CPSA Shanghai 2018

New Horizons in Drug Discovery and Development:
Bioanalysis, Biomarkers and ADME

Meeting Program     Wednesday | Thursday | Friday

Updated 24 April 2018

Wednesday 星期三 18 April

10:00 am

Renaissance Shanghai
4th Floor Lobby

Registration Open

1:00 PM - 3:30 PM

Ballroom I

Workshop

Introduction to Drug Discovery

Workshop Leader: Cornelis Hop, Genentech

How to Succeed in Drug Discovery
Cornelis Hop, Genentech

Bioanalysis & Metabolism
Jeff Zhang, Novartis

Current Challenges in Clearance Assessments
Zhengyin Yan, Genentech

1:00 PM - 3:30 PM

Ballroom II

Workshop

怎样在中国支持临床试验
Supporting Clinical Trials in China
(presentations in Chinese)

Workshop Leader: Jonathan Wang, Genentech

中国新药 临床试验中的代谢和药动力学研究
Clinical DMPK Studies of Innovative Drugs in China
Dafang Zhong, Shanghai Institute of Materia Medica

临床试验生物样品检测的主要关注点与常见问题
The Key Points and Common Issues for Clinical Sample Bioanalysis
Hongliang Jiang, Huazhong University of Science and Technology

为获得好的分析测试结果,临床中心应该做
How Could Clinical Centers Get Better Experimental Results
Qing Wen, Jinan Central Hospital

4:00 PM - 4:45 PM

Ballroom II

Keynote Lecture

2018 Keynote Speaker Zaiqi Wang

Future Prospect of Drug Innovation in China: Challenges and Opportunities
Zaiqi Wang
Roche

5:00 PM - 6:00 PM

Ballroom I

Executive Roundtable

Outsourcing

Discussion Leader: Mira Hinman, Abbvie

Benchmarking Survey of Outsourcing Practices in the Pharmaceutical Industry
Mira Hinman, Abbvie

Participants:
Ajai Chaudhary, Merck; Helen Yu, Novartis

6:00 PM

Ballroom II

Opening Reception & Happy Hour

Greet old friends, meet new friends, and get an overview of the week’s events and activities.
Welcome to CPSA Shanghai 2018!

Sponsor's Toast

Given by Liping Bian, Antpedia

Thursday 星期四 19 April

7:30 am

Renaissance Shanghai
4th Floor Lobby

Registration Open

8:30 am - 9:00 am

Ballroom I/II

Welcome & Opening Remarks

Mike Lee

Welcome
Mike S. Lee
Milestone Development Services

Corneli Hop

Format, Objectives, Opening Remarks
Cornelis Hop
Genentech

9:00 am - 9:45 am

Ballroom I/II

Plenary Lecture

2018 Plenary Speaker Philip Timmerman

Regulated Bioanalysis: A Perspective on the Future Benefits and Challenges of Globalisation
Philip Timmerman
EBF / Janssen Research & Development (ret)

9:00 am - 5:00 pm

Yangtze Ballroom

Poster Hall Open

Posters will be available all day today and Friday

10:00 am - 11:45 am

Ballroom I/II

Symposium Session

MIST and Drug Metabolism

Chairs: Susanna Tse, Pfizer; Jens Sydor, Abbvie

M.I.S.T.: Overall Strategy for Identification of Human Metabolite(s) and Estimation of Human and Toxicological Exposures
Susanna Tse, Pfizer

How to handle MIST Issues: The Use of the Mixed Matrix Method Illustrated with Clinical Examples
Cornelis Hop, Genentech

Case Studies of Disproportionate Human Metabolites – Ombitasvir and Venetoclax
Jens Sydor, Abbvie

MIST Case Studies
Hua Lv, Roche Shanghai

11:00 am - 2:00 pm

4th Floor Lobby

CPSA Shanghai Expo

Where Technology and Solutions Meet!

11:30 am - 1:30 pm

Yangtze Ballroom

Poster Session

Young Scientist Award Review

12:00 pm - 1:00 pm

Lunch & Learn Workshops

Ballroom I

WORKSHOP

Combining Selectivity and Sensitivity for Targeted Peptide Quantitation
Dr. Zhimin Long, SCIEX

1:30 pm - 3:00 pm

PARALLEL SESSIONS : Tracks 1 - 4

Ballroom I

TRACK 1
In Vitro ADME Challenges and Advances

Chairs: Mandy Xu, Pharmaron; Zhengyin Yan, Genentech

Improving Confidence in PPB Determinations for Highly Bound Drugs
Zhengyin Yan, Genentech

Novel Hepatic Spheroid Systems for Drug Discovery and Development
Volker Lauschke, Karolinska Institutet

Preclinical Evaluation of BBB Penetration of EGFR TKIs using in vitro and in vivo Tools
Kan Chen, AstraZeneca Asia

In vitro Human-Based Experimental Systems for the Evaluation of Human Drug Properties
Albert Li, In Vitro ADMET Laboratories

