Satellite Workshop

Sponsored by
New Objective, Inc.
Cambridge Isotope Laboratories, Inc.

Mass-Based Protein Analysis

Workshop Chair: Yang Peng-Yuan, Institute of Biomedical Sciences, Fudan University

Introduction to the Workshop
Prof. Yang Peng-Yuan, Institute of Biomedical Sciences, Fudan University

What's Your Spray DNA?
Gary Valaskovic, New Objective

Methods and Data Analysis for Large-Scale Proteomics
John Yates, Scripps Institute

Methods and Data Processing for PTM Analysis
Catherine Wong, National Protein Research Centre

Quantitative Proteomics Based on MS Intensity vs. Peptide Concentration
Prof. Yang Peng-Yuan, Institute of Biomedical Sciences, Fudan University

Application of Stable Isotope-Based Quantitative Mass Spectrometry to Decode Neurological Disease Pathways
Liao Lu-Jian, Shanghai Key Laboratory of Regulatory Biology, East China Normal University

Differential MS and Clound-Based Search
Nathan Yates, University of Pittsburgh

Question and Answer

Wrap-up
Yang Peng-Yuan, Institute of Biomedical Sciences, Fudan University

Satellite Workshop
Sponsored by Simcere Pharmaceuticals

Frontiers of Drug Metabolism Science and Technology

Workshop Co-Chairs: Baiming Xiao, Simcere Pharmaceuticals and Zheming Gu, Xenobiotic, China

Local organization committee: Peipei Zhang, Xenobiotic; Guanya Xu, Xenobiotic; Fei Zhang, Simcere Pharmaceutical Group; Mangting Shan, BioSciKin

Introduction to the Workshop
Baiming Xiao, Simcere

Current Status of DMPK in China
Professor Guangji Wang, Member of Chinese Science Acadamy; Professor Xiaojin Yin, Simcere Pharmaceutical Group

Practical DMPK Experimentation
Zheming Gu, Xenobiotic China

Shimadzu New Technology in Drug Discovery

Lunch

Sciences and Regulations in Analytical Laboratories

Sciences and Regulations in Pharmaceutical Analytical Laboratory
Baiming Xiao, Simcere

Establishment of Good Bioanalytical Laboratory
Naidong Weng, Janssen Pharmaceuticals

Current Regulation and GLP Laboratory Inspection
Helen Xu, Janssen Pharmaceuticals

Concluding Remarks
Zheming Gu, Xenobiotic China

Registration Open

Workshop

ADME Assays and Human Pharmacokinetics Projection

Chair: Liangfu Chen, GlaxoSmithKline

Metabolic Stability and Drug Interaction Assays
Weiqing Chen, ChemPartner

Case Studies in Metabolite Identification by Triple-TOF
Kerong Zhang, AB SCIEX

Transporter Assays in Drug Discovery and Development
Liangfu Chen, GlaxoSmithKline

Human Pharmacokinetics (PK) and Dose Projection
Cheng Chang, Pfizer

Executive Roundtable

Development of Personalized Medicine - Opportunities and Challenges

Personalized medicine aims to deliver the right drug to a right patient at the right time. It offers unique opportunities to integrate new technologies and concepts to disease prognosis, diagnosis and therapeutics. Over the past several years, there has been continuing interest in the research and development of personalized medicine in pharmaceutical industry. In this roundtable, we have invited executives from pharma, contract research organizations and instrument companies to lead a discussion on the current trends and strategy for personalized medicine R&D as well as the role they could play.

Moderator: Jeff Zhang, Novartis

Discussion Panel: Patrick Bennett, Executive Director Biomarker Operations, PPD
Honggang Bi, General Manager, Covance China
Stephen Clarke, Head Drug Metabolism and Pharmacokinetics, GlaxoSmithKline
Cornelis Hop, Senior Director Drug Metabolism and Pharmacokinetics, Genentech
Hua-fen Liu, Director of Application Support, AB SCIEX
Bin Peng, Executive Director and Global Head of Oncology Translational Medicine China, Novartis
Wei Tang, Vice President and Head of DMPK, ChemPartner

Sponsor's Reception & Dinner

Sponsored by Thermo Scientific

Mass Spec Immunoassay Method for the High Sensitive Quantification and Qualification of Protein Drugs
Urban Kiernan, Business Development Manager, Thermo Fisher Scientific

