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Friday, May 11

 08:00 Short Course and Workshop Registration
 09:00 Concurrent Short Course and Workshop

Short Course 1: Mechanistic PK/PD Modeling and Simulation: Steps to Become a PBPK/QSP Modeler

Chairs: Yanyan Zhang, Sanofi Shanghai and Rukmini Kumar, Vantage Research, India

Workshop 1: Metabolite Evaluations and Mass Balance Studies

Chairs: Frances Wang, J & J, China and Mandy Xu, Pharmaron, China

09:00 - 10:00 Introduction to Mechanistic PK/PD Modeling and its Application in Drug R&D, the Use of PBPK in Decision-making during Regulatory Review
Jiansong Yang, Mosim, Shanghai
09:10 - 09:50 Reactive Metabolite
Thomas Baillie, University of Washington, USA
10:00 - 11:00  Overview of QSP and FDA Regulatory Outlook to QSP
Rukmini Kumar, Vantage Research, India
09:50 - 10:30  Mass Balance Study-Design, Data Analysis, Implications for Dosing, and Labeling Recommendations
Yi Liu, WuXi AppTec, China
11:00 - 12:00 General Equations to Construct the Systems Model, and MATLAB Simbiology Software Orientation
Yan-Yan Zhang & Yoshihisa Shitara, Sanofi Shanghai and Tokyo
10:40 - 11:20  Metabolic Profiling and Mass Balance Study in Preclinical Species and Human 
Jeff Zhang, Novartis, China
12:00 - 12:30  Panel Discussion and Q&A  11:20 - 12:00  Metabolite Screening and Evaluation in Early Drug Clinic Trials 
12:30 - 13:00  Lunch  12:00 - 13:00  Lunch Seminar 

 

13:00 Concurrent Short Course and Workshop

Short Course 2: Application of PBPK modeling in drug discovery and development: case studies 

Chairs: Houfu Liu and Michael Bolger

Workshop 2: Understanding 2017 DDI Guidance - Case Studies

Chairs: Xiuwen Liu (Shouzhou Xishan Zhongke, China) and Hong Wan (HengRui, China)

13:00 - 13:45 Introduction to Mechanistic PK/PD Modeling and its Application in Drug R&D, the Use of PBPK in Decision-making during Regulatory Review
Jiansong Yang, Mosim, Shanghai
09:10 - 09:50 Reactive Metabolite
Thomas Baillie, University of Washington, USA
13:45 - 14:30 Overview of QSP and FDA Regulatory Outlook to QSP
Rukmini Kumar, Vantage Research, India
9:50 - 10:30 Mass Balance Study-Design, Data Analysis, Implications for Dosing, and Labeling Recommendations
Yi Liu, WuXi AppTec, China
14:30 - 15:15 General Equations to Construct the Systems Model, and MATLAB Simbiology Software Orientation
Yan-Yan Zhang & Yoshihisa Shitara, Sanofi Shanghai and Tokyo
10:40 - 11:20 Metabolic Profiling and Mass Balance Study in Preclinical Species and Human
Jeff Zhang, Novartis, China
15:15 - 16:00 Panel Discussion and Q&A 11:20 - 12:00 Metabolite Screening and Evaluation in Early Drug Clinic Trials
12:30 - 13:00 Lunch 12:00 - 13:00 Lunch Seminar

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
 May 11, Friday Morning
   Short Course and Workshop Registration
  Workshop for Pharmaceutical Industries - ADME/DMPK Evaluation for Supporting Therapeutic Innovation

Concurrent with Short Course 1 and 2

Location: Hall 139

Chairs: Genfu Chen (WuXiAppTec, China) and Sylvia Zhao (Novartis, China)

  Opening Remark
   Concurrent Workshop and Short Course 
  Short Course 1: Mechanistic PK/PD Modeling and Simulation: Steps to Become a PBPK/QSP Modeler

Chairs: Yanyan Zhang and Rukmini Kumar

Workshop 1: Metabolite Evaluations and Mass Balance Studies

Chairs: Frances Wang, (J & J, China) and Mandy Xu (Pharmaron, China)

