Article | July 2, 2018

Getting to First-in-Human Clinical Trials: A Make-Or-Break Milestone For Small Biopharmas

Source: Patheon, part of Thermo Fisher Scientific

By David Kenyon, Sr. Director Scientific and Technical Affairs at Patheon, part of Thermo Fisher Scientific

Getting to First-in-Human Clinical Trials: A Make-Or-Break Milestone For Small Biopharmas

“Faster and better” has become the mantra for biopharmaceutical companies as they face intense pressure to get therapies to market quicker than ever before.

The incentive of securing market share with first-to-market offerings is felt by all industry players. Pressure mounts from here for small companies, which often must meet certain milestones before receiving funding from investors. Quickly proving efficacy in first-in-human (FIH) trials is a make-orbreak milestone for cash-strapped companies whose hopes for success hinge upon just one or two molecules.

Speed and revenue are also intertwined at Large Pharma. As Large Pharma struggles with R&D productivity, companies need to fill pipelines with promising options. Many large biopharma companies have numerous molecules with therapeutic potential but screening them at the same time and determining the best ones to
pursue in FIH trials is a huge challenge.

Speed to market takes on even greater urgency when you consider that many biopharmaceuticals are intended for treating chronic, serious and/or life-threatening conditions. Many patients cannot wait years for therapies to enter the clinic and come to market.

Thus, whether biopharmaceutical companies have one candidate or 100, the directive is clear: moving quickly into FIH testing is essential. But, how?

Patheon, part of Thermo Fisher Scientific