Biopharma Development & Production 2018

2018年5月15-17日, 中国 上海、Hilton Shanghai Hongqiao

Biopharma Development & Production 2018
-生物医薬品開発製造週間:2018年-
開催日:2018年5月15-17日
開催地:中国 上海、Hilton Shanghai Hongqiao

 

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概要

中国の医薬品市場で重要な役割を担っている企業の幹部など350人以上の参加者が集まるBiopharma Development & Production Weekは、製薬業界における研究を促進し、革新的な技術を紹介し、事業面での関係構築を後押しするという役割を担っています。会期中は、3つのカンファレンスが同時併催され、技術分野と商業分野のトピックに関する60以上のセッションのなかで70人を超える専門家が講演などを行います。

このイベントでは、最新の破壊的な技術の基盤、新世代の設備、連続プロセスの改善といったトピックに関する質の高い実践的な情報を入手することが可能であり、細胞株、バイオシミラー、バイオベター、抗体、ワクチン、新規生物製剤の開発と製造に関する能力を発展させることができます。



第8回 Biomanufacturing 2018

8:00 am

Registration Opens and Morning Coffee

BIOPHARMA DEVELOPMENT AND PRODUCTION 2018 OPENING PLENARY SESSIONS 2018

9:00 am

Chairperson's Opening Remarks

9:10 am

  • Innovation in biopharma pipelines - what can we expect
  • Recent regulatory developments - obstacle or opportunity?
  • How digitalisation of BioPharma is creating new value propositions
  • Biomanufacturing market snapshot in China
  • Biosimilars market potential - what can we achieve?
  • New trends in cell line development

 

9:50 am

[Industry Address] Understanding the Investment Climate in Biopharma Industry - How is Market Responding to Inflow and Outflow of Investments?

Abrar Mir, Managing Partner, Quadria Capital Investment Management Pte Ltd, Singapore

10:20 am

Transforming BioPharma with Technology and Digitalisation

Wang Honglou, CIO, livzon Pharmaceutical Group, China

10:50 am

Morning Networking and Refreshment Break

END OF OPENING PLENARY AND BIOMANUFACTURING CONFERENCE COMMENCES

11:20 am

Chairperson's Opening Remarks

THE MARKETING AUTHORIZATION HOLDER (MAH) REGIME

11:25 am

  • General requirements for manufacturing of biotech products: current FDA guidances
  • What should be submitted in BLA for US FDA for biotech products including biosimilar products
  • FDA Pre-license inspection coverages: three objectives

11:55 am

  • How CMOs can step up to ensurequality compliance and stable supply chains
  • Opportunities with ‘Infrastructure' improvement
  • Investments needed
  • Ket criteria to make the MAH regime work

More panelists to be confirmed

12:30 pm

Networking Lunch

UTILITY EFFICENCY AND OPTIMIZATION

1:30 pm

  • Biopharmaceuticals booming in marketplace
  • Biomanufacturing facilities sprouting in China
  • Facility design/operation challenging to meet both CFDA and FDA/EMA requirements
  • Examples to illustrate cultural difference as reason

2:00 pm

  • The needs to optimize bioproduction and improve facility utilization
  • Modular continuous processing skids
  • Smart automation enable integrated continuous processing

2:30 pm

Case Study: Building a World-Class Highly Flexible Continuous Manufacturing Facility and Quality System in China

Dr. Frank Ye, SVP of Manufacturing and Quality, Hangzhou Just Biotherapeutics Co., Ltd., China

3:00 pm

Afternoon Teabreak

3:30 pm

Effect of Fully Continuous Process for Mab Manufacturing: Speed to Market and Cost Reduction mAb

Noel Rob, Business Development Manager, Pall Life Sciences, UK

4:00 pm

Innovation in Chromatograpy Platform: Lattice Supported Modular Chromatography using Conventional Resin Enabling Flexible Operations, Linear Scalability & Hyper-Productive Processes

Masayoshi Nagaya, Sr. Global Technology Manager, JSR Life Sciences

4:30 pm

Current Challenges of Biologics Manufacturing in China

Xu Wei, Vice President, Manufacturing, Innovent Biologics, China

5:00 pm

Efficacy of Insulation Systems in Aseptic Areas and Facilities: A Practical Guide to Facility Cost Reduction

David Sadler, President & CEO, Kunshan Zotek Kinglai Co. Ltd. U.K.

5:30 pm

From Process Development to cGMP Manufacturing - Process Control Strategy

Zack Zheng, Ph.D. VP of Process Development (Wuhan), JHL BioTech, China

5:55 pm

Chairperson's Summary and End of Main Conference Day One followed by Networking Cocktail

8:50 am

Chairperson's Opening Remarks

INNOVATIONS IN MANUFACTURING SCIENCE TECHNOLOGY

9:00 am

  • Racing to clinical trials is crucial for startup biotech survival.
  • CMC development is one of the most critical IND enabling deliverables.
  • Leverage phase- and region- appropriate strategies is the key to expedite CMC development and IND filings

9:20 am

Rapid Sterility Testing: A Bioluminescence - Growth Based Approach

John Dubczak, Director of Operations, Charles River Laboratories, U.S.

9:50 am

Perspectives in Process Intensification for mAb Purification mAb

Dr Yvan Ruland, Technology Manager Biopharma, Novasep, China

COLD CHAIN MANAGEMENT

10:20 am

Creating Integrated Visibility, Demand Driven, with Data on Intelligent Cold Chain Solutions

Senior Representative, Envirotainer,

10:40 am

Morning Tea Break

QUALITY COMPLIANCE AND SYSTEMS

11:10 am

Meeting the Quality and Compliance Requirements in Manufacturing Process

Joycelyn Kwek, Former Director, Quality Assurance, Amgen Singapore

11:40 am

Boehringer-Ingelheim, bring your biologics to the clinic and market

Dr. Bin Wang, Head of Business Development, Boehringer Ingelheim Biopharmaceuticals, China

12:10 pm

Networking Lunch

1:10 pm

  • Risk based microbial control strategy
  • Identification and implementation of measures to control the sources of microorganisms and the conditions that promote their survival and persistence
  • Monitoring of the facility, equipment, personnel, process, product and their interactions
  • Intervening or remediating when there is a drift from established controls

1:40 pm

Strategic Practice in Building Quality Management Systems (QMS) in China Facilities

Dr. Dennis Yu Xia, Vice President of Manufacturing and Quality, Akeso Bio, China

FACILITIES AS COMPETITIVE ADVANTAGE

2:10 pm

  • Meeting WHO PQ requirement
  • Streamlining facility concept design to engineering design
  • Building out facility in a quick and efficient way

2:40 pm

Smart Automation: Achieving Increased Productivity through Optimized Asset Utilisation

Dr. Bin Wang, Head of Business Development, Boehringer Ingelheim Biopharmaceuticals, China

3:10 pm

Design, Construction and Commissioning Biomanufacturing Facilities

Yifang Wu, President, Wanbang Biopharmaceuticals Co., Ltd, China

3:40 pm

Afternoon Networking and Refreshment Break

BIOPHARMA DEVELOPMENT & PRODUCTION 2018 CLOSING PLENARY SESSIONS

4:20 pm

  • Enabling drivers of innovation in China
  • Consolidation of local players
  • Shifting investment from manufacturing focus to innovative portfolios
  • Adopting technologies that enable the potential in manufacturing, cell development and similarity
  • Attracting the right talent

5:00 pm

Chairperson's Summary of the Day and End of Conference

9:00 am

Pall has built the capability to offer End 2 End solution for monoclonal antibody manufacturing, both in batch processing and in continuous processing. This workshop will help you to update the newest strategy to build a pilot or commercial facility for Mab manufacturing.

 

4:00 pm

End of workshop

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。



第9回 Biosimilars Asia 2018

8:00 am

Registration Opens and Morning Coffee

BIOPHARMA DEVELOPMENT AND PRODUCTION 2018 OPENING PLENARY SESSIONS

9:00 am

Chairperson's Opening Remarks

9:10 am

  • Innovation in biopharma pipelines - what can we expect
  • Recent regulatory developments - obstacle or opportunity?
  • How digitalisation of BioPharma is creating new value propositions
  • Biomanufacturing market snapshot in China
  • Biosimilars market potential - what can we achieve?
  • New trends in cell line development

9:50 am

[Industry Address] Understanding the Investment Climate in Biopharma Industry - How is Market Responding to Inflow and Outflow of Investments?

