CPSA Shanghai 2016

Innovative Approaches to Reduce Attrition and Predict Clinical Outcomes

Meeting Program     Wednesday | Thursday | Friday | Saturday

Updated 11 April 2016

Wednesday 星期三 20 April

10:00 am
Renaissance Shanghai
4th Floor Lobby

Registration Open

2:00 pm - 4:00 pm
Ballroom I

Educational Pre-Conference Workshop

Advantages of Novel Data Acquisition Strategies for Accurate Metabolite Identification
Kerong Zhang, SCIEX

Practical Considerations of Large Molecule Bioanalysis in Complex Matrices
Shaw Xia, SCIEX

4:00 pm - 6:00 pm
Ballroom I

Executive Roundtable

The Balance of Scientific Integrity and Regulatory Burden in Drug Discovery and Development
Chair: Naidong Weng, Janssen Research & Development

DMPK and Asia Outsourcing
Ajai Chaudhary, Merck

CRO Bioanalysis
Xinping Fang, WuXi AppTec

Medicinal Chemistry and External Lead Discovery
Peter Meinke, Merck

EBF and Pharmaceutical Bioanalysis
Philip Timmerman, Janssen Research & Development

Instrument Sector
Hua-Fen Liu, SCIEX

6:00 pm - 9:00 pm
Ballroom II

Opening Reception

Thursday 星期四 21 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

Kelly Dong

Format, Objectives, Opening Remarks
Kelly Dong
GlaxoSmithKline

9:00 am - 9:45 am
Ballroom I/II

Plenary Lecture

2016 Plenary Speaker Valeriu Damian

Quantitative Systems Pharmacology – a key approach to reduce attrition in drug discovery and development
Valeriu Damian
GlaxoSmithKline

9:00 am - 5:00 pm
Yangtze Ballroom

Poster Hall Open

Posters will be available all day today and Friday

10:15 am - 11:45 am
Ballroom I/II

Joint ADME/BA Symposium
Innovative Approaches to Reduce Attrition
Chairs: Sylvia Zhao, Novartis and Fan Jin, Covance

Early Reading of Drug-Drug Interactions by Using Endogenous Biomarkers and Recommendation of IQ Bioanalytical Subteam on Use of 4ß-Hydroxycholesterol for P450 3A4/5 DDI
Naidong Weng, Janssen Research & Development

Bioanalytical Strategies to Help Drive Drug Development
Joseph Bower, Covance

Bioanalytical Strategy for Antibody Drug Conjugates
Mary Hu, Shanghai Miracoge

11:00 am - 2:00 pm
4th Floor Lobby

CPSA Shanghai Expo   Where Technology and Solutions Meet!

11:30 am - 2:00 pm
Yangtze Ballroom

Young Scientist Awards Poster Review Session

Chairs: Mingdan Wu, Wuxi AppTec and Jeff Zhang, Novartis
Young Scientist Excellence Committee Members: Luke Bi, Covance; Joseph Bower, Covance; Xiao Ding, Genentech; Jonathan Josephs, Thermo Fisher Scientific; Fred Li, Hua Medicine; Min Liu, Merck; Qun Lu, Celgene; Marjoleen Nijsen, AbbVie; Suma Ramagiri, SCIEX; Jasminder Sahi, Sanofi; Gary Valaskovic, New Objective; Sihe Wang, Cleveland Clinic; Naidong Weng, Janssen; Tianyi Zhang, Frontage Laboratories; Sylvia Zhao, Novartis

12:00 pm - 1:00 pm

Lunch & Learn Workshops

Ballroom I

Accurate Metabolite Identification using SWATH™, A Data Independent Acquisition and SelexION™ Gas Phase Separation
Shaw Xia, SCIEX

Ballroom II

Workshop

1:30 pm - 3:00 pm

PARALLEL SESSIONS Tracks 1 - 4

Ballroom I

Drug Metabolism
Chairs: Dafang Zhong, Shanghai Institute of Materia Medica and Jeff Zhang, Novartis

Metabolism and Pharmacokinetics of Vicagrel, A Novel Thienopyridine P2Y12 Inhibitor, Compared with Clopidogrel in Humans
Dafang Zhong, Shanghai Institute of Materia Medica

Metabolite Profiling of Artemisinin-Based Combination Drugs
Jie Xing, Shandong University

Rapid Identification of Biotransformation-Mediated Modification of Endogenous Proteins and Biologics Using HRMS, Background Subtraction and PEAKS
Mingshe Zhu, Bristol-Myers Squibb

