CPSA Shanghai 2019

Translating Challenges in the Biotechnology Industry:
From Drug Discovery to the Clinic

Meeting Program     Wednesday | Thursday | Friday

Updated 22 March 2019

Wednesday 星期三 10 April

12:00 pm

Renaissance Shanghai
4th Floor Lobby

Registration Open

1:00 PM - 3:30 PM

Ballroom I

Workshop (Chinese)

Workshop Leader: Tianyi Zhang, Frontage

如何获得好的临床试验结果,从临床试验管理的角度 - 温清,济南中心医院
How to Obtain Good Outcome from Clinical Trials, from Clinical Trial Management Perspective
Qing Wen, Jinan Central Hospital

申办方对临床研究中的大分子生物分析项目的管理 -顾为华,齐鲁制药
Sponsor's Management of Large Molecule Bioanalysis Project for Clinical Studies
Weihua Gu, Qilu Pharmaceutical

基于FDA新指导原则(2019)的免疫原性生物分析策略 -施鑫,方达医药
Bioanalytical Strategies for Immunogenicity Based on 2019 FDA New Guidance
Xin Shi, Frontage

1:00 PM - 3:30 PM

Ballroom II

Workshop (English)

Emerging Challenges and Issues for Biologics Development and Support: Multiple Modalities for Therapeutic Proteins, Vaccines, Viral Vectors and Oligos

Workshop Leader: Ajai Chaudhary, Merck; Hong Shen, Sanofi; Dobrin Nedelkov, Isoformix; and Emily Ehrenfeld, New Objective

Pharma/Biopharma Perspective and Vision
Hong Shen, Sanofi

Clinical Laboratory Workflows, Issues and Needs
Dobrin Nedelkov, Isoformix

Integrated Technology and Solutions
Emily Ehrenfeld, New Objective

Panel Discussion:
Pat Bennett, PPD Labs
Hao Jiang, Bristol-Myers Squibb
Baomin Xin, Shanghai Medicilon

5:00 PM - 6:00 PM

Ballroom I

Executive Roundtable

East Meets West

6:00 PM

Ballroom II

Opening Reception & Happy Hour

Greet old friends, meet new friends, and get an overview of the week’s events and activities.
Welcome to the 10th Annual CPSA Shanghai Event!

Sponsor's Toast

Ballroom II

Keynote Lecture

2018 Keynote Speaker Zaiqi Wang

不可逆靶向抗肿瘤药物与血浆蛋白的共价结合
(Covalent Binding of Irreversible Targeted Anticancer Drugs to Plasma Proteins)
Dafang Zhong
Shanghai Institute of Materia Medica

Thursday 星期四 11 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

Min Liu

Format, Objectives, Opening Remarks
Min Liu
Merck

9:00 am - 9:45 am

Ballroom I/II

Plenary Lecture

Plenary Speaker Petr Vachal

The Invention of MK-8262, a CETP Inhibitor Backup to Anacetrapib (with Best in Class Properties)
Petr Vachal
Merck

9:00 am - 5:00 pm

Yangtze Ballroom

Poster Hall Open

Session Chairs: Fred Li, Hua Medicine; Jing Lin, QL Regor Therapeutics; Young Shin, Chungnam National University; Beryl Yang, Wuxi AppTec

10:15 am - 11:45 am

Ballroom I/II

Symposium Session

The Emerging Area of PKPD

Chairs: Kelly Dong, UP Pharma; Jeff Zhang, Novartis

Machine Learning: Taming the Beast of Complex PK/PD Modeling
Emile Chen, GlaxoSmithKline

Integrating PK and PD: Incorporation of Biomarker Readouts into PK Designs for Quantitative PK/PD Models
Edmund Hoppe, Grunenthal

Bridging the Dose-Exposure-Response Relationship,
A Case Example
Peiming Ma, GlaxoSmithKLine

11:00 am - 2:00 pm

4th Floor Lobby

CPSA Shanghai Expo

Where Technology and Solutions Meet!

