BioMedicaal Asia 2008 ŒöŽ®ƒTƒCƒg
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Day One 15 April 2008 Tuesday
 

08.00 Registration and refreshments

08.30 Organiserfs welcome remarks 

08.45 Guest-of-honour address 
         Lim Hng Kiang
, Minister 
         Ministry of Trade & Industry, Singapore

08.55 Chairman's welcome remarks

09.00  Global keynote address and executive interview: The evolving biomedical 
          science and industry

          • Market trends and drivers of the biomedical industry and crystal balling future growth
          • Emerging biomedical innovation from Asia and its impact 
          • The evolution of the global biotech capital market: Where and how does Asia fit into the 
            equation
         Keynote speakers:    
         Gordon Binder, Managing Director, Coastview Capital, USA
         Founder & former CEO, Amgen Inc, USA         
         Philippe Kourilsky, Chair of Immunology, College de France        
         Former Director General, Pasteur Institute, France    
         Ansbert Gadick, Founder & General Partner, MPM Capital, USA       
         Interviewer:
        
Lorraine Hahn, Journalist & TV Presenter, Former TV Talk-show-host & Anchor
         CNN and CNBC, Hong Kong

10.00 Morning refreshments, BioMedical Technology Showcase session & 
         combined
 

11.00 Chairmanfs Opening Address

UNCOVERING THE POTENTIAL OF ASIAfS BIOTHERAPEUTICS LANDSCAPE: AN INDUSTRY PERSPECTIVE

11.10 Keynote: Contributing to the global growing biotherapeutics pipeline: How Asia 
         biopharmaceuticals play a role
 
         • Emergence of biotherapeutics as an important therapeutic focus for many innovative 
           biotechs in Asia
         • Strategies Asian biopharmas adopt to compete to gain global recognition for innovation
         • Long and short term planning to gain sustainability and growth in global markets
         In-Chull Kim, Chief Executive Officer
         LG Life Sciences, Korea

11.40 Panel Discussion: How Asian nonprofits organizations can help your company 
         innovate and accelerate biotherapeutics development

         • Identify the most innovative research collaborations in Asia for a win-win partnership 
            between biopharma industry and nonprofits organisations
         • Navigate the key expertise for biotherapeutics development in Asia
         Chairman:      
         Andre Wan, Deputy Executive Director
         A*STAR, Singapore         
         Panelists:   
         Guotong Xu, Acting Director, Professor
         Institute of Health Sciences, China  
         Hyang-Sook Yoo, Director
         Fred Hutchinson Cancer Research Centre – KRIBB Collaboration Centre  
         Korea 
         
         Kakihara K
, Director
         Riken (Singapore Representative Office), Japan     
         Suet Wun Lim, Chief Executive Officer
         National Healthcare Group, Singapore

12.30 Networking luncheon hosted by

EVALUATING HOW CONDUCTING R&D IN ASIA CAN BE PART OF YOUR GLOBAL STRATEGY

14.00 Keynote: Major Biopharma requirements for partnerships with Asian academic 
        and industrial organizations

         • Insights into UCB R&D Strategy
         • Sustainability of the industry requires partnerships
         • What capabilities are the large biotechs looking for to invest in as part of strategic R&D 
            planning?
         Melanie Lee, Executive Vice President, Research and Development
         UCB Group, UK

14.30 Promises and challenges in biotherapeutics research and development     
         • How are biotherapeutics research and development framework differs from small molecule 
           drugs
         • What are the challenges faced and strategies to address biotherapeutics research and 
           development at discovery, pre-clinical and clinical stages
         Peter Buckel, Chief Executive Officer
         Suppremol GmbH, Germany

15.00 Developing future biotherapeutics in Asia: A regulatory approach to fast-track 
         biotherapeutics development to global market

         • Identify differences in regulatory requirements for various biotherapeutics including 
            therapeutic proteins, antibodies, vaccines, stem cells, tissues and other cellular therapies
         • Determine approaches towards assessing safety, efficacy, immunogenicity, potency, risks 
           and benefits of pre-clinical and clinical phases of biotherapeutics development
         • Perspectives on biotherapeutics developed in Asia compared to non-Asian countries, 
           establish key requirements for biotherapeutics developed in Asia to enter global markets
        Christopher Bravery, Pharmaceutical Assessor, Biologicals and Biotechnology Unit,  
        Medicines and Healthcare Products Regulatory Agency (MHRA), UK

