Mitigating Risk In IND And Drug Product Development

By Johannes Clemens, Chief Commercial Officer

Moving a drug from early research into clinical development requires more than demonstrating safety and efficacy. A major challenge is ensuring the drug can actually be manufactured at scale. This means addressing key CMC (Chemistry, Manufacturing, and Controls) requirements early—such as stability, process design, and practical large‑scale implementation. Without this foundation, programs often face delays, regulatory setbacks, or even failure during IND submission.

To successfully cross this “Valley of Death,” developers must generate the right data at the right time. This includes confirming that the drug product remains stable throughout manufacturing steps and gathering the necessary evidence to support IND and later BLA filings. Early risk assessment is also essential, helping teams predict issues before they become costly. Balancing time, cost, and data depth ensures smarter decision‑making and keeps development on track.

This proactive approach reduces program risk, supports regulatory readiness, and increases the chances of advancing efficiently toward clinical trials.