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Workshop

Physiologically Based Pharmacokinetic (PBPK) Modeling: Fundamentals, Regulatory Guidance & Applications


Speakers: Yuan Chen (Genentech), Michael Bolger (Simulations Plus), Alice Ke (Certara), Susie Zhang (FDA), Ying Ou (BeiGene), Venkatesh Pilla Reddy (AstraZeneca), Ping Zhao (Gates Foundation)
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:2019-10-18  (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.

Morning sessions: 

Physiologically-based Pharmacokinetic Modeling:  Overview of Basic Knowledge and Applications

  1. Overview of Basic Knowledge (Yuan Chen, 25min)

-What is PBPK model, Why PBPK, differences from empirical model

-Components of PBPK model

-Principle of ADME prediction using mechanistic approach

  1. Concept and Application (Alice Ke and Michael Bolger)

1)      Prediction of absorption (Michael Bolger, 60 min)

 - Fa /Ka; PK linearity; Food  / PPI effect; Formulation

2)      Prediction of Drug-drug interaction (Alice Ke, 90min)

 - CYP-mediated DDI (substrate, inhibition, induction etc)

 - Transporter –mediated DDI (substrate and inhibitor etc.)

3)      Prediction of PK in special populations (Alice Ke)

 - PK in organ impaired population; PK in pediatrics; Others


Afternoon Sessions:

Physiologically Based Pharmacokinetic Modeling:  Role in drug development and regulatory filing by case examples

  1. Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the FDA and overview of PBPK guidance (Susie Zhang, 30min)
  1. Physiologically Based Pharmacokinetic Model Qualification and Reporting procedure for Regulatory Submission: A Consortium Perspective (Yuan Chen, 30min)
  1. PBPK impact on the label of CYP DDI, PPI (absorption), oral contraception (Ying Ou, 45min)
  1. PBPK Modeling and simulation to predict transporter mediated drug-drug interactions: are we there yet? (Venkatesh Pilla Reddy, 45min)
  1. PBPK models for dose recommendation in organ impaired and pediatric population (Ping Zhao, 30min) 


2019-09-13, Biotransformation and Disposition of Larger Molecules: Peptides, Nucleotides, Proteins, mAbs, and ADCs
2019-10-03, Small-Molecule Bioanalytical Method Validation & Regulated Bioanalysis: Fundamentals, the New FDA Guidance and Regulatory Trends
2019-11-12, Antibody Drug Discovery and Development: Hit Generation, Engineering, Cell-line Development, IND enabling studies, and Biosimilars
2019-12-10, In Vitro Diagnostics, Companion Diagnostics and Precision Medicine
2020-01-21, Best Practices for Clinical Trial Design
2020-02-11, Drug-Device Combination
2020-02-24, Advanced LC-MS/MS (Day1) & Interpretation of MS/MS CID Spectra (Day2)
2020-05-12, Regulated Large Molecule Bioanalysis: Fundamentals, the New FDA Guidance and Beyond
2020-05-22, No More Undruggables: Unconventional Approaches for Drug Discovery and Design - prodrugs, PROTACS, fragment-based design, directed evolution and beyond
2020-06-23, Advances in Immuno-Oncology (A Joint Symposium by PBSS and BioScience Forum)
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