Registration Open

Welcome & Opening Remarks

Plenary Lecture

Poster Hall Open

Sponsored by Agilent Technologies

Posters will be available all day today and Friday

Joint ADME/BA Symposium
The World of Antibody-Drug Conjugates: Bioanalytical and PK/PD Challenges
Chairs: Young Shin, Chungnam National University and Alicia Du, ChemPartner

Delineating ADC ADME: Challenges and Impact on ADC Development
Ben Shen, Genentech

Challenges and Solutions in Large Molecule Quantification using LC-MS/MS (LM by LCMS): "A Hot Topic in Regulated Preclinical and Clinical Bioanalysis"
Fabio Garofolo, Algorithme Pharma

Model Based Development of Antibody Drug Conjugates
Dhaval Shah, University of Buffalo

CPSA Shanghai Expo   Where Technology and Solutions Meet!

Chairs: Kelly Dong, GlaxoSmithKline; Shaolin Zhou, Novartis

Participating Exhibitors

Young Scientist Awards Poster Review Session

Co-Chairs: Liangfu Chen, GlaxoSmithKline; Jenny Zheng, Janssen

Lunch & Learn Workshops

Mass Spectrometry Technology Research and Innovation in Shanghai

Sponsored by McKinley Scientific

Development of Fast Screening Ionization Source and Digital Ion Trap with the Perspectives in Personal Medicine
Wenjian Sun, Shimadzu

The Structure and Performance of Some New Ion Trap Mass Analyzer
ChuanFan Ding, Fudan University

TBA

Sponsored by Agilent Technologies

Addressing Analytical Challenges in the Characterization & QC of Biologics, Biosimilars and Antibody Drug Conjugates.
Gurmil Gendeh, Agilent Global Biopharma

PARALLEL SESSIONS

Traditional Chinese Medicine and Natural Product Research
Chairs: Chuan Li, Shanghai Institute of Materia Medica and Yang Sai, Hutchison MediPharma

Pharmacokinetics and Disposition of Tanshinol and Associated Herb-drug Interaction Potential
Chuan Li, Shanghai Institute of Materia Medica, CAS, Shanghai

In Vivo Metabolic Characteristics of Alkaloids in Natural Product
Yan Wang, Institute of Materia Medica, CAMS, Beijing

The Rationale of Herbal Combinations: How to Tackle the DDI's from ADMET Perspectives
Guoyu Pan, Shanghai Institute of Materia Medica

Challenges and Opportunities of Bioanalysis in China (Roundtable Discussion)
Chairs: Alicia Du, ChemPartner and Philip Timmerman, Janssen Pharmaceuticals

Panelists:
Kelly Dong, GlaxoSmithKline; Tee Zhang, Frontage Laboratories; Alicia Du, ChemPartner; Philip Timmerman, Janssen; Hisanori Hara, Novartis

Moving Towards Next Generation Development
Chairs: Todd Gillespie, Eli Lilly and Company and Chao-Pin Lee, GlaxoSmithKline

Translational Systems Medicine Enabling Patient Centric Drug Development
Thomas Keller, GlaxoSmithKline

Application of the Quality-by-Design Principals in Early Pharmaceutical Development
Qun Lu, Celgene

The Role and Advantages of Open Access LC/MS In Support of Recombinant Protein Drug Development
Gurmil Gendeh, Agilent Technologies

PARALLEL SESSIONS

The Clinical and Regulatory Significance of In Vitro and Clinical Transporter Studies
Chairs: Marcel Hop, Genentech and Liangfu Chen, GlaxoSmithKline

Drug Transporters, Drug Interactions and Drug Agency Review of Dolutegravir: A Case Study Review and Lessons Learned
Joe Polli, GlaxoSmithKline

Predicting Clinical Relevance of Drug Transporters in Drug Discovery
Marcel Hop, Genentech

Understanding Transporter DDI: Regulatory Stance and Industry Case Studies
Mingxiang Liao, Takeda

Bioanalysis of Chinese Medicine
Chairs: Dafang Zhong, Shanghai Institute of Materia Medica and Kate Yu, Waters

Simultaneous Determination of Five Active Components of Radix Isatidis in Rat Serum by LC-MS/MS
Haiyan Xu, Shenyang Pharmaceutical University

