Workshop: ADME and Translational Sciences

Held at Renaissance Shanghai Pudong Hotel

Part I - The Role Overview of Drug Discovery and Development for New Chemical Entities Workshop Leaders: Jing Lin, Sunovion; Jenny Zheng, Janssen Pharmaceuticals

• How to Succeed in Drug Discovery
  Cornelis E.C.A. Hop, Genentech
• The Overview of Drug Discovery and Development for New Chemical Entities
  Dayao Zhao, Janssen

LUNCHEON -Sponsored by Agilent Technologies

Part II - Challenges of Developing Biologics
Workshop Leaders: Haifeng Song, Beijing Institute of Radiation Medicine; Cindy Xia, Millennium Pharmaceuticals

• Overview of Biotherapeutics: An ADME Perspective
  Gregory L. Weber, Pfizer
• Therapeutic Proteins: Clinical Pharmacology Studies and Regulatory Submissions
  Yaowei Zhu, Janssen
• Strategy of Immunogenicity Assessment for Therapeutic Proteins by Biacore
  Jasmine Zhang, Beijing Institute of Radiation Medicine/United-Power PharmaTech

Workshop: Protein/Peptide Characterization and Quantitation
Workshop Leaders: Gary Valaskovic, New Objective; Nathan Yates, University of Pittsburgh

Held at Yisheng Hall, Shanghai Institute of Materia Medica

Workshop: Pharmaceutical Sciences
Workshop Leaders: Todd Gillespie, Eli Lilly and Company; Fred Li, Hua Medicine Limited

Held at Chenggu Hall, Shanghai Institute of Materia Medica

Executive Roundtable

Current Strategy on Research and Development of Novel Therapies

Faced with the productivity challenge in pharmaceutical R&D, pharmaceutical/biotech and contract research organizations are striving to come up with new strategies on the research and development of novel therapies. In this roundtable, we have invited executives from pharma, biotech, and contract research organizations to lead a discussion on the current strategy for new drug R&D.

Moderators: Jing-Tao Wu, Millennium Pharmaceuticals; Todd Gillespie, Eli Lilly and Company; Jenny Zheng, Janssen Pharmaceuticals

Discussion Panel:
Honggang Bi, General Manager, Covance China
Li Chen, Co-Founder and CEO, Hua Medicines
Cornelis E.C.A. Hop, Senior Director, DMPK, Genentech
John Newton, Vice President and Global Head, Drug Disposition, Sanofi
Dayao Zhao, Vice President, Head of China R&D, Janssen Pharmaceuticals

Reception & Sponsor's Dinner
Hosted by Thermo Scientific

Improving the Selectivity of Quantitative Analysis in Biologics by Using HRMS
Patrick Bennett, Thermo Scientific

HRMS Strategy for the Characterization of Biopharmaceuticals
Zhiqi Hao, Thermo Scientific

Registration Open

Opening Remarks

Welcome
Mike Lee, Milestone Development Services

Objectives, Format, & Opening Remarks
Program Chair
Naidong Weng, Janssen Pharmaceuticals

Plenary Lecture

The Impact of Metabolism and Pharmacokinetics in Translational Medicine: What Innovation Has Brought Us and What Challenges Still Exist?
John Newton
Vice President and Global Head, Drug Disposition Projects,
Standards and Innovation
Sanofi

Poster Hall Open

Chairs: Alicia Du, ChemPartner; Frances Wang, Roche; Shaolian Zhou, Novartis

Symposia & Roundtables

DMPK Role in Drug Discovery, Development, and Regulatory Interaction
Chairs: Cindy Xia, Millennium Pharmaceuticals; Jenny Zheng, Janssen Pharmaceuticals

Physiologically Based Pharmacokinetics Joined with In Vitro-In Vivo Extrapolation of ADME: A Marriage Under the Arch of Systems Pharmacology
Amin Rostami, University of Manchester

