BDP China 2020 Bro€¦ · Yin Nan Po Director, Asia Supply Chain, Amgen, China NEW John Zhang Vice...
Transcript of BDP China 2020 Bro€¦ · Yin Nan Po Director, Asia Supply Chain, Amgen, China NEW John Zhang Vice...
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19–20 MAY 2020Hilton Shanghai Hongqiao, China
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CHINA & GLOBAL BIOPHARMA EXPERTSDr. Song RulinExecutive President, China Pharmaceutical Innovation and Research Development Association (PhIRDA), China
NEWMagnus BodinDirector Market Access, Biogen Biosimilars, Switzerland
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Lisa ZhengExecutive Director, Cell Line Development, Transcenta, China
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Yin Nan PoDirector, Asia Supply Chain, Amgen, China
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John ZhangVice President, Manufacturing Technology and Process Development, BeiGene, China
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Dr. Chris ChenChief Executive Officer, WuXi Biologics, China
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Li Jing RongSenior Vice President, Product Development and Manufacturing, CStone Pharmaceuticals, China
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Zhang Zhe RuPresident, Head of CMC and Manufacturing, I-MAB Biopharma, China
Dr. Zhu JianweiProfessor and Director of MOE Engineering Research Center of Cell Engineering and Antibody, Shanghai Jiaotong University; CEO and Chief Scientist, Jecho Biopharmaceuticals, China
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Dr. Kerstin OtteProfessor, Institute of Applied Biotechnology, Biberach University of Applied Sciences, Germany
NEWYi JizuSenior Vice President, CMC & Quality Operations, YZY Biopharma, China
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Liu XunPresident, Biomedicine Development and Business Division, Jiangsu Hengrui Medicine, China
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Dr. Orit Aharonovitz Senior Director, Cell Line & Process Development, Teva Pharmaceuticals, Israel
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Dr. Bruce HeExecutive Director, Research and Development, Shanghai Henlius Biotech, China
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Jerry SuChief Executive Officer, Zhejiang Huahai Biopharmaceuticals
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Xi ChenDirector, Cell Engineering, Qilu Pharmaceuticals, China
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Ma Yuan HuiExecutive Director, Preclinical Science, Shanghai HaiHe Pharmaceutical, China
NEWDr. Sanjeev HedgeAssociate Vice President, Global Clinical Operations, Mylan, India
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Dr. Allen HoSenior Director, Regulatory Technical CMC, JHL Biotech Inc, China
David ShaoPresident, Chief Executive Officer, Yisheng Biopharma, China
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Glenn HassanChief Finance Officer, Chief Business Officer, CANbridge Pharmaceuticals, China
NEWWu You LingChief Executive Officer, Zhejiang Teruisi Pharmaceuticals, China
Dennis TanManager, Quality Assurance, Tanvex Biopharma, Taiwan
Dr. Pan ZhiweiSenior Director, Process Development, Junshi Pharma, China
Frank YeSenior Vice President, Technical Operations, Transcenta, China
Rani JarkasChairman, Cedrus Investments, Hong Kong
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Liang TangVice President, CMC Management, WuXi Biologics, China
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Dr. Song ZhiweiPrincipal Scientist, Bioprocessing Technology Institute, Singapore
Eric ChangHead, Cell Line Development, JHL Biotech, China
Fu WeiChief Executive Officer, CBC Group, China
Bao CaiSenior Director, Manufacturing, Bio-Thera Solutions, China