Abrar Mir, Managing Partner, Quadria Capital Investment Management Pte Ltd, Singapore

10:20 am

Transforming BioPharma with Technology and Digitalisation

Wang Honglou, CIO, livzon Pharmaceutical Group, China

10:50 am

Morning Networking and Refreshment Break

END OF OPENING PLENARY AND 9TH BIOSIMILARS ASIA CONFERENCE COMMENCES

11:10 am

Chairperson's Opening Remarks

Dr. Ming Wang, President and Chief Executive Officer, Phanes Biopharmaceuticals, China

CHINA'S BIOSIMILARS MARKET

11:15 am

Global Biosimilars Outlook

Ryan Karcher, Senior R&D Scientist & Team Lead, Merck, USA

11:40 am

The Importance of Media and Supplements in Two Biosimilar CHO Cell Lines

Henry Zhang, APAC Technical Application Representative - Cell Nutrition, Kerry Inc., China

12:30 pm

Networking Lunch

1:30 pm

China Market Insight: Market Growth and Opportunities in Therapeutic Biosimilars

Xiao Zhi Hua, Chief Executive Officer, OPM Biosciences

2:00 pm

Managing Costs and Technology Adoption in Biosimilar Development

Manfred Weiler, Senior Vice President, Medical & Scientific Strategy, Syneos Health

2:30 pm

Changing Landscape of Global Biosimilars Market and What it Means for China?

Dr. Christopher J. Hickey, Senior Director, International Public Affairs, Asia-Pacific, Pfizer Inc.

3:00 pm

Afternoon Networking & Refreshment Break

3:30 pm

Biosimilars Development in China: Challenges in Bevacizumab Clinical Trial Design

Dr. Jacqueline Ming Liu, Vice President, TOT Biopharma, China

QUALITY AND SIMILARITY ASSESSMENT

4:00 pm

Biosimilar Clinical Materials: Changes and Comparability

Dr Qiwei Wu, Ph.D, Vice President of Process Development and Manufacturing, Livzon Mabpharma

4:35 pm

Fireside Chat: Analytical and Quality Assessment of Biosimilars :

Dr Amy Hong Que, Vice President - Quality, Innovent Biologics

5:10 pm

Biological Products Development to Meet International Quality Standards

Dr. Li Shi, Chief Executive Officer, Shanghai Zerun Biotech Co. Ltd, China

5:45 pm

Chairperson's Summary and End of Main Conference Day One followed by Networking Cocktail

9:00 am

Chairperson's Opening Remarks

GOING GLOBAL AND PARTNERSHIPS

9:10 am

Opening Address: Key Learnings from a Global Perspective How to Unlock the Full Potential of Biosimiliars - Learnings from EU on Access and Procurement :

Prof. Dr. Florian Turk, Head Global Payor Marketing, Sales and Relations, Sandoz Biopharmaceuticals Sandoz International GmbH, Germany

9:40 am

Case Study: Global Development Strategy on Biosimilars: How to Win in the International Space :

Pearl Fong, Associate Vice President, Division of Project Development, Mycenax Biotech Inc., Taiwan

10:10 am

Biopharma's Case Study: Perspective on Biosimilars Market Development, and China Market Potential and Partnerships :

Bryan Kim, Vice President of Business Development, Samsung Bioepis, Korea

10:40 am

Morning Networking & Refreshment Break

SAFETY AND EFFICACY

11:10 am

The Long and Winding Road: Operational Challenges for Biosimilar Clinical Trials

Dr. Xin Zhang, Vice President of Global Clinical Operations and Affairs, Shanghai Henlius Biotech, Inc., China

11:40 am

Pharmacovigilance of Biologics and Biosimilars: Manufacturing, Branding, Post Approval Surveillance for Immunogenicity and Evolving Guidelines :

