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6th Asia Pacific Meeting Program
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May 11 Friday

Registration

9:00-17:00

Registration

 

 

 

 

May 11 Friday-Morning

Short Courses

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)

9:00-9:10

Opening Remark

 

SC 1: 9:00-12:00
Mechanistic PK/PD Modeling and Simulation: Steps to Become a PBPK/QSP Modeler

 

Workshop 1: 9:00-12:00
Metabolite Evaluations and Mass Balance Studies

 

Chairs: Yanyan Zhang and Rukmini Kumar

 

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

9:00-10:00

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

9:10-9:50

Thomas Ballie (University of Washington, USA)
Reactive metabolite

10:00-11:00

Rukmini Kumar (Vantage Research, India)
Overview of QSP and FDA regulatory outlook to QSP

9:50-10:30

Yi Liu (WuXi AppTec, China)
Mass Balance Study–Design, Data Analysis, Implicationsfor Dosing, and Labeling Recommendations

11:00-12:00

Yan-Yan Zhang & Yoshihisa Shitara (Sanofi Shanghai and Tokyo)
General equations to construct the systems model, and MATLAB Simbiology software orientation

10:30-10:40

Coffee break

10:40-11:20

Jeff Zhang (Novartis, China)Metabolic profiling and mass balance study in preclinical species and human

12:00-12:30

Panel discussion and Q&A

11:20-12:00

Zheming Gu (Value Pharmaceutical Services Co., Ltd. China)
Metabolite Screening and Evaluation in Early Drug Clinic Trials

12:30-13:00

Lunch

12:00-13:00

Lunch Seminar

 

May 11 Friday-Afternoon

SC 2: 13:00-16:00
Application of PBPK modeling in drug discovery and development: case studies

 

Workshop 2: 13:00-15:15
Understanding 2017 DDI Guidance – Case Studies

 

Chairs: Houfu Liu and Michael Bolger

 

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

13:00-13:45

Chuang Lu (Sanofi, US)
Application of Physiologically-based Pharmacokinetic Modeling and Simulation in Prediction of Human PK and Drug-drug Interactions.

13:00-13:45

Jing Lin (Sumitomo Dainippon Pharmaceuticals, USA)Interpretation and Integration for Time-Dependent Inhibition in New FDA DDI 2017 Draft Guidance - from In Vitro Experiment, PBPK Modeling to Clinical

13:45-14:30

Hongcan Ren (Hutchison Pharma, Shanghai)
Modeling and simulation of double peaks in dogs using a modified PBPK model-mechanism exploring and clinical risk evaluation.

13:45-14:30

Hongjian Zhang (Suzhou University, China)
Understanding and applying 2017 USFDA DDI guidance - Case Studies

14:30-15:15

Noriko Okudaira (DAIICHI SANKYO, Japan)
Application of PBPK model analysis to oncology drug development.

14:30-15:15

By (to be determined)
Designing Clinical DDI trials based on the results of In Vitro DDI evaluation - Case Studies

15:15-16:00

Michael B. Bolger (Simulation Plus, US)
Discovery PBPK: How to estimate the expected accuracy of ISIVE and IVIVE for new chemical entities.

15:15-15:45

Coffee break

16:00-16:30

Panel discussion and Q&A

 

Workshop 3: 15:45-18:00
Biologics and Transporter

 

Chairs: Guorong Fan (Shanghai 1st People’s Hospital, China) Lilly Xu (Chempartner, 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 / write a winning CV

15:45-16:30

Yuanguo Cheng (National Shanghai Center for Drug Safety Evaluation, China)
PK Evaluation for Biologics –Challenges and Solutions

16:30-17:15

Jing Shi (WuXiAppTec, China)
Biologics: clinical sample analysis

Tom Baillie, Mingshe Zhu, Zhuohan Hu, Mike Sinz, John Miners, Bill Smith, Su Zeng, Jasminder Sahi and any other faculty who can be there

17:15-18:00

Buyun Chen (Genentech, USA)
Quantitative evaluation of drug transporter activities - Case Studies

18:00-18:45

Panel Discussion
Panel Members: Session chairs and speakers

18:45-19:00

Close remark

19:00-20:30

Dinner for workshop attendees and faculty

19:00-20:30

Dinner for workshop attendees and faculty

 

May 12 Saturday-Morning

Keynote Lectures /Sessions

08:30-09:00

Opening Ceremony(5 mins each)

