An emerging cellular therapeutics company was entering phase 1 clinical testing for their lead hematology candidate based on their antibody-coupled T-cell receptor (ACTR) technology. In order to move their vision for a singular therapeutic platform approach to treat many different cancers through the development process, they needed a plan, processes and hands-on support.
BioBridges provided the key functional expertise necessary in biostatistics, clinical operations, medical writing, pharmacovigilance, and quality assurance.
The BioBridges team provided the following:
- Contributed to and supported the writing and QC of early phase documents related to their IND submission; protocols, briefing documents, investigator’s brochures (IB), development safety update reports (DSURs)
- Provided strategic biostatistics support and assisted in developing statistical analysis plan (SAP), determining endpoints, and patient populations
- Provided an Interim Head of Quality upon departure of Full-Time Head of Quality
- Liaised with FDA for queries
- Developed and implemented a company-wide program for budget reporting and invoice review and approval
- Assessed existing pharmacovigilance (PV) processes and supported the creation and/or enhancement of PV procedures, PV compliance structure, PV system capabilities, and PV resourcing model
- Developed clinical operations SOPs
- Assisted in completing a competitive landscape analysis, KOL selection, and clinical site evaluation
Our client was able to achieve an IND submission within corporate timelines and has since used the same structure for 2 additional, successful IND submissions.