Solutions For Challenges Medical Entrepreneurs Face When Creating Biotechnology Startups

Many obstacles impede the success of biotechnology startups. The Food and Drug Administration's (FDA) clinical trials is one of the primary challenges. The FDA currently imposes rigorous standards before a biotechnology company’s product is approved for dissemination to the public. A result of FDA standards is a costly 7.5-year average product development pipeline that hinders companies, already limited in cash and resources, from quickly generating steady streams of income to sustain their businesses. After a literature review, several important areas of focus were highlighted by individuals who successfully started biotechnology companies or have expertise in the area. They advocated best-practice policies in areas for securing funding, navigating the FDA’s clinical trials, utilizing local resources, and testing products. In addition, a case study was conducted on a Texas-based biotechnology company called Mirna Therapeutics Inc., to highlight some of the best-practices endorsed from literature, as well as to show their limitations. This research could potentially foster a new way of looking at biotechnology startups and provide insightful techniques which entrepreneurs could utilize for their current or future businesses in the field.