·Welcome by Su Zeng + Jasminder Sahi

·Opening words by CSSX chair

·Opening words by ISSX chair

 

Keynote Lectures
Chairs: Su Zeng and Jasminder Sahi

 

9:00-9:50

Tom Baillie (Univ Washington USA and Chair ISSX)
Targeted Covalent Drugs and the Promise of Personalized Medicine

9:50-10:40

Guangji Wang (China Pharmaceutical University, China)
Cellular Pharmacokinetics

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

Session 1 (13:30 - 17:00)

Session 2 (13:30 - 17:00)

In vivo Function and Regulation of Drug
Transporters

ADMET of Drugs and Chemicals

 

Chairs: Yuichi Sugiyama & Wooin Lee

Chairs: Bill Smith and Sylvia Zhao

13:30-14:00

Yuichi Sugiyama (RIKEN Inst, Tokyo)
Use of “Extended Clearance Concept” to predict Clinical Outcomes from In Vitro Metabolism and Transport Data; focusing on the transporters in the liver

Jim Halpert (Univ Connecticut, USA)
Implications of human P450 structures for drug design

14:00-14:30

Ayman El-Kattan (Pfizer, USA)
The use and abuse of extended clearance concept

Xinxin Ding (University Albany, USA)
Utility of transgenic mice for identification of biomarkers and metabolism-mediated toxicological mechanisms

14:30-15:00

Yoshihisa Shitara (Sanofi, Tokyo)
Time-dependent and long-lasting inhibition of OATP transporters

Bill Smith (Gilead, USA)
From Enzymology to Human ADME: Case study of a disproportionate metabolite.

15:00–15:15

Coffee break

 

Chairs: Yuichi Sugiyama & Hua Li

Chairs: Bill Smith & Genfu Chen

15:15-15:45

Wooin Lee (Seoul National University, S.Korea)
Complexity and Diversity in SLCO Transporters, via Epigenetic and Splicing Regulation

Mike Zientek (Takeda, USA)
Unraveling the contribution of aldehyde oxidase to drug clearance: getting closer to an elusive parameter.

15:45-16:15

Hua Li (Academy of Military Medical Sciences, China)
Role of P-glycoprotein in BBB penetration and respiratory toxicity of opioid drugs

Aimin Yu (UC Davis, USA)
MicroRNAs in the regulation of DMPK

16:15-16:30

(young speaker)

(young speaker)

16:30-16:45

Gold sponsor speaker

Gold sponsor speaker, Genfu Chen (Wuxi)

16:45-17:15

Panel Discussion and Q&A

Panel Discussion and Q&A

17:15-18:15

Poster Session

18:15-20:00

Welcome Reception

 

May 13 Sunday-Morning

 

 

8:30-9:20

Keynote lecture

Chair: Zhuohan Hu (RILD)

Yuichi Sugiyam (RIKEN Institute, Japan)
Role of Transporters in pharmacokinetics (PK)/ pharmacodynamics (PD )/ toxicodynamics (TD)

 

Session 3 (9:30 -12:00 )

Session 4 (9:30 -12:00 )

 

Personalized Medicine - Roles of Omics and Disease States

Drug Interactions and Liver Injury

 

Chairs: John Miners & Min Huang

Chairs: Mike Sinz & Eric Chan

9:30-10:00

Magnus Ingelman Sundberg (Karolinska Instuitute, Sweden)
Predictive pharmacogenomic biomarkers for personalized medicine tomorrow

Mike Sinz (BMS, India)
Drug drug interactions: Enzyme Induction

10:00-10:30

Wichittra Tassaneeyakul (Khon Kaen University, Thailand)
Pharmacogenomic of drug-induced SCARs

Eric Chan (National Univ of Singapore)
PBPK-modeling of complex DDIs between rivaroxaban and amiodarone

10:30-10:45

Coffee break

Coffee break

10:45-11:15

Min Huang (Sun Yat-sen University, China)
Omics-based personalized medicine

Wen Xie (Univ of Pittsburgh, USA)
Disease effect on liver drug metabolism

11:15-11:45

John O. Miners (Flint Univ, Australia)
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

Li Wang (University of Connecticut, USA)
Disruption of mitochondria glucose oxidation pathway sensitizes liver to acute injury

11:45-12:00

(young speaker)

(young speaker)

