Jim Rogers has over 15 years of experience as an applied statistician in the biomedical industry. He currently holds the title of Principal Scientist II at Metrum Research Group, where he leads a team of statistical modeling and simulation scientists. Prior to joining Metrum Research Group, Jim was an Associate Director of Statistics at Pfizer Global Research and Development, where he was the statistical lead on numerous clinical and preclinical projects in neuroscience. In 2008, Jim joined Metrum Research Group in order to work in closer collaboration with quantitative biologists and pharmacometricians. From a methodological perspective, Jim has been especially active in longitudinal modeling of constrained responses (e.g. cognitive rating scales in neuroscience), simulation-assisted design of dose-ranging trials and trials with adaptive features, and technologies for dynamic / interactive statistical support.
Bojan Lalovic, James Rogers, Jonathan French, Mary Flack. PK-PD Analysis of PASI with Data at Boundary: BI 655066, an Anti-IL-23A mAb for the Treatment of Psoriasis. ACoP6. October 4, 2015.
Klaus Romero, Vikram Sinha, Sandra Allerheiligen, Meindert Danhof, Jose Pinheiro, Naomi Kruhlak, Yaning Wang, Sue-Jane Wang, John-Michael Sauer, J. F. Marier, Brian Corrigan, James Rogers, H. J. Lambers Heerspink, Tawanda Gumbo, Peter Vis, Paul Watkins, Tina Morrison, William Gillespie, Mark Forrest Gordon, Diane Stephenson, Debra Hanna, Marc Pfister, Richard Lalonde, Thomas Colatsky. Modeling and simulation for medical product development and evaluation: highlights from the FDA-C-Path-ISOP 2013 workshop. Journal of Pharmacokinetics and Pharmacodynamics
December 2014, Volume 41, Issue 6, pp 545-552.
Daniel G. Polhamus, Jia Kang, James A. Rogers, and Marc R. Gastonguay. Web-based Software for Real-time Simulation-assisted Trial Design in Alzheimer’s Disease. CTAD 2014.
Knebel W, Rogers J, Polhamus D, Ermer J, Gastonguay MR. Modeling and simulation of the exposure-response and dropout pattern of guanfacine
extended-release in pediatric patients with ADHD. J Pharmacokinet Pharmacodyn. 2014 Nov 6.
Angelica Quartino, Dan Polhamus, James Rogers, and Jin Jin. An integrated natural disease progression model of nine cognitive and biomarker endpoints in patients with Alzheimer’s Disease. PAGE 2014. Abstr 3187.
Daniel G. Polhamus, Ph.D., James A. Rogers, Ph.D., William R. Gillespie, Ph.D., Jonathan French, Sc.D. Clinical Dementia Rating Modeling and Simulation: Joint progression of CDR and biomarkers in the ADNI cohort. AAIC 2013.
Jorge Luiz Gross, James Rogers, Daniel Polhamus, William Gillespie, Christian Friedrich, Yan Gong, Brigitta Ursula Monz, Sanjay Patel, Alexander Staab, Silke Retlich. A novel model-based meta-analysis to indirectly estimate the comparative efficacy of two medications: an example using DPP-4 inhibitors, sitagliptin and linagliptin, in treatment of type 2 diabetes mellitus. BMJ Open. 5 March 2013.
William Knebel, Jim Rogers, Dan Polhamus, Sharon Youcha, Carla White, Jim Ermer, and Marc Gastonguay. Modeling and Simulation of Guanfacine Extended-Release to Support Pediatric Trial Design. American Academy of Child and Adolescent Psychiatry, 59th Annual Meeting. 2012.
Rogers JA, Polhamus D, Gillespie WR, Ito K, Romero K, Qiu R, Stephenson D, Gastonguay MR, Corrigan B. Combining patient-level and summary-level data for Alzheimer’s disease modeling and simulation: a beta regression meta-analysis. J Pharmacokinet Pharmacodyn. October 2012, Volume 39, Issue 5, pp 479-498.
James Rogers, Peter Lockwood, Dan Polhamus, Yves Brault, Anne Desmet, Kaori Ito, Klaus Romero, Ruolun Qiu, Bill Gillespie, Brian Corrigan, Marc Gastonguay. Model-based Analysis to Support Strategic Decision Making: A Case Study from the Development of a 5HT6 Antagonist for the Treatment of Alzheimer’s Disease.