11:30 am - 2:00 pm

Yangtze Ballroom

Poster Session

Young Scientist Award Review

Chairs: Kelly Dong, UP Pharma; Jeff Zhang, Novartis

Review posters and open discussions with the next generation of up-and-coming scientists as they present their work and answer questions.

12:00 pm - 1:00 pm

Lunch & Learn Workshops

Ballroom I

Integrated Solutions for NanoFlow and MicroFlow LC-MS: A Vision for a Validated CPU

Ballroom II

WORKSHOP

1:30 pm - 3:00 pm

PARALLEL SESSIONS : Tracks 1 - 4

Ballroom I

TRACK 1
Hot Topics in Bioanalysis I
Joint Session with CA-CA

Chair: Baomin Xin, Shanghai Medicilon

Chiral Separation by Normal Phase Liquid Chromatography-ambient Mass Spectrometry
Huwei Liu, Peking University

Interpretations of FDA 2019 Guidance for Developing and Validation Assay for Anti-drug Antibody Detection
Dongbei Li, Accurant Bio

Lab Automation Strategies in Bioanalytical Process
Baomin Xin, Shanghai Medicilon

Ballroom II

TRACK 2
Advancement of LC-MS Applications in Bioanalysis of Biotherapeutics

Chair: Hao Jiang, Bristol-Myers Squibb

Strategies and Challenges for LC-MS/MS Based Peptide Quantification to Support GLP TK and Clinical PK Studies
Yang Xu, Merck

Combining LBA and LC-MS Technologies to Better Support Biologics Development
Hao Jiang, Bristol-Myers Squibb

LC-MS for Bioanalysis of Therapeutic Peptides, Polymer Excipient and Nano-DDS
Jingkai Gu, Jilin University

Danube

TRACK 3
DMPK 中文专场 (CHINESE)

Chairs: Frances Wang, Johnson & Johnson;
Tianyi Zhang, Frontage

桥接细胞与整体的纳米尺度药代动力学研究 - 顾景凯,吉林大学
Nanoscale Pharmacokinetics of Bridging Cells and Whole Cells
Jinkai Gu, Jilin University

DMPK在药物研发中的作用 – 林静,齐鲁锐格
The Role of DMPK in Drug R&D
Jing Lin, QL Regor Therapeutics

创新生物大分子药物PK-PD研究中分析方法的策略 – 程远国,上海益诺思
Analytical Strategies in PK-PD Studies for Biological Drugs
Yuanguo Cheng, Innostar

Rhine

TRACK 4
Pharmaceutical Development:
Preformulation and Formulation Challenges

Chair: Qun Lu, Celgene

Challenges and Opportunities for Solubility Measurement in Drug Discovery and Development Title
Dian Zhang, Merck

Formulation Challenges of Poorly Water Soluble Drugs
Cai Ting, Chinese Pharmaceutical University

To Be Announced
Rob Ju, AbbVie

3:30 pm - 5:00 pm

PARALLEL SESSIONS : Tracks 5 - 8

Ballroom I

TRACK 5
Analytical Technology and Development

Chairs: Min Li, Huahai Pharmaceutical; Min Liu, Merck

Advances in UPLC and its Applications in Pharmaceutical Development
Naijun Wu, Celgene

Modern Mass Spectrometry and its Applications in Pharmaceutical Analysis
Yuanjiang Pan, Zhejiang University

ASMS (Affinity-Selection Mass Spectrometry):
A New Active Hit Screening Platform Using 2D-HPLC-MS Technique Established at WuXi AppTec
Chunhui Ma, Wuxi Apptec

Ballroom II

TRACK 6
Emerging Technology, Methods, and Workflows in Modern Drug Discovery: Generating the Appropriate Data for the Patient

Chair: Hong Shen, Sanofi

Data Integrity and Risk Management
Yin Xiong, XiHua Scientific Co., Ltd.

