How Do I Get My Compound Into Phase I?

By Dr. Scott E. Boley and Greg Ruppert

The primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy and toxicity prior to entering into human clinical trials. Nonclinical testing is required to establish both the efficacy of a new therapeutic as well as establishing a safe starting dose for the initial human clinical trials.

MPI Research has conducted thousands of efficacy and safety studies for small molecules and biopharmaceuticals. As a company, we work to maximize quality and efficiencies on behalf of our Sponsors’ regulatory applications. In partnering with our pharmaceutical and biotechnology Sponsors in designing the studies required for the development of their particular therapeutic, there isn’t much that we haven’t seen. Our goal is to improve the odds for Sponsors to select the right lead candidates, and to conduct the right studies in the right way, taking into consideration all factors to ensure their IND submission is successful.