Get Full Government Meeting Transcripts, Videos, & Alerts Forever!
Get email alerts on the Regulatory topic
No spam. Unsubscribe anytime.
Experts: converting investigator INDs to sponsor‑driven programs is possible but depends on data quality
Summary
Podcast guests said investigator‑initiated INDs can be converted to commercial/sponsor‑driven INDs, but success depends on the quality of records and data; sponsors must typically assume regulatory responsibilities, insurance and safety database management.
In response to an audience question, ImmunoPhotonics’ David Anderson and Lou Alaruzzo discussed converting investigator‑initiated investigational new drug (IND) applications into sponsor‑driven commercial INDs.
Anderson said sponsor‑driven programs are "much more accepted by the agencies" and enable stronger support of the data. He noted that investigator‑initiated INDs play a valuable role and that, where possible, opening an IND early can be strategically useful. Converting an investigator IND to a sponsor‑driven program is a process that "can be done," Anderson said, but it requires appropriate data quality and records.
Alaruzzo added that the sponsor must take on additional responsibilities — covering insurance and managing the safety database — and that the cost implications grow as a program moves later into phase 2. If records from the investigator IND are incomplete or poorly managed, the work may be more expensive to repair than to repeat, he said.
Both advised using existing institutional data‑management tools at academic centers to increase the value of investigator studies and facilitate conversion to sponsor‑driven development when appropriate.
The exchange framed the conversion as feasible but conditional on data quality and cost, and as something founders should plan for in regulatory and budget estimates.
