Pre-IND Meeting

The Project

European client initiating US development of its gene therapy product.

The Challenge

The Challenge

  • Company beginning first discussions with the FDA regarding IND development and submission of intra-cerebral gene therapy product
  • Intent to gain agreement on completed nonclinical program to support first in human study
  • Intent to gain agreement on the use of historical controls to support clinical development in rare disease space.
The Solution

The Solution

Regulatory strategy, dossier support, and pre-IND meeting attendance.

  • Assisted client with review and submission of pre-IND meeting materials
  • Regulatory lead for FDA meeting discussions and management of all follow up activities
  • Scope of Biopharma Excellence activities:
    • Lead regulatory strategy for US based development incl. review of FDA proposed questions, meeting request letter, briefing dossier
    • Preparation and attendance at FDA Pre-IND meeting.
The Outcome

The Outcome

Productive Pre-IND meeting with FDA to support IND submission.

  • Gained FDA guidance on completed and intended nonclinical program to support first in human study
  • Received FDA feedback on CMC requirements for manufacturing transfer and comparability process
  • Collaborative discussions regarding clinical design relative to patient population, endpoints, and natural history controls

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