5 co-located conferences · 2019-04-24 · 8th annual cell line development & engineering asia...

14 - 16 May 2019 Shanghai Marriott Hotel Parkview China

5 CO-LOCATED CONFERENCES

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CELL& GENETHERAPY

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9th ANNUAL BIO MANUFACTURING CONFERENCE AGENDA

08:00 Main Conference Registration and Morning Co�ee

09:00 Chairperson’s Opening Remarks

Opening Keynote Sessions

09:05 Outlook for China’s BDP Market – Investments, Regulations, Innovation and Vision of Chinese Manufacturers Senior Representative from Fosun Pharma*

09:30 PANEL DISCUSSION: China’s Biopharma Leaders’ Roundtable: Growth through innovation, quality and new business modelsPanellists:Richard Wang, Chief Executive O�cer, Fosun Kite Biotech, ChinaHe Ting, Chief Executive O�cer, ImmunoChina, ChinaDong Wei, Chief Executive O�cer, Edigene, ChinaZonghai Li, President and Chief Executive O�cer, CARsgen Therapeutics, ChinaPeter Luo, Chief Executive O�cer, Adagene Pharma, ChinaRuirong Yuan, President, Chief Medical O�cer and Board Director, Adlai Nortye Biopharma, ChinaEddy Wu, China Head/Vice-President, Terns Pharmaceutical, ChinaJonathan Zhao, Chief Executive O�cer, Hangzhou JUST Biotherapeutics, ChinaZhou Mingdong, Chief Executive O�cer and Chief Scientist, Zensun, China Zhengyu Yuan, President & Chief Executive O�cer, MicuRx Pharmaceuticals Inc., China

10:30 Morning Networking and Refreshment Break

11:20 Chairperson’s Opening RemarksDr Junli Zhang, Senior Vice President of Global Manufacturing and Technical Operation, Shanghai Henlius Biotech, Inc.

Smart Biomanufacturing and Digitalisation

11:30 Smart Bioprocessing and Manufacturing Use Case in China Jian Dong, Senior Vice President Global Biomanufacturing and & Wuxi Site Head of Manufacturing, Wuxi Biologics, China

12:00 Promoting Scalability by Bioprocessing in a Flexible, Open, and Agile Automation PlatformJason Lukasek, Senior Director, BEA, BPD Commercial, Thermo Fisher Scientific

12:30 Networking Lunch

13:30 PANEL DISCUSSION: Manufacturing and Technology – An Industry Follow Up on Digitalisation and Future Facilities in ChinaModerator: Dr Junli Zhang, Senior Vice President of Global Manufacturing and Technical Operation, Shanghai Henlius Biotech, Inc.Panelists: Dr. Xiangyang Zhu, Chief Executive O�cer, Huabo Biopharma, ChinaRacho Jordanov, Co-founder, Co-Chairman, President and Chief Executive O�cer, JHL Biotech, China Jian Dong, Senior Vice President Global Biomanufacturing and & Wuxi Site Head of Manufacturing, Wuxi Biologics, China Jerry Yang, Senior Vice President, Process & Product Development, Hangzhou JUST Biotherapeutics Co., Ltd. ChinaMore panellists to be confirmed

World-Class Facilities

14:10 E�ect of Fully Continuous Process for Mab Manufacturing: Speed to Market and Cost Reduction (TBC)Senior representative, Pall

14:40 Benchmarking regulatory, compliance and tech needs for future facilitiesDr Junli Zhang, Senior Vice President of Global Manufacturing and Technical Operation, Shanghai Henlius Biotech, Inc.

15:10 Afternoon Networking & Refreshment Break

15:40 Session reserved for GE

CMO Pricing Outsourcing ans Pricing Strategy

16:10 Outsourcing Strategy for Early Stage CMC DevelopmentDr Qinghai Zhao, Vice President, Technical Development and Manufacturing, Forty-Seven Inc. USA

16:40 PANEL DISCUSSION: CMO Pricing Trends and Market ComparisonPanellists: Dr Qinghai Zhao, Vice President, Technical Development and Manufacturing, Forty-Seven Inc. USAWenzhi Tian, MD, Chairman & CEO, ImmuneOnco Biopharma Co., Ltd, ChinaMichelle Peake, Senior General Manager, PT Kalbio Global Medika, Indonesia

17:30 Chairperson’s Summary and End of Main Conference Day One


Quality in Spotlight

09:10 Meeting the requirements of CMC Quality Systems and StandardsDr Jerry Dong, Vice President of CMC and Regulatory A�airs, Shanghai Henlius Biotech, Inc.

09:40 Internationalisation of Local Manufactured Drugs through Quality and Manufacturing Excellence Michelle Peake, Senior General Manager, PT Kalbio Global Medika, Indonesia


11:00 Large Scale Manufacturing and Quality by Design Dr Youling Wu, Chairman and CEO, Zhejiang Teruisi Pharmaceutical, China

Single-Use, Tech Transfer and AI

11:30 Built-in Product Lifecycle Management Rhona McIntyre, Associate Director Commercial Development, Lonza Pharma & Biotech

12:00 Global Single-Use Concept and Facilities Design – The Journey to Build the World’s Largest Single-Use Modular Facility in ChinaRacho Jordanov, Co-founder, Co-Chairman, President and Chief Executive O�cer, JHL Biotech, China


13:30 Trends in Upgrading Manufacturing Facilities in China Shou Bai Chao, Senior Vice President, Bio Venture AstraZeneca China

14:00 Advances in Establishing World-Class Bioprocess and Biomanufacturing Capabilities in ChinaJerry Yang, Senior Vice President, Process & Product Development, Hangzhou JUST Biotherapeutics Co., Ltd. China

Cell Line and Gene Therapy Manufacturing

14:30 Optimising Cell Line Development for Better-Yield ManufacturingJohn K. Kawooya, Director, Biologics Optimization, Amgen, Inc

15:00 Case Studies in Cell and Gene Therapy ProductionDr. Lin Yang, Chief Executive O�cer, PersonGen Biomedicine, China


