Workshops – vredif2024.sccq.com.co

Workshop

April 22nd and 23rd 2024

Notes:
1) In every workshop, the maximum number of attendees is 20.
2) After paying for the workshop, please register using this form to indicate your preferred workshop. https://forms.gle/L9MMo2bWfrJqQQmJA

1. Certara Workshop: An Introduction to CAR-T Population Kinetic Analysis

Speaker: Dr Mirjam Trame (Vice President, Certara Drug Development Solutions)

This hands-on workshop will provide an introduction to CAR-T population kinetic analysis and CAR-T concepts including:

Therapeutic utility and challenges in drug development of CAR-T initiatives
The basis for understanding the cellular kinetics of CAR-T cells
Models that have been used to describe the kinetics of CAR-T cells and typical inferences
CAR-T cell kinetic modelling

The workshop consists of lectures and interactive hands-on sessions using NONMEM and R. During the hands-on session participants will have the opportunity to explore CAR-T cell data and key features of cellular kinetics as well as fit base models to cellular kinetic data in order to understand the nuances of CAR-T cell kinetic modeling for autologous and allogenic CAR-T cell therapies.

It is expected that participants will bring their own devices and have access to and familiarity with NONMEM and R.

Language: English
Note: This is a one-day workshop (April 23rd).

1. Course on Population Pharmacokinetic and Pharmacodynamic Analysis

Speakers: Manuel Ibarra (Udelar, Uruguay), and Iñaki F. Trocóniz (UNAV, Spain)

Objective: The aim of this workshop is to introduce the concepts, notions and basic skills needed to get involved and perform population pharmacokinetic/pharmacodynamic/disease analyses using nonlinear mixed effect models with the software MonolixSuiteTM (SimulationsPlus, Inc.).

The target audience of this Workshop is broad including academics, regulators, drug developers and clinicians.

Basic knowledge in pharmacokinetics and pharmacodynamics is highly recommended.

Outline
Introduction to population analysis
• Nomenclature, Concepts, and Scope
Leveraging available information
• Dataset requirements and organization
Model implementation
• Biopharmaceutic, Pharmacokinetic, Pharmacodynamic and disease progression models
Model evaluation, validation, and exploration
• Goodness of fit plots, simulation-based diagnostics, bootstrap analysis
Simulations
Reporting of results
Case studies
• Clinical pharmacokinetics of antibiotics in critical patient populations
• Tumor growth inhibition and myelosuppression

MonolixSuiteTM (SimulationsPlus, Inc.) will be used as support for theory and examples. It is expected that participants will bring their own devices.

Language: Spanish
Note: This is a two-day workshop (April 22nd and 23rd).

2. PK-Sim: an open-source tool to bring your compound from in vitro to the market.

Speakers:

· Dr. José David Gómez-Mantilla. Senior Principal Scientist at Boehringer Ingelheim Pharma GmbH & Co. KG

· Luis David Jiménez. Senior Scientist Systems Pharmacology at esqLABS GmbH.

First Day
• Principles of PBPK
• Model building
• Data handling and Parameter optimization
• Individual and Population Simulations
• Inter-species extrapolation

Second Day
• First in vivo dose estimation
• Special populations
• Strengths and limitations
• PBPK group challenge

It is expected that participants will bring their own devices.

Language: Spanish
Note: This is a two-day workshop (April 22nd and 23rd).

3. An interactive train-the-trainer course on PKPD exploration and pharmacometrics problem solving using open-source tools including nlmixr2, PKNCA and ShinyMixR.

Speakers: · Anne Keunecke; LAP&P consultants; Leiden, Netherlands and Bill Denney; Human Predictions, LLC; Boston, MA, USA

Objective: This interactive train-the-trainer course is intended for researchers and professionals with knowledge of the basic PK/PD concepts and the population approach, preferably with basic modelling experience.

Pre-requisites: Attendees should have experience using R and some amount of experience using the nlmixr2 package for R (or experience with nlmixr, rxode2, or RxODE). Participants will be asked up front to provide some detail on their experience in the form of a questionnaire, to align expectations. Hands-on activities will use R and nlmixr2 within a shinyMixR workflow [Fidler et al., 2019]. Installation of R is required before the course, and installation instructions for nlmixr2 and related packages will be shared shortly before the course. More information on these open-source packages please visit: https://nlmixr2.org/

Learning objectives: In this two-day course we will specifically discuss the importance of understanding PK/PD data to make the right decisions in popPK/PD model development and application of popPK/PD approach to answer your research question or support dose/treatment decisions, etc.

If you want to learn more on:
· Identifying typical and less common pharmacokinetic (PK) profiles for linear and some nonlinear PK models.
· Understanding the interplay between PK and PD (e.g., direct and indirect effects),
· Scaling the model for first in human (FIH) approaches.
· Obtaining initial estimates to PK models, fitting, and modifying the PK models, and fitting PK/PD models.

After a short introduction, we will directly dive into a hands-on session, in which the participants work in small groups on data-exploration, the development of linear and some nonlinear PK models and the most common of PK/PD models addressing direct and indirect effects using nlmixr2, PKNCA and ShinyMixR

It is expected that participants will bring their own devices.

Language: English
Note: This is a two-day workshop (April 22nd and 23rd).

4. GastroPlus Workshop on PBBM: applications on IVIVC and Virtual Bioequivalence.

Speaker: James Mullin- Associate Research Fellow- Simulations Plus

Day 1
Introduction to Physiologically Based Biopharmaceutics Modeling Using GastroPlus
Mechanistic Absorption Modelling Considerations
Mechanistic Dissolution Modelling Considerations Part 1
Mechanistic Dissolution Modeling Considerations Part 2

Day 2
Mechanistic IVIVCs & Virtual Bioequivalence Part 1
Mechanistic IVIVCs & Virtual Bioequivalence Part 2
Food Effect Modeling
Complex Generics: “The Next Frontier”

Note(s): Simulations Plus will set up a cloud server. Will have hands-on activities.
Prerequisite: Assuming mixed audience of beginners and advanced.