The big data revolution, accompanied by development and deployment of wearable medical devices and mobile health applications, has enabled the biomedical community to access more data with which to apply artificial intelligence and machine learning algorithms. This has created new research opportunities in predictive analytics, precision medicine, virtual diagnosis, patient monitoring, and drug discovery and delivery. This meeting considered the opportunities and challenges related to the application of AI and ML to translational research in biomedicine, and explored how the pharmaceutical and biotechnology industries can learn from adoption and regulation of emerging AI tools and technologies in other sectors.