Chemical & Pharmaceutical Structure Analysis

Where Technology and Solutions Meet...
Where East Meets West

CPSA Shanghai 2011

Changing Paradigm in Drug Discovery and Development:
East Meets West

April 13 - 16, 2011
Renaissance Shanghai Pudong Hotel
Shanghai, China

Symposium Program

Updated April 7, 2011

Wednesday, April 13

1:00 pm - 5:00 pm


Biotransformation: Lead Optimization and Clinical Candidate Selection Through in Vitro ADME Evaluation
Workshop Leader: Mingshe Zhu, Bristol-Myers Squibb

Common in Vitro ADME Assays:
Methods and Data Interpretation
Weiqing Chen, ChemPartner

Assessment of Transporter-Mediated Drug-Drug Interactions:
Current Strategy and Methodology
Guangqing Xiao, Biogen Idec

Drug Metabolite Identification in Drug Discovery Using High-Resolution Mass Spectrometry
Jie Xing, University of Shandong, China

Design Proper in Vitro ADME Studies to Meet Needs
in Drug Discovery
Mingshe Zhu, Bristol-Myers Squibb

Bioanalysis: LC/MS Bioanalysis from Drug Discovery to Development Processes, Technologies and Regulations
Workshop Leader: Jian Wang, Bristol-Myers Squibb

Overview of LC-MS/MS Bioanalysis in Pharmaceutical Industry: Processes and Applications
Danlin Wu, Roche

Technical Fundamentals in LC-MS/MS Bioanlytical Method Development, Validation and Sample Analysis: Procedures, Issues and Solutions
Yuan-Qing Xia, Bristol-Myers Squibb

Performing Regulated Bioanalysis, Challenges and Case Studies from CRO Perspective
Xiaohang Shen, WuXi AppTec

Discovery Bioanalysis
Jian Wang, Bristol-Myers Squibb

Pharmaceutical Analysis
Workshop Leaders: Gang Xue, Pfizer; Yong-Guo "Fred" Li, Roche

High Speed and High Efficiency Method Development
Gang Xue, Pfizer

ICH Q-Series, Key Points Exploration
Yong-Guo "Fred" Li, Roche

Dissolution Design and Testing, Critical for Oral Drug
Mufeng Xie, Shanghai Institute for Food and Drug Control (SIFDC)


Sponsor's Dinner
Hosted by Thermo Fisher Scientific

Introduction and Welcome
Iain Mylchreest, Vice President and General Manager, Thermo Fisher Scientific

Applying Proven Proteomic Workflows and Tools for Quantitative Bioanalysis of Large Molecules
Jonathan McNally, Marketing Manager for Bioanalysis, Thermo Fisher Scientific

Thursday, April 14

8:30 am - 8:45 am

Mike S. Lee, Milestone Development Services

8:45 am - 9:00 am

Jing-Tao Wu of Takeda/Millennium Pharmaceuticals in Cambridge, MA will chair CPSA Shanghai 2011
Meeting Overview
CPSA Shanghai 2011 Chair
Jing-Tao Wu, Ph.D.
Millennium Pharmaceuticals

9:00 am - 10:00 am

Plenary Lecture

Challenges and Future Direction of Oncology Drug Development
Pete Smith, Senior Vice President, Millennium Pharmaceuticals

10:15 am - 11:45 am

Parallel Sessions

Parallel Track I

Comparison of Regulatory Requirments on DMPK Package
Chair: Jeff Zhang, Novartis

Overview of DMPK Package in China: Regulatory Requirement and Current Practice
Dafang Zhong, Shanghai Institute of Materia Medica

US/Europe Regulatory Requirements on Metabolites in Safety Testing
Mingshe Zhu, Bristol-Myers Squibb

US/Europe Regulatory Requirements on Drug/Drug Interactions
Lawrence Gan, Biogen Idec

Parallel Track II
Pharmaceutical Sciences

Emerging Trends and Technologies in Pharmaceutical Sciences
Chair: Jack Chen, DSM

