Zhihao (Peter) Qiu Branch Chief, Division of Inspectional Assessment Office of Process and Facilities, Office of Pharmaceutical Quality CDER, FDA, U.S. Andrew Huntley Senior Managing Director BDA Partners, UK Jerry Yang SVP, Process & Product Development, Hangzhou JUST Biotherapeutics Co., Ltd., China Dong Huifang Director of Cell Line Development WuXi Biologics, China Xu Wei Vice President Manufacturing Innovent Biologics, China Bryan Kim Vice President of Business Development Samsung Bioepis, Korea Dr. Dennis Yu Xia Vice President of Manufacturing and Quality Akeso Bio, China Jiang Junjun Assistant Director WuXi Biologics, China Minseob Lee Team Leader of R&D CMC/PM Celltrion R&D, Korea Yun Kang Vice President of Manufacturing Generon Beijing, China Yifang Wu President Wanbang Biopharmaceuticals Co., Ltd, China Jian Dong Vice President & Site Head of Manufacturing Wuxi AppTec, China Dr. Jinyou Zhang Senior Vice President/Head, Bio Development and Manufacturing BeiGene Co Ltd, China Sunny Zhou Professor, Department of Chemistry and Chemical Biology Northeastern University, USA Alvin Luk Senior Vice President and Chief Medical Officer – Global Clinical Operations and Affairs Shanghai Henlius Biotech Co Ltd, China Prof. Dr. Florian Turk Head Global Payor Marketing, Sales and Relations Sandoz Biopharmaceuticals Sandoz International GmbH, Germany Dr Xin Zhang Vice President of Global Clinical Operations and Affairs Shanghai Henlius Biotech, Inc., China Sam Zhang Senior Principal Scientist/Group Leader, Cell Line Development, Bioprocess R&D Pfizer Inc, USA Dr Qiwei Wu, Ph.D Vice President of Process Development and Manufacturing Livzon Mabpharma, China Ng Say Kong Staff Scientist, Animal Cell Technology 2, Bioprocessing Technology Institute A*STAR, Singapore Shaoqing Yang Vice President Zhejiang Doer Biologics Co., China Zack Zheng, Ph.D. VP of Process Development (Wuhan) JHL BioTech, China Prof. David James University of Sheffield, UK Dr Jun Yuan Vice President Quacell Biotech, China Dr. Jacqueline Ming Liu Vice President TOT Biopharma, China 15 - 17 May 2018 Hilton Shanghai Hongqiao Hotel, China ATTRACTIVE GROUP RATES AVAILABLE! SEE REGISTRATION PAGE FOR DETAILS! IBC LIFE SCIENCES UNRIVALLED LINE-UP OF BIOPHARMA LEADERS CHINA’S LEADING AND MUST ATTEND BIOPHARMA EVENT WITH QUALITY CONTENT & EXCELLENT PLATFORM TO NETWORK WITH LEADERS OF THE INDUSTRY 中国 生物制药研发和产品周 www.biopharmaproduction.com 3 CO-LOCATED CONFERENCES WITH INTERACTIVE SESSIONS 300+ SENIOR PHARMA ATTENDEES 60+ EXPERT SPEAKERS 60+ MARKET FACING SESSIONS 1 JOINT EXHIBITION & NETWORKING AREA BDP CHINA 2018 STRONG VALUE PROPOSITION
Transcript
Zhihao (Peter) Qiu Branch Chief, Division of
Inspectional Assessment Office of Process and Facilities, Office of
Pharmaceutical Quality CDER, FDA, U.S.
