and Medical Sciences in the Department of Medical Life Systems at Doshisha University. He received his Ph.D. from The University of Tokyo, Japan in 1989. He works primarily in Life Sciences and Pharmacology with a focus on health and biochemistry. He has more than 33 years of experience as a researcher and has 56 publications in peer-reviewed international journals. He also holds several industrial property rights.

Biological

Milrem Robotics delivers the first THeMIS Unmanned Ground Vehicle to the Spanish Army

The European leading robotics and autonomous systems developer Milrem Robotics has delivered the first THeMIS Unmanned Ground Vehicle to the Spanish Ministry of Defence.

The Ministry, through the Directorate of Armament and Material, awarded the contract for one THeMIS UGV to A.Paukner, S.A., Milrem Robotics’ representative in Spain.

The THeMIS was acquired in the framework of the Scorpion program that was launched in early 2021 to evaluate the capabilities of existing unmanned ground vehicles. During the first phase of the program a list of missions will be defined that can benefit from the usage of unmanned ground systems.

“The THeMIS has already proven itself to 12 countries, seven of which are members of NATO, as a capable, robust and versatile system. We are glad that Spain has joined as the 13th user of THEMIS and chosen Milrem Robotics as a partner to build their robotic and autonomous systems capabilities,” said Kuldar Väärsi, CEO of Milrem Robotics.

"A.Paukner, S.A is proud to become the first supplier of a UGV platform to the Spanish MoD within the framework of the ambitious “Escorpion program” devoted to testing and evaluating these unmanned ground systems,” said G. Ingo Paukner, CEO of A.Paukner, S.A.

“The THeMIS UGV is a very powerful, flexible, and easy to deploy multirole platform (also quickly configurable for disaster relief and firefighting missions, if needed) to be incorporated with leading edge Spanish Industry solutions. The combination of technologies provides a solid product and new capabilities to the Spanish Army which could potentially also generate joint business opportunities with other allied Armed Forces. The support and commitment of Milrem Robotics for this project have been outstanding. We are grateful for this support as well for the MoD’s trust in our company and its unmanned systems portfolio,” G. Ingo Paukner added. 

“THeMIS provides a robust robotic platform ready to be equipped with several payloads in order to boost experimentation and other R&D activities with a reliable and well-known solution,” said a representative of the Spanish MoD’s program.

The THeMIS UGV is a multi-mission capable system intended to support dismounted troops that can serve as a mule for transporting a squad’s gear or be rapidly converted into a weaponized remotely operated unit to offer force protection.

It is the first system in its size class deployed to a conflict area during the anti-insurgency operation Barkhane in Mali. During the deployment, the THeMIS traversed 1200 km in one of the world’s harshest terrains of lava rock soil and climates climbing to 50 degrees Celsius in the shade. The UGV was operational for over 330 hours.

Milrem Robotics is the leading European robotics and autonomous systems developer and system integrator. The company is known for its THeMIS and Multiscope Unmanned Ground Vehicles and the Type-X Robotic Combat Vehicle. The THeMIS supports dismounted troops while the Multiscope is intended for civilian use such as forestry and firefighting.  The Type-X Robotic Combat Vehicle is a wingman for mechanized units.

Milrem Robotics is the leader of a consortium awarded 30.6M (EUR) from the European Commission’s European Defence Industrial Development Program (EDIDP) to develop a European standardized unmanned ground system (UGS). During the project, titled iMUGS, modular and scalable architecture for hybrid manned-unmanned systems will be developed to standardize a European wide ecosystem.

UGV

DetectaChem/MD-Bio Introduce Assay for Monkeypox Detection

DetectaChem and its subsidiary MD-Bio, the global leaders in innovative threat detection solutions used extensively by the U.S. Department of Defense, U.S. Homeland Security, law enforcement, first responders and public health agencies around the world, today announce the launch of their MD-Bio qPCR Monkeypox Detection Assay.

As the global need for monkeypox testing solutions rapidly grows, the MD-Bio qPCR Monkeypox Detection Assay will give testing centers the ability to quickly and accurately screen for active monkeypox infections using their own PCR machines.

The MD-Bio qPCR Monkeypox Detection Assay works by detecting active infections through targeting the hemagglutinin gene found in the virus.

"In the U.S. and around the world, we are seeing cases sharply rising and in response we have worked to launch a viable testing assay solution," says DetectaChem and MD-Bio COO, Travis Kisner. "This new assay will help our testing centers and communities prepare for any surges in monkeypox cases or testing needs."

