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

Start a conversation today

Socials:








    We are now Cencora PharmaLex 

    PharmaLex is now part of Cencora, a leading global healthcare company with a foundation in pharmaceutical distribution. In 2024 and beyond PharmaLex and all the companies in PharmaLex family will begin a journey to becoming Cencora as well. Cencora brings the companies and services together under one new name. The name will change, but the level of attention and service you receive remains the same.  

    Know more