Sunit Maity, Director, Product Development, Zumutor Biologics, India

12:10 pm

Networking Lunch

COMMERCIALISATION OF BIOSIMILARS

1:10 pm

  • Partnership and collaboration models
  • Potential markets for partnerships
  • What are the opportunities for outlicensing

1:50 pm

Establishing Product Development Partnerships

Mitul Agarwal, General Manager - Business Development & Licensing, Intas Pharmaceuticals, India

2:30 pm

Commercialization Practicality: CFDA's Requirement on Biosimilar's Clinical Trial Application

Eric Liu, China Biosimilars Regulation Publishing Manager, Pfizer, China

3:05 pm

Applying High Throughput Process Development Platform to Develop Downstream Process for Clinical Manufacturing

Jiang Junjun, Assistant Director, WuXi Biologics, China

3:40 pm

Afternoon Networking and Refreshment Break

BIOPHARMA DEVELOPMENT & PRODUCTION 2018 CLOSING PLENARY SESSIONS

4:20 pm

  • Enabling drivers of innovation in China
  • Consolidation of local players
  • Shifting investment from manufacturing focus to innovative portfolios
  • Adopting technologies that enable the potential in manufacturing, cell development and similarity
  • Attracting the right talent

5:00 pm

Chairperson's Summary of the Day and End of Conference

9:00 am

China's regulators, the pharmaceutical industry, and policy makers are working together to address both affordability and availability of these new medicines-especially mAbs. Monoclonal antibodies (MAbs) are capturing a significant share of the biosimilars market globally as several biologics come off patent in the next a few years. Developing complex biosimilar MAbs requires a huge investment including facilities, human resources and technology as well as clear regulatory pathways. How can benefit from this interactive workshop:

  • What are the trends and development in MAbs biosimilars?
  • New areas of commercial opportunity for MAbs
  • Understand complexity of Monoclonal Antibodies and clinical challenges for establishing biosimilarity
  • Commercialisation

1:00 pm

End of workshop

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。



第7回 Cell Line Development and Engineering 2018

8:00 am

Registration Opens and Morning Coffee

9:00 am

Chairperson's Opening Remarks

BIOPHARMA DEVELOPMENT AND PRODUCTION 2018 OPENING PLENARY SESSIONS 2018

9:10 am

  • Innovation in biopharma pipelines what developments can we expect?
  • Recent regulatory developments obstacle or opportunity?
  • How digitalization of the BioPharma industry is creating new value propositions
  • Biomanufacturing market snapshot in China
  • Biosimilars market potential what can we achieve?
  • New trends in cell line development

 

 

9:50 am

  • Investment outlook and market drivers for biopharma investments in Asia
  • Taking advantage of a variety of innovative R&D financing and partnership models
  • Assessing current investment climate and its implications on Chinese biotech market

10:20 am

Transforming BioPharma with Technology and Digitalisation

Wang Honglou, CIO, livzon Pharmaceutical Group, China

10:50 am

Morning Networking and Refreshment Break.

END OF OPENING PLENARY AND CELL LINE DEVELOPMENT & ENGINEERING ASIA COMMENCES

11:20 am

Chairperson's Opening Remarks

Sunny Zhou, Professor, Department of Chemistry and Chemical Biology Faculty Fellow, Barnett Institute of Chemical and Biological Analysis Northeastern University, Boston, Massachusetts

CLONE SELECTION STRATEGIES, ESTABLISHING CLONALITY AND STABILITY :

11:30 am

  • FDA concerns regarding single cell cloning procedures and assurance of monoclonality
  • Expectations for clonal cell lines
  • Identifying alternative methods and control strategies for establishment of clonality

12:00 pm

 

  • Novel technologies engineered to provide process control while at the same time enabling optimal leverage of the cell factory using ChemStress fingerprinting
  • Utility of CHO cell factories derives from exploitation of their acquired genetic/functional variation, which enable industry to identify cell lineages with desirable manufacturing properties
  • Analyzing cell clone stability profiles using the ChemStress Fingerprint and product-specific algorithms - shortening clone stability assessment timelines and reducing costs

 

12:30 pm

Networking Lunch

1:30 pm

  • Strategies for faster and more efficient selection of suitable clones
  • Ensuring cell-line monoclonality
  • Ensuring cell-line stability and clonal heterogeneity

ADVANCEMENTS IN CELL LINE DEVELOPMENT TECHNIQUES

2:00 pm

  • Overview of the current regulatory position on monoclonality
  • A new, verified, analytical approach to the estimation of the probability of monoclonality that greatly improves the quality of monoclonality reporting in regulatory submissions.
  • Case studies covering the positive impact on workflow and laboratory efficiency
  • Application to CAR-T and targeted gene editing methods such as ZFNs, TALENS and CRISPR/Cas9

2:30 pm

  • Cell line development as a process
  • How to monitor/control the process
  • Early predictors of final outcomes

3:00 pm

Afternoon Networking & Refreshment Break

3:30 pm

  • CFDA expectations for cell-line development process
  • Analytical requirements for proper characterization & optimization of host cell line
  • Determining performance characteristics of qualified cell lines

QBD, PAT AND EARLY INTERVENTION STRATEGIES QbD,PAT

4:00 pm

  • Changes in cell culture conditions affect more than just product yield & glycosylation steps
  • Working to reduce post-translational modifications, which could severely impact drug product quality
  • Happy cells for happy products: metabolite profiling as an indicator of cell line "happiness"

4:30 pm

  • N-Glycans play a critical role in the pharmacology of biotherapeutics
  • N-Glycan analysis has traditionally been a tedious and time-consuming process
  • Next-generation sample preparation and analytical methods shorten time to results from days to hours

5:00 pm

  • Development of a "design space" for integrating CQAs, risk assessment/management and control strategies
  • Identifying process parameters and interactions that adversely affect cell culture performance and product attributes early on, to prevent problems at late-stage cell culture
  • Ensuring consistency in delivery of a cell culture process for therapeutic mAbs

5:30 pm

  • Control of glycosylation patterns is essential for ensuring safety, efficacy and clearance of therapeutic product
  • More effective process optimization & purification for critical control
  • Improving analytical capabilities and glycoform analysis
  • Glycosylation issues and its relation to clinical trial PK

6:00 pm

Networking Cocktails

9:00 am

Chairperson's Opening Remarks

Sam Zhang, Senior Principal Scientist/Group Leader, Cell Line Development, Bioprocess R&D, Pfizer Inc, USA

EMERGING CELL CULTURE TECHNOLOGIES AND APPLICATIONS

9:10 am

  • Currently there are no systematic analyses of small molecule function or platform technologies that permit cell culture engineers to rationally harness their potential to control manufacturing performance in a cell line and/or product specific manner
  • Development of a medium to high-throughput platform that enables rapid quantitative assessment of small molecules additives as a tool to create bespoke media environments designed to engineer cell factory function for optimal manufacturing performance

9:40 am

  • Impact of host cell line on product glycosylation
  • Using CRISPR-Cas9 technology to knockout GLUL from HEK293 cells
  • Production of rhEPO using engineered HEK293

10:10 am

  • 3D cell culture systems as a new utility tool for cancer stem cell research
  • Revealing a more realistic drug response in 3D culture systems as opposed to conventional culture methods
  • Generating significantly realistic results earlier in epigenetic experiments for more effective translational research

10:40 am

Morning Networking & Refreshment Break

THERAPEUTIC MAB INNOVATION AND DISCOVERY

11:10 am

  • Importance of structuring appropriate antibody studies that are selective, specific & reproducible
  • Generating genetically humanized mouse models for preclinical antibody efficacy studies
  • Strategies for generating good evaluation data and pitfalls to avoid

11:40 am

  • Highlighting the potential to lead to a novel therapy principle for the treatment of diabesity, NASH
  • Dual activation of the GLP-1R and GCGR
  • A novel GLP-1/GCG chimeric peptide/Fc fusion protein - developed and exhibit potent body reduced effect, improvements in multiple metabolic parameters in DIO mouse

12:10 pm

Networking Lunch

NEXT GENERATION CELL LINE ENGINEERING AND EXPRESSION SYSTEMS

1:10 pm

  • Development of alternative expression systems especially for mAb variants without in vivo counterparts, new conjugated formats, or artificial molecules
  • Alternative expression systems offer biopharmaceutical manufacturers the chance to establish a stronger intellectual property position and improve their processes
  • Collaborating to advance novel expression technologies
  • Further advances and demonstration of utility

Moderator:
Sam Zhang, Senior Principal Scientist/Group Leader, Cell Line Development, Bioprocess R&D, Pfizer Inc, USA

 

1:50 pm

  • Novel NGS-integrated approach to identify transcriptionally active site(s) and beyond
  • Constructing landing pad for site specific integration via CRISPR/Cas9-mediated genome editing
  • Design and execute a pooled CRISPR/Cas9 screen using a knowledge-based focused library

2:20 pm

2:40 pm

  • Facilitating development of cell lines with predictable phenotypic performance, improved product quality attributes and productivity
  • Utilizing novel gene editing approaches in the engineering of cell lines
  • Rational design of cells to improve cell line development outcomes and generate cell-based therapies

3:10 pm

  • Exploring transient gene expression models as an alternative to development of stable cell lines for early-stage development work
  • Enabling superior transfection efficiency and cell viability following transient transfection
  • Rapid generation of high-yield stable cell lines within lowered timeframes

3:40 pm

Afternoon Networking & Refreshment Break

  • Enabling drivers of innovation in China
  • Consolidation of local players
  • Shifting investment from manufacturing focus to innovative portfolios
  • Adopting technologies that enable the potential in manufacturing, cell development and biosimilarity
  • Attracting the right talent

BIOPHARMA DEVELOPMENT & PRODUCTION 2018 CLOSING PLENARY SESSIONS

4:20 pm

Chairperson's Summary and End of Main Conference Day Two

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。


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講演者

Xu Wei

Vice President, Manufacturing, Innovent Biologics, China

Xiao Zhi Hua

Chief Executive Officer, OPM Biosciences

Abrar Mir

Managing Partner, Quadria Capital Investment Management Pte Ltd, Singapore

Wang Honglou

CIO, livzon Pharmaceutical Group, China

Jerry Clifford

Chief Operating Officer, Valitacell, Ireland

George Hutchinson

Head of Global Distribution, Solentim

Dr Zhang Peiqing

Analytical Science and Technology Coordinator, Novartis

Sunny Zhou

Professor, Department of Chemistry and Chemical Biology Faculty Fellow, Barnett Institute of Chemical and Biological Analysis Northeastern University, Boston, Massachusetts

Dr. John Yan

Applications Scientist, ProZyme

Fai Poon Hung

President, Quacell Biotech, China

Prof. David James

University of Sheffield

Ng Say Kong

Staff Scientist, Animal Cell Technology 2, Bioprocessing Technology Institute, A*STAR

Qingcong Lin

Vice-President, Shenogen Pharma Group, China

Shaoqing Yang

Vice President, Zhejiang Doer Biologics Co.

Jian Dong

VP & Site Head of Manufacturing, Wuxi AppTec, China

Dr. Jinyou Zhang

Senior Vice President/Head, Bio Development and Manufacturing, BeiGene Co. Ltd., China

David Sadler

President & CEO, Kunshan Zotek Kinglai Co. Ltd. U.K.

Wendy Chiang

Managing Director of Microbial Solutions, Greater China Region, Charles River Laboratories

Joycelyn Kwek

Former Director, Quality Assurance, Amgen Singapore

Hui Cai

Head of QC Laboratory 2 & Head of Microbial Control Team, WuXi Biologics, China

Dr. Dennis Yu Xia

Vice President of Manufacturing and Quality, Akeso Bio, China

Dr. John Zeng

Executive Vice President, Bioprocess Development & Pilot Plant Manufacturing, Shanghai Zerun Biotech Co Ltd, China

Grace Zheng

Head of Bioprocess, ZaiLab, Ltd.

