Agenda

Day 1

7th November 2017, Tuesday

08:00     
Registration and Morning Coffee

Opening Plenary Session

09:00
Chairman’s Opening Remarks
Ken Wong, Deputy Director, Process Technology, Sanofi Pasteur, United States

09:05
[Panel Discussion] Asia Pacific’s Innovation, Regulation and the Next Frontier of Biopharma Market  

  • How is Asia progressing in the biopharmaceutical front?
  • Recent trends in Asian Pacific Regulations for biological drug development
  • What’s the next direction of Biopharmaceutical industry? Disease-based or Epidemic-based?
  • Development in biopharmaceutical production trends
  • Manufacturing cost – how to remain cost efficient while improving production efficiency 
  • Choosing the right partner – suppliers and CMO’s, how do we manage quality is up to standard?
  • Funding and investment challenges and options
  • Impact of the demise of Trans-Pacific Partnership on APAC LifeSciences industry
  • What are the unmet needs with the Biosimilars current on the market?
  • Is the Biosimilar market over-saturated? What are the alternatives?
  • Development of next-generation therapeutic drugs, antibodies, bispecific and innovative drugs

Moderator:
Ken Wong, Deputy Director, Process Technology, Sanofi Pasteur, United States

Panelists:
Joo Sik Choi, Head of Business, Pharmerging Market, Celltrion Healthcare, South Korea
Michelle Peake, Senior General Manager, PT Kalbio Global Medika, Indonesia
Dr Abhay Kumar Sinha, Regional Director, Pharmexcil (the Ministry of Commerce & Industry, Govt of India)

09:40
Investment Outlook in Asia’s Biopharma and Biotech
Abrar Mir, Managing Partner, Quadria Capital Investment Management

10:15
Morning Networking & Tea Break

11:00
Chairman’s Opening Remarks
Dr Abhay Kumar Sinha, Regional Director, Pharmexcil (the Ministry of Commerce & Industry, Govt of India)

Biosimilars Market Developments in Asia Pacific

11:05
Biosimilar Deals – Highly Similar or Different?

  • Overview of recent transactions in the biosimilar industry
  • Case studies of biosimilar deals to showcase diversity of deal structures
  • Review of biosimilar deal trends in Asia

Cheni Kwok, Head of Business Development, Shanghai Henlius Biotech Co. Ltd

11:45
Pricing, Reimbursement and Market Access Outlook in South East Asia

  • Reimbursement and Payer Landscape
    • Overview of Healthcare System
    • Reimbursement Process
    • Pricing Regime & Policies
    • Trends & Development
  • Evaluation of regulatory framework in bringing biosimilar products from non-reference countries (non-European) prior to entering the market
  • Key market drivers & barriers
Jamaludin Elis, Country Managing Director, Culia Life Sciences, Malaysia 
Regulatory Approval Pathways and Approaches

12:05
Biosimilars Market in India – Market Potentials, Pipelines and Regulation

  • An overview on Biosimilars Sector in India
  • Regulations and licensing for biosimilars products
  • Pharmacovigilance  
  • Market Challenges
  • Strategies for Emerging Markets

Dr Abhay Kumar Sinha, Regional Director, Pharmexcil (the Ministry of Commerce & Industry, Govt of India)

12:45
Networking Lunch

13:45
Biosimilars Prospects in Malaysia: The Regulator's Perspective

  • Recent Trends & Development in Biosimilar Regulations in Malaysia : Scope & definition
  • Guidelines for Approval Process and the Duration
  • Business case on approval process, reviews and regulatory snapshots
  • Common findings & challenges

Chua Hui Ming, Senior Principal Assistant Director, Biologics Section, Center for Product Registration, National Pharmaceutical Regulatory Division (NPRA), Ministry of Health Malaysia

14:25
The Australian Biosimilars Market  

  • The Australian Government’s effort to reduce healthcare costs and increase uptake of biosimilars
  • Market access challenges and opportunities
  • The evolving regulatory landscape and international harmonisation  

Belinda Wood, Chief Executive Officer, Generic and Biosimilar Medicines Association, Australia  

15:05
Networking Afternoon Tea

Launch and Globalization of Biosimilars

15:35
[Case Study] Commercialization Development of Biosimilar: the Celltrion Healthcare’s Experience

  • Accelerating market access development
  • Future challenges of Biosimilar Developer and Distributor

Joo Sik Choi, Head of Business, Pharmerging Market, Celltrion Healthcare, South Korea

16:15
Maintaining Price Competitiveness While Encouraging Acceptance of Biosimilars

  • Price impact on market penetration
  • From the beginning to the end—COG control
  • Something beyond the price

Pearl Fong, Associate Vice President, Division of Project Development, Mycenax Biotech Inc., Taiwan

17:00
End of Conference Day One

11:00
Chairman’s Opening Remarks

Dr Stefan Kappeler, Senior Project Manager, Compliance & Validation, M+W Group, Switzerland

Commercialization of Biologics

11:05
[Best Practices] Improving Design of Tech-Transfer and Streamline the Process

  • Aseptic bioprocess strategies
  • Importance of GMP in quality manufacturing
  • Regulatory compliances and GMP in Bio processing

Sugumar Parthasarathy, Head – Bio Risk Management and Quality Assurance Manager, Indian Immunologicals Limited, India

11:45
Challenges of Biomanufacturing in Southeast Asia

  • Cold chain management
  • Logistics
  • Quality

Michelle Peake, Senior General Manager, PT Kalbio Global Medika, Indonesia

12:05
Safeguard your process: viral safety from cell line to drug product

  • What is the viral contamination risk throughout your entire process?
  • Is your biologic system what you believe it to be?
  • How can you tell if your system is contaminated or impure?
  • What can you do to protect your upstream process?
  • What are the key parameters for mitigating risk in your downstream process?

Kerry Roche Lentine, Director of Technology Management, Process Solutions, Life Science Business of Merck KGaA

12:45
Networking Lunch

Latest Technologies To Improve Process Development

13:45
Clonality, Assurance, Efficiency; from Cell Line Development to Manufacturing Control Strategy

  • Regulatory drivers and impact on production control strategies
  • Practical considerations and case studies
  • Introducing a new technical Innovation that increases workflow efficiency and improve the quality of documented assurance data

George Hutchinson, Head of Asia Pacific Business, Solentim Ltd., United Kingdom

14:25
Leading the Way in Advancing Discovery: New Workflow Innovations for Discovery, Development and Manufacturing

  • A brief overview of Bio-Rad as a trusted global partner supporting pharma and biotech
  • How new innovative products in Cell Biology and digital PCR are helping Pharma and Biotech get to market faster
  • Examples of new innovations in workflows supporting Pharma and Biotech industries needs to become more efficient 

Steven Blakely, Director, Drug Discovery & Development Business, Bio-Rad Laboratories

15:05
Networking Afternoon Tea

Raw Material Variability and Contamination Control Strategies

15:35
BioPhorum Operations Groups (BPOG’s) Extractable Recommendations and Leachable Best Practice Guide

  • Short intro to BioPhorum Operation Groups (BPOG)
  • Overview of BPOG recommendation on harmonization of extractable data development from suppliers. Include current suppliers implementation status
  • Overview of BPOG Leachable best practice and risk Assessment Model

Ken Wong, Deputy Director, Process Technology, Sanofi Pasteur, United States

Achieving Cost Efficiencies and Operational Excellence

16:05
Delivering Cost Savings through Multiple Considerations

  • Importance of cost reduction of bio pharmaceutical manufacturing – Manufacturer view
  • Impact of cost efficiencies of productions in the market.
  • Role and importance of COGS (Cost of goods sold) for any new bio product manufacturing
  • Optimizing the process design (upstream/downstream) to increase the productivity
  • Facility optimization/up gradation to decrease the process time and increase the yield

