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Day One Wednesday 3 September 2008
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08.00 | Registration and refreshments
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08.45 | Chairman's opening remarks
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| | Mr Rathin Das, Senior VP Corp Development, Chief Business Officer, Affitech, USA
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| UNDERSTANDING THE ANTIBODY INDUSTRY LANDSCAPE IN ASIA |
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09.00 | Asia-Pacific leaders panel discussion: The emerging Asian antibody industry landscape: Navigate your business opportunities in Asia
- Key players in Asia’s antibody industry, status and proportion of big and small players
- Comparison of technology gap, market readiness of domestic and international antibodies industry development
- Growth through creation of innovative drugs and new markets: Are there innovative antibodies in development in Asia?
- Crystal balling the future: What is the position of Asia’s antibody
industry on the world map?
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| | Dr Ya-Jun Guo, Director, Shanghai Cell Engineering and Antibody Centre, China Dr Rob Crombie, COO and VP Business Development, Arana Therapeutics, Australia
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09.45 | Cross Talk: Capitalizing on strategic alliances to tap into Asia’s burgeoning antibody market
- Roche’s leading antibody portfolio leveraging on innovation as the core of Roche’s growth strategy
- External alliances and partnerships central to strengthening
its R&D portfolio, building up its antibody portfolio and gaining
access to key technologies
- Examples of product and technology alliances and Roche’s
latest steps for tapping into the emerging Asian market
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| | Dr Frank Grams, Business Development Director, Asia , Roche Pharma Partnering, Roche, China
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10.15 | Morning refreshments
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| THE EVOLVING BUSINESS MATCHMAKING IN ASIA:PROFITABLE BUSINESS MODELS |
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10.45 | Case study: A successful story of east west partnerships to capture Asia’s growing antibody market
- Innovative partnership models capitalizing on Asia’s burgeoning antibody market
- Leverage on mutual strengths to expand development and
product pipelines
- Strategies for early and late stage product development
partnerships
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11.15 | Case study: Zooming into innovative partnerships in China, India and Southeast Asia to penetrate Asia's antibody business
- Perspectives from emerging markets on differences in partnerships needs
- Case studies of partnership models among institutions and Asia’s biopharmaceutical companies to leverage on mutual assets in strategic alliances
- Moving forward: Where are the opportunities and key strategies
to bring products into markets
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11.45 | Case study: Creating one of the largest pipeline monoclonal antibody companies in Asia-Pacific through smart partnerships,licensing deals and M&A
- Innovative acquisition business models to fast track antibody development
- Novel technology platforms to overcome challenges in identifying novel therapeutic leads of commercial potential for licensing opportunities
- Partnership models to share upstream risks and downstream costs
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| | Dr Rob Crombie, COO and VP Business Development, Arana Therapeutics, Australia
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12.15 | Networking luncheon and poster session
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| SPEED UP YOUR MARKETING APPROVAL FOR MONOCLONAL
ANTIBODY PRODUCTS |
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13.30 | Regulatory requirements essential for made-in-Asia antibody products for entry into the European and US markets
- Strategies to get your antibody to market rapidly
- Pre-clinical and clinical regulatory requirements
- How the recent EMEA update impact on monoclonal antibodies
production
- Regulatory issues affecting business strategy
- Is the biosimilar paradigm applicable to monoclonal antibodies
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14.00 | Panel discussion: Industry gurus’perspective on penetration into the global market with smart strategies to fast track marketing approval into USA and Europe
- Challenges in application for marketing approval for Asian antibody product developers and manufacturers
- Differences in regulatory standards and framework between Asia, USA and Europe for antibody products
- Case studies from Asia for bringing antibody products into the global market
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| | Mr Jay Madan, Vice President, Business Development, Reliance Biopharmaceuticals, India
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14.45 | Biosimilar antibody development in Asia: Unleash the
commercialization potential in Asia’s biopharmaceutical
landscape
- Comparison of biosimilar development landscape in India with other Asian countries
- Regulatory requirements for biosimilar antibodies to enter India, South America, East Europe and Central Asia markets
- What are the pricing strategies of biosimilar antibodies in different markets
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15.15 | Speednetworking
 Bring plenty of business cards for a fast and furious interactive session
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15.45 | Afternoon refreshments
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| STRATEGIC PLANNING IN COMMERCIAL MANUFACTURING |
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16.15 | Best practices for asian manufacturers in producing high
quality antibodies
- The actual cost of setting up key facility and infrastructure for commercial scale manufacturing
- Modern approaches to scale-up from a pilot scale to commercial scale production
- Bridging the technology gap between Asian and Western manufacturers
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| | Dr Ya-Jun Guo, Director, Shanghai Cell Engineering and Antibody Centre, China
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16.45 | Panel session: The future of Asia being a monoclonal antibody manufacturing hub
- Emerging trends in pharmaceutical outsourcing market for biological products. Why outsource manufacturing and risk costly technology transfer delays?