Simultaneous Determination of Butyl Phthalide and Four Metabolites in Human Plasma by LC-MS/MS
Xingxing Diao, Shanghai Institute of Materia Medica

Quantification of Two Major Bioactive Saponins of Lysimachia Capillipes in Rat Plasma by LC-MS/MS and its Application to a PK Study
Hongliang Jiang, Huazhong University of Science and Technology

Clinical Herb-Drug Interactions: Reassessing the Variability of Biological System Specific Properties
Ling Yang, Dalian Institute of Chemical Physics

Technology Developments in the Application of Mass Spectrometry for Protein and Peptide Biomarker Discovery
Chairs: Gary Valaskovic, New Objective and Shaolian Zhou, Novartis

Study of non-coding RNA's (miRNA and IncRNA)- Protein Interaction Based on Integrated Mass Spectrometry
Catherine CL Wong, National Center for Protein Science, Shanghai

Sensitivity and Throughput Using Nanospray Based LC-MS: Proteomics and Beyond
Gary Valaskovic, New Objective

Chemical Biology Technologies for Drug Target Identification
Qian Zhao, Novartis

Distinguished Lecture Series

Sponsored by AB SCIEX

The Use of LC/MSMS for the Bioanalysis of Complex Antibody Drug Conjugates (ADC)
Suma Ramagiri
AB SCIEX Global Technical Marketing Manager
Quantitation and Metabolism

Evening Social Event (offsite)

Hosted & Sponsored by AB SCIEX

An Evening at ERA Shanghai: Intersection of Time

A must-see in Shanghai, ERA Shanghai a stunning acrobatic show combining traditional Chinese arts and modern technologies. The performers present Chinese acrobatics, martial arts and dance perfectly in harmony with music, sound, lighting, and other special effects, including a spectacular water screen.
The story of China’s evolution from its ancient past to the future is told. Hence, the title ‘Intersection of Time’, as the viewpoint of the audience is set in the present between the past and the future.
For passes and more information, visit the AB SCIEX table.

Registration Open

Plenary Lecture

Poster Hall Open

Sponsored by Agilent Technologies

Posters will be available all day today

Joint ADME/BA Symposium
Translational Biomarkers for Accelerating Drug Development: Bioanalytical and Emerging Applications
Chairs: Haojing Rong, Pfizer and Naidong Weng, Janssen Pharmaceuticals

Pk/Biomarker/Efficacy Relationship of Anti-GDF8 mAb for Efficacious Dose Projection in Humans
Haojing Rong, Pfizer

Protein and SM Biomarker Quantification
Naidong Weng, Janssen Pharmaceuticals

Small Molecule Biomarker Quantitation
Xiaorong Liang, Genetech

CPSA Shanghai Expo   Where Technology and Solutions Meet!

Chairs: Chairs: Kelly Dong, GlaxoSmithKline; Shaolin Zhou, Novartis

Participating Exhibitors

Young Scientist Awards Poster Review Session

Co-Chairs: Liangfu Chen, GlaxoSmithKline; Jenny Zheng, Janssen

Lunch & Learn Workshops

Combining very high resolution accurate mass with customizable workflows: A human metabolism case study

Sponsored by Thermo Fisher Scientific

Tim Stratton, Thermo Fisher Scientific

What's Your Spray DNA?™

Sponsored by New Objective

Gary Valaskovic, New Objective

PARALLEL SESSIONS

Pharmacokinetics in Chinese Populations: Ethnic Differences and Global Clinical Trial Strategies
Chairs: Jenny Zheng, Janssen Pharmaceuticals and Jun Shi, Roche

Ethnic Sensitivity Assessment in Drug Development: Introduction of Roche-PUMCH Clinical Pharmacology Fellowship
Jun Shi, Roche

Dealing with Ethnic Differences in Clinical Development
Peiming Ma, GlaxoSmithKline

Population Pharmacokinetics of Mycophenoic Acid and Its Main Glucuronide Metabolite: Comparison Between Chinese and Caucasian Healthy Subjects Administrated with Mycophenolate Mofetil
Zheng Jiao, Fudan University

New Technology
Chairs: Shaolian Zhou, Novartis and Chad Briscoe, PRA International

Automation of Bioanalysis in PK Studies
Professor Yin Zheng, Nankai University

Opportunities and Challenges of Using HRMS in Regulated Bioanalysis
Mike Huang, Janssen Pharmaceuticals

