Time for a change: addressing R&D and commercialization challenges for antibacterials.
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pathogens, the overall industry pipeline is described as dry and most multinational pharmaceutical companies have withdrawn from the area.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.
Infectious Diseases Therapeutic Area Unit, GlaxoSmithKline, 1250 South Collegeville Road, Collegeville, PA 19426, USA david.j.payne@gsk.com.
David J
DJ
Payne
Infectious Diseases Therapeutic Area Unit, GlaxoSmithKline, 1250 South Collegeville Road, Collegeville, PA 19426, USA.
Linda Federici
LF
Miller
Immuno-inflammation and Infectious Diseases Franchise, GlaxoSmithKline, 980 Great West Road, Brentford, Middlesex TW8 9GS, UK.
David
D
Findlay
Government Affairs, Public Policy and Patient Advocacy, Communications and Government Affairs, GlaxoSmithKline, 980 Great West Road, Brentford, Middlesex TW8 9GS, UK.
James
J
Anderson
Projects, Clinical Platforms and Sciences, GlaxoSmithKline, 709 Swedeland Road, King of Prussia, PA 19406, USA.
Lynn
L
Marks
D000900:Anti-Bacterial Agents / Q000191:economics* / Q000600:supply & distribution*; D001424:Bacterial Infections / Q000175:diagnosis* / Q000188:drug therapy*; D019937:Diagnostic Techniques and Procedures / Q000639:trends*; D055808:Drug Discovery / Q000191:economics* / Q000379:methods; D004352:Drug Resistance, Microbial / Q000502:physiology*; D006801:Humans; D057970:Inappropriate Prescribing / Q000639:trends; D019095:Point-of-Care Systems / Q000639:trends; D012106:Research / Q000191:economics*
D000900:Anti-Bacterial Agents
antibacterials; challenges; commercialization