ACoP14

Welcome to ACoP

 

Enhance your ACoP14 Conference experience by taking part in our carefully curated pre and post-meeting workshops. These workshops have been designed to provide you with valuable insights, skills, and knowledge that complement the conference content.

Pre-Meeting Workshops:  Prepare yourself for ACoP14 by participating in our pre-meeting workshops. These sessions are tailored to provide in-depth training and perspectives before the conference even begins. Dive into specialized topics and gain a competitive edge in discussions during the main event.

Post-Meeting Workshops:  Extend the benefits of ACoP14 by joining our post-meeting workshops. These workshops allow you to continue your learning journey, reflect on conference insights, and delve deeper into relevant subject matter. Capitalize on the momentum from the main event and keep the conversation going.

Why Attend Our Workshops:

  • Comprehensive Training:  Our workshops offer comprehensive training led by industry experts, ensuring you acquire practical skills and knowledge.
  • Interactive Learning:  Engage in hands-on activities, discussions, and case studies that facilitate active learning and application.
  • Tailored Content:  Choose from a diverse range of workshops that align with your interests and professional goals.
  • Networking Opportunities:  Connect with fellow participants who share your passion for growth and development.
  • Enrich Your Experience:  These workshops are designed to enrich your ACoP14 experience, offering valuable takeaways that will impact your career long after the event concludes.

Don't miss out on the chance to make the most of your ACoP14 Conference participation. Explore our lineup of pre and post-meeting workshops, and secure your spot today to embark on a journey of growth, discovery, and skill-building.

Click Here to Register for a Workshop


Pre-and Post-Meeting Workshop Information 

Saturday, November 4, 2023

Model-Based Meta-Analysis (MBMA): Concepts, Methodologies, and Hands-on Workshop - Full Day
Organizer: Certara
Pricing: Non Member - $550 | Member - $500 | Trainee - $250
Time:
8:00 am - 5:00 pm 

Attendees of this one-day workshop will learn about model-based meta-analysis (MBMA) – starting with the basic principles of meta-analysis and moving toward detailed applications of complex MBMA methodologies.   Concepts will be explained using case studies, accompanied by detailed hands-on R scripts and real datasets.  We will also explore datasets and perform directed analyses using Certara’s CODEx software platform.

Some critical topics include:

MBMA of binary and continuous data
Dose-response MBMA
Longitudinal MBMA
Relative effect vs absolute outcome modeling
Unstructured (nonparametric) placebo methodology
Random effects and weighting of data
Data transformations
MBMA covariate exploration
Joint MBMA of multiple endpoints


Finch Studio NONMEM Workbench with Case Studies in Target-Mediated Drug Disposition - Full Day 
Organizer: Enhanced Pharmacodynamics
Pricing: Non Member - $825 | Member - $725 | Trainee - $300
Time: 8:00 am - 5:00 pm

Join us for a comprehensive workshop on pharmacometric modeling with Finch Studio. The day includes an introduction, installation guidance, hands-on Finch Basics, NONMEM model evaluation, lunch, lectures on drug disposition principles, and advanced Finch features like R Scripts and Bootstrap. The day ends with an open discussion and Q&A. Get ready to enhance your modeling skills!


Reporting Pharmacometrics Analyses Introduction to Quarto - Full Day
Organizer: Gilead Sciences
Pricing: $75
Time: 8:00 am - 5:00 pm

Quarto is a general reporting system tool designed to facilitate data science workflow. It can be a helpful tool for pharmacometricians to construct, visualize, and report pharmacokinetic and pharmacodynamic data modeling and simulation. It provides a range of features to support the analyses (implementing R, Python or Julia), and its user-friendly interface makes it accessible to both novice and experienced pharmacometricians.  Key topics:  Introduction to Quarto: The workshop will start with an introduction to Quarto, its user interface, and the different features available to pharmacometricians. Creating your first document with different formats (HTML, PDF, Beamer, and Word).  Quarto speaks pharmacometrics: Using quarto in pharmacometric analyses.  Case studies and hands-on exercises: To reinforce the concepts covered in the workshop, participants may be given case studies to work through and hands-on exercises to complete. This will allow them to apply what they have learned in a practical setting and get feedback from the instructor.  Overall, attending a Quarto workshop for pharmacometrics can be an excellent way to enhance your skills and knowledge in using this powerful software tool. Whether you are new to Quarto or already have some experience using it, you will likely benefit from the insights and the interactive learning environment provided by the workshop.


