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Conference Day One - Tuesday 9 June 2009
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8am | Registration and refreshments
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8.40am | Organiser’s welcome remarks
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8.45am | Chairman’s opening remarks
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| OUTLOOK AND GROWTH POTENTIAL OF VACCINE BUSINESS IN ASIA |
CEO Keynote and Interview
In this session, leading CEOs are put in the spotlight with a one-on-one headliner interview, fielding questions on sustainability and growth of vaccine business in Asia. We will hear from leaders of international vaccine companies with a huge stake in
Asia vaccine business on how they reshaped and reinvent their business models with a focus on Asia markets.
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9.20am | Forging ahead with new and innovative strategies to enter
international vaccine marketplaces: An Indian vaccine
manufacturer’s perspective
- What are your visions on India’s vaccine industry?
- What are the secrets to the success of Indian Immunologicals?
- How does Indian Immunologicals leverage on the current success to succeed and maintain its position in the industry?
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9.40am | Intercell’s Success Story on becoming a globally significant player in the industry
- What do you think are the key decisions you have made in contributing to the success of Intercell?
- From a start-up biotech to a globally signifi cant player, what was
- Intercell’s major turning point that has led to this success?
- How does Intercell compete with major pharmaceuticals with larger muscles in the global marketplace?
- How do you foresee Asia’s participation in Intercell’s business strategy?
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10am | ‘Live in conversation’ with 3 legendary Vaccine Business
CEOs
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10.30am | Morning refreshments
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| ASSESSING AND FORECASTING PUBLIC MARKETS |
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11am | Public health panel: Strategies and plans in using vaccines to prevent infectious diseases in developing nations
- Identifying diseases with the highest priority and demand for vaccines development
- Pre-requisites in introducing vaccines to developing nations
- Innovative strategies from public health authorities to increase demand for underutilized vaccines
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| | Yoshikuni Sato, Medical Officer, World Health Organisation, Philippines Ann Ottosen, Contracts Officer, Immunization Team, UNICEF Supply Divison, Denmark Dr Rajat Goyal, Country Director, International AIDS Vaccine Initiative (IAVI), India, India
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11.45am | Immunization officer panel: Identifying in-demand vaccines in Asia for government immunization strategies
- Immunization plans of CDCs in Asian countries
- Identifying which vaccines to prioritize in implementing country-wide programs
- Unique challenges for Asian countries to access new vaccines
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| | Prof Sann Chan Soeung, Deputy Director General for Health and EPI Program Manager , Ministry of Health, Cambodia, Cambodia Moderator: Rajiv Khanna, Director, Australian Centre for Vaccine Development
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12.30pm | Networking lunch
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| SUCCESSFUL PRODUCT DEVELOPMENT STRATEGIES IN ASIA
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2pm | Navigating product development priorities and selection
strategies for sustainable profitability
- Evaluating market condition for product development priorities
- Balancing development portfolio: How do you make the shift form generic versus innovative vaccines
- Determining the driving factors in deciding how much to invest in specific vaccine developments
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| | Dr Yaqoob Ali, Chief Operating Officer, Shantha Biotechnics Limited, India
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2.30pm | U-Turn
U-Turn is a panel session with you and your peers as conference delegates assuming panel roles extemporaneously.
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3pm | Speed networking
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3.30pm | Afternoon refreshments
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| PARTNERSHIP STRATEGIES TO EXPAND VACCINE BUSINESS IN ASIA
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4pm | Leveraging on collaborative partnerships to enable greater
access to technology
- Understanding the signifi cant role of technology in vaccine development
- Maximizing technologies readily available in the market
- Building a collaborative partnership with the right partners as the key to integrating new technology successfully
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4.30pm | Building a West-East partnership so as to achieve greater
access to emerging markets
- Looking into the mutual benefi ts in East-West partnership
- Leveraging on partnerships to advance expansion of vaccine business in Asia
- Creating a win-win partnership to attain future business goals
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| | Dr Klaus Stohr, Vice President, Global Head, Influenza Vaccine Franchise, Novartis Vaccines & Diagnostics
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5pm | Understanding the important role of NGO and Vaccine
Manufacturer partnership
- Establishing the value of PPP for Asian vaccine business
- Implications in immunization programs in Asian countries?