Andrew Huntley Senior Managing Director
BDA Partners, UK
Jerry Yang SVP, Process & Product
Development, Hangzhou JUST Biotherapeutics Co., Ltd., China
Dong Huifang Director of Cell Line Development
WuXi Biologics, China
Xu Wei Vice President Manufacturing
Innovent Biologics, China
Bryan Kim Vice President of Business
Development Samsung Bioepis, Korea
Dr. Dennis Yu Xia Vice President of Manufacturing
and Quality Akeso Bio, China
Jiang Junjun Assistant Director
WuXi Biologics, China
Minseob Lee Team Leader of R&D CMC/PM
Celltrion R&D, Korea
Yun Kang Vice President of Manufacturing
Generon Beijing, China
Yifang Wu President
Wanbang Biopharmaceuticals Co., Ltd, China
Jian Dong Vice President & Site Head of
Manufacturing Wuxi AppTec, China
Dr. Jinyou Zhang Senior Vice President/Head, Bio
Development and Manufacturing BeiGene Co Ltd, China
Sunny Zhou Professor, Department of
Chemistry and Chemical Biology Northeastern University, USA
Alvin Luk Senior Vice President and Chief Medical Officer – Global Clinical
Operations and Affairs Shanghai Henlius Biotech Co
Ltd, China
Prof. Dr. Florian Turk Head Global Payor Marketing,
Sales and Relations Sandoz Biopharmaceuticals Sandoz International GmbH,
Germany
Dr Xin Zhang Vice President of Global Clinical
Operations and Affairs Shanghai Henlius Biotech, Inc.,
China
Sam Zhang Senior Principal Scientist/Group Leader, Cell Line Development,
Bioprocess R&D Pfizer Inc, USA
Dr Qiwei Wu, Ph.D Vice President of Process
Development and Manufacturing Livzon Mabpharma, China
Ng Say Kong Staff Scientist, Animal Cell
Technology 2, Bioprocessing Technology Institute A*STAR, Singapore
Shaoqing Yang Vice President
Zhejiang Doer Biologics Co., China
Zack Zheng, Ph.D. VP of Process Development
(Wuhan) JHL BioTech, China
Prof. David James University of Sheffield, UK
Dr Jun Yuan Vice President
Quacell Biotech, China
Dr. Jacqueline Ming Liu Vice President
TOT Biopharma, China
15 - 17 May 2018 Hilton Shanghai Hongqiao Hotel, China
ATTRACTIVE GROUP
RATES AVAILABLE!
SEE REGISTRATION PAGE FOR DETAILS!
IBCLIFE SCIENCES
UNRIVALLED LINE-UP OF BIOPHARMA LEADERS
CHINA’S LEADING AND MUST ATTEND BIOPHARMA EVENT WITH QUALITY CONTENT & EXCELLENT PLATFORM TO NETWORK WITH LEADERS OF THE INDUSTRY
中国 生物制药研发和产品周
www.biopharmaproduction.com
3
CO-LOCATED CONFERENCES
WITH INTERACTIVE SESSIONS
300+
SENIOR PHARMA ATTENDEES
60+
EXPERT SPEAKERS
60+
MARKET FACING SESSIONS
1
JOINT EXHIBITION & NETWORKING AREA
BDP CHINA 2018 STRONG VALUE PROPOSITION
10:50 Morning Networking & Refreshment Break
BIOPHARMA DEVELOPMENT AND PRODUCTION 2018 OPENING PLENARY SESSIONS08:00 Main Conference Registration and Morning Coffee
08:50 Welcome Address from IBC Asia
09:00 Chairperson’s Opening RemarksDr. Ming Wang, President and Chief Executive Officer, Phanes Biopharmaceuticals, China
09:10 Global and Local Biopharma Market Trends and Implications • 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 developmentModerator:Dr. Ming Wang, President and Chief Executive Officer, Phanes Biopharmaceuticals, China
Panellists: Jerry Yang, SVP, Process & Product Development, Hangzhou JUST Biotherapeutics Co., Ltd., ChinaXu Wei, Vice President, Manufacturing, Innovent Biologics, ChinaXiao Zhi Hua, Chief Executive Officer, OPM Biosciences, China Jun Liu, Vice President, TOT Biopharma, China Yanshan Huang, Chief Executive Officer, DOER Biologics, China
10:10 Global M&A Trends and Deal Flow in the Outsourced Pharma Manufacturing Services SectorAndrew Huntley, Senior Managing Director, BDA Partners, UK
MAIN CONFERENCE DAY ONE - WEDNESDAY, 16 MAY 2018
15:00 Afternoon Networking & Refreshment Break
12:30 Networking Lunch
17:55 Chairperson’s Summary and End of Main Conference Day One followed by Networking Cocktail
11:25 Overview of Biotech Product Manufacturing-A Regulatory PerspectiveZhihao(Peter) Qiu, Branch Chief, Division of Inspectional Assessment, Office of Process and Facilities, Office of Pharmaceutical Quality, CDER, FDA, U.S.
