Remediation of CRL Issues in Preparation for BLA Resubmission
This client had late-stage experience….but not with cell or gene therapies. In a younger industry such as C>, previous agency guidance is not yet as robust as it is for fields that have been around longer. For that reason, sponsors benefit from C>-specific expertise.
The client came to Dark Horse to request remediation and resolution of multiple areas for which their original submission was rejected. Due to the time constraints of resubmission, a sense of urgency accompanied getting the product back on track and executing each element of this process on time and with quality as a top priority.
This engagement addressed a wide range of overlapping service areas spanning at least six of DHC’s twelve service offerings.
Among the many services provided by DHC were:
- Strategic regulatory support to identify the path to issue resolution and BLA resubmission
- Tactical/operational regulatory support such as document authorship of briefing book and BLA subsections
- Creation of a cross functional project plan detailing the range of necessary activities and sequencing; accompanying detailed
project Gantt charts and dashboards for visibility and tracking completion as well as critical path mapping - Technical expertise relating to C> analytical, process development and manufacturing, to ensure technically sound
remediation to quality and regulatory concerns in these areas - Management and oversight of relationship with an external testing house requiring special attention for deliverables on
and near the critical path for resubmission - Root cause analysis of process failures to accelerate issue identification and remediation
The client successfully completed their post-rejection regulatory agency meeting, allowing for next steps towards resubmission. Dark Horse’s C>-specific project management plan provided necessary clarity and visibility for efficient and effective project remediation along with critical path mapping. Additionally, DHC’s subject matter expertise and technical know-how, combined with project leadership skills, not only prepared the client for their resubmission (along with potential submissions in different regulatory jurisdictions), but also set them up for future successes.
- Regulatory support
- Analytical Development
- Quality Systems
- Process Development