Wednesday, April 25

Workshops
Workshop lunch sponsored by Agilent Technologies

9:30 am–4:30 pm

DMPK Workshop
Workshop Leaders: Lucy Xu, Novartis; Hua Li, Academy of Military Medical Sciences

The Role of DMPK in Exploratory Drug Development
Francis Tse, Novartis

DDI Overview
Tonika Bohnert, Biogen Idec

Transporter-Mediated Drug-Drug Interactions
Cindy Xia, Novartis

In Vitro and In Silico Predictions of Drug-Drug Interactions
Tonika Bohnert, Biogen Idec

Roundtable Discussion
Lucy Xu, Novartis; Francis Tse, Novartis; Lawrence Gan, Biogen Idec; Angela Wong, Merck Serono; Jing Lin, Sunovian

9:30 am–4:30 pm

Regulated LC-MS Bioanalysis Workshop
Workshop Leaders: Wenkui Li, Novartis; Naidong Weng, Janssen

Instructors:
Wenkui Li, Novartis
Wenying Jian, Janssen
Naidong Weng, Janssen
Fengying Chen, WuXi AppTec
Robert Coldreck, WuXi AppTec

12:00 pm–1:30 pm

Lunch Seminar
Sponsored by Agilent Technologies

Agilent QTOF Workflow for Pharmaceutical Impurity Profiling
Presenter: Dr. Na Pi Parra, LC/MS Marketing, Agilent Technologies, Inc.

1:00 pm–4:00 pm

Held at Shanghai Institute for Materia Medica
Pharmaceutical Sciences Workshop
Analytical Science and Technology in Pharmaceuticals
Workshop Leaders: Dongying Chen, Shanghai Institute of Materia Medica; Yong-Guo "Fred" Li, Roche

Pharmaceutical Profiling: Meet Your Molecule!
Jeannine Petrig Schaffland, Roche

Overview of Analytical Development in Pharmaceutical
Liu Fang, WuxiApptec

Electrospray Ionization: Wrong-Way-Round or Right-Way-Round?
Shaolian Zhou, Novartis

This workshop will be held at the following location:
The Shanghai Institute of Materia Medica, Chinese Academy of Sciences (CAS),
Cheng Gu Hall, 555 Zu Chong Zhi Road, Zhang Jiang Hi-Tech Park, Pudong, Shanghai

4:00 pm–5:00 pm

Executive Roundtable

Emerging Drug R&D Models in China
Moderators: Todd Gillispie, Eli Lilly & Co. and Jing-Tao Wu, Millennum Pharmaceuticals

Drug research and development is a fast growing area in China. In this roundtable, invited executives from two multinational large pharmaceutical companies, a medium-sized biopharmaceutical company, a China-based start-up company, and a China-based contract research organization will lead a discussion on the strengths, opportunities, and challenges in conducting drug R&D in China which lead to different emerging drug R&D models.

Discussion Panel:
Tony Zhang   Vice President, Eli Lilly & Co.
Richard Connell   Vice President, Pfizer
Boliang Lou   Chief Executive Officer, Pharmaron
Mingxin Qian   President, Metabomics
Frank Lee   Vice President, Millennium Pharmaceuticals

6:00 pm–9:00 pm

Reception & Sponsor's Dinner
Hosted by Thermo Scientific

Tools for Discovery DMPK - Faster Answers
Timothy Stratton, Thermo Scientific

Research to Routine: Workflows for Large Molecule Quantitation
Using Proteomic Tools and Q Exactive HRMS
Patrick Bennett, Thermo Scientific

Thursday, April 26

8:30 am–9:00 am

Welcome
Mike S. Lee, Milestone Development Services

9:00 am–9:45 am

Plenary Lecture

Predicting Drug Disposition and Drug Dosing Parameters for New Molecular Entities
Leslie Benet, University of California at San Francisco

9:00 am–5:00 pm

Poster Hall Open

11:00 am–2:00 pm

CPSA Shanghai Expo - Where Technology and Solutions Meet
Lunch served in lobby and exposition area

10:15 am–11:45 am

Symposia
Current Understanding of Regulatory Requirement of DDI
Chairs: Yan Li, Institute of Materia Medica, Chinese Academy of Medical Sciences & Peking Union Medical College; Yurong Lai, Pfizer

Application of Pharmacogenomic Knowledge in Clinical Pharmacokinetics
Jin-Ding Huang, National Cheng Kung University