15.30  Afternoon refreshments, showcase session &

COMMERCIAL AND CLINICAL POTENTIAL OF BIOTHERAPEUTICS DEVELOPMENT: OPPORTUNITIES AND CHALLENGES

16.30 CEO panel discussion: addressing unmet medical needs through biotherapeutics 
         development
 
         • Identify the existing therapies for key disease clusters
         • Determine how therapeutic proteins & antibodies, stem cells, gene therapy, RNAi silencing 
           therapy and other emerging therapy could provide a better medical solution
         • Comparison of opportunities and challenges in developing various biotherapeutics targeting 
            key disease clusters
         Moderator:    
         Brian Salmon
, Chairman and Managing Director
         Austrianova Singapore Pte Ltd, Singapore        
         Panelists:   
         Enrico Bastianelli, Chief Executive Officer
         Bone Therapeutics, Belgium    
         Iwao Nozawa
, Chief Executive Officer
         alphaGEN, Japan  
         Peter Buckel, Chief Executive Officer
         Suppremol GmbH, Germany 
         Thomas Okarma
, Chief Executive Officer
         Geron, USA   
         Paul Anderson, Chief Executive Officer
         Orthocell, Australia

17.20 Chairmanfs closing remarks

17.30 End of Day One

19.00 BioMedical Industry Awards & Gala Dinner

 

 

8.30  Registration and refreshments

8.50  Chairmanfs Opening Address

Focus Track 1: Protein Therapeutics

DISCOVERY, SCREENING AND DESIGN

9.00  Opening Keynote: Evolving development of next generation therapeutic antibody 
        by design
  
        • Development of re-engineered, improved, whole antibody and antibody fragment-based 
          products
        • Reduction in risk of immunogenicity by using fully human recombinant antibodies or human 
          antibodies derived from transgenic mice
        • Update on current humanization technologies developed and how scaffolding design are 
           used to improve efficacy characteristics
        • Upcoming trends in antibody engineering and design: concept of nanobodies
        Alejandro A Aruffo, Vice President, Global Pharmaceutical Development
        Abbott Bioresearch Center, USA

9.45  Case Study - Beyond Antibodies: Developing next generation biologicals from 
        protein scaffolds
  
        • Overview of the concept and development of beyond antibodies
        • Introduce the field of protein based scaffolds with real-world case studies
        • Where are the challenges in biotherapeutics development
        • Validating phylomers as a next generation class of therapeutic peptides
        Paul Watt, Vice President Technology Development
        Phylogica, Australia

10.30  Morning refreshments

IMPROVING, EVALUATING AND RE-ENGINEERING

11.00 Pre-clinical development and optimization of monoclonal antibodies  
        • Engineering and selection issues of protein therapeutics
        • Criteria for pre-clinical and clinical assessment of immunogenecity
        • Methods and strategies to deimmunise protein therapeutics
        Stephan Fischer, Senior Vice President, Biologics Research and Strategy
        Roche Pharma Research, Germany

11.45 Case study: Development of a monoclonal antibody for the treatment of B-cell 
         malignancies
  
        • Proof of Concept – strategies for target identification and characterization
        • Preclinical pharmacology and safety testing – immunogenicity
        • Clinical Development – broadening disease application
        Rosanne Dunn, Founder and Head of Clinical Development
        Immune System Therapeutics, Australia

12.30  Networking luncheon & showcase session

INNOVATIVE BIOTHERAPEUTICS DEVELOPMENT IN ASIA

14.00 Case study: Moving from traditional research to advanced technology to 
         spearhead therapeutic antibodies development in China

         • Use of proprietary technologies licensed and/or developed in-house for antibodies of better 
           characteristics
         • Challenges faced when developing innovative technologies for higher potency therapeutic 
           antibodies
         • Current state of biotherapeutics development in China and advantages of developing 
           therapeutic antibodies in China
        Jian Ni, Chief Executive Officer and Chief Scientist
        Human Antibodomics, China

