Clinical Development Plans

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.

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