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GMP -2-day workshop “Physiologically based Pharmacokinetic (PBPK) Modeling” (8-9 Decembre 2022 – Marseille): Registration open

14 Sep

This workshop is designed to provide participants with the necessary information needed for Physiologically Based Pharmacokinetic (PBPK) modeling. New Chemical and Biological Entities will be considered when applicable. You can find the program hereafter.

The number of participants is limited to 30:

  • 20 students registered in one of the 5 Master co-organizing this workshop (please contact the director of your Master if you are interested) – Fee: free registration
  • 10 industrial/academic delegates – Fee: 750 € (700 € for registration + 50 € for GMP membership)

You can find all relevant information (program, speakers, location…) in the attached document or on the GMP website.

For registration and information, please contact Fabrice Hurbin (fabrice.hurbin@sanofi.com)

Best regards

Workshop PBPK_8-9 décembre 2022_Final version

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Thursday 8 December 2022: Keynote lectures

Time Title Speakers
9:45 – 9:50 Welcome GMP
09:50 – 11:20 Prediction of human pharmacokinetics from preclinical data

  • Cross species extrapolation in PBPK
  • Use of in vitro data to predict Pharmacokinetics
  • Use of in vitro data to predict Pharmacodynamics
Donato Teutonico
(Sanofi)
11:20 – 11:45 Coffee break  
11:45 – 13:15 Biopharmaceutic

  • Food effect prediction
  • Formulation optimization
  • IVIVC with PBPK
Letizia Carrara
(Servier)
13:15 – 14:15 Lunch  
14:15 -15:45 Special populations

  • Maternal PBPK modeling
  • Lactational PBPK modeling
Marc Codaccioni
(Certara)
15:45 – 16:15 Coffee break  
16:15 – 17:45 Environmental & toxicologic applications

  • Development of PBPK models for data-poor chemicals
  • Interpretation of human biomonitoring data
  • Derivation of regulatory thresholds
Céline Brochot (INERIS)
From 18:30 Cocktail  

Friday 9 December 2022: Hands-on exercises

Time Title Facilitators
8:30 – 12:30* Building a PBPK model

  • Case study of hydrocodone (CYP3A4 and CYP2D6 substrate)
  • Modeling of parent drug and metabolite
Florence Gattacceca
(Aix-Marseille Université)

 

Kahina Haouchine
(PhinC)

 

Jeremy Perrier
(PhinC)

12:30 – 14:00 Lunch
14:00 – 17:30* Subgroup 1
(15 delegates)
Subgroup 2
(15 delegates)
  Biopharmaceutic applications

  • Modeling extended release (ER) tablets using in vitro data
  • Prediction of exposure with different ER tablets
DDI applications

  • Case study with paroxetine, a strong inhibitor of CYP2D6
* Including a coffee break
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Election GMP board 2022: 2 members to renew

14 Sep

According to our status, two of our members will leave the GMP board after four years (Massimiliano Fonsi and Ashwani Sharma for this year), and they have to be replaced. These two new members will join the GMP board as advisors for their first year.

We are pleased to announce that this year two people have submitted an application to join the GMP Board. You will find their bios on the GMP website (https://gmp.asso.fr/election-du-gmp-2021-renouvellement-de-2-membres-du-bureau/). You can vote from now until Thursday September 29th midnight.

To vote, select “Login” (you will need your member username and password) and then “Election in progress”.

Thank you for your participation in this election which is important in the life of our association.

Best regards,

The GMP Board

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[GMP] Renewal of GMP board

01 Aug

GMP is an association rich by its diversity and pluralism, especially by the profile of the members and Board. If you wish to actively participate in the life of GMP and bring your dynamism and ideas, we recommend you to apply for becoming a member of the GMP Board.

Being a GMP Board includes the following key elements:

  • personal investment in the life of the association, bimonthly teleconferences, one face to face working meeting, organization of the congress and webinars, newsletter writing, …
  • teamwork with sharing and learning, including some fun
  • Being elected for 4 years

To apply please send a short summary of your career path and professional interests, including your motivation to join the GMP Board, as well as a picture.

Applications should be sent by 9 September 2022 at the latest to Fabrice Hurbin by email (fabrice.hurbin@sanofi.com). They will be shared online to proceed with electronical vote of the members between the 14 and 29 September 2022. The results of the election will be communicated to the members and the composition of the new board will be subjected to vote during the annual general assembly of the GMP on the 4 October 2022.

Do not hesitate to join us!

Of note, we would like to remind all the GMP members of the importance of the vote for the election of the new members of the board and during the annual general assembly. Your presence and vote represent great support for us!

We count on you !

The GMP board

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Final program FOR TRANSPORTER WORKSHOP 2022

21 Jun

Please Register by link:

https://docs.google.com/forms/d/1QEzVLBBXnn-HZb8LWxlRtSLMyrCTFVZWNTeCr9A4–E

The instructions for the workshop will be in ENGLISH.

 Registration fees (Deadline 30th June 2022):

  • Academic rate: 150 € (100 € for registration + 50 € for membership)
  • Standard rate: 300€ (250 € for registration + 50 € for membership)
  • Payment could be done by credit card via the GMP site (http://app.gmp.asso.fr/dons) using “Make a donation”.   If you want to pay by bank transfer, please contact at fabrice.hurbin@sanofi.com.