  09:00 - 10:00

Introduction to mechanistic PK/PD modeling and its application in drug R&D, the use of PBPK in decision-making during regulatory review

Chair: Jiansong Yang (Mosim, Shanghai)

09:10 - 09:50

Reactive metabolite

Chair: Thomas Baillie (University of Washington, USA)

  10:00 - 11:00

Overview of QSP and FDA regulatory outlook to QSP

Chair: Rukmini Kumar (Vantage Research, India)

09:50 - 10:30

Mass Balance Study-Design, Data Analysis, Implications for Dosing, and Labeling Recommendations

Chair: Yi Liu (WuXi AppTec, China)

  11:00 - 12:00

General equations to construct the systems model, and MATLAB Simbiology software orientation

Chairs: Yan-Yan Zhang & Yoshihisa Shitara (Sanofi Shanghai and Tokyo)

10:40 - 11:20

Metabolic profiling and mass balance study in preclinical species and human 

Chair: Jeff Zhang, (Novartis, China)

  12:00 - 12:30  Panel discussion and Q&A 11:20 - 12:00 Metabolite Screening and Evaluation in Early Drug Clinic Trials
  12:30 - 13:00  Lunch 12:00 - 13:00 Lunch Seminar
   
   May 11, Friday Afternoon
   Concurrent Workshop and Short Course
  Short Course 2: Application of PBPK modeling in drug discovery and development: case studies 

Chairs: Houfu Liu and Michael Bolger

Workshop 2: Understanding 2017 DDI Guidance - Case Studies

Chairs: Xiuwen Liu (Shouzhou Xishan Zhongke, China) and Hong Wan (HengRui, China)

  13:00 - 13:45

Application of Physiologically - based Pharmacokinetic Modeling and Simulation in Prediction of Human PK and Drug-drug Interactions. 

Chair: Chuang Lu (Sanofi US)

13:00 - 13:45

Interpretation and Integration for Time - Dependent Inhibition in New FDA DDI 2018 Draft Guidance - from In Vitro Experiment, PBPK Modeling to Clinical

Chair: Hongjian Zhang (Suzhou University, China)

   13:45 - 14:30

Modeling and simulation of double peaks in dogs using a modified PBPK model-mechanism exploring and clinical risk evaluation.

Chair: Hongcan Ren (Hutchison Pharma, Shanghai)

13:45 - 14:30

Understanding and applying 2017 USFDA DDI guidance - Case Studies 

Chair: Jing Lin (Sumitomo Dainippon Pharmaceuticals, USA)

  14:00 - 15:00

Workshop: Mechanistic PK/PD Modeling and Simulation - Steps to Become a PBPK/QSP Modeler

Introduction to mechanistic PKPD modeling and its application in drug R&D, the use of PBPK in decision-making during regulatory review

Chair: Dr. Jiansong Yang, CEO Mosim, Shanghai

  14:00 - 14:45

Workshop theme: Application of PBPK modeling in drug discovery and development: case studies

Case studies in drug discovery

Chair: Neil Miller, leading PBPK expert at GSK reviewing drug discovery PBPK cases

   14:30 - 15:15 

Application of PBPK model analysis to oncology drug development.

Chair: Noriko Okudaira (Daiichi, Sankyo, Japan)

14:30 - 15:15

Designing Clinical DDI trials based on the results of In Vitro DDI evaluation - Case Studies

Chair: To be Determined

  14:45 - 15:25

Workshop: Case studies from Hutchison Pharma 

Chair: Hongcan Ren

  15:00 - 16:00

Workshop: Introductory/overview of QSP, FDA regulatory outlook to QSP

Chair: Dr. Rukmini Kumar, Principle Scientist from Vantage Research, Tamil Nadu, India

   15:15 - 16:00  

Discovery PBPK: How to estimate the expected accuracy of ISIVE and IVIVE for new chemical entities

Chair: Michael B. Bolger (Simulation Plus, US)

15:15 - 15:45 Coffee Break
  15:35 - 16:15

Workshop: Case studies in formulation development from Wuxi

Chair: Kelvin Zhao

  15:45 - 18:00

Workshop 3: Biologics and Transporters 

Chairs: Guorong Fan (Shanghai 1st People's Hospital, China) and Lilly Xu (Chempartner, China)