Hands-On Tutorial: Introduction to Immuno-Oncology (IO) Quantitative Systems Pharmacology (QSP) Modeling Using the Open Source Julia Programming Language - Full Day
Organizer: Metrum Research Group
Price: Non Member $900| Member $900 | Trainee $400
Time: 8:00 am - 5:00 pm

Join us for a packed day of learning! We'll start with breakfast at 7:30 AM, followed by workshop logistics and logging into Metworx at 8:30 AM. From 9:00 AM to 10:30 AM, we'll provide an overview of Immuno-Oncology Drug Development, covering its history, model-informed development, and various modeling approaches. After a short break from 10:30 AM to 11:00 AM, we'll introduce you to the Julia Computing Environment and Jupyter Notebooks from 11:00 AM to 12:00 PM. Lunch will be served from 12:00 PM to 12:45 PM. In the afternoon, we'll dive into hands-on tutorials on Antibody Drug Conjugate (ADC) and Bispecific Antibody QSP Modeling from 12:45 PM to 4:30 PM, with a break in between. The day concludes with a thirty-minute session on miscellaneous problem-solving tips, followed by questions, discussions, and a wrap-up session from 4:30 PM to 5:00 PM. Don't miss this opportunity to enhance your knowledge and skills in Immuno-Oncology Drug Development!


Scientific Modeling Augmented by Machine-Learning with DeepPumasTM - Two Day
Organizer: Pumas AI
Price: Non Member $750 | Member $750 | Trainee $200
Time: 8:00 am - 5:00 pm (Two Day)

Join us for an intensive two-day workshop on November 4th and 5th, 2023. On the first day, we'll kick off with an Introduction to Pumas and DeepPumas, followed by Setting up the workspace. The morning will continue with a deep dive into Population Pharmacokinetic modeling, covering both an overview of Pumas and its workflow and iterative model building. After a short coffee break, we'll explore Sequential PKPD with a focus on the Indirect response model and break for lunch. In the afternoon, we'll shift our attention to Survival modeling, and conclude the day with Data Wrangling.

Day two begins with a lecture on Machine Learning & Neural Networks. We'll then delve into topics like fitting, overfitting, and regularizing Neural Networks. After a coffee break, we'll explore the capabilities of DeepPumas, including automatic identification of dynamics, and the theory behind DeepPumas. Lunch will be followed by an engaging afternoon session, with topics such as DeepPumas Tumor size modeling, DeepPumas survival modeling, and exploring joint tumor size inhibition and overall survival models. We'll wrap up the workshop with concluding remarks and a glimpse into future possibilities. Don't miss this opportunity to enhance your skills and understanding of Pumas and DeepPumas!


Applying PBBM/PBPK Modeling to Predict Absorption-Related Drug-Drug Interactions: Approaches, Special Considerations, and link toward population PK" - Half Day
Organizer: Simulations Plus
Pricing: Non Member $100 | Member $100 | Trainee $50
Time: 8:00 am - 5:00 pm

The focus of this 1-day workshop will be to discuss how the co-administration of proton pump inhibitors (PPIs) and acid-reducing agents (ARAs) impact gastrointestinal physiology and have been incorporated into physiologically based biopharmaceutics (PBBM) / pharmacokinetic (PBPK) models to predict absorption-related DDIs. A combination of presentations and interactive examples using the GastroPlus® PBBM/PBPK modeling platform will illustrate how to parameterize baseline models for several drugs and, once validated, apply them to predict the changes in absorption and systemic exposure when the drug is co-administered with PPIs/ARAs. Proposed workflows to inform clinical development and regulatory interactions will be discussed, and gaps in the current methods will also be explored.

