Pharm/Biotech/Med InnovReg

2 Credits · Level: Graduate

Rapid technological advancement and convergence of fields such as molecular biology, immunology, computer science and AI are leading to revolutionary progress in medical care. For example, the new Hepatitis B drugs and new immunotherapies for some cancers are revolutionary treatment compared to a decade ago. As emerging technologies and corresponding innovation lead to new products, services, businesses, and service models, governments must consider policy and regulatory ramifications. As needed, we need to create, modify, and enforce regulations. Significant challenges exist for regulators who struggle to maintain a balance between promoting innovations, protecting consumers, and addressing the potential unwanted consequences of technological advancements. The course reviews regulatory and public policy approaches for pharmaceutical, biotech and medical devices and regulatory challenges for new and emerging technologies. Technologies and innovations reviewed and considered include CRISPR, mRNA innovation and cancer immunotherapies, AI, robotics and miniaturization, and software and medical devices including associated cybersecurity.