- Summarizing the challenges, progress and rewards in going into this partnership
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5.30pm | Chairperson’s closing remarks
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5.45pm | World Vaccine Congress Asia Party : The Balinese Delight
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Conference Day Two - STREAM ONE - Wednesday 10 June 2009
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8am | Registration and refreshments
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8.40am | Organiser’s welcome remarks
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8.45am | Chairman’s opening remarks
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| NAVIGATING REGULATORY CHALLENGES TO CREATE OPPORTUNITIES IN UNTAPPED MARKETS |
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9am | Asian regulator panel: Assessing the current and future
regulatory challenges that are unique to the Asian market
- Scrutinizing the essential requirements in gaining marketing approval in Asian markets
- Setting the criteria to obtain manufacturing approval in various markets
- Regional harmonization updates: Review of what has changed and how to improve vaccine uptakes in the region
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| | Selvaraja Seerangam, Director, National Pharmaceutical Control Bureau (NPCB), Ministry of Health, Malaysia, Malaysia A.B. Ramteke, Joint Drug Controller, Central Drugs Control Administration, India Dr Nobumasa Nakashima, Deputy Director, Blood and Blood Products Division, Pharmaceutical and Food Safety Products, Ministry of Health Labour and Welfare (MHLW), Japan
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10am | Deciphering the global biologics regulatory framework for
rapid new vaccine introduction into new markets
- Comparing the regulatory market approval process for biologics in USA, Europe, Middle East and Asia Pacifi c
- Achieving speed to market in Asia to increase accessibility of new vaccines to patients
- Overview of recent regulatory updates and its impact on Asia markets accessibility
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| | Stephen Cook, Vice President, Head of Worldwide Vaccine Registration Management, GlaxoSmithKline Biologicals, Belgium
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10.30am | Morning refreshments
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| VACCINE FINANCING & INVESTMENT |
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11am | Innovative financing to drive development of vaccines with highest priority for the developing nations
- Advanced market commitments (AMC): Assurance of future market for timely investment
- Strategies to overcome challenges in introduction of new vaccines in developing nations
- Finding a sustainable financing model for the vaccine market
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11.30am | Vaccine investor panel: Weighing the risks and returns of
investing in vaccine business
- What is the current investment and risk appetite for vaccine development and manufacturing projects in Asia?
- How is the Asian vaccine investment landscape changing and where are the opportunities?
- Impact of the financial crisis on vaccine investments
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| | Moderator: Ms Florence Leong, Investment Director, ATP Capital Pte Ltd, Singapore, Singapore
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12.15pm | Networking luncheon
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| GLOBAL AND REGIONAL EXPANSION STRATEGY FOR VACCINE BUSINESS
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2pm | Creating an effective expansion strategy to achieve market
leadership in Asia
- Identifying the benefi ts and challenges in expanding operations in Asia
- Looking into the main drivers for exploring the Asian market
- Highlighting the important role of Asia in the future of the vaccine industry
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| | Mr Michel Baijot, Vice President, Worldwide Business Development & Strategic Alliance, GlaxoSmithKline Biologicals, Belgium
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2.30pm | Strategic business models of Chinese companies in expanding their vaccine business globally
- Overview of the trends and developments of the vaccine industry in China
- Looking into CNBG’s and other Chinese companies’ expansion strategies moving towards the global market
- Success story of CNBG’s expansion into other Asian markets and its future plans
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| | Dr Bing Zeng, Vice President, China National Biotec Group, China
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3pm | Afternoon refreshments
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3.30pm | Case study: Wyeth: Bringing a billion-dollar pediatric vaccine for pneumococcal diseases into Asia
- Key challenges in introduction of pediatric vaccines into Asia markets
- How to leverage on partnerships and initiatives to overcome the unique challenges?
