|
CPSA Shanghai 2018
New Horizons in Drug Discovery and Development: Bioanalysis, Biomarkers and ADME
Updated 27 August 2018
Wednesday 星期三 18 April
10:00 am
Renaissance Shanghai
4th Floor Lobby
1:00 PM - 3:30 PM
Ballroom I
Workshop
Introduction to Drug Discovery
Workshop Leader: Cornelis Hop, Genentech
How to Succeed in Drug Discovery
Cornelis Hop, Genentech
Bioanalysis & Metabolism
Jeff Zhang, Novartis
Current Challenges in Clearance Assessments
Zhengyin Yan, Genentech
1:00 PM - 3:30 PM
Ballroom II
Workshop
怎样在中国支持临床试验
Supporting Clinical Trials in China
(presentations in Chinese)
Workshop Leader: Jonathan Wang, Genentech
中国新药 临床试验中的代谢和药动力学研究
Clinical DMPK Studies of Innovative Drugs in China
Dafang Zhong, Shanghai Institute of Materia Medica
临床试验生物样品检测的主要关注点与常见问题
The Key Points and Common Issues for Clinical Sample Bioanalysis
Hongliang Jiang, Huazhong University of Science and Technology
为获得好的分析测试结果,临床中心应该做
How Could Clinical Centers Get Better Experimental Results
Qing Wen, Jinan Central Hospital
4:00 PM - 4:45 PM
Ballroom II
Keynote Lecture
Future Prospect of Drug Innovation in China: Challenges and Opportunities
Zaiqi Wang
Roche
5:00 PM - 6:00 PM
Ballroom I
Opening Reception & Happy Hour
Greet old friends, meet new friends, and get an overview of the week’s events and activities. Welcome to CPSA Shanghai 2018!
Sponsor's Toast
Given by Liping Bian, Antpedia
Thursday 星期四 19 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
Cornelis Hop
Genentech
9:00 am - 9:45 am
Ballroom I/II
Plenary Lecture
Regulated Bioanalysis: A Perspective on the Future Benefits and Challenges of Globalisation
Philip Timmerman
EBF / Janssen Research & Development (ret)
9:00 am - 5:00 pm
Yangtze Ballroom
Poster Hall Open
Posters will be available all day today and Friday
10:00 am - 11:45 am
Ballroom I/II
Symposium Session
MIST and Drug Metabolism
Chairs: Susanna Tse, Pfizer; Jens Sydor, Abbvie
M.I.S.T.: Overall Strategy for Identification of Human Metabolite(s) and Estimation of Human and Toxicological Exposures
Susanna Tse, Pfizer
How to handle MIST Issues: The Use of the Mixed Matrix Method Illustrated with Clinical Examples
Cornelis Hop, Genentech
Case Studies of Disproportionate Human Metabolites – Ombitasvir and Venetoclax
Jens Sydor, Abbvie
MIST Case Studies
Hua Lv, Roche Shanghai
11:00 am - 2:00 pm
4th Floor Lobby
CPSA Shanghai Expo
Where Technology and Solutions Meet!
11:30 am - 1:30 pm
Yangtze Ballroom
Poster Session
Young Scientist Award Review
WORKSHOP
Combining Selectivity and Sensitivity for Targeted Peptide Quantitation
Dr. Zhimin Long, SCIEX
PARALLEL SESSIONS : Tracks 1 - 4
TRACK 1
In Vitro ADME Challenges and Advances
Chairs: Mandy Xu, Pharmaron; Zhengyin Yan, Genentech
Improving Confidence in PPB Determinations for Highly Bound Drugs
Zhengyin Yan, Genentech
Novel Hepatic Spheroid Systems for Drug Discovery and Development
Volker Lauschke, Karolinska Institutet
Preclinical Evaluation of BBB Penetration of EGFR TKIs using in vitro and in vivo Tools
Kan Chen, AstraZeneca Asia
In vitro Human-Based Experimental Systems for the Evaluation of Human Drug Properties
Albert Li, In Vitro ADMET Laboratories
TRACK 2
Small Molecule Bioanalysis
Chairs: Luke Bi, Covance; Jonathan Wang, Genentech
The Determination of Antiretroviral Triphosphate Metabolite in Human Peripheral Blood Mononuclear Cells
Deqing Xiao, Gilead
Bioanalytical Challenges in the Development of Combination Therapies
Jonathan Wang, Genenetech
LC-MS/MS Analysis of Drug in Hemolyzed Samples for Supporting BE Application: A Case Study
Minji Wei, Institute of Clinical Pharmacology, Peking University
