The journey to clinic and beyond

Pharma companies hoping to achieve regulatory approval for their candidate drug must be able to show efficacy and demonstrate safety for use in a Phase III trial. However, the journey to late stage trials begins with the complex path from formulation development to first in human (FIH) trials.

Thinking too much in the short term can result in wasted funds and a promising drug candidate not reaching its full potential.

Decisions made even the earliest stage in the process can have a huge impact on whether a drug is successful in not only reaching clinical trials but ultimately the commercial market, as such careful consideration is vital.

Torkel Gren, senior director, science & technology officer at Recipharm AB, has authored an article in Journal for Clinical Studies discussing the challenges of bringing a drug candidate from formulation development to the clinical trial centre, and eventually to commercialisation.

For the full article see pg 26-27: