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CPSA Shanghai 2015

Connecting the Dots:
Sharing Science Across Disciplines Helps Projects Progress

Meeting Program     Wednesday | Thursday | Friday | Saturday

Updated 16 April 2015    Download Program

Monday 星期一 13 April PRE-CONFERENCE WORKSHOP

12:00 noon - 4:00 pm
Fudan University

Multi-Chromatographic Separation and Identification of Glycoproteomics

Lunch

Breaking the Megapixel Boundary with Multi-Dimensional Proteomic Analysis
Nathan Yates, University of Pittsburgh

Column-Array Based Multi-Dimensional Liquid Chromatographic System and It's Application to Analysis of Human Plasma Proteome
Zhang Xiang-Ming, Chemistry Department, Fudan University

TBA
Yang Peng-Yuan, Institute of Biomedical Sciences, Fudan University

What's Your Spray DNA? Combining Sensitivity with Ease of Use for High Performance Nano LC-MS
Gary Valaskovic, New Objective

More information

Wednesday 星期三 15 April

10:00 am
Renaissance Shanghai
4th Floor Lobby

Registration Open

1:00 PM - 4:00 PM
Ballroom I

Workshops

Workshop on PBPK
Chair: Philip Timmerman, Janssen Research & Development

Physiologically-Based Pharmacokinetic Modelling and Simulations – Challenges Today and Future Trends
Sheila Annie Peters, AstraZeneca

Mechanistic PBPK: Approaches to Understanding Tissue Distribution
Avijit Ghosh, Janssen Research & Development

PBPK Modeling for Non-Oral/IV Routes: Pulmonary, Dermal, Ocular
Valeriu Damian, GlaxoSmithKline

Physiologically-Based Pharmacokinetic Modelling of Monoclonal Antibodies: A Case Study
Jiansong Yang, GlaxoSmithKline

Physiologically Based Pharmacokinetic Modeling as a Tool to Predict Drug Interactions for Antibody-Drug Conjugates
Yuan Chen, Genentech

1:00 PM - 4:00 PM
Ballroom II

Workshop

Pharmaceutical R&D and How DMPK Fits In
Chair: Jim Shen, Bristol-Myers Squibb

Session Introduction - Panelist Introduction
Jim Shen, Bristol-Myers Squibb

Introduction to DMPK
Mingdan Wu, WuXi AppTec

DMPK in Pharmaceutical Development
Zack Cheng, AstraZeneca

Contract Research and How DMPK Fits In
Duxi Zhang, WuXi AppTec

Career Options in Pharmaceutical Development
Qun Lu, Celgene

What It Is Like to Work For, or Start Up, a Small Company
Gary Valaskovic, New Objective

Career Development, Job Skills, Interview
Jing Lin, Sunovion Pharmaceuticals

Career Development, Job Skills, Resume
Min Liu, Merck

Career Development, Job Skills, PowerPoint Presentations
Jim Shen, Bristol-Myers Squibb

Roundtable Discussion on Career Development
David Abramowitz, SCIEX; Zack Cheng, AstraZeneca; Paul Corcoran, McKinley Scientific; Jing Lin, Sunovion Pharmaceuticals; Min Liu, Merck; Qun Lu, Celgene; Jim Shen, Bristol-Myers Squibb; Sihe Wang, Cleveland Clinic; Mingdan Wu, WuXi AppTec; Duxi Zhang, WuXi AppTec

4:00 pm - 6:00 pm
Ballroom I/II

Executive Roundtable

The Value of Modeling in Today’s Drug Development: An Industry and Regulator’s Perspective

Discussion Panel:
Valeriu Damian, GlaxoSmithKline
Cornelis (Marcel) Hop, Genentech
David Jones, MHRA, UK
Mario Monshouwer, Janssen Research & Development
Dr. Hu Pei, Peking Union Medical College Hospital
Steve Yang, WuXi AppTec
Ping Zhao, USA

6:00 pm - 9:00 pm
Ballroom I/II

Opening Reception

Greet old friends, meet new friends, and get an overview of the week’s events and activities.
Welcome to CPSA Shanghai 2015!

Sponsor's Toast

Thursday 星期四 16 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

Jeff Zhang

Format, Objectives, Opening Remarks
Philip Timmerman
Janssen Research & Development

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

Plenary Lecture

Avijit Ghosh

Trends, Success Stories, and Works in Progress with Physiologically Based Pharmacokinetic Modeling: On the Optimization of Free Exposure at the Site of Action
Avijit Ghosh
Janssen Research & Development

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
Preparing for a successful First into Human (NCE perspective)
Co-Chairs: Kelly Dong, GlaxoSmithKline and Marjoleen Nijsen, AbbVie

What Pharmacokinetics Can Do in Early Phase Clinical Development of Innovative Drug
Pei Hu, Peking Union Medical College Hospital

AbbVie's Strategy for Human PK & FIH Dose Prediction with Retrospective Analysis
Marjoleen Nijsen, AbbVie

First-Time-in-Human (FTIH) Studies: Dose Selection and Study Design
Jiansong Yang, GlaxoSmithKline

Early Clinical Development: A Critical Stage to Move a Right Compound for Global Development
Zhigang Yu, Amgen

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

CPSA Shanghai Expo   Where Technology and Solutions Meet!

11:30 am - 12:30 pm
Yangtze Ballroom

Young Scientist Awards Poster Review Session

12:00 pm - 1:00 pm

Lunch & Learn Workshops

Ballroom I

Molecular Discovery-SCIEX Collaboration to Process SWATH Data Analysis

SWATH Data Analysis Within the Mass-MetaSite Framework: Metabolite and Soft Spot Identification Workflows
Ismael Zamora, Molecular Discovery

Comprehensive Metabolite Identification using SWATH Acquisition
Eva Duchoslav, SCIEX

Ballroom II

Applications of Novel Acquisition Modes and Instrument Geometries in Time-of-Flight Mass Spectrometer for Target Quantitation

Russell Mortishire-Smith, Waters Corporation

Boardroom

Connecting the Dots and Helping Projects Progress with Asset Management

Martin Steel, McKinley Scientific

1:30 pm - 3:00 pm

PARALLEL SESSIONS

Ballroom I

Traditional Chinese Medicine and Natural Product Research
Chair: Chuang Lu, Takeda Pharmaceuticals

Involvement of P-gp and CYP3A In The Liver Disposition of Triptolide: Implications for Understanding Triptolide-induced Hepatotoxicity
Xiaomei Zhuang, Beijing Institute of Pharmacology and Toxicology

Role of Herb-Drug Interaction Study In The Practice of Integrative Medicine in Hong Kong: Fact and Challenges
Joan Z. Zuo, Chinese University of Hong Kong

PXR and CAR-Mediated Transcriptional Activation of CYP2B6 and UGT1A1 By Natural Constituents From Traditional Chinese Medicines
Lushan Yu, Zhejiang University

Reaction Phenotyping Of Drug Metabolizing Enzymes, The Central Piece Of Victim Drug DDI Prediction
Chuang Lu, Takeda Pharmaceuticals

Ballroom II

New Technologies for Early Bioanalytical Support
Chair: Tianyi Zhang, Frontage Labs

A Novel Selective Peptide Derivatization Strategy For Sensitivity Enhancement For LC-MS/MS Bioanalysis Of Proteins
Long Yuan, Bristol-Myers Squibb

Ultra-sensitive method for analysis of midazolam in DDI studies
Wenzhe Lu, Roche China

Bioanalytical Challenges and Strategies for Antibody-Drug Conjugate (ADC) Therapeutics
John Lin, Frontage Labs

LC-MS/MS Bioanalytical Support To Potent Therapeutic Peptides In Early Development – How To Manage Sensitivity Demands?
Magnus Knutsson, Ferring Pharmaceuticals

Rhine Ballroom

ADME/PK session: New Technologies for ADME
Chair: Swapan Chowdhury, Takeda Pharmaceutical

Important Role of DMPK In Drug Discovery: A Lesson Learned From Aldehyde Oxidase-Mediated Issue
Pan Deng, Shanghai Institute of Materia Medica

Revealing Novel Drug Metabolites Using Liquid Chromatography-High Resolution Mass Spectrometry: Case Studies in Drug Development
Shuguang Ma, Genentech

From Data To Information And From Information To Knowledge
Ismael Zamora, Pompeu Fabra University