Mitul Agarwal, General Manager - Business Development & Licensing, Intas Pharmaceuticals, India

16:35
Expanding Manufacturing-Site Capacity and Achieving Cost Efficiencies

  • Addressing upcoming challenges in drug substance manufacturing
  • Cost effective ways to produce individualised medicines and biosimilars
  • Flexibility with the choice of suppliers
  • Understanding the quality and safety by sophisticated process design  

Dr Stefan Kappeler, Senior Project Manager, Compliance & Validation, M+W Group, Switzerland

17:05
End of Conference Day One

 

Day 2

8th November 2017, Wednesday

08:55
Chairman’s Opening Remarks
Dr Anurag Tiwari, Biologic Development and Scientific Manager, Zumutor Biologics, India

Biosimilars Development in Emerging Markets

09:05
Current Evidence Related to Biosimilar Switching

  • The Immunogenicity Switching Challenge
  • Summary of the current evidence of biosimilar switching and limitations
  • Considerations on future switches possible among several biosimilars

Daniel Furtner, Area Therapeutic Lead Rheumatology & Biotherapeutics, Japan-Asia-Pacific (JAPAC), Global Medical Affairs, Abbvie Pty Ltd, Australia

09:40
[Interview Session]
Biosimilars Prospects in Asia Pacific from Regulatory Perspectives

  • Guidelines for approval process and the duration
  • Roles in the region and biosimilars development
  • What is needed for us to be able to truly harmonize biosimilar regulation?
  • When do you expect a full-scale implementation of biosimilars guideline?
  • How would the guideline difference from rest of SEA or will it following EU or US biosimilars guideline?

Interviewee:
Mary Ramos, Regional Regulatory Manager - APAC for Accord Healthcare

Interviewer:
Dr Anurag Tiwari, Biologic Development and Scientific Manager, Zumutor Biologics, India

10:20
Morning Networking Tea Break

10:50
Key Considerations in Demonstration Similarity in Biosimilar Development

  • Development Strategy for Analytical Methods
  • Design of Similarity and Characterization Study
  • Justification of Difference in Quality

Lee Kyoung Hoon, Assistant Senior Manager, Physico-chemical assay team Analytical Science Dept. R&D, Celltrion, South Korea

11:30
Digitalization and Innovation - From Clinical to Commercialization
Evelyn Pang, Head of Operations, Sanofi Aventis, Singapore

12:10
Networking Lunch

Legal Issues and Intellectual Property Rights

13:10
Overcoming Challenges in Licensing Deals for Biosimilars

  • Case study of big licensing deals
  • Lessons learnt
  • Pre-emptive understanding of challenges
  • Good licensing deals structure

Dinesh Kundu, General Manager, Biologics Business Strategy, Business Development & Program Management, Intas Pharmaceuticals, India

13:50
Transitioning from Biosimilar to Biobetter and Novel Biologics: Different Strategies for Optimised Antibody Production 
Dr Anurag Tiwari, Biologic Development and Scientific Manager, Zumutor Biologics, India

Closing Plenary Session
Joint Session with 3rd Annual Bioprocess & Technology Conference and 3rd Annual Biosimilars APAC Summit

14:30
Closing Q&A Session 
With speakers of the day from Bioprocess & Technology and Biosimilars APAC 

Biopharma Development and Production Asia Pacific Conference Wrap Up Q&A Session  

  • Where do we see the industry headed?
  • What are the emerging bioprocess technology trending in APAC?
  • Talent and technology – how is the synergy taking place?  
  • Biosimilars prospects in the region – opportunities and challenges
  • Taking local innovations and initiatives globally
  • The way forward

Pearl Fong, Associate Vice President, Division of Project Development, Mycenax Biotech Inc., Taiwan
Associate Professor Dieter TRAU, Associate Head Research, Department of Biomedical Engineering and Department of Chemical & Biomolecular Engineering, Faculty of Engineering, National University of Singapore (NUS)
Dinesh Kundu, General Manager, Biologics Business Strategy, Business Development & Program Management, Intas Pharmaceuticals, India
Karthik Ramani, Senior Director, Process and Product Development, Biocon 
Wen Zaiqing, Vice President of CMC, Generon Corpoation (Shanghai) Limited, China

