Registration Open

Guideline and Practice of Evaluation of Consistency of Quality and Efficacy of Generic Drugs
仿制药质量与疗效一致性评价的指导原则和实践

Workshop Leaders: Tianyi (Tee) Zhang, Frontage Laboratories; Jeff Zhang, Novartis

Sponsored by SCIEX

How to Conduct Clinical Bioequivalence Study and Related Bioanalysis
如何开展生物等效性（BE）临床试验及生物样本分析
Tianyi (Tee) Zhang, Frontage Laboratories
张天谊，方达医药（中国）

Formulation Development Related to BE Study
与生物等效性（BE）临床试验相关的制剂开发研究
Jun Fan, Overseas Pharmaceuticals
范军, 越洋医药

Regulatory Requirement and Inspection with BE Study
生物等效性（BE）临床试验的监管要求和检查
Minji Wei, Institute of Clinical Pharmacology, Peking University First Hospital
魏敏吉, 北大药理研究所

Hot Topics in DMPK
Workshop Leader: Naidong Weng, Janssen Research & Development

Sponsored by SCIEX

Full Measurement of Highly Protein Bound Drugs
Sophia Xu, Bristol-Myers Squibb

Bioanalytical Strategy for MIST Coverage: Human Unique Metabolites
Shaolian Zhou, Roche

Microdosing/Microtracers in Clinical Development
Shuguang Ma, Genentech

PBPK Application in Drug Development
Jialin Mao and Yuan Chen, Genentech

Bioanalytical and Biotransformation of ADC Drugs
Keyang Xu, Genentech

Fast and Sensitive Quantitation of Low Levels of Intracellular Substrates in Uptake Transporter Assays using Liquid Chromatography Mass Spectrometry
Ming Yao, Bristol-Myers Squibb

Executive Roundtable

The Paradigm Shifting for Global and China Bioanalysis Support
Chairs: Naidong Weng, Janssen Research & Development; Ajai Kumar Chaudhary, Merck

Discussion Panel:
Renuka Pillutla, Bristol-Myers Squibb
Cornelis Hop, Genentech
Shaolian Zhou, Roche
Kelly Dong, GlaxoSmithKline
Xinping Fang, Wuxi AppTec
Tianyi (Tee) Zhang, Frontage Laboratories
Jin Fan, Covance
James Munday, Covance

With the increasing globalization and merge of pharma companies, bioanalysis is rapidly evolving – more outsourcing in global setting, new platforms from both instrument technology and drug pipeline scaffolds, and more perhaps even more diversified regulations pertaining to bioanalysis. Traditional boundary between for example large and small molecules is being taken done to support newer drug pipelines such as ADC or PDC. The same can be said for bioanalysis and biotransformation, as newer instrument platform offered the possibilities of higher sensitivity, higher resolution, and information rich data acquisition. Even some of the traditional partnership such as toxicology and bioanalysis also sees new revolution – for example microsampling to drive 3R to reduce animal usages. On the other hand, delivery of high quality data with lower cost on time in an ever more complicating regulatory environment remains to be a major incentive for pharma to implement new strategy such as scientific validation and outsource bioanalytical work, particularly for GLP and clinical studies. A number of questions need to be answered to drive optimal bioanalytical support. Below are a few exemplary questions:

• How to do we bioanalytical scientists/managers adapt to the concept of scientific validation?
• Do we have the right bioanalytical infrastructures to support drug discovery/development?
• Do we fully explore the potential of new generation of instruments?
• How do we manage the regulatory environment globally and locally, for example, in China?
• Where do CROs, globally and locally, view their strategies to support global and local pharma in the future?

Opening Reception & Happy Hour

Sponsored by Wuxi-AppTec

Greet old friends, meet new friends, and get an overview of the week’s events and activities.
Welcome to CPSA Shanghai 2017!