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Dr. Karen LiuFounding Partner, 3E Bioventures Capital, China
NEWNEW
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CONFERENCE AGENDA
08.00 Conference Registration & Morning Coffee
PLENARY SESSIONS
09.00 Chairperson’s Opening Remarks
09.10 OPENING ADDRESS China’s Big Leap Towards BioPharma 2030 – Innovation, Industrialization, Internationalization Dr. Song Ru Lin, Executive President, China Pharmaceutical Innovation and Research Development Association (PhIRDA), China
09.30 KEYNOTE ADDRESS China’s Biological Facilities for the Future – WuXi’s Story on Technology and Innovation Dr. Chris Chen, Chief Executive Officer, WuXi Biologics, China
09.50 Manufacturers’ Panel:New Therapies, New Tech and New Investments• New frontiers in drug development • What is the gap in quality and investment?• Embracing new tech and start-ups to drive progress • New therapeutics manufacturing, commercialisation
and global access• Biomanufacturing 4.0 – Where are we at? • DAL’s GAMP and licencing laws – How is it affecting
our business and what we can expect? • The GQCE framework – quality consistency and
better pricing
Panelists: Jerry Su, Chief Executive Officer, Zhejiang Huahai Biopharmaceuticals Co., China Glenn Hassan, Chief Finance Officer, Chief Business Officer, CANbridge Pharmaceuticals, ChinaMore panellists to be confirmed
10.30 Morning Networking & Refreshment Break
9th Annual Cell Line Development & Engineering Asia Commences
11.00 Chairperson’s Opening Remarks Dr. Orit Aharonovitz, Senior Director, Cell Line & Process Development, Teva Pharmaceuticals, Israel
THE STATE-OF-PLAY FOR CLD
11.10 OPENING KEYNOTE Optimising Cell Line Development: Applications for Furthering Biopharma R&D Strategy Dr. Orit Aharonovitz, Senior Director, Cell Line & Process Development, Teva Pharmaceuticals, Israel
11.40 Enhancing Complex Protein Expression with Highly-Efficient Gene Integration TechnologySenior Representative from Lonza
12.10 Networking Lunch
NOVEL ADVANCES IN CLD TECHNIQUES & TECHNOLOGY
13.10 Novel Transposases in Accelerating Cell Line Development Dr. Claes Gustafsson, Chief Commercial Officer and Co-Founder, ATUM, U.S.
13.40 Efficient Cell Lines and Technology Applications Lisa Zheng, Executive Director, Cell Line Development, Transcenta, China
14.10 Developing a New CLD Process from Ground-Up Mark Stockdale, Amalgamator of Business and Biology, Solentim, U.K.
14.40 Whole-Genome Sequencing with Bioinformatics Tools for CHO Cell Lines Senior Representative from Selexis
15.10 Afternoon Networking Break & Tea
15.40 High-Throughput Cloning Screening and Performance for Next-Generation Innovative TherapeuticsTing Chen, Director, Alphamab Oncology, China
16.10 Precise Cell Processing and Workflow Automation in CLDSenior Representative from Berkeley Lights
16.40 Industry Panel: Utilising Platform Technologies for CLD
Panelists: Dr. Orit Aharonovitz, Senior Director, Cell Line & Process Development, Teva Pharmaceuticals, Israel
Xi Chen, Director, Cell Engineering, Qilu Pharmaceuticals, China Eric Chang, Head, Cell Line Development, JHL Biotech, China Lisa Zheng, Executive Director, Cell Line Development, Transcenta, China
17.20 End of Conference Day 1
DAY 1, TUESDAY 19 MAY 2020 JOINT PLENARY SESSIONS
09.00 Chairperson’s Opening Remarks
09.10 KEYNOTE ADDRESS China’s Biopharma Capital Markets – Future Funds and Innovative FinancingFu Wei, Chief Executive Officer, CBC Group, China
09.40 Venture Capitals’ Roundtable: Show Me the Drug• Investment landscape in the Chinese biopharma
market • Evaluating drug pipelines and development prospects • Mergers, expansion and JVs – Where do we see
transactions picking up? • Financing new plants, new therapeutics, product
launch and scaling-up operations – How do we review?
• Manufacturing 4.0 – How do VCs and banks play a part in modernising the value chain?