Click Here to Register for a Workshop


Sunday, November 5, 2023

Practical application of MID3 to inform Early Drug Discovery Decisions using Applied BioMath Assess™ - Half Day
Organizer: Applied BioMath LLC
Pricing: Non Member $300 | Member $100 | Trainee $50
Time: 1:00 pm - 5:00 pm (Half Day)

Session 1 (1 hour): Understanding of the EFA methodology and how it can be used to inform early drug discovery decisions. * 30 min break* Session 2  (1 hour):  EFA case study based upon a complex biotherapeutics drug. Participants will break into small teams to implement an EFA for their target.  Using provided web-based software, models, and literature, teams will be expected to select an appropriate model, parameterize it with data from the provided literature, and analyze the model to answer their specific questions. Experts will be available to help participants.* 30-minute break* Session 3  (1 hour): Team presentations on conclusions from case studies. Teams will present the conclusions of their assessment to the group, and their recommendation for the program. The organizers will then present an analysis for discussion.


Simcyp Designer PBPK-QSP Focused Workshop - Full Day
Organizer: Certara
Pricing: Non Member $600 | Member $400 | Trainee $200
Time: 8:00 am - 5:00 pm

This year, Certara UK is running a one-day Simcyp hands-on workshop on developing population-PBPK driven PD/QSP (quantitative systems pharmacology) models within its new integrated platform ""Simcyp Designer"". The course reviews the fundamentals of PBPK and QSP modelling using the Simcyp Simulator and builds rapidly to specialised applications where you will modify existing PBPK models with your own PD/QSP extensions. We will also examine the propagation of population variability to mechanistic models of therapeutic effects dynamically interacting with drug distribution models, as well as analysing population variability in clinical data.

The key topics covered are:

  • Latest advances of PBPK modelling using the Simcyp Simulator,
  • Generation of realistic population variability using correlated Monte Carlo sampling, covariate modeling within the Simcyp Simulator,
  • Replacing or modifying a tissular compartment within the Simcyp Simulator with a user-defined model,
  • Creating PD/QSP models using the Simcyp Designer's graphical editor,
  • Incorporating physiological covariates within a user-defined mechanistic effect model,
  • Adding target mediated drug disposition (TMDD) processes to tissue compartments,
  • Extending PBPK models for therapeutic proteins,
  • Optimising PBPK models using data across different clinical trials simultanoulsy."

New and Advanced Methods of NONMEM7 - Full Day
Organizer: ICON
Pricing: Non Member $600 | Member $600 | Trainee $150
Time: 8:00 am to 5:00 pm

The objective of this course is to introduce advanced concepts of population pharmacokinetics in NONMEM.  The course is targeted to individuals interested in solving population PK/PD problems using the new stochastic methods.  The course is for those who are familiar with classic NONMEM methods (first order (FO)/first-order conditional estimation (FOCE)/Laplace), and are familiar with constructing control stream files.  Most of the course is instructional, with several hands-on examples for attendee participation. A thorough discussion of stochastic approximation expectation maximization (SAEM), Importance sampling (IMP), and Markov chain Monte Carlo Bayesian analysis (Gibbs BAYES sampling and new in NONMEM7.4: Hamiltonian no-U turn sampling) will be presented, along with hands-on exercises.  In addition, the FAST algorithm for FOCE analysis, new in NONMEM 7.4, will be introduced.  New in NONMEM 7.5: Optimal clinical design and evaluation tool is available, as well as delay differential equation solvers.  After attending this course, the participant will know how to use advanced stochastic methods for analyzing population PK/PD data; structure the models into a MU-referencing format that will greatly increase the efficiency of the analyses; apply prior information from previous analyses to the present data; create population mixture models; create models for categorical data; use new abbreviated code features for easier modeling of inter-occasion variability; model additional mixed effects levels for grouping individuals, such as inter-clinical site variability; use the DO loop feature in abbreviated code, such as for handling multiple bolus doses in transit compartment models that use the analytical absorption function.  Additional topics covered are: parallel computing and dynamic memory allocation for efficient memory usage; symbolic referencing to thetas, etas, and sigmas; Monte Carlo search algorithms to improve FOCE estimation; built-in individual weighted residuals; bootstrap tools for simulation; and greater control in average eta shrinkage calculations; and automatic protection against numerical exceptions using NONMEM7.4’s new $ABBR PROTECT feature.


