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Clinical Research Coordinator Analysis

LN-145 Product Logistics and Administration Timing

Finding: The protocol (Section 8.2) mandates infusion of the fresh TIL product, LN-145, within 24 hours of its release from the central manufacturing facility. While this is crucial for product viability, this tight timeframe presents a significant logistical challenge for the site. Potential issues include variability in manufacturing release times, unexpected courier delays, internal site delays in receipt and pharmacy processing, and ensuring the patient (who will have just completed multi-day lymphodepletion) is clinically ready precisely at the infusion time. Any hitch in this chain could lead to product expiration, a serious protocol deviation, and the inability to treat a highly vulnerable patient. Recommendation: To proactively manage this critical window, we recommend developing a detailed, site-specific "LN-145 Receipt-to-Infusion" checklist and workflow plan. This plan should clearly delineate:

1. Roles and responsibilities for each step (CRC, Pharmacy, Nursing, PI).

2. Primary and backup contact personnel for the central manufacturing facility, courier, and key site staff.

3. A precise communication tree for real-time updates on manufacturing release, shipment tracking, and estimated site arrival.

4. Pre-defined steps for product receipt, temperature verification, immediate transfer to pharmacy/infusion suite, and final identity checks.

5. A contingency plan for minor delays, including criteria for escalating communication to the PI and Sponsor if the 24-hour window is at risk.

Furthermore, conducting a "dry run" or tabletop simulation of this entire process before the first patient intended for LN-145 treatment would be invaluable for identifying and mitigating site-specific bottlenecks.

Rationale: Implementing a detailed workflow and conducting simulations will significantly enhance our site's preparedness, ensure seamless coordination between all parties, minimize the risk of LN-145 product expiry, and ultimately safeguard patient treatment following lymphodepletion, thereby improving protocol compliance and patient safety.