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  • Documentation gap analysis in preparation for FDA scientific advice meeting

Challenge:

Our client was committed to applying a deep understanding of axon regeneration and neuronal signaling pathways to transform the lives of patients afflicted with neurotrauma or neurovascular disorders; its lead product was in development for acute cervical spinal cord injury. The client required FDA advice on its intended Phase II trial design and other non-clinical aspects on the program and therefore required support in preparing for a Type B meeting with the FDA's Division of Neurology Products.

Solution:

There were several key areas on which the client required FDA response to, these included:
  • Clinical: To reach agreement with the Agency regarding the design of a Phase IIb trial
  • Chemistry, Manufacturing, and Controls: To discuss plans to re-derive the product Master Cell Bank following discovery of the use of animal-derived products as well as minor proposed modifications to the downstream processing
  • Nonclinical: To discuss the whether the nonclinical toxicology package is sufficient to support approval.
The documentation that Alacrita reviewed included:
  • Introductory and Administrative Information Section
  • Brief Background Information Section
  • Specific Questions for Discussion Section
  • Overview of Development Program To Date
  • Proposed Phase IIb Trial Protocol
  • Proposed Investigator’s Brochure
  • Proposed Data Monitoring Committee (DMC) Charter
We performed the gap analysis on these documents and provided feedback to the client on amendments required to ensure the briefing document was fit for purpose.
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