Sponsor's Toast

Keynote Lecture

Registration Open

Welcome & Opening Remarks

Plenary Lecture

Poster Hall Open

Posters will be available all day today and Friday

Innovative Approaches to Drug Development, Including SM, Biologics and Conjugates

Chairs: Shaolian Zhou, Roche; Sylvia Zhao, Novartis

Labelled Isotope Compounds in LC-MS Based Bioanalysis
Naidong Weng, Janssen Research & Development

Clinical Pharmacology Impact on the Recommended Phase II dose Selection in Immuno-oncology
Jian Xu, Novartis

Innovative LC-MS Applications in Characterization and Quantification of Biologics In Vivo: Challenges and Opportunities
Keyang Xu, Genentech

CPSA Shanghai Expo   Where Technology and Solutions Meet!

Young Scientist Awards Poster Review Session

Chairs: Min Liu, Merck; Jeff Zhang, Novartis; Naidong Weng, Janssen Reasearch & Development;
Young Scientist Excellence Committee Members: Luke Bi, Covance; Joseph Bower, Covance; Xiao Ding, Genentech; Kelly Dong, GlaxoSmithKline; Jonathan Josephs, Thermo Fisher Scientific; Fred Li, Hua Medicine; Qun Lu, Celgene; Hua Lv, Roche; Shuguang Ma, Genentech; Jasminder Sahi, Sanofi; Sihe Wang, Cleveland Clinic; France Wang, Janssen Research & Development; Yin Xiong, Wuxi AppTec; Sophia Xu, Bristol-Myers Squibb; Tianyi (Tee) Zhang, Frontage Laboratories; Sylvia Zhao, Novartis

Lunch & Learn Workshops

WORKSHOP

Sponsored by McKinley Scientific

WORKSHOP

Sponsor to be announced

PARALLEL SESSIONS Tracks 1 - 4

Drug Metabolism
Chairs: Shuguang Ma, Genentech; Jeff Zhang, Novartis

Integrated Workflow for Biotransformation Study of Therapeutic Proteins
Ji Ma, Amgen

Can We Select a Drug Candidate Which May Have Potential Auto-induction?
Frances Wang. Janssen Research & Development

Hydrolytic Metabolism of Cyanopyrrolidine DPP4 Inhibitors Mediated by Dipeptidyl Peptidases
Xiaoyuan Pang, Shanghai Institute of Materia Medica, Chinese Academy of Sciences

Small Molecule Bioanalysis
Chairs: Xiao Ding, Genentech; Jin Fan, Covance

Regulated Clinical Bioanalysis and Its Impact on the Clinical Study in China
Luke Bi, Covance

Development of a Multi-Matrix LC-MS/MS Method for Urea Quantitation and Its Application in Human Respiratory Disease Studies
Jonathan Wang, Genentech

Scientific and Regulatory Balance in Regulated Bioanalytical Studies Following FDA/EMA/CFDA BMV Guidance
Xinping Fang, WuXi AppTec

Incurred Sample Reanalysis - Investigation of Unexpected 5-Flurouracil Results
Xiao Ding, Genentech

Biomarker Challenges
Chairs: Wenying Jian, Janssen Research & Development; Naidong Weng, Janssen Research & Development

Biomarker for Patient Selection
Yang Qiu, Janssen Reasearch & Development

Clinical Application of LC-MS/MS Detection Method in Evaluation of Endogenous Vitamins, Amino Acids and Hormones
Li Li, iPhase Pharma Services

Complexities and Solutions for Biomarker Support of an Increasingly Complex Drug Development Portfolio
Daniel Sikkema, Frontage Labs

Drug Developability
Chairs: Qun Lu, Celgene; Sachin Lohan, Janssen Research & Development

Designing Drugs for Systemic vs Gut-restricted Exposure via Oral Route
Sachin Lohani, Janssen Research & Development

Rational Strategy for Solid Form Research in Discovery and Early Development
Yanfeng Zhang, CrystalPharmatech

Nanoformulation for Discovery, Preclinical and Clinical Studies
Sunny Panmai, WuXi AppTec

PARALLEL SESSIONS Tracks 5 - 8

Drug Discovery & Development
Chair: Min Liu, Merck

Forced Degradation Studies: Regulatory Expectations and Best Practices in Developing Stability-Indicating Methods and Elucidating Degradant Structures
Min Li, Huahai Pharmaceutical

Definitive Metabolite Identification Coupled With Automated Ligand Identification System (ALIS) Technology: A Novel Approach to Uncover Structure-Activity-Relationships and Guide Drug Design in a Factor IXa Inhibitor Program
Yong Liu, Merck & Co.

