Panel
Reducing the Cost of Antimicrobial Resistance
Milken InstituteAllan Coukell, Ella Balasa, Nick Crabb, Mark Feinberg, Jeremy Knox, Jenelle Krishnamoorthy, Alan Kockel, John Rigg, Robert Horn
- Antimicrobial resistance is identified as a top 2019 public health priority with a trend of increasing infection rates and a shrinking number of companies developing traditional antibiotics, which experts state will not decrease without new treatment approaches.
- Pharmaceutical and biotech sectors face a "valley of death" where early-stage companies funded by initiatives like the GAIN Act and CARB-X cannot secure financing for Phase 2 and 3 trials, necessitating models that de-link revenue from volume to ensure later-stage R&D is an investable proposition.
- Merck remains dedicated to the antibiotic field but warns that many companies lack the resilience to stay in business, evidenced by recent closures, while the CF Foundation has committed $100 million over the next five years to explore novel therapies like inhaled nitric oxide used in synergy with traditional antibiotics.
- The UK's five-year national action plan and a specific project aim to demonstrate a commercial model where payments to companies are based on the value of antimicrobials to the NHS rather than volume, potentially involving multi-year payment periods and review points, with a plan to report on detailed timelines in late November.
- Success criteria for the UK project include the evaluation of two products leading to commercial negotiations and the implementation of de-linked multi-year payment models, alongside a strategic goal to collaborate internationally to encourage similar models in other territories.
- Philanthropic and government funding for research is at risk of failing to reach patients without pull incentives, yet political engagement for such solutions remains limited primarily to the US and UK, creating a sustainability gap for later-stage development.
- Experts caution that non-traditional therapeutics must be used for longer periods to prevent resistance, and there is a growing appetite to modify regulatory environments and clinical trial networks to lower costs, though small companies likely require big pharma or alternative vehicles to reach global commercialization.
- Risks include the potential for resistance emergence due to antibiotic misuse and counterfeit product sales in other countries, alongside the risk that the US and UK's funding efforts will fail to translate into a broader global commitment without engagement from other G20 nations.
- Current policies like the GAIN Act exclude host-targeting therapies, raising questions about broadening the definition of antimicrobial resistance combatants, while public outrage remains insufficient to drive political risk-taking, with experts urging a communication shift toward immediate consequences rather than 2050 predictions.
- The ecosystem requires a concerted, focused effort to hold stakeholders accountable through integrated product development models, as removing private profit and risk via a public champion or nationalized model is viewed as detrimental to the innovative potential of small and medium enterprises.