Panelists: Rani Jarkas, Chairman, Cedrus Investments, Hong Kong Judith Li, Partner, Lilly Asia Ventures, China Dr. Karen Liu, Founding Partner, 3E Bioventures Capital, China Lynn Yang, Managing Director, Sequoia Capital, China Dr. John Zhu, Partner, 6 Dimensions Capital, China
10.20 Morning Networking & Refreshment Break
9th Annual Cell Line Development & Engineering Asia Resumes
10.50 Chairperson’s Opening Remarks Dr. Song Zhiwei, Principal Scientist, Bioprocessing Technology Institute, Singapore
ENGINEERING HOST CELL LINES, GENOMICS & CRISPR IN FOCUS
11.00 Advances in Glycosylation and Expression Vectors for Recombinant Proteins Dr. Song Zhiwei, Principal Scientist, Bioprocessing Technology Institute, Singapore
11:10 Applications for Glycan Analysis Workflows and Bioanalytical ProteinsSenior Representative from ProZyme
11.40 CRISPR in Cell Line Development: Applications of CRISPR in Rapid Development of Stable Transgene CHO Cell Lines Dr. Zhu Jianwei, Professor and Director of MOE Engineering Research Center of Cell Engineering and Antibody, Shanghai Jiaotong University; CEO and Chief Scientist, Jecho Biopharmaceuticals, China
12:30 Networking Lunch
13.30 Next-Generation Cell Line Engineering for Biopharmaceutical Production Dr. Kerstin Otte, Professor, Institute of Applied Biotechnology, Biberach University of Applied Sciences, Germany
OPTIMISING WORKFLOWS AND BIOPROCESSES
14.00 Integrated Cell Line Development Strategy in Whole CMC Picture
Xi Chen, Director, Cell Engineering, Qilu Pharmaceuticals, China
14.30 Exploring the Synergies between Engineered Host Cells and Process DevelopmentEric Chang, Head, Cell Line Development, JHL Biotech, China
15.00 Panel Discussion: What’s Next in the Future of CLD&E
Panelists: Dr. Zhu Jianwei, Professor and Director of MOE Engineering Research Center of Cell Engineering and Antibody, Shanghai Jiaotong University; CEO and Chief Scientist, Jecho Biopharmaceuticals, China Dr. Kerstin Otte, Professor, Institute of Applied Biotechnology, Biberach University of Applied Sciences, Germany Dr. Song Zhiwei, Principal Scientist, Bioprocessing Technology Institute, Singapore
15.40 Afternoon Networking & Refreshment Break
16.10 Outsourcing and Insourcing of CLD: End-User Perspectives and Commercial ROISenior Representative from TOT Biopharma, China
16.40 A Fully-Integrated Platform Approach for Highly-Quality CLD Senior Representative from Shanghai Henlius Biotech, China
17.10 Accelerating CLD for Commercial Success Dr. Pan Zhiwei, Senior Director, Process Development, Junshi Pharma, China
17.40 End of Conference Day 2
DAY 2, WEDNESDAY 20 MAY 2020
*Please note that conference agenda and timing are subjected to change according to market development.
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CONFERENCE AGENDA
11.40 Impact of CNDA Reform on CMC Strategy at IND Stage Dr. Ma Yuan Hui, Executive Director, Preclinical Science, Shanghai HaiHe Pharmaceutical, China
12.10 Networking Lunch
BIOMANUFACTURING 2030 – CHINA’S GREAT LEAP
13.10 Trends in Pharma 4.0 Standards and China’s New Drug Delivery Strategy Dr. Liu Xun, President, Biomedicine Development and Business Division, Jiangsu Hengrui Medicine, China
13.40 Debottlenecking and Process Optimisation in China BioPharma Landscape Dr. Simon Hsu, Senior Vice President, Technical Operations, Henlius, China
14.10 China’s Cell and Gene Therapy Market: Manufacturing CAR-T Cell Therapy Products – Technology Acquisition in Bioprocess Development while Building Independent R&D Capability Dr. Richard Wang, Chief Executive Officer, Fosun Kite Biotechnology, China
14.40 PANEL DISCUSSION Cell and Gene Therapy Manufacturing – Regulation, Investment and Commercialisation
Panellists:Senior representative, LonzaMore panelists to be confirmed
15.10 Afternoon Networking & Refreshment Break
15.40 The New Age of Smart Continuous Manufacturing as Market Moves to Commercial Dr. Li Jing Rong, Senior Vice President, Product Development and Manufacturing, CStone Pharmaceuticals, China
16.40 Scaling Up the Commercial Production of mAb Therapeutics in China Dr. Wu You Ling, Chief Executive Officer, Zhejiang Teruisi Pharmaceuticals, China
17.10 WuXi “Factory of the Future” – A CMC Manufacturing Case Study Dr. Liang Tang, Vice President, CMC Management, WuXi Biologics, China
17.40 End of Conference Day 1
The BDP Party
DAY 1, TUESDAY 19 MAY 2020 DAY 2, WEDNESDAY 20 MAY 202008.00 Conference Registration & Morning Coffee
PLENARY SESSIONS
09.00 Chairperson’s Opening Remarks