14.30 Case study: Moving from biosimiliars to innovative therapeutics in India          • Identify the driving forces for India biopharmaceuticals to move from biosimilars to 
           development of innovative therapeutics
         • Challenges in moving away from biosimilars and strategies developed to progress towards 
            innovative therapeutics development
         • Case studies of innovative antibodies developed by Indian biotechs
         Subhra R. Chakrabarti, Head, Molecular Immunology and Drug Discovery
         Shantha Biotech, India

15.00 Therapeutic protein development for a niche market with cutting edge 
         technologies: Case studies from Japan

         • Understand the current state of therapeutic protein development in Japan
         • Identify the driving force and strategies Japan pharma adopt in developing innovative 
           therapeutic proteins
         • key challenges faced and opportunities for collaboration and partnerships to boost pipeline
         Hisafumi Okabe, Head, Research Planning and Coordination
         Chugai Pharmaceutical, Japan

15.30 Case study: Innovative therapeutics antibody development in Korea      
         • Leveraging on proprietary technological platform to achieve clinical success for its antibody 
           designed and developed in-house
         • Novel antigen screening, lead development and manufacturing process
         • Current state of biotherapeutics development in Korea and key advantages of developing 
            therapeutic antibodies in Korea
         June-Young Park, Chief Technology and Business Development Officer
         ISU Abxis, Korea

16.00 Afternoon refreshments

16.30 Interactive roundtable discussion

17.30 Chairmanfs closing remarks

Focus Track 2: Stem Cells

8.50  Chairmanfs opening remarks     
        Chris Mason, Director for Regenerative Medicine, Bioprocessing Unit
        University College London, UK

GLOBAL OVERVIEW OF STEM CELLS THERAPY: DISCOVERIES, OPPORTUNITIES AND COMMERCIALISATION

9.00  Honorary Opening Keynote: Stem cells and regenerative medicine as next 
        generation therapeutics: Opportunities and challenges

        • Provide a brief overview of the identification and role of stem cells
        • Give an update on the progress of stem cell therapeutics to the clinic, highlighting both 
           opportunities and challenges
        • Provide an overview of prospects for patient-specific cellular therapeutics 
        • Prospects for drugs to awaken and harness the activities of the patientfs own stem and 
          progenitor cells 
        Alan Colman, Executive Director
        Singapore Stem Cell Consortium, Singapore

9.30  Global partnerships and alliances among stem cells companies and academics to 
        bring stem cells therapy into clinic 

        • Provide overview of stem cells research funding in Asia, Europe and USA
        • Funding models for stem cells research to encourage global partnerships in stem cells 
           therapy
        • Legislation and regulatory framework for stem cells research and development to establish 
          best practices among academic and industry player globally
        Octavi Quintana Trias, Director, Health Research DG
        European Commission, Europe

10.00 Commercialization of Stem Cells: Translating Great Science into Successful 
         Business
  
         • Sources of funding for stem cells ventures 
         • Address issues in raising funds for stem cells ventures
         • How to project stem cells technologies and innovations to investors
         Greg Bonfiglio, Managing Partner
         Proteus Ventures, USA

10.30 Morning refreshments 

EMBRYONIC STEM CELLS

11.00 Overview of human embryonic stem cells therapy     
         • Recent breakthroughs in human embryonic stem cells therapy
         • Challenges and opportunities in developing human embryonic stem cells therapy
         • Niches for Asian stem cells players to accelerate stem cells therapy progression into clinic
         Thomas Okarma, President and Chief Executive Officer
         Geron, USA

11.30 Case study: stem cells research in China     
         • Provide an overview of stem cells research in China
         • Present the latest clinical data on stem cells research and development
         • Future directions of stem cell research and development in China
         Ling Song Li, Chief Scientific Officer, Stem Cell Research Center
         Beijing University, China

12.00 Case study: Embryonic stem cells to treat diabetes      
        • Describe proprietary encapsulation technologies use to generate a renewable source of 
           specialized cells that can be used to treat chronic cellular diseases
        • Latest clinical data demonstrating functional embryonic stem cells in curing life-threatening 
          diseases
        • Strategies in moving from proof-of-concept to clinical trials
        Alan Lewis, President & Chief Executive Officer
        Novocell, USA