PAT Applications in a Quality-by-Design(QbD) Environment
Kevin J. Bittorf, Vertex Pharmaceuticals

Enhancing Product Performance through Innovative Formulation and Manufacturing
Qun Lu, Merck

New Technology in Polymorph Studies
Beth Sarsfield, Bristol-Myers Squibb

Parallel Track III

Dried Blood Spots and Other Emerging Bioanalytical Technologies
Chair: Naidong Weng, Johnson & Johnson

Applications of DBS for Clinical Bioanalysis Support
Tom Verhaeghe, Johnson & Johnson

Case Study of Dried Blood Spots Application in Toxicology Study
Luke Bi, Covance

High Resolution Accurate Mass Spectrometry in Quantitative Bioanalysis: Effect of Mass Resolution and Extraction Window on Selectivity
Yuan-Qing Xia, Bristol-Myers Squibb

High-Throughput Bioanalysis Using an Ultra-fast On-line Extraction System
Wenying Jian, Johnson & Johnson

11:00 am - 2:00 pm

CPSA Shanghai Expo

11:45 pm - 1:15 pm

Lunch & Roundtable Discussion

12:15 pm - 1:15 pm

Sponsored Workshops

Sponsored by AB Sciex
High Resolution Quantitation for Bioanalysis using AB Sciex 5600 Triple Tof
Hesham Ghobarah, AB Sciex

Targeted Peptide Quantitation using MIDAS Workflow
Wenhai Jin, AB Sciex

Sponsored by McKinley Scientific
Analytical Equipment and Clinical Systems: New Business Models to Assist Research in Academia, Pharmaceuticals, and Hospitals
Martin Steel, McKinley Scientific

1:15 pm - 5:00 pm

Parallel Sessions

1:15 pm - 2:45 pm

Parallel Track I

Drug-Drug Interactions
Chairs: Cindy Xia, Millennium; Angela Wong, WuXi AppTec

DDI of Herbal Medicines
Yan Sun, Shanghai Institute of Materia Medica

Application of In-Vitro Data to Predict Clinical PK and Drug-Drug Interaction by Simcyp
Jing Lin, Pfize

Pharmacogenetics in Drug Discovery and Development
Renke Dai, South China University of Technology

3:00 pm - 5:00 pm

ADME Optimization to Advance CNS and Oncology Drug Discovery and Development: Industry Case Studies
Chairs: Zack Cheng, GlaxoSmithKline; Haojing Rong, Pfizer

Blood-Brain Barrier Transporters: Friend or Enemy for CNS Drug Discovery and Development?
Zack Cheng, GlaxoSmithKline

Human CNS Penetration: Can It Be Predicted from Preclinical Data?
Haojing Rong, Pfizer

ADME Support of Oncology Programs: Risk Management vs. Pursuit of Appropriate Drug-Like Properties
Hongjian Zhang, PharmaResources

Predictive Toxicology Approaches for Small Molecule Oncology Drugs
Vic Kadambi, Millennium Pharmaceuticals

1:15 pm - 2:45 pm

Parallel Track II
Pharmaceutical Analysis Summit

High-speed, High-Resolution Techniques for Pharmaceutical Analysis
Chairs: Anne-Françoise Aubry, Bristol-Myers Squibb; Xiaoyi Gong, Merck

Chromatographic Methodology and Technology for Developing TCM
Xinmiao Liang, Dalian Institute of Chemical Physics

Mass Spectrometry and Ion Mobility-Based Techniques for Rapid Pharmaceutical Analysis: No Sample Preparation?
Zhongli Zhang, Pfizer

GC-MS and Flow-Modulated GCXGC-FID/MS for the Analysis of Fatty Acids in Bacteria and Marine Biota Using Polar and Ionic Liquid Columns
Qun Gu, Dalian Institute of Chemical Physics

3:00 pm - 5:00 pm

Analytical Approaches for the Determination of Low-Level Impurities to Comply with International Regulations
Chairs: Todd Gillespie, Eli Lilly and Company; Roman Szucs, Pfizer

Analytical Strategy for Quantifying Low-Level Genotoxic Impurities
Todd Gillespie, Eli Lilly and Company