09.10 OPENING ADDRESS China’s Big Leap towards BioPharma 2030 – Innovation, Industrialization, Internationalization Dr. Song Rulin, Executive President, China Pharmaceutical Innovation and Research Development Association (PhIRDA), China
09.30 KEYNOTE ADDRESS China’s Biologics Facilities for the Future – WuXi’s Story on Technology and Innovation Dr. Chris Chen, Chief Executive Officer, WuXi Biologics, China
09.50 Manufacturers’ Panel:New Therapies, New Tech and New Investment• New frontiers in drug development• What is the gap in quality and investment?• Embracing new tech and start-ups to drive progress• New therapeutics manufacturing, commercialization
and global access• Biomanufacturing 4.0 – Where are we at?• DAL’s GAMP and licensing laws – How is it affecting
our business and what can we expect?• The GQCE framework – Quality consistency and
better pricing
Panelists: Jerry Su, Chief Executive Officer, Zhejiang Huahai Biopharmaceuticals, China Glenn Hassan, Chief Finance Officer, Chief Business Officer, CANbridge Pharmaceuticals, China
10.30 Morning Networking & Refreshment Break
10th Annual Biomanufacturing commences
11.00 Chairperson’s Opening Remarks
GMP IMPLEMENTATION – THE MADE IN CHINA 2025 PLAN
11.10 Under Chinese New Drug Administration Law and New Vaccine Law – Oversight and Implementation on Commercial Bioprocess Development and Process Performance Qualification Dr. John Zeng, Executive Vice President, Product Development and Commercialization, Shanghai Zerun Biotechnology, China
12.30 Networking Lunch
INNOVATIVE BIOPROCESS DEVELOPMENT
13.30 Glycosylation of Monoclonal Antibody and the Manipulation Liu Dong Lian, Vice President, Manufacturing, TOT Biopharma, China
14.00 Process Intensification for mAb Purification – Upfront Removal of HCP & HCD and Use of Protein A Resin with High Selectivity Dr. Bjorn Hammarberg, Business Development Asia, Bio-Works, Sweden
14.30 China’s Biological Facilities for The Future – Growth, Innovation and Investments Larry Zhang, Chief Executive Officer, CASI Pharmaceuticals. China
15.00 Vaccine Manufacturing Innovation Dr. David Shao, President, Chief Executive Officer, Yisheng Biopharma, China
15.30 Afternoon Networking & Refreshment Break
QUALITY MANAGEMENT & EFFICACY STANDARDS
16.00 Integrated CMC Platforms to Develop Robust Downstream Process for Clinical Manufacturing Dr. Zhang Zhe Ru, President, Head of CMC and Manufacturing, I-MAB Biopharma, China
16.30 Ensure Uninterrupted Supply of Biological DrugsYin Nan Po, Director, Asia Supply Chain, Amgen, China
17.00 Biopharma Quality Assurance Best Practices and PAT Insights Dr. Yi Jizu, Senior Vice President, CMC and Quality Operations, YZY Biopharma, China
17.30 Biomanufacturing Process Validation and Quality Risk Management Bao Cai, Senior Director, Manufacturing, Bio-Thera Solutions, China
18.00 End of Conference Day 2
08.00 Morning Coffee
PLENARY SESSIONS
09.00 Chairperson’s Opening Remarks
09.10 Keynote Address: China’s Biopharma Capital Markets – Future Funds and Innovative FinancingFu Wei, Chief Executive Officer, CBC Group, China
09.40 Venture Capitals’ Roundtable: Show Me the Drug• Investment landscape in the Chinese biopharma
market• Evaluating drug pipelines and development prospects• Mergers, expansion and JVs – Where do we see
transactions picking up?• Financing new plants, new therapeutics, product
launch and scaling-up operations – How do we review?
• Manufacturing 4.0 – How do VCs and banks play a part in modernising the value chain?
Panelists: Rani Jarkas, Chairman, Cedrus Investments, Hong KongJudith Li, Partner, Lilly Asia Ventures, China Dr. Karen Liu, Founding Partner, 3E Bioventures Capital, ChinaLynn Yang, Managing Director, Sequoia Capital, ChinaDr. John Zhu, Partner, 6 Dimensions Capital, China
10.20 Morning Networking & Refreshment Break
10th Annual Biomanufacturing resumes
10.50 Chairperson’s Opening Remarks
FUTURE FACILITIES & SMART BIOMANUFACTURING
11.00 Manufacturing Technology Showcases – Improving Cost and Efficiency Frank Ye, Senior Vice President, Technical Operations, Transcenta, China
11.30 Manufacturing Technology – From Tech Transfer to Risk Analysis and Migration Strategy Dr. John Zhang, Vice President, Manufacturing Technology and Process Development, BeiGene, China
12.00 Tech Transfer Development for mAb Manufacturing Productivity Optimization Dr. Zack Zheng, Vice President, Process Development, JHL Biotech, China
*Please note that conference agenda and timing are subjected to change according to market development.