12.30 Afternoon luncheon & showcase session

ADULT STEM CELLS

14.00 Strategies to bring a novel stem cell therapy through the regulatory process and 
         into the clinic: ReN001 for stable ischemic stroke, a case study

         • Technology issues: ReNeuronfs c-mycER technology for cGMP stem cell scale-up: 
            Advantages and burdens on the regulatory process
         • Preclinical issues: Understanding the appropriate GLP safety testing models and the 
            particular issues for stem cells 
         • Clinical Trials and Trial sites, what are the options and what are the difficulties?
         • The Regulators: Understanding the differing concerns from National Competent Authorities
         • What opportunities might lie in Asia for R&D partnerships? 
         John Sinden, Chief Scientific Officer
         ReNeuron, UK

14.30 Asia Pacific Case study: Adult stem cells therapy for wound healing  
        • Expansion of adult stem cells of clinical potential from both allogenic sources
        • Development of novel treatments for orthopaedic conditions, including the  
          commercialization of a unique adult stem cell technology aimed at the regeneration and 
          repair of bone and cartilage
        • Strategies to successfully bring stem cells therapy into clinics leveraging on its patented 
           proprietary technologies
        Silviu Itescu, Chief Executive Officer
        Mesoblast Limited, Australia

15.00  Technologies leveraging on multi-disciplinary approach to demonstrate stem 
          cells therapy feasibility

          • Proprietary technologies developed in the field of gene analysis, cell research and drug 
            discovery
          • Development of technologies and reagents specific to diabetes that use somatic stem cell 
             that can differentiate into pancreatic beta cell in addition to muscular dystrophy
          • Development of therapies for serious cardiac insufficiency and obstructive arteriosclerosis, 
            ischemia that uses human multipotent adipose-derived stem (hMADS) cells
          Mahendra Rao, Vice President, Stem Cell Technologies
          Invitrogen, USA

15.30  Case study: stem cells research in India     
          • Provide an overview of stem cells research in India
          • Present the latest clinical data on stem cells research and development
          • Future directions of stem cell research and development in India
          Satish Totey, Chief Scientific Officer
          Stempeutics Research Labs, India

16.00  Afternoon refreshments

16.30  Interactive roundtable discussion

17.30  Chairmanfs closing remarks

17.40  End of Day Two 

 

 

* Registration for the Masterclass will commence at 08.30am. The class will commence from 9am 
   to 5pm and refreshments & lunch will be served at appropriate times.
  

Protecting your IP while outsourcing to Asia

The wave of foreign outsourcing is continuing to fuel the expansion of Asiafs biomedical industry. However, some Asian countries are not yet reaching their full potential, as fears over inadequate intellectual property (IP) laws are holding many international companies back. This masterclass will address the current state of intellectual property (IP) law development in Asia countries, highlight case studies and strategies to adequately protect your IP while outsourcing R&D and manufacturing
to Asia, and evaluate the implications of IP protections when planning for outsourcing strategies in Asia.

This masterclass will address the following issues: 

• Venturing into Asia: Exercising IP Due Diligence
• Pharmaceutical IP Enforcement & Litigation in Asia
• Case Studies of Outsourcing to India and China
• Outsourcing to Asia: Key IP protection provisions in contracts
• The Interface between Pharmaceutical IP, Competition and Regulatory Laws, and Government 
   policy in Asia

 

Benefits of attending:

• Understand the current state of IP protection in Asia
• Gain insights into the challenges associated with identifying suitable advisors and conducting IP 
   risk analysis/freedom to operate
• Evaluate the importance of IP due diligence to secure protection through registration strategies
• Assist participants identify where weaknesses exist and the risk posed by such weaknesses
• Learn from real life case studies presented by end-users in assessing various key factors crucial 
   to outsourcing decisions

Who should attend?

• CEO, COO, CTO, CSO, CLO
• Head of Licensing
• Head of Business Development
• Head of New Technology Development
• Head of Strategic Alliances
• Head of Search and Development
• Head of Marketing
• Patent Agent/ Partner/ Attorney/ Legal Counsel
• Commercialisation Officer
• Venture Capitalist
• Analyst

Masterclass leader:                                                                                                       Edward A Madden, Associate Director & International Counsel
Biogen Idec, Switzerland

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