EDF-2021-MCBRN-R-CBRNDIM: Detection, identification and monitoring (DIM) of CBRN threats
Rapid detection of hazardous agents, detailed identification and monitoring over time and geographical area are an essential part of the CBRN response chain, and the demands vary depending on the specific task. Based on the situational awareness that DIM provides, military commanders can decide how to best proceed throughout their mission (whether the context is a military conflict or support to civilian society in a crisis situation). It is therefore crucial that the DIM system covers a broad range of CBRN-agents with an output of high reliability.
Performant CBRN DIM is not a single task using one technology or methodology. Existing technologies and their capabilities vary for DIM of biological, chemical, radioactive and nuclear substances. In a simplified manner, the order of technical and functional maturity level between the agent types can be described as B < C < RN.
The general challenges for performant DIM equipment (stand-off, point, integrated and/or personal worn, UxV, mobile devices or in critical infrastructures) are to address and improve performance parameters such as response time, sensitivity, selectivity, and false positive/false negative characteristics. Furthermore, the capability to detect, identify and characterize (un)known hazardous agents in a complex background need to be improved. Also, operational features such as robustness, size, mobility, power consumption and the possibility to widely and easily deploy/integrate the equipment into different surroundings and situations are of importance. In addition, sampling capability, for different matrices (air, water, soil, surfaces), as well as the ability to have a reliable chain of custody is required as an integrated part of the DIM process. Finally, the DIM equipment must be manageable by military personnel without scientific background.
Several of the commonly used DIM technologies are based on collection of a large number of data (e.g genetic and spectral data) that may need post processing and be interpreted or compared to library data bases in order to become useful. As potential threats continue to evolve and technology development proceeds, the data handling becomes more complex.
Specific challenges for B-DIM
A specific challenge with B-DIM is that microorganisms such as pathogenic viruses, bacteria, fungi and protozoa, or toxins, have to be detected or unambiguously identified in the presence of a high and varying natural non-pathogenic background. Stand-off and/or remote detection as well as continuous monitoring to trigger an alert for potential B threats is a challenge. Another challenge is the ability to identify rare and unexpected pathogens or organisms that have been (genetically) modified, which eludes certain specific identification methods.
Specific challenges for C-DIM
The capability of detecting low volatile C-agents on surfaces and corresponding aerosols needs to be improved. In particular, non-classical agents and new formulas for distributing agents requires new detection and identification methods and the adaption of existing ones. The stand-off detection capability of vapour phase C-agents also needs improvement. In addition, toxins poses a challenge due to their diversity in size and physical properties.
Specific challenges for R-DIM
Detection and characterisation of nuclear detonations are important for early warning and fallout predictions in order to minimize consequences and preserve freedom of military action after the use of nuclear weapons. For this purpose, systems that can determine location, yield and type of nuclear detonation (e.g. air or surface burst) needs to be developed and refined. Possible methods that can be used are (but not limited to) seismic-, peak overpressure-, infrasound-, optical-, EMP- and initial radiation detection methods. For example, limitations that R-detection and monitoring instruments may suffer from lack of accuracy, or even overload at high counting rates needs to be overcome.
Proposals must cover the generation of knowledge, methods and technologies leading to improved capacities for sampling, detection, identification, characterisation, and monitoring of CBRN threats and data management. Proposals may also cover the dynamic mapping of threats, vulnerabilities and capacities to respond at geographical levels as well as mapping of strategic CBRN detection technologies and related production capacities in the Union. Considering maturity and current capabilities, the priority order is: prio 1: B-DIM; prio 2: C- DIM and prio 3 R-DIM. Proposals must cover one or several of the scopes described below.
To improve the decision making process, the quality of the basic input, i.e. data from sensors, needs to be significantly enhanced. Future detection devices need to target a broader spectrum of agents with higher sensitivity and selectivity at relevant response times, compared to existing devices. Their improved capability should preferably be demonstrated via benchmarking against current sensors as well as against agents of interest. The ability to rapidly detect hazards without sampling, preferably at safe distances, is desirable. The main scope of this call is development of technology and components (including algorithms for improved data extraction, risk assessment and spread prediction).
Methodology for identification and characterization of agents in complex bio-samples including sampling procedures also needs to be further developed. Methods that can initially provide indicative results for rapid response, but also provide data for deeper analysis such as characterization of properties of relevance for protection and treatment, as well as identification of previously uncharacterized agents, are preferred. Such deeper analysis can be done in the field or in specialized analysis reference centres. Development of tools (or databases) necessary for the characterization of non-standard or modified organisms and discrimination between natural/antagonistic origin of an outbreak is also required. As part of the DIM concept, sampling capability in different matrices should also be addressed.
Incorporations of novel and/or disruptive technologies is also encouraged, for instance, development of detectors on unconventional platforms and usage of AI for agent classifications. It is essential that the research activities generates new and improved DIM capability according to requirements generated from the operational need of the MS military forces. There is a specific need to reduce logistics in military operations, so next generation CBRN DIM systems should strive towards being mobile, fieldable, modular, scalable and adaptable to the nature of the mission. Also the system should be user-friendly and be as autonomous as possible. Handling must not be entirely dependent on personnel with a scientific background.
