For latest version: please go to https://academicentrepreneurship.pubpub.org/pub/8a05fz36/release/4 Drug development costs range from $2 to $3 billion and may span from 7 to 12 years. Beginning with drug discovery, key steps in the process include preclinical testing, Phase 1–3 clinical trials, FDA New Drug Application (NDA) approval, and subsequent Phase 4 clinical research. Academic entrepreneurs should understand the unique needs of each phase and their potential role in the process, as well as the services their academic medical center can provide.