Time for a change: addressing R&D and commercialization challenges for antibacterials

Abstract

The antibacterial therapeutic area has been described as the perfect storm. Resistance is increasing to the point that our hospitals encounter patients infected with untreatable pathogens, the overall industry pipeline is described as dry and most multinational pharmaceutical companies have withdrawn from the area. Major contributing factors to the declining antibacterial industry pipeline include scientific challenges, clinical/regulatory hurdles and low return on investment. This paper examines these challenges and proposes approaches to address them. There is a need for a broader scientific agenda to explore new approaches to discover and develop antibacterial agents. Additionally, ideas of how industry and academia could be better integrated will be presented. While promising progress in the regulatory environment has been made, more streamlined regulatory paths are still required and the solutions will lie in global harmonization and clearly defined guidance. Creating the right incentives for antibacterial research and development is critical and a new commercial model for antibacterial agents will be proposed. One key solution to help resolve both the problem of antimicrobial resistance (AMR) and lack of new drug development are rapid, cost-effective, accurate point of care diagnostics that will transform antibacterial prescribing and enable more cost-effective and efficient antibacterial clinical trials. The challenges of AMR are too great for any one group to resolve and success will require leadership and partnerships among academia, industry and governments globally.

Keywords: antibacterials; challenges; commercialization.

Figure 1.

Overview of the ND4BB project funded by the IMI.

Figure 2.

(a) The traditional pharmaceutical commercial model. (b) Application of traditional commercial model to antibacterials (AB) demonstrating the poor/negative return on investment (ROI). (c) Illustration of how the traditional commercial model does not incentivize R&D on antibacterials that could address future potential unmet needs. (d) Principles of a de-linked model, where the ROI is provided by either a lump sum or a series of payments provided over several years.

Figure 3.

Potential impact of rapid diagnostic on clinical trial costs [27].