Translational Science Operations

Translational Science Operations works to coordinate IND-enabling activities and manage the scientific aspects of Phase I clinical research. Work begins with an initial evaluation of the pre-clinical data package and manufacturing feasibility status, which is used to provide feedback related to regulatory strategy and identification of information gaps.  Prior to submission of the IND application, the Science Operations team reviews and revises study reports and performs a quality assurance review of all documents intended for FDA submission. This group is also the key contact for high level management of pre-IND activities, assuring alignment of various other functional groups (Clin Ops, PDL, CVPF, etc.) within CCI and communicating timelines and projections to key stakeholders. Whenever possible, activities are arranged in a coordinated, parallel fashion to optimize the timing of regulatory filings and ensure trial readiness upon IND opening.  Post-IND submission, the team manages amendments, advises on manufacturing issues, serves as point of contact for FDA requests for information, analyzes trial data, and supports manuscript preparation.

The Translational Science Operations team has authored and managed over 30 INDs related to cell therapies for hematologic malignancies, solid tumors and HIV infection.  In preparing for an IND submission, the Ph.D level scientists within the team use their extensive experience and expertise to coordinate across various groups to ensure efficiency in bringing promising cell therapy candidates to the clinic.  Services include:

Pre-IND	Post-IND
Project Consultation Pre-clinical (Pharm/Tox) Assessment Regulatory Strategy Construct Archiving Support and Procurement of Vector Manufacturing Vector Characterization and Stability Testing IND writing RFI support Grant Support Project Coordination	RFI Support IND Amendments/Annual Reports Data Analysis Manuscript Preparation DSMB Support

 Additional project-specific support is available upon request.