Drug Transporter DDI: ITC Workshop Report and New QSAR Analysis
Toshihisa Ishikawa, RIKEN Yokohama Institute

A Comparison of Current Modeling & Simulation Softwares to Predict DDI
using Irinotecan (CPT-11) as a Model Compound
Stephen Wang, Millennium Pharmaceuticals

11:30 am–12:30 pm

Poster Session / Young Scientist Excellence Award Review
Chairs: Ziqiang "Zack" Cheng, GlaxoSmithKline and Xiaoyi Gong, Merck
Poster authors will be present for question and answers
Sponsored by McKinley Scientific & Waters Corporation

12:00 pm - 1:00 pm

Lunch & Learn Workshops

Parallel Sessions

1:15 pm–3:00 pm

Parallel Track I
Transporters
Chairs: Cindy Xia, Millennium Pharmaceuticals; Zack Cheng, GlaxoSmithKline

Quantitative Investigation of Drug Transport Across the Blood-Brain Barrier
Hiroyuki Kusuhara, University of Tokyo

Quantitative Investigation of the Impact of P-gp Inhibition on Drug Absorption and Disposition at the Drug Discovery Stage
Hiroshi Sugimoto, Takeda Pharmaceutical Company, Japan

Roadmap of Drug Transporter Evaluation in Pharma
Yurong Lai, Pfizer

Application of Pgp/BCRP Double-Transduced MDCK Cell Assay for CNS Drug Discovery
Sijie Lu, GlaxoSmithKline

1:15 pm–3:00 pm

Parallel Track II
Bioanalysis I
Chairs: Naidong Weng, Janssen; Dafang Zhong, Shanghai Insitute of Materia Medica

Critical Aspects in the Quantification of Radioactive Samples Using an LC-MS/MS Assay
XinPing Fang, Xenobiotics Laboratories

Accelerator Mass spectrometry for Studying Absolute Bioavailability in Humans:
Challenges & Benefits
Xiaohui "Sophia" Xu, Bristol-Myers Squibb

Strategy of Biomarker Quantitation Using LC-MS
Wenying Jian, Janssen

Strategy on Analysis and Quantitation of Intact Proteins Using HRMS
Qian Ruan, Bristol-Myers Squibb

1:15 pm–3:00 pm

Parallel Track III
Pharmaceutical Sciences I
Pharmaceutical Profiling & Formulation Design
Chairs: Fred Li, Roche; Xiaoping Cao, Pfizer

Dissolution and Imaging as Powerful Tools in the Formulation Development Process
Thorsten Lobert, Hoffman- La Roche

Materials Science: Integrated API and Drug Product Design
Xiaoping Cao, Pfizer

Design of Clinical Formulations for Drug Development Candidates Based on the Developability Profiles
Chao-Pin Lee, GlaxoSmithKline

Impurity Analysis by Differential UV Detection
Chris Zhao, Frontage Laboratories

3:00 pm–3:30 pm

Break

3:30 pm–5:15 pm

Parallel Track IV
Biotransformation
DDI and Safety Implications of Drug Biotransformation and Disposition
Chairs: Ge Lin, The Chinese University of Hong Kong; Mingshe Zhu, Bristol-Myers Squibb

Pharmacokinetic and Pharmacodynamic Drug-Drug Interactions and Drug Toxicity
Aiming Yu, University at Buffalo, State University of New York

Mechanism-based Biomarker for the Assessment of Biotransformation-induced Toxicity of Medicinal Herbs
Ge Lin, The Chinese University of Hong Kong

Absorption, Disposition, and Pharmacokinetics of Saponins from Chinese Medicinal Herbs and the Associated Potential Herb-drug Interactions
Chuan Li, Shanghai Institute of Materia Medica

3:30 pm–5:15 pm

Parallel Track V
Bioanalysis II
Chair: Daniel Tang, ICON

GBC Update and Impact to Regulated BA in China
Daniel Tang, ICON

DBS From EBF?
Philip Timmerman, Janssen

Bioanalysis in Clinical Trials in China
Pei Hu, Peking Union Medical College

Challenges and Opportunities of Conducting GLB BA in China
Chengwei Fang, Pharmaron

3:30 pm–5:15 pm

Parallel Track VI
Analytical Methodology & Technology
Chairs: Kevin Bittorf, Vertex Pharmaceuticals; Xiaoyi Gong, Merck

Discovery of Active Components from Chinese Herbs Based on Integration of Sample Preparation and HPLC Analysis
Shao-ping Li, University of Macau

Analytical Technologies for Enabling Continuous Process Development
Todd Gillespie, Eli Lilly & Co.

