You are here: Home News April 27th 2017 : Club Phase I workshop "Physiologically Based PharmacoKinetic modeling (PBPK): A new Paradigm in Drug Development"

April 27th 2017 : Club Phase I workshop "Physiologically Based PharmacoKinetic modeling (PBPK): A new Paradigm in Drug Development"

PhinC Development is pleased to organise in partnership with the Club Phase 1, one entire day dedicated to Physiologically Based PharmacoKinetic (PBPK) used in early drug development.

Everything you need to know about PBPK, the advantage of this tool in drug development, the software used to perform useful modeling and simulations, several study cases and a focus on regulatory requirements.

Welcome of the participants at 09:30am

Complete program:

09:30am Welcome

10:00am Introduction: Physiologically Based Pharmacokinetic principles
-> Virginie Gualano, Director and Pharmacometrician, PhinC Development

10:15am GastroPlus™ Software general presentation and presentation of the specific modules: Transdermal, nasal pulmonary, oral cavity drug delivery, ocular, Biologic module
-> John Dibella, Vice president, SimulationsPlus

10:45am Break

11:00am PBPK, a Platform for Bridging People & Knowledge in Early Drug Development
-> Neil Miller, DMPK Investigator and PBPK Leader, GSK

11:45pm A comparison of liver models for drug-drug interaction predictions: From static to mechanistic models -> Mohammed H. Cherkaoui, PKPD Translational Medicine Scientist, Medicines for Malaria Venture

12:15am Application/study case: Use of combined in vitro, in silico (GastroPlus™) and in vivo (dog) models to anticipate PK behavior of different prototypes of a given compound in human
-> Sylvaine Galiegue, Pharmacokineticist, Sanofi

12:45am-02:15pm Lunch Break

02:15pm Application/study case: FIM preparation: use of PBPK modeling to select the dose schedule and early static DDI assessment
-> Florent Mazuir, Pharmacokineticist, Sanofi

02:45pm PBPK modelling to derisk DDI: a case study at UCB
-> François Bouzom, Director DMPK strategic group, UCB

03:30pm Break

03:45pm PBPK to guide dose selection in early development and meet regulatory requirements
-> Thierry Lavé, Head Project Leader/Modelling & Simulation Pharmaceutical Sciences, Roche

04:30pm Guidelines presentation and feedback on regulatory review*
-> Ridha Belaiba (To be confirmed), Pharmacokinetics reviewer at ANSM and member of the Pharmacokinetics Working Party (PKWP) at EMA

05:15pm-05:30pm Conclusion

Cost (without accommodation)

Club Phase I member price: 150 €

Non member price: 200 €


Registration

Registration required before 20th April 2017

To register send an email to Club Phase I,  Isabelle Paty isabelle.paty@ipsen.com

!!! Limited places !!!

 

Location : Maison de la Chimie, 28, rue Saint Dominique, 75007 PARIS, France

If you want to have more information, do not hesitate to contact us.

Event supported by Genopole.