The MD-Bio qPCR Monkeypox Assay is available for purchase now and is for research purposes only. For more information, please contact 

Detection, Biological

DEVCOM CBC posthumously inducts William Klein into their Hall of Fame

The CBC Hall of Fame is designed to recognize and preserve the rich history of the organization. “It is a place where we honor the achievements of our most illustrious and outstanding individuals, and Bill is most certainly worthy of being counted among that number,” said DEVCOM CBC Director Dr. Eric L. Moore.

Klein served as deputy or associate director of engineering at DEVCOM CBC for 25 years across several organization name changes and at least 12 directors both acting and permanent. He managed more than 500 members of the Center workforce and provided leadership in efforts to design, build, test and support the acquisition and sustainment of chemical biological defense systems. Klein died suddenly on Feb. 25, 2020.

“Bill was a friend to everyone. He was patriotic and a dedicated civil servant. He was known as a trusted advisor, confidante and leader. He loved the people of this organization,” Moore said. “It is a great honor to announce Bill’s induction to the CBC Hall of Fame.”

Klein was a champion of many CBC workforce programs such as Women in Leadership, Black Engineer of the Year, Balanced Scorecard, Seal of Excellence, Fit-to-Win, APG Cohort, and Workforce Engagement Teams. He made significant contributions within individual protection, collective protection and chemical detection across development, production and sustainment. He was also awarded the Special Award for Distinguished Service from the Executive Office of the White House and was inducted into the Chemical Corps Regimental Association Honorary Order of the Dragon. His leadership and contributions throughout his career helped to drive the evolution of chemical and biological defense within the DoD and the nation.

“This means everything to my family,” said Klein’s son, Justin Klein. “The Chemical Biological Center was just as important to my dad as his actual family. Everything he did was for CBC.”

Kromek releases end of year results

Kromek, a leading developer of radiation and bio-detection technology solutions for the advanced imaging and CBRN detection segments, has announced its final results for the year ended 30 April 2022.

Kromk have had a particulalry good year in terms of receiving new, and renewed, contracts for their CBRN products. 

Financial Highlights

  • Revenue increased 16% to £12.1m (2021: £10.4m)
  • Gross margin was 46.7% (2021: 48.4%)
  • Adjusted EBITDA loss reduced to £1.2m (2021: £1.7m loss)*
  • Loss before tax reduced to £6.1m (2021: £6.3m loss)
  • Cash and cash equivalents at 30 April 2022 were £5.1m (30 April 2021: £15.6m)

*A reconciliation of adjusted EBITDA can be found in the Financial Review.

Operational Highlights

Advanced Imaging

  • Strong revenue growth with delivery under component supply agreements and increased customer engagement for future projects
  • Sustained delivery in medical imaging:
  • Ramp up in delivery continued as planned under medical imaging contract expected to be worth US$58.1m over the seven-year life of the contract that was awarded in 2019
  • Completed delivery of a US$600k order from an OEM customer for detectors to be used in niche SPECT applications, with further orders expected
  • Commenced commercial development engagement with three new strategic OEM customers
  • In security screening, the Group completed a two-year US$1.6m project with the US Department of Homeland Security and entered two new commercial development engagements with OEMs
  • Signed a seven-year supply agreement, worth up to US$17m, in industrial screening with a US-based OEM and secured a US$250k repeat order from a US-based aerospace and defence company

CBRN Detection

  • Significant momentum in nuclear security, with the winning of new and repeat orders and participation in a greater number of tenders reflecting the growth in global government defence spending:
  • Awarded a two-year contract, worth up to US$1.6m, by a US federal entity for the D3S-ID wearable nuclear radiation detector – with a further US$300k order received during the year and US$695k post year end
  • Repeat orders received from the European Commission for the D3S-ID
  • Received orders from three customers for the D5 RIID
  • A four-year contract worth £1.7m was received from a UK government agency customer for CBRN detection products and services
  • Invested in developing new channels to market, including the signing, post year end, of a distribution agreement with Smiths Detection Inc. for the North and South American markets
  • 32 new customers won in the civil nuclear segment
  • Significant progress in the development of bio-security solutions:
  • Awarded a US$6m contract extension from the Defense Advanced Research Projects Agency (“DARPA”), an agency of the US Department of Defense, to advance the development of a mobile wide-area bio-security system
  • Successfully completed piloting in schools, airports and other locations of an airborne COVID-19 detection system under a project funded by Innovate UK and commenced productisation phase

Everything is Converging!

