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&GT, 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&GT-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:

  1. Strategic regulatory support to identify the path to issue resolution and BLA resubmission
  2. Tactical/operational regulatory support such as document authorship of briefing book and BLA subsections
  3. 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
  4. Technical expertise relating to C&GT analytical, process development and manufacturing, to ensure technically sound
    remediation to quality and regulatory concerns in these areas
  5. Management and oversight of relationship with an external testing house requiring special attention for deliverables on
    and near the critical path for resubmission
  6. Root cause analysis of process failures to accelerate issue identification and remediation
This is a sample gantt chart demonstrating some of the primary activities taken before a BLA resubmission

The client successfully completed their post-rejection regulatory agency meeting, allowing for next steps towards resubmission. Dark Horse’s C&GT-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

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