Quantitation of API Impurities Near the Qualification Level
Tianmin Zhu, Hisun Pharmaceuticals

Bioanalytical ICP-MS in Drug Development
Jaap Wieling, QPS Netherland

High-throughput Chiral Analyses
Xiaoyi Gong, Merck

1:15 pm - 5:00 pm

Parallel Track III

Absolute Quantification of Peptides and Proteins: From Sample Preparation and Chromatography to ESI-MS/MS
Leaders: Gary Valaskovic, New Objective; Nalini Sadagopan, Agilent

5:00 pm - 6:00 pm

Poster Viewing

6:00 pm - 9:00 pm

Reception & Keynote Lectures
Hosted by Agilent Technologies

Welcome Toast

Stable and Reactive Metabolites in Drug Research
Scott Obach, Pfizer

Simultaneous Determination of the PK Profile of Clozapine and its Metabolites in Rat Plasma Using a High-Resolution 6540 QTOF Instrument
Lester C. Taylor, Shane Tichy, and Na Pi, Agilent Technologies

Friday, April 15

8:30 am - 9:15 am

Plenary Lecture

Multi-dimensional Chromatography-Mass Spectrometry for Protein Analysis
Xiangmin Zhang, Fudan University

9:30 am - 11:00 am

Parallel Sessions

Parallel Track I
Novel Drug Delivery Technologies
Chair: Nick Zhang, Novartis

Antibody Drug Conjugates - A General Review
Boahua Gu, Novartis

Drug Targeting and Nanotechnology
Jianxin Wang, Fudan University

Novel Technologies for the Delivery of Biologics
Zhixuan Wang, Novartis

Parallel Track II
Biomarker Analysis in Drug Discovery, Development and the Clinic
Chairs: Scott Fountain, Pfizer; Nalini Sadagopan, Agilent

Application of Target and Mechanism Biomarkers in Advancing Biotherapeutics and Pharmatherapeutics
Scott Fountain, Pfizer

Implementing Biomarkers into Clinical Trials on a Global Scale
Tom Turi and LiBin Ma, Covance

Proteomics Approaches to the Development of Plasma Markers for Predicting Pre-Term Birth
Kevin P. Rosenblatt, The Brown Foundation Institute of Molecular Medicine

Parallel Track III
Comparison of Regulations for Pharmaceutical Science
Chair: Gang Xue, Pfizer

Reviews of CMC Requirements for Drug Development, Registration and Post Approval
Yanyun Chen, Pfizer

CMC Requirements for Analytical/QC
Wenfang Miao, Pharmaron

11:00 am - 12:00 pm

Poster Session

11:00 am - 2:00 pm

CPSA Shanghai Expo

12:00 pm - 1:30 pm

Lunch / Roundtable Discussion

12:30 pm - 1:30 pm

Sponsored Workshops

Sponsored by Thermo Fisher Scientific
Identification and Screening for Drug Impurities, Leachables, and Extractables Using New Software and High Resolution Mass Spectrometery
Kate Comstock, Thermo Fisher Scientific

Sponsored by New Objective
The Application of Nanospray Techniques and Methods for Product Development
Todd Gillespie, Eli Lilly and Company

Ultra-low-flow Nanospray for Low-Level Biomarkers, Metabolites, and Beyond:
Addressing Needs for Sensitivity, Selectivity, and Throughput
Gary Valaskovic, New Objective, Inc.

Sponsored by Agela Technologies
What is the Most Convenient and General Approach for Plasma Sample Clean-up?
Jerry Wang, Agela Technologies

1:30 pm - 5:15 pm

Parallel Sessions

Parallel Track I

1:30 pm - 3:00 pm

Development of Biologics as Therapeutics
Chair: Lawrence Gan, Biogen; Haijing Rong, Pfizer

Introduction of Biologics
Jennifer Visich, Genentech

Biologics Drug Drug Interaction
Lewis Klunk, Biogen

PK/PD of Biologics
Anup Zutshi, Pfizer

3:15 pm - 5:00 pm

PK/PD in Drug Discovery & Development
Chairs: Jenny Zheng, Pfizer; Zhuohan Hu, Research Institute for Liver Diseases

