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GMP 2023 Symposium
18 October 2023 12:30 pm - 20 October 2023 2:00 pm
€50.00 – €820.00
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
09.30 – 12:30
Workshops (free for members, needs to be booked separately, first come-first served basis):
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.
Jointly organized by STP-PT (Suivi Thérapeutique Pharmacologique & Personnalisation des Traitements) unit of the SFPT (Société Française de Pharmacologie et de Thérapeutique), more information to come
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
Chairs: Olivier Nicolas (Sanofi), Jeremy Perrier (PhinC), Yannick Parmentier (Servier)
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.
1- Amélie Moreau (Servier): MicroPhysiological Systems to address Pharmacokinetics or Drug interactions issues
2- Christian Maass (EsqLABS): Humanizing Drug Development. How Organ-on-Chips and their digital twins improve prediction of clinical outcomes
3- Felicien Le Louedec (Institut Universitaire du Cancer, Toulouse): Bioavailability and the extent of drug-drug interactions with oral kinase inhibitors
15:10 – 15:40
Coffee Break and Poster Session
Session 2
15:40 – 17:10
Update on Drug Metabolism Strategy
Chairs: Madeleine Coimbra (Sanofi), Olivier Nicolas (Sanofi), Yannick Parmentier (Servier)
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.
1- Jonathan Dhenin (Sanofi): Monitoring biotransformations of biotherapeutics in mouse plasma using innovative top-down and middle-down mass spectrometry
2- Esther Van Duijn (TNO): The role of microtracers in drug development: Generating human mass balance data and metabolites profiles as early as possible
3- Patricia Moliner & Priscilla Brun (Sanofi): AMS to support human metabolism and DDI assessments of a highly metabolised compound
17:10 – 18:05
Students Poster Blitz
Chairs: Sarah Lobet (Tours University, France), Jessica Ou (Aix-Marseille University, France), Carla Troisi (Bologne University, Italy), Anna Zerdoug (Rennes 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 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: Daniel Kramer (Sanofi)
Immunogenicity: Challenges and Opportunities for the Development of Biotherapeutics
Chair: Madani Rachid (Sandoz)
Immunogenicity presents a major hurdle for the development of biotherapeutics as it can impair both efficacy and safety of the treatment. This lecture will introduce the audience to the concept of immunogenicity and will discuss the specific challenges it provides for the development of biologics. It will also review novel approaches to anticipate, predict and prevent the formation of anti-drug antibodies.
09:30 – 10:00
Coffee Break and Poster Session
Session 3
10:00 – 12:00
New Approaches in PK Modelling and QSP of Biologics
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 modelling is used to assess new targets and support the development of new biological drugs.
1 – Piet van der Graaf (Certara): Quantitative Systems Pharmacology to guide complex biologics drug development and regulatory decision making
2 – Wilbert de Witte (EsqLABS): Integrated QSP-PBPK modelling for biologics in drug discovery and development
3 – Eric Gerard Fernandez (Boehringer): An immuno-oncology QSP platform model for simulating treatment with oncolytic virus VSV-GP
4 – Jérémy Seurat (The Weitz group: Quantitative Viral Dynamics): Modeling of in vivo bacteriophage dynamics
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
Chairs: Christine Bain (Active Biomarkers), Madeleine Coimbra (Sanofi), Yannick Parmentier (Servier)
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.
1 – Nicolas Fourrier(Inotrem): Gearing up your bioanalysis for your drug development
2 – Erwan Werner (Servier): PK assay design for biological entities – Why format and key reagents matter
3 – Maximilian Breitner (Sandoz): Design, development and validation of a pharmacokinetics assay for the clinical development of a biosimilar
15:30 – 16:00
Coffee Break and Poster Session
Session 5
16:00 – 17:00
New Trends in PK and Immunogenicity Assessments in Ophthalmology
Chairs: Olivier Petricoul (Novartis), Olivier Nicolas (Sanofi)
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.
1 – Fraser McBlane (Novartis): Dose selection for ocular gene therapies
2 – Katrijn Bogman (Roche): The right regimen for every patient in ophthalmology, a drug development example
17:00 – 18:00 One Step Aside
Impact of Contaminants/Drugs on Public Health and Environment assessed by PBPK
Chairs: Fabrice Hurbin (Sanofi), Quyen Nguyen (Novartis)
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.
1-Thomas Gastellu (ANSES): Lifetime exposure in the dietary risk assessment, usefulness of PBPK models
2 – Katharina Brotzmann (Heidelberg University): Fishing for answers: How zebrafish helps to assess the risk of pharmaceuticals in the aquatic environment
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
Chairs: Fanny Gallais (Pharmetheus),Laurence Del Frari (Pierre Fabre), Madani Rachid (Sandoz), Quyen Nguyen (Novartis)
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.
1 – Matthias Hoch (Novartis): Applying a totality of evidence approach including model-informed drug development (MIDD): asciminib development in the context of FDA’s Project Optimus
2 – Andreas Lindauer (Calvagone): From model to decisions: effective simulations to support drug development
3 – Niclas Jonsson (Pharmetheus): Using Forest plots to support drug development decision making – difficulties and opportunities
4 – Roland Baumgartner (Sandoz): Application of pharmacometrics analysis in clinical biosimilar development
11.00 – 11.30
Coffee Break
Session 7
11.30 – 12.30
Digital Data Sciences in Drug Development
Chairs: Olivier Barberan (Elsevier), Etienne Chatelut (Institut Universitaire du Cancer Toulouse), Quyen Nguyen (Novartis)
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.
1 – Sebastien Tourlet (Capgemini): Data Science & Artificial Intelligence : enablers to support and accelerate drug development and translational science evidence
2 – Romain Clément (ArcaScience): AI discovery of novel safety biomarkers in a preclinical environment applied to multiple sclerosis
12:30 – 12:45
Poster Awards
12:45 – 12:55
Closing Remarks
12:55 – 14:00
Farewell Lunch