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.
The approaches used in drug development with regard to the Investigational New Drug (IND) process are as diverse as the classes of drugs developed by the pharmaceutical/ biotech industry each year. As a result, there isn’t a ‘one size fits all’ nonclinical package, and the studies required in support of an IND or Biologics License Application (BLA) must be tailored to the specific drug, indication, and proposed clinical trials they are meant to support. In this reference material, various scenarios in designing a nonclinical plan to support the initial clinical trials for a drug will be discussed. The nonclinical support needed past Phase I clinical trials, and the support needed for medical devices or animal health products will not be covered.