The worldwide influenza vaccine market is valued at approximately $1.5 billion annually. Unlike other vaccines, flu vaccines must be modified yearly to maintain their efficacy due to the quick mutation of flu viruses. The influenza vaccine market is booming and growing at an unprecedented speed globally. How does the influenza market look like in Asia? Will there be an universal flu vaccine available in coming years to wipe off all sorts of influenza infection?

• Opportunities and challenges of the global flu vaccine market
• Market size, trend, drivers, competitive landscape and market growth dynamics in Asia
• Status of international players vs. status of local players in Asia

• The emerging pipelines of innovative influenza vaccines and their market promise in Asia and globally
• Advantage of cell culture-based influenza vaccines over the traditional 
• Challenges and strategies to penetrate into the private and public flu vaccine market of Asia
  

• Prospects of a universal flu vaccine: Is it only a fantasy to attack the fast mutating virus?
• Design, formulation and combination strategies
• What are the recent achievements?

Inactivated or attenuated live human influenza vaccines are now in worldwide use, especially in high-risk groups . To continually improve its efficacy, safety and reliability for optimum vaccination and protection, scientists globally are venturing into new strategies and approaches. This session will address the latest breakthroughs of flu vaccine innovation through innovative adjuvant and delivery systems.

• An overview of adjuvants for flu vaccines available on the market
• Adjuvant IC31â„¢ and its mechanism for improved immune response of flu vaccines
• Clinical studies and safety issues

• What are the latest developments?
• Results to date
• Efficacy and safety issues

Followed by the recent SARS and bird flu outbreaks, pandemic flu vaccines are becoming the hottest topic in Asia! Currently, no vaccine is available to protect humans against the H5N1 virus that is being seen in Asia. But vaccine development efforts are intensively underway. What is the latest development stage of pandemic vaccines? What challenges are we facing? Are we ready to conquer the next pandemic? What can we do to prevent future flu pandemics?

• The current development stage of pandemic influenza vaccines
• Current technology and approaches to address the manufacturing capacity for influenza vaccines
• Future pandemic forecast: Are we ready for the challenge?

• Development and clinical results to date
• Public and private collaboration to facilitate vaccine development
• Accessing the quality and efficacy of the vaccines and strategies to handle a flu pandemic in China

• Current world influenza vaccine production capacity and the gap between supply and demand
• The role of rapid scale-up technology in addressing the urgent need in a flu pandemic
• Novel technology and successful case studies to speed up production of flu vaccines

This round table discussion session is an open moderated session where delegates are divided into groups of 10 each to discuss a set of topics. This session aims to address the issues, problems and ideas of each delegate. 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
What can we do together to make prevention of an influenza pandemic feasible?

Flu pandemics are spreading at least a few months faster than the time it takes to develop the updated vaccines. It is also nearly impossible to predict the exact immune signatures of a pandemic virus strain in advance. Distinct sublineages of the H5N1 virus and cross infection to non-avian species have also been found recently in Asia. The fact is that, inevitably, vaccines will be either unavailable or in extremely short supply during the first waves of future pandemics. So what can we do together to make prevention of an influenza pandemic feasible? How can we develop a global network to facilitate flu vaccine development in Asia?

This roundtable will gather key strategic leaders from the flu vaccine industry, NGOs, health authorities and regulatory bodies to discuss future approaches and joint efforts to make prevention of new flu pandemic possible.

Roundtable 2
New methods of making flu vaccines: Evaluating the pros and cons

After 50 years traditional vaccine making in hen’s eggs, new manufacturing methods and approaches are emerging with promising advantages. However, safety, efficiency and cost issues for these new methods are limiting their industrial application. 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 – traditional egg, live-attenuated, cell-based, DNA and universal, and to develop and exchange new ideas to optimize influenza vaccine production.

This is a wonderful opportunity to meet other attendees and gain first impression before the conference begins! Enjoy your first evening in Singapore by mingling and getting to know other attendees. A great ice breaker to kickstart the next three days!

