The future, beyond the horizon
Abstract number: 1133_107
Development of novel antibacterial molecules, particularly from new drug classes, presents several challenges. The demonstration of utility against bacteria resistant to other antibacterial classes is essential for registration, reimbursement and marketing, but presents issues related to clinical trial size, costs and end-points. Furthermore, product labelling and use may be restricted in the future, at least at initial introduction, by regulators and policy makers. For some indications, such as self-limiting infections or indications where the value of antibacterials is debatable, paradigms for clinical trials are changing towards patient-reported outcome measures and demonstration of superiority over comparators. Additionally, antibacterial molecules of new classes present unknown safety liabilities, requiring extensive evaluation and tracking throughout the product's lifespan. The commercial potential of new products may be impacted by reduced use owing to continuing efforts to control resistance and costs through guidelines and reimbursement controls, as well as narrowed indications. Furthermore, a product's lifespan may be reduced by the development of antibacterial resistance if use is expanded greatly or inappropriately. Positive solutions must be found to encourage the development of new antibacterials. Strategies could include lowering R&D costs by introducing measures such as guaranteed fast-track regulatory review or by focusing on the quality rather than the quantity of clinical trials. Regulatory agencies could further assist by providing direction on regulatory expectations and identifying areas of debate to be addressed during the development process. Additionally, research costs could be offset by partnerships between academia and industry, or by provision of public or private funding, tax breaks, and revision of patent terms. Given the delay between initial research and final approval, we must act now to improve future antibacterial development and introduction of new molecules. To achieve success, coordinated action by pharmaceutical companies, regulatory agencies, health organizations, government bodies and the scientific community will be required.
|Session name:||XXIst ISTH Congress|
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