In this audiocast, the focus is on how Artificial Intelligence (AI) and Augmented Intelligence can impact the regulatory CMC strategies and submissions during drug development. The use of AI-based methods such as predictive analytics and machine learning can help in decision-making regarding quality control, reducing costs associated with corrective action plans, and identifying potential data requirement issues before they become serious problems. The audiocast also highlights an example of how an emerging biotech sponsor used AI-powered software to generate a CMC submission for a new drug candidate, saving time and reducing the risk of errors during the submission process. The audiocast concludes by emphasizing the importance of understanding the specific goals and objectives of the drug development process, selecting the right AI-powered tools, and having the right team in place to harness the power of AI to improve the regulatory CMC process.
This audiocast discusses the impact of Artificial Intelligence (AI) and Augmented Intelligence on regulatory strategies and submissions in drug development. AI methods, such as predictive analytics and machine learning, can aid in quality control decision-making, cost reduction through corrective action plans, and identifying data requirement issues early on. The audiocast presents an example of an emerging biotech company using AI-powered software to generate a CMC submission for a new drug candidate, resulting in time savings and reduced errors. It emphasizes the importance of understanding drug development goals, selecting appropriate AI tools, and assembling a capable team to leverage AI's potential in improving the regulatory CMC process.