Closing Plenary Panel

16:00 China’s Biopharma Leaders’ Panel Roundup: The Next Fontier for BDP ChinaPanellists:Alvin Luk, Senior Vice President of Global Clinical R&D and Chief Medical O�cer, Shanghai Henlius Biotech, Inc., ChinaChen-Yuan Lin, Ward Director and Attending Physician at the Division of Hematology and Oncology, China Medical University Hospital, TaiwanDr Lin Shiwen, Vice President of Downstream Process Development, WuXi Biologics, ChinaDr. Senyon Choe (Teddy), Professor Biology, University of California San Diego (UCSD), USA, President/Director of joint Center for Biosciences, Korea Jerry Yang, SVP, Process & Product Development, Hangzhou JUST Biotherapeutics Co., Ltd. China

17:00 Chairperson’s Summary and End of the Conference

DAY 1 - WEDNESDAY 15 MAY DAY 2 - THURSDAY 16 MAY


8th ANNUAL CELL LINE DEVELOPMENT & ENGINEERING ASIA CONFERENCE AGENDA

8.00 Registration Starts & Morning Co�ee

9.00 Chairperson’s Opening Remarks



9.30 PANEL DISCUSSION: China’s Biopharma Leaders’ Roundtable: Growth through Innovation, Quality and New Business ModelsPanelists: Richard Wang, Chief Executive O�cer, Fosun Kite Biotech, ChinaHe Ting, Chief Executive O�cer, ImmunoChina, ChinaDong Wei, Chief Executive O�cer, Edigene, ChinaZonghai Li, President and Chief Executive O�cer, CARsgen Therapeutics, ChinaPeter Luo, Chief Executive O�cer, Adagene Pharma, ChinaRuirong Yuan, President, Chief Medical O�cer and Board Director, Adlai Nortye Biopharma, ChinaEddy Wu, China Head/Vice-President, Terns Pharmaceutical, ChinaJonathan Zhao, Chief Executive O�cer, Hangzhou JUST Biotherapeutics, ChinaZhou Mingdong, Chief Executive O�cer and Chief Scientist, Zensun, China Zhengyu Yuan, President & Chief Executive O�cer, MicuRx Pharmaceuticals Inc., China

10.30 Morning Networking & Refreshment Break


Assurance and Proof of Monoclonality

11.30 Case Study and Application of Plate Imaging Systems for ClonalityGeorge Hutchinson, Head, Global Distribution, Solentim, U.K.

12.00 Accelerating Cell Line Development using Transposase-Mediated Integration and Verified In-Situ Plate SeedingThomas Kelly, Scientist, Cell & Developability Sciences, Pharmaceutical Development & Manufacturing Sciences (PDMS), Janssen R&D, U.S.

12.30 Networking Lunch

New Technologies and Host Cell Lines

13.30 N-Glycan Sample Preparation and Analysis Workflows for Screening and Characterization of BiotherapeuticsJohn Yan, Applications Scientist, Prozyme, U.S.

14.00 Spotlight Presentation in Characterisation, Small-Scale Analysis, Stable Cell Lines, Quality, TitreJames (Jianguo) Yang, Chief Executive O�cer, Tayu Huaxia Biotech Medical Group, China

14.30 Novel Analytical Solutions for Cell Line DevelopmentDr. Carolanne Doherty, Marketing & Sales Manager, Valitacell, Ireland

15.00 Spotlight Technology PresentationDr. Ben Borgo, Associate Director, Assays, Reagents, and Software, Berkeley Lights, U.S.

15.30 Afternoon Networking & Refreshment Break

Advances in Genome Editing Technologies - CRISPR & CAR-T

16.00 CRISPR in Cell Line Development: Applications of CRISPR in Rapid Development of Stable Transgene CHO Cell LinesDr. Jianwei Zhu, Chair Professor and Dean of School of Pharmacy, Shanghai Jiao Tong University (SJTU); Director of MOE Engineering Research Center of Cell Engineering and Antibody; President and Chief Executive O�cer, Jecho Biopharmaceuticals, China

16.30 Cell Line and Process Development for Cell TherapyDr. Steve Oh, Institute Scientist and Director, Stem Cell Bioprocessing, Bioprocessing Technology Institute, A*STAR, Singapore

17.00 GeneRideTM, as the Novel Gene Therapy Technology for Pediatric DiseaseJing Liao, Senior Scientist, LogicBio Therapeutics, U.S.

17.30 Chairperson’s Summary and End of Conference Day 1

8.30 Morning Co�ee


High Throughput Platforms for Cell Line Development

9.05 Next Generation CHO Cell Line Development and Engineering by Systems ApproachesDr. Dong-Yup Lee, Associate Professor, College of Engineering, Sung Kyun Kwan University (SKKU), South Korea

9.35 Leveraging High-Throughput Imaging Technology in CLD: Benefits in Every Process StepBenjamin Werdelmann, Director, Business Development and Applications, SYNENTEC GmbH, Germany

10.05 Feasibility and Implementation of a Cell Line Development PlatformDr. John E. Gill IV, Director, Head of Cell Line Generation, Takeda, U.S.

10.35 Morning Networking & Refreshment Break

11.05 Overcoming the Limits of Therapeutic Cells through High Throughput Platforms Dr. Senyon Choe (Teddy), Professor, Biology, University of California San Diego (UCSD), U.S. and President and Director of Joint Center for Biosciences, South Korea

11.35AM PANEL DISCUSSION: Rise of Platform Technologies: Automation and Big Data Integration in CLDPanellists: Dr. John E. Gill IV, Director, Head of Cell Line Generation, Takeda, U.SDr. Dong-Yup Lee, Associate Professor, College of Engineering, Sung Kyun Kwan University (SKKU), South KoreaDr. Senyon Choe (Teddy), Professor Biology, University of California San Diego (UCSD), USA, President and Director of Joint Center for Biosciences, Korea

12.15 Networking Lunch

Continuous Manufacturing and Accelerating Process Development

13.30 Integrated Strategy of Cell Line Development for Speed to INDJerry Yang, Senior Vice President, Process & Product Development, Just Biotherapeutics, China

14.00 CMC Perspective: Optimising Cell Line Development for Biologics CMC Development Qinghai Zhao, Vice President, Technical Development & Manufacturing, Forty Seven, Inc., U.S.

