Getting Started

Abstract

In recent decades, we in academia have focused on advancing scientific understanding through basic research and counted on the biopharmaceutical industry to translate promising discoveries into new therapeutics. Given the recent developments, however, this paradigm needs to change. Pharmaceutical companies have drastically cut their research budgets and basic research staffs to decrease costs and improve short-term profits. Additionally, the number of biotechnology venture funds has contracted, especially those that invest in new biotechnology start-up companies. As a result, we can expect that fewer novel drug programs will originate in the biopharmaceutical sector. Academic inventors can and should step in to fill this gap in the discovery pipelines. But we often lack the expertise and resources to advance our projects through this applied science stage of drug discovery and development. This chapter introduces the process of drug development and highlights some of the important first steps: understanding the clinical needs, developing a target product profile (which defines the new drug’s essential characteristics), and adopting a project management approach. These essential steps not only increase the likelihood of success, but can also help decrease both the cost and time required to accomplish our goal. Translating discoveries from bench to bedside is a challenging, but incredibly rewarding process, allowing us to advance scientific discovery and ensure that our government-funded research translates into improved health for our society.