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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: (1)Catalent Pharma Solutions;(Major Sponsorship - afternoon session still open)
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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