A new concept these days in experimental drug development is ‘Phase 0.’  Simply put it means a small trial in a limited number of subjects or patients who are highly controlled to get an assessment of the pharmacological activity for compounds.  The hope is to created innovative ways to establish proof-of –concept for new mechanisms by exploring clinical models that could yield better, faster, and more cost-effective ways to prioritize drug development.  Biotech companies and experts have a number of nick names for such type of early small-sample sized experiments, pre-Phase I.  The aim of this exploratory INDs is to push more promising drugs into clinical trials and increase the odds of success.  However, IT and bioinformatics-as always- will play a vital role in achieving this and help with data organization, comparison and analysis.   The information obtained from Phase 0 trials could provide vital information on pharmacokinetics, risk-benefit ratio, and the need for compound modification before moving on to more expensive and larger experimental models.  Thus, Phase 0 is not just another clinical trial or here to replace animal studies but an opportunity to develop a biomarker that can  get promising drugs into clinical trials faster, reject doomed drugs sooner, and invigorate the pharmaceutical pipelines once more.