Drug Metabolism Related Issues in Support of Drug Development and Registration
W. Griff Humphreys, Bristol-Myers Squibb

Panel Discussion: Panel Discussion: Latest Development in Regulatory Requirement for DDI Assessment
Moderators: Cindy Xia, Millennium Pharmaceuticals; Jenny Zheng, Janssen Pharmaceuticals

Bioanalysis of Biomolecules
Chair: Daniel Tang, ICON

Overview and Case Study of Cross-Lab Assay Transfer in Immunoassay and Bioassay
Dong-Bei Li, WuXi AppTec

A Generic Approach to BAN2401 (MAb) Quantitation in Clinical Samples by LC/MS/MS
John Lin, Frontage Laboratories

LC-MS/MS Bioanalysis of Biotherapeutics in Drug Development
Guowen Liu, Bristol-Myers Squibb

CPSA Shanghai Expo - Where Technology and Solutions Meet!

Chairs: Kelly Dong, GlaxoSmithKline; Shaolin Zhou, Novartis

Young Scientist Excellence Award Poster Session Review

Award Committee:
Zack Cheng, AstraZeneca; Griff Humphreys, Bristol-Myers Squibb; Fred Li, Hua Medicine Limited; Jing Lin, Sunovion; Jasminder Sahi, GlaxoSmithKline; Jing-Tao Wu, Millennium Pharmaceuticals (co-chair); Cindy Xia, Millennium Pharmaceuticals; Sylvia Zhao, Janssen; Jenny Zheng, Janssen (co-chair); Shaolian Zhou, Novartis

Lunch & Learn Workshops

Workshop Sponsored by Thermo Scientific
High Efficient Front-End for MS in Pharmaceutical Analysis Application Field
Luye Liu, Thermo Scientific

Workshop Sponsored by PharmoGo
Application of GastroPlus Modeling & Simulation in Pre-Clinical and Clinical Development
Chaopin Lee, GlaxoSmithKline
Yang Sai, Hutchison Pharma
ao Chen, PharmoGo

Workshop Sponsored by VWR China
Applications of Human Hepatocytes for In Vitro ADME Studies
Maciej Czerwinski, XenoTech LLC

Workshop Sponsored by New Objective
Innovation in High-Performance LC-MS through Nano-Electrospray: The Future of Mass Spectrometry
Gary Valaskovic, New Objective

Symposia & Roundtables

Translational Sciences
Chairs: Jing Lin, Sunovion; Cindy Xia, Millennium Pharmaceuticals

Improving the Predictive Power of Preclinical Tumor Models Through Translational Pharmacokinetic-Pharmacodynamic Analysis
Harvey Wong, Genentech

Model-Based Drug Development: Roles and Applications of PK/PD Modeling and Simulation
Xiang Gao, Pfizer

Ethnicity in Variability of Drug Responses: A Translational Approach
George Liu, Sanofi

Development Bioanalysis
Chair: Chengwei Fang, Pharmaron

EBF Perspective on Endogenous Analytes
Philip Timmerman, Janssen Pharmaceuticals

Achieving Low Detection Limit for Hormone Quantitation in Biofluid by Using Accurate Mass
Zheng Jiang, Thermo Fisher Scientific

Strategies for Dealing with Hemolyzed Samples in Regulated Bioanalysis
Daniel Tang, ICON

Pharmaceutical Profiling and Formulation Design
Chairs: Andy Lu, Shanghai Aucta Pharmaceuticals; Xiaoping Cao, Pfizer

Form and Function: The Role of Materials Science in Formulation Design
Alex Chen, Crystal Pharmatech

The Role of In Vitro-In Vivo (IVIVC) in Early and Full Development
Andy Lu, Shanghai Aucta Pharmaceuticals

Clinical Formulation Design and Best Practice with Case Studies
Anand Kulkarni, WuXi AppTec

