Master clinical phase transitions with insights from industry leaders! Piet van der Graaf, SVP and Head of QSP, Hugo Geerts, Head of Neuroscience Modeling QSP, Mirjam Trame, VP of Certara Drug Development Solutions, and Julie M. Bullock, PharmD, SVP of Drug Development Services at Certara welcomed keynote speaker and panelist Larry Lesko, B.S., Ph.D., Clinical Professor Emeritus, and Founding Director, Center for Pharmacometrics and Systems Pharmacology at the University of Florida College of Pharmacy.
Key Takeaways:
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- Gain insights into modeling from limit to rich data during a development program.
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- Learn to simulate effective dose ranges for proof-of-concept studies in specific patient populations.
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- Navigate the challenges of transitioning from clinical data-rich outcomes to trial designs with limited clinical data but a solid understanding of pathology.
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- Explore case studies on utilizing quantitative understanding of diseases, such as Parkinson’s, to inform dosing strategies.
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- Address considerations for Phase 3 pivotal trials, including the relaxation of inclusion criteria and managing potential pharmacodynamic interactions.
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- Build a compelling argument for the integration of pharmacometrics and QSP in your drug development strategy.