The Myths of PK/PD - Empirical? Mechanistic? Or System?
Jenny Zheng, Pfizer

A Mechanistic-Based PK/PD Modeling for Drug Metabolism by CYP3A in Rat
Wei Lu, Peking University, China

Case History: Use of PK/PD in Drug Candidate Selections
Ellen Rohde, Biogen Idec

Application of PBPK and In-Vitro Hepatocyte Models to Accurately Predict Human PK
Yurong Lai, Pfizer

Parallel Track II
Regulated Bioanalysis Summit

1:30 pm - 3:30 pm

Regulated Bioanalysis: State of the Art
Chair: Danlin Wu, Roche

Perspectives on Regional Differences in Bioanalytical Regulations
Mark Arnold, Bristol-Myers Squibb

Strategies to Avoid Pitfalls in Developing and Validating High-quality Quantitative Bioanalytical Methods to Support Regulated Studies
Jinsong Xing, Wuxi

Importance of Reagent Quality for Ligand Binding Assay Development
Roland Staak, Roche

Validation and Application of Ligand Binding Assays for Protein Therapeutics Quantitation and Immunogenicity Testing: A GLP Bioanalytical Lab Perspective
Eginhard Schick, Roche

3:45 pm - 5:15 pm

Current Issues in Regulated Bioanalysis
Chair: Anne Françoise-Aubry, Bristol-Myers Squibb

Unexpected Event Investigations in the Bioanalytical Laboratory
Anne Françoise-Aubry, Bristol-Myers Squibb

Bioanalytical Method Transfer - Challenges & Opportunities
Naidong Weng, Johnson&Johnson

Harmonization of Regulated Bioanalytical Operation at Both U.S. and China Sites
XinPing Fang, XenoBiotic Laboratories

Parallel Track III

1:30 pm - 5:15 pm

Pharmacokinetic Applications in Drug Discovery and Development: Human PK and Efficacious Dose Prediction
Leaders: Frances Wang, Astra Zeneca; Xingmei Han, Novartis

6:00 pm - 9:00 pm

CPSA Shanghai Social
Held in conjunction with local bioanalytical and metabolism discussion groups

6:00 pm - 7:00 pm

Social Hour

7:00 pm - 7:30 pm

Awards & Announcements

7:30 pm - 9:00 pm

Point/Counter-Point Discussions

Challenges and Opportunities for ADME Science in Pharmaceutical R&D in China
Chair: Jeff Zhang, Novartis
Panel: Chunlin Chen, Medicilon; Jenny Zheng, Pfizer; Jinsong Xing, Wuxi; Su Zeng, Zhejiang University; Dafang Zhong, Shanghai Institute of Materia Medica

Topics for discussion:
Current Drug Discovery Models
Program-based vs. Study-based Outsourcing
One-stop Shop vs. Core Expertise

Saturday, April 16

10:00 am - 12:00 pm

Joint sessions with local bioanalytical and metabolism discussion groups

Held at The Shanghai Institute for Materia Medica

Application of PK/PD in Drug Discovery and Development
Li Yu, Roche

Overview of DMPK Process in Drug Discovery and Development
Jeff Zhang, Novartis

Application of Radioisotopes in Drug Absorption, Distribution, Metabolism, and Excretion Studies
Zhe-ming Gu, Xenobiotic Laboratories

From the Renaissance Shanghai Pudong Hotel, take a taxi to The Shanghai Institute of Materia Medica (���������������������������������) located at 555 Zu Chong Zhi Road, Zhang Jiang Hi-Tech Park, Pudong, Shanghai (������������������������������������555������). The cost of the taxi is around RMB 18 ($3.00).
To take public transportation, walk to The Shanghai Science and Technology Museum and take Subway Line #2 towards the airport. Get off at Zhang Jiang Hi-Tech Park (third stop). The Shanghai Institute of Materia Medica is located directly across the street from the subway station.

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