11:55 Industry Panel: Striving to Achieve Nationwide Implementation of the MAH Regime- What Can we Expect?Moderator: Xu Wei, Vice President, Manufacturing, Innovent Biologics, China Jerry Yang, SVP, Process & Product Development, Hangzhou JUST Biotherapeutics Co., Ltd. ChinaZhihao(Peter) Qiu, Branch Chief, Division of Inspectional Assessment, Office of Process and Facilities, Office of Pharmaceutical Quality, CDER, FDA, U.S.Zack Zheng, Ph.D. VP of Process Development (Wuhan), JHL BioTech, China
11:10 Chairperson’s Opening RemarksDr. Ming Wang, President and Chief Executive Officer, Phanes Biopharmaceuticals, China
CHINA’S BIOSIMILARS MARKET
11:10 Nutritional Levers for BiosimilarityDr. Ryan Karcher, Senior R&D Scientist & Team Lead, Merck, U.S
11:40 The Importance of Media and Supplements in Two Biosimilar CHO Cell LinesHenry Zhang, APAC Technical Application Representative, Kerry Inc., China
12:10 China Market Insight: Market Outlook and Update on Biosmilars Pipelines Dr. Scott Liu, President and CEO, Shanghai Henlius Biotech Inc., China
11:20 Chairperson’s Opening RemarksSunny Zhou, Professor, Department of Chemistry and Chemical Biology, Northeastern University, USA
CLONE SELECTION STRATEGIES, ESTABLISHING CLONALITY AND STABILITY
11:30 Generation of Unique Clone Fingerprints for Control and Enhancement of CHO Cell FactoriesJerry Clifford, Chief Operating Officer, Valitacell, Ireland
12:00 Using Nanoscale Bioreactors To Select Top CHO Clones and Predict Stability in 5 DaysKeith Breinlinger, Chief Technology Officer, Berkeley Lights Inc.
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UTILITY EFFICIENCY AND OPTIMIZATION
13:30 A Case Study on Setting Up Merck’s E2E Biodevelopment Center in ShanghaiAurore Lahille, Head of EMEA E2E Process Development, Merck, France
14:00 Optimising Continuous Process with Smart Technologies Swee Nguan Lim, Director of Asia Pacific Sales, Finesse, part of Thermo Fisher Scientific, Singapore
14:30 Case Study: Building a World-Class Highly Flexible Continuous Manufacturing Facility and Quality System in ChinaDr. Frank Ye, SVP of Manufacturing and Quality, Hangzhou Just Biotherapeutics Co., Ltd., China
ADVANCEMENTS IN CELL LINE DEVELOPMENT TECHNIQUES
13:40 Applications of a New All-in-One Seeding and Imaging System in the Rapid Establishment of Monoclonal Cell LinesGeorge Hutchinson, Head of Global Distribution, Solentim, UK
14:20 Highly Productive Cell Line Development PlatformEric Chang, Head of Cell Line Development, JHL Biotech, Taiwan
13:30 China Market Insight: Market Growth and Opportunities in Therapeutic Biosimilars Xiao Zhi Hua, Chief Executive Officer, OPM Biosciences, China
14:00 Managing Costs and Technology Adoption in Biosimilar DevelopmentDr. Manfred Weiler, Senior Vice President, Medical & Scientific Strategy, Syneos Health, UK
14:30 Biosimilars Development in China: Challenges in Bevacizumab Clinical Trial Design Dr. Jacqueline Ming Liu, Vice President, TOT Biopharma, China
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15:30 Case study: Scale-up of Continuous Capture ChromatographyJohnson David M, Senior Global Product Manager, Continuous Purification, Pall Life Sciences, U.K.
