CPSA Shanghai 2011
Changing Paradigm in Drug Discovery and Development:
East Meets West
April 13 - 16, 2011
Renaissance Shanghai Pudong Hotel
Shanghai, China
Symposium Program
Updated April 7, 2011
Wednesday, April 13 | |
1:00 pm - 5:00 pm |
Workshops
Biotransformation: Lead Optimization and Clinical Candidate Selection Through in Vitro ADME Evaluation
Common in Vitro ADME Assays:
Assessment of Transporter-Mediated Drug-Drug Interactions:
Drug Metabolite Identification in Drug Discovery Using High-Resolution Mass Spectrometry
Design Proper in Vitro ADME Studies to Meet Needs
Bioanalysis: LC/MS Bioanalysis from Drug Discovery to Development Processes, Technologies and Regulations
Overview of LC-MS/MS Bioanalysis in Pharmaceutical Industry: Processes and Applications
Technical Fundamentals in LC-MS/MS Bioanlytical Method Development, Validation and Sample Analysis: Procedures, Issues and Solutions
Performing Regulated Bioanalysis, Challenges and Case Studies from CRO Perspective
Discovery Bioanalysis
Pharmaceutical Analysis High Speed and High Efficiency Method Development ICH Q-Series, Key Points Exploration Dissolution Design and Testing, Critical for Oral Drug |
Evening |
Sponsor's Dinner Introduction and Welcome Applying Proven Proteomic Workflows and Tools for Quantitative Bioanalysis of Large Molecules |
Thursday, April 14 | |
8:30 am - 8:45 am |
Welcome
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8:45 am - 9:00 am | 
CPSA Shanghai 2011 Chair Jing-Tao Wu, Ph.D. Millennium Pharmaceuticals |
9:00 am - 10:00 am | Plenary Lecture
Challenges and Future Direction of Oncology Drug Development
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10:15 am - 11:45 am | Parallel Sessions |
Parallel Track I Comparison of Regulatory Requirments on DMPK Package Overview of DMPK Package in China: Regulatory Requirement and Current Practice US/Europe Regulatory Requirements on Metabolites in Safety Testing US/Europe Regulatory Requirements on Drug/Drug Interactions | |
Parallel Track II | |
Emerging Trends and Technologies in Pharmaceutical Sciences
PAT Applications in a Quality-by-Design(QbD) Environment
Enhancing Product Performance through Innovative Formulation and Manufacturing New Technology in Polymorph Studies | |
Parallel Track III | |
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Dried Blood Spots and Other Emerging Bioanalytical Technologies Applications of DBS for Clinical Bioanalysis Support Case Study of Dried Blood Spots Application in Toxicology Study High Resolution Accurate Mass Spectrometry in Quantitative Bioanalysis: Effect of
Mass Resolution and Extraction Window on Selectivity High-Throughput Bioanalysis Using an Ultra-fast On-line Extraction System | |
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11:00 am - 2:00 pm |
CPSA Shanghai Expo |
11:45 pm - 1:15 pm | Lunch & Roundtable Discussion |
12:15 pm - 1:15 pm |
Sponsored Workshops Sponsored by AB Sciex Targeted Peptide Quantitation using MIDAS Workflow Sponsored by McKinley Scientific |
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1:15 pm - 5:00 pm | Parallel Sessions |
1:15 pm - 2:45 pm |
Parallel Track I Drug-Drug Interactions DDI of Herbal Medicines Application of In-Vitro Data to Predict Clinical PK and Drug-Drug Interaction by Simcyp Pharmacogenetics in Drug Discovery and Development
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3:00 pm - 5:00 pm |
ADME Optimization to Advance CNS and Oncology Drug Discovery and Development: Industry Case Studies Blood-Brain Barrier Transporters: Friend or Enemy for CNS Drug Discovery and Development? Human CNS Penetration: Can It Be Predicted from Preclinical Data? ADME Support of Oncology Programs: Risk Management vs. Pursuit of Appropriate Drug-Like Properties Predictive Toxicology Approaches for Small Molecule Oncology Drugs
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1:15 pm - 2:45 pm |
Parallel Track II High-speed, High-Resolution Techniques for Pharmaceutical Analysis Chromatographic Methodology and Technology for Developing TCM Mass Spectrometry and Ion Mobility-Based Techniques for Rapid Pharmaceutical
Analysis: No Sample Preparation? GC-MS and Flow-Modulated GCXGC-FID/MS for the Analysis of Fatty Acids in Bacteria and Marine Biota Using Polar and Ionic Liquid Columns |
3:00 pm - 5:00 pm |
Analytical Approaches for the Determination of Low-Level Impurities to Comply with International Regulations Analytical Strategy for Quantifying Low-Level Genotoxic Impurities Quantitation of API Impurities Near the Qualification Level Bioanalytical ICP-MS in Drug Development High-throughput Chiral Analyses |