- What are the best marketing and distribution strategies to achieve market leadership in Asia?
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| | Mr Mark Larsen, President, Asia Pacific and Nutrition, Wyeth Pharmaceutical, United States
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4pm | Strategies for marketing biosecurity vaccines in Asia
- Analyzing the opportunities at a country level
- Recognizing the challenges and opportunities in this nontraditional market
- How does Asia differ from other regions of the world?
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| | Dr Peter Khoury, Vice President, Global Marketing, Baxter Vaccines, United States
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4.30pm | Case study: Introducing Japanese Encephalitis vaccines into Asia markets
- CNBGs strategies in marketing JE vaccine in India
- Identifying the key lessons learnt that are key to a successful market penetration
- CNBG’s expansion strategy of its marketing and distribution of JE vaccine in Asia
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| | Mrs Lingjiang Yang, Manager
International Business and Cooperation , Chengdu Institute of Biological Products, China
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5pm | Case study: Challenges in marketing and manufacturing of
vaccines in developing countries
- Identifying the problems in technology availability and sourcing
- Looking at the constraints in R&D and product development
- Government initiatives in distribution and availability of vaccines
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| | Dr K.R.S. Krishnan, Executive Director, Research and Development and Strategic Planning, HLL Healthcare, India
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5.30pm | Chairperson’s closing remarks
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5.45pm | End of conference
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Conference Day Two - STREAM TWO - Wednesday 10 June 2009
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8am | Registration and refreshments
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8.40am | Organiser’s welcome remarks
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8.45am | Chairman’s opening remarks
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| NEW AND NEXT GENERATION VACCINES DEVELOPED FROM ASIA |
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9am | The development of a safe and immunogenic tetravalent live-attenuated dengue vaccine for the Asian markets
- Identifying key learnings in developing a dengue vaccine
- Presenting the latest key clinical developments of the dengue vaccine candidate
- Looking into future of dengue vaccine
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9.30am | Developing a Hand Foot and Mouth Disease vaccine for the
Asian market
- Asserting the need for a Hand Foot and Mouth Disease vaccine to address Asia’s unmet need
- Examining the challenges in developing the vaccine
- Assessing the prospect of launching the vaccine
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10am | Development of vaccine against chronic hepatitis
- Focusing on the current achievements in the development chronic hepatitis vaccine
- Current research effort concentrates on improved vaccination against hepatitis B
- Challenges in developing hepatitis C vaccine
- The future research directions and opportunities for bringing chronic hepatitis vaccine in the Asia market
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10.15am | Morning refreshments
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| MANUFACTURING & PRODUCTION |
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11am | Development and introduction of vaccines which address
the needs of the poor in developing countries through large scale production
- Challenges of developing a low cost vaccine that meets the cGMP requirements and that can be produced at large scale
- Development and technology transfer of Cholera and Typhoid vaccines to developing country manufacturers
- Large scale production and introduction of Cholera and Typhoid vaccines in India
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11.30am | Cell based vaccine development to address scale-up issue on production
- Understanding the advantages and disadvantages of moving into cell culture for vaccine production
- How does cell culture based production impact on quantity produced and timelines?
- What are the pre-requisites in transitioning to cell culture production?
