Agenda

08:00
Registration Starts & Morning Coffee

09:00
Chairperson’s Opening Remarks


DAY ONE OPENING PLENARY SESSIONS
Bioprocess & Technology and Cell and Gene Therapy Conferences


09:10
Keynote Opening Session:
Bioprocess Innovation and Personalised Medicines in the Age of Everything 4.0

James Yang, CEO, You Lou Biotechnology, Yuandong Biopharmaceuticals, China

09:40
Keynote Panel:
Bringing Together Trends in Process Technology, 4.0 And New Therapy Development

  • Collaborative efforts in promoting Pharma 4.0
  • Technological and commercial drivers
  • Scaling up production of CGT – What do we need in the region?
  • Digital strategy and preparing workforce for pharma 4.0
  • Next generation tech tools for manufacturing regenerative medicines

Panellists:
Tan Kar Wai PhD, Research Director, R&D department, Tessa Therapeutics, Singapore
Chung-Liang Shih PhD, Director-General, Department of Medical Affairs, Ministry of Health & Welfare, Taiwan
LI Yi PhD, Chief Scientific Officer, Xiangxue Life Sciences, China

10:30
Morning Networking & Refreshment Break


INNOVATIONS IN BIOPROCESS AND NEW THERAPIES


Chairman’s Opening Remarks

11:00
Innovation in Biomanufacturing / Digital Biomanufacturing – Global and Regional Perspectives

  • Rise of personalised medicines and effects on biomanufacturing
  • Challenges in the supply chain and regulatory considerations
  • Innovations available to address the challenges

Charles Jeffries, Pharma Tech Operations, Site Operational Management, Roche, Switzerland

11:30
Rethinking Efficiency with Biopharma 4.0 – How China is Moving Ahead

  • Regional technology trends investment in pharma industry
  • Embracing digital transformation and effective innovations for immediate implementation in pharma
  • Converging Biotech and Infotech – Where does feasibility stand?
  • Use cases on digital accelerators like cloud-based systems, big data and wireless sensors

James Yang, Chief Executive Officer, You Lou Biotechnology, Yuandong Biopharmaceuticals, China

12:00
Biosimilars in Clinical Practice – Real World Outcomes

  • Biosimilar study design aspects
  • Clinical trial versus real world data
  • Non-medical switching considerations

Daniel Furtner, Medical Director, Regional Medical Affairs, Janssen Asia-Pacific

12:30
Industry Panel:
Innovation in Process, and Investment Trends in Tech

  • Bioprocessing for cell and gene therapy – trends and market needs
  • Machine learning and digital transformation in bioprocessing
  • Innovation trends in managing virus contamination
  • Robotic automation to enable high throughput development
  • Convergence of IT and processing technologies in smart facilities
  • What to consider, upgrading facilities for new therapies

Panellists:
Charles Jeffries, Pharma Tech Operations, Site Operational Management, Roche, Switzerland
Michelle Peak, Senior General Manager, PT Kalbio Globa Medika, Indonesia
Tulip Nuwal, Head – Biopharma Business Operations and Excellence, Intas Pharma, India
Michael Chua, CEO, GenomixLAB, Malaysia

13:00
Networking Lunch


MANUFACTURING OPERATIONS IN THE DIGITAL AGE


14:00
Using Data, Artificial Intelligence and Machine Learning to Improve R&D Productivity

  • Utilising Data Science & PAT Tools for decision making in the Bioprocess Life Cycle
    • Opportunities in data management
    • Optimising the biologics development lifecycle
    • Data-driven operations for next generation bioprocessing
    • Roche’s case study

Ivan John Clement, R&D Portfolio Data Strategy Lead, Roche, Switzerland

14:30
Operational Excellence and Agile Biopharma Operations

  • Capex Planning and procurement to positively impact bioprocess
  • Benchmarking Agile biopharma operations
  • Manufacturing facilities compliance and sustainability
  • Building quality culture in digital age
  • Quality manufacturing best practices

Tulip Nuwal, Head – Biopharma Business Operations and Excellence, Intas Pharma, India

15:00
Developing Biotechnology Solutions for DNA Genetics and Stem Cells Innovation

  • Exploring Cell Culture Systems
  • Working on Protein Expression and purification
  • Applications in Medical

Michael Chua, CEO, GenomixLAB, Malaysia

15:30
Afternoon Networking & Refreshment Break

16:00
Using Statistical Inference and Mathematical Modelling for Perfusion Process

  • Identifying value to impact bioprocess
  • Optimising outcomes in cell viability and robustness
  • Improving productivity and quality

For speaking opportunities, contact yvonne.leong@ibcasia.com.sg


DOWNSTREAM PROCESSING AND SCALABILITY


16:30
Addressing Tech Transfer Challenges

  • Technical Challenges from adaptation to commercialisation
  • Why communication is key
  • What tools are needed to deal with the challenges
  • Role of intellectual property (IP) in tech transfer
  • Effective tech transfer from R&D to clinical to commercial

