The Impact Of DMPK Clinical Failures

By John James Vrbanac, MPI Research

According to the Pharmaceutical Research and Manufacturers of America (PhRMA), out of 10,000 compounds that begin the drug discovery process, a mere 250 make it to the preclinical stage, only five will enter the clinic, and just one will land on the shelves of pharmacists. It is a process that takes up to 15 years or more and costs more than $1B.

These exorbitant attrition rates, often associated with pharmacokinetic issues (PK), are blowing holes in drug development pipelines. That’s tragic for patients and for drug developers. Given that attrition rates as high as 40% have been attributed to PK issues, drug developers need to carefully evaluate the quality of the Drug Metabolism and Pharmacokinetic (DMPK) studies conducted on their behalf. Not doing so can cause a company to potentially spend millions of dollars unnecessarily, if an unqualified candidate is moved along the drug development pathway or if a qualified candidate is “killed” too early in the process.