Cathie Wood recently shared insights on the X platform, highlighting that, according to ChainCatcher, ARKInvest's research identifies healthcare as the most transformative application area for AI. The relaxation of regulations is accelerating this transformation in the healthcare sector. Significant advancements have been made in the science of evaluating drug efficacy, with research and development projects gathering evidence through various dimensions such as mechanisms of action, biomarker effects, and intermediate endpoints. This validation evidence, ranging from mechanistic data to real-world evidence, can replace the need for a second pivotal trial.
Historically, there has been considerable regulatory flexibility in the fields of rare diseases and oncology. The anticipated shift from requiring two trials to just one is expected to have the greatest impact on common diseases such as cardiovascular and respiratory conditions. Each project could potentially save up to $350 million in costs and reduce the development cycle by several years.