• Overview of influenza vaccines development
• Strategies adopted by various stakeholders in developing pandemic and seasonal flu vaccines
• Impact of emerging technologies on influenza vaccines development

• Overview of global and regional avian influenza situation
• WHO global strategy for the control of Avian Influenza and pandemic preparedness
• Update on WHO initiative on pandemic influenza vaccine

• Update by key Asian countries in preventing influenza pandemic
• National plan for influenza vaccine procurement and stockpiling
• How countries in this region could benefit from its network in term of vaccine availability and accessibility?

• Pandemic challenge to the mutating influenza strain
• Where are the emerging influenza vaccine markets in Asia?
• What are the new strategies to achieve sustainability in current influenza market in Asia?

Universal influenza vaccine update
Influenza is a recurrent global threat and many leading scientists are racing to develop a powerful human universal influenza vaccine providing life-long
protection against influenza. For the first time in
Asia, leading biotechs developing influenza vaccines
are convening in Asia to discuss the latest trend, challenges and opportunities to realize the objective of reducing or even eradicating influenza disease in humans.

• Approaches to development of universal influenza vaccines
• Advantages and disadvantages of universal influenza vaccines
• Clinical data and nucleoproteins update

• Concept of M2 influenza vaccine development
• Preclinical data demonstrating potent immune response
• Future of M2 influenza vaccines

• Universal influenza vaccines offering protection against challenge with drift and shift influenza A strains
• Strategies to induce strong specific immune responses
• Approaches to enhance antibody and cell mediated responses to vaccine components.

• Concept of TLR vaccine technology
• Advantages and challenges in development of pandemic and seasonal influenza vaccine
• Facility design for development of technology for influenzavaccines

• Animal study data demonstrating safety and effectiveness of seasonal flu vaccine
• Production of pandemic flu vaccine in BSL2+ effectively
• Design of automated flu vaccine production facility

• Novel liposome-based adjuvant & delivery system
• Strategies in development of novel influenza vaccines
• Strategies to bring novel influenza vaccines: Bench to clinic

• Concept and design of H5N1 vaccine development
• Safety and immunogenicity concerns
• Current update with latest pre-clinical and clinical data
 

• Current trends and developments in the global vaccine industry
• Challenges in developing HIV, malaria and tuberculosis vaccines
• Harnessing resources to accelerate the development of Third World vaccines
• Public funding strategies and private efforts

• Analysing the gap between Asian and Western vaccine manufacturers
• Addressing the challenges faced by Asian manufacturers in developing high quality vaccines for the global market
• How to achieve international standard? What are the practical approaches that can be adopted?

• Latest updates on the national immunisation programmes
• Vaccine priorities and consideration factors in introducing a new vaccine into the immunisation programme
• Reviewing the success of the current immunisation
programmes and future improvements
• Strategies in designing the most effective immunisation plan

• How vaccine manufacturers in the developing countries can meet international quality standards, and at the same time, deliver low-cost vaccines to these countries?
• Financing solutions and feasible business strategies for vaccine manufacturers in developing nations to ensure long term sustainability and incentives
• Unity is strength- cooperation and collaboration among developing countries vaccine industry players to achieve greater competitive edge
• Striking a balance between providing affordable vaccine for developing nations and promoting the development of homegrown vaccine manufacturers

• Drivers and values in vaccine alliances between Western and Asian vaccine companies
• Analysing different partnership models- technology transfer, licensing and co-distribution
• Key factors in a successful vaccine partnership in Asia

• Development status of vaccines for neglected diseases and technologies related to developing countries
• What are sources of new technologies for licensing to developing country vaccine manufacturers?
• Pooling of important IPs for common use
• Various options available for funding research in developing countries
• Case studies of past and current technology transfer partnerships

• Challenges in developing a dengue vaccine
• Recent progress and results
• Clinical trials development

• Current situation
• Challenges
• The PATH Malaria Vaccine Initiative perspective

• Killed oral and live vaccines
• Hybrid vaccines
• Subunit vaccines
• Multiple-serotype protection strategies

An exclusive discussion forum led by national public health opinion leaders in respective country rooms, focusing on vaccine supply, market outlook and immunisation policies of year 2008 and beyond
for each of the featured Asian countries.