Dried Blood Spots
Tee Zhang, Frontage Laboratories

Applications of Protein and Peptide Biomarkers from Research to Development
Chair: Catherine CL Wong, National Center for Protein Science

Quantification of Active and Inactive Biomarkers in Blood with Absolute Molecular Specificity
Nathan Yates, University of Pittsburgh

Discovery and Targeted Proteomics to Study Transplant Rejection
John Yates, The Scripps Research Institute

Technology Development of Proteomic Reactor and its Application in Biomarker Discovery
Hu Zhou, Shanghai Institute of Materia Medica

PARALLEL SESSIONS

Working with CROs in China: Opportunities, Challenges, and Lessons Learned
Chairs: Rick Connell, Pfizer and Hongshi Yu, WuXi AppTec

Introduction and Context to the Session
Rick Connell, Pfizer

DMPK Outsourcing to China: A CRO's Perspective
Hongshi Yu, WuXi AppTec

Sourcing for Success
Jonathan Connick, Merck

Panel Discussion
Rick Connell, Pfizer; Hongshi Yu, WuXi AppTec; Jonathan Connick, Merck

MS and Bioanalysis: Diagnostics and Hospitals
Chairs: Patrick Bennett, PPD; Shuijun Li, Xuhui Hospital

Application of LC-MS in Clinical Laboratory Testing
Sihe Wang, Cleveland Clinic

Human Endogenous Steroids Analysis in Clinical Reference
Hua-Fen Liu, AB SCIEX

25-hydroxyvitamin D: Clinical Significance, Measurement, and Method Comparison
Shuijun Li, Xuhui Hospital

Innovator Award Session

Chairs: Chairs: Kelly Dong, GlaxoSmithKline; Shaolian Zhou, Novartis

Outsourcing and Standardization of Global Studies
Joseph Bower, Covance

Metabolite Analysis Using A Novel Relationship And Database Driven Software Platform Approch For Screening Metabolism
Hui Wang, Waters

a LC/MS based-method combined with data analysis software was developed to evaluate the quality of Pu’er tea.
Hui Wang, Waters

Prediction of Valsartan Pharmacokinetics in Different Pediatric Age Groups using Physiologically Based Pharmacokinetic (PBPK) Models
Linda Lin, PharmoGo

Pharmacokinetics of Exendin-4-Fc fusion protein in Cynomolgus Monkey
Hongzhen Li, Yan Xia, Joinn Laboratories

Quantification of 5 Steroid Hormones in Human Serum Using the ionKey MS system
Hui Wang, Waters

Simultaneous Quantification of Human Insulin and Five Analogs in Human Plasma Using 2D UPLC MS System
Hui Wang, Waters

Quantification of Bradykinin in Human Plasma Using the IonKey/MS System
James Murphy, Waters

Metabolite Analysis Using A Novel Relationship And Database Driven Software Platform Approach For Screening Metabolism
Hui Wang, Waters

Dinner, Awards & Celebration

Sponsored by Agilent Technologies

Sponsor's Toast

Program Chair Recognition
Mike Lee, Milestone Development Services

CPSA Shanghai 2015 – Program Chair Announcement
Jeff Zhang, Novartis

Innovator Award Presentation
Kelly Dong, GlaxoSmithKline; Shaolian Zhou, Novartis

Young Scientist Excellence Award Presentation
Liangfu Chen, GlaxoSmithKline; Jenny Zheng, Janssen Pharmaceuticals

Registration Open

Joint Session with Local Bioanalytical & Metabolism Discussion Groups & RDPAC Preclinical Focus Group

Challenges and Opportunities of DMPK Studies in CFDA New Drug Submissions

Interpretation of the Chinese Guideline of Non-Clinical Drug Metabolism and Pharmacokinetics Studies
Dafang Zhong, Shanghai Institute of Materia Medica

Accelerating Drug Development with Quality Pharmacokinetics Data in China: Sanofi’s Experience
George Liu, Sanofi

Human Relevance: The Implications From The Updated cFDA Nonclinical PK/DM Guideline
Yi Gu, Hutchinson China

Hengrui’s Focus on DMPK Studies in Novel Drug Development Process
Changyong Yang, Hengrui Pharmaceutical