Michelle Peak, Senior General Manager, PT Kalbio Globa Medika, Indonesia

17:00
Downstream Process Development of Recombinant Biosimilar Products

  • Design and validation (IQ, OQ and PQ) of equipment
  • Evaluating downstream processes in the production environment
  • Allocation of resources in MS&T

Pankaj Gour, Senior Director, MS&T Wuxi Biologics, China

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


CELL & GENE THERAPY REGULATORY UPDATES


Chairman’s Opening Remarks

11:00
Taiwan:
Implications of New Regulation on Cell and Gene Therapy Product in Taiwan

  • Overview regulatory of cell therapy product
  • Current Regulatory Framework
  • New regulation update on cell therapy

Chung-Liang Shih PhD, Director-General, Department of Medical Affairs, Ministry of Health & Welfare, Taiwan

11:30
Thailand:
Current Regulatory System for CGT Development – Challenge and Opportunity

  • Development of registration pathway for ATMPs and cell therapy product
  • Thailand’s regulatory system and quality management
  • ASEAN’s potential for CGT, and partnership opportunities
  • How can we scale up?

Morakot Papassiripan PhD, Pharmacist at the Professional Level at the Biological Sub-Division, Bureau of Drug Control, Food and Drug Administration of Thailand


MANUFACTURING OUTLOOK


12:00
Singapore:
World Largest Solid Tumor Phase III Trial and Treatment for HPV Related Cancers

  • Multi-center trial to evaluate the safety and efficacy of HPVST therapy
  • Novel Combination CAR-T Cell Therapy
  • Overcome the challenges of the immunosuppressive tumor microenvironment
  • Safety switches
  • Clinical trials costs considerations

Tan Kar Wai PhD, Research Director, R&D department, Tessa Therapeutics, Singapore

12:30
China:
Clinical Trials and Manufacturing for TCR-T Product

  • Discovery, development and commercialisation of novel therapies for the treatment of cancer and related conditions
  • Cutting-edge technologies with high affinity specific T-cell receptor (TCR)
  • Manufacturing strategies for TCR-T cells
  • Overcome the challenge of scale up cell therapy products
  • Flexible cell processing and digital connectivity

LI Yi PhD, Chief Scientific Officer, Xiangxue Life Sciences, China

13:00
Networking Lunch

14:00
How is Taiwan Looking into Next-gen Cell and Gene Therapies Manufacturing Technologies?

  • Supportive cell therapies environment in Taiwan
  • Cell therapy: is there the future for medicine?
  • Safe and effective new techniques to address the unmet medical needs
  • Raw or starting materials sourcing
  • Cell therapy and regeneration medicine development in Taiwan
  • R&D case studies

Rita Yen-Hua Huang PhD, Distinguished Professor and Dean Office of Research and Development, Taipei Medical University (TMU), Director, TMU Research Center for Cell Therapy and Regeneration Medicine, Executive Director Board, Taiwan Association for Cell Therapy (TACT), Taiwan Society for Stem Cell Research (TSSCR)

14:30
Indonesia:
Challenges in Stem Cell Production in Indonesia

  • Indonesian regulation updates since 2018
  • Manufacturing challenges and opportunities
  • Processing technology updates
  • Marketing overview and tips sharing in investing in Indonesia
  • Cell harvest case studies in Indonesia

Sandy Qlintang, Deputy Director of Stem Cell and Cancer Institute, PT Kalbe Farma, Indonesia 

15:00
Outlook for Commercial Transfer of Innovative Immune Cell Therapy Technologies in Asia

  • Collaborations to drive immune cell therapy for virus-related tumors
  • Optimising production of materials cell therapy

Victor Li, CEO, Biosyngen, Singapore

15:30
Afternoon Networking & Refreshment Break


CAR-T AND REGENERATION TECH


16:00

CAR-T Technology Development and QbD in CAR-T Manufacturing

  • Latest developments in CAR-T technology process
  • CAR-T design and process automation, key to large scale stem cell manufacturing
  • Focus on efficacy, reproducibility, manufacturing costs
  • How to manufacture of high-quality cell therapy product?

Yarong Liu, Director of Research and Development, HRAIN Biotechnology Co., Ltd, China

16:30
New Technology Pipeline for CAR-T and Developments in Solid Tumors

  • Overview of global technology development in CART and TCR-T
  • Winning strategies to meet new challenges to treat solid tumors: choice of antigen, T cell fitness, and sensitization of tumor milieu
  • Cutting-edge science to develop new targeted CAR T therapies for solid tumors
  • Pipeline and technology platform building

Li Zhu PhD, Chief Strategy Officer, Legend, China

17:00
Commercialising Cell Therapy Products- Strategy and Challenges

  • Hospital’s role in cell therapy manufacturing
  • Innovation in commercial operation
  • QbD: Is the current model suitable for cell and gene therapy products?
  • Solution for large-scale C&G therapy manufacturing