The interpretation of comprehensive DIM data into assessments of risk areas, mapping of strategic CBRN capacities and other decision making processes requires development of advanced methods to interpret and present the information (i.e. virtual reality/augmented reality, real-time data fusion methodologies, uncertainty analyses and dispersion model protocols). In addition, methods for background signal discrimination and prediction of potential dissemination source have to be improved.
In order to achieve utilization and adaptation of the latest scientific developments, realization of the technology into products and to ensure applied usage of the systems, several partners are required. It must be outlined in the project proposal how the active involvement from industry, defence research organisations and academia as well as end users will be achieved.
The proposals must cover the following activities as referred in article 10.3 of the EDF Regulation, not excluding possible downstream activities eligible for research actions if deemed useful to reach the objectives:
Activities aiming to create, underpin and improve knowledge, products and technologies, including disruptive technologies, which can achieve significant effects in the area of defence;
Activities aiming to increase interoperability and resilience, including secured production and exchange of data, to master critical defence technologies, to strengthen the security of supply or to enable the effective exploitation of results for defence products and technologies.
The proposals must substantiate synergies and complementarity with foreseen, ongoing or completed activities in the field of CBRN DIM, notably through EU funded actions under Horizon 2020 and Horizon Europe or in the framework of the European Defence Agency.
EDF-2021-MCBRN-D-MCM: Development of defence medical countermeasures
Defence medical countermeasures (MCMs) must be kept up-to-date, available and able to respond to the continuously changing and novel health threats posed by CBRN. MCMs may include any medicines or medical devices aimed to combat CBRN threats. This extends to countermeasures that prevent or treat the threat, but also to countermeasures that combat novel modes of delivery of such threats. Proposals should focus on innovation and development of MCMs or an additional integration into military intelligence and information systems and corresponding civil capacities. Proposals are encouraged to provide for an analysis into novel MCMs and related technology, analysis of gaps and recommendations to ensure baseline preparedness standards and indicators, mapping of CBRN MCM capacities across EU, as well as options for ensuring EU’s access and availability of MCMs.
In recent years, chemical, biological and radiological threats have been continuously rising. For example, one cannot ignore the fact that groups/nations in the future might use disease- promoting microbes and viruses to damage a country’s society or weaken its defence. The objective of proposals under this call is to update and/or develop medical countermeasures (MCMs) for the armed forces of EU and – wherever applicable – related civil/health protection to respond to the continuously changing and novel health threats posed by CBRN. It thus aims at developing shared capabilities for EU armed forces against CBRN crises generated by a natural or provoked event, and to treat pathologies or injuries of significant impact. It will thus contribute to responding more efficiently to conflicts, crises, or isolated events involving CBRN situations. Such MCMs should continue to be bolstered by both academia and industry within the EU due to:
The large funding to be engaged for r&d and poor market prospects;
The low occurrence of such threats even though proliferation is increasing worldwide (thus increasing operational risks for armed forces);
The large funding to be engaged for preclinical and clinical trials;
The large scope of threats to be considered and final demand of the medical countermeasure.
Proposals should focus on innovation and development of MCMs against CBRN threats as well as their integration into armed forces. Proposals may also provide for analysis of the relevance and feasibility of novel MCMs and related technology, mapping of CBRN MCM capacities across EU, as well as options for ensuring EU’s access and availability of MCMs.
MCMs may include any medicines or medical devices that are aimed at combating CBRN threats. This extends both to countermeasures that prevent or treat the threat.
For MCMs to be updated, available and able to respond, this entails a large scope covering innovation, development and analysis.
The proposals must cover the following activities as referred in article 10.3 of the EDF Regulation, not excluding possible upstream and downstream activities eligible for development actions if deemed useful to reach the objectives:
Studies, such as feasibility studies to explore the feasibility of new or improved technologies, products, processes, services and solutions.
The design of a defence product, tangible or intangible component or technology as well as the definition of the technical specifications on which such design has been developed which may include partial tests for risk reduction in an industrial or representative environment.
Generating and integrating knowledge, testing, qualification, and certification of MCMs, as defined below, are desirable. Given that they concern CBRN MCMs, these activities are specific and should be understood, e.g. for immunotherapies, as:
Generating knowledge: choice of pharmacological target, antigen, or physiological process; target or antibody validation; elucidation of mechanism of action.
Integrating knowledge: development of industrial production under GMP conditions; demonstration of the stability of MCMs (GMP) in bulk and distributed form (ICH Stability testing of new drug substances and drug products).
Studies: In vitro assays, in aerosol particles, in vivo proof of concept studies, and mapping of defence industrial CBRN MCM capacities.
Design: Preclinical trials (DRS, safety, efficacy) on relevant animal models, quality control tests, validation of industrial production process under GMP conditions. Pivotal efficacy studies on animal models as close as possible to humans (authorization under exceptional circumstances).
Testing: phase I clinical trial with most advanced MCM candidates.
Qualification: finalization of a dossier for marketing authorization.
Certification: New drug application (NDA) delivered by the regulatory authority (EMA) or early access program.
Innovative disruptive technologies, like MCMs that limit the development of resistance (e.g. broad-spectrum MCMs), and platforms for local production of MCMs on-demand, are warranted.