Part 1 – Timing Is Everything: Choosing The Right Bioassay At The Right Time For Successful Drug Development

By Dr. Erika Kovacs, Senior Director of Bioassay

Bioassays and functional evaluations are essential components throughout the entire drug development journey. These assessments provide vital information about a drug candidate’s effectiveness, safety profile, and biological mechanism. From simple biochemical tests to sophisticated systems like spheroids and co-cultures, these methods help quantify biological activity and support key decision-making from the earliest discovery stages through lead optimization, preclinical (pre-IND) analysis, clinical studies, and even commercial manufacturing.

Yet, their true impact stems not just from scientific accuracy but from how strategically they are implemented. Using the appropriate assay at each stage of development helps streamline progress, avoid unnecessary setbacks, and make the most of available resources. Most importantly, it ensures that a therapy’s safety and efficacy are thoroughly evaluated in ways that align with regulatory standards — paving the way for successful clinical and commercial outcomes.

In the opening post of this four-part blog series, Dr. Erika Kovacs, Senior Director of Bioassay, discusses the importance of tailoring bioassays and functional assessments to each phase of development. She highlights how these fit-for-purpose tools generate robust, regulatory-ready data that instill confidence and clarity from early-stage discovery to full-scale production.