  16:15 - 17:00  

Workshop: Case studies from a senior scientist from Simulation Plus 

Chair: TBD

  16:15 - 17:00

Workshop: General equations to construct the systems model, and MATLAB Simbiology software orientation

Chair: Dr. Yan-Yan Zhang, Sanofi

   16:00 - 16:30 Panel Discussion and Q&A 15:45 - 16:30

PK Evaluation for Biologics - Challenges and Solutions

Chair: Yuanguo Cheng (National Shanghai Center for Drug Safety Evaluation, China)

  17:30 - 19:00

Career Development for Students and Young Scientists: Session with a select group from Industry and Academia on career paths, how to interview, and writing a winning CV

Panel: Tom Baille, Mingshe Zhu, Zhuohan Hu, Mike Sinz, John Miners, Bill Smith, Su Zeng, Jasminder Sahi and any other faculty who can participate. 

16:30 - 17:15

Biologics: clinical sample analysis

Chair: Jing Shi (WuXiAppTec, China)

  17:15 - 18:00

Quantitative evaluation of drug transporter activities - Caste Studies

Chair: Buyun Chen (Genentech, USA)

  18:00 - 18:45

Panel Discussion

Panel Members: Session chairs and speakers 

   19:00 - 20:30 Dinner for workshop attendees and faculty 18:45 - 19:00 Close remark
  19:00 -20:30 Dinner for workshop attendees and faculty
 
   May 12, Saturday Morning
 

 Keynote Lectures/Sessions

Chairs: Su Zeng & Jasminder Sahi

  8:30 - 9:00

 Opening Ceremony (5 mins each)

  • Welcome by Su Zeng & Jasminder Sahi
  • Opening words by CSSX Chair
  • Opening words by ISSX Chair
  9:00 - 9:50

Targeted Covalent Drugs and the Promise of Personalized Medicine 

Speaker: Tom Baillie (Univ Washington USA and ISSX Chair)

  9:50 - 10:40

Cellular Pharmacokinetics and Pharmacokinetics for intracellular targeted drug evaluation

Speaker: Guangji Wang (China Pharmaceutical University, China) 

  10:40 - 11:00 Group Photo
  11:00 - 12:00  Poster Session
  12:00 - 13:00 Industry sponsored sessions over lunch 
   May 12, Saturday Afternoon
   Concurrent Sessions
  Session 1 (13:30 - 17:00)

In vivo Function and Regulation of Drug Transporters

Chairs: Yuichi Sugiyama & Wooin Lee

Session 2 (13:30 - 17:00)

ADMET of Drugs and Chemicals 

Chairs: Bill Smith and Sylvia Zhao


  13:30 - 14:00

Use of "Extended Clearance Concept" to predict Clinical Outcomes from In Vitro Metabolism and Transport Data; focusing on the transporters in the liver

Chairs: Yuichi Sugiyama & Wooin Lee

13:30 - 14:00

Implications of human P450 structures for drug design 

Chairs: Jim Halpert (Univ Connecticut, USA)

  14:00 - 14:30

The use and abuse of extended clearance concept

Chair: Ayman El-Kattan (Pfizer, USA)

14:00 - 14:30

Utility of transgenic mice for identification of biomarkers and metabolism-mediated toxicological mechanisms

Chair: Xinxin Ding (University Albany, USA)

  14:30 - 15:00

Time-dependent and long-lasting inhibition of OATP transporters

Chair: Yoshihisa Shitara (Sanofi, Tokyo)

14:30 - 15:00

From Enzymology to Human ADME: Case study of a disproportionate metabolite

Chair: Bill Smith (Gilead, USA)

  15:00 - 15:15

Coffee Break

  15:15 - 15:45

Complexity and Diversity in SLCO Transporters, via Epigenetic and Splicing Regulation

Chair: Wooin Lee (Seoul National University, S. Korea

 15:15 - 15:45

Unraveling the contribution of aldehyde oxidase to drug clearance: getting closer to an elusive parameter

