10th Annual Biomanufacturing Agenda

Day 1: 3 November 2020

1300
Chairperson’s Opening Remarks


Joint Opening Plenary
Joint Plenary Sessions with 9th Annual Cell Line Development and 2nd Annual Cell & Gene Therapy Manufacturing


1310
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

1330
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

1400
Online Networking & Stretch Break


10th Annual Biomanufacturing commences
BIOMANUFACTURING 2030 – CHINA’S GREAT LEAP


1420
Trends in Pharma 4.0 Standards and China’s New Drug Delivery Strategy

  • Demand for capacity drives China’s biomanufacturing expansion – is China on the fast track?
  • Approval process for biologics – a US-China comparison
  • QbD and quality matrix for meeting regulatory requirements

Dr. Liu Xun, President, Biomedicine Development and Business Division, Jiangsu Hengrui Medicine, China

1450
Debottlenecking and Process Optimisation in China BioPharma Landscape

  • Rate-limiting steps in China biopharma’s facilities and what are the solutions
  • Data, complexity and variability in biomanufacturing
  • Advances in bioprocess monitoring and analytics, and bioinformatics and computational biology in China

Dr. Simon Hsu, Senior Vice President, Technical Operations, Henlius, China

1520
The New Age of Smart Continuous Manufacturing as Market Moves to Commercial

  • Optimizing continuous process with fixed stainless-steel facilities
  • Speed-to-market and cost reduction strategies utilizing fully continuous process development
  • Case study on building a world-class continuous manufacturing facility and quality system in China

Dr. Li Jing Rong, Senior Vice President, Product Development and Manufacturing, CStone Pharmaceuticals, China

1550
Online Networking & Stretch Break

1610
China’s Biological Facilities for The Future – Growth, Innovation and Investments

  • Understanding Chinese’s bioprocessing capacity – which market and what pipeline
  • Challenges and opportunities in innovative drug development and manufacturing in China
  • Insights on growth strategies and how to manage risks associated with geography and product development

Larry Zhang, Chief Executive Officer, CASI Pharmaceuticals. China

1640
Scaling Up the Commercial Production of mAb Therapeutics in China

  • China’s capacity outlook and how do we capitalize on the mAb therapeutics markets
  • Teruisi’s breakthrough of mAb’s tech transfer and large-scale production in China while in-line with international standards – challenges and key learnings
  • Manufacture showcase to improve cost and efficiency

Dr. Wu You Ling, Chief Executive Officer, Zhejiang Teruisi Pharmaceuticals, China

1710
WuXi “Factory of the Future” – A CMC Manufacturing Case Study

  • Process development and pilot manufacturing at WuXi Biologics
  • Case study sharing on WuXi’s facilities based on disposable technologies
  • Process and quality control best practices upon extensive analytic testing

Dr. Liang Tang, Vice President, CMC Management, WuXi Biologics, China

1740
End of Conference Day 1

Day 2: 4 November 2020

1300
Chairperson’s Opening Remarks


Joint Opening Plenary
Joint Plenary Sessions with 9th Annual Cell Line Development and 2nd Annual Cell & Gene Therapy Manufacturing


1310
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 (tentatively confirming)
William Cao, Founder, Chairman &CEO, Gracell Biotechnologies Group, China

1400
Online Networking & Stretch Break


10th Annual Biomanufacturing continues
FUTURE FACILITIES & SMART BIOMANUFACTURING


1420
Manufacturing Technology Showcases – Improving Cost and Efficiency

  • Next gen manufacturing facilities design and investment trends
  • Smart automation case studies to increase facility efficiency and cost optimization
  • Intelligent bioreactors – advantages and benefits

Frank Ye, Senior Vice President, Technical Operations, Transcenta, China

1550
Manufacturing Technology – From Tech Transfer to Risk Analysis and Migration Strategy

  • Essential elements of tech transfer and leading to successful validation and robust commercialization
  • Best practices of a structured risk analysis, quality management and migration strategy
  • Case study on BeiGene’s new biologics manufacturing facility in Guangzhou – technology used from cell line development to manufacturing

Dr. John Zhang, Vice President, Manufacturing Technology and Process Development, BeiGene, China

