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GMP 2023 Symposium preliminary Program

October 18 12:30 pm - October 20 2:00 pm

Dear members,
On behalf of the GMP Board and Scientific Committee, it is our great pleasure to share with you the preliminary program to the 35th GMP Symposium.
Registrations will be open in May.
We hope to see you there with the exciting scientific and social programs.

You will find below a selection of hotel with negociated prices near the Espace Centenaire.

Please, be advice that the rooms are getting more and more scarce. We then recommend to book as early as possible.

Warm regards,

The GMP Board


 

35th GMP SYMPOSIUM
PRELIMINARY PROGRAM

Day 1 – 18 Oct 2023

12.30 – 13:30

Arrival and Registration
Welcome Coffee/Tea

13:30 – 13:40

Welcome to 2023 GMP Symposium

Session 1

13:40 – 15.10

Translation of Drug-Drug-Interaction from In-Vitro to In-Vivo
Microphysiological systems aim to mimic the complex structure, microenvironment and physiological functions of human organs, so it has gradually become an ideal tool for in vitro ADMET, drug-drug-interaction and pharmacological studies. The aim of the session is to highlight the advantages of those models and how to translate the data generated to the human situation in particular for DDI predictions.

15:10 – 15:40

Coffee Break and Poster Session

Session 2

15:40 – 17:10

Update on Drug Metabolism Strategy
Over the last years, the field of metabolite investigations has evolved. New guidelines requirements and the emergence of new modalities and new technologies foster the choice of new strategies for the metabolite profiling studies. This session will provide an overview on last trend for metabolite identification for biologics and small drugs, including the impact on DDI assessment.

17:10 – 18:05

Students Poster Blitz
We welcome student abstracts in the field of pharmacology (ADME, PK, PD, PBPK, DDI).

All submitted abstracts will be reviewed by the selection committee and chosen to be part of a poster presentation and short-oral presentation. A “Best Student presentation” awards will be announced during the GMP Congress 2023.
The program is open to all students at the Undergraduate, Masters, and Doctoral levels.
Presenters must be present during the congress.

18:05 – 19:30

Poster Session & Cocktail

Day 2 – 19 Oct 2023: What’s new in the Biologics World?

8.00 – 8.30

Welcome Coffee/Tea

8:30 – 9.30

Key Note Speaker: Immunogenicity

09:30 – 10:00

Coffee Break and Poster Session

Session 3

10:00 – 12:00

New Approaches in PK Modelling and QSP of Biologics
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 modelling is used to assess new targets and support the development of new biological drugs.

12:00 – 12:45

GMP Assemblée Générale

12:45 – 14:00

Lunch & Posters

Session 4

14:00 – 15.30

Spotlighting on Bioanalytical Data for Biologics PK Interpretation
Understanding the pharmacokinetics and pharmacodynamics of biologic therapeutics, and the bioanalytical methods they rely on, is key to build an optimal drug development plan. As the development of the drug progresses, so do the methods used for bioanalysis. The reliability of the bioanalytical results is a prerequisite for correct interpretation of PK profiles. Therefore, for pivotal nonclinical and clinical studies, it is essential to employ well-characterized and fully validated bioanalytical methods to yield accurate and reliable results. This session will provide an overview of the methodologies and illustrate the topic with a few examples from in-vivo preclinical cases
to clinical settings.

15:30 – 16:00

Coffee Break and Poster Session

Session 5

16:00 – 17:00

New Trends in PK and Immunogenicity Assessments in Ophthalmology
Over the last 10-15 years the treatment options in ophthalmology have considerably evolved. Injections of monoclonal antibodies and smaller proteins have emerged as a new standard of treatment, and recently gene therapy has also been introduced. In this session a few examples will be presented that highlight the new challenges of assessing PK and immunogenicity in ophthalmology and how to define the dose.

17:00 – 18:00 One Step Aside

Impact of Contaminants/Drugs on Public Health and Environment assessed by
PBPK
In a global context of environmental crisis, the chemical risk assessment is a matter of public health and environmental protection. This session will provide an overview on how PBPK modelling plays a key role for this risk assessment.

19:30

Gala Dinner (please do not forget to get your additional ticket tickets)

Day 3 – 20 Oct 2023

8.30 – 9.00

Welcome Coffee/Tea

Session 6

9:00 – 11.00

Supporting Decision-Making in Drug Development
Decision making occurs at all stages of drug development. Optimus Project from FDA as well as different tools such as clinical pharmacology and/or pharmacometrics are key to support decision making. In this session we will hear about examples of how to improve drug development decision-making.

11.00 – 11.30

Coffee Break

Session 7

11.30 – 12.30

Digital Data Sciences in Drug Development
The use of digital tools and their impact on drug development will be discussed in this session. Illustration will be performed with case studies on Omics Sciences, Biomarkers and Digital Biomarkers along R&D value chain.

12:30 – 12:45

Poster Awards

12:45 – 12:55

Closing Remarks

12:55 – 14:00

Farewell Lunch


Hotel Reservation

Details

Start:
October 18 12:30 pm
End:
October 20 2:00 pm
Event Tags:
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Venue

Espace centenaire
189 rue de Bercy
Paris, 75012 France
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Event Oct 18 - Oct 20 2023