Dear members,
On behalf of the GMP Board and Scientific Committee, it is our great pleasure to share with you the program of the 36th GMP Symposium.

We hope to see you there with the exciting scientific and social programs.

You will find below a selection of hotel with negotiated prices near the Espace Ouest Lyonnais.

This symposium fees are as follow (actualized price appears on the left hand-side when you are logged in, membership fees not included):

• Satellite sessions: free (members only)
• Gala dinner: 50 euros
• Symposium:
  • Early Bird (up to Aug, 31st 2024):
    • Student members WITH poster: 50 euros (Gala dinner included, see abstract guidelines for contacts and application before getting your tickets)
    • Student members WITHOUT poster: 375 euros
    • Academic members: 375 euros
    • Industrial members: 750 euros
  • Standard (after Aug, 31st 2024):
    • Student members WITH poster: 50 euros (Gala dinner included, see abstract guidelines for contacts and application before getting your tickets)
    • Student members WITHOUT poster: 425 euros
    • Academic members:425 euros
    • Industrial members: 850 euros

Warm regards,

The GMP Board

36th GMP SYMPOSIUM
PRELIMINARY PROGRAM

Day 1 – 16th Oct 2024

09.30 – 12:30

Workshops (free for members, needs to be booked separately, first come-first served basis):

GMP Satellite session 1: Feel the power of GPX in our upcoming workshop dedicated to special populations! (registrations HERE)

GMP satellite session 2: DDIs in a changing regulatory landscape. What are the latest requirements and solutions? (registrations HERE)

12.30 – 13:30

Arrival and Registration
Welcome Coffee/Tea

13:30 – 13:40

Welcome to 2024 GMP Symposium

Session 1

13:40 – 14.40

Contribution of new in vitro models for DMPK prediction

Chairs: Madeleine Coimbra (Sanofi), Yannick Parmentier (Servier)
In vitro tools are continuously being optimized for better performance. Their many benefits (increased accuracy and representativity to in vivo situation, decreased reliance on animal testing, high throughput capabilities, personalized medicine applications and safety assessment features) make them essential resources that the scientific community is working hard to perfect. Join this session to explore the potential of HepaSH and 3D models for DMPK prediction and expand your knowledge on this topic. 

1- Sylvie klieber & Estelle Yau (Sanofi) : Integrating 3D/Microphysiological data within advanced computational models of biology to improve the prediction of human hepatic clearance  

2- Pr Olivier Fardel (IRSET, Rennes) : The use of HepaSH cells from humanized liver TK-NOG mice for drug detoxification and elimination studies 

Session 2

14:40 – 15:40

Transgenic models for DMPK

Chairs: Celine Amara (Sanofi), Sylvain Fouliard (Servier), Olivier Petricoul (Novartis)

Preclinical Transgenic models have shown to be essential tools that improve the human translation of drug PK and/or PK/PD profile for clinical development. Humanized preclinical models of disease or humanized FcRn mice are of increasing usage, reducing uncertainty of prediction of exposure and drug effects in human, and also ultimately reducing the number of animal experiments to be run. This session will delve into the properties of these experimental models and the challenges that need to be tackled for them to deliver their full potential.

1- Pauline Vachin (Sanofi): Transgenic models from design to reality: challenges prior to use in R&D 

2- Michael Kiffe and Monika Gajewska (Novartis): Humanized FcRn mouse model for evaluating PK and allometric scaling

15:40 – 16:10

Coffee Break and Poster Session

Session 3

16:10 – 17:10

Impact of gut microbiome on small molecules metabolism and integration of these parameters in Drug Discovery and Development

Chairs: Priscilla Brun (Sanofi), Laurence Del Frari (Pierre Fabre)
This session will present the reasons behind the under-consideration of the microbiome in pharma, the present limitations and progress of the microbiome tools (i-screen), and the recommendation to integrate as early as possible the gut microbiome in the drug discovery and development process of small molecules. 

1- Patrick Jimonet (Medicen): Integration of Gut Microbiome Drug Metabolism in Drug Discovery and Development of Small Molecules  

2-Frank Schuren (TNO): Microbiome mediated drug metabolism studies in the TNO i-screen model  

17:10 – 18:10

Students Poster Blitz

Chairs: Rayane Boufalaas (Aix-Marseille University, France), Bibiana Cardozo (Aix-Marseille University, France)

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 2024. 

The program is open to all students at the Undergraduate, Masters, and Doctoral levels. Presenters must be present during the congress.

18:10 – 19:30

Poster Session & Cocktail

Day 2 – 17th Oct 2024

8.00 – 8.30

Welcome Coffee/Tea

8:30 – 9.30

Key Note Speaker: Susan Cole (MHRA)

Medicines for All: Pharmacokinetic models to support medicines use in special populations

Chair: Isabelle Deprez (Certara), Maxime Lemerdy (SimulationsPlus), Madani Rachid (Sandoz)

09:30 – 10:00

Coffee Break and Poster Session

Session 4

10:00 – 12:00

Special Populations in Drug Development & Clinical Practice

Chairs:  Fanny Gallais (Pharmetheus), Olivier Petricoul (Novartis), Madani Rachid (Sandoz),  Carla Troisi (esqLABS GmbH)

Special populations, including pediatrics and underrepresented subpopulations such as obese patients, require additional consideration with regard to clinical research. This session will present case studies and strategies for handling such populations both in drug development and clinical practice.  

1 – Justin Hay (Certara): From Bench to Crib: Leveraging model-informed drug development and navigating regulatory considerations for paediatric drug development.

