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Detalle de la convocatoria

EDF-2021-MCBRN-D-MCM: Desarrollo de medidas correctivas médicas en defensa


Proposals should focus on innovation and development of defense medical countermeasures (MCMs) against chemical, biological, radiological and nuclear (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.



Targeted activities

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.



Functional requirements

It is essential that the development activities in this topic generate new or improved medical countermeasure capabilities that are in alignment with requirements from the Member States (MS)’ armed forces themselves, or in combination with the operational needs of related civil protection or health authorities. According to the recommendations of national or European regulatory agencies, efficacy of the MCMs should be demonstrated on animal models as close as possible to humans -such as swine or non-human primates - during preclinical studies. MCMs may be developed from early technology readiness levels and, for most advanced products, up to GMP production, clinical trials, and certification for use in humans. Safety must be demonstrated in human volunteers during phase I clinical trials. The final product should be able to be administered in field conditions by trained medical personnel.

MCMs address the three letters C, B, and R, in the CBRN term:

- Chemical threat (C) MCMs against severe poisoning by any chemical agent as indicated in the Chemical Weapons Convention, especially nerve agents.

- Biological threat (B) MCMs against B agent for which classical treatments (e.g. antibiotics) are not available or not sufficiently efficient.

- Radiological threat (R) MCMs against ionizing radiation effects like Acute Radiation Syndromes.

Financiación: hasta 70 M€ para todos los proyectos.

Fecha Límite 09/12/2021

 

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