Global Sensitivity Analysis with SimBiology - Half Day
Organizer: Mathworks
Price: Free
Time: 8:00 am - 12:00 pm (Half Day)

Sensitivity analysis lets you explore the effects of variations in model quantities on a model response. You can use the analysis to identify key pathways and parameters or validate preexisting knowledge on influential model quantities.  Local sensitivity analysis (LSA) analyzes the effect of one model parameter at a time, keeping the other parameters fixed. In global sensitivity analysis (GSA), on the other hand, model inputs are varied together to simultaneously evaluate the relative contributions of each quantity with respect to a model response. Thus, GSA can be used to understand which model inputs drive the model response across the entire input space and inform parameter calibration strategy. SimBiology provides the following methods to perform GSA: Calculation of Sobol Indices, Multiparametric GSA (MPGSA), and Elementary Effects (EE).  In this half-day workshop, we will introduce the Global Sensitivity Analysis (GSA) functionality in MATLAB/SimBiology and discuss:

  • The differences between Local and Global Sensitivity analysis when it is appropriate to apply each method
  • How to perform Local and Global Sensitivity Analysis with SimBiology
  • How Sobol-indices, Multiparameteric GSA, and Elementary Effects are calculated and differences between methods - Interpretation of the results
  • How to choose your sample size for these GSA methods

Effective Simulation with mrgsolve for Model-Informed Drug Development - Full Day
Organizer: Metrum Research Group
Price: Non Member $900 | Member $900 | Trainee $300

Time: 8:00 am - 5:00 pm

Get ready for an engaging workshop with a flexible schedule. We'll cover essential topics in pharmacometrics modeling using mrgsolve:

  • Workshop Logistics, including an overview and Metworx login.
  • A brief hands-on introduction to mrgsolve.
  • Modeling with NONMEM and mrgsolve in an MIDD Project Context.
  • Simulation for Typical Project Objectives, encompassing model diagnostics and outcome simulation.
  • Simulation case studies to support MIDD, highlighting common simulations.
  • Wrapping up with tips, tricks, an open discussion, and questions.

Join us to enhance your mrgsolve modeling skills.


An introduction to probabilistic decisions support in drug development - Full Day
Organizer: Pharmetheus
Price: Non Member $825 | Member $550 | Trainee $275

Time: 8:00 am - 5:00 pm

The workshop aims to introduce how Model-Informed-Drug-Development (MIDD) principles can be applied to facilitate probability-based decision-making in drug development. The workshop will introduce a number of relevant concepts such as; power, assurance, probability of pharmacological success (PoPS), probability of technical success (PTS), probability of technical and regulatory success (PTRS), etc. Furthermore, the workshop will highlight important requirements for the basis of such probability predictions incl. fit-for-purpose models, clinical trial simulation methodology, etc. In addition to basic theory with regards to these topics, the workshop will include practical recommendations on the application and efficient communication of MIDD approaches from tutors with extensive experience in this area. The target audience is scientists with a modeling and/or statistics background and a basic understanding of the overall drug development process. 


Modeling Delays in Pharmacokinetics and Pharmacodynamics using NONMEM - Full Day
Organizer: ISOP SIG MCS
Price: Non Member $800 | Member $400 | Trainee $200
Time: 8:00 am to 5:00 pm

This comprehensive course covers a range of important topics related to modeling biological systems with delays. It includes an introduction to concepts like lifespan-driven pharmacodynamic responses, cell maturation modeling, and nonlinear mixed-effect lifespan models. Participants will also gain hands-on experience in implementing delay differential equations (DDEs) and distributed delay differential equations (DDDEs) using NONMEM version 7.5. The course offers a combination of lectures and practical computer exercises to ensure a thorough understanding of the subject matter.