- Analyzing best practice outsourcing strategies to ensure implementation into future processes
- Critical assessment of Biomanufacturing outsourcing focusing on key current issues such as patent protection and related legislative changes
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| | Dr Donald Gerson, COO & President, Technology & Manufacturing Divisional Group, Celltrion, Inc.
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17.30 | Chairman's closing remarks and close of Day One
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18.00 | Networking cocktail
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Day Two Thursday 4 September 2008
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08.30 | Registration and morning refreshments
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08.45 | Chairman's opening remarks
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08.46 | STATE OF THE ART TECHNOLOGIES FOR ANTIBODY DISCOVERY
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09.00 | Keynote: Propelling the growth of new antibody therapeutics discovery and development through smart product differentiation strategies
- Accessing & validating novel targets
- Antibody discovery platforms & lead selection strategies
- Optimization through engineering for improved efficacy
- Payload strategies & combination therapies
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09.30 | Ideal targets for development of highly potent cancer
antibodies
- Scientific and pharmacological concept of ideal targets
- Approaches for their discovery and validation
- Target customized antibody development
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| | Dr Ugur Sahin, Co-founder and Chief Medical Officer, Ganymed Pharma, Germany
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09.50 | Efficient selection and manufacturing strategies for human
antibodies
- Process challenges when selecting customized therapeutic lead antibody candidates from large antibody libraries
- High-throughput methods for lead selection of antibody candidates
- Various strategies to provide antibody material from different expression systems: Screening to pre-clinical trial supply
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10.10 | Potent and highly selective protease inhibitors from antibody phage display
- Phage display and automated screening allows deep mining of libraries for protease inhibitor lead candidates
- In vitro selection strategies can enhance inhibitor yields
- Pharmacology of protease inhibitor antibodies to be presented
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| | Dr Clive Wood, Executive Vice President and Chief Scientific Officer, Dyax Corp, USA
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10.30 | Morning refreshments
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| MODERN TECHNOLOGIES IN ANTIBODY ENGINEERING |
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11.00 | Antibody selection against novel protein targets through
protein mimics identified with cutting-edge technology
- Mapping of discontinuous epitopes and complex receptorligand binding sites
- Selection of highly potent immunogens that induce antibodies that recognize the native antigen
- Future trends in selection of antibodies against “impossible targets”(GPCR’s) through synthetic protein mimics
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| | Dr Jerry Sloostra, Director, Epitope Mapping and Protein Mimicry, PepScan, Netherlands
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11.20 | Generation of therapeutic human antibodies in TransChromo
mouse
- Advantage of KM mouse for generation of functional antibodies
- Induction of the signal to target cells by agonistic antibody
- Improvement of therapeutic antibody by alteration of Fc sequence
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11.40 | A clinically validated, novel method for human antibody
engineering: Humaneering
- Closer to human germline than other technologies
- Improves 'down stream processing' issues
- Doesn't rely on other engineering technologies
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12.00 | Case study: Therapeutic Antibodies without Helper T cell epitopes
- Concept of therapeutic antibodies without helper T cells
- Preclinical immunogenicity data
- Platform for early assessment of relative risk of immunogenicity
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| | Dr Frank Carr, Founder, Director of Biologics Research, Antitope Ltd, United Kingdom
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| INNOVATIVE ANTIBODY DEVELOPMENT IN ASIA |
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14.00 | Case study: Development of a therapeutic monoclonal antibody against Hepatitis B virus