We are looking forward to having your participation in the workshop.

GMP, France

Final Program-Integrated In-vitro_in-silico transporter workshop 6 July 2022

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2022 Joint Meeting (DMDG-GMP-SPS): Registration opening & Call for speakers

26 Apr

You will find attached the preliminary agenda prepared by our joint scientific committee. A more detailed program is available here. The final program is under finalization and will be distributed soon.

For logistical reasons, registrations are made via the DMDG website. You can register by clicking here and benefit from a preferential rate (early bird). An academic rate and free registration for students selected to present a poster are proposed. There are a limited number of free places available for Students who wish to present a poster. These are available on a first-come-first-served basis. We would like to draw your attention to the fact that the registration fees (standard early bird: €990€ and academic: €700) include accommodation for the nights and lunch of 3rd & 4th October and refreshments on 3rd, 4th & 5th.

A call for speakers is launched. If you are interested to speak in one of the sessions, please get in touch with the session chairs. The contact details and a description of the sessions can be found on the draft program. The deadline for speaker abstracts is Friday 27th May. For any hot topics or interesting case studies that don’t fit within the regular sessions, please contact the Free Communications session chairs.

We also take opportunity of this announcement to launch a call for Poster to all participants. If you would like to present a poster, please tick the relevant box on the registration form and send your poster abstract to info@dmdg.org. Deadline for poster abstracts is Friday 29 July.

We are looking forward to meeting you at this 1st joint meeting co-organized with the DMDG and SPS. In the meantime do not hesitate to contact us for any enquiries at contact@gmp.asso.fr

Best regards,

 GMP Board

Preliminary agenda_GMP-DMDG-SPS_Joint meeting October

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GMP Newsletter

25 Jan

The GMP board is delighted to share its newsletter number 9, which you will find attached.

We also take this opportunity to inform you that you are closing the call for applications for the scientific committee one week in advance. The members of the 2022 scientific committee will be communicated to you very soon.

Yours faithfully.

GMP Board

GMP Newsletter 9_English_2022-01

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PBPK webinar on 14 January 2022 (2 to 3 pm CET)

08 Dec

GMP webinar : A Growing Network of Open Science: PBPK modelling of Drug–Drug Interactions with the Open Systems Pharmacology Suite

In this webinar we want to feature Physiologically based pharmacokinetics (PBPK) as important tool in drug development [1], which is usually performed when results from known clinicals scenarios are used to predict unknown scenarios [2]. PBPK modelling represents a subdiscipline of System Pharmacology striving to understand the fate of the drug in body including impact of drug-drug interactions (DDI) and drug-gene interactions (DGI) [3]. Despite its generic relevance for drug applications, only a few verified, freely accessible, modifiable, and comprehensive DDI PBPK models are available. The Open Systems Pharmacology (OSP) community aims to overcome this bottlenecks and to grow PBPK knowledge with an open science approach [4]. OSP offers professional open access and open-source software tools (PK-Sim/MoBi) including qualified CYP3A4 DDI networks. Recently this network has been expanded with a CYP1A2 and CYP2C19 network, which can be applied to investigate drug-drug-gene interactions (DDGI). In his presentation Tobias Kanacher will show you how you can leverage the OSP software platform and the community for your drug development project, with a special focus on DDI.

[1]          J. E. Sager, J. Yu, I. Ragueneau-Majlessi, and N. Isoherranen, “Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulation Approaches: A Systematic Review of Published Models, Applications, and Model Verification,” Drug Metab. Dispos., vol. 43, no. 11, pp. 1823–1837, Nov. 2015, doi: 10.1124/dmd.115.065920.

[2]          L. Kuepfer et al., “Applied Concepts in PBPK Modeling: How to Build a PBPK/PD Model,” CPT Pharmacomet. Syst Pharmacol, vol. 5, no. 10, pp. 516–531, Oct. 2016, doi: 10.1002/psp4.12134.

[3]          T. Kanacher et al., “A Physiologically-Based Pharmacokinetic (PBPK) Model Network for the Prediction of CYP1A2 and CYP2C19 Drug–Drug–Gene Interactions with Fluvoxamine, Omeprazole, S-mephenytoin, Moclobemide, Tizanidine, Mexiletine, Ethinylestradiol, and Caffeine,” Pharmaceutics, vol. 12, no. 12, Art. no. 12, Dec. 2020, doi: 10.3390/pharmaceutics12121191.

[4]          J. Lippert et al., “Open Systems Pharmacology community – an open access, open source, open science approach to modeling and simulation in pharmaceutical sciences,” CPT Pharmacomet. Syst. Pharmacol., vol. n/a, no. n/a, doi: 10.1002/psp4.12473.

Dr. Tobias Kanacher is a senior consultant in pharmacometrics at Pharmetheus. He is a licensed pharmacist and received his PhD from the University of Tübingen in 2003, for biochemical analysis and characterization of enzymatic regulatory domains as potential drug targets. Before joining Pharmetheus (2019-present), he gathered extensive experience in drug discovery and translational clinical development at Altana Pharma AG (2003-2006), Nycomed (2006-2011), Takeda (2011-2012), Bayer (2012-2017) and for SGS-Exprimo (2017-2019). He has broad experience to advice clinical development teams when and how to apply PBPK modelling for influencing internal and regulatory decisions across different stages of clinical drug development.

invite

 

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