Harry Lam, CTO, JW Therapeutics, China

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

08:30
Morning Coffee

09:00
Chairperson’s Opening Remarks


OPENING PLENARY
BIOPROCESSING AND COMMERCIALISATION OF CELL AND GENE THERAPY


9:10
Panel Discussion:
Meeting the Demands of the C&GT Products – How Can Technology Help Improve Speed to Market

  • Typical challenges in commercialisation
  • Use cases of process and technology impacting speed to market
  • How do regional facilities need to adapt?
  • Regulatory considerations
  • Supply chain considerations

Panellists:
Lietao Li PhD, Chief Executive Officer, BioSyngen Pte Ltd, Singapore
Harry Lam, CTO, JW Therapeutics, China
Sandy Qlintang, Deputy Director of Stem Cell and Cancer Institute, PT Kalbe Farma, Indonesia 
LI Yi PhD, Chief Scientific Officer, Xiangxue Life Sciences, China
SweeHai Lim, Cell Culture Manufacturing Lead, Shire, Singapore

9:50
Panel Discussion:
Biotech and Investors’ Views on the Money Market

  • Investment in advanced engineering and manufacturing technology to reduce cost of product
  • What’s the next wave of cell and gene therapies?
  • New business models and partnerships
  • Where is investment being directed

Panellists:
Chung-Liang Shih PhD, Director-General, Department of Medical Affairs, Ministry of Health & Welfare, Taiwan
Lynn Yap PhD, Senior Research Fellow, Duke-NUS Medical School, Singapore
Morakot Papassiripan PhD, Pharmacist at the Professional Level at the Biological Sub-Division, Bureau of Drug Control, Food and Drug Administration of Thailand

10:30
End of Plenary Sessions
Morning Networking & Refreshment Break


OPTIMISING UPSTREAM PROCESSING


11:00
Optimizing Cell Line Development

    • Advances in Cell line deveopment and cell culture engineering
    • Challenges of cell line development for antibody production

Matheus Alvin Prawira, Stem Cell and Cancer Institute, PT Kalbe Farma, Indonesia

11:30
Monitoring the Scale Up of a Biopharma Cell Culture Process

  • Ensuring product safety in biomanufacturing
  • Dealing with FDA and other regulatory audits
  • Completing process validation activities

SweeHai Lim, Cell Culture Manufacturing Lead, Shire, Singapore

12:00
Process Development of MAbs

  • Process Characterisation and qualification
  • Process Validation and continuous verification
  • Increase robustness through statistical control and analysis

Mayank Garg, Process Expert/Team Lead, Sanofi, France

12:30
Networking Lunch

13:30
Speed to First-In-Human: Advanced Analytical Technologies Supporting Monoclonal Antibody Product and Process Development

  • Early phase CMC development processes, risk management, and timelines
  • What’s on the cutting edge of analytical technologies and method development
  • Integrating process development, product development, with advanced analytics

Peiqing Zhang, Director of Analytical Sciences, Transcenta, Singapore


SCALE-UP AND COMMERCIALISATION STRATEGIES


14:00
Improvement Opportunities in Scale Up and Manufacturing Operations

  • Commercial process development and scaling up
  • Strategies of innovative manufacturing for scaling up production
  • Cost savings on R&D, process scale up and manufacturing operations

Minh Tran, Chief Operations Officer and Global Manufacturing Head, Stelis Biopharma, Singapore

14:30
Improving Purification & Recovery

Mahesh Bhalgat, COO, Syngene International, India

15:00
Afternoon Networking & Refreshment Break

15:30
Quality Management Systems: Optimising Formulation, Quality & Stability of Biologics

  • Ensuring quality in Bioprocessing
  • Emerging technologies to support speed and quality of formulation development
  • Solving challenges in an era of accelerating timelines

Ronald Marascheni, Senior Vice President QA, Alvotech, USA

16:00
A Look at Computational Biology and Bioinformatics

  • The impacts data age to bioprocess management and drug discovery
  • Updates on use in the region
  • Computer-aided drug design, machine learning, and pharmainformatics
  • What can we expect in the near future?

Kumar Selvarajoo, Senior Research Scientist @ BioTrans, A*Star, Adjunct Principal Investigator, Synthetic Biology center (SynCITI), NUS, Singapore

16:30
Cost Control Panel:
Winning the War on Manufacturing Costs

  • Operations managers’ views on managing cost
  • Lean strategies for cutting and managing manufacturing costs
  • Benchmarking regional OPEX cases
  • Key takeaways

Panellists:
Mahesh Bhalgat, COO, Syngene International, India
Minh Tran, Chief Operations Officer and Global Manufacturing Head, Stelis Biopharma, Singapore
Mayank Garg, Process Expert/Team Lead, Sanofi, France
Ronald Marascheni, Senior Vice President QA, Alvotech, USA
More panellists to be confirmed

17:15
Chairperson’s Summary and End of Conference