Analytical Testing Strategies For Clinical And Commercial Operations

By Bikash Chatterjee, CEO, Pharmatech Associates

According to Medpace, overall outsourced drug development spending is expected to grow to $31 billion in 2019. As the complexity and characterization of new drug therapies increase, so does the challenge for organizations to accommodate technical, capital, and resource requirements.

Central to every drug development program is the need to establish a capable analytical testing strategy. The complexity of the drug development marketplace has continued to escalate, moving from small molecules to large molecules and those that include complex molecules — such as cellular and gene therapy products — resulting in enormous technical challenges associated with managing such a broad diversity of analytical testing requirements. Couple this with the expansion of partnering and in-licensing as a core component of pipeline development, and the necessity for a cohesive analytical testing strategy has never been greater.