14.30 Adapting Cell Line Workflows for Cell Line and Media DevelopmentCuiyun Xu, Director, Upstream Process Development, Shanghai Henlius Biotech, Inc., China

15.00 Development of Biosimilar Cell LinesEric Chang, Head of Cell Line Development, JHL Biotech, China

3.30 Afternoon Networking & Refreshment Break

Closing Plenary Panel

4.00 The Next Frontier for BDP ChinaPanellists:Alvin Luk, Senior Vice President of Global Clinical R&D and Chief Medical O�cer, Shanghai Henlius Biotech, Inc., ChinaChen-Yuan Lin, Ward Director and Attending Physician at the Division of Hematology and Oncology, China Medical University Hospital, TaiwanDr. Lin Shiwen, Vice President of Downstream Process Development, WuXi Biologics, ChinaDr. Senyon Choe (Teddy), Professor Biology, University of California San Diego (UCSD), USA, President and Director of Joint Center for Biosciences, Korea Jerry Yang, SVP, Process & Product Development, Hangzhou JUST Biotherapeutics Co., Ltd. China

5.00 Chairperson’s Summary and End of Conference



10th ANNUAL BIOSIMILARS ASIA CONFERENCE AGENDA






09:30 PANEL DISCUSSION: China’s Biopharma Leaders’ Roundtable: Growth through innovation, quality and new business modelsPanellists: Richard Wang, Chief Executive O�cer, Fosun Kite Biotech, ChinaHe Ting, Chief Executive O�cer, ImmunoChina, ChinaDong Wei, Chief Executive O�cer, Edigene, ChinaZonghai Li, President and Chief Executive O�cer, CARsgen Therapeutics, ChinaPeter Luo, Chief Executive O�cer, Adagene Pharma, ChinaRuirong Yuan, President, Chief Medical O�cer and Board Director, Adlai Nortye Biopharma, ChinaEddy Wu, China Head/Vice-President, Terns Pharmaceutical, ChinaJonathan Zhao, Chief Executive O�cer, Hangzhou JUST Biotherapeutics, ChinaZhou Mingdong, Chief Executive O�cer and Chief Scientist, Zensun, China Zhengyu Yuan, President & Chief Executive O�cer, MicuRx Pharmaceuticals Inc., China


China’s Upward Trends In BiosimilarsChairperson’s Opening Remarks

11:20 China’s Biosimilars Market: Now and the Future A�ordable Innovation in China for the Global MarketDr Scott Liu, President and Chief Executive O�cer, Shanghai Henlius Biotech, China

12:00 China’s mAbs in Oncology Treatment Dr Wu Youling, Chief Executive O�cer, ZheJiang Teruisi Biopharmaceutical, China


New Clinical Trials In Biosimilars

13:30 Teva’s biosimilars pipelines and developments Jim Cucinotta, Senior Director, Global Clinical Operations, Oncology/Hematology & Biosimilars, Head of Clinical Supply Chain, Teva Pharmaceuticals, USA

14:10 From China to the World- Strategies for Global Biosimilar Development Dr Manfred Weiler, Senior Vice President, Medical & Scientific Strategy, SyneosHealth, Germany

14:50 Case study of Intas’ biosimilars pipelines and development platformsLakshimikanth Gandikota, Vice President, Innovation Science and Technology, Intas Pharmaceuticals, India


Future Manufacturing and Tech Strategies

16:00 Innovation and Technology Breakthroughs for Biosimilar DevelopmentFor speaking opportunities, please contact [email protected]

16:30 Improving Biosimilars Manufacturing DataDr Lin Shiwen, Vice President of Downstream Process Development, WuXi Biologics, China

17:00 Innovative Manufacturing Strategies, and Process Control to Ensure Safety and E«cacy Dr Dennis Lin, Supervisor, Upstream Process Development, Mycenax Biotech Inc, Taiwan


Regulatory Impacts on Biosimilars

09:00 Chairperson’s Opening RemarksAsif Mahmood, Disease Area Cluster Lead, Pfizer, USA

09:10 Fast Track Global Biosimilar Development in China Dr. Allen Ho, Head of Regulatory A�airs CMC, JHL Biotech Inc, China

09:40 The Biosimilars Think Tank: Adopting Evolving Regulatory Guidelines to Streamline Biosimilars Development Moderator: Asif Mahmood, Disease Area Cluster Lead, Pfizer, USAPanelists: Dr Scott Liu, President and Chief Executive O�cer, Shanghai Henlius Biotech, ChinaDr Wu Youling, Chief Executive O�cer, ZheJiang Teruisi Biopharmaceutical, ChinaWang Yongzhong, President of Pharmaceuticals, Executive Vice President, Simcere Pharmaceutical Group, China More panelists to be confirmed


11:00 Latest Regulations on Biosimilars Development in JapanDr Sumimasa Nagai, Deputy Director of the Translational Research Centre, Clinical Expert Advisor at the O�ce of New Drug V (Oncology) and Companion Diagnostics Working Group, University of Tokyo Hospital, Pharmaceuticals and Medical Devices Agency, Japan

11:30 Benchmarking Regulatory Comparison between Two Most Populous Nations – The Case of India and China Biosimilars Markets Dr Abhay Sinha, Regional Director, Pharmaceuticals Export Promotion Council of India, India

Pricing and Promotion

12:00 An Integrated Approach to Biosimilar Pricing and Market Access Wang Yongzhong, President of Pharmaceuticals, Executive Vice President, Simcere Pharmaceutical Group, China