Strategy and Cases Shared for Resolving the Impact from Hemolysis of Plasma Samples During LC-MS/MS Bioanalysis
Biao Huang, Covance

Hot Topics of Bioanalysis I 
Chairs: Sophia Xu, Bristol-Myers Squibb and Frances Wang, Janssen Research & Development

Key Considerations for the Regulated Immunogenicity Assessment in Support of Clinical Trials
Qikuan Huang, WuXi AppTec

Commonly Asked Bioanalytical Questions by FDA, EMA, Health Canada (TPD) and Japan PMDA
John Ling, Gilead Sciences, Inc.

Clinical BE Studies and Related Bioanalysis Requirements in China
Tianyi (Tee) Zhang, Frontage Laboratories

Biosimilar Drug Development in China and Global Markets: From CMC to Filing
Co-Chairs: Xiao-Yan Cai, Wuxi AppTec; Yi Du, Huahai Pharmaceutical

Development of Insulin Analog Biosimilar: From China to U.S.
Heng Li, Gan & Lee

Quality Development for Biosimilars and Interchangeable Biologics
Yan Fang, Hengrui Medicine Co. Ltd

A Case Study of Immunogenicity Assessment in a Biosimilar Comparability Study: Impact of Target Interference and Solutions
Jing Shi, WuXi AppTec

Recent Industry (US) Recommendations for Immunogenicity Assay (ADA and NAb) Development and Validation to Support Comparability Studies for Biosimilar Drug Development
Xiao-Yan Cai, WuXi AppTec

In vitro ADME
Chairs: Hua Lv, Roche; Li Wang, Eli Lilly & Co.

Theoretical Approach based on a 3-Compartment Model for Estimating the Apparent Permeability Coefficient (Papp) in a Transcellular Transport Study
Kazuhisa Ozeki, Chugai Pharmaceutical Co., Ltd.

Quantitative Proteomics: A Promising Tool for the Prediction of Transporter-mediated Drug Disposition
Li Wang, Eli Lilly & Co.

Assessing the Reactivity of Acyl Glucuronides - A New Rapid in-vitro Assay for Drug Discovery
Giorgio Ottaviani, Roche Innovation Center Shanghai

Innovative DMPK Mechanistic Assays and Strategies to Support the Design of Liver Targeting Small Molecules
Hua Lv, Roche Innovation Center Shanghai

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!

 

Registration Open

Plenary Lecture

Poster Hall Open

Posters will be available all day today

Combined DMPK/Bioanalysis
Chairs: Cornelis Hop, Genentech; Kelly Dong, GlaxoSmithKline

Prediction of Human Pharmacokinetics Parameters Using Chimeric Mice with Humanized Liver
Maki Miyamoto, Takeda, Japan

From Oral to Inhaled Drugs, Strategies for Successful Clinical PK Predictions
Ken Grime, AstraZeneca, Sweden

In Vitro PK Study in A Long-Term Liver Model to Assess DDI Potentials and Major Clearance Pathways of a Drug Candidate in Healthy and Disease State
Nicole Kratochwil, Roche, Switzerland

CPSA Shanghai Expo   Where Technology and Solutions Meet!

Lunch & Learn Workshops

WORKSHOP
Preclinical and Clinical Development of Antibody-Drug Conjugates: What Do We Need to Consider from Regulatory Perspectives?
Workshop Leaders: Stephen Dueker, HeeJoo Le, and Sookie La, BioCore, Seoul, Korea

Sponsored by BioCore

Antibody drug conjugates provide specific delivery of often toxic small molecules to target tissues. Many of the same approaches applied for small molecule metabolism are increasingly being required for ADCs and other large molecule biologics. The development from both a bioanalytical and regulatory perspective are fraught with difficulties as species of small molecule drug, drug conjugate, and metabolites derived from both, require monitoring in tissues and fluids. We present an overview of some of the challenges in this important but complex area of development and close with discussion of radiolabeled techniques using Accelerator Mass Spectrometry and recently developed Cavity Ring Down Laser 14C technology. This is an open forum – participation and insights are greatly appreciated.