Jorge L. Gross, James Rogers, Dan Polhamus, William Gillespie, Sanjay Patel, Christian Friedrich, Yan Gong, Brigitta Monz, Alexander Staab, Silke Retlich. Novel Model-based Meta-Analysis to Estimate comparative Efficacies of 2 Drugs: an Example Using the DPP-4 inhibitors Linagliptin and Sitagliptin in Type 2 Diabetes Mellitus. American Diabetes Association 72nd Scientific Sessions (2012).
James Rogers, Dan Polhamus, William Gillespie, Christian Friedrich, Alexander Staab, and Silke Retlich. Model-based Meta-analysis Comparison of the Effects of Linagliptin and Sitagliptin on HbA1c Levels in Patients with Type 2 Diabetes Mellitus. PAGE 21 (2012).
Dan Polhamus, Jim Rogers, Bill Gillespie, Jonathan French, and Marc Gastonguay. From Evidence Synthesis to Trial Optimization: The adsim Package for Model-based Simulation in Alzheimer’s Disease. PAGE 21 (2012).
M. M. Riggs, T. T. Bergsma, J. A. Rogers, M. R. Gastonguay, G. M. Subramanian, C. Chen, M. Devalaraja, A. E. Corey, H. Sun, J. Yu, and D. S. Stein. Population pharmacokinetics and exposure-response of albinterferon alfa-2b. J Clin Pharmacol, 52(4):475–86, Apr 2012.
Rogers J, Polhamus D, Ito K, Qiu R, Gillespie B, Corrigan B. The Value of Evidence Synthesis: Model-based Meta-analysis Based on the CAMD Database, the ADNI AD Cohort Data, and Literature Meta-data. 2012.
Rogers JA. Combining Summary-level and Patient-level Data for Longitudinal Dose-Response Models: Why and How. Presented at ACOP 2011, San Diego, CA.
Polhamus, D, Baron KT, Purohit, VS, Ravva P, Rogers, JA, Gastonguay MR. A Time to Event Approach for Standard of Care Meta-Analysis in HCV Trials. Presented at ACOP 2011, San Diego, CA
Bergsma T, Fisher J, Gastonguay MR, Hane J, Knebel W, Riggs MM, Rogers JA. Systematic Review of Versioned Files for Modeling and Simulation Quality Control: The“review” R Package. Presented at ACOP 2011, San Diego, CA.
Rogers JA, Ito K, Gillespie WR, Corrigan BW, Gastonguay MR. A Longitudinal Dose-response Model for the Progression of Alzheimers Disease, Based on a Combination of Summary-level and Patient-level Data. Presented at Fourth Annual Bayesian Biostatistics Conference, Houston, TX, Jan 26–28, 2011.
Rogers JA, Wilbur J, Cole S, Bernhardt PW, Bupp JL, Lennon MJ, Langholz N, Steiner CP. Quantifying Uncertainty in Predictions of Hepatic Clearance. Statistics in Biopharmaceutical Research. 2011;3(4):515-525.
James A. Rogers, Ph.D. An Issue in Controlling the Type I Error Rate with Adaptive Designs Using Time-to-Event Endpoints. 3rd Annual FDA/MTLI Medical Device and IVD Statistics Workshop. 28 April 2010.
James A. Rogers, Matthew M. Riggs, Monte Cofﬁner, William R. Gillespie, Robert Burford, Francis Vanderbist, Sophie De Niet, Marc R. Gastonguay. Clinical Trial Simulation to Compare Adaptive and Fixed Designs for a Phase 3 Clinical Trial of Nacystelyn® (L-Lysine-N-acetyl-L-cysteinate) for Cystic Fibrosis. ACOP 2009.
William R. Gillespie, James A. Rogers, Kaori Ito, Marc R. Gastonguay. Population Dose-Response Model for ADAS-cog Scores in Patients with Alzheimers Disease by Meta-Analysis of a Mixture of Summary and Individual Data.
Timothy Bergsma, Jeffrey Hall, Michael S. Smith, Malaz A. AbuTarif, David R. Taft, William Knebel, Joseph Hebert, James Rogers, Jeffrey T. Hane, and Marc R. Gastonguay. Development and Pilot Evaluation of a High-Performance Computing System for Web-Based Deployment of Pharmacometrics Applications in a Multi-User Training Environment. ACOP 2009.
Gillespie B, Rogers JA, Ito K, Gastonguay MR. Population Dose-Response Model for ADAS-cog Scores in Patients with Alzheimer’s Disease by Meta-Analysis of a Mixture of Summary and Individual Data. ASCPT 110th Annual Meeting, March 18-21, 2009.