13:30 PANEL DISCUSSION: Biosimilars Pricing and Promotion StrategiesModerator: Asif Mahmood, Disease Area Cluster Lead, Pfizer, USAPanelists: Dr Abhay Sinha, Regional Director, Pharmaceuticals Export Promotion Council of India, IndiaDr Keith Watson, Executive Vice President, Global Regulatory Strategy / Research and Development, Polus Inc, South KoreaMore panelists to be confirmed

Proving Similarity and Development Platforms

14:10 Proving Similarities and Managing Product Variations Dr Jiang Weidong, Vice President and Chief Scientific O�cer, Shanghai Henlius Biotech, China

14:35 Polus’ biosimilar pipelines and development platforms Dr Keith Watson, Executive Vice President, Global Regulatory Strategy / Research and Development, Polus Inc, South Korea

15:05 Biosimilars: A Biologic Revolution - Implications for Safety Asif Mahmood, Disease Area Cluster Lead, Pfizer, USA


BDP China Closing Plenary Session

16:00 The Next Fontier for BDP ChinaPanellists: Alvin Luk, Senior Vice President of Global Clinical R&D and Chief Medical O�cer, Shanghai Henlius Biotech, Inc., ChinaChen-Yuan Lin, Ward Director and Attending Physician at the Division of Hematology and Oncology, China Medical University Hospital, TaiwanDr Lin Shiwen, Vice President of Downstream Process Development, WuXi Biologics, ChinaDr. Senyon Choe (Teddy), Professor Biology, University of California San Diego (UCSD), USA, Presiden, Director of Joint Center for Biosciences, South Korea Jerry Yang, SVP, Process & Product Development, Hangzhou JUST Biotherapeutics Co., Ltd. China

17:00 Chairperson’s Summary and End of Main Conference


9th ANNUAL CELL & GENE THERAPY CONFERENCE AGENDA





09:30 PANEL DISCUSSION: China’s Biopharma Leaders’ Roundtable: Growth through innovation, quality and new business modelsPanellists: Richard Wang, Chief Executive O�cer, Fosun Kite Biotech, ChinaHe Ting, Chief Executive O�cer, ImmunoChina, ChinaDong Wei, Chief Executive O�cer, Edigene, ChinaPeter Luo, Chief Executive O�cer, Adagene Pharma, ChinaRuirong Yuan, President, Chief Medical O�cer and Board Director, Adlai Nortye Biopharma, ChinaEddy Wu, China Head/Vice-President, Terns Pharmaceutical, ChinaJonathan Zhao, Chief Executive O�cer, Hangzhou JUST Biotherapeutics, ChinaZhou Mingdong, Chief Executive O�cer and Chief Scientist, Zensun, China Zhengyu Yuan, President & Chief Executive O�cer, MicuRx Pharmaceuticals Inc., China


China Market and Regulatory Developments Chairperson’s Opening Remarks

11:20 China’s Cell and Gene Therapy Industry Panel From “made in China” to “discovered in China”: Progress of Cell and Gene Therapy Development and Regulations in ChinaPanelists: Zonghai Li, President and Chief Executive O�cer, CARsgen Therapeutics, ChinaDody Bautista, Chief Expert of Sibiono Genetics Research Institute, Sibiono GeneTech, ChinaRichard Wang, Chief Executive O�cer, Fosun Kite Biotechnology, ChinaDong Wei, Chief Executive O�cer, Edigene, China Shuyuan Yao, General Manager, Wuxi ATU Co., Ltd., China


13:30 China Biotech Investors Panel: Big Bucks in the Cell and Gene Therapy Pipelines Panelists: Judith Li, Partner, Lilly Asia Ventures, Hong KongLynn Yang, Managing Director, Sequoia Capital, ChinaChelsea Zhang, Partner, Ping An Ventures, China

Manufacturing for Cell and Gene Therapy

14:30 Scaling up Tech Platforms for Pipelines in Cell and Gene TherapyFor speaking opportunities, please contact [email protected]


CAR-T and CRISPR Tech Developments

15:30 Commercializing the first US FDA-Approved CAR-T, KTE-C19, in ChinaRichard Wang, Chief Executive O�cer, Fosun Kite Biotechnology, China

16:00 Developments in the Manufacturing Process for CAR-T Cell TherapiesJiansong Tong, Director and Head of CAR-T Cell Therapy, Shanghai Hengrui Pharmaceutical, China

16:30 Edigene’s Case Study: Secret to Cracking the Code for Gene-Editing in China and the USDong Wei, Chief Executive O�cer, Edigene, China

17:00 Wuxi’s Perspectives on the Nuts and Bolts of Manufacturing for Cell and Gene Therapy in ChinaShuyuan Yao, General Manager, Wuxi ATU Co., Ltd., China

17:30 The first SFDA Approved Gene Therapy: Sibiono’s Journey with the R&D and Commercialization of Gendicine Dody Bautista, Chief Expert of Sibiono Genetics Research Institute, Sibiono GeneTech, China


Pricing and Commercialization for Cell & Gene Therapy


09:10 Japan: A Proactive Approach to Regulating Cell and Gene Therapy in JapanSumimasa Nagai, Deputy Director of the Translational Research Centre, Clinical Expert Advisor at the O�ce of New Drug V (Oncology) and Companion Diagnostics Working Group, University of Tokyo Hospital, Pharmaceuticals and Medical Devices Agency, Japan

09:50 LUXTURNA: First EMA- and USFDA-Approved Gene Therapy for Treatment of an Inherited Retinal DystrophyDaniel Takefman, Head of Regulatory A�airs, Spark Therapeutics, United States


11:00 Commercialization and Market Access for Cell and Gene Therapy in the US and EuropePaolo Morgese, Director for EU Market Access and Member Relations, Alliance for Regenerative Medicine, Switzerland

11:30 Thailand: Where is Thailand today in the field of Cell and Gene Therapy?Morakot Papassiripan, Pharmacist at the Professional Level at the Biological Sub-Division, Bureau of Drug Control, Food and Drug Administration of Thailand, Thailand

