Summary of the Network
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 members’ portfolio. These new options include improved time-to-cure, anti-virulence, involvement of immune system, impact on flora, prevention, etc. both for animal and human medicine. But whereas 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 cannot 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 conditions. As a consequence, private investors are reluctant to engage and to play their 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 thus to implement a pilot action working on:
- How the above-mentioned differentiation criteria could be defined and
- The proper way to share the gained knowledge among AMR community.
Such pilot action will be used to validate a more general and long-term communication flow within the future VRI between academic labs, industrial and institutional actors in a non-competitive manner with a focus on innovative product development.
The proposed communication workflow model will ensure building capacity and strengthening capability of VRI members through knowledge exchange mainly on the non-scientific side, but including business skills such as regulatory frameworks, manufacturing policies, marketing, and technology or policy development. This can be part of a more general Training Plan to be implemented at the whole VRI level.
Expected outputs of the Network
- Mapping information – Catalogue of surveys
- Report on the expected new differentiation criteria for alternatives to antibiotics
- Communication workflow model
- Final grant report
JPIAMR priority topics: Therapeutics, Diagnostics