Ballroom II

TRACK 2
Small Molecule Bioanalysis

Chairs: Luke Bi, Covance; Jonathan Wang, Genentech

The Determination of Antiretroviral Triphosphate Metabolite in Human Peripheral Blood Mononuclear Cells
Deqing Xiao, Gilead

Bioanalytical Challenges in the Development of Combination Therapies
Jonathan Wang, Genenetech

LC-MS/MS Analysis of Drug in Hemolyzed Samples for Supporting BE Application: A Case Study
Minji Wei, Institute of Clinical Pharmacology, Peking University

Rhine

TRACK 3
Omics and Biomarker Challenges

Chairs: Yu Tian, Abbvie; Kelly Dong, UP Pharma

A Simple and High-Coverage Quantitative Metabolomics Platform Based on Chemical Isotope Labeling LC-MS
Liang Li, University of Alberta

Highly Sensitive Targeted Quantification of Proteins, Isoforms, and Modifications in Biofluids or Specific Cellular Pathways
Weijun Qian, Pacific Northwest National Laboratory

Critical Factors in Exploratory Biomarker Outsourcing in Clinical Studies
Helen Yu, Novartis

Danube

TRACK 4
Pharmaceutical Development:
From Discovery to First-in-Human

Chair: Qun Lu, Celgene

FIH Clinical Supply in China: Challenges and Changes
Larry Fang, Sinotherapeutics

Development, Characterization and Physical Stability of Amorphous Pharmaceutical Solids
Cai Ting, Chinese Pharmaceutical University

Roundtable Discussion

3:30 pm - 5:00 pm

PARALLEL SESSIONS : Tracks 5 - 8

Ballroom I

TRACK 5
Challenges in Drug Discovery and Development

Chairs: Lilly Xu, ChemPartner; Hua Lv, Roche

Implications of the New FDA Guidance for ADME Profiling
Stephen Fowler, Roche

The Application of in vitro Assays for in vivo DDI Prediction
Lilly Xu, Chempartner

Safety Assessments of Preclinical Candidates – Some Considerations from DMPK Perspectives
Hong Wan, Shanghai Hengrui

Ballroom II

TRACK 6
Issues in Regulated Bioanalysis

Chairs: Naidong Weng, Janssen Research & Development; Tianyi Zhang, Frontage

Challenges of Immunogenicity Testing for Supporting Clinical Trials of Biotherapeutics
Weiping Shao, Regeneron

ADC PK Profiling Strategies on LC-MS Platforms: Top-Down, Bottom-Up, and Multiplexing
Song Zhao, Frontage

Advancement of High-throughput Bioanalysis to Support Research and Development of Oligonucleotide Therapeutics and Biomarkers
Laixin Wang, Denali Medpharma

Rhine

TRACK 7
MS Imaging

Chair: Cornelis Hop, Genentech

MALDI-TOFMS Imaging for Environmental Toxicology
Chao Zhao, Hong Kong Baptist University

Imaging Mass Spectrometry: A Powerful Tool Enabling In Situ ADME Assessments
Cristine Quiason-Huynh, Genentech

Potential Usefulness of MS Imaging Technology with High Spatial Resolution in Pharmaceuticals
Miho Ayabe, Chugai

Danube

TRACK 8
Non-Cytochrome P450 Metabolism

Chairs: Jeff Zhang, Novartis; Kelly Dong, UP Pharma

Aldehyde Oxidase and its Involvement in the Metabolism of a cMet Inhibitor
Jeff Zhang, Novartis

An Investigation into the Prediction of in vivo Clearance for a Range of Flavin-Containing Monooxygenase Substrates
Yu Wang, Pharmaron

Induction of Aldehyde Oxidase by Nimesulide and its Regulation Mechanism
Lei Zhong, Shanghai Institute of Materia Medica

6:00 pm

Yangtze Ballroom

CPSA Social

Cocktails & Karaoke at CPSA

Whether you like to command the stage or cheer from the audience, it’s hard to have a forgettable time of karaoke.

Join colleagues and friends – old and new – to relax and unwind!

Request a song - click here!

Friday 星期五 20 April

7:30 am

Renaissance Shanghai
4th Floor Lobby

Registration Open

8:30 am - 9:15 am

Ballroom I/II

Plenary Lecture

2018 Plenary Speaker Lei Zhangg

Transporters in Drug Development:
Current Status and Contemporary Issues
Lei Zhang
Silver Springs, MD

9:00 am - 5:00 pm

Yangtze Ballroom

Poster Hall Open

Posters will be available all day today

9:30 am - 11:30 am

Ballroom I/II

Symposium Session

Drug Transporters

Chairs: Jasminder Sahi, Sanofi; Ikumi Tamai, Kanazawa University

Drug-Drug and Drug-Food Interaction on Transporters
Ikumi Tamai, Kanazawa University

Interactions Between Saponins and Hepatic Transporters
Chuan Li, Shanghai Institute of Materia Medica

Prediction of Brain-to-Blood Unbound Concentration Ratios in CNS Drug Discovery Employing in silico and in vitro Model Systems
Houfu Liu, GlaxoSmithKline

Contribution of Xenobiotic Transporters to Drug Disposition – Regulatory Case Studies
Jasminder Sahi, Sanofi

11:00 am - 2:00 pm

4th Floor Lobby

CPSA Shanghai Expo

Where Technology and Solutions Meet!

