This MassBioEd online course builds on the business overview of “The Business of Biotech 101” course. For those considering careers in the biopharma space or transitioning from the science and technical aspects of the industry, this course delivers an outline of Clinical, Regulatory, and Quality considerations and practices. Students will be provided foundational information about the BioPharma industry and regulations via instruction, storytelling, and breakout group discussions. Industry ethics will be discussed, with emphasis on historical precedents. We will explore the decision-making process by touching on relevant topics such as market share and phases of development.
Guest speakers will be invited to represent specific considerations and to showcase their roles and experiences. We will review Research and Development processes and considerations from pre-clinical through market approval.