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The Effective Statistician - in association with PSI
VetenskapNaturvetenskap

Clinical Development Plans

36 min•28 oktober 2024
Interview with Carrie Li
Key points:
  • Clinical Development Plan (CDP): strategy for compound progression
  • Early Decisions: impact on clinical phases, timeline, cost
  • Statistical Role: balancing science, speed, and cost
  • Target Product Profile (TPP): guides CDP objectives
  • Cross-functional Collaboration: clinical, commercial, regulatory teams
  • Big Pharma vs. Startups: differences in resources, risk, investor expectations
  • Adaptive Design: flexibility in clinical phases, risk management
  • Regulatory Engagement: early involvement of FDA, EMA for approvals
  • Competitor Landscape: use of competitive intelligence for CDP design
  • Cost & Timeline Estimation: sample size, Gantt chart for budgeting

Together, 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.

Don’t miss this conversation—listen to the full episode, and if you find it valuable, share it with friends and colleagues who are passionate about advancing healthcare.

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The Effective Statistician - in association with PSI med Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry finns tillgänglig på flera plattformar. Informationen på denna sida kommer från offentliga podd-flöden.