Analytical Methods for Continuous Drug Product Processing
Kevin Bittorf,Vertex Pharmaceuticals

Process Analytical Technology (PAT): A Tool for Building Quality into Products
Danny Zhou, WuXi AppTec

6:00 pm–7:00 pm

CPSA Shanghai Distinguished Lecture Series
Sponsored by AB SCIEX

The New AB Sciex TripleQuad 4500 and QTRAP 4500 Systems:
Setting a New Benchmark for Ruggedness & Performance
Gary Impey, AB SCIEX

AB Sciex TripleTOF 5600 System:
The Power of High Resolution for Selective Quantitation
Matt Grigg, AB SCIEX

7:00 pm–9:00 pm

Friday, April 27

8:30 am–9:15 am

Plenary Lecture

Targeted Covalent Inhibitors versus Chemically-Reactive Drug Metabolites:
Considerations for Rational Drug Design and Toxicological Risk Assessment
Thomas Baillie, University of Washington

9:00 am–5:00 pm

Poster Hall Open

9:30 am–11:00 am

Symposia
Emerging Drug Discovery DMPKT Platform in China
Chair: Jeff Zhang, Novartis

The Evolving Face of Drug Metabolism Research and Service in China
Mingshe Zhu, Bristol-Myrs Squibb

Emerging Drug Discovery Models in China: DMPKT Challenges
Jeff Zhang, Novartis

Difference of SFDA GLP Compliance vs. U.S. FDA GLP: Medicilon Experience
Chunlin Chen, Medicilon

11:00 am–12:00 pm

Poster Session / Young Scientist Excellence Award Review
Chairs: Ziqiang "Zack" Cheng, GlaxoSmithKline and Xiaoyi Gong, Merck
Poster authors will be present for question and answers
Sponsored by McKinley Scientific & Waters Corporation

11:00 am–2:00 pm

CPSA Shanghai Expo - Where Technology and Solutions Meet!
Lunch served in lobby and exposition area

12:00 pm–1:00 pm

Lunch & Learn Workshops

Parallel Sessions

1:30 pm–3:00 pm

Parallel Track I
Biomarkers
Biomarker Applications from Bench to Bedside—Case Studies in Biomarker Translation
Chairs: Scott Fountain, Pfizer; Nathan Yates, University of Pittsburgh

Biomarker Applications–From Bench to Bedside
Scott Fountain, Pfizer

Experimental Designs for Discovery Proteomics
Nathan Yates, The University of Pittsburgh

Verification of Biomarkers with Targeted Proteomics
Weixun Wang, Merck

Development and Application of Diagnostic Tools through Research, Development, Application - A Case Study
General Discussion

1:30 pm–3:00 pm

Parallel Track II
Biologics
Challenges of Biologics Drug Development
Chair: Haojing Rong, Pfizer; Binodh Desilva, Bristol-Myers Squibb

Ligand Binding Bioanalytical Approaches to Quantify "Total" and "Free" Therapeutic Antibodies and Their Targets
Binodh Desilva, Bristol-Myers Squibb

Immunogenicity: Concerns, Detection and Perspectives
Haifeng Song, AMMS

Using Cerebrospinal Fluid (CSF) as Surrogate for Assessing Drug Transport into CNS
Qin Wang, Biogen Idec

1:30 pm–3:00 pm

Parallel Track III
Metabolites
Metabolite Data in Regulatory Submission
Chairs: Ron Kong, PTC Therapeutics; Andy Ayrton, Scinovo/GlaxoSmithKline; Zheming Gu, XenoBiotics Laboratories

Practical Considerations of Metabolite Measurement in MIST
Naidong Weng, Janssen

Drug Metabolite profiling and identification in animals and humans in support of regulatory submission to SFDA
Dafang Zhong, Shanghai Institute of Materia Medica

A Strategy for MIST: Early Human Metabolism Data Using AMS Combined with Tiered Approach in Metabolite Quantification
Martin Jørgensen, Lundbeck A/S

3:00 pm–3:30 pm

Break

3:30 pm–5:00 pm

Parallel Track IV
Translational Sciences
Research Applications of Translational Sciences in the 21st Century
Chairs: Chris Lepsy, Pfizer; Wei Lu, Peking University, China