Considerations of Analytical Method Development and Validation: Feasibility and Reproducibility
Chuncheng Huang, Wuxi Apptec

MALDI-TOF Mass Spectrometry for Protein Biomarker Analysis
Dobrin Nedelkov, Isoformix

Danube

TRACK 7
Focus on Bioequivalence 中文专场 (CHINESE)

Chairs: Frances Wang, Johnson & Johnson;
Tianyi Zhang, Frontage

口服固体制剂的体内外相关性 - 何仲贵,沈阳药科大学
In vitro and In vivo Correlation of Oral Solid Dose Formulations
Zhonggui He, Shenyang Pharmaceutical University

仿制药和原研药的食物影响会不一样吗?处方工艺在食物影响中的作用初探 – 杨劲,中国药科大学
Can Food Effect be Different in Generic Drug and Innovative (Reference) Drug? Preliminary Study of Impact of Formulation Technology in Food Effect.
Jin Yang, China Pharmaceutical University

生物等效性试验(BE)的生物分析要求 – 张天谊
Bioanalytical Requirements in Bioequivalence (BE) Studies
Tianyi Zhang, Frontage

Rhine

TRACK 8
Biosimilar Drug Development

Chair: Yi Du, Huahai Pharmaceutical

6:00 pm

Ballroom I/II

Distinguished Scientist Lecture & Roundtable

2018 Plenary Speaker Mingquiang Zhang

Ultrasensitive Ambient Mass Spectrometry Immunoassays: Detection of Protein Biomarkers of Some Cancers
Huwei Liu
Peking University

Held in conjunction with CA-CA

Chairs: Kelly Dong, UP Pharma; Emily Ehrenfeld, New Objective; Dobrin Nedelkov, Isoformix

Moderators: Tianyi Zhang, Frontage; Baomin Xin, Shanghai Medicilon China

Friday 星期五 12 April

7:30 am

Renaissance Shanghai
4th Floor Lobby

Registration Open

8:30 am - 9:15 am

Ballroom I/II

Plenary Lecture

2018 Plenary Speaker Min Li

Application of Multi-Stage Mass Spectrometry (MSn) in Solving Challenging Problems in Pharmaceutical Industry: From Rapid Structure Elucidation, Drug Degradation Mechanism Studies, to Detection of Genotoxic impurities
Min Li
Huahai Pharmaceutical Co., Ltd

This presentation will cover two aspects of multi-stage mass spectrometry (MSn) application: the first one covers the utilization of LC-MSn in conjunction with mechanism-based stress studies for rapid elucidation of degradant structures and drug degradation mechanisms. The second aspect covers the application of MSn in the detection and quantification of genotoxic impurities. The particular challenges, such as sensitivity and specificity (e.g., sample matrix interference) at sub-ppm levels of these impurities, will be presented and discussed.

9:00 am - 5:00 pm

Yangtze Ballroom

Poster Hall Open

Session Chairs: Fred Li, Hua Medicine; Jing Lin, QL Regor Therapeutics; Young Shin, Chungnam National University; Beryl Yang, Wuxi AppTec

9:30 am - 11:30 am

Ballroom I/II

Symposium Session

Biomarkers: New Area in Bioanalysis

Chairs: Kelly Dong, UP Pharma; Jeff Zhang, Novartis

Embracing Biomarker Analysis: Beyond the Regular Bioanalysis
Kelly Dong, UP Pharma

Biomarker Validation Activities for non-LBA Technologies. How Do We Bridge the Gap to Current Guidance Documents?
James Munday, Covance

Ultrasensitive Immunoassay Technologies – Biomarker and PK/PD in Immuno-Oncology, Autoimmune, Neuroscience, Metabolic and Infectious Diseases
Dan Sikkema, Quanterix

11:00 am - 2:00 pm

4th Floor Lobby

CPSA Shanghai Expo

Where Technology and Solutions Meet!