- Targeted discovery by screening phage display antibody library
- Characterization assays and platforms to determine cross reactivity of antibodies on various in vivo models
- Strategies to overcome challenges faced when establishing cell lines to produce specific antibodies of desired characteristics
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| | Dr Se-Ho Kim, Research Director, Research Center, Green Cross Corp, Korea
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14.20 | Case study: An overall study of the efficient control of hepatocellular carcinoma (HCC) with HAb18G/CD147 antibody systems
- LICARTIN is one of promising drugs in HCC therapy
- Inhibitory effect on HCC metastasis and recurrence
- HAb18G/CD147 as a cancer biomarker in diagnosis, differentiated diagnosis and prognosis evaluation
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| | Prof Zhinan Chen, Director, Cell Engineering Research Centre / Department of Cell Biology, Fourth Military Medical University , Fourth Military Medical University, China
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14.40 | Case study: Generation of fully-human monoclonal antibodies for the treatment of colon cancer and ovarian cancer
- Immunotherapy of colorectal cancer using anti-TAG72 antibody
- Humanization and affinity maturation
- Tumor targeting efficacy
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| | Dr Hyo Jeong Hong, Director, Therapeutic Antibody Research Center, Korea Research Institute of Bioscience and Biotech, Korea
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15.00 | Monoclonal drug development - An indian perspective
- Experience of developing novel monoclonal antibodies through early phase clinical trials in India
- Role of biomarkers using immunohistochemistry for an oncology study
- Mechanism of action of a novel immunomodulatory monoclonal in inflammation
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15.20 | Afternoon refreshments
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| NEXT GENERATION ANTIBODIES: PROMISES AND CHALLENGES |
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15.50 | Case study: T cell-engaging BiTE antibodies for cancer therapy
- BiTE antibodies uniquely recruit T cells for cancer therapy
- Clinical proof of concept: CD19-specific BiTE antibody
- Anti-tumor activity for EpCAM-specific BiTE antibody
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16.10 | Therapeutic potential of antibody fragments
- Comparing antibody structure and understanding mechanism of action
- Alternative means of antibody production: microbial versus mammalian
- Antibody fragments in the clinic
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| | Dr David Glover, Director, Bioprocess R&D, UCB Celltech, UCB Celltech, UK, United Kingdom
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16.30 | Case study: Enhancing interaction efficiency using proprietary technologies to increase anti-tumor activity of a humanised monoclonal antibody
- Generation of fucose-free antibodies
- Increased binding affinity to Fc Receptor
- Reduced therapeutic doses, lowered cost of goods and no immunogenicity concern
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16.50 | Asia Antibody Congress poster award ceremony
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17.10 | Chairman's closing remarks
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17.20 | End of conference
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Pre Conference Masterclass A: Tuesday 2 September 2008
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08.00 | Registration
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| GAINING REGULATORY APPROVAL FOR THERAPEUTIC MONOCLONAL ANTIBODY FOR THE US AND EU MARKETS |
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09.00 | Start of Masterclass
 The favorable regulatory climate and mechanism that facilitates accelerated approval provides an attractive landscape for the development and production of innovative therapeutic antibodies in Asia for both the unique Asian and global market.There has been an increasing number of Asia biologics manufacturers developing antibody products for entry into the US and European markets. Regulatory approval framework varies between different markets. Against this backdrop, this workshop serves to address the key issues that will help Asian antibody manufacturers bring made-in- asia antibody products into the US and European markets.
Key issues to be addressed:
- Strategy of development of therapeutic monoclonal antibodies in Asia.
- Regulatory perspective on therapeutic antibodies development for US
market.
- Pharmacology and Toxicology studies required by US FDA for clinical
trial of therapeutic monoclonal antibody.