TRACK 3
Omics and Biomarker Challenges
Chairs: Yu Tian, Abbvie; Kelly Dong, UP Pharma
A Simple and High-Coverage Quantitative Metabolomics Platform Based on Chemical Isotope Labeling LC-MS
Liang Li, University of Alberta
Highly Sensitive Targeted Quantification of Proteins, Isoforms, and Modifications in Biofluids or Specific Cellular Pathways
Weijun Qian, Pacific Northwest National Laboratory
Critical Factors in Exploratory Biomarker Outsourcing in Clinical Studies
Helen Yu, Novartis
TRACK 4
Pharmaceutical Development: From Discovery to First-in-Human
Chair: Qun Lu, Celgene
FIH Clinical Supply in China: Challenges and Changes
Larry Fang, Sinotherapeutics
Development, Characterization and Physical Stability of Amorphous Pharmaceutical Solids
Cai Ting, Chinese Pharmaceutical University
Roundtable Discussion
PARALLEL SESSIONS : Tracks 5 - 8
TRACK 5
Challenges in Drug Discovery and Development
Chairs: Lilly Xu, ChemPartner; Hua Lv, Roche
Implications of the New FDA Guidance for ADME Profiling
Stephen Fowler, Roche
The Application of in vitro Assays for in vivo DDI Prediction
Lilly Xu, Chempartner
Safety Assessments of Preclinical Candidates – Some Considerations from DMPK Perspectives
Hong Wan, Shanghai Hengrui
TRACK 6
Issues in Regulated Bioanalysis
Chairs: Naidong Weng, Janssen Research & Development; Tianyi Zhang, Frontage
Challenges of Immunogenicity Testing for Supporting Clinical Trials of Biotherapeutics
Weiping Shao, Regeneron
ADC PK Profiling Strategies on LC-MS Platforms: Top-Down, Bottom-Up, and Multiplexing
Song Zhao, Frontage
Advancement of High-throughput Bioanalysis to Support Research and Development of Oligonucleotide Therapeutics and Biomarkers
Laixin Wang, Denali Medpharma
TRACK 7
MS Imaging
Chair: Cornelis Hop, Genentech
MALDI-TOFMS Imaging for Environmental Toxicology
Chao Zhao, Hong Kong Baptist University
Imaging Mass Spectrometry: A Powerful Tool Enabling In Situ ADME Assessments
Cristine Quiason-Huynh, Genentech
Potential Usefulness of MS Imaging Technology with High Spatial Resolution in Pharmaceuticals
Miho Ayabe, Chugai
TRACK 8
Non-Cytochrome P450 Metabolism
Chairs: Jeff Zhang, Novartis; Kelly Dong, UP Pharma
Aldehyde Oxidase and its Involvement in the Metabolism of a cMet Inhibitor
Jeff Zhang, Novartis
An Investigation into the Prediction of in vivo Clearance for a Range of Flavin-Containing Monooxygenase Substrates
Yu Wang, Pharmaron
Induction of Aldehyde Oxidase by Nimesulide and its Regulation Mechanism
Lei Zhong, Shanghai Institute of Materia Medica
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!
Request a song - click here!
Friday 星期五 20 April
7:30 am
Renaissance Shanghai
4th Floor Lobby
8:30 am - 9:15 am
Ballroom I/II
Plenary Lecture
Transporters in Drug Development: Current Status and Contemporary Issues
Lei Zhang
Silver Springs, MD
9:00 am - 5:00 pm
Yangtze Ballroom
Poster Hall Open
Posters will be available all day today
9:30 am - 11:30 am
Ballroom I/II
Symposium Session
Drug Transporters
Chairs: Jasminder Sahi, Sanofi; Ikumi Tamai, Kanazawa University
Drug-Drug and Drug-Food Interaction on Transporters
Ikumi Tamai, Kanazawa University
Interactions Between Saponins and Hepatic Transporters
Chuan Li, Shanghai Institute of Materia Medica
Prediction of Brain-to-Blood Unbound Concentration Ratios in CNS Drug Discovery Employing in silico and in vitro Model Systems
Houfu Liu, GlaxoSmithKline
Contribution of Xenobiotic Transporters to Drug Disposition – Regulatory Case Studies
Jasminder Sahi, Sanofi
11:00 am - 2:00 pm
4th Floor Lobby
CPSA Shanghai Expo
Where Technology and Solutions Meet!
