11th Annual Biosimilars Asia – Agenda

Day 1: Tuesday, 19 May 2020

0800
Conference Registration & Morning Coffee


BDP China 2020 Joint Opening Plenary Sessions


0900
Chairperson’s Opening Remarks

0910
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

0930
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

0950
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

Confirmed Panelists:
Jerry Su, Chief Executive Officer, Zhejiang Huahai Biopharmaceuticals, China
Wu Yifang, Chief Executive Officer, Fosun Pharma, China*
Larry Zhang, President, CASI Pharmaceuticals, China*
Glenn Hassan, Chief Finance Officer, Chief Business Officer, CANbridge Pharmaceuticals, China
More panelists to be confirmed

1030
Morning Networking & Refreshment Break


11th Annual Biosimilars Asia Commences

The China Market


1100
Chairperson’s Opening Remarks

1110
New Product Launches, International Standards and Global Market Access

  • The future of Chinese biosimilars market – Where does it lead to?
  • Next step- moving from China to the rest of the world
  • Current pipelines and what the market can expect
  • Local investments and expansions: Manufacturing facilities and Clinical landscape

Dr Scott Liu, President and Chief Executive Officer, Shanghai Henlius Biotech, China

1140
Investing in Biosimilars

  • What’s in store for TOT – pipeline updates
  • Spend in R&D and manufacturing capacity
  • Technology and manufacturing considerations
  • Pricing and market access

Dr Jacqueline Liu, Vice President, TOT Biopharma, China

1210
Networking Lunch

1310
Case Study of Bio-Thera’s pipelines and moving forward in the Chinese and Global Markets

  • Market potential for Humira
  • R&D and clinical trial costs and outcomes experience in China
  • Working with CNDA’s requirement to review analytical, preclinical and clinical data
  • Compatibility and similarities for Adalimumab
  • Humira and Adalimumab pipeline update

Bert Thomas, Senior Vice President, Business Development, Bio-Thera Solutions, Ltd, USA

1340
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

1420
Market Access and Commercialisation of Anti-TNF Biosimilars in Europe

Magnus Bodin, Director Market Access, Biogen Biosimilars, Switzerland


Clinical Trials in Biosimilars


1450
Pre-Clinical Considerations: Design Thinking for Quality Biosimilars

  • Innovation in design thinking of clinical trials
    Gathering quality extrapolation data to meet international regulatory requirements
  • Improving design with feedback loops

Dr Sanjeev Hedge, Associate Vice President, Global Clinical Operations, Mylan, India

1510
Afternoon Networking & Refreshment Break

1540
Case Study: JHL’s Fast Track Strategy for CMC Approvals

  • Pathway for parallel submission
  • Global clinical strategy for better CMC data
  • Accelerating clinical trials and expediating approval processes

Dr. Allen Ho, Senior Director, Regulatory Technical CMC, JHL Biotech Inc, China

1620
Managing Late-Stage Clinical Operations and Biosimilars Development

  • Working with data compatibility
  • Using real world evidence in trials for better efficiency
  • Enhancing quality of drug development

Dr Anup Choudhury, Associate Clinical Development Medical Director, Novartis, India

1650
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

1730
Chairperson’s Summary and End of Main Conference Day One

*Please note that conference agenda and timing are subjected to change according to market development.

Day 2: Wednesday, 20 May 2020

0800
Morning Coffee


BDP China 2020 Joint Opening Plenary Sessions


0900
Chairperson’s Opening Remarks

0910
Keynote Address:
China’s Biopharma Capital Markets – Future Funds and Innovative Financing

Fu Wei, Chief Executive Officer, CBC Group, China

0940
Venture Capitals Roundtable: Show Me the Drug

  • Investment landscape of 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
More panellists to be confirmed

1020
Morning Networking & Refreshment Break


11th Annual Biosimilars Asia Commences

Quality, Safety and Efficacy


1100
mAbs Case Study:
Extractable & Leachable (E&L) Study for Single Use Manufacturing System (SUS)

  • Opportunities and E&L Challenges for SUS;
  • Requirements and risk assessment of E&L for seeking NDA/MAA filings;
  • E&L case studies for NDA/MAA of biosimilar and innovator monoclonal antibodies (mAbs)

Michael H. Xie, Vice President, Analytics; Head, Bioassay and Analytical Development, Shanghai Henlius Biotech, USA

1130
Proving Similarities for Biosimilars and Managing Product Variations

For speaking opportunities, please contact Yvonne.Leung@Informa.com

1200
Case Study:
Maintaining High Quality, Safety and Efficacy of Biosimilars

  • Maintaining biosimilarity against reference product
  • Mass production and quality control
  • Balancing quality vs. cost considerations and scaling-up for manufacturing
  • Meeting regulatory requirements

Dennis Tan, Manager, Quality Assurance, Tanvex Biopharma, Taiwan

1230
Networking Lunch

1330
Case Study:
Quality Control and Cost-effective Manufacturing of Biosimilars

  • Quality compliance
  • Manufacturing gap assessments and remedies
  • Improving manufacturing processes to minimise cost
  • Considerations for scaling up production

Nicholas Dukwon Kang, Global Quality Management Team Lead, GC Pharma, Korea


Market Access, Patent and Pricing


1400
Global and China Market Patent Expiry – Market Outlook, and Cost Savings Associated with Substituting

For speaking opportunities, please contact Yvonne.Leung@Informa.com

1430
Fireside Chat:
Commercialisation of Biosimilars in China: Challenges and Opportunities

  • Introducing biosimilars to the Chinese market- demand forecast and matching supply
  • Pricing mechanisms
  • Alternative payment methods and patient assistance

Dr. Joe Zhou, Chief Executive Officer, Genor Biopharma, China

1500
Value-add Partnerships and Investments in the Chinese Biosimilars Market

  • Biosimilars investment strategies – Available funds and how do we review for partnership?
  • Opportunities in the Chinese market
  • Capitalising on local partnerships for rapid market penetration

Senior Representative from select venture capital

1530
Afternoon Networking & Refreshment Break

1600
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

1645
Chairperson’s Summary and End of Main Conference Day Two

*Please note that conference agenda and timing are subjected to change according to market development.