In this podcast, we discuss artificial intelligence (AI) and machine learning, exploring their pivotal roles in drug development. AI, a fusion of computer science, statistics, and engineering, employs algorithms to perform tasks like learning, decision-making, and prediction. Within the context of drug development, we unravel three significant applications of AI. First, it aids in scanning medical literature for pertinent findings; second, it predicts individual responses to treatments and assesses side effect risks; and third, it enables the creation of digital twins for intervention modeling.
Join us as we navigate the potential of conversational agents and chatbots equipped with AI, serving as invaluable tools in clinical trial inquiries and adverse event reporting. Yet, the integration of AI comes with its own set of risks. As regulatory bodies like the FDA shift toward a risk-based analysis approach, it is crucial for stakeholders—whether practitioners, sites, sponsors, or research organizations—to remain vigilant and comprehend the evolving regulatory landscape. In this episode, we shed light on the impact and risks associated with AI in drug development, offering insights into navigating this transformative era.