GMP 2023 Symposium (Groupe de Métabolisme et Pharmacocinétique)

Join us in Paris from October 18th-20th, 2023. The aim of the meeting is to produce a lively open discussion around the key topics of interest with delegates from a wide range of companies and groups from Europe. Click here to view the preliminary program.

Stop by and see us in booth #3.

Workshops

Title: First in Human (FIH) Dose Selection: from Basic Concepts to Novel Considerations: PBPK for FIH
Date/Time: Tuesday, October 17, 2023, from 9:30 am – 6:00 pm
Presenter: François Bouzom, Director, Simulations Studies will present as part of the workshop from 11:30 am – 12:10 pm on PBPK for FIH
First-in-Human (FIH) Dose Selection is a key consideration in the drug development of new promising drug candidates. Such estimation involving cross-functional expertise and collaborations is essential for the design of efficient and successful Phase 1 clinical trials. FIH dose is based on the Regulatory requirements and the concept and strategy differ depending on drug modality, from small molecules to innovative biotherapeutics. For more information click here.

Title: Pediatric PBPK workshop using GastroPlus™
Date/Time: Wednesday, October 18, 2023, from 9:00 am – 12:30 pm
In this 3-hour workshop, the general concepts of developing a PBPK model will be reviewed, followed by an in-depth focus on the use of PBPK modeling for pediatric simulation. The aim will be to understand the difference between adult and pediatric simulations, highlighting the points of attention to ensure quality predictions. Examples will be provided, and hands-on exercises performed.
(free for members, needs to be booked separately, first come-first served basis)

Presentation

Title: New Approaches in PK Modeling and QSP of Biologics
Date/Time: Thursday, October 19, 2023, from 10:00 am – 12:00 pm
Chairs: Maxime Le Merdy (Simulations Plus), Jeremy Perrier (PhinC), Carla Troisi, Sarah Lobet (Tours University), Isabelle Deprez (Certara)
The world of Biologics is expanding with new entities and new targets, thus requiring new approaches to understand the PK and interactions with its biological environment.
This session will present how modeling is used to assess new targets and support the development of new biological drugs.