16:00 Innovation in Chromatograpy Platform: Lattice Supported Modular Chromatography using Conventional Resin Enabling Flexible Operations, Linear Scalability & Hyper-Productive ProcessesMasayoshi Nagaya, Sr. Global Technology Manager, JSR Life Sciences, US
16:30 Current Challenges of Biologics
Manufacturing in ChinaXu Wei, Vice President, Manufacturing, Innovent Biologics, China
17:00 Efficacy of Insulation Systems in
Aseptic areas and facilities: A Practical Guide to Facility Cost ReductionDavid Sadler, President & CEO, Kunshan Zotek Kinglai Co. Ltd. U.K.
17:30 From Process Development to cGMP Manufacturing - Process Control StrategyZack Zheng, Ph.D. VP of Process Development (Wuhan), JHL BioTech, China
15:30 One Step Approach of Scale-Up in Process Development Dr Jun Liu, Vice President, TOT Biopharma, China
QBD, PAT AND EARLY INTERVENTION STRATEGIES
16:00 Improving Late-Stage Product Quality Through Early Cell Culture InterventionSunny Zhou, Professor, Department of Chemistry and Chemical Biology, Northeastern University, USA
16:30 Glycans Before Lunch: Rapid N-Glycan Sample Preparation Workflows for Liquid Chromatography and Capillary Electrophoresis PlatformsDr. John Yan, Applications Scientist, ProZyme, USA
17:00 A Quality by Design (QbD) Approach for Early Stage Cell-Culture Process Development Hung Fai Poon, President, Quacell Biotech, China
17:30 Glycosylation Analysis and Control for Improved Product Quality Julie Wei, Director, JUST Biotherapeutics, China
QUALITY AND SIMILARITY ASSESSMENT
15:30 Biosimilar Clinical Materials: Changes and ComparabilityDr Qiwei Wu, Ph.D, Vice President of Process Development and Manufacturing, Livzon Mabpharma, China
16:10 Fireside Chat: Analytical and Quality Assessment of Biosimilars Interviewer:Dr. Ming Wang, President and Chief Executive Officer, Phanes Biopharmaceuticals, ChinaInterviewee: Dr Amy Hong Que, Vice President – Quality, Innovent Biologics, China
16:40 End of Day Round-up Q&A session
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MAIN CONFERENCE DAY TWO - THURSDAY, 17 MAY 2018
Session outline may change to accomodate market-specific or company development.
10:40 Morning Networking & Refreshment Break
12:10 Networking Lunch
15:40 Afternoon Networking and Refreshment Break
BIOPHARMA DEVELOPMENT AND PRODUCTION 2018 CLOSING PLENARY SESSIONS
16:20 BDP China 2018 Round Up Panel: A vision for China’s Biopharma Industry in the Next Decade • 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
Moderator: Yun Kang, Vice President of Manufacturing, Generon Beijing, ChinaPanellists: Zheru Zhang, President, I-Mab Biopharma, China Dr. Alvin Luk, Senior Vice President and Chief Medical Officer, Shanghai Henlius Biotech, Inc., ChinaShaoqing Yang, Vice President, Zhejiang Doer Biologics Co., China
17:00 Chairperson’s Summary of the Day and End of Conference
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13:10 The Practice and Challenge of MAH Pilot Program under Current CFDA RegulationDr. Jiali Luo, General Manager, Boehringer Ingelheim Biopharmaceuticals, China
FACILITIES AS COMPETITIVE ADVANTAGE
13:50 Case Study: Building a WHO PQ Compliant New Facility Dr. John Zeng, Executive Vice President, Bioprocess Development & Pilot Plant Manufacturing Shanghai Zerun Biotech Co Ltd, China
14:30 GMP Biomanufacturing Facility Design and Operation – Cultural Clash Between East and WestDr. Jinyou Zhang, Senior Vice President/Head, Bio Development and Manufacturing, BeiGene Co. Ltd., China