15:15
Networking Afternoon Tea

16:00
End of Conference

0855
Chairman’s Opening Remarks
Karthik Ramani, Senior Director, Process and Product Development, Biocon, India

Next-Generation Therapeutics

0900
[Case Study] Successful Strategies for Development of Antibody-Drug Conjugates

  • Overcoming unique manufacturing and analytical challenges for ADCs
  • Case studies, with science-based control strategies
  • Opportunities for alignment

Nathan Ihle, Vice President, CMC Strategy & Management, Seattle Genetics, United States

0940
Targeted-integration Based CHO Glycoengineering for Producing High Efficacy Monoclonal Antibodies

Yang Yuan Sheng, Senior Staff Scientist, Bioprocessing Technology Institute, Singapore  

1020
Morning Networking Tea Break
Analytical Method Development Strategies

1050
Conducting Comparability Studies for Biologics Products

  • Principles for assessing the comparability of biological products before and after changes are made in the manufacturing process for the drug substance or drug product
  • Technical information to be acquired/assessed and which will serve as evidence that the manufacturing process changes will not have an adverse impact on the quality, safety and efficacy of the drug product

Karthik Ramani, Senior Director, Process and Product Development, Biocon, India

1130
[Case Study] High Throughput Analytical Platforms for Early Biopharma Development

  • Current Commercially Available High Throughput Analytical Techniques for Biopharma Development
  • High Throughput Methodologies Under Development
  • Analysis of High Throughput Data

Associate Professor Dieter TRAU, Associate Head Research, Department of Biomedical Engineering and Department of Chemical & Biomolecular Engineering, Faculty of Engineering, National University of Singapore (NUS)

1210
Networking Lunch

Upstream & Downstream Process Development & Characterization

1310
Downstream Process Characterization of Biotherapeutic Products

  • Scale down model
  • Resin life cycle validation
  • Virus clearance study

Pearl Fong, Associate Vice President, Division of Project Development, Mycenax Biotech Inc., Taiwan

Fill & Finish Operations

13:50
Advantages and Challenges in Prefilled Syringe for Biological Product Delivery

  • Advancement in syringe technology
  • Development of novel analytical methods
  • Possible solutions to overcome these manufacturing challenges

Wen Zaiqing, Vice President of CMC, Generon Corpoation (Shanghai) Limited, China

Closing Plenary Session
Joint Session with 3rd Annual Bioprocess & Technology Conference and 3rd Annual Biosimilars APAC Summit

14:30
Closing Q&A Session 
With speakers of the day from Bioprocess & Technology and Biosimilars APAC 

Biopharma Development and Production Asia Pacific Conference Wrap Up Q&A Session  

  • Where do we see the industry headed?
  • What are the emerging bioprocess technology trending in APAC?
  • Talent and technology – how is the synergy taking place?  
  • Biosimilars prospects in the region – opportunities and challenges
  • Taking local innovations and initiatives globally
  • The way forward

Pearl Fong, Associate Vice President, Division of Project Development, Mycenax Biotech Inc., Taiwan
Associate Professor Dieter TRAU, Associate Head Research, Department of Biomedical Engineering and Department of Chemical & Biomolecular Engineering, Faculty of Engineering, National University of Singapore (NUS)
Dinesh Kundu, General Manager, Biologics Business Strategy, Business Development & Program Management, Intas Pharmaceuticals, India
Karthik Ramani, Senior Director, Process and Product Development, Biocon 
Wen Zaiqing, Vice President of CMC, Generon Corpoation (Shanghai) Limited, China

15:15
Networking Afternoon Tea

16:00
End of Conference

 

 

*Session outline may change to accommodate market-specific or company development.