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| | Dr Bram Palache, Global Scientific Communication and Public Affairs Director for Influenza Vaccines, Solvay Biologicals, The Netherlands
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12pm | Networking luncheon
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| MANUFACTURING & PRODUCTION (CONT'D) |
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1.30pm | Achieving robust and consistent vaccine manufacturing
processes
- Identification of key process and validation requirements associated with scale-up and tech transfer to manufacturing
- Establishment of critical and non-critical process parameters to reduce risk
- Case studies used to highlight approach and results
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| | Mr Robert Shaw, Director of Strategic Marketing and WW Training
Program Director - Vaccines and Emerging Biotech, Millipore, United States
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2pm | Building a world class plant facility as a key to producing the best quality vaccines
- Understanding the key factors in achieving an international GMP standard
- Identifying the challenges that Asian companies face in expanding their business internationally
- Building a facility that is adequate for current business need with the flexibility of expansion for future expansion plans
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| | Dr B.G. Rhee, Executive Vice President, Corporate Development, Green Cross
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2.30pm | Design and construction of a vaccine manufacturing plant
with international GMP standards in Asia
- Identifying the challenges commonly faced by manufacturers in building a vaccine facility
- Best practices in continuously improving GMP standards to ensure high quality vaccines
- Integrating the most relevant and advanced technology to foster efficiency and operational excellence
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| | Dr Wu Ke, Vice President, Shanghai Zerun Biotechnology Co., Ltd., China
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3pm | Afternoon refreshments
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| ADJUVANTS & DELIVERY TECHNOLOGY |
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3.30pm | Therapeutic vaccination: Critical need for novel adjuvantation and delivery strategies
- Proven need for optimal adjuvantation and delivery/route of administration
- Identifying key technology platforms for success
- Second generation therapeutic vaccines with further enhanced HLA coverage
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| | Dr Christoph Klade, VP, Technical & Clinical Development & Clinical Immunology, Intercell Ag, Austria
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4pm | Examining the impact of moving from vial to prefill
- Presenting an overview on the market trend of moving to prefillable presentations
- Identifying key drivers behind this growing trend
- Uncovering the implications of this trend in the delivery of immunization
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| | Fiona Garin, Director, Strategic Marketing, Europe, BD Medical - Pharmaceutical Systems
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4.15pm | Development of novel adjuvants for vaccines in a business
and regulatory perspective
- Addressing regulatory challenges for a novel adjuvant with broad application
- Aligning development strategy with commercial strategy
- Strategies to inform the risk versus benefit assessment throughout the development program
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4.45pm | Assessing the various developments in vaccine technologies, cell lines and adjuvants
- Influencing immunization programs through new vaccine technologies
- Integrating designer cell lines in vaccine production
- Exploring alternative adjuvants for vaccine development –
- What is there beyond alum adjuvants?
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| | Dr G S Reddy, Chief General Manager, Indian Immunologicals Ltd, India
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5.15pm | Chairperson’s closing remarks
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5.30pm | End of conference
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Pre-conference Summit: Influenza Vaccines Summit - Monday 8 June 2009
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9am | Chairman’s opening remarks
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| | Dr Klaus Stohr, Vice President, Global Head, Influenza Vaccine Franchise, Novartis Vaccines & Diagnostics
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| THE FLU VACCINE BUSINESS IN ASIA |
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9.15am | Outlook of the influenza vaccine market: Preparing for
expansion of the Asia market
- Overview of the infl uenza market and Asia as the next growth market
- Developing the right strategy in expanding your business in Asia
- Challenges in marketing and distribution of infl uenza vaccines
- Finding the right approach in becoming the market leader in Asia
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9.45am | Managing the supply and demand of influenza vaccines in the evolving Asian market
- Assessing the market trends to effectively address the evolving influenza vaccine market
- Global strategy for the control and pandemic preparedness
- Commitment in ensuring the supply and demand balance of influenza vaccines
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| | Victor Carey, Medical Director, Asia Pacific, Sanofi Pasteur, Australia
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10.15am | Smart marketing and distribution strategies in the evolving influenza vaccine market of Asia
- Key challenges in the introduction of influenza vaccines into Asian markets
- Preparing for sudden surges in demand during a pandemic
- Leveraging partnerships and initiatives to overcome the unique challenges