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CONFERENCE AGENDA
13:30 Case Study: Quality Control and Cost-effective Manufacturing of Biosimilars Nicholas Dukwon Kang, Global Quality Management Team Lead, GC Pharma, Korea
MARKET ACCESS, PATENT AND PRICING
13:45 Global and China Market Patent Expiry – Market Outlook, and Cost Savings Associated with Substituting For speaking opportunities, please contact [email protected]
14:15 Fireside Chat: Commercialisation of Biosimilars in China: Challenges and Opportunities
Dr. Wu You Ling, Chief Executive Officer, Zhejiang Teruisi Pharmaceuticals, China*
14:45 Afternoon Networking & Refreshment Break
15:15 Value-add Partnerships and Investments in the Chinese Biosimilars Market Senior Representative from select venture capital
15:45 Panel Discussion: Global and Regional Marketing Strategies- What worked and what didn’t • Product and brand differentiation between originators • How to overcome barriers to entry to the market• Go-to market strategies in the region • Working with local stakeholders for affordable
healthcare
16:30 End of Main Conference Day 1
13:40 China Biosimilars Manufacturers’ Panel: Moving Ahead with Product Innovation- Challenges and Opportunities • Ensuring quality differentiation between originators
and biosimilars • Considerations for innovation and meeting regional
and international regulatory requirements • Moving towards international product standards• Best practices and strategies to achieve high CMC
requirements
Panellists: Dr Jacqueline Liu, Vice President, TOT Biopharma, China Dr Sam Xie, Vice President, Research and Development, ZheJiang Teruisi Biopharmaceutical, China Dr Bruce He, Executive Director, Research and Development, Shanghai Henlius Biotech, China Bert Thomas, Senior Vice President, Business Development, Bio-Thera Solutions, Ltd, USA Magnus Bodin, Director Market Access, Biogen Biosimilars, Switzerland
14:20 Market Access and Commercialisation of Anti-TNF Biosimilars in Europe Magnus Bodin, Director Market Access, Biogen Biosimilars, Switzerland
CLINICAL TRIALS IN BIOSIMILARS
14:50 Pre-Clinical Considerations: Design Thinking for Quality Biosimilars Dr Sanjeev Hedge, Associate Vice President, Global Clinical Operations, Mylan, India
15:10 Afternoon Networking & Refreshment Break
15:40 Case Study: JHL’s Fast Track Strategy for CMC Approvals Dr. Allen Ho, Senior Director, Regulatory Technical CMC, JHL Biotech Inc, China
16:20 Managing Late-Stage Clinical Operations and Biosimilars Development
Dr Anup Choudhury, Associate Clinical Development Medical Director, Novartis, India
16:50 Panel Discussion: Maximising Successful Clinical Trials Operations and Lowering Costs • Managing drug development and pipelines • Balancing quality, cost and speed for biosimilars
developments • Utilising CMC data for speedier trials
Panellists: Dr Sanjeev Hedge, Associate Vice President, Global Clinical Operations, Mylan, India Dr. Allen Ho, Senior Director, Regulatory Technical CMC, JHL Biotech Inc, China Dr Anup Choudhury, Associate Clinical Development Medical Director, Novartis, India More panellists to be confirmed
17:30 Chairperson’s Summary and End of Main Conference Day 1
DAY 1, TUESDAY 19 MAY 2020 DAY 2, WEDNESDAY 20 MAY 202008.00 Main Conference Registration and Morning Coffee
PLENARY SESSIONS
09.00 Chairperson’s Opening Remarks
09.10 Opening Address: China’s Big Leap towards BioPharma 2030– Innovation, Industrialization, Internationalization Dr. Song Rulin, Executive President, China Pharmaceutical Innovation and Research Development Association (PhIRDA), China
09.30 KEYNOTE ADDRESS China’s Biologics Facilities for the Future – WuXi’s Story on Technology and Innovation Dr. Chris Chen, Chief Executive Officer, WuXi Biologics, China
09.50 Manufacturers’ Panel:New Therapies, New Tech and New Investment• New frontiers in drug development• What is the gap in quality and investment?• Embracing new tech and start-ups to drive progress• New therapeutics manufacturing, commercialization
and global access• Biomanufacturing 4.0 – Where are we at?• DAL’s GAMP and licensing laws – How is it affecting
our business and what can we expect?• The GQCE framework – Quality consistency and
better pricing
