View more job listings or post a job
Revolution Medicines Senior Scientist, DMPK and Clinical Pharmacology
Quintara Discovery Research Scientist (Bioanalysis)
Quintara Discovery Research Scientist (Bioanalysis)
Chinook Therapeutics, Inc Sr. Scientist, In Vivo Pharmacology (Team Lead)
AbVision Senior/Principle Scientist (Immunology/Cell Biology)
Genentech, Inc. Associate Scientist, Biomarker Mass Spectrometry Laboratory  
Genentech, Inc. Senior Scientific Researcher for Biomarker Mass Spectrometry Laboratory
Genentech Inc. Contractor Scientist–Drug Metabolism
Genentech, Inc. Associate Scientist / Scientist, Biotransformation and ADME of New Modality  
Genentech, Inc. Scientist / Sr. Scientist, Drug Metabolism and Pharmacokinetics  
Post a job


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 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

2020-09-17, Regulated Large Molecule Bioanalysis: Fundamentals, the New FDA Guidance and Beyond
2020-10-19, [New Date] Preclinical and Clinical Development of Cell-based Immunotherapies: Translational PKPD, Safety, Biomarker, CMC, Clinical Pharmacology & Clinical Trials
2021-07-29, Development of Inhalation Therapeutics (a joint symposium by AAPS-BADGE / PBSS / Genentech)
┬ęPharmaceutical & BioScience Society, International; Last Modified: 7/5/2020; Admin Logon
Ads (in random order)
Submit a Text Ad
($250 for 2 months)

Hypha Discovery Ltd. Experts in scalable synthesis & purification of drug metabolites, including CYP, AOX, FMO metabolites as well as O-, N-, acyl glucuronides & sulfates.
Alturas Analytics, Inc. Expert GLP & non-GLP LC-MS/MS, GC-MS/MS bioanalytical & PK/TK analysis services of small & large molecules in any matrix. Discovery through phase IV.
Submit a Text Ad