Scientific Advancements in Cell and Gene Therapy

12:00 Utilizing Fully Human Monoclonal Antibody Fragments for T-Cell ImmunotherapyHe Ting, Chief Executive O�cer, ImmunoChina, China


13:30 Translating Scientific Advancements to Cell and Gene Therapies Steve Oh, Institute Professor and Scientist at the Bioprocessing Technology Institute, A-STAR, Singapore

China and other Regional Markets for Cell and Gene Therapy

14:00 Indonesia: Perspectives on Cell and Gene Therapy from Indonesia’s Largest Pharma Manufacturer Sandy Qlintang, Deputy Director of Stem Cell and Cancer Institute, PT Kalbe Farma, Indonesia

14:30 Taiwan: Beyond the Dish: Taiwan’s Cell and Gene Therapy Ambitions Chen-Yuan Lin, Ward Director and Attending Physician at the Division of Hematology and Oncology, China Medical University Hospital, Taiwan

15:00 Sino-Dutch Partnership: Cooperation for Innovation in Life Sciences David Bekkers, O�cer for Innovation, Technology & Science, Holland Innovation Network in China, Netherlands



16:00 The Next Frontier for BDP China Panellists: Alvin Luk, Senior Vice President of Global Clinical R&D and Chief Medical O�cer, Shanghai Henlius Biotech, Inc., ChinaChen-Yuan Lin, Ward Director and Attending Physician at the Division of Hematology and Oncology, China Medical University Hospital, TaiwanDr Lin Shiwen, Vice President of Downstream Process Development, WuXi Biologics, ChinaDr. Senyon Choe (Teddy), Professor Biology, University of California San Diego (UCSD), USA, President/Director of joint Center for Biosciences, Korea Jerry Yang, SVP, Process & Product Development, Hangzhou JUST Biotherapeutics Co., Ltd. China

17:00 Chairperson’s Summary and End of Main Conference

CELL& GENETHERAPY



4th ANNUAL CLINICAL TRIALS CONFERENCE AGENDA




09:05 Outlook for China’s BDP Market – Investments, Regulations, Innovation and Vision of Chinese ManufacturersSenior Representative from Fosun Pharma*

09:30 PANEL DISCUSSION: China’s Biopharma Leaders’ Roundtable: Growth through innovation, quality and new business modelsPanellists: Richard Wang, Chief Executive O�cer, Fosun Kite Biotech, ChinaHe Ting, Chief Executive O�cer, ImmunoChina, ChinaDong Wei, Chief Executive O�cer, Edigene, ChinaZonghai Li, President and Chief Executive O�cer, CARsgen Therapeutics, ChinaPeter Luo, Chief Executive O�cer, Adagene Pharma, ChinaRuirong Yuan, President, Chief Medical O�cer and Board Director, Adlai Nortye Biopharma, ChinaEddy Wu, China Head/Vice-President, Terns Pharmaceutical, ChinaJonathan Zhao, Chief Executive O�cer, Hangzhou JUST Biotherapeutics, ChinaZhou Mingdong, Chief Executive O�cer and Chief Scientist, Zensun, China Zhengyu Yuan, President & Chief Executive O�cer, MicuRx Pharmaceuticals Inc., China


China’s Clinical Trials Regulations ReformChairperson’s Opening Remarks

11:20 Working with Current Regulatory Landscape in ChinaXin Zhang, Vice President of Global Clinical Operation and A�airs, Shanghai Henlius Biotech, Inc., China

11:50 Industry Panel Discussion: Interpreting the Impact and Working with Recent Regulation Changes in ChinaPanellists:Xin Zhang, Vice President of Global Clinical Operation and A�airs, Shanghai Henlius Biotech, Inc., ChinaTing He, Chief Executive O�cer, ImmunoChina, ChinaHei Yongjiang, Chief Medical O�cer, Oncology, Zai Laboratory, China RuiRong Yuan, President, Chief Medical O�cer and Board Director, Adlai Nortye Biopharma Co, China


Immunotherapy and CAR -T Trials

14:10 CAR-T Trial: CAR-T Cell Therapy – A New Era in Cancer ImmunotherapyTing He, Chief Executive O�cer, ImmunoChina, China

14:40 Immunotherapy Trial: Neoantigen: A Personalized Immunotherapy for CancerLiu Baorui, Medical School of Nanjing University, Clinical Cancer Institute of Nanjing University, China


16:40 Building Clinical Research Teams for Therapeutic TrialsJennifer Harmon, Director, Clinical A�airs, SynAgile, Singapore

Digitalisation in Clinical Trials

17:10 PANEL DISCUSSION: Enhancing Quality of Clinical Research with New Tech ToolsPanellists:Jennifer Harmon, Director, Clinical A�airs, SynAgile, SingaporeLiu Baorui, Medical School of Nanjing University, Clinical Cancer Institute of Nanjing University, China Joanne Chio, Head, Clinical Trials - Healthcare services, National University Hospital Singapore, SingaporeDr Alvin Luk, Senior Vice President of Global Clinical R&D and Chief Medical O�cer, Shanghai Henlius Biotech, Inc., China


New Developments in the Oncology Trial Space

09:00 Chairperson’s Opening RemarksDr Alvin Luk, Senior Vice President of Global Clinical R&D and Chief Medical O�cer, Shanghai Henlius Biotech, Inc., China

09:10 Shifting Landscape of Oncology Drug Development – Managing the Complexities of Clinical Trials Joanne Chio, Head, Clinical Trials - Healthcare services, National University Hospital Singapore, Singapore

09:40 Intravenous Oncolytic Viral Therapy for Breast Cancer (IOVs)RuiRong Yuan, President, Chief Medical O�cer and Board Director, Adlai Nortye Biopharma Co, China

10:10 The “Embarrassing” Richness of Clinical Trials in Immune-Oncology – Where Do We Go From Here?Hei Yongjiang, Chief Medical O�cer, Oncology, Zai Laboratory, China