WORKSHOP
Translating Protein MS Assays and the Challenging Road Ahead
Dobrin Nedelkov, Isoformix
PARALLEL SESSIONS : Tracks 1 - 4
TRACK 1
PBPK Modeling
Chairs: Tom Wilde, Janssen Research & Development; Avi Ghosh, Janssen Research & Development
The Important Role of Virtual Chinese Population for PK/PD Prediction: Perspective View from an Academic Institution
Pei Hu, Peking Union Medical College Hospital
Beyond Small Intestine Absorption: Physiological Modeling and Interspecies Translation of Gut Tissue PK
Tom Wilde, Janssen Research & Development
Predicting Drug Concentrations in Renal Tubules Combining in vitro and in silico Methods
Kas Subramanian, Syngene
TRACK 2
Large Molecule Bioanalysis
Chairs: Wenying Jian, Janssen Research & Development; Xiao-Yan Cai, Consultant
Total and Free Quantification of Therpeutic Antibodies by Liquid Chromatography-Tandem Mass Spectrometry
Ichio Onami, Chugai
Strength and Challenges of LBA on Biologics Bioanalysis: Case Studies
Xiao-Yan Cai, Consultant
Strategies for Drug Transporter Quantitation by LC-MS
Alan Deng, Genentech
TRACK 3
Radiolabeled Tools for Drug Development
Chairs: Stephen Dueker, BioCore; Alicia Du, Calibra Diagnostics
Current Status and Requirement of Radio-ADME Studies in China
Zhe-ming Gu, Value Pharmaceutical Services
Human PK of 14C-Tagged Biologics
Wouter Vaes, TNO
A Benchtop CRDS Laser System for 14C Quantitation
Stephen Dueker, BioCore
TRACK 4
Biomarker Quantitation
Min Liu, Merck; Min Li, HuaHai Pharmaceutical
Quantitative Aspects of MALDI-TOF MS for Protein Biomarkers Analysis
Dobrin Nedelkov, Isoformix
The Importance of Bioanalytical Testing in Bioequivalence Evaluation of Generic Drugs
Xiaohang Shen, Xihua Scientific
Considerations for Fit for Purpose Biomarker Method Validation Activities
James Munday, Covance
PARALLEL SESSIONS : Tracks 5 - 7
TRACK 5
PK/PD Modeling
Chairs: Tom Wilde, Janssen Research & Development; Avi Ghosh, Janssen Research & Development
Modeling the Impact of Renal Tubular Drug Dynamics on Plasma Drug Concentration
Kas Subramanian, Syngene
Applications of Pharmacokinetic/Pharmacodynamic Modeling in Biologics Development
Songmao (Ben) Zheng, Janssen Research & Development
PK/PD Analyses of Vfend (Voriconazole) Used for Pediatric License Renewal in China
Ping Lu, Pfizer
TRACK 6
What's New - Recent Developments for ADCs
Chairs: Keyang Xu, Genentech; Young Shin, Chungnam National University
Bioanalytical Assays for ADCs - New Developments and Case Studies
Mark Qian, Takeda Pharmaceuticals
Creating Next Generation ADCs with Industry Leading DAR Precision and Plasma Stability
Jeiwook Chae, LegoChemBio
Key Scientific and Regulatory Aspects of Nonclinical Development of an ADC Biosimilar
Yue Liu, 3S Bio
TRACK 7
Distinguished Scientist Lectures
Chairs: Liping Bian, Antpedia and Emily Ehrenfeld, New Objective
Early Identification of Potential DMPK Risks to Ensure Future Clinical Success
Kelly Dong, UP Pharma
Post-Translationally Modified Proteins as Biomarker Targets for Clinical Protein MS Tests
Dobrin Nedelkov, Isoformix
5:00 pm - 7:30 pm
Ballroom I/II
Dinner, Awards & Celebration
Closing Toast
Given by Emily Ehrenfeld, New Objective
Program Chair Recognition
Mike Lee, Milestone Development Services
CPSA Shanghai 2019 – Program Chair Announcement
Cornelis Hop, Genentech
Young Scientist Excellence Award Presentation
Chairs: Min Liu, Merck and Jeff Zhang, Novartis
|