Chapter 5 commences by discussing how intellectual property rights and patents affect the rate and direction of progress. The idea behind intellectual property rights in general is to incentivize innovation by allowing the holders of the patents to capture a larger share of the returns on these research investments. On the face of it, this seems like a fair bargain. The person who discovers something should be compensated with the ability to get a higher return on investment on it than the rest of the population. But can patents actually stifle modern day medical innovation? These concerns, and the extent to which they hold true, are the main focus of Chapter 6. Later in the chapter, the role of regulation more generally in influencing the trajectory is discussed. The chapter explores how regulation can act both as a deterrent and as a stimulator of medical progress, using the regulation of MDMA in the United States and Orphan Drug Designations as case examples to explore this dynamic.

From the long path through preclinical development, entering the regulatory field of interactions for human clinical trials can sometimes feel like you are walking into the lion’s den. This chapter guides you through an understanding of how to interact and how to prepare for FDA meetings so that they are on your side rather than fighting you. The common goals of companies and the FDA are highlighted here. Specific issues with identifying the appropriate regulatory approval pathway are discussed here with cautionary case studies. Complex new technologies which combine diagnostics and drugs, or devices and software, or AI-based dynamic software are reviewed here. The best approach to the appropriate regulatory pathway will be clear after reading this chapter. Case studies are used to show successful pathways taken by cutting-edge developments, such as cell-based therapy.