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
Step 1: Pre-IND Submission Development
Actions:
- 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.
Step 2: FDA Question Development
Actions:
- 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.
Step 3: Meeting Preparation
Actions:
- 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
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.
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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