12:00-12:15

Gold sponsor speaker

Gold sponsor speaker

12:00-13:00

Industry-Sponsored Sessions over lunch

13:00-14:00

Poster Sessions

 

May 13 Sunday-Afternoon

 

 

 

Session 5 (13:00 - 15:30)

Session 6 (13:00 - 15:30)

 

Drug Interactions and Regulatory Guidance

ADMET of Herbal Medicine

 

Chairs: Dafang Zhong and Chuang Lu

Chairs: Ge Lin and Chuan Li

14:00-14:30

Alex Xu (CFDA China)
Safety testing of drug metabolites in drug development

Ge Lin (Chinese University of Hong Kong)
CYP-mediated metabolic activation and pyrrole-protein adduct formation—the cause and biomarker of pyrrolizidine alkaloid N-oxide-induced herbal hepatotoxicity

15:00-15:30

Dafang Zhong (Chinese Academy of Sciences)
Clinical trials using radiolabeled drugs - guidance and application

Jiang Zheng (Shenyang Pharmaceutical University China)
Metabolism-mediated toxcities of terpene furanoids

15:00-15:30

Lu Chuang (Sanofi USA)
How PBPK modeling can be leveraged for drug drug interactions

Chuan Li (Chinese Academy of Sciences, Shanghai)
Role of the herbal medicine in drug interactions: perpetrator and victim

15:30-15:45

Coffee break

15:45-16:15

Hong Shen (BMS USA)
Comparative evaluation of coproporphyrins I and III with other endogenous compounds as markers of OATP inhibition in healthy subjects

Haipin Hao (China Pharamceutical University, Nanjing)
Bile acids catabolism and TCM functional regulation

16:15-16:30

(young speaker)

(young speaker)

 

16:30-17:30

Round Table Discussions

 

Discussion 1: Bionalysis 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 (Jas Sahi, Zhuohan Hu, Alex Xu, Dafang Zhong, Sylvia Zhou)

17:30-18:15

Awards for best abstracts and young speakers

18:30

Banquet

 

May 14 Monday

Sunrise Forum Session

 

Session 7 (9:00-10:15)

Session 8 (9:00-10:15)

 

Evolving topics in drug metabolism

Drug metabolism mediated efficacy and adverse effects

 

Chairs: Lushan Yu and Xiaomei Zhuang

Chairs: Yong Hee Choi and Cai-sheng Wu

9:00-9:25

Ru Yan (University of Macau)
Application of targeted metabolomics and 16S microbial profiling in PK-PD study of herbal medicines: case study of Ginseng

YoungHeeChoi (DonggukUniversity, South Korea)
DruginteractionofmetforminandScutellariaeradixinmice

9:25-9:50

Lan Tang (Southern Medical University, China)
Relationship of transcriptional factors to the expression and activity of UGTs in human liver and kidney: Co-expression network analysis

Xiaoqiang Xiang (Fudan University, China)
Application of PBPK in patient treatment to improve efficacy

9:50-10:15

Lushan Yu (Zhejiang University, China)
Epigenetic activation of the drug transporters in cancer cells

Huichang Bi (Sun Yat-sen University, China)
Regulation of metabolizing enzymes and transporters via p53 and its effect on liver toxicity

10:15-10:30

Coffee break

Coffee break

 

 

Session 9 (10:30 - 11:45)

Session 10 (10:30 - 11:45)

 

Application of advanced drug metabolism models

Analytical technology for ADME studies of new drug platforms

 

Chairs:Sandhya Mandlekar and Yan Yang

Chairs: Mingshe Zhu and Kenji Yahata

10:30-10:55

Xin Wang (East China Normal University)
Characterization and application of novel P450 knockout rat models

Haifeng Song (Beijing National Proteomics Research Center)
Disposition of celltherapeutics: Analytical strategy and methods

10:55-11:20

Sandhya Mandlekar (BMS in India)
Animal Models in the prediction of drug-drug interaction potential of new chemical entities

Kenji Yahata (Sanofi Japan)
Direct quantitation of drugs in organelles from living cell by mass-spectrometry

11:20-11:45

Guangbao Ge (Shanghai University of Chinese Medicine)
Development and application of specific probes and biosensors of metabolizing enzymes

Mingshe Zhu (MassDefect Technologies, USA)
Novel approach for study of exposure and disposition of herbal medicines

 

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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