• The global ecology and trends of the vaccine business
• Market size, trend, drivers and market growth dynamics
• Status of international players vs status of local players in Asia
• Impact of Asia: Rising market opportunities, entry challenges and its impact on the shape of the global vaccine industry

• Is the current vaccine funding enough to introduce needed vaccines to the developing world?
• The challenges and issues: Divergence of products, incentives of development, increasing cost and complexity
• Is the trend to move south coming? Drivers, incentives and prospects

• Market opportunities,challenges and regulation comparative analysis across key markets of Asia
• Accessing local vaccine industry development and the technology gap
• Investment opportunities in the vaccine industry. Where is the money coming from?
• Crystal balling the future: What is the position of Asia’s vaccine industry on the world map?

• National Immunization programme showcase
• Updates on the recent planned national immunization programmes
• Evaluation criteria to incorporate new vaccines into immunization programmes
• What has been achieved through immunization programmes
  and what needs to be done?
• National influenza vaccine programme: Where are we now?

• The role of private-public partnership and achievements in elevating public health by immunization
• What can you expect from a private-public partnership?
• Case studies on recent successful partnerships in Asia

• The expectations of the East vs West, small & big players
• The role of technology transfer and licensing between manufacturers, developers and research institutes
• Case studies on successful partnerships, and evaluating key factors for a successful local partnership
• How should companies approach the deal making process

Much like speed dating, through a rotating cocktail table format, you will get the opportunity to meet all your fellow attendees face to face in just 45 minutes. Bring plenty of business cards along for a fast and furious interactive session.

• New discovery areas for adjuvants current states and future trends
• Optimizing potency and safety for vaccine adjuvants
• Case studies on advances in formulation for more effective delivery

• The advantage of the VIASKIN® technology compared to other patches in the market
• Potential applications on improved vaccine delivery
• Potency, safety and cold chain issues

• Effective antigen delivery and activation of the dendritic cells of the immune system
• A simple cationic lipid/E7 peptide vaccine demonstrates therapeutic benefit in HPV-induced tumors
• In-vitro and in-vivo observations in preclinical studies

The Esmirada Mediterranean Restaurant and Wine Bar is located near the heart of Orchard Road, Singapore’s most famous shopping and dining belt. With a lively atmosphere accompanied by good food and music, Esmirada provides the perfect ambience to unwind for a night out after a hard day at the conference So make sure you come for a taste of Esmirada’s exquisite Mediterranean fare, and gain extra mileage networking in Esmirada’s inviting environment

• Modern manufacturing technology available and methods to acquire them
• Novel technology evaluation and vaccine manufacturing technology transfer for cost effective scale-up production
• Handling product throughput and viral clearance issues
• Quality assurance and vaccine testing issues

• Example of applications of single-use technology from cell culture to filling and formulation
• Validation aspects: What needs to be done and the effects on implementation time
• How single-use technology has reduced manufacturing costs

• Understanding the importance of vaccine quality and technology gap between the east and west
• Specific challenges facing chinese manufacturers to improve quality and recent achievements
• Best compliance and validation implementation practices

The Esmirada Mediterranean Restaurant and Wine Bar is located near the heart of Orchard Road, Singapore’s most famous shopping and dining belt. With a lively atmosphere accompanied by good food and music, Esmirada provides the perfect ambience to unwind for a night out after a hard day at the conference So make sure you come for a taste of Esmirada’s exquisite Mediterranean fare, and gain extra mileage networking in Esmirada’s inviting environment

• What are the current gaps in evidence impeding vaccine introduction into developing countries?
• What types of studies are most important?
• What strategies can be used to enhance the impact of generated evidence?

• Funding principles and vaccine strategies 
• Identifying the role of Gates Foundation in funding development of vaccines for the Asian population through case studies 
• What have been achieved and what are the targets for future?
  

• Leading-edge analytical technology to speed up vaccine development 
• Supporting technologies that drive efficiency and save capital expense for cell-based production 
• Disposable manufacturing solutions that drive speed of response and economics of manufacturing  
• Services that address simplification of manufacturing workflow to improve quality, time, cost, regulatory compliance, and security of supply
  

• HPV vaccine progress in the private sector
• Updates on vaccine trials, evaluation programme and efficacy test
• Accessing the route to licensure and introduction into the Asian market

• Clinical results to date
• Vaccine safety and immunogenicity testing through boosting study
• Importance of DTaP based combination vaccine in the Korean market

• Advantage over traditional JE vaccines
• Safety analysis and clinical results to date
• Tissue culture vs live organisms
  

