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CPSA Shanghai 2015
Connecting the Dots:
Sharing Science Across Disciplines Helps Projects Progress
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
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
8:30 am - 9:00 am
Ballroom I/II
Welcome & Opening Remarks
Welcome
Mike S. Lee
Milestone Development Services
Format, Objectives, Opening Remarks
Philip Timmerman
Janssen Research & Development
9:00 am - 9:45 am
Ballroom I/II
Plenary Lecture
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
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
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
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
8:30 am - 9:15 am
Ballroom I/II
Plenary Lecture
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
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
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
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
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.
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