In Vitro ADME Evaluation for Supporting IND Submission: Guidance, Challenges, and Solutions
Zhuohan Hu, Fudan University

Ballroom II

Small Molecule Bioanalysis
Chairs: Xiao Ding, Genentech and Luke Bi, Covance

Application of LC-AMS for the Determination of the Absolute Bioavailability of Taselisib in Human
Xiao Ding, Genentech

Bioanalytical Challenges and Strategies for Analysis of Unstable Small Molecules
Hongliang Jiang, Hua Zhong Sci Tech University

Addressing Matrix Effect Issues in Clinical Bioanalysis
Luke Bi, Covance

Rhine Ballroom

Protein Biomarkers: Defining Industry Trends and Meeting Needs through Technology

Chairs: Nathan Yates, University of Pittsburgh and Gary Valaskovic, New Objective

Protein Subtyping for the Diagnosis of Amyloidosis
Sihe Wang, Cleveland Clinic

Is Urine a Better Biomarker Source than Blood?
Youhe Gao, Beijing Normal University

The Phoenix Center and National Proteomics Programs in China
Jun Qin, Beijing Proteome Research Center

Danube Ballroom

Advances in New Technologies for Pharmaceutical Development
Chair: Qun Lu, Celgene

Solid Form Transformation During Pharmaceutical Processing
Lei Zhu, Merck

High Speed Chromatography to Expedite Pharmaceutical Development
Naijun Wu, Celgene

High Resolution Mass Spectrometry for Structure Elucidation of Impurity and Degradation Products in Pharmaceutical Industry
Wendy Zhong, Merck

3:30 pm - 5:00 pm

PARALLEL SESSIONS Tracks 5 - 8

Ballroom I

Enabling Capabilities in Support of Drug Discovery and Development
Chair: Min Liu, Merck

Enabling Capabilities in Drug Discovery
Petr Vachal, Merck

Small Molecule Research: The Present and the Future
Hong Sheng, Roche

Applications and Impact of Alternative Synthetic Technologies in Lilly Research Labs
Óscar de Frutos, Eli Lilly and Company

Ballroom II

Changing World of Biomarkers in Drug Development
Chair: Wenying Jian, Janssen and Naidong Weng, Janssen

An Overview of the Changing World of Biomarkers in Drug Development
Patrick Bennett, PPD

Crystal City VI Biomarker Meeting
Robert Dodge, Bristol-Myers Squibb

Biomarker Challenges and Innovative Approaches to Predict Clinical Outcomes: 4ß-Hydroxycholesterol as an Emerging Endogenous Biomarker of Hepatic CYP3A
Jialin Mao, Genentech

Rhine Ballroom

Young Scientist Excellence Award Session

Danube Ballroom

Bioanalytical Application in Biosimilar Preclinical and Clinical Development
Chairs: Xiao-Yan Cai, WuXi AppTec and Yi Du, HuaHai Pharmaceutical Co., Ltd.

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 22 April

7:30 am
Renaissance Shanghai
4th Floor Lobby

Registration Open

8:30 am - 9:15 am
Ballroom I/II

Plenary Lecture

2016 Plenary Speaker Nathan Yates

Differential Mass Spectroscopy - Biomarker Discovery from Basic Research to the Clinic
Nathan Yates
University of Pittsburgh

9:00 am - 11:00 am
Yangtze Ballroom

Poster Hall Open

Posters will be available all day today

9:30 am - 11:00 am
Ballroom I/II

Joint ADME/BA Symposium
Innovative Translational PKPD Approaches to Optimize Clinical Outcomes
Chair: Jing Lin, Sunovion and Marjoleen Nijsen, AbbVie

Innovative Translational Modeling to Build Confidence in PoC
Marjoleen Nijsen (Abbvie, US)

Translation of Preclinical In Vivo and In Vitro Data to Predict Clinical Exposures and Drug-Drug Interactions for a Novel NAMPT Inhibitor
Bianca Liederer, Genentech

Mechanism-Based PK/PD Modeling in Drug Development
Sylvia Zhao, Novartis

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

Defining Needs and Solutions to Enable Success with High-Performance Mass Spectrometry

Ballroom II

Advances in Blood Collection and Plasma Preparation for Clinical Trials
Tim Schlabach, Novilytic

1:30 pm - 3:00 pm

PARALLEL SESSIONS Tracks 9 - 12

Ballroom I

Prediction of Clinical Dose
Chairs: George Liu, Novartis and Jiansong Yang, MOSIM