Monitor and Control API Form Change in Tablet
Xiaoping Cao, Pfizer

Symposia & Roundtables

ADMET Role in Drug Discovery
Chairs: Jenny Zheng, Janssen Pharmaceuticals; Jing-Tao Wu, Millennium Pharmaceuticals

Issue-Driven Approaches to Effective Minimization of DMPK Liability in Drug Discovery
Wei Tang, ChemPartner

Higher Throughput Assays for Adverse Drug Effects with Cryopreserved Human Hepatocytes
Albert Li, In Vitro ADMET Laboratories LLC

Panel Discussion: New ADMET approaches for drug discovery
Moderators: Jenny Zheng and Jing-Tao Wu

Current Regulatory Discussion and Bioanalytical Perspectives
Chair: Yang Wang, Janssen Pharmaceuticals

Practical BA Considerations for Development of Therapeutic Proteins in China
Haifeng Song, Beijing Institute of Radiation Medicine

Japan Bioanalysis Forum (JBF) as a Member of Worldwide Bioanalysis Community
Yoshiaki Ohtsu, Astellas Pharma

Panel Discussion:
Dong-Bei Li, WuXi AppTec; Daniel Tang, ICON; Philip Timmerman, Janssen Pharmaceuticals;Haifeng Song, Beijing Institute of Radiation Medicine; Yoshiaki Ohtsu, Astellas Pharma

Targeted Proteomics: Innovation and Applications for Protein Quantitation
Chairs: Gary Valaskovic, New Objective; Nathan Yates, University of Pittsburgh

Introduction to Targeted Proteomics
Nathan Yates, University of Pittsburgh

Data Independent Methods on HRMS for Quantitative Proteomics
Zhiqi Hao, Thermo Scientific

Emerging Technologies for Targeted Proteomics
Gary Valaskovic, New Objective

Distinguished Lecture Series

Sponsored by AB SCIEX

Data Metabolite Detection and Identification by Q-TRAP: Application of New Data Acquisition and Mining Tools
Ming Yao, Bristol-Myers Squibb

Combining Selectivity and Sensitivity for Peptide Quantitation using the QTRAP® 6500 System with IonDrive™ Technology
Gary Impey, AB Sciex

Evenig Social Event - Offsite

Sponsored by AB SCIEX

Registration Open

Plenary Lecture

Biomarker Discovery and Validation: Challenges and Promises
Ian A. Blair
A.N. Richards Professor of Pharmacology
University of Pennsylvania School of Medicine

Poster Hall Open

Chairs: Alicia Du, ChemPartner; Frances Wang, Roche; Shaolian Zhou, Novartis

Symposia & Roundtables

ADME Enabling Technology and Approach
Chairs: Dafang Zhong, Shanghai Institute of Materia Medica; Mingshe Zhu, Bristol-Myers Squibb

Application of High Resolution Mass Spectrometry to Comprehensive Drug Metabolite Profiling: Case Studies
Jie Xing, Shandong University

Development and Application of Expressed Metabolizing Enzymes for Drug Metabolism Studies
Shuqing Chen, Zhejiang University

Radiolabeling is an Essential Technology for ADME Studies: Current Methodologies and Applications
Mingshe Zhu, Bristol-Myers Squibb

Discovery Bioanalysis and New Technologies
Chair: Kelly Dong, GlaxoSmithKline

Analysis of Small Molecules In Vivo by MALDI TOF MS
Zhongxiu Nie, Beijing Center for Mass Spectrometry

MW, Sequencing and Glycosylation Site for Antibody Characterization by Using Hybrid Orbitrap Elite
Ai-yin Nie, Thermo Scientific

Application of HRMS and Swath Technology to Quantitative and Qualitative Analysis in DMPK Studies: Advantages and Challenges
Hong Cai, Bristol-Myers Squibb

Young Scientist Excellence Award Poster Session Review

Award Committee:
Zack Cheng, AstraZeneca; Griff Humphreys, Bristol-Myers Squibb; Fred Li, Hua Medicine Limited; Jing Lin, Sunovion; Jasminder Sahi, GlaxoSmithKline; Jing-Tao Wu, Millennium Pharmaceuticals (co-chair); Cindy Xia, Millennium Pharmaceuticals; Sylvia Zhao, Janssen; Jenny Zheng, Janssen (co-chair); Shaolian Zhou, Novartis

CPSA Shanghai Expo - Where Technology and Solutions Meet!

