Logan Butt
Associate Director, Regulatory Affairs Teva Pharmaceuticals
Seminars
Patient experience data (PED) is transforming how therapies are developed and evaluated – but regulatory expectations are evolving rapidly. This interactive workshop provides practical insights into global regulatory requirements and strategies to maximize the impact of patient engagement throughout the product development lifecycle.
This Workshop Will Gather Experts to Discuss:
- Understanding current PED expectations from regulators by exploring FDA, EMA, and MHRA requirements for patient experience data in drug development
- Leveraging early dialogues with regulators by engaging them early to shape development strategies with patient insights
- Reviewing case examples of patient engagement impact by analyzing real-world examples showing how patient engagement influences drug development and regulatory decisions
- Examining recent regulatory developments by assessing EMA’s reflection paper and FDA initiatives and applying insights to real-world scenarios
- Collaborating on optimizing patient experience data across the lifecycle by developing strategies to effectively collect, analyze, and apply patient experience data from early development through treatment
- Co-designing the dashboard by involving patients directly in shaping the digital tools and AI systems that measure their engagement, ensuring these platforms are intuitive, useful, and respectful of their time and energy
- Delivering the transparency dividend by giving patients direct access to their own engagement data, helping them see how their activity connects to personalized actions and building trust, motivation, and data accuracy
- Interpreting data with context by ensuring AI algorithms incorporate the patient’s voice to prevent harmful biases, recognizing that qualitative stories and feedback are essential for understanding quantitative engagement data and avoiding misreadings such as assuming low usage equals disengagement
- Establishing ethical guardrails as a foundation by involving patient advocates in creating the frameworks for data use, ensuring that measuring engagement is ethical, consensual, and aligned with patient approval