15:10 Microbial Control During Biologics Manufacturing Hui Cai, Head of QC Laboratory 2 & Head of Microbial Control Team, WuXi Biologics, China
13:10 Panel Discussion: Next Generation Non-CHO Expression Systems for Novel Biotherapeutic ApplicationsModerator:Sam Zhang, Senior Principal Scientist/Group Leader, Cell Line Development, Bioprocess R&D, Pfizer Inc, USA Panellists:Dong Huifang, Director of Cell Line Development, WuXi Biologics, China Dr Jun Yuan, R&D Director, Quacell Biotech, ChinaSai Ling Liu, Product Development Expert, Surfer Biotech, China
14:00 Aiming for High Productivity and Stability in the Era of CHO GenomeSam Zhang, Senior Principal Scientist/Group Leader, Cell Line Development, Bioprocess R&D, Pfizer Inc, USA
14:40 Challenges & Opportunities of Biotherapeutic GlcosylationZhou Hui, Chief Executive Officer, Glycogene Biotherapeutics, China
15:10 Rapid Protein Production in CHO Cells: From Transfection to 100 g in 6 WeeksDong Huifang, Director of Cell Line Development, WuXi Biologics, China
COMMERCIALISATION OF BIOSIMILARS
13:10 Biopharma’s Case Study: Remsima® Success Story and Strategy to Overcome Hurdles, Move into MainstreamMinSeob Lee, Team Leader of R&D CMC/PM, Celltrion R&D, Korea
14:00 Commercialization Practicality: CFDA’s Requirement on ‘Biosimilar Application and RA Operation Support ModelEric Liu, China Biosimilars Regulation Publishing Manager, Pfizer, China
14:50 Applying High Throughput Process Development Platform to Develop Downstream Process for Clinical ManufacturingJiang Junjun, Assistant Director, WuXi Biologics, China
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09:00 Chairperson’s Opening RemarksDr. Alvin Luk, Senior Vice President and Chief Medical Officer, Shanghai Henlius Biotech, Inc., China
GOING GLOBAL AND PARTNERSHIPS
09:10 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
09:40 Case Study: Global Development Strategy on Biosimilars: How to Win in the International SpacePearl Fong, Associate Vice President, Division of Project Development, Mycenax Biotech Inc.,Taiwan
10:10 Biopharma’s Case Study: Perspective on Biosimilars Market Development, and China Market Potential and PartnershipsBryan Kim, Vice President of Business Development, Samsung Bioepis, Korea
09:00 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 Liquid Engineering: CHO Cell Culture Performance Enhancement Using Small MoleculesProf. David James, University of Sheffield, UK
9:40 Engineering a Fully Human HEK293 System for the High Titer Production of Recombinant Glycoprotein Ng Say Kong, Staff Scientist, Animal Cell Technology 2, Bioprocessing Technology Institute, A*STAR, Singapore
10:10 Progressing Tech-Transfer and Cell Culture Scale-Up for BiotherapeuticsZhiwei Pan, Senior Director of Process Development, Livzon Mabpharm, China
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09:00 Chairperson’s Opening RemarksYun Kang, Vice President of Manufacturing, Generon Beijing, China
INNOVATIONS IN MANUFACTURING SCIENCE AND TECHNOLOGY
09:00 Expediting the Process from CMC Development to Multi-Region Clinical Trials Yun Kang, Vice President of Manufacturing, Generon Beijing, China
09:20 Rapid Microbiological Methods: Current Endotoxin/Sterility/Bacterial ID Applications in Bio Pharmaceutical OperationsJohn Dubczak, Director of Operations, Charles River Laboratories, U.S.