Noel Rob

Business Development Manager, Pall Life Sciences, UK

Dr. Christopher J. Hickey

Senior Director, International Public Affairs, Asia-Pacific, Pfizer Inc.

Dr. Scott Liu

President and CEO, Shanghai Henlius Biotech Inc., China

Dr. Lutz Hilbrich

Head Strategic Task Force Biologics, Sanofi

Jiang Junjun

Assistant Director, WuXi Biologics, China

Wen Yong

Vice Director, Drug Research Institutes, Biopharmaceutical Institute, Jiangsu Aosaikang Pharmaceutical Co Ltd, China

Dr. Jacqueline Ming Liu

Vice President, TOT Biopharma, China

Dr Qiwei Wu

Ph.D, Vice President of Process Development and Manufacturing, Livzon Mabpharma

Dr Amy Hong Que

Vice President - Quality, Innovent Biologics

Ai-Min Hui

Chief Medical Officer, Shanghai Fosun Pharma

Prof. Dr. Florian Turk

Head Global Payor Marketing, Sales and Relations, Sandoz Biopharmaceuticals Sandoz International GmbH, Germany

Pearl Fong

Associate Vice President, Division of Project Development, Mycenax Biotech Inc., Taiwan

Bryan Kim

Vice President of Business Development, Samsung Bioepis, Korea

Dr. Xin Zhang

Vice President of Global Clinical Operations and Affairs, Shanghai Henlius Biotech, Inc., China

Sunit Maity

Director, Product Development, Zumutor Biologics, India

MinSeob Lee

Team Leader of R&D CMC/PM, Celltrion R&D, Korea

Mitul Agarwal

General Manager - Business Development & Licensing, Intas Pharmaceuticals, India

Dr. Alvin Luk

Senior Vice President and Chief Medical Officer, Shanghai Henlius Biotech, Inc., China

Dr Jun Yuan

Vice President, Quacell Biotech, China

Jerry Yang

SVP, Process & Product Development, Hangzhou JUST Biotherapeutics Co., Ltd., China

Dong Huifang

Director of Cell Line Development, WuXi Biologics, China

Eric Chang

Head of Cell Line Development, JHL Biotech, Taiwan

Sam Zhang

Senior Principal Scientist/Group Leader, Cell Line Development, Bioprocess R&D, Pfizer Inc, USA

Debby Chang

Associate Director - Cell Line Engineering and Development, Shanghai Hengrui Pharmaceutical, China

Sai Ling Liu

Chief Scientific Officer, Surfer Biotech, China

Wen Zaiqing

Vice President of CMC, Generon Corpoation (Shanghai) Limited, China

Dr. Li Shi

Chief Executive Officer, Shanghai Zerun Biotech Co. Ltd, China

Eric Liu

China Biosimilars Regulation Publishing Manager, Pfizer, China

Zheru Zhang

President, I-Mab Biopharma, China

Zack Zheng

Ph.D. VP of Process Development (Wuhan), JHL BioTech, China

Masayoshi Nagaya

Sr. Global Technology Manager, JSR Life Sciences

Dr. Frank Ye

SVP of Manufacturing and Quality, Hangzhou Just Biotherapeutics Co., Ltd., China

John Dubczak

Director of Operations, Charles River Laboratories, U.S.

Dr. Bin Wang

Head of Business Development, Boehringer Ingelheim Biopharmaceuticals, China

Yifang Wu

President, Wanbang Biopharmaceuticals Co., Ltd, China

Iris Desiree Sioson

Reliability Manager, APAC, Envirotainer, Singapore

Swee Nguan Lim

Director of Asia Pacific Sales, Finesse, part of Thermo Fisher Scientific, Singapore

Nicolas-Julian Hilbold

DSP Innovation Specialist, Merck KGaA (sponsored by Novasep)

Aurore Lahille

Head of EMEA E2E Process Development, Merck, France

Yun Kang

Vice President of Manufacturing, Generon Beijing, China

開催期間と開催地

2018年5月15-17日

Hilton Shanghai Hongqiao
No. 1116 Hong Song East Rd, Shanghai, 201103, China
Tel: +86-21-3323 6666