Chairs: Kelly Dong, GlaxoSmithKline; Shaolin Zhou, Novartis

Lunch & Learn Workshops

Workshop Sponsored by McKinley Scientific
Extending the Utility and Performance of Legacy LC/MS/MS - Through Service and Innovation
Martin Steel, McKinley Scientific; Simon Bergeron, MSparts

Symposia & Roundtables

Reactive Metabolites and Toxicity
Chairs: Dafang Zhong, Shanghai Institute of Materia Medica; Mingshe Zhu, Bristol-Myers Squibb

Metabolic Activation and Pulmonary Toxicity of Bisbenzylisoquinoline
Jiang Zheng, University of Washington

Bioactivation of Chlorogenic Acid Under Pathological Conditions and Potential Drug-Drug Interaction with Baicalin
Cen Xie, Shanghai Institute of Materia Medica

Integrate Reactive Metabolite Evaluation Approach to Assess and Reduce Safety Risk
Liangfu Chen, GlaxoSmithKline

Biosimilars: Regulatory Considerations and Structure Analysis
Chair: Kate Yu, Waters Corporation; Hao Wang, State Key Lab of Antibody Medicine and Targeted Medicine

Panel Discussion:
Analytical Characterization Techniques, Needs and Adoption
Biosimilar in China: Regulation and Update
Bioanalysis Needs
Glycan Analysis
HDX: Higher Order Structure Analysis

Pharmaceutical Sciences – Analytical Methodology and Technology
Chairs: Todd Gillespie, Eli Lilly and Company; Fred Li, Hua Medicine Limited

Supercritical Fluid Chromatography and its Application in Drug Discovery and Development with Case Studies
Baoning Su, WuXi AppTec

Elemental Impurities, A New Requirement
Jiong Yu, Lab Service of USP China

Geneotoxic Impurity Analysis and Control Strategy
Wei Li, Roche China

Symposia & Roundtables

Drug-Drug Interactions
Chairs: Jeff Zhang, Novartis; Yurong Lai, Pfizer

New Aspects of Metabolizing Enzyme-Mediated DDI
Chuang Lu, Millennium Pharmaceuticals

Impact of Transporter Studies on Drug Discovery and Development: Cynomolgus Monkey OATP DDI In Vitro to In Vivo Extrapolation
Hong Shen, Bristol-Myers Squibb

Assessment of Transporter Related Toxicity in Drug Discovery and Development
Jasminder Sahi, GlaxoSmithKline

Strong Inhibitory Effects on Human Metabolizing Enzymes by TCM Constitutes and Related Herb-Drug Interactions
Ling Yang, Dalian Institute of Chemical Physics

Traditional Chinese Medicine: Addressing TCM Challenges with Modern Analytical Tools
Chairs: Xijun Wang, Heilongjiang TCM University; Kate Yu, Waters Corporation

Chromatography: From Nano to Prep – The Foundation of TCM Analysis
Yan Zhou, Chengdu Institute of Biology, Chinese Academy of Sciences

LC/TOF MS for Effective Ingredient Identification for TCM
Yi Dai, College of Pharmacy, Jinan University

Metabonomics Approach to Understand Therapeutic Mechanisms of TCM
Xijun Wang, Heilongjiang TCM University

