The objective of the course is to introduce the student to the world of biomaterials, providing them with the concepts to understand to which extent biomaterials can synergically interact with the development of new therapies. The course is divided into 3 main units. The first will introduce the concept of materials and biomaterials, and will provide a deep-dive into different class of materials, depending on their nature (polymeric, metallic, and ceramic biomaterials). The second unit will introduce the concept of controlled release, and the use and fabrication techniques of different material-based devices for drug delivery will be explored. Finally, during the third unit, the course will introduced the drug development regulatory process, focusing on its criticalities, and on possible solutions. In particular it will be showed how materials can be exploited to produce predictive platforms for safety and efficacy tests, with the finel aim to refine, reduce, and replace animal experimentation.