Eighteen biosimilars were approved by the FDA through the 351(k) pathway as of the end of March 2019, but the regulatory pathway in the U.S. is still considered a new frontier, especially when compared to regulatory guidance in the EU.

It can be a challenge to stay on top of the ever-changing regulatory landscape when looking to re-register or take a new chemical to market.

As crop protection products play such a crucial role in maintaining global crop yields to feed an ever-growing population, it's important that you are able to drive your product R&D forward with speed and accuracy - while staying on top of the always-shifting regulatory landscape.

After receiving Fast Track designation from the U.S.

This case study delves into how a sponsor and Labcorp Drug Development worked together to support a multi-faceted project for both biomarker discovery and assay development.

Early insights and a holistic approach are critical to leverage the benefits of a biomarker strategy that includes a 3x greater probability of successful transition from Phase I to regulatory approval.

Maximizing the efficiency of patient support services offers patients the greatest possible access to life-changing medicines. Rapid innovations in technology are driving opportunities for connectivity and efficiency, but how do we ensure the best integration of technology for patient support?

Minimizing development time is challenging yet critical to maximizing asset value. The faster you develop your molecule, the better positioned you are to realize the full value of your asset with longer market exclusivity for you or your co-development partner. How to accomplish this most effectively may surprise you.

Proposing offshore contact centers in the pharmaceutical industry has historically met with resistance, despite decades of successful application by telecommunications, technology, financial, energy and other industries.

Recruiting healthy volunteers for Phase I studies is generally simple and can be accomplished easily, without great cost. That's often not the case, however, when a Phase I study requires patients. Not only is there little, if any, therapeutic benefit to the patient, but depending on the protocol, participation can be burdensome.