Panelists: Jerry Su, Chief Executive Officer, Zhejiang Huahai Biopharmaceuticals, China
Glenn Hassan, Chief Finance Officer, Chief Business Officer, CANbridge Pharmaceuticals, ChinaMore panelists to be confirmed
10.30 Morning Networking & Refreshment Break
11th Biosimilars Asia Commences
CHINA’S UPCOMING BIOSIMILARS
11:10 Chairperson’s Opening Remarks New Product Launches, International Standards and Global Market Access Dr Scott Liu, President and Chief Executive Officer, Shanghai Henlius Biotech, China
11:40 Touting the Manufacturing Strengths – TOT Biopharma’s Pipelines and Developments Dr Jacqueline Liu, Vice President, TOT Biopharma, China
12:10 Networking Lunch
13:10 Case Study of Bio-Thera’s pipelines and moving forward in the Chinese and Global Markets Bert Thomas, Senior Vice President, Business Development, Bio-Thera Solutions, Ltd, USA
PLENARY SESSIONS
09:00 Chairperson’s Opening Remarks
09.10 Keynote Address: China’s Biopharma Capital Markets – Future Funds and Innovative Financing
Fu Wei, Chief Executive Officer, CBC Group, China
09.40 Venture Capitals’ Roundtable: Show Me the Drug• Investment landscape in the Chinese biopharma
market • Evaluating drug pipelines and development prospects • Mergers, expansion and JVs – Where do we see
transactions picking up? • Financing new plants, new therapeutics, product
launch and scaling-up operations – How do we review?
• Manufacturing 4.0 – How do VCs and banks play a part in modernising the value chain?
Panelists: Rani Jarkas, Chairman, Cedrus Investments, Hong Kong Judith Li, Partner, Lilly Asia Ventures, China Dr. Karen Liu, Founding Partner, 3E Bioventures Capital, China Lynn Yang, Managing Director, Sequoia Capital, China Dr. John Zhu, Partner, 6 Dimensions Capital, China
10:20 Morning Networking and Refreshment Break
QUALITY, SAFETY AND EFFICACY
11:00 mAbs Case Study: Extractable & Leachable (E&L) Study for Single Use Manufacturing System (SUS) Michael H. Xie, Vice President, Analytics; Head, Bioassay and Analytical Development, Shanghai Henlius Biotech, USA
11:30 Proving Similarities for Biosimilars and Managing Product Variations For speaking opportunities, please contact [email protected]
12:00 Case Study: Maintaining High Quality, Safety and Efficacy of Biosimilars Dennis Tan, Manager, Quality Assurance, Tanvex Biopharma, Taiwan
12:30 Networking Lunch
*Please note that conference agenda and timing are subjected to change according to market development.
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With numerous shifts on the horizon, the Chinese biopharma industry approaches a tipping point as companies reevaluate current trends and strategies to achieve commercial excellence. The 6th Biopharma Development & Production Week 2020 will address the 2020 investment climate, technological advancements, industry case studies, and partnerships and expansion opportunities across key value chains.
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THE BDP PARTY Day 1 | Tuesday, 19 May 2020 Day 2 | Wednesday, 20 May 2020
BDP Week 2020 | Joint Opening Plenary Sessions
Opening Address: China’s Big Leap towards BioPharma 2030– Innovation, Industrialization, Internationalization
Keynote Address: China’s Biopharma Capital Markets – Future Funds and Innovative Financing
Keynote Address: China’s Biologics Facilities for the Future – WuXi’s Story on Technology and Innovation
Venture Capitals’ Roundtable: Show Me the Drug
Manufacturers’ Panel:New Therapies, New Tech and New Investments
• DAL’s New GAMP and Licensing Law – Implementation and oversight
• Biomanufacturing 4.0 – making it happen
• GAMP and Data Integrity requirements
• C> – regulation, investment and market opportunities
• BioTech Start ups collaboration hour
• The State-of-Play for CLD&E: Current Landscape & Key Developments
• Novel Advances in CLD Techniques & Technology
• Automation, Digitalization, and Integration of Big Data
• Engineering Host Cell Lines, Genomics & CRISPR in Focus
• Optimising Workflows and Bioprocesses
• China and International Developments and Investments in Biosimilars
• Innovation and Product Differentiation
• Market Access, Marketing and Commercialisation
• Clinical Trials Landscape
End of Conference
AGENDA AT-A-GLANCE
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