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1:15 pm - 5:00 pm |
Parallel Track III
Absolute Quantification of Peptides and Proteins: From Sample Preparation and Chromatography to ESI-MS/MS
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5:00 pm - 6:00 pm | Poster Viewing |
6:00 pm - 9:00 pm |
Reception & Keynote Lectures Welcome Toast Stable and Reactive Metabolites in Drug Research Simultaneous Determination of the PK Profile of Clozapine and its Metabolites in Rat Plasma Using a High-Resolution 6540 QTOF Instrument
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Friday, April 15 | |
8:30 am - 9:15 am | Plenary Lecture
Multi-dimensional Chromatography-Mass Spectrometry for Protein Analysis |
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9:30 am - 11:00 am | Parallel Sessions |
Parallel Track I Antibody Drug Conjugates - A General Review Drug Targeting and Nanotechnology Novel Technologies for the Delivery of Biologics | |
Parallel Track II Application of Target and Mechanism Biomarkers in Advancing Biotherapeutics
and Pharmatherapeutics Implementing Biomarkers into Clinical Trials on a Global Scale Proteomics Approaches to the Development of Plasma Markers for Predicting Pre-Term Birth | |
Parallel Track III Reviews of CMC Requirements for Drug Development, Registration and Post
Approval CMC Requirements for Analytical/QC | |
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11:00 am - 12:00 pm |
Poster Session |
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11:00 am - 2:00 pm |
CPSA Shanghai Expo |
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12:00 pm - 1:30 pm | Lunch / Roundtable Discussion |
12:30 pm - 1:30 pm | Sponsored Workshops Sponsored by Thermo Fisher Scientific Sponsored by New Objective Ultra-low-flow Nanospray for Low-Level Biomarkers, Metabolites, and Beyond: Sponsored by Agela Technologies |
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1:30 pm - 5:15 pm | Parallel Sessions |
Parallel Track I | |
1:30 pm - 3:00 pm |
Development of Biologics as Therapeutics Introduction of Biologics Biologics Drug Drug Interaction PK/PD of Biologics |
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3:15 pm - 5:00 pm |
PK/PD in Drug Discovery & Development The Myths of PK/PD - Empirical? Mechanistic? Or System? A Mechanistic-Based PK/PD Modeling for Drug Metabolism by CYP3A in Rat Case History: Use of PK/PD in Drug Candidate Selections Application of PBPK and In-Vitro Hepatocyte Models to Accurately Predict Human PK |
Parallel Track II | |
1:30 pm - 3:30 pm |
Regulated Bioanalysis: State of the Art Perspectives on Regional Differences in Bioanalytical Regulations Strategies to Avoid Pitfalls in Developing and Validating High-quality Quantitative Bioanalytical Methods to Support Regulated Studies Importance of Reagent Quality for Ligand Binding Assay Development Validation and Application of Ligand Binding Assays for Protein Therapeutics
Quantitation and Immunogenicity Testing: A GLP Bioanalytical Lab Perspective |
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3:45 pm - 5:15 pm |
Current Issues in Regulated Bioanalysis Unexpected Event Investigations in the Bioanalytical Laboratory Bioanalytical Method Transfer - Challenges & Opportunities Harmonization of Regulated Bioanalytical Operation at Both U.S. and China Sites |
Parallel Track III | |
1:30 pm - 5:15 pm |
Pharmacokinetic Applications in Drug Discovery and Development: Human PK and Efficacious Dose Prediction
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6:00 pm - 9:00 pm | CPSA Shanghai Social |
6:00 pm - 7:00 pm | Social Hour |
7:00 pm - 7:30 pm | Awards & Announcements |
7:30 pm - 9:00 pm | Point/Counter-Point Discussions Challenges and Opportunities for ADME Science in Pharmaceutical R&D in China Topics for discussion: |
Saturday, April 16 | |
10:00 am - 12:00 pm | Joint sessions with local bioanalytical and metabolism discussion groups Held at The Shanghai Institute for Materia Medica Application of PK/PD in Drug Discovery and Development Overview of DMPK Process in Drug Discovery and Development Application of Radioisotopes in Drug Absorption, Distribution, Metabolism, and Excretion Studies From the Renaissance Shanghai Pudong Hotel, take a taxi to The Shanghai Institute of Materia Medica (���������������������������������) located at 555 Zu Chong Zhi Road, Zhang Jiang Hi-Tech Park, Pudong, Shanghai (������������������������������������555������). The cost of the taxi is around RMB 18 ($3.00). |