Innovator Award Session

Chairs: Kelly Dong, GlaxoSmithKline; Shaolian Zhou, Novartis

A Complete Workflow Solution for Monoclonal Antibody Glycoform Characterization Combining a Novel Glycan Column Technology and Bench-Top Orbitrap LC-MS/MS
Zhiqi Hao¹, Udayanath Aich², Julian Saba¹, Rosa Viner¹, Xiaodong Liu², Srinivasa Rao², Chris Pohl², Andreas Huhmer¹ and Patrick Bennett^1
1 Thermo Fisher Scientific, San Jose, CA, USA; ² Thermo Fisher Scientific, Sunnyvale, CA, USA

A Flexible SPE/LC/MS/MS Platform for the Simultaneous Quantitation of Multiple Amyloid Peptides in Cerebrospinal Fluid
Erin E.Chambers¹, Mary E.Lame², Diane M.Diehl¹, Wang Hui^3
1 Waters Corporation, Milford, MA USA; ²Pfizer, Groton,CT USA; ³Waters Corporation, Shanghai

A System for Reliable Ultra-low Flow Nanospray: Breaking barriers to Enable Metabolite Quantitation
Gary Valaskovic¹, Ben Ngo¹, Jing-Tao Wu², Shaoxia Yu^2
1New Objective Inc. Woburn MA USA; ² MIllennium:The Takeda Oncology Company, Cambridge MA USA

A Generic Multiple Reaction Monitoring-based Approach for Flavonoids Profiling in Plants using a Hybrid Triple Quadrupole Linear Ion Trap Mass Spectrometer
Zhixiang Yan, Ru Yan
State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau

Simultaneous Determination of Four Endogenous Phytosterol Biomarkers in Human Serum by LC/MS/MS
Ming Zuo, Shenghui Tang, Tianyi Zhang
Frontage Laboratories (Shanghai) Co., Ltd.

Dinner, Awards & Celebration

Sponsor’s Toast

Program Chair Recognition
Mike Lee, Milestone Development Services

CPSA Shanghai 2014 – Program Chair Announcement
Naidong Weng, Janssen Pharmaceuticals

Innovator Award Presentation
Kelly Dong, GlaxoSmithKline; Shaolian Zhou, Novartis; Mingshe Zhu, Bristol-Myers Squibb

Young Scientist Excellence Award Presentation
Jenny Zheng, Janssen Pharmaceuticals; Jing-Tao Wu, Millennium

Registration

Held at The Shanghai Institute of Materia Medica

Joint Session with Local Bioanalytical & Metabolism Discussion Groups

I. Drug Metabolism and Pharmacokinetics
Chair: Jing-Tao Wu, Millennium

• Higher Throughput Human Hepatocyte Assays for Reversible and Time-dependent CYP3A4 inhibition, CYP3A4 Induction, and Hepatotoxicity
  Albert Li, IVAL
• The Role of DMPK in Drug Discovery and Development
  Jing Lin, Sunovion
• Transporters in Drug Disposition, Safety, and Efficacy: Implications and Strategy in Drug Discovery and Development
  Liangfu Chen, GlaxoSmithKline

II. Bioanalysis
Chair: Kelly Dong, GlaxoSmithKline

• Challenges in Bioanalysis of Endogenous Analytes: Quantitation of Glucose in Plasma, Zheming Gu, XBL-China
• LC/MS/MS Analysis of Proteins and Peptides
  John Lin, Frontage
• Bioanalysis in Human Bioequivalence Studies
  Huichen Liu, Beijing Aerospace Hospital

Directions to The Shanghai Institute for Materia Medica
From the Renaissance Shanghai Pudong Hotel, take a taxi to The Shanghai Institute of Materia Medica (中国科学院上海药物研究所) located at 555 Zu Chong Zhi Road, Zhang Jiang Hi-Tech Park, Pudong, Shanghai (上海市浦东张江祖冲之路555号). The cost of the taxi is approximately RMB 18 ($3.00).

To use public transportation, walk to 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 directly across the street from the subway station