• Processing challenges facing vaccine-manufacturers and technical approaches to address these
• Fermentation based vaccine manufacturing technology
• 'Speed to production' through the acceleration of stable clone development in fermentation and the use of 'disposable' production platforms
• Particular challenges in downstream processing

• Asia’s bio-defence vaccine market outlook
• Anthrax vaccine and its significance for Asia
• Strategies to improve access to Anthrax vaccines in Asia
• Safety and efficacy of Anthrax vaccines

• Research and advances on improved JE vaccines in China
• Safety and immunogenicity concerns
• The clinical results and efficacy

    This round table discussion session is an open moderated session where delegates are divided into groups of 10 each to discuss a chosen topic. This session aims to address the issues, problems and ideas of each delegate. 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
Building sustainable financing strategies for vaccine producers of the developing countries

Vaccine manufacturers of developing countries are contributing significantly over the years in furnishing affordable vaccines to improve public health in third world countries. However, by delivering vaccines at a much cheaper price than the multinationals, profit margins are much lower due to the high costs associated with the purchase of equipment and manufacturing technology to meet international quality standards.

On the other hand, vaccine development is a very lengthy and costly process that requires huge funding and investment. How can we venture into alternative investments and growth vehicles for a company to ensure its long term sustainability and incentives?

This roundtable will gather corporate strategic leaders, NGOs and financing bodies to discuss and evaluate the most feasible financing solutions for vaccine producers in developing countries.

Roundtable 2
Addressing manufacturing and application challenges for new vaccines in Asia

The challenges of vaccine development are not limited to identification of suitable antigens, adjuvants and delivery methods, but include regulatory, technical and manufacturing hurdles in translating a vaccine candidate to the clinic.

How can we make the best choice for the right delivery, formulation and adjuvants? How to design the most appropriate process development and scale-up strategies? How to demonstrate the quality, safety and efficacy of your vaccines for quickest market introduction? What are the regulatory, infrastructure and logistic issues to be considered for different vaccines and markets?

This roundtable will gather R&D, process development and technology leaders to share their daily operational best practices for extensive learning and profound discussion.

                Masterclass will run from 9am - 5pm.
Refreshments and lunch will be served at appropriate times

WHO pre-qualification is a frequently misunderstood process.  As the number of vaccines increases and our world becomes more global we need to understand the role of WHO pre-qualification and the balance with the empowerment of national regulatory authorities.  This evolving situation becomes increasingly complex as not only the number of products increases but also the number of manufacturers and producing countries. In this workshop we will explore the evolution of WHO prequalification, the intention and limitation of WHO prequalification and its relationship with national registration, GMP and QMS best practices as well as looking at the barriers and challenges to pre-qualification for new producers.  In addition, we will discuss how future scenarios may test the system.

9:00    WHO pre-qualification: What is it really about?

• Brief history of the evolution of the WHO-pre-qualification process
• Background on the UN agencies position, EPI, GIVS and GAVI Alliance
• WHO as the UN agency and UNICEF nominated pre-qualification assessor
• NRA assessment scheme as a precondition to prequalification
• The WHO prequalification procedures
• Not Pre-Qualified to Pre-Qualified to Suspended, to disqualified - The cost of Prequalification, the cost of non-compliance – the cost of failure – some case histories

Morning coffee will be served at 10am

11:30  Barriers and challenges in achieving pre-qualification – case studies and discussions with the floor and story telling

12:15 Networking Luncheon

13:30 Compliance with the principles of manufacturing practices to meet GMP and Quality Management Systems requirements throughout vaccine production

15:30 WHO visit and what companies should do to ensure a smoothly run site visit

16:00 Interactive Roundtable Discussions
This round table discussion session is an open moderated session where delegates are divided into groups of 10 each to discuss a set of topics. This session aims to address the issues, problems and ideas of each delegate. Moderated by key industry experts, the round table discussion will ensure debate and discussion on thought-provoking and controversial issues with industry peers.

Topics to be discussed are:

• The role of WHO prequalification
• How prequalification can affect procurement, financing and international licensure
• How does WHO prequalification relate to national licensure and registration
• Future challenges of international vaccine markets and regulation

Afternoon refreshments will be served at 3pm

16:45 Wrap up and conclusion

17.00 Workshop closes

Workshop leader: