Manufacturing Novel Therapies & Imaging Agents

Catalog description

Novel therapeutic and diagnostic agents (eg. CAR T cells, gene therapy for sickle cell disease, radionuclides etc.) have revolutionized modern clinical medicine. Historically, these agents were first developed in academia then transferred to industry for clinical scale manufacturing. Recently, however, some academic centers have developed clinical scale biomanufacturing facilities. Operation of these new facilities requires a unique blend of manufacturing, clinical, basic, regulatory and laboratory sciences. Examples of areas in which academic medical centers have developed in-house manufacturing include cell therapy, gene therapy and novel imaging agents. This course will cover manufacturing approaches, challenges, and controversies in each of these domains. At the completion of this course students will understand: -The general approach to development, manufacturing, quality control and regulatory compliance in academic manufacturing facilities -Critical steps in the manufacturing cycles of cell therapies, gene therapies and imaging agents -Current challenges in development, manufacturing, and maintaining regulatory compliance in academic manufacturing -Key considerations and relative merits of different positions in the current controversies surround these agents Each week includes a combination of synchronous and asynchronous work. Synchronous sessions will include instructor led discussions based on pre-recorded lectures or case-based discussions. Asynchronous material includes pre-recorded lectures and discussion board prompts to which students will respond throughout the week. One unique aspect to this course are the debates. For each debate week, two students will be assigned as debaters and will represent opposing points of view. All students will be provided with required pre-reading and pre-recorded lectures relevant to the debate topic. Ahead of the…