12:00 pm - 1:00 pm

Lunch & Learn Workshops

Ballroom I

The Future of Personalized Healthcare:
Integrated Solutions

Ballroom II

WORKSHOP

1:30 pm - 3:00 pm

PARALLEL SESSIONS : Tracks 1 - 4

Ballroom I

TRACK 1
Invitro to Invivo Translation and PBPK Modeling

Chair: Yuan Chen, Genentech

Translational Aspects of Drug Discovery
Matthew R. Wright, Genentech

Utilities of Physiologically-based Pharmacokinetic Modeling in Pediatric Drug Development
Ming Zheng, Bristol-Myers Squibb

Towards Prospective Pharmacokinetic Prediction of Organic Anion Transporting Polypeptide (OATP) Substrates
Jialin Mao, Genentech

Ballroom II

TRACK 2
New Technologies for in vitro ADME

Chair: Yu Wang, Pharmaron China

Antisense Oligo DMPK
Zack Cheng, Zion Pharma

In vitro Methods for Assessing Long-term Hepatic Clearance
Simon Taylor, Pharmaron

Rhine

TRACK 3
New Biotherapeutic Modalities and Bioanalytical Support

Chairs: Pat Bennett, PPD Labs; Hao Jiang, Bristol-Myers Squibb

Introduction of New Biotherapeutic Modalities:
Cellular and Gene Therapies
Pat Bennett, PPD Labs

Driving Biomarker Research in Chinese Clinical Trials – Experience Sharing from the Central Lab Perspective
Guo Jingjing, Teddy Lab

Utilizing HRMS for Quantitative and Qualitative Bioanalysis for Drug Development
Min Meng, Denali Medpharma

Danube

TRACK 4
Biomarkers from Discovery to Clinic

Chair: Liling Liu, Genentech

Quantitation of Biomarkers & Racemate Analytes by Chiral Supercritical Fluid Chromatography-Tandem MS
Liling Liu, Genentech

Bioanalytical Tools Supporting Preclinical and Clinical Applications for Cell and Gene Therapy
Paul Byrne, Covance

Ultrasensitive Biomarker Technology
Dan Sikkema, Quanterix

3:30 pm - 5:00 pm

PARALLEL SESSIONS : Tracks 5 - 7

Ballroom I

TRACK 5
Technologies and Applications for Quantitation in the Clinic

Chairs: Emily Ehrenfeld, New Objective; Dobrin Nedelkov, Isoformix

Emerging Workflows in the Modern Laboratory: Perspectives from Drug Discovery and the Clinic
Hong Shen, Sanofi

Sensitive and Precise Characterization of Combinatorial Histone Modifications by Selective Derivatization Coupled with RPLC-EThcDMS/MS
Rijing Liao, Shanghai Institute of Precision Medicine

Next Generation Clinical Diagnostic Assays
Dobrin Nedelkov, Isoformix

Ballroom II

TRACK 6
Hot Topics in Bioanalysis II

Chair: Tianyi Zhang, Frontage Laboratories

Early Human Dose Prediction as a Scoring Metric in Lead Optimization Campaign
Sean Kim, Blueprint Medicines

The Scientific Considerations of Developing the Bioanalysis Assay for Low Molecular Weight Heparins
Song Zhao, Frontage Laboratories

Meaningful Immunogenicity Assessment for Innovative versus Biosimilar Products
Linglong Zou, Henlius

Rhine

TRACK 7
To Be Announced

Chairs: To Be Announced

5:00 pm - 7:30 pm

Ballroom I/II

Dinner, Awards & Celebration

Closing Toast

Program Chair Recognition

Mike Lee, Milestone Development Services

CPSA Shanghai 2020 – Program Chair Announcement

Min Liu, Merck
Mike Lee, Milestone Development Services

Young Scientist Excellence Award Presentation

Kelly Dong, UP Pharma
Jeff Zhang, Novartis