AI For Pharma Growth

E174 | How AI is Transforming Regulatory Submission and Medical Writing in Biopharma

Jul 15, 2025
Tim Martin, Vice President of Product at Yseop, specializes in AI-driven solutions for clinical documentation. He discusses how AI is revolutionizing regulatory submissions, drastically cutting document creation times by over 70%. This transformation not only accelerates drug approval processes but also brings significant cost savings for pharma companies. Tim highlights the importance of human oversight in automation and how tools like Veeva are enhancing document workflows. Insights on future skills needed in medical writing are also explored, providing valuable knowledge for industry professionals.
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INSIGHT

Automation Shortens Approval Timelines

  • Automating dossier document generation can accelerate drug approvals by weeks or months.
  • Tim Martin estimates this earlier delivery can save pharma $1–5M per day and speed patient access to therapies.
ADVICE

Keep Humans Accountable

  • Use AI as a human-centric tool and keep humans accountable for final outputs.
  • Let AI handle tedious analysis so medical writers focus on science and strategy.
INSIGHT

Change Management Determines Adoption

  • Adoption depends heavily on change management and internal champions.
  • Strong advocacy accelerates uptake while weak programs create resistance and misunderstanding.
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