VeRI BEAM

All recent reports establishing a roadmap to tackle the global, worldwide antimicrobial resistance (AMR) problem highlight the need to enlarge the current armamentarium beyond the sole “full antibiotic” model. Many efforts are being devoted to fulfil these needs both by academia and industry, as exemplified by the BEAM Alliance member portfolio (https://beam-alliance.eu/ba_pipeline). These new options include improved time-to-cure, anti-virulence, involvement of immune system, impact on flora, infection prevention, etc. both for animal and human medicine.

Completed project

However, while there is a clear path to Health Technology Assessment on antibiotic candidates (thanks to the EUCAST clinical breakpoint guidelines) no such established methodology is available for alternative antimicrobial treatments. Thus, any new treatment option faces the problem of lacking differentiation criteria to allow assessments of their products that do not have the possibility to be assessed by the classical MIC – PK/PD method. The clear definition of such criteria could benefit to the whole AMR research community. This uncertainty turns any such drug development into an undefined and risky market access condition. Consequently, private investors are reluctant to engage and to play a supporting role to pull-out promising candidates and bring them to the market. Most of the time, private companies learn or even co-build these requirements with (inter)national stakeholders, but this knowledge is rarely shared with e.g. academic labs or funding agencies, although it is of tremendous importance to anticipate pitfalls and avoid misuse of public funding.

The purpose of the VeRI BEAM Network is to implement a pilot action aiming at defining i) the above mentioned differentiation criteria and ii) the proper way to share the gained knowledge among AMR community. The pilot action will be used to validate a more general and long-term communication flow within the future JPIAMR-VRI between academic labs, and industrial and institutional actors in a non-competitive manner with a focus on innovative product development. Such a workflow will be helpful in anticipating R&D pitfalls and avoiding misuse of public funding.

For that purpose, the Network aims at:
• Mapping the information needs both in terms of content and format expressed by academic and institutional actors;
• Proposing an information workflow model;
• Developing the differentiation criteria use case to challenge the foreseen model.

The proposed communication workflow model will ensure building capacity and strengthening capability of JPIAMR-VRI members through knowledge exchange mainly on the non-scientific side, but including business skills such as regulatory frameworks, manufacturing policies, marketing, technology or policy development. This can be part of a more general Training Plan to be implemented at the whole JPIAMR-VRI level. Finally yet importantly, the work focusing on the definition of new differentiation criteria is fully aligned with the goal of producing scientific evidence for developing policy and guidelines.

 

Network partners

  • Florence Séjourné, BEAM Alliance, France (Coordinator)

This network includes 26 partners, please click on the following link to see complete network composition: Network composition VeRI BEAM

 

Publications