Therapeutics Trials

11:10 Leukemia Trial: New Frontiers in Treating LeukemiaChen Chien Shing, Executive Director, Cancer Center, Shanghai Jiahui International Hospital and Clinics, China

11:40 HIV Trial: HIV Vaccines Trials: Challenges in Clinical Trials for Preventive HIV VaccinesDr Jean-Louis Excler, Program Director, New Initiatives, International Vaccine Institute, Republic of Korea

12:10 NASH Disease Trial: Development of New Drugs Against NASH Disease – Making it a RealityEddy Wu, China Head (VP), Terns Pharmaceuticals, China


13:40 Rheumatology Trial: Clinical Trials for the Rheumatology FieldJames Cheng-Chung Wei, Professor, Institute of Medicine, Chief, Division of Allergy, Immunology and Rheumatology, Director, Chinese Medicine Clinical Trial Center, Chung Shan Medical University Hospital, Taiwan

Winning with Biosimilars Trials

14:10 Clinical Experience of First Biosimilar Trial in ChinaDr Alvin Luk, Senior Vice President of Global Clinical R&D and Chief Medical O�cer, Shanghai Henlius Biotech, Inc., China

14:40 Biosimilars Clinical Trials – What Does it Take?Rong Chen, Chief Medical O�cer, JHL Biotech, China

15:10 Q&A Session with China’s Leading Biosimilars Manufacturers Dr Alvin Luk, Senior Vice President of Global Clinical R&D and Chief Medical O�cer, Shanghai Henlius Biotech, Inc., ChinaRong Chen, Chief Medical O�cer, JHL Biotech, China



16:00 The Next Fontier for BDP ChinaPanellists:Alvin Luk, Senior Vice President of Global Clinical R&D and Chief Medical O�cer, Shanghai Henlius Biotech, Inc., ChinaChen-Yuan Lin, Ward Director and Attending Physician at the Division of Hematology and Oncology, China Medical University Hospital, TaiwanDr Lin Shiwen, Vice President of Downstream Process Development, WuXi Biologics, ChinaDr. Senyon Choe (Teddy), Professor Biology, University of California San Diego (UCSD), USA, President/Director of Joint Center for Biosciences, Korea Jerry Yang, SVP, Process & Product Development, Hangzhou JUST Biotherapeutics Co., Ltd. China

17:00 Chairperson’s Summary and End of Main Conference Day Two



Top Speakers Across the 5 Co-located EventsALVIN LUK Senior Vice President of Global Clinical R&D and Chief Medical O�cer Shanghai Henlius Biotech, Inc., China

DR WU YOULING Chief Executive O�cer ZheJiang Teruisi Biopharmaceutical, China

DR. DANIEL TAKEFMAN Head of Regulatory A�airs Spark Therapeutics, United States

DR. JIANSONG TONG Director and Head of CAR-T Cell Therapy Shanghai Hengrui Pharmaceutical, China

DR. SENYON CHOE (TEDDY) Professor Biology, University of California San Diego (UCSD), USA, President and Director, Joint Center for Biosciences, South Korea

DR. XU WEI, Senior Vice President, Manufacturing, Innovent Biologics

EDDY WU China Head/Vice-President Terns Pharmaceutical, China

JONATHAN ZHAO Chief Executive O�cer Hangzhou JUST Biotherapeutics, China

LIN JIAN Vice President of Regulatory A�airs Bio-Thera Solutions Ltd, China

LIU BAORUI Medical School of Nanjing University Clinical Cancer Institute of Nanjing University, China

PAOLO MORGESE Director for EU Market Access Alliance for Regenerative Medicine, Switzerland

PETER LUO Chief Executive O�cer Adagene Pharma, China

RACHO JORDANOV Co-founder, Co-Chairman, President and CEO JHL

RUIRONG YUAN President, Chief Medical O�cer and Board Director Adlai Nortye Biopharma, China

SHOU BAI CHAO Senior Vice President Bio Venture AstraZeneca China

THOMAS KELLY Scientist, Cell & Developability Sciences, Pharmaceutical Development & Manufacturing Sciences (PDMS), Janssen R&D, U.S.

XIN ZHANG Vice President of Global Clinical Operation and A�airs Shanghai Henlius Biotech, Inc., China

ZHENGYU YUAN President & Chief Executive O�cer MicuRx Pharmaceuticals Inc., China

ZHOU MINGDONG Chief Executive O�cer and Chief Scientist Zensun, China

Chief Executive O�cerZheJiang Teruisi Biopharmaceutical, China

JONATHAN ZHAOChief Executive O�cerHangzhou JUST Biotherapeutics, China

Adlai Nortye Biopharma,

CUIYUN XU Director,Upstream Process Development Shanghai Henlius Biotech, Inc., China

CUIYUN XU

Shanghai Henlius Biotech, Inc.,

TherapyShanghai Hengrui Pharmaceutical,China

Medical School of Nanjing UniversityClinical Cancer Institute of Nanjing University,

THOMAS KELLYScientist, Cell & Developability Sciences, Pharmaceutical

Sciences (PDMS),

ALVIN LUKSenior Vice President of Global Clinical R&D and Chief Medical O�cerShanghai Henlius Biotech, Inc.,

DR SCOTT LIU President and Chief Executive O�cer Shanghai Henlius Biotech, ChinaShanghai Henlius Biotech,

HE TING Chief Executive O�cer ImmunoChina, ChinaChief Executive O�cerImmunoChina,

RICHARD WANG Chief Executive O�cer, Fosun Kite Biotech, ChinaChief Executive O�cer, Biotech,

CHEN-YUAN LIN Ward Director and Attending Physician at the Division of Hematology and Oncology China Medical University Hospital, Taiwan

CHEN-YUAN LINWard Director and Attending Physician at the Division of

China Medical University Hospital,

Spark Therapeutics,

Vice President of Regulatory A�airsBio-Thera Solutions Ltd,

SHOU BAI CHAOSenior Vice PresidentBio Venture AstraZeneca China

DR JEAN-LOUIS EXCLER Head of Clinical Development & Regulatory International Vaccine Institute, KoreaInternational Vaccine Institute,