Dosing in Children: Prediction and Optimization
Wei Zhao, Shandong University

Ethnic Differences and Precise Medicine in Clinical Drug Development and Medical Practice
Charles Xie, Boehringer Ingelheim

A Systems Pharmacology Model for Predicting Effects of Factor Xa Inhibitor in Healthy Subjects: Assessment of PK and Binding Kinetics
Xuan Zhou, Novartis

Ballroom II

Biomolecule Bioanalysis
Chairs: Eric Liang, Novartis and Dongbei Li, WuXi

Important Considerations and Case Studies for Anti-Drug Antibody Assay Development
Dongbei Li, Wuxi AppTec

Large Molecule Quantification by LC-MS and Case Studies
Tianyi (Tee) Zhang, Frontage

Analytical Considerations for Bi-Specific Antibodies and Antibody Drug Conjugates
James Munday, Covance

Rhine Ballroom

Protein Biomarkers and Proteomic Quantification: Addressing Needs from Pharmaceuticals to Clinical Application
Chairs: Nathan Yates, University of Pittsburgh and Gary Valaskovic, New Objective

Bioanalytical Strategies for Serum Apolipoprotein A-1: A Biomarker for Cardiovascular Disease Risk
Wenying Jian, Janssen Pharmaceutical Research and Development and Ian A. Blair, University of Pennsylvania

Technological Advancements to Decode Complex Biomarker Analysis and its Contribution to Drug Discovery & Development
Hua-Fen Liu, SCIEX

TBA
Catherine Wong, National Center for Protein Science

The Use of High Resolution Accurate Mass (HRAM) to Maximize Selectivity in Quantitative Analysis
Jonathan Josephs, Thermo Fisher Scientific

Danube Ballroom

Pharmaceutical Development
Chairs: Deepak Hegde, GlaxoSmithKline and Fred Li, Hua Medicine

Preformulation – Key to Efficient and Effective Formulation Design
Feng Tao, Zai Lab

Drug Substance (API) for Early Drug Development
Jun Lu, GlaxoSmithKline R&D

Formulation Selection Matrix in Early Clinical Development
Anand Kulkarni, Bioduro

3:30 pm - 5:00 pm

PARALLEL SESSIONS Tracks 13 - 16

Ballroom I

Quantitative System Pharmacology

Chairs: Valeriu Damian, GlaxoSmithKline and Peiming Ma, GlaxoSmithKline

Application of QSP Modeling to Support Drug Development Projects
Oleg Demin, Institute for Systems Biology Moscow

Mechanistic Physiological PhysioPD™ Models in Drug Development: A Proven Quantitative Systems Pharmacology (QSP) Approach
Ananth Kadambi, Rosa & Co. LLC

Practical Applications of DILIsym, A Simulation Tool for Drug-Induced Liver Injury
Brett Howell, DILIsym Services, Inc.

Ballroom II

Challenges and Opportunities for Biomarkers in Scientific Space

Chairs: Wenying Jian, Janssen and Naidong Weng, Janssen

Metabolomics in the Search for Pancreatic Cancer Biomarkers
Huichang Bi, Sun Yat-sen University

Advanced Technology for Mass Spectrometry Based Small Molecule Biomarker Quantitation
Allan Xu, Keystone Bioanalytical

Quantification of 14 Bile Acids Using UHPLC-HRAM
Min Meng, Covance

Rhine Ballroom

Innovator Award Session

Innovator Award Committee: Robert Dodge, Bristol-Myers Squibb; Yi Du, HuaHai Pharmaceutical Co., Ltd.; Xianyu Jiang, WuXi; Wenzhe Lu, Roche; Yi-Min She, Shanghai Center for Plant Stress Biology

Danube Ballroom

Scientific Validation

Chair: Philip Timmerman, Janssen Research & Development

The Principles of Tiered Approach and Scientific Validation: History and EBF Recommendation
Philip Timmerman, Janssen Research & Development - on behalf of the EBF

Bioanalytical Support of Early Development Studies at WuXi: A Perspective
Xinping Fang, WuXi AppTec

Perspective on Translating Tiered Approach and Science Validation into LBA
Joseph Bower, Covance

Panel Discussion

5:00 pm - 7:30 pm
Ballroom I/II

Dinner, Awards & Celebration

Sponsor's Toast

Program Chair Recognition
Mike Lee, Milestone Development Services

CPSA Shanghai 2017 – Program Chair Announcement
Kelly Dong, GlaxosmithKline

Innovator Award Presentation

Young Scientist Excellence Award Presentation
Chairs: Mingdan Wu, Wuxi AppTec and Jeff Zhang, Novartis