Master clinical phase transitions with insights from industry leaders! Join 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. We are thrilled to welcome 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.
- Gain insights into modeling from limit to rich data during a development program.
- Learn to simulate effective dose ranges for proof-of-concept studies in specific patient populations.
- Navigate the challenges of transitioning from clinical data-rich outcomes to trial designs with limited clinical data but a solid understanding of pathology.
- Explore case studies on utilizing quantitative understanding of diseases, such as Parkinson’s, to inform dosing strategies.
- Address considerations for Phase 3 pivotal trials, including the relaxation of inclusion criteria and managing potential pharmacodynamic interactions.
- Build a compelling argument for the integration of pharmacometrics and QSP in your drug development strategy.
Build a compelling argument for integrating pharmacometrics and QSP in your drug development strategy.
Don’t miss this opportunity to elevate your insights and strategies in drug development!
注意：Limited spots available. Reserve your place now to stay at the forefront of drug development strategies
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
Dr. Lesko, Clinical Professor Emeritus at UF College of Pharmacy in Lake Nona, FL, is the Founding Director of the UF Center for Pharmacometrics and Systems Pharmacology. Formerly the Director of the Office of Clinical Pharmacology at FDA’s CDER, he chaired the clinical pharmacology coordinating subcommittee. Dr. Lesko established regulatory programs in pharmacometrics and drug safety, and was an author on over 210 peer-reviewed articles and book chapters. He received several awards, including the ASCPT’s Rawls-Palmer Progress in Medicine award, Gary Neil Prize for Innovation in Drug Development, and the Coriell Scientific Leadership Award for Personalized Medicine. Board Certified in Applied Pharmacology, Dr. Lesko served as ACCP President and is a Fellow in AAPS, the Japanese Society for the Study of Xenobiotics, and the College of Physicians of Philadelphia.