ABSTRACT
This chapter reviews the courageous start-up’s entire company life cycle, starting from its own incorporation, discussing some of the challenges it has faced along the way, reviewing the major risks it has faced, and also the founders’ debate about taking the company forward. A series of meetings and potential responses by company executives or external experts hopefully leads to the full resolution of all outstanding issues, upon which Food and Drug Administration confers the New Drug Application license for commercial availability to the biotech organization. Immediately after, the company may launch its product within the US market, either on its own or through biopharma or big pharma collaborators. A biopharma having its primary product candidate through clinical trials may face previously unforeseen challenges forcing to it either scale back its research and development program, temporarily withdraw its product from the clinical trial program, or even decide to abandon its program all together.