How To Distinguish Drug-Related Ions From A Complex LC-MS Spectra And Chromatogram- A Background Subtraction Software Tool
Swapan Chowdhury, Takeda Pharmaceutical

3:30 pm - 5:00 pm

PARALLEL SESSIONS

Ballroom I

Clinical Session: How Can Clinical PK and Bioanalysis Work Together To Contribute To Mutual Success?
Chairs: Sylvia Zhao, Novartis and Luke Bi, Covance

The Critical Roles Of BA/BE Studies In Drug Development
Jim Wei, Medpace

What a BA Analyst Thinks of a Clinical Pharmacokineticist
Eric Liang, Novartis

Develop A Sensitive LC/MS/MS Assay For A Peptide Drug In A SAD Study
Luke Bi, Covance

Considerations in the Design and Data Presentation of Clinical Pharmacokinetic Studies Used for Bridging Caucasian Data into Chinese Population
Minji Wei, Institute of Clinical Pharmacology, Peking University

Panel Discussion: Current Challenges in Bioanalysis and Impact on PK
Luke Bi, Covance
Xiaohang Shen, Wuxi AppTec
Chad Briscoe, PRA Health Sciences

Ballroom II

Bioanalysis of Herbal Medicines
Zhuohan Hu, Research Institute for Liver Diseases

Quantification of Systematic Exposure to Herbal Compounds and Metabolites
Chuan Li, Shanghai Institute of Materia Medica

Bioanalysis and Pharmacophore of Iridoids from Chinese Herbs
Li Yang, Shanghai University of Chinese Medicines

HRMS-Based Metabolite Identification for Traditional Chinese Medicine
Gary Impey, SCIEX

Rhine Ballroom

Technology Developments in the Application of Mass Spectrometry for Protein and Peptide: Are Both Technologies Complementary?
Chair: Wenying Jian, Janssen Research & Development

Studies On New Methods For Protein Quantification By High Performance Liquid Chromatography Coupled To Mass Spectrometry
Yangjun Zhang, Beijing Proteome Research Center

Develop A Sensitive LC/MS/MS Assay For A Peptide Drug In A SAD Study
Luke Bi, Covance
(This talk has been moved to Ballroom I)

Bioanalysis of Peptides and Proteins In Drug Research and Development: LBA and LCMS!
Lieve Dillen, Janssen Research & Development

Challenges and Assay Strategies for Bioanalytical Assessment of Antibody-Drug Conjugates In Vivo
Keyang Xu, Genentech

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!

 

Friday 星期五 17 April

7:30 am
Renaissance Shanghai
4th Floor Lobby

Registration Open

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

Plenary Lecture

Binodh DeSilva

Advances In Biologic Therapeutics Development Beyond The Era of Monoclonal Antibodies
Binodh DeSilva
Bristol-Myers Squibb

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
Preparing For A Successful First Into Human (NBE Perspective)
Chair: Fan Jin, Covance

Ongoing Assay Design and Modification Choices throughout the Drug Development Life Cycle
Joe Bower, Covance

Challenges of Biosimilar Method Development and Validation For Phase 3 Clinical Trials - Focusing On Appropriate Bioanalytical Assay Formats To Avoid Matrix Interference Issues In The Disease State. Using Some Examples For Humira, Herceptin and Enbrel.
James Munday, Covance

Status/Strategy/Challenge of Biological BA in China
Haifeng Song, Chinese Military Academy of Science

FIM: Starting A New Journey Of Bioanalytics
Eric Liang, Novartis

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

CPSA Shanghai Expo   Where Technology and Solutions Meet!

11:30 am - 12:30 pm
Yangtze Ballroom

Young Scientist Awards Poster Review Session

12:00 pm - 1:00 pm

Lunch & Learn Workshops

Ballroom I

Validation of LC/MS Instruments for Part 11 Compliance

How to Migrate to an Integrated Compliance Strategy for Your Lab
Dave Abramowitz, SCIEX

Ballroom II

The Future of High Data Capacity Mass Spectrometry in the Analytical and Clinical Sciences Connecting Disciplines with High Performance Nanospray

CHORUS: Mass Spectrometrists Look to Cloud Computing for Data Permanence and Re-Analysis
Nathan Yates, University of Pittsburgh