California San Diego (UCSD),

Biosciences,

Alliance for Regenerative Medicine, Switzerland

XIN ZHANGVice President of Global Clinical Operation and A�airsShanghai Henlius Biotech, Inc.,

DR LIN SHIWEN Vice President of Downstream Process Development WuXi Biologics, China

Vice President of Downstream Process

WuXi Biologics,

China Head/Vice-PresidentTerns Pharmaceutical,

Co-founder, Co-Chairman, President and CEOJHL

ZHOU MINGDONGChief Executive O�cer and Chief ScientistZensun,

DONG WEI Chief Executive O�cer Edigene, ChinaChief Executive O�cerEdigene,

DR. JUNLI ZHANG Senior Vice President of Global Manufacturing and Technical Operation Shanghai Henlius Biotech, Inc

Senior Vice President of Global Manufacturing and Technical OperationShanghai Henlius Biotech, Inc

DONG-YUP LEE Associate Professor, College ofEngineering Sung Kyun Kwan University (SKKU), South Korea

Associate Professor, College ofEngineeringSung Kyun Kwan University (SKKU), South Korea

WANG YONGZHONG President of Pharmaceuticals, Executive Vice President Simcere Pharmaceutical Group, China

WANG YONGZHONG

Simcere Pharmaceutical Group,

DR JIANG WEIDONG Vice President and Chief Scientific O�cer Shanghai Henlius Biotech, China

Vice President and Chief Scientific O�cerShanghai Henlius Biotech,

Manufacturing,

Chief Executive O�cerAdagene Pharma,

ZHENGYU YUAN

MicuRx Pharmaceuticals Inc.,


Sponsors And Exhibitors Exhibition Floorplan

Gold Sponsor:

Conference Partners:

SPONSORSHIP OPPORTUNITIESSponsorship opportunities are now also available. To position your company as a market leader at this event, and to explore the range of branding and marketing opportunities available, please contact:Ms. Yvonne Leong at Tel: +65 6508 2489 l Email: [email protected]

Bronze Sponsors:

Exhibitors:

Associate Sponsor: Sessions Spotlight Sponsor:


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Exclusive SponsorMeeting RoomsAvailable Upon

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Host Lucky DrawsDuring the

Networking Breaks

Exclusive Sitting LunchRoom Available for

Sponsorship

WIFISponsor

Area

INTERACTIVECOMMON AREA FOR

EXHIBITION ANDREFRESHMENT BREAKS

=VIP

Entrance

With a brand-new focus, 5th Biopharma Development and Production Week 2019 is your go-to event to reach out to key decision makers in the pharmaceutical industry. With demonstrated success year on year, IBC’s BDP Week in China enjoys unparalleled

industry support. Known for generating knowledge, creating business opportunities, and

bringing innovative ideas to the table, the conferences, learning seminars, focuses trade show

and business matching to boot.

• 4th Annual Clincial Trials• 9th Annual BioManufacturing• 8th Annual Cell Line Development and Manufacturing• Cell and Gene Therapy - Trials, Manufacturing, Commercialisation• 10th Annual BioSimilars Asia

Explore customized options that suit your budget and discover how you can gain prime exposure!

INDUSTRY REGION

Unrivalled Opportunity to Profile your Company!

Sponsorship & Exhibition Opportunities Available! Please contact: Yvonne Leong Tel: +65 650 82489 Email: [email protected]

STRATEGIC BRANDING

Profile your organisation as

an Industry leader and leverage on our integrated

marketing campaign to extend your

marketing reach.

NETWORKING FUNCTIONS

Engage your captive audience at an exclusive event

hosted by your organisation.

ONSITE BRANDINGReinforce your

branding and seize opportunity to

enhance your brand visibility at the

event.

PRODUCT SHOWCASEShowcase your products and solutions and engage your

targeted audiemce through the

exhibiton stands or table displays.

China/MNC Pharma & Biotech ...............................................50%Scientific Research & Universities ......................................... 25%Tech Solution Providers ...............................................................10%Regulators, Healthcare Agencies & Associations ............5%CDMOs/CROs/CMOs ......................................................................5%Others ......................................................................................................5%

China .....................................................................................................50%Japan, Korea, HK, Taiwan ............................................................ 15%USA .........................................................................................................10%Europe ...................................................................................................10%Southeast Asia ..................................................................................10%Other Region .......................................................................................5%

Biopharma Development and Production Week in Numbers!

PRE-CONFERENCE WORKSHOP

THE BDP PARTY

Tuesday, 14 May 2019 • 9:00am – 1:00pm

Wednesday, 15 May 2019 • 6:30pm • Shanghai Marriott Parkview Hotel

Registration is not limited to conference participants and we encourage all who are in the BDP industry to attend.

• Dinner will only proceed when wehave reached 100 participants.

• Payment is only required whenthe dinner is confirmed.

• Participants list for the dinner willbe made available online oncethe registration reaches 100participants.

Biopharma Production and Development China: Investments and Financing

5 EASY WAYS TO REGISTER:MAIL the attached registration form with your cheque to: IBC Asia (S) Pte Ltd, c/o Informa Regional Business Services, 103 Penang Road, Visioncrest Commercial #04-01, Singapore, 238467

Customer Service Hotline: +65 6508 2401

Email: [email protected]

Web: www.biopharmaproduction.com

Fax: +65 6508 2407

BIOPHARMA DEVELOPMENT & PRODUCTION WEEK

REG

NO

. 200

1082

03N

P46372

Yes! I/We will attend Biopharma Development & Production Week, 14 - 16 May 2019

I cannot attend this event but please include me on your mailing list

I would only like to purchase the conference documentation at SGD1,000 / SGD1,070 (with 7% GST) per set

RESERVE YOUR PLACE TODAY!

