Welcome & Opening Remarks
Dr. Vikram Sinha — FDA/CDER

Keynote Panel

Moderator:
Dr. Vikram Sinha — FDA/CDER

Dr. Issam Zineh (FDA), Dr. Sandra Allerheiligen (Merck), Prof. Meindert Danhof (Leiden University),
Dr. Jose Pinheiro (J&J)

Session I: FDA Perspective on Applying Modeling & Simulation in Regulatory Decision-Making—
Successes and Lessons Learned

Moderator:
Dr. Vikram Sinha — FDA/CDER

Chemistry Models & Impact on Safety Assessment in Drug Development
Dr. Naomi Kruhlak — FDA/CDER

Continuous Learning from Confirmatory Trials
Dr. Yaning Wang — FDA/CDER

Biostatistics Contributions to Modeling & Simulation and Adaptive Trial Design
Dr. Sue-Jane Wang — FDA/CDER

Panel Discussion: Drs. Issam Zineh, Naomi Kruhlak, Yaning Wang, Sue-Jane Wang, Mohammad Huque

Session II: Industry Perspective on Applying Modeling & Simulation in Regulatory Decision-Making and Translational Pharmacology — Successes and Lessons Learned

Moderator:
Dr. John-Michael Sauer — C-Path

Quantitative Tools to Support Biomarker Qualification
Dr. J.F. Marier — Pharsight

Comprehensive Clinical Trial Simulation Tool for Alzheimer’s Disease

Dr. Brian Corrigan — Pfizer

Quantitative Modeling in Pre-Dementia Stages
Dr. James Rogers — Metrum Research Group

Application of Multiple Risk Marker Models for Prediction of Renal & Cardiovascular Drug Efficacy
Prof. H.J. Lambers Heerspink —University of Groningen

Panel Discussion: Drs. Sandy Allerheiligen, Zaven Khachaturian, J.F. Marier, Brian Corrigan, James Rogers, H.J. Lambers Heerspink

Session III: Future Perspectives for Modeling & Simulation Tool Development & Applications

Moderator:
Dr. Sandra Allerheiligen — Merck

Translational Modeling Tools for Combination Drug Development
Dr. Tawanda Gumbo — University of Texas

Gap Identification as a Critical Step to Enable Integrated Clinical Trial Simulation Platforms
Dr. Peter Vis — LAP&P

Collaborative Approaches to Mechanistic Modeling
Dr. Paul Watkins — University of North Carolina

Making Models Publicly Available: Successes & Challenges
Dr. Tina Morrison — FDA/CDRH

Open-Source Platform for Model & Knowledge Sharing
Dr. William Gillespie — Metrum Research Group

Panel Discussion: Drs. Tawanda Gumbo, Peter Vis, Paul Watkins, Tina Morrison, William Gillespie

Closing Remarks
Prof. Meindert Danhof