In the past ten years, Neal has provided in-depth IIT services to researchers and study teams supported by SCI-CCTO, including submitting IND/IDE initial application packages on behalf of PI, assisting with annual IND reports, managing IRB records for IITs, preparing and submitting ClinicalTrial.gov result reporting and offering protocol consultation. Unfortunately, Neal retired on February 3, 2023.
We have started recruiting for his position, and replacing such an expert takes work. While focusing on finding a suitable replacement for IND services, we developed a coverage plan relying on internal resources. Madhulika Dayal, SCI-CCTO Regulatory Manager, and I developed an interim coverage plan until we hire a new person for Neal’s work responsibilities. Sweta Tamboli, Regulatory Specialist 2, will support your current and future IND submissions, including new INDs, IND annual reports, and any amendment to existing INDs. Madhulika Dayal, her manager, will be supporting her and providing backup. Swetha Dintakurthi, Regulatory Specialist 2, and I will assist with CliicalTrials.gov result reporting. Yoriko Imae, Regulatory Specialist 2, will support Single Patient IND projects. We have met with Neal regularly in the past few weeks to transition current projects.
In the upcoming weeks, we will contact PIs to provide status updates on their IND and IIT.
Summary of coverage plan
| Task | Interim Coverage |
| IND application initial submission to FDA, IND annual report, amendments to existing INDs, and closing INDs | Shweta Tamboli / Madhulika Dayal as back up |
| IIT study submission to IRB | Shweta Tamboli / Madhulika Dayal as back up |
| Single Patient IND | Yoriko Imae / Shweta Tamboli as back up |
| Ct.gov result reporting | Agnes Nika / Swetha Dintakurthi |
| IIT protocol consultation | TBD; no current available expertise |
| Safety Reporting | Soulaima Houcheime / Yoriko Imae |
Please contact Madhulika and Agnes Nika with any questions and/or concerns.