Interview with Carrie Li
Key points:
Clinical Development Plan (CDP): strategy for compound progressionEarly Decisions: impact on clinical phases, timeline, costStatistical Role: balancing science, speed, and costTarget Product Profile (TPP): guides CDP objectivesCross-functional Collaboration: clinical, commercial, regulatory teamsBig Pharma vs. Startups: differences in resources, risk, investor expectationsAdaptive Design: flexibility in clinical phases, risk managementRegulatory Engagement: early involvement of FDA, EMA for approvalsCompetitor Landscape: use of competitive intelligence for CDP designCost & Timeline Estimation: sample size, Gantt chart for budgetingTogether, we explore how to balance scientific rigor with business goals, collaborate across teams, and navigate the regulatory landscape to bring new therapies to life. Carrie shares practical advice and insights that can help anyone involved in drug development make a real impact.
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