Click Here to Register for a Workshop


Thursday & Friday, November 9 & 10, 2023

Pharmacometrics modeling & simulations using MonolixSuite: from introductory to advanced concepts and applications." - 1 1/2 Day
Organizer: Lixoft/Simulations Plus
Price: Non Member $1,000 | Member $1,000 | Trainee $1,000

Time: 1:00 pm - 5:00 pm (Thursday) | 8:00 am - 5:00 pm (Friday)

This training will give you the keys to move your modeling skills to the next level. It is designed for modelers with already some experience with Monolix, who wish to i) better understand the algorithms and their options, ii) acquire the skills to implement complex models, iii) improve their model building strategy. The course will alternate lectures and interactive, hands-on sessions with Monolix.I - Algorithms and good practices for parameter estimation* Estimating the population parameters: theory and practice** SAEM and its settings** Assessing the convergence** Handling parameters without variability** When to use simulated annealing* Estimating the EBEs: the Nelder-Mead algorithm* Estimating the conditional distribution: settings of MCMC, transition kernels, automatic stopping rule* Estimating the Fisher Information Matrix with linearization or stochastic approximation* Estimating the likelihood with linearization or importance sampling Monte Carlo* Simulated BLQs and their usage in MonolixII - Methods for statistical model building* Diagnostics for the statistical model** Interpretation of diagnostic plots** Understanding shrinkage and how to circumvent it** Performing unbiased statistical tests* Strategies for automated model building** Covariate search using COSSAC** Model building using SAMBA* Implementing complex statistical models** Non-standard inter-individual variability** Complex covariate-parameter relationships** Inter-occasion variability


PBPK-PD/QSP modeling with the OSPSuite (PK-Sim®, MoBi®) - 1 1/2 Day
Organizer: Pharmetheus
Price: Non Member $1,100 | Member $700 | Trainee $400
Time: 1:00 pm - 5:00 pm (Thursday) | 8:00 am - 5:00 pm (Friday)

Do you want to improve decision-making with PBPK and PD/QSP modeling in drug development? This workshop will teach how to leverage the Open Systems Pharmacology (OSP) suite (also known as PK-Sim® and MoBi®) to create WB-PBPK-PD/QSP models. We will utilize the standardized and well-established whole-body PBPK model provided in PK-Sim® and combine it with the open modeling possibilities in MoBi®. The workshop will highlight several relevant OSP techniques, such as create and reuse PK-Sim building blocks, cloning simulations, performing Parameter identifications, add reactions or additional PD read outs in MoBi. The goal is to give participants (beginners to advanced users) a solid foundation to apply PK-Sim® and MoBi® in future projects.


Advanced Clinical Trial Simulations to Support MIDD - 1 1/2 Day
Organizer: Pumas AI
Price: Non Member $750 | Member $750 | Trainee $750
Time: 1:00 pm - 5:00 pm (Thursday) | 8:00 am - 5:00 pm (Friday)

This hands-on workshop is designed for experienced scientists leading MIDD projects to support key drug development and regulatory decisions. MIDD has been used to alleviate Phase 3 trials, evaluate efficacy or safety-guided precision dosing, accelerate drug development for oncology and rare diseases, set regulatory policy, and support surrogate selection.  Pumas modeling and simulation workflows feature a flexible and powerful interface for you to seamlessly set up simulation models, create patient populations, simulate clinical trials using high-performance computing, and determine probability of technical success. Pumas allows end-to-end project execution at lightning speeds. The workshop will cover a case study featuring a full clinical trial simulation workflow. At the end of the workshop, participants will:

  • Learn good-simulation-practices.
  • Gain an overview of the Pumas modeling and simulation ecosystem.
  • Learn how to generate patient populations under specific inclusion/exclusion criteria.
  • Learn how to perform simulation qualifications.
  • Master how to boost computational power to perform large simulations.
  • Learn how to perform post-processing and visualizations of simulations for reporting.
  • Understand the strategy behind precedent-setting MIDD case studies.

Click Here to Register for a Workshop


 

 

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