In July 2025, the U.S. FDA published a white paper on how strategic investments in quality management initiatives in the pharmaceutical sector have the potential to yield returns for companies and for public health (here). 

The primary focus of this white paper is on pharmaceutical companies and manufacturing. However, this perspective is also highly relevant to early-stage biotech, their investors, and research that is conducted before clinical proof-of-concept (POC). This is our area of interest where we have previously illustrated how investing in quality management can improve return on investment in early-stage biotech.

Why is this now relevant?

For a number of years, the most common (by far!) exit strategy for pre-POC biotech investment was IPO, i.e., clinical data would validate predictions about safety and efficacy made using preclinical methods (here). This game is over at least for now and a successful exit these days requires convincing clinical safety and efficacy data that in turn requires high-quality preclinical data.