Workshop
Physiologically Based Pharmacokinetic (PBPK) Modeling: Fundamentals, Regulatory Guidance & Applications
Speakers:
Yuan Chen (Genentech), Michael Bolger (Simulations Plus), Sebastian Polak (Certara), Susie Zhang (FDA), Ying Ou (BeiGene), Venkatesh Pilla Reddy (AstraZeneca), Tycho Heimbach (Novartis)
Organizers:
Yuan Chen (Genentech), Tracy Chen (Jazz), Snow Ge (Nektar), Ying Ou (BeiGene)
Date:
2019-10-18
Time:
8:45-17:00 Pacific Time
Registration fee:
(USD): Regular - Full Day: $195; Regular - Morning Only: $125; Regular - Afternoon Only: $125; Academic: $125; For unemployed or students: $35; For vendor-show rep: $35; For major-sponsor rep (incl lunch): $0
Location:
SF Bay Area: Foster City Crowne Plaza
Major Sponsor:
Vendor show vendors registered to date:
(3)MicroConstants; Pion Inc.; SEKISUI XenoTech
Registration: http://www.PBSS.org
Registration deadline:2019-10-16
(it will close sooner if the seating cap is reached)
About the Topic
Physiologically based pharmacokinetic (PBPK) models have been widely used at various stages of drug product development and regulatory review for different purposes, such as predicting absorption, distribution, metabolism and excretion (ADME), assessing drug-drug interaction (DDI) potentials, providing mechanistic explanation to PK characteristics, and predicting pharmacokinetics (PK) in specific populations.
Workshop Agenda
8:45am - 8:55am PBSS Welcome - Shichang Miao
Morning Session PBPK: Overview of Basic Knowledge and Applications
8:55am - 9:15am 1. Overview of Basic Knowledge in PBPK - Yuan Chen (Genentech)
9:20am - 10:20am 2. PBPK Concept and Application - Absorption Prediction - Michael Bolger (Simulations Plus)
10:20am - 10:30am Major Sponsor Presentation - Catalent
10:30am - 10:45am Break
10:45am - 12:00pm 3. PBPK Concept and Application - DDI & PK in special population.- Sebastian Polak
12:00pm - 1:00pm Lunch
Afternoon Session PBPK: Role in drug development and regulatory filing by case examples
1:00pm - 1:30pm 1. PBPK in Regulatory Science: An Update From the FDA and overview of PBPK guidance - Susie Zhang (FDA)
1:30pm - 2:00pm 2. PBPK Model Qualification and Reporting procedure for Regulatory Submission: A Consortium Perspective - Yuan Chen (Genentech)
2:00pm – 2:45pm 3. PBPK Modeling and simulation to predict transporter mediated drug-drug interactions: are we there yet? - Venkatesh Pilla Reddy (AstraZeneca)
2:45pm - 2:55pm Major Sponsor Presentation - TBD
2:55pm – 3:15pm Break & Raffle
3:15pm – 4:00pm 4. Impact of PBPK Models on Regulatory Reviews and Product labels: Complex DDI, PPI and Oral Contraceptives - Ying Ou (BeiGene)
4:00pm - 4:45pm 5. PBPK Modelling of Renal and Hepatic Organ Impairment, and pediatric population -A Pharmaceutical Industry Perspective and regulatory experience - Tycho Heimbach (Novartis)
5:00pm - 5:30pm Panel Discussion - All speakers
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