Deb Rosenblum, assistant secretary of defense for nuclear, chemical and biological program, recently hopped on the  convergence bandwagon by announcing something called 'bio-convergence.' National Defence magazine quoted her speech from the recent NDIA CBRN conference; "“Technologies like artificial intelligence, nanotechnology and physics are being applied to the life sciences, creating what the national security community is calling ‘bio-convergence.’” .

This threat is going to resuilt in an addiitonal $300m in biodefence, following on from the biological posture review that we talked about in the December issue of the magazine. Genetically targeted diseases have also been in the news as part of this bio-convergence, with concerns that they could target food security and subsections of the population. People like the FBI's Ed You (see CBRNe World 2017-4) have been worried about China harvesting data for years, and while there is something to be concerned about the findings of Project Coast, and other attempts to create weapons that only target certain genetic sequences, are still likely to hold true - that any such weapon would have massive blowback, we are not as genetically 'pure' as we think we are.  

Any increase in CBRN funding can only be a good thing, I just hope it isn't wasted in bloated bureaucracy!

 

Dr. Kemper Talley named the 2022 Joseph D. Wienand STEM Excellence Award winner.

Teledyne FLIR Defense has announced that Dr. Kemper Talley was named the 2022 Joseph D. Wienand Science, Technology, Engineering and Math (STEM) Excellence Award winner. The award was presented by the National Defense Industrial Association (NDIA) at its 2022 Chemical Biological Radiological and Nuclear (CBRN) Conference and Exhibition in Baltimore.

Teledyne FLIR Vice President and General Manager of Detection Dr. David Cullin, and Director of Science & Technology Dr. Jeremy Walker, served as conference panelists, while Director of Business Development Jay Reckard moderated two panels at the event.

Dr. Talley is currently pioneering the development of real-time, 3D CBRN threat mapping and augmented reality (AR) visualization of threats through programs in which Teledyne FLIR serves as prime contractor for the U.S Department of Defense.

In its award citation NDIA officials wrote: “Dr. Talley is at the forefront of creating digital CBRN battlefield capabilities that will improve warfighter situational awareness and safety by enabling them to more efficiently conduct CBRN recon and decon missions. [His] innovation, creativity and passion in the areas of STEM have directly impacted the improvement of CBRN defense.”

“Kemper is a highly skilled scientist whose contributions are pushing the envelope not only for threat detection technology, but also in how threat data is seen, shared and managed on today’s battlefield,” said Teledyne FLIR’s Cullin. “He and the rest of our team – in labs across the United States – are working closely with Pentagon program offices to optimize our ability to defend against weapons of mass destruction.

“Our goal is to allow warfighters to see previously unseen threats and avoid them,” Cullin added.

Dr. Talley is a principal investigator and theoretical physicist at Teledyne FLIR’s facility in Oak Ridge, Tenn. He graduated summa cum laude with a B.S. in Physics  from Clemson University before obtaining his Ph.D. in Energy Science and Engineering with a concentration in Nuclear Science at the Bredesen Center for Interdisciplinary Research and Graduate Education at the University of Tennessee, Knoxville.

ASPR Upgraded

The U.S. Department of Health and Human Services (HHS) announced on July 22nd that Secretary Xavier Becerra has elevated the existing Office of the Assistant Secretary for Preparedness and Response (ASPR) from a staff division to an operating division, taking on the new name of the Administration for Strategic Preparedness and Response (ASPR). 

The move elevates ASPR to a standalone agency within the Department alongside other HHS agencies, such as the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), the Health Resources and Services Administration (HRSA), and the Substance Abuse and Mental Health Services Administration (SAMHSA), among others. This change will allow ASPR to mobilize a coordinated national response more effectively and efficiently during future disasters and emergencies in close collaboration with its sister agencies.

While the change in name and organizational status are effective immediately, the transition will be phased in over the next one to two years, and, when complete, will provide ASPR with greater administrative capabilities to help it execute its work more effectively.  

“Our mission at HHS is to improve the health and wellbeing of all Americans, and our country must be prepared to respond to health-related emergencies,” said HHS Secretary Xavier Becerra. “The reclassification of ASPR helps strengthen our long-term preparedness posture by better positioning the division to continue coordinating health-related emergency response in collaboration with our various HHS teams.”

ASPR will continue to be led by Dawn O’Connell, who retains the title of Assistant Secretary for Preparedness and Response, and will continue to advise the Secretary on preparedness and response issues and coordinate response to health-related emergencies on the Secretary’s behalf as defined in statute, in partnership with HHS’s other staff and operating divisions.  

