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#31: Preparing for a US FDA Advisory Committee Meeting


  • Lisa  Peluso

    Lisa Peluso

    • Principal Consultant, Strategic Communications
    • PharmApprove, a Member of the NDA Group, United States

    Lisa helps development teams to align strategically and communicate persuasively with global regulators and payers. She empowers teams to create and deliver clear, consistent, and convincing messages to critical audiences and decision-makers. She has coached hundreds of individuals and provided presentation, Q&A and facilitation training to teams in pharma, and biotech, and has helped 45+ teams prepare to present and defend their positions at FDA Advisory Committee meetings and EMA Oral Explanations. Lisa also creates and leads dynamic workshops to empower teams to communicate complex science with clarity.

  • Kaia  Agarwal, MSc

    Kaia Agarwal, MSc

    • Strategic Lead
    • PharmApprove, A Member of the NDA Group, United States

    Kaia Agarwal is an independent regulatory consultant working with PharmApprove, with over 30 years of global leadership experience in the pharmaceutical and biotechnology industry, with strategic regulatory expertise across CMC and Clinical Development. Kaia has extensive experience leading teams in the development and registration of several small molecules, vaccines and biologic products across all major therapeutic areas and regions, including Cardiovascular, Endocrine, CNS, Pain, Immunology, Oncology, Antivirals, and Vaccines. She has led teams preparing for global filings, global agency meetings and has supported over 16 advisory committee meetings. She was most recently the VP and Global Head Regulatory Affairs for Novartis Vaccines.