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.
- 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
When you get an infection, your doctor may give you an antibiotic. But on which ground is that specific pill being chosen to address your specific condition? It is sometimes quite difficult to choose between the different available antimicrobial drugs because they are basically compared on the basis of a single criterion: the required dose to kill or inhibit the pathogen measured in a specific (and sometimes irrelevant) experimental laboratory assay while the drug is being developed. In order to curb the AMR threat, innovators are now looking at the problem differently and are designing new approaches. Besides just killing the pathogen, drugs can exert other features that might be equally important such as the speed at which it kills the pathogen, the ability to circumvent existing resistance mechanism or pathogen-derived injuries to your organism, etc. But none of these features are being rigorously evaluated during the drug development and approval processes, because the regulatory pathways intended to validate the performance of all these new approaches are not ready.
The goal of our network was to highlight the need to develop new criteria to evaluate more comprehensively the different features exerted by an antimicrobial drug to enable an informed prescription, with the drug that is the most suited for your particular condition. Improving the differentiation of the AMR products would increase both their clinical value (to match the patient’s needs with the drug actions) and their market value (more benefits for the patient and the health system deserve a better price).
As a first step we defined a categorization framework allowing the identification of one or multiple medicinal activity for each drug. Then, we started discussing with the regulatory agencies to agree on the way to establish new criteria. We then focus on a particular category, regrouping microbes able to modulate their metabolism to become tolerant to the antimicrobials. Finally, we identified relevant assays to support the definition of appropriate evaluation criteria and designed a decision tree to help clinicians handle such medical cases.
The regulatory path to get new criteria accepted is a long way to go; but the work has been initiated and must be pursued to improve the way drugs are being developed and the valuable antimicrobials are prescribed.