2 – Johanna Eriksson (Pharmetheus) : Optimizing Formulations for Treatment of Cryptococcal Meningoencephalitis in Sub-Saharan HIV Patients: Insights from PBPK Modeling 

3 – Catherijne Knibbe (Leiden University, St. Antonius Hospital): The importance of studying drug exposure in individuals with obesity during drug development: examples of antimicrobial and other agents  

4 – Sandra Cvijic (University of Belgrade): PBBM Modeling: Empowering Pharmacotherapy Strategies for Gastric Bypass Patients 

12:00 – 12:45

GMP Assemblée Générale

12:45 – 14:00

Lunch & Posters

Session 5

14:00 – 15.30

Methodologies and applications of therapeutic drug monitoring for treatment individualization

Chairs: Etienne Chatelut (Institut Universitaire du Cancer Toulouse), Sarah Lobet (Calvagone),  Alicja Puszkiel (Université Paris Cité / Cochin University Hospital), Carla Troisi (esqLABS GmbH)

This session explores developments in dose optimization and individualization across various medical disciplines. Presentations will cover optimizing antibiotics, personalized targeted therapies in oncology, and dose adaptation strategies in psychiatric pharmacotherapy. 

1 – Romain Guilhaumou (APHM Marseille),Therapeutic drug monitoring and pharmacogenetics : applications in psychiatric disorders

2 – Sylvain Goutelle (CHU Lyon), From therapeutic drug monitoring to model-informed precision dosing of anti-infective drugs 

3 – Benoit Blanchet (Hôpital Cochin, APHP), Precision medicine in oncology : which role for therapeutic drug monitoring? 

15:30 – 16:00

Coffee Break and Poster Session

Session 6

16:00 – 17:30

Biomarker strategy for Dose selection/optimization

Chairs: Laurence Del Frari (Pierre Fabre), Loic Laplanche (Abbvie), Carla Troisi (esqLABS GmbH)
This session examines the utilization of biomarkers (ctDNA, cfDNA, phosphorylation of inhibition…) to enhance dose selection and optimization strategies across a spectrum of therapeutic areas and molecules – spanning from pre-clinical to clinical applications. Further explore the methodologies for biomarker measurements and gain a comprehensive understanding of the various modeling approaches (statistical analysis, machine learning, and non-linear mixed effects models) used in decision-making in clinical trials. 

1 – Christine Bain (Active biomarkers): How biomarkers contribute to driving the clinical development of DMTs in neurodegenerative diseases 

2 – François Riglet (Servier): Using target engagement biomarker for early decision-making in oncology

3 – Linh Nguyen-Phuong  (Aix-Marseille University): Computational modeling approaches for circulating cell-free DNA in oncology 

17:30 – 18:30 One Step Aside

Impact of AI in our pharmaceutical R&D day to day life

Chairs: Laurence Del Frari (Pierre Fabre), Yannick Parmentier (Servier)
In this presentation, we will explore the current and potential roles of AI in drug R&D and how it redefines the way scientists integrate data generation with technological applications and wet-lab validation. We will deep-dive into the scientific implications, impacts on researchers, and the research process itself. A key question we will address is whether AI represents merely another tool or signifies a more profound shift in scientific inquiry.  

1-Thibaut Geoui (Charles Rivers Lab, Germany): How Data and AI are re-inventing Drug R&D

19:30

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

Day 3 – 18th Oct 2024

8.30 – 9.00

Welcome Coffee/Tea

Session 7

9:00 – 11:00

Biodistribution : from technology to therapeutic support

Chairs: Sarah Lobet (Calvagone), Olivier Nicolas (Sanofi), Yannick Parmentier (Servier)
Reaching the right target tissue at the right time and effective concentration is the main objective of a therapeutic modality. Biodistribution studies explore either the best way to reach the target or where the modality, including potential metabolites and endogenous biomarkers stand over time. This session will give an overview of the new technologies including mass spectrometry imaging or ultrasound to tackle the biodistribution challenges. 

1 – David Bonnel (Aliri Bioanalysis): De-risking and Accelerating Drug Development Programs: Applications and Integration of Spatial Bioanalysis and Spatial Biology at the Site of Action

2 – Michiel Vandenbosch (MI4, Maastricht University); MultiModal Molecular imaging in Drug Discovery and Development  

3 –Jean Michel Escoffre (Université de Tours) : Delivery of anti-cancer drugs using microbubble-assisted ultrasound in digestive oncology: from preclinical to clinical studies   

4- Amandine Manon (Certara): Clinical pharmacology considerations and model-informed drug development (MIDD) applied to Targeted Radiation Therapies (TRT)  

11.00 – 11.30

Coffee Break

Session 8

11.30 – 12.30

New insights for biologics

Chairs: Celine Amara (Sanofi),  Priscilla Brun (Sanofi), Loic Laplanche (Abbvie)
The diversity and importance of biologics create opportunities to apply innovative bioanalytics as well as modeling framework to measure, characterize and manage immunogenicity risks. This session will showcase such applications that should ultimately support the advancement of patient-centric care and enhance therapeutic benefit. 

1 – Gianluca Selviaggio (Pharmetheus): A quantitative systems pharmacology framework of immunogenicity to propose mitigation strategies after subcutaneous administration. 

2 – Stéphane Muccio (Sanofi): Innovative hybrid LCMS methods for the semi-quantification and isotyping of ADAs (Anti-Drug Antibodies) responsible for affecting the bioavailability and the activity of the biotherapeutic.  

12:30 – 12:45

Poster Awards

12:45 – 12:55

Closing Remarks

12:55 – 14:00

Farewell Lunch

Hotel Reservation