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

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infected with untreatable pathogens, overall industry pipeline dry and most multinational pharmaceutical companies have withdrawn from area.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