Past Events

Pharmacometrics-Enabled Dose Optimization (PEDOOP) for Seamless Phase I-II Trials in Oncology

Webinar

StatsforPMx

The application and utility of a dose-optimization design for a first-in-human oncology trial that aims to identify a suitable dose for late-phase drug development will be reviewed.

ACoP15 Programming

ACoP15

Program

SxP reviewed the ACoP program and abstracts to select content of interest for SxP

ACoP15 Posters

ACoP15

Posters

SxP reviewed the ACoP program and abstracts to select content of interest for SxP

Comparison between PD-1 and PD-L1 treatments using model-based meta-analysis (MBMA) and traditional meta-analysis (MA) of objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) in metastatic non-small-cell lung cancer (mNSCLC)

Webinar

StatsforPMx

The application and utility of MBMA and MA of immune checkpoint inhibitors to inform decisions on development plans in mNSCLC will be reviewed.

Maximizing on Minimal Data using Pharmacometric Modeling to Estimate the Probability of Technical Success: John Prybylski and Min Zhang

Webinar

StatsforPMx

Dermatomyositis, a rare disease affecting skin and muscle tissues, poses unique challenges for clinical trials. Learn how exposure-response modeling helped overcome data limitations in a Phase 2 study of an investigational IFNβ monoclonal antibody, paving the way for further development.

PFIM 6.0 on CRAN

Announcement

Optimal Design

Announcement of PFIM 6.0 availability on CRAN.

Overview of CDISC ADaM Population PK Data Standard ADPPK Implementation Guide

Webinar

PKPD PROGRAMMING SUBGROUP

CDISC

ADPPK

Overview of a CDISC ADaM standard for data supporting Population PK (PopPK) analysis with the FDA’s perspective in adopting these standards.

Handling missing covariates in model-Based meta-analysis (Use-case for competitive benchmarking): Rana Jreich and Phyllis Chan

Webinar

StatsforPMx

Discussion of statistical approaches to handle missing baseline characteristics in MBMA with a use case example for fenebrutinib in rheumatoid arthritis.

ACoP14 SxP SIG Lunch

Meeting

ACoP

ACoP14 SxP SIG Lunch - Presentations from SxP SIG LT and SxP Trainee Abstract Award Winner

ACoP14 Programming

ACoP14

Program

SxP reviewed the ACoP program and abstracts to select content of interest for SxP

ACoP14 Posters

ACoP14

Posters

SxP reviewed the ACoP program and abstracts to select content of interest for SxP

Changes to Population PK/PD data and supplemental information based on FDA Guidance for PopPK

Webinar

PKPD Programming Subgroup

FDA Guidance

PopPK

In this presentation the speakers highlight the updates in the latest FDA Guidance for Population PK that impact the PMx Datasets, Report and eSub aspects.

The Decision-Equivalence Metric (DEM) method for Evaluating Surrogate Endpoints for Accelerated Clinical Development Using a Combination of Individual Level and Aggregate Level Literature Data: Chandni Valiathan, John Maringwa and Lixia Pei

Webinar

StatsforPMx

ASA BioPharm

Define and explore the decision-equivalence metric (DEM) method that leverages both individual and aggregate data and uses practical approaches to assess surrogate markers for clinical development.

Evaluation of covariate effects using forest plots and introduction to the coveffectsplot R package: Samer Mouksassi

Webinar

StatsforPMx

Webinar on why forest plots are needed for an effective communication of covariates effects, how they are constructed, and how they should be presented.

A Gentle Introduction to Optimal Design for Pharmacometric Models

Webinar

StatsforPMx

Webinar on introduction to basic concepts of optimal design with examples

Estimands and Causal Inference: Oliver Sander and Christian Bartels

Webinar

StatsforPMx

Webinar to help pharmacometricians understand statistical concepts on Estimands and Causal Inference

Variability and Uncertainty: Chuanpu Hu

Webinar

Rosa Webinar - Variability and Uncertainty- Interpretation and Usage of Pharmacometric Simulations And Intervals

ACoP13 SxP SIG Lunch

Meeting

ACoP

ACoP13 SxP SIG Lunch - Presentations from SxP SIG LT and SxP Trainee Abstract Award Winner

ACoP13 Posters

ACoP13

Posters

SxP Education Committee reviewed the ACoP program and abstracts to select content of interest for SxP

ACoP13 Programming

ACoP13

Program

SxP Education Committee reviewed the ACoP program and abstracts to select content of interest for SxP

ADA/Immunogenicity Data Handling

Webinar

PKPD Programming Subgroup

ADA

Immunogenicity

We would like to take this opportunity to give an overview of development of anti-drug antibody(ADA), interpretation of immunogenicity data, industry practices of structured data…

Update on CDISC ADaM Population PK Data Standard ADPPK

Webinar

PKPD Programming Subgroup

CDISC

ADPPK

In this presentation we will provide a status update and present the current CDSIC ADPPK Standard. We will also discuss how companies can adopt ADPPK and implement it into their workflows.

Review of proposed NCA ADAM standard

Webinar

PKPD Programming Subgroup

NCA

CDISC

ADNCA

We would like to take this opportunity to give an overview of ADNCA, dataflow considerations and open up for discussion and questions from everyone across the industry.

Introduction to MBMA

Webinar

MBMA

MBMA Subgroup

The Model-Based Meta-Analysis sub-Special Interest Group (MBMA sub-SIG) of the Statistics and Pharmacometrics Special Interest group (SxP SIG) held an Introduction to MBMA webinar on 26th January, 2021.

You say ‘Tomato’, I say ‘Tomahto’

Session

ACoP