23-25 October 2024

Rockville, MD - USA

Bayes 2024

DAY 1 – 23 October 2024

TIME
SPEAKER
AFFILIATION
08:30 - 09:00
Registration
09:00 - 12:30
J. Kyle Wathen
Cytel
SHORT COURSE Navigating the Complexities of Platform Trials: Design and Simulation
12:30 - 13:30
Lunch
13:30 - 13:40
Welcome and Opening
Bruno Boulanger
Cencora PharmaLex
James Travis
FDA/CDER
Chair:
Bradley Carlin
Cencora PharmaLex
13:40 - 14:10
James Travis
FDA/CDER
The future of the Bayesian Biostatistics in the regulatory world
14:10 - 14:30
Raviv Pryluk
PhaseV
To Bayes or Not to Bayes:Practical Challenges and Considerations in Supporting the Design of Bayesian Adaptive Trials
14:30 - 14:50
Pantelis Vlachos
Cytel
Simulation-based optimization of adaptive designs using a generalized version of assurance
14:50 - 15:10
Yong Zang
Indiana University
A Bayesian Adaptive Marker-Stratified Design for Phase II Clinical Trials Using Calibrated Spike-and-Slab priors
15:10 - 15:30
Michael Sonksen
Eli Lilly and Company
Considerations on Mixture Priors for Historical Borrowing in Confirmatory Studies
15:30 - 15:55
Coffee break
Chair:
Peter van de Ven
CBG-MEB
15:55 - 16:25
Peter F. Thall
MD Anderson Cancer Center
Bayesian Personalized Treatment Selection for Advanced Breast Cancer
16:25 - 16:45
Steven Andrew Gilbert
Pfizer
Prediction of Overall Survival (OS) from Disease Progression Dynamics in Metastatic Cancer Trials
16:45 - 17:05
Danila Azzolina
Ferrara University
Navigating Challenges in Pediatric Trial Conduct: Integrating Bayesian Sequential Design with Semiparametric Elicitation for Handling Primary and Secondary Endpoints
17:05 - 17:25
Roberto Crackel
FDA/CDER
Application of Bayesian borrowing methods in clinical trials for children with type II diabetes mellitus using simulation and case studies
17:25 - 17:45
Robert Abugov
FDA/CDER
Aligning Bayesian Trial Designs with Expert Opinion: Some Rules of the Road

The BAYES Organising Committee is delighted to invite all registered delegates to the social dinner at Kumbia Restaurant at h. 19:00

