The Effective Statistician - in association with PSI

Clinical Development Plans


Listen Later

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.

    ...more
    View all episodesView all episodes
    Download on the App Store

    The Effective Statistician - in association with PSIBy Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry

    • 4.4
    • 4.4
    • 4.4
    • 4.4
    • 4.4

    4.4

    9 ratings


    More shows like The Effective Statistician - in association with PSI

    View all
    Stuff You Should Know by iHeartPodcasts

    Stuff You Should Know

    78,338 Listeners

    Freakonomics Radio by Freakonomics Radio + Stitcher

    Freakonomics Radio

    32,082 Listeners

    Planet Money by NPR

    Planet Money

    30,647 Listeners

    Hidden Brain by Hidden Brain, Shankar Vedantam

    Hidden Brain

    43,572 Listeners

    Pivot by New York Magazine

    Pivot

    9,483 Listeners

    JAMA Clinical Reviews by JAMA Network

    JAMA Clinical Reviews

    497 Listeners

    HBR IdeaCast by Harvard Business Review

    HBR IdeaCast

    162 Listeners

    Page 94: The Private Eye Podcast by Page 94: The Private Eye Podcast

    Page 94: The Private Eye Podcast

    343 Listeners

    The Peter Attia Drive by Peter Attia, MD

    The Peter Attia Drive

    8,623 Listeners

    The Journal. by The Wall Street Journal & Spotify Studios

    The Journal.

    6,060 Listeners

    Huberman Lab by Scicomm Media

    Huberman Lab

    29,124 Listeners

    Biotech Hangout by Daphne Zohar, Josh Schimmer, Brad Loncar, Tim Opler & more

    Biotech Hangout

    19 Listeners

    The Rest Is Politics by Goalhanger

    The Rest Is Politics

    3,096 Listeners

    DER TRUMP EFFEKT  –  ZDF auslandsjournal – Der Podcast by ZDF

    DER TRUMP EFFEKT – ZDF auslandsjournal – Der Podcast

    10 Listeners

    Die Peter Thiel Story by Deutschlandfunk

    Die Peter Thiel Story

    27 Listeners