Concept Developer: Young Shin, Professor, ChungNam University, Daejeon, Korea

WORKSHOP
Benefits of Larger Studies in Discovery Proteomics:
The Need for High Performance MS
Nathan Yates, University of Pittsburgh

Sponsored by New Objective

PARALLEL SESSIONS Tracks 9 - 11

Drug Drug Interaction Prediction: Translation from In Vitro to In Vivo using the PBPK Approach
Chair: Jialin Mao, Genentech

A Case Example of PBPK Application in a Discovery Project: How to Translate the Preclinical in vitro and in vivo Data to Assess Human CYP3A Induction Risk?
Jialin Mao, Genentech

Prediction of the Pharmacokinetic Interaction between Wuzhi Capsule (TCM) and Tacrolimus using PBPK Modeling
Xiaoqiang Xiang, Fudan University

Assessment of OATP Transporter Mediated DDI between GDC-0810 and Pravastatin using PBPK Modeling
Yuan Chen, Genentech

Biomolecule and Oligonucleotides Bioanalysis
Chairs: Qin Ji, Bristol-Myers Squibb; Naidong Weng, Janssen Research & Development

LC-HRMS Based Bioanalysis of Intact Proteins
Wenying Jian, Janssen Research & Development

The Total Solution for DNA Damage Response Pathway Protein Biomarker Analysis
Hua-fen Liu, Sciex

LC/MS/MS for Large Molecule Bioanalysis
Song Zhao, Frontage Laboratories

Biomarkers: From Discovery to Patient Care
Chair: Sihe Wang, Cleveland Clinic

Targeted Biomarker Quantitation by LC-MS
Naidong Weng, Janssen Research & Development

FDA: A Brief Description of a Biomarker's Journey from Submission to Approval
Michael Leuther, Roche

Validation of Mass Spectrometry Assays for Clinical Use
Shuijun Li, Xuhui Central Hospital

PARALLEL SESSIONS Tracks 12 - 15

Technologies and Applications for Quantitation
Chairs: Erik Hansen, New Objective; Sihe Wang, Cleveland Clinic

Lessons and Pitfalls During PK/IMG/NAb Assay Transfer
Linlin Luo, Bristol-Myers Squibb

Quantification of Drugs and Metabolites to Support Pain Management
Sihe Wang, Cleveland Clinic

Challenges in Cross Validation and Transfer of Biomarker Assays: Evaluating Use of Data, Compliance, Technology, Geography and Laboratory Focus
Pat Bennett, PPD

Hot Topics of Bioanalysis II
Co-Chairs: Tianyi (Tee) Zhang, Frontage Laboratories and John Ling, Gilead Sciences, Inc.

Challenges in Developing and Validating a Biomarker/Endogenous LBA following GLP Guidelines
Jing Tu, PPD

Bioanalytical Challenge of Measuring Highly Protein Bound Drugs
Sophia Xu, Bristol-Myers Squibb

Conducting Bioequivalence Studies in China: Challenges and Solutions
Min Meng, Consultant

Innovator Session
Chairs: Kelly Dong, GlaxoSmithKline; Shaolian Zhou, Roche

Scientific Validation from Early to Regulatory Stage
Chairs: Xinping Fang, WuXi AppTec and James Munday, Covance

Scientific Validation Approaches in Supporting Global and Domestic (China) Pre-IND to IND Projects
Yi Tao, WuXi AppTec

Scientific Validation Approaches in Early Biologic Drug Development
James Munday, Covance

Balance of Scientific Focus to Compliance from Early to Late Stage of Drug Development Projects: Roundtable Discussion
Naidong Weng, Janssen Research & Development

Dinner, Awards & Celebration

Closing Toast

Program Chair Recognition
Mike Lee, Milestone Development Services

CPSA Shanghai 2018 – Program Chair Announcement
Nathan Yates, University of Pittsburgh

Innovator Award Presentation
Kelly Dong, GlaxoSmithKline and Shaolian Zhou, Roche

Young Scientist Excellence Award Presentation
Chairs: Min Liu, Merck and Jeff Zhang, Novartis