DAY 2 – 24 October 2024

TIME
SPEAKER
AFFILIATION
Chair:
Astrid Jullion
Novartis
08:30 - 09:00
Jennifer Kirk
FDA/CBER
Bayesian Statistics and Real-World Evidence: A Successful Example from CBER
09:00 - 09:20
Emma K Mackay
Inka Health Toronto
Bayesian Hierarchical Modelling Approaches to Indirect Treatment Comparisons between Single-arm Basket Trials: An Application to NTRK-fusion Solid Tumours
09:20 - 09:40
Sai Dharmarajan
Sarepta Therapeutics
Enhancing Medical Product Development and Review with Bayesian Quantitative Benefit Risk Methods
09:40 - 10:00
Zhengfan Wang
Genesis Research Group
Bayesian Survival Models for Real-World Evidence: Implementation in Assessing Treatment Duration and Mortality Risk
10:00 - 10:20
Laura Thompson
FDA/CDER
Synthetic Data to Augment Clinical Studies
10:20 - 10:45
Coffee break
Chair:
Yong Zang
Indiana University
10:45 - 11:15
Yanxun Xu
Johns Hopkins University
Enhancing Decision Making with Causal Inference and Unmeasured Confounders in a Bayesian Framework
11:15 - 11:35
Ryan Batten
Phastar
Bayesian Parametric G-Formula as a Sensitivity Analysis for Causal Inference
11:35 - 11:55
Oshri Machluf
PhaseV
The Wolf Will Live with the Lamb:Combining Conformal Prediction with Bayesian Approaches to Enhance Heterogeneity Detection in Clinical Trials
11:55 - 12:15
Gene Pennello
FDA/CDRH
Weighted Posterior Odds: An Evidence Summary for Decision Making
Chair:
Bruno Boulanger
Cencora PharmaLex
12:15 - 12:30 MY TALK
IN 5 MINUTES
Danila Azzolina
Ferrara University
Enhancing Pediatric Clinical Trials: A Shiny App for Bayesian Adaptive Semiparametric Design, Communication and Implementation
Reynaldo Martina
University of Utrecht
The application of a Poisson difference model under the skellam distribution assumption for the analysis of the change in count measurements in a random effects repeated measures model
Joseph Sartini
Johns Hopkins University
Bayesian Multilevel Functional Principal Components Analysis with Application to Continuous Glucose Monitoring Data
12:30 - 13:30
Lunch
Chair:
Bruno Boulanger
Cencora PharmaLex
13:30 - 14:00
Yize Zhao
Yale University
Bayesian Modeling for Brain Connectivity and Its Link to Genetics and Behavior
14:00 - 14:20
Elena Sizikova
FDA/CDRH
Bayesian statistical methods for evaluating interchangeability of clinical samples with non-clinical samples in evaluating measurement procedure and diagnostic test accuracy
14:20 - 14:40
Bill Pikounis
Johnson & Johnson
Comparability with Statistical Rigor in Manufacturing Development
14:40 - 15:00
Will Landau
Eli Lilly and Company
brms.mmrm: an R package for Bayesian MMRMs
15:00 - 15:20
Tingting Hu
FDA/CDRH
Evaluating diagnostic test accuracy in studies with extreme verification bias
15:20 - 15:45
Coffee break
Chair:
Bradley Carlin
Cencora PharmaLex
15:45 - 16:15
Ying Yuan
MD Anderson Cancer Center
A Bayesian latent-subgroup phase I/II platform design to co-optimize doses in multiple indications
16:15 - 16:35
Jonathon Vallejo
FDA/CDER
FDA Project Optimus: Current Status and General Regulatory Perspectives
16:35 - 16:55
Ming-Dauh Wang
Bayer Pharmaceuticals
A Comprehensive Bayesian Double-Adjustment Approach to Dynamic Borrowing of External Data
16:55 - 17:15
Saijun Zhao
Indiana University
Precision Generalized PhaseI-II Designs for Personalized Dose Optimization

DAY 3 – 25 October 2024

TIME
SPEAKER
AFFILIATION
Chair:
Ming-Dauh Wang
Bayer
09:00 - 09:30
Bhramar Mukherjee
Yale University
High Dimensional Bayesian Mediation Analysis for Understanding Biological Mechanisms
09:30 - 09:50
Boaz N. Adler
Cytel
Flexibility in Clinical Trial Design using Software in combination with R Code: Incorporating Bayesian Treatment Resistance Assumptions
09:50 - 10:10
Jacqueline Buros
Generable
Multi-State Models with Multiple Timescales: a Bayesian Approach
10:10 - 10:35
Coffee break
Chair:
James Travis
FDA/CDER
10:35 - 11:05
Amy Crawford
Berry Consultants
Identifying the Population Responsive to EVT: Bayesian Modeling in the STEP Platform Trial
11:05 - 11:25
Mark Rothmann
FDA/CDER
Bayesian Supplemental Analysis Demonstration Project
11:25 -11:45
Shaoming Yin
Takeda
Augmenting clinical trial data with external controls through energy balancing weighted power prior
11:45 -12:05
Reynaldo Martina
University of Utrecht
The analysis of TMS-EEG data in a Bayesian multivariate Copula model for prediction of clinical efficacy
12:05 -12:25
Yun Wang
FDA/CDER
Bayesian hierarchical model for subgroup analysis
12:25 - 12:35
Closing Remarks
Bruno Boulanger
Cencora PharmaLex
Peter van de Ven
CBG-MEB

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