(Please photocopy for additional delegates)

Payment Method (Please tick:) I enclose my Cheque/Draft payable to IBC Asia (S) Pte Ltd

I am paying by bank transfer (copy attached)

Payment by Credit Card: Visa Mastercard Amex

Credit Card PaymentsThe best way to pay by credit card is through our secure on-line registration process, simply log on to the website at www.ibc-asia.com/event/biopharma-development-production and click “Register On-line”. If you would prefer to pay over the phone please complete the contact name and details and our Customer Services Team will call within 24 hours to take payment. As we treat your credit card information in the strictest confi dence, please do not send payment details by email.

Credit card contact:: Department:

Direct phone number: Email:

(Please provide photocopy of front & back of your Credit Card)

• Group rate is based on normal rate of 2-day main conference package only. For Group Registrations of more than 3 team members: email [email protected] or call +65 6508 2477• Fee stated is the price PER DELEGATE. Only one discount scheme applies at one time; either the early bird rate OR group rate.• All fees stated include luncheons, refreshments and complete set of documentation. It does not include the cost of accommodation and travel.• Registration fees are subject to the prevailing government tax*The organizer reserves the right to determine the industry to which your company belongs, and to stop the promotion at any stage.

ATTRACTIVE GROUP DISCOUNTS AVAILABLE!

SPECIAL RATES FOR LOCAL CHINA COMPANIES!

Delegate 1 Details

Name: Dr/Mr/Ms

Job Title:

Department

Tel:

Mobile No.:

Email:

Delegate 2 Details

Name: Dr/Mr/Ms

Job Title:

Department

Tel:

Mobile No.:

Email:

Who is Head of your Department?

Who is Head of Training?

Company Name: Main Business/Activity:

Address: Postal Code:

INTERNATIONAL COMPANIES - OUTSIDE CHINA

Fee Per Delegate Early Bird Rate Register & Pay by 8 March 2019

Normal Rate Register & Pay After 8 March 2019

Group Savings(2 or more Delegates)

Group Savings(4 or more Delegates)

(Applicable accross 5 events, only on 2-day main conference package)

2 Day Package 2 Day Conference (15-16 May 2019)

USD 1,695 USD 1,895 USD 1,495 USD 1,295

ADDITIONAL OPTIONS: Pre conference workshop (14 May 2018) .... USD 150 / CNY 1,000BDP Party / Dinner (15 may 2019)....................... USD 50 / CNY 350

LOCAL CHINA COMPANIES

2 Day Package 2 Day Conference (15-16 May 2019)

CNY 5,500 CNY 6,500 CNY 5,000 CNY 4,500

ADDITIONAL OPTIONS: Pre conference workshop (14 May 2018) .... USD 150 / CNY 1,000BDP Party / Dinner (15 may 2019)....................... USD 50 / CNY 350

Please quote the name of the delegate, event title and invoice number on the advice when remitting payment. Bank charges are to be deducted from participating organisations own accounts. Please fax your payment details (copy of remittance advice, cheque or draft to +65 6508 2407).

Attendance will only be permitted upon receipt of full payment. Participants wishing to register at the door are responsible to ensure all details are as published. IBC assumes no further liability or obligation, beyond the refund of the paid registration fee, in the event of postponement or cancellation by IBC.

IMPORTANT NOTE

Should you be unable to attend, a substitute delegate is welcome at no extra charge. Cancellations must be received in writing at least 10 business days before the start of the event, to receive a refund less 10% processing fee per registration. The company regrets that no refund will be made available for cancellation notifications received less than 10 business days before the event.

CANCELLATIONS / SUBSTITUTION

The personal information entered during your registration/order, or provided by you, will be held on a database and may be shared with companies in the Informa Group in the UK and internationally. Occasionally, your details may be obtained from or shared with external companies who wish to communicate with you offers related to your business activities. If you do not wish your details to be used for this purpose, please contact our Database Department at Email: [email protected], Tel: +65 6508 2400 or Fax: +65 6508 2408.

DATA PROTECTION

Shanghai Marriott Hotel Parkview333 Guang Zhong Road West, Jing’an DistrictShanghai, 200072 ChinaPhone:+86 21 3669 8888Fax:+86 21 3669 8668

Cartrina Wang 王洁琼 | Senior Sales [email protected]: 86 21 3669 8666 | M:13585605981

www.marriott.com/hotels/travel/shamp-shanghai-marriott-hotel-parkview

HOTEL INFORMATION

Payment must be received 10 business days prior to the event. To take advantage of discounts with an expiry cut-off date, registration and payment must be received by the cut off date. All payments should be made in Singapore dollars.

Payments by S$ bank draft or cheque should be made in favour of “IBC Asia (S) Pte Ltd” and mailed to:

IBC Asia (S) Pte Ltdc/o Informa Regional Business Services103 Penang Road Visioncrest Commercial #04-01 Singapore 238467

Payment by telegraphic transfer in S$ must be made to:

IBC Asia (S) Pte LtdA/CNo.: 147-059513-001 (SGD)The Hongkong and ShanghaiBanking Corporation Limited21 Collyer Quay, HSBC Building,Singapore 049320Bank Swift Code: HSBCSGSGBank Code: 7232

Payment by Credit Card (AMEX, VISA or MASTERCARD).

Please provide your Card Number, Name of Cardholder, Expiry Date and Signature and send it by fax to +65 6508 2407.

PAYMENT TERMS

Bank Name: The Hongkong and Shanghai BankingCorporation LtdBank Address: 21 Collyer Quay HSBC BuildingSingapore 049320Bank Account Name: IBC Asia (S) Pte LtdSWIFT CODE: HSBCSGSGA/c No.: 260-457866-178 (USD)

Bank account name: 艾毕思会务服务（上海）有限公司Company Address: 上海市静安区西康路828号311室Bank Name: 汇丰银行(中国)有限公司上海分行Bank Address: 上海市静安区南京西路1376号上海商城5层504室Bank Account Number: 720-031103-001(CNY)Swift code: HSBCCNSH

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