Success Story: Support for Vitiligo Pre-IND Submission and FDA Meeting Preparation

 

Project Overview

    The client sought support for their pre-IND (Investigational New Drug) submission and development program. Our goal was to contribute to the clinical section of the pre-IND submission package and prepare clinical questions for their Vitiligo asset.

     

     

    Steps and Actions Taken

     

     

    Steps

    Actions
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    Pre-IND Submission Development
      • Clinical Section Development: Assisted in preparing the required pre-IND submission package, detailing their planned clinical activities.
      • Study Synopsis: Developed the study synopsis and plan for their first clinical study, ensuring alignment with regulatory requirements.

     
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    FDA Question Development
      • Question Formulation: Created a set of questions for the FDA, including rationale and study design suggestions, based on our extensive experience.
      • Literature Analysis: Conducted literature reviews to support the proposed study designs and questions.

     
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    Meeting Preparation
      • Scenario Planning: Prepared narratives for various potential FDA scenarios, helping the client anticipate and prepare for different outcomes.
      • FDA Meeting Representative: Actively participated in the FDA video conference to provide real-time answers to any questions. Developed a supportive document to address the FDA’s clinical questions, incorporating literature research and client discussions.

     

    Outcomes

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    FDA Meeting

    The client successfully engaged with the FDA in a virtual meeting. Despite high concerns, the FDA agreed with their proposed plan by the end of the meeting.

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    Client Feedback

    The client’s parent company’s CEO personally thanked the team for their contributions to the successful FDA engagement.

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