Clinical Science, Digital Fluidics, and Mass Spectrometry: What Would You Do with Infinite Speed?
Gary Valaskovic, New Objective

1:30 pm - 3:00 pm

PARALLEL SESSIONS

Ballroom I

Global Regulated Bioanalysis: Looking into China from the Outside
Chairs: Philip Timmerman, Janssen Research & Development and Naidong Weng, Janssen Research & Development

Highlights of the Bioanalysis Guidance in Chinese Pharmacopoeia 2015
Prof. Dafang Zhong, Shanghai Institute of Materia Medica

All for One, One for All - The Chinese BMV Guidance in Perspective to other Guidelines
Peter van Amsterdam, Abbott

Integrating Internal and External Bioanalytical Support to Deliver a Diversified Pharmaceutical Portfolio
Eric Yang, GlaxoSmithKline

Outsourcing to China: Opportunities and Challenges, an Industry Perspective
Ajai Chaudhary, Merck & Co

Panel Discussion
Peter van Amsterdam, Eric Yang, Dafang Zhong, Ajai Chaudhary, Naidong Weng

Ballroom II

New Technology
Chairs: Chad Briscoe, PRA Health Sciences and Duxi Zhang, WuXi AppTec

Can We Solve the ADME Mystery of Traditional Chinese Medicines? A New Analytical Approach for Studying Metabolism and Disposition of Multiple Herb Components In Vivo
Mingshe Zhu, Bristol-Myers Squibb

The Application of Immunocapture LC-MS/MS to Simultaneously Quantify Biological Biomarkers and Drug Candidates
Jim Shen, Bristol-Myers Squibb

Software Driven Workflow Enhancements to Accelerate DMPK Analysis
Eva Duchoslav, SCIEX

Rhine Ballroom

DMPK:
Developing Smart DDI Strategies For NCE and NBE
Chair: Cornelis Hop, Genentech

Predictions of Drug-Drug Interactions Involving Inhibitory Metabolites - A Case Study of Amiodarone
Yuan Chen, Genentech

Induction Based Drug-Drug Interaction Strategies During Preclinical and Clinical Development
Jasminder Sahi, GlaxoSmithKline

Cytochrome P450 Mediated Drug-Drug Interactions For Therapeutic Proteins And Antibody-Drug Conjugates.
Cornelis Hop, Genetech

3:30 pm - 5:00 pm

PARALLEL SESSIONS

Ballroom I

Microsampling Beyond DBS An Industry And Regulators Perspective On Microsampling
Chair: Philip Timmerman, EBF

Microsampling: A Progress Update And Perspective From The EBF
Philip Timmerman, EBF

Latest Technology Developments on Blood/Plasma Microsampling, and the Perspectives from the IQ Consortium on Implementing DBS for Clinical Pharmacokinetic Studies
Eric Yang

Reducing Pre-Clinical Blood Volumes From Macro To Micro: Toxicologists, Pharmacokineticists And Bioanalysts Unite
Cathy Vickers, NC3R Consortium / David Jones, MHRA

3:30 pm - 5:00 pm
Rhine Ballroom

Innovator Award Session

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

Adding Immuno-purification to a Plasma Collection Device
Tim Schlabach, Novilytic

Ease-of-use and Sensitivity with Nanospray: An Integrated Chip-Based Solution Incorporating Column Temperature Control, Long Columns, and Nebulization
Gary Valaskovic, New Objective

Development and Validation of LC-MS/MS Method for the Quantitation of Infliximab in Human Serum
Hui Wang, Waters Corporation

WebMetabase: A Tool to Exploit Metabolite Identification Information in Drug Discovery
Ismael Zamora,. Molecular Discovery

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 2016 – Program Chair Announcement
Philip Timmerman, Janssen Research & Development

Innovator Award Presentation

Young Scientist Excellence Award Presentation

Saturday 星期六 18 April

Today's sessions will be held at the Shanghai Institute of Materia Medica

8:00 am

Registration Open

9:00 am - 11:15 am

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

Bioanalysis of Peptides and Proteins Using LC-MS
Wenying Jian, Janssen Research & Development

Understanding Stability and Biotransformation of ADCs in Drug Discovery
Keyang Xu, Genentech

Role of Drug Transporters in Drug Disposition
Peihua Sun, PharmaResources (Shanghai) Co., Ltd.