Library

• Leveraging Longitudinal Modeling to Improve Drug Development Efficiency, by Olga Marchenko (Bayer)
• Opportunities and pitfalls in the use of nonlinear mixed-effects models for leveraging longitudinal information in drug development, by Andrew C. Hooker (Pharmacometrics Research Group, Department of Pharmaceutical Biosciences, Uppsala University, Sweden)
• Interim Decision Making Using Parametric LM, by Tobias Mielke (Jassen)
• Calibrated predictions of survival based on tumor size dynamics and new lesions in lung cancer via Joint Modeling approach, by Katsuomi Ichikawa (Clinical Pharmacology & Drug Safety and Metabolism, Science & Data Technology Division, R&D Japan, AstraZeneca)

• Effective Application of Modeling, Simulation and Knowledge Sharing in Drug Development, Discussant, by Gary L. Rosner (Johns Hopkins)

• Integration of Pharmacometrics and Statistics to Support Study Design Optimization, by Michael Heathman (Metrum Research Group & Eli Lilly and Company (retired))

• Meta-Analysis of Clinical Dose Response and Its Application, by Neal Thomas (Pfizer)

• Adaptive Borrowing of Adult Data for Pediatric Trials: Collaborative Research at the Intersection of Pharmacometricsand Statistics, by Chyi-Hung Hsu (Janssen)

• Trial Simulations to Support Proof of Concept Study Design: Application to Immunology, By John Gibbs (Abbvie)

• Mechanistic Modeling of Metastasis: Cancer at the Organism Scale (Part 1), by Dr. Sebastien Benzekry (INRIA) 

• Mechanistic Modeling of Metastasis: Cancer at the Organism Scale (Part 2), by Dr. Sebastien Benzekry (INRIA) 
• Bayesian Meta-Analysis Model for Chemical Risk Assessment, by Dr. Witold Wiecek (Certara) 
• Bayesian Individual Dynamic Predictions of Biomarkers and Risk of Event in Joint Modeling (with Uncertainty): a Comparison Between Stan, Monolix and NONMEM , by Dr. Francois Riglet (INSERM Paris University) 
• A Hybrid Genetic Algorithm for NONMEM Structural Model Optimization, by Rob Bies (Buffalo University) 
• Dose-Response, Small Data & Big Decisions, by Mike Smith (Pfizer) 
• Real-World Clinical Effectiveness and Utility of Ustekinumab in Adults with Moderate to Severe Psoriasis: Statistical and Pharmacometric Perspectives, by Dr. Shan Pan (St. John's Institute of Demartology)

• Introduction and overview of the SxP Pharmacometrician and Statistician Survey, by Dr. France Mentré, University Paris Diderot 
• Causa Nostra: the potentially legitimate business of drawing causal inferences from observational data, by Dr. James A. Rogers, METRUM Research Group
• Common concerns in visualization of pharmacometric data and models, by Andreas Krause, Idorsia.
• Multiplicity Issues with Covariate Analysis: Strategies and Perspectives on Pre-specification of Pharmacometric Analyses, by Dr. Steven Xu and Dr. José Pinheiro, Janssen R&D

• THIS ISN’T PEEWEE SOCCER: BUILDING TEAMWORK BETWEEN STATISTICIANS AND PHARMACOMETRICIANS, by Bret J. Musser, Ph.D., Regeneron
• BRIDGING THE GAP between Pharmacometricians and Biostatisticians, by France Mentre, Ph.D., University Paris Diderot
• Poster: The Statistics and Pharmacometrics Interest Group (SxP): Membership and Mission, by Fred Balch, Alan Hartford, Matthew Rotelli , Bret Musser, Enrico Smith, Brian Smith, Stacey Tannenbaum, Jose' Pinheiro, France Mentre.

Presentations from 2016 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop:

• BRIDGING THE GAP between Pharmacometricians and Biostatisticians, by France Mentre, Ph.D., University Paris Diderot
• An Industry Perspective on Statistics and Pharmacometrics,  

  by Marc R. Gastonguay, Ph.D.

• Pharmacometrics and Biostatistics Interactions at the FDA, by Jeffry Florian, Ph.D., Division of Pharmacometrics, OCP/OTS/CDER, U. S. Food and Drug Administration 

Dose-Response and Exposure-
Response Analyses in Dose Selection , by Bret J Musser and Ronda K Rippley

My Career as a Pharmacometrician and Commentary on the Overlap Between Statistics and Pharmacometrics in Drug Development, by Kenneth G. Kowalski

An Introduction of PK/PD Modeling - Part 1, by Alan Hartford

 An Introduction of PK/PD Modeling - Part 2, by Yaming Hang

How to Create NONMEM Data Sets:

• Training - Creating NONMEM Data Sets

• Best Practices for Creating NONMEM Data Sets

How to Prepare NONMEM Data Sets for Regulatory Submission:

• Naming Conventions for Regulatory Submission of Pharmacometrics Analysis Datasets and Define.doc

• Best Practices for Preparation of Pharmacometric Analysis Data Sets

Presentations in 2017 JSM SxP Sessions:

• Challenges and Strategies in Pharmacometric Programming, Jing Su, Merk & Co., Inc.
• Data Standards for Pharmacometric Analysis Data Sets, Neelima Thanneer, Bristol-Myers Squibb
• ELECTRONIC SUBMISSION OF PHARMACOMETRICS DATA SETS AND REPORTS FOR REGULATORY SUBMISSIONS, Jeffry Florian, PhD, Biomedical Informatics and Regulatory Review Science Team, Office of New Drugs, Immediate Office
• Importance of PharmacometricProgramming, Amit Roy

Presentations in 2018 PharmaSUG 2018:

• Challenges and Strategies in PKPD Programming, Jing Su and Jianna (Jane) Kang, Merk & Co., Inc.
• Data Standards for Population Pharmacokinetic Analysis (POPPK) and Non-Compartmental Analysis (NCA), Neelima Thanneer, Bristol-Myers Squibb
• Preventing Premature Unblinding in PK/PD Related Studies, Alice Zhong, Debbie Sisco, Janssen Research & Development, LLC.
• How PK and PD Analyses Drive Dataset Designs, David B. Radtke and Brian A. Moser, Eli Lilly and Company