Prevention

Infection Prevention and Control strategies are important levers to prevent and reduce the spread of AMR. But infection prevention goes beyond.

Preventative therapies (PvTx) represent a complementary set of approaches.

PvTx are of particular importance for the population with a higher risk of infection, and even more in case of resistant infections.

Unfortunately, establishing the clinical evidence of PvTx efficacy can be difficult. First, a number of issues forces, by design, the setup of very large trials (low predictability of infection, high patient attrition rate, need for large control group, etc.).

Then, the clinical development framework lacks clarity (clear definition of the infection is missing, clinical guidelines are limited, etc.).

All these factors make clinical study more costly than therapeutic trials. In the case of AMR, where financial resources are scarce, the task is almost impossible. Regulatory adjustments could however ease the path.

Our Approach

The BEAM Taskforce on Preventative Therapies (BTF-Pv) aims to raise awareness on:

• • The variety of innovation being developed in the field of AMR prevention.
  • The peculiarities of developing PvTx solution, especially in AMR.
  • The need to adjust regulatory frameworks to ease the demonstration of safety and efficacy of the developed products.

The team is eager to engage with policymakers to discuss possible solutions able to boost the innovation in the field.

BTF-Pv is freely accessible to all BEAM members.