1520
Tech Transfer Development for mAb Manufacturing Productivity Optimization 

  • Creating a robust development platform utilizing technologies for scalable and cost-efficient mAb manufacturing process
  • JHL’s efforts to develop a suitable manufacturing process and technologies used
  • Case study sharing on Asia’s largest single-use bioprocessing technology-based modular biopharma manufacturing facility – how is it being implemented and how has it benefited the manufacturing process development

Dr. Zack Zheng, Vice President, Process Development, JHL Biotech, China

1550
Online Networking & Stretch Break


INNOVATIVE BIOPROCESS DEVELOPMENT


1610
Glycosylation of Monoclonal Antibody and the Manipulation

  • Glycosylation manipulation + upstream PB-Hybrid platform + ADC development

Liu Dong Lian, Vice President, Manufacturing, TOT Biopharm, China

1640
Vaccine Manufacturing Innovation

Dr. David Shao, President, Chief Executive Officer, Yisheng Biopharma, China

1710
Case Study:
Bio-Works’ 3rd Gen Agarose Resins to Purifying Antibody-based Therapies Using A Different 3-step Column Chromatography Approach

Dr. Bjorn Hammarberg, Business Development Asia, Bio-Works, Sweden

1740
End of Conference Day 2

Day 3: 5 November 2020

1300
Chairperson’s Opening Remarks


Joint Opening Plenary
Joint Plenary Sessions with 9th Annual Cell Line Development and 2nd Annual Cell & Gene Therapy Manufacturing


1310
Keynote Address:
China’s Biopharma Capital Markets – Future Funds and Innovative Financing

Fu Wei, Chief Executive Officer, CBC Group, China

1330
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?

Moderator:
Fu Wei, Chief Executive Officer, CBC Group, China

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

1420
Online Networking & Stretch Break


10th Annual Biomanufacturing continues
GMP IMPLEMENTATION – THE MADE IN CHINA 2025 PLAN


1440
Under Chinese New Drug Administration Law and New Vaccine Law – Oversight and Implementation on Commercial Bioprocess Development and Process Performance Qualification

  • Industry challenges and opportunities upon the introduction of Chinese new vaccine law
  • Overview of the manufacturing best practices and process performance qualification in cGMP environment
  • Process scale-up and optimization within Shanghai Zerun’s commercial production

Dr. John Zeng, Executive Vice President, Product Development and Commercialization, Shanghai Zerun Biotechnology, China

1510
Impact of NMPA Reform on CMC Strategy at IND Stage

  • Regulatory environment before reform – what are the challenges and how it differs with global standards
  • New IND review procedure
  • Understanding the CMC strategy of biologic development for FDA and NMPA IND Fillings

Dr. Ma Yuan Hui, Executive Director, Preclinical Science, Shanghai HaiHe Pharmaceutical, China


QUALITY MANAGEMENT & EFFICACY STANDARDS


1540
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

1610
Online Networking & Stretch Break

1630
Ensure Uninterrupted Supply of Biological Drugs

  • Challenges in the biopharma supply chain – long manufacturing lead time, yield variability, testing and quality assurance, CMC compliance, global footprint, demand fluctuation
  • Strategical and tactical elements of biopharma supply chain management
  • Supply chain integration best practices across different functions to cater for global supply
  • Key measures should pharmaceutical companies take to improve connections with external supply chain

Yin Nan Po, Director, Asia Supply Chain, Amgen, China

1700
Biopharma Quality Assurance Best Practices and PAT Insights

  • National standards for Chinese biological products and current challenges in quality management
  • Case study sharing on product stability and quality assurance during biomanufacturing
  • Quality system implementation and PAT compliance standards – assessment, review and results

Dr. Yi Jizu, Senior Vice President, CMC and Quality Operations, YZY Biopharma, China

1730
Biomanufacturing Process Validation and Quality Risk Management

  • New process concepts of CQAs, CPPs, and QbDs
  • Best practices on quality risk management in bioprocess development
  • Case study on Bio-Thera’s manufacturing process quality control on the newest Humira biosimilar

Bao Cai, Senior Director, Manufacturing, Bio-Thera Solutions, China

1800
End of Conference Day 3