Chair: Mike Zientek (Takeda, USA)

  15:45 - 16:15

Role of P-glycoprotein in BBB penetration and respiratory toxicity of opioid drugs

Chair: Hua Li (Academy of Military Medical Sciences, China)

15:45 - 16:15

MicroRNAs in the regulation of DMPK

Chair: Aimin Yu (UC Davis, USA)

  16:15 - 16:30 Young Speaker 16:15 - 16:30 Young Speaker
  16:30 - 16:45 Gold Sponsor Speaker 16:30 - 16:45 Gold Sponsor Speaker, Genfu Chen (WuxiAppTec, China)
  16:45 - 17:15 Panel Discussion and Q&A 16:45 - 17:15 Panel Discussion and Q&A
  17:15 - 18:15 Poster Session

  18:15 - 20:00 Welcome Reception

 
   May 13, Sunday Morning
  Keynote Lecture

Chair: Zhuohan Hu (RILD)

 8:30 - 9:20

Role of Transporters in pharmacokinetics (PK)/ pharmacodynamics (PD)/ toxicodynamics (TD)

Speaker: Yuichi Sugiyam (RIKEN Institute Japan)

  Concurrent Sessions
  9:30 - 12:00

Session 3: Personalized Medicine - Roles of Omics and Disease States

Chairs: John Miners & Min Huang

9:30 - 12:00

Session 4: Drug Interactions and Liver Injury

Chairs: Mike Sinz & Eric Chan 

  9:30 - 10:00

Predictive pharmacogenomic biomarkers for personalized medicine

Chair: Magnus Ingelman Sundberg (Karolinska Institute, Sweden)

 9:30 - 10:00

Drug-drug interactions: Enzyme Induction

Chair: Mike Sinz (BMS, India)

  10:00 - 10:30

Pharmacogenomic of drug-induced SCARs

Chair: Wichittra Tassaneeyakul (Khon Kaen University, Thailand)

10:00 - 10:30 

PBPK-modeling of complex DDIs between ravroxaban and amiodarone

Chair: Eric Chan (National Univ of Singapore)

  10:30 - 10:45 Coffee break
  10:45 - 11:15

Omics-based personalized medicine 

Chair: Min Huan (Sun Yat-sen University, China)

10:45 - 11:15

Disease effect on liver drug metabolism

Chair: Wen Xie (Univ of Pittsburgh, USA)

  11:15 - 11:45

The role of the kidney in drug metabolic clearance: Renal drug metabolism and the effects of impaired renal function on non-renal drug metabolic clearance

Chair: John O. Miners (Flint Univ, Australia)

11:15 - 11:45

Disruption of mitochondria glucose oxidation pathway sensitizes liver to acute injury 

Chair: Li Wang (University of Connecticut, USA)

  11:45 - 12:00 Young Speaker 11:45 - 12:00 Young Speaker
  12:00 - 12:15 Gold Sponsor Speaker 12:00 - 12:15 Gold Sponsor Speaker
  12:00 - 13:00 Industry-Sponsored Sessions over lunch
  13:00 - 14:00  Poster Sessions
 
   May 13, Sunday Afternoon
  Concurrent Sessions
  13:00 - 15:30

Session 5: Drug Interactions and Regulatory Guidance

Chairs: Dafang Zhong and Chuang Lu

13:00 - 15:30

Session 6: ADMET of Herbal Medicine

Chairs: Ge Lin and Chuan Li

  14:00 - 14:30

Safety testing of drug metabolites in drug development

Chair: Alex Xu (CFDA China)

14:00 - 14:30

CYP-mediated metabolic activation and pyrrole-protein adduct formation - the cause and biomarker of pyrrolizidine alkaloid N-oxide induced herbal hepatoxicity

Chair: Ge Lin (Chinese University of Hong Kong)

  14:30 - 15:00

Clinical trials using radiolabeled drugs - guidance and application

Chair: Dafang Zhong (Chinese Academy of Sciences)

14:30 - 15:00

Metabolism-mediated toxicities of terpene furanoids 

Chair: Jiang Zheng (Shenyang Pharmaceutical University China)

