PDUFA VII and Beyond: Building Confidence in AI Tools as New “Gold Standards” for Drug Development

Companies are using AI/ML models to make pre-clinical drug development a more streamlined process for securing an FDA IND in a fraction of the time. Better pre-clinical models can also generate key insights that can guide patient selection and clinical trial design to maximize the likelihood of generating convincing safety and efficacy data. This panel will feature a thoughtful look at the future of AI-driven drug development and what advances need to take place, from regulators, industry, and the AI research community, to transform a 4-5 year pre-IND process to 2 years by using a fully digital (in silico) process.