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

Indero

Indero

Team of Experts

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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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Jeff Smith

Chef de la direction

Jeff Smith, Chef de la direction d’Indero Recherches, apporte prĂšs de 30 ans d’expĂ©rience dans l’industrie pharmaceutique et CRO, s’Ă©tant distinguĂ© par son leadership exceptionnel, sa vision stratĂ©gique et son innovation. L’expertise de Jeff couvre des opĂ©rations mondiales, la gestion de la croissance, ainsi que la promotion d’une culture d’entreprise collaborative. Ses atouts en matiĂšre de crĂ©ation de valeur, de gestion des partenaires et d’opĂ©rations CRO ont toujours contribuĂ© au succĂšs dans ses fonctions prĂ©cĂ©dentes. Sous la direction de Jeff, Indero continue d’étendre ses capacitĂ©s, faisant progresser les connaissances mĂ©dicales et les nouvelles thĂ©rapies en dermatologie et en rhumatologie.

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