RC3 - Roller Coaster 3

Wednesday, November 13, 2024

10:45 AM – 12:15 PM MST

Location: Sonoran Sky Ballroom 5 - 8

Moderator(s)

Navin Goyal, PhD

Sr Director, CPP
Johnson and Johnson, New Jersey, United States

Speaker(s)

JC

Jenny Chien, PhD

Associate Vice President
Eli Lilly and Company
Indianapolis, Indiana, United States

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Sebastiaan Goulooze, PhD (he/him/his)

Senior Expert Pharmacometrician
LAP&P Consultants BV
Leiden, Zuid-Holland, Netherlands

PDF Slides
Eleni Caratzas, MSc, PhD

Senior Scientist
Janssen RnD

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Stephan Schmidt, PhD (he/him/his)

Professor and Director CPSP
University of Florida, Department of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology, Florida, United States

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Ahmed Salem, PhD, FCP

Senior Research Fellow
Abbvie

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Disclosure(s):

Navin Goyal, PhD: Johnson & Johnson: Employment (Ongoing), Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing)

Jenny Chien, PhD: Eli Lilly and Company: Employment (Ongoing), Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing)

Sebastiaan C. Goulooze, PhD: No financial relationships to disclose

Eleni Caratzas, MSc, PhD: Janssen Research & Development: Employment (Ongoing)

Stephan Schmidt, PhD: No financial relationships to disclose

Ahmed H. Salem, PhD, FCP: Abbvie: Employment (Ongoing), Ownership Interest (stocks, stock options, patent or other intellectual property or other ownership interest excluding diversified mutual funds) (Ongoing)

Presentations:

10:50 AM – 11:05 AM MST

Advancing Drug Development through Model Informed Drug Development: Insights from the ICH M15 MIDD Guidance Working Group
Speaker: Jenny Chien, PhD – Eli Lilly and Company
11:05 AM – 11:20 AM MST

Overadjustment bias and mediation analysis in PK/PD modeling
Speaker: Sebastiaan C. Goulooze, PhD (he/him/his) – LAP&P Consultants BV
11:20 AM – 11:35 AM MST

MIDD in the clinical development of gene therapy: from bench to bedside
Speaker: Eleni Caratzas, MSc, PhD – Janssen RnD
11:35 AM – 11:50 AM MST

Breaking down barriers within and across disciplines: the power of data integration
Speaker: Stephan Schmidt, PhD (he/him/his) – University of Florida, Department of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology
11:50 AM – 12:05 PM MST

Power Determination During Drug Development: Is Optimizing the Sample Size Based on Exposure- Response Analyses Underutilized?
Speaker: Ahmed H. Salem, PhD, FCP – Abbvie