PK/PD in Drug Discovery for Target Validation and Biomarker Identification
Chris Lepsy, Pfizer

PKPD Modeling Application in Preclinical – Case Study
Wei Lu, Peking University

Modeling and Simulation in the Individualized Therapy of Antiepileptic Drugs
Zheng Jiao, Huashan Hospital

Apply Modeling and Simulation to Aid the Drug Discovery and Development
Wen Chyi Shyi, Millennium Pharmaceuticals

3:30 pm–5:00 pm

Parallel Track V
Technology & Strategy
Technology, Solutions and Decisions-Making
Chairs: Todd Gillespie, Eli Lilly & Co.; Naidong Weng, Janssen

Candidate Selection and Preclinical Development Strategies to Reduce Development Risks
John Mao, QPS LLC

Analytical Strategy for Filing a Biologics/Biosimilar IND in China
Weidong Jiang, Henlius Biopharmaceuticals

A New Automated Dried Blood Spot LC/MS System
Lester Taylor, Agilent Technologies

3:30 pm–5:00 pm

Parallel Track VI
Innovation at CPSA Shanghai
Innovator Award Presentations
Chairs: Xioyi Gong, Merck; Kelly Dong,GlaxoSmithKline; Frances Wang, AstraZeneca;
Mingshe Zhu, Bristol-Myers Squibb

The CPSA Shanghai 2012 Innovator Award is presented to the outstanding technology or service shown at CPSA Shanghai 2012, as determined by the award judging committee.

An Automated On-Line Card Extraction LC/MS System for the Determination of Clozpaine and its Metabolites in Rat Blood
Na Pi Parra, Lester Taylor, Doug McIntyre, and Yuqin Dai
Agilent Technologies, Inc., Santa Clara, CA, USA

PicoChip: A Robust, Easy-to-use Solution for Nanospray Enabled LC-MS
Gary Valaskovic, Carla Marshall-Waggett, Ben Ngo
New Objective, Inc., Woburn, MA USA

Simultaneous, Fast Analysis of Melamine and Analogues in Pharmaceutical Components Using Q Exactive Benchtop Orbitrap LC-MS/MS
Tim Stratton, Kate Comstock, Hongxia "Jessica" Wang, Yingying Huang
Thermo Fisher Scientific, San Jose, CA USA

A Collaborative LC/MS/MS Solution for Urine Testing for Detection and Quantification of Drugs-of-Abuse and Pain Management
Martin Steel
McKinley Scientific, LLC, Sparta, NJ USA

A Unique LC/MS/MS Method by Combining MRM and Q3 Ion Modes for Simultaneous Determination of Deuterium-containing Drug and Metabolites
Tianyi Zhang - Frontage Laboratories (Shanghai)

Metabolic Stability Screening Workflow using a High Resolution Accurate Mass Benchtop Instrument and Novel Data Mining Software
Tim Stratton, Kate Comstock, Hai-Ling Sun, Daniel Soohoo, Kelly (Wei) Wang
Gilead Sciences, Foster City, CA
Thermo Fisher Scientific, San Jose, CA

A Dedicated, Ultra-low Flow Pump for Flow Injection Nanospray Useful for the Relative Quantification of Analytes
Gary A. Valaskovic, Ben Ngo
New Objective, Inc., Woburn, MA USA

6:00 pm–7:30 pm

CPSA Shanghai Closing Gala

Dinner & Awards

Young Scientist Excellence Award
Sponsored by McKinley Scientific & Waters Corporation
Chairs: Zack Cheng, GlaxoSmithKline, Xiaoyi Gong, Merck

Innovator Award
Chairs: Kelly Dong, GlaxoSmithKline; Xiaoyi Gong, Merck; Frances Wang, AstraZeneca;
Mingshe Zhu, Bristol-Myers Squibb

Saturday, April 28

9:00 am–11:15 am

Joint Session with Local Bioanalytical & Metabolism Discussion Groups

This session will be held at:
The Shanghai Institute of Materia Medica, Chinese Academy of Sciences (CAS),
Cheng Gu Hall, 555 Zu Chong Zhi Road, Zhang Jiang Hi-Tech Park, Pudong, Shanghai

9:00 am–9:45 am

Drug Transporters
Cindy Xia, Millennium Pharmaceuticals

9:45 am–10:30 am

DMPK in DrugDiscovery
Wei Tang, Chempartner

10:30 am–11:15 am

Clinical Drug-Drug Interactions
Hongjian Zhang, PharmaResources