“Across the Department, we continue to look for opportunities to build on our core capabilities while also strengthening our ability to respond to future health threats,” said HHS Deputy Secretary Andrea Palm. “This administrative change is recognition of the growing size and scope of ASPR, which plays an important coordination role in responding to health threats and emergencies.”

ASPR, which was established in 2006, has always had operational responsibilities including the missions of the National Disaster Medical System (NDMS), the Biomedical Advanced Research and Development Authority (BARDA), and Medical Reserve Corps. In recent years, however, particularly during the multi-year COVID-19 pandemic response, ASPR’s operational functions have grown significantly to include the Strategic National Stockpile (SNS) in 2018, public health supply chain in 2020, and the establishment of the HHS Coordination Operations and Response Element (H-CORE) at the beginning of 2022. 

The reclassification of ASPR as an operating division is recognition of the growing size and scope of ASPR’s mission over the years, especially in light of the multi-year COVID-19 response. 

Fastox to present its long-lasting botulinum toxin LAST technology at the TOXINS 2022 6th International Conference.

Swiss biotech Fastox Pharma will present for the first time its groundbreaking long-lasting botulinum toxin LAST technology at the leading conference on neurotoxins from July 27thto July 30th in New Orleans, USA.

Fastox has discovered that combining botulinum toxin type A (BoNT/A) with fast-acting myorelaxant drugs could accelerate BoNT/A onset of action, but, most importantly and surprisingly, could also significantly increase its duration of action. Pre-clinical results on such combination will be presented including mechanism of action.

Increasing BoNT/A duration of action is a long-awaited innovation in the $5.5bn BoNT/A aesthetic and therapeutic markets. The LAST™ technology, validated in pre-clinical models, will fulfill this unmet need. Fastox plans to start first-in-human Phase I/II trial early next year.

Fastox VP Innovation, Mickaël Machicoane, PhD, says: “I am honored to present our discovery at the Toxins 2022 International Conference towards renowned experts from all over the globe. I will notably shed light on the mechanism of action of our LAST™ technology, that has been dissected through a fruitful collaboration with the Neuroparalysis and Neuroregeneration Laboratory of the University of Padova.”

The poster will be presented on site and available during 6 months after the conference in the Toxicon journal.

The latest developments in the basic science and clinical applications of neurotoxins are presented at the TOXINS conferences. More information can be found at TOXINS 2022 | International Neurotoxin Association (neurotoxins.org).

Biological, Medical Countermeasure

Donald Alway Named Assistant Director in Charge of the Los Angeles Field Office

Director Christopher Wray has named Donald Alway as the assistant director in charge of the Los Angeles Field Office. Mr. Alway most recently served as the assistant director of the Weapons of Mass Destruction Directorate at FBI Headquarters in Washington, D.C.

Mr. Alway joined the FBI as a special agent in 1996. He was first assigned to the Los Angeles Field Office, where he investigated drug trafficking organizations. After the 9/11 attacks, he assisted at the crime scenes in New York City and at the Pentagon.

Mr. Alway was promoted to supervisory special agent in the Counterterrorism Division at Headquarters in 2003. He served as the deputy on-scene commander in the Iraq Theatre of Operations for the Regimes Crimes Task Force in 2005, then worked as the acting legal attaché in Doha, Qatar.

In 2007, Mr. Alway transferred to the New York Field Office to supervise a joint terrorism task force squad, specialized responses, and special event planning. He was promoted in 2011 to assistant special agent in charge of the National Security Branch in the Cincinnati Field Office.

Mr. Alway returned to Headquarters in 2012 as a section chief in the Weapons of Mass Destruction Directorate, which investigates, prevents, counters, and responds to weapons of mass destruction threats and events. He left the WMDD in 2014 when he was appointed special agent in charge of the Jackson Field Office in Mississippi.

Mr. Alway was appointed the deputy assistant director of the Training Division in 2016, and as assistant director in 2018. The Training Division, based in Quantico, Virginia, provides training for FBI special agents, intelligence analysts, and other specialized law enforcement training.

In 2019, Mr. Alway was appointed assistant director of the WMDD.

Prior to joining the FBI, Mr. Alway was a deputy sheriff in Los Angeles County. He earned a bachelor’s degree from the University of Southern California and master’s degrees from California State University at Long Beach and from the Indiana University of Pennsylvania.

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