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

Abstract

One contribution of 9 to a theme issue 'Antimicrobial resistance: addressing the threat to global health'. 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pathogens, the overall industry pipeline is described as dry and most multinational pharmaceutical companies have withdrawn from the area.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.

Broad-range lytic bacteriophages that kill Staphylococcus aureus local field strains

“…Besides those factors, pharmaceutical companies are limited by the low number of suitable bacterial targets amenable for drug development and by the costs imposed for such development [2,3]. However, a major effort has to be made to produce new ways to control bacterial pathogens both at a prophylactic level and for infection treatment.…”

Strategic account management as a value co-creation selling model in the pharmaceutical industry

“…Efforts are directed in creating products and services and then pushing generic offerings to clients (Wenzel et al, 2014) via means such as detailing, sampling, direct-to-consumer advertising, and journal advertising (Hilsenrath, 2011). This has a firm-and product-centric view of value and the process of value creation (Matthing et al, 2004;Johannessen and Olsen, 2010;Prahalad and Ramaswamy, 2004;, which is increasingly becoming inflexible in accommodating changes in line with the rapidly changing environmental conditions in the pharmaceutical industry: an increasingly competitive environment and especially the changing customer needs and higher client expectations (Klein, 2008;Patterson, 2008;Payne et al, 2015 ; 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 …”

“…Over the past decade, the pharmaceutical market has evolved and a direct consequence has been to challenge the sustainability of the model companies employ to market products and services and serve client needs (Patterson, 2008;Payne et al, 2015;Wenzel et al, 2014). The current selling model used by pharmaceutical companies is primarily product-centered.…”

Thiophene antibacterials that allosterically stabilize DNA-cleavage complexes with DNA gyrase

“…Efforts to identify and optimize novel mechanism-of-action antibacterials to cope with the current limited pipeline are thus of high importance. Furthermore, many multinational pharmaceutical companies have withdrawn from antibacterial research due to, among other reasons, a perceived lack of commercial return of investment (3). Recently, several calls for renewed and concerted efforts in antibiotic discovery have been made (4,5).…”