12:00 pm - 1:00 pm

Lunch & Learn Workshops

Ballroom I

WORKSHOP

Translating Protein MS Assays and the Challenging Road Ahead
Dobrin Nedelkov, Isoformix

1:30 pm - 3:00 pm

PARALLEL SESSIONS : Tracks 1 - 4

Ballroom I

TRACK 1
PBPK Modeling

Chairs: Tom Wilde, Janssen Research & Development; Avi Ghosh, Janssen Research & Development

The Important Role of Virtual Chinese Population for PK/PD Prediction: Perspective View from an Academic Institution
Pei Hu, Peking Union Medical College Hospital

Beyond Small Intestine Absorption: Physiological Modeling and Interspecies Translation of Gut Tissue PK
Tom Wilde, Janssen Research & Development

Predicting Drug Concentrations in Renal Tubules Combining in vitro and in silico Methods
Kas Subramanian, Syngene

Ballroom II

TRACK 2
Large Molecule Bioanalysis

Chairs: Wenying Jian, Janssen Research & Development; Xiao-Yan Cai, Consultant

Total and Free Quantification of Therpeutic Antibodies by Liquid Chromatography-Tandem Mass Spectrometry
Ichio Onami, Chugai

Strength and Challenges of LBA on Biologics Bioanalysis: Case Studies
Xiao-Yan Cai, Consultant

Strategies for Drug Transporter Quantitation by LC-MS
Alan Deng, Genentech

Rhine

TRACK 3
Radiolabeled Tools for Drug Development

Chairs: Stephen Dueker, BioCore; Alicia Du, Calibra Diagnostics

Current Status and Requirement of Radio-ADME Studies in China
Zhe-ming Gu, Value Pharmaceutical Services

Human PK of 14C-Tagged Biologics
Wouter Vaes, TNO

A Benchtop CRDS Laser System for 14C Quantitation
Stephen Dueker, BioCore

Danube

TRACK 4
Biomarker Quantitation

Min Liu, Merck; Min Li, HuaHai Pharmaceutical

Quantitative Aspects of MALDI-TOF MS for Protein Biomarkers Analysis
Dobrin Nedelkov, Isoformix

The Importance of Bioanalytical Testing in Bioequivalence Evaluation of Generic Drugs
Xiaohang Shen, Xihua Scientific

Considerations for Fit for Purpose Biomarker Method Validation Activities
James Munday, Covance

3:30 pm - 5:00 pm

PARALLEL SESSIONS : Tracks 5 - 7

Ballroom I

TRACK 5
PK/PD Modeling

Chairs: Tom Wilde, Janssen Research & Development; Avi Ghosh, Janssen Research & Development

Modeling the Impact of Renal Tubular Drug Dynamics on Plasma Drug Concentration
Kas Subramanian, Syngene

Applications of Pharmacokinetic/Pharmacodynamic Modeling in Biologics Development
Songmao (Ben) Zheng, Janssen Research & Development

PK/PD Analyses of Vfend (Voriconazole) Used for Pediatric License Renewal in China
Ping Lu, Pfizer

Ballroom II

TRACK 6
What's New - Recent Developments for ADCs

Chairs: Keyang Xu, Genentech; Young Shin, Chungnam National University

Bioanalytical Assays for ADCs - New Developments and Case Studies
Mark Qian, Takeda Pharmaceuticals

Creating Next Generation ADCs with Industry Leading DAR Precision and Plasma Stability
Jeiwook Chae, LegoChemBio

Key Scientific and Regulatory Aspects of Nonclinical Development of an ADC Biosimilar
Yue Liu, 3S Bio

Rhine

TRACK 7
Distinguished Scientist Lectures

Chairs: Liping Bian, Antpedia and Emily Ehrenfeld, New Objective

Early Identification of Potential DMPK Risks to Ensure Future Clinical Success
Kelly Dong, UP Pharma

Post-Translationally Modified Proteins as Biomarker Targets for Clinical Protein MS Tests
Dobrin Nedelkov, Isoformix

5:00 pm - 7:30 pm

Ballroom I/II

Dinner, Awards & Celebration

Closing Toast

Given by Emily Ehrenfeld, New Objective

Program Chair Recognition

Mike Lee, Milestone Development Services

CPSA Shanghai 2019 – Program Chair Announcement

Cornelis Hop, Genentech

Young Scientist Excellence Award Presentation

Chairs: Min Liu, Merck and Jeff Zhang, Novartis