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10.45am | Morning refreshments
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| NEW SEASONAL FLU VACCINES DEVELOPED FROM ASIA
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11.15am | Developing inactivated influenza vaccines
- Clinical data of a trivalent, inactivated, split influenza vaccine GC501 produced in embryonated eggs
- Evaluating the safety and immunogenicity of a single intramuscular dose of GC501
- Presenting current updates with the latest clinical data
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| | Dr Woo Joo Kim, Professor, Division of Infectious Diseases, Department of Internal Medicine, Korea University Guro Hospital
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11.45am | Rational design of a fully synthetic universal T-cell vaccine
- Capability of targeting all potential seasonal and pandemic influenza-A strains and its development
- Discussing the focus on 5 key elements of the vaccine design
- Potential to counter the emergence of swine H1N1 and avian H5N1 strains
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12pm | Developing a revolutionary new influenza subunit vaccine
- Bringing a new strain production in three weeks
- 4 in 1 vaccine for seasonal and pandemic flu
- Advantages of the new vaccine - intranasal delivery, low maintenance and low cost of production
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12.30pm | Luncheon
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| ARE WE PANDEMIC-READY? |
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1.30pm | CSL's influenza vaccine research and development program
- CSL's approach to the influenza vaccine business
- Presenting the prototype H5N1 pandemic influenza vaccine
- Presenting other research and development within CSL's influenza portfolio
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| | Dr Emma Ball, Program Director, Influenza, CSL Limited, Australia
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2pm | Live infectious influenza vaccines to reduce a pandemic
- Operation counter-fi re is a pre-emptive strike against highly pathogenic H5N1 pandemic
- Minimally pathogenic Bird Flu H5N1 virus developed by reverse genetics is to be used to diminish highly pathogenic Bird Flu H5N1 virus.
- Developing minimally pathogenic H5N1 by reverse genetics to be used as live infectious vaccine for humans.
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2.30pm | Innovative H5N1 virus-like particles: a unique combination of product and manufacturing solutions
- A novel manufacturing solution addressing the gaps in country pandemic preparedness
- What makes Medicago’s H5N1 VLP vaccine different
- Sharing the advantages of this H5N1 VLP vaccine
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2.45pm | Baculovirus vector as a delivery vehicle for influenza vaccines
- Looking into the improvements in baculovirus engineering in the development of bacoluvirus expression system
- Presenting the advantages of baculovirus vaccine in immunogenicity and safety
- Exploring the various strategies in aiding the improvement of baculovirus based influenza vaccine to produce the next generation influenza vaccine
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| | Jimmy Kwang, Scientist, Shanghai United Cell Biotechnology Co. Ltd, China
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3pm | Moving from vaccines to antibodies: Human monoclonal
antibodies to fight influenza
- Single antibody versus mixtures of antibodies
- Potency, breadth of protection, duration of effectiveness
- Emphasizing the importance of therapeutic antibodies to fight influenza
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3.30pm | Afternoon refreshments
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4pm | Roundtable discussion
This round table discussion session is an open
moderated session where delegates are divided into
groups of 10 each to discuss a set or topics. Moderated by key industry experts, the round table discussion will ensure debate and discussion on thought-provoking and controversial issues with
industry peers.
Roundtable 1:
Investigating various approaches to prevent an influenza pandemic In an influenza pandemic, most of the world’s population will be highly susceptible to the virus infection and it is conceivable that the virus will spread rapidly. The availability of a pandemic vaccine will be delayed by several months because of the requirements for vaccine formulation and production lead-time. Furthermore, it is probable that insufficient production capacity will restrict global access to the vaccine, at least during the first phase of the pandemic. Planning for appropriate availability of vaccines to manage a pandemic response requires a global perspective and concerted effort, not only in developing a vaccine but also in producing and distributing it. What are the different approaches
in preventing a pandemic? How do you pro-actively respond to an eventual pandemic?
Roundtable 2:
Evaluating the current and future methods to optimize infl uenza vaccine production.Several methods of production of influenza vaccine exist, each with its pros and cons for use. Different requirements in terms of capital investment, effi ciency and response time are key considerations in
choosing the best method. Also, there are still hurdles to overcome in the adoption of each of the technology. This roundtable provides an excellent platform for flu vaccine producers to be involved in an
open and interactive discussion on the pros and cons of various vaccine methods to develop and exchange new ideas to optimize influenza vaccine production.
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4.05pm | Chairperson’s closing remarks and end of summit
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5pm | Welcome Cocktail Reception: Meet the vaccine buyers
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