  15:00 - 15:30

How PBPK modeling can be leveraged for drug drug interactions

Chair: Lu Chuang (Sanofi, USA)

15:00 - 15:30

Role of the herbal medicine in drug interactions: perpetrator and victim

Chair: Chuan Li (Chinese Academy of Sciences, Shanghai)

  15:30 - 15:45 Coffee Break
  15:45 - 16:15

Comparative evaluation of coproporphyrins I and III with other endogenous compounds as markers of OATP inhibition in healthy subjects

Chair: Hong Shen (BMS USA)

15:45 - 16:15

Bile acids catabolism and TCM functional regulation

Chair: Haipin Hao (China Pharmaceutical University, Nanjing)

  16:15 - 16:30 Young Speaker 16:15 - 16:30  Young Speaker
  16:30 - 17:30 Round Table Discussions
  Discussion 1: Bioanalysis of Biologics - challenges and triumphs (Tao Hong) Discussion 2: How to leverage Modeling to bridge Asian PK studies (Jiansong and Jing Yang)
  Discussion 3: New FDA DDI Guidance (Mike Sinz and Bill Smith) Discussion 4: Impact of recent CFDA guidances on drug development (Alex Xu, Dafang Zhong, Sylvia Zhou)
  17:30 - 18:15 Awards for best abstracts and young speakers
  18:15 Banquet
 
   May 14, Monday
  Concurrent Sessions
  9:00 - 10:15

Session 7: Evolving topics in drug metabolism

Chairs: Lushan Yu

9:00 - 10:15

Session 8: Drug metabolism mediated efficacy and adverse effects

Chairs: Yong Hee Choi and Cai-sheng Wu

  9:00 - 9:25

Application of targeted metabolomics and 16S microbial profiling in PK-PD study of herbal medicines: case study of Ginseng

Chair: Ru Yan (University of Macau)

9:00 - 9:25

Drug interaction of metformin and Scutellariae radix in mice

Chair: Young Hee Choi (Dongguk University, South Korea) 

  9:25 - 9:50

Relationship of transcriptional factors to the expression and activity of UGTs in human liver and kidney: Co-expression network analysis

Chair: Lan Tang

9:25 - 9:50

Application of PBPK in patient treatment to improve efficacy

Chair: Xiaoqiang Xiang (Fudan University, China)

  9:50 - 10:15

Epigenetic activation of the drug transporters in cancer cells

Chair: Lushan Yu

9:50 - 10:15

Regulation of metabolizing enzymes and transporters via p53 and its effect on liver

Chair: Huichang Bi (Sun Yat-sen University, China) 

  10:15 - 10:30 Coffee Break
  10:30 - 11:45

Session 9: Application of advanced drug metabolism models

Chairs: Sandhya Mandlekar and Yan Yang

10:30 - 11:45

Session 10: Analytical technology for ADME studies of new drug platforms 

Chairs: Mingshe Zhu and Kenji Yahata

  10:30 - 10:55

Characterization and application of novel P450 knockout rat models

Chairs: Xin Wang (East China Normal University)

 10:30 - 10:55

Disposition of cell therapeutics: Analytical strategy and methods

Chair: Haifeng Song (Beijing National Proteomics Research Center)

  10:55 - 11:20

Animal Moels in the prediction of drug-drug interaction potential of new chemical entities 

Chair: Sandhya Mandlekar (BMS in India)

10:55 - 11:20

Direct quantitation of drugs in organelles from living cell by mass-spectrometry

Chair: Kenji Yahata (Sanofi Japan)

  11:20 - 11:45

Development and application of specific probes and biosensors of metabolizing enzymes 

Chair: Guangbao Ge (Shanghai University of Chinese Medicine)

11:20 - 11:45

Novel approach for study of exposure and disposition of herbal medicines

Chair: Mingshe Zhu (MassDefect Technologies, USA)

  11:45 - 12:00  Closing Ceremony
 
  • Closing words by Zeng Su and Zhuohan Hu
  • Closing words by CSSX President
  • Closing words by ISSX President

 

 

 

 

 

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