Managing Cell Therapy Investigational New Drug (IND) Timeline Risks

Successfully filing an IND for a cell therapy program requires more than scientific innovation—it calls for early, strategic planning to navigate complex preclinical challenges. Timelines can easily be derailed by issues such as manufacturability, variability in raw materials and cell sources, and limited early process characterization. These factors not only delay progress but can also threaten the viability of a program.

Identifying risks and gaps early helps avoid costly rework and months of lost time. Upfront manufacturability assessments may reveal critical limitations, including whether a candidate can be produced to meet commercial objectives. While difficult, deciding to halt a non-viable program early preserves capital and allows teams to redirect resources toward more promising opportunities. Innovators can take practical steps to mitigate these risks and keep development on track. Standardized assessments, robust process development strategies, and proactive risk management can make the difference between a stalled program and a successful IND submission.

In cell therapy, time is more than a resource; it’s a gateway to opportunity, impact, and ultimately, patient access.