09:50 Multi-column, Parallelized Unit Operations Using a Single-Skid for Intensified DSP at Pilot ScaleNicolas-Julian Hilbold, DSP Innovation Specialist, Merck KGaA (sponsored by Novasep)
10:20 New Challenge by Samsung BioLogics in Biopharmaceutical Development and ManufacturingEun Young Yang, Executive Director, Head of CDO Business Development Team, Samsung BioLogics, Korea
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COLD CHAIN MANAGEMENT
11.10 Designing and Developing a Quality Driven Process to Mitigate Risk in Delivering Temperature Sensitive Biopharmaceuticals to MarketIris Desiree Sioson, Reliability Manager, APAC, Envirotainer, Singapore
QUALITY COMPLIANCE AND SYSTEM
11:40 Strategic Practice in Building Quality Management Systems (QMS) in China Facilities Dr. Dennis Yu Xia, Vice President of Manufacturing and Quality, Akeso Bio, China
SAFETY AND EFFICACY
11:10 A Biopharma Solution for Automated Glycan CharacterizationDr. Sven Bahrke, Senior Director Cooperations, Glycotope GmBH, Germany
11:40 The Long and Winding Road: Operational Challenges for Biosimilar Clinical TrialsDr Xin Zhang, Vice President of Global Clinical Operations and Affairs, Shanghai Henlius Biotech, Inc., China
THERAPEUTIC MAB INNOVATION AND DISCOVERY
11.10 Design Novel Polyagonist Drugs forObesity & Type II DiabetesShaoqing Yang, Vice President, Zhejiang DoerBiologics Co., China
NEXT GENERATION CELL LINE ENGINEERING AND EXPRESSION SYSTEMS
11.40 Fireside Chat: Manufacturing Stable Expression Platforms by Gene Engineering TechnologyInterviewer:Sam Zhang, Senior Principal Scientist/Group Leader, Cell Line Development, Bioprocess R&D, Inc, USA Interviewee:Wang Tong Ying, Chief Technical Officer, Hangzhou Jiuyuan Gene Engineering, China
Johnson David M., Senior Global Product Manager, Continuous
Purification
Peter Shen, VP, Process Development & Clinical Manufacturing, WuXi
Biologics, Inc
Meng Yang, Senior Technical Manager,
Biotech BU, Pall China
Tao Shi, Senior SLS Manager, Biotech BU,
Pall China
9.00AM - 1.00PM
1. INTEGRATED PROCESS DEVELOPMENT AND PROTEIN ANALYTICS TO IMPROVE BIOSIMILARITY
Yunfen He, Senior Director, OPM Biosciences
2. QUALITY CONTROL & CHARACTERIZATION IN ANTIBODY DRUGS DEVELOPMENT
Zhigui Zhou, Director, OPM Biosciences
3. KEY CONSIDERATIONS IN PK OF BIOSIMILAR DEVELOPMENT
Lihou Dong, Senior Director, United-Power Pharma
EXPLORE MAH REGIME FOR BOTH PHARMA AND CMOS IN CHINA
DISCOVER APPLICATION OF NEW DISRUPTIVE TECHNOLOGIES AND
IMPROVEMENT ON PROCESS DEVELOPMENT
GLOBAL TRENDS IN FACILITIES OF THE FUTURE
SINGLE USE SYSTEMS
NEW CASE STUDIES ON ACHIEVING OPERATIONAL, QUALITY AND COST
EFFECTIVENESS
COMPLIANCE IMPROVEMENTS AND HOW TO GET CLOSER TO FDA
EXPECTATIONS
CLONE SELECTION STRATEGIES, ESTABLISHING CLONALITY AND
STABILITY
ADVANCEMENTS IN CELL LINE DEVELOPMENT TECHNIQUES
QBD, PAT AND EARLY INTERVENTION STRATEGIES
EMERGING CELL CULTURE TECHNOLOGIES AND APPLICATIONS
THERAPEUTIC MAB INNOVATION AND DISCOVERY
NEXT GENERATION CELL LINE ENGINEERING AND EXPRESSION
SYSTEMS
OVERVIEW OF THE GLOBAL BIOSIMILARS MARKET AND OUTLOOK
EXPLORE GLOBAL MARKET POTENTIAL AND PARTNERSHIPS
STRATEGY
PROCESS, RESTRICTIONS AND GUIDELINES TO GAIN REGULATORY
APPROVAL
ASSESS QUALITY AND SIMILARITY OF BIOSIMILARS
SAFETY, EFFICACY AND RISK CONSIDERATION
COMMERCIALIZATION OF BIOSIMILARS – CHALLENGES AND
OPPORTUNITIES
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Senior Medical Manager, Shanghai Hengrui Pharmaceutical Co., Ltd
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The Biopharma Development & Production Week hosts China’s key biopharma leaders and international experts, prides itself as a leading industry platform for its practical contents, quality of sessions, excellent networking platform and THE gathering place for pharma, biotech, CMOs, CROs, research institutes, investors, technology and industry stakeholders.
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