- Immunogenicity issues in development of therapeutic antibodies
Benefits of attending
- Hear opinions from the former US FDA reviewer who worked many
years in division of monoclonal antibodies
- Learn the current technology and strategy for development of therapeutic antibodies
- Learn necessary preclinical studies on therapeutic antibodies for clinical
trial
- Learn regulatory issues in manufacturing of therapeutic monoclonal
antibodies
- Learn immunogenicity issues in development of monoclonal antibodies
- Learn appropriate strategy for therapeutic monoclonal antibodies for
asia biopharmaceuticals
Who should attend:
- Middle to high level management personnels from pharmaceutical
companies, R&D companies and venture capitals
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Pre Conference Masterclass C: Tuesday 2 September 2008
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08.00 | Registration
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| MANUFACTURING AND SCALE-UP ISSUES OF MONOCLONAL ANTIBODIES PRODUCTION |
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09.00 | Start of Masterclass
Monoclonal antibodies are one of the most important classes of therapeutic recombinant proteins. They are under clinical evaluation for a broad range of important therapeutic areas including cancer, rheumatoid arthritis and infectious diseases. Significantly, classical Biotech companies are no longer the only players and traditional large Pharma companies have now also recognized the potential of recombinant manufactured monoclonal antibodies.
This Masterclass will cover topics process development (e.g. cell line optimization and down stream processing), analytics, formulation aspects and manufacturing. An important element of the Masterclass will be the attention paid to current regulatory requirements for the introduction of
monoclonal antibodies.
Key issues to be addressed:
- Latest advancements in upstream development including expression systems and feed strategies
- Downstream development including purification and recovery
optimization
- Physical characterization, formulation and delivery systems
- Scale-up issues and production scale manufacturing
- Analytics and specifications
Benefits of attending:
- An understanding of the principles of process validation as they apply to vaccine production
- An appreciation and practical application of how to incorporate process mapping and risk assessment into the validation plan
- A basic understanding of planning validation projects
- Practical tips on pitfalls and how to avoid them
Who should attend:
- Bioprocess, manufacturing and production directors and scientists
- Process validation scientists and engineers
- Quality assurance and control professionals
- Antibody technology research and development directors and scientists
- Biologics Process R&D Vice Presidents, Directors and Scientists
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| | Dr Donald Gerson, COO & President, Technology & Manufacturing Divisional Group, Celltrion, Inc.
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Post Conference Masterclass B: Friday 5 September 2008
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08.00 | Registration
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| IMMUNOGENICITY ASSESSMENT OF THERAPEUTIC ANTIBODIES: STRATEGIES AND REGULATORY ENVIRONMENT |
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09.00 | Start of Masterclass
Immunogenicity of biological products can occur pre-clinically and clinically when products elicit immune responses in animals or humans receiving the products. This is a concern for manufacturers, regulatory agencies and clinicians as immune responses can result in effects on product effectiveness and safety. The clinical sequelae of immunogenicity range from no effects to serious, life-threatening syndromes. Although many biological products are immunogenic to some extent, it is quite rare that immunogenicity will lead to serious adverse events. This workshop will provide an overview of regulatory, clinical and non clinical approaches to immunogenicity and the impact of new guidelines on design, assessment and manufacturing of new and existing antibodies. This workshop will also demonstrates the use of structural bioinformatics in the smart design of therapeutic antibodies.
Key issues to be addressed:
- Overview of the regulatory, clinical and non-clinical approaches to
assess the immunogenicity of therapeutic proteins.
- New guidelines for immunogenicity screening of protein therapeutics
issued by the EMEA, and guidelines for biosimilars drafted.
- Explore how the guidelines apply to therapeutic antibodies.
- Information provided for a risk based approach in immunogenicity
screening, and how this is translated in the clinical assay development
strategy.
Special attention will be given to preclinical and predictive immunogenicity screening methodologies, addressing in vivo, in vitro and in silico methods
supporting the drug design cycle.
Benefits of attending:
- Gather a general overview of the risk assessment related to
immunogenicity
- Learn best strategies to follow in order to optimally assess and address
immunogenicity of antibody therapeutics
- Gain insights from industry experts as they share their thoughts on
immunogenicity in an interactive session addressing your specific
questions
Who should attend:
- Project managers
- Scientific directors
- Protein engineers
- CMC managers
- Pre-clinical development directors
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