PARALLEL SESSIONS : Tracks 1 - 4

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

Chair: Baomin Xin, Shanghai Medicilon

MS/MS^ALL for Shotgun Lipidomics
Fei Gao, Durbrain Medical Laboratory

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

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

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

TRACK 4
Pharmaceutical Development:
Preformulation and Formulation Challenges

Chair: Qun Lu, Celgene

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

Use of Flash Nano-Precipitation (FCP) for development of poorly Soluble compounds
Sunny Panmai, STA Pharmaceutical

Opportunities and Challenges in Biologics Formulation Development
Sheng Tu, Wuxi Biologics

PARALLEL SESSIONS : Tracks 5 - 8

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

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

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

TRACK 8
Biosimilar Drug Development

Chair: Yi Du, Huahai Pharmaceutical

Distinguished Scientist Lecture & Roundtable

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

Sponsored by Antpedia & New Objective

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

Registration Open

Plenary Lecture

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.

Poster Hall Open

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

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

CPSA Shanghai Expo

Where Technology and Solutions Meet!

Lunch & Learn Workshops

The Future of Personalized Healthcare:
Integrated Solutions

Sponsored by New Objective