• Lack of immunogenicity and acceptable levels of protection for conventional vaccines
• Use of molecular tools to understand and identify new target molecules so as to generate very specific immune response
• Potential of therapeutic and protective vaccines
• Development of new generation vaccines that are likely to be made available within a decade

• Developing Japanese encephalitis vaccine using cell culture methods
• Pros and cons of using mouse brain and cell culture
• Recent clinical development and findings

• Research and advances on new second-generation tuberculosis vaccine candidates
• Safety and immunogenicity
• Clinical results to date and future prospects

• Success of HBV vaccination and opportunities for improvement
• Clinical results for HEPLISAVTM demonstrate significant advantages
• Proof of concept for TLR-9 enhancement of vaccines

• Continuous efforts on vaccine development for hepatitis viruses since the launch of Hepavax B, the world�fs best selling Hepatitis B vaccine
• Critical aspects in the successful launch of Hepatitis B vaccines
• Current approaches and challenges in the treatment of Hepatitis C viral infection
• HCV/HBV fusion prophylactic vaccine

• Requirements for improved adjuvants and formulation characterization
• Impact of emerging adjuvant technologies on vaccine development
• Considerations when incorporating adjuvant in vaccines
• Leishmaniasis as a case study for therapeutic vaccines, adjuvants for TB vaccines and adjuvants for malaria vaccines

• Risks and benefits of various different types of adjuvant being used in the market
• Approaches to incorporate adjuvants in vaccines formulation
• Strategies to assess key strengths and weakness of adjuvants technology

• Strategies and advantages offered by adjuvant technology for rapid induction and dose sparing capability of pandemic and seasonal influenza vaccines
• Current status and development of wider applications
• Key advantages and challenges in developing nasal adjuvant

• CpG ODN TLR9 agonists activate B and pDC cells directly and other immune cells indirectly and when co-administered with antigen lead to enhanced antigen-specific responses
• Animal studies demonstrating synergism with different types of antigen and most other adjuvants/delivery systems
• More than 30 clinical studies with CPG 7909, a B Class CpG, show significantly enhanced antibody and T cell responses to a variety of antigens

• Novel particulate vaccine delivery
• Delivery of encapsulated immune potentiators
• Pre-clinical data and Next Steps

• A new delivery system utilizing unique characteristics of H.pylori to deliver foreign peptides
• H. pylori infection induces specific antibodies triggering both local and systemic immune responses
• Latest clinical data demonstrating feasibility and advantages of this novel delivery system

• Commercial scale planning- build, retrofit or outsource?
• Facility construction
• Process and equipment validation
• Regulatory issues

• The role of Manufacturing and Industrialisation in the Biotech-Value proposition
• Key challenges for a biotech�fs first product development towards commercialisation
• From Manufacturing set-up to obtaining US FDA approval

• Are there any shortcuts- and would that be an advantage or disadvantage?
• What role does the nature of the first product play?
• Licensing a pilot plant- what role does that play and what are the relevant considerations?
• Platform technologies- are they back after a long time in the doghouse?

• Assessing the vaccine quality and technology gap between the East and the West
• Challenges facing Asian vaccine manufacturers in reaching international GMP standards
• Best practices to implement and continuously maintain GMP in vaccine manufacture

• Increase fermentation yield
• Metabolic modeling
• How to improve timelines?
• Scale-up application
• Innovative methods

• 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

• Comparison on the key advantages and challenges in using cell culture and egg-based technology to produce flu vaccines
• Robustness and flexibility design of manufacturing process
• Regulatory challenges in adopting cell-culture technology for flu vaccines production
• How is it relevant to Asia manufacturers

• What are the technical manufacturing challenges to increase production capacity
• What are the strategies use by various manufacturers
• Assessment of emerging innovative technologies that are to be developed
• Continuous progress to improve vaccine production technology and production of vaccines for broader protection

• Adopting Good Cold Chain Management Practices to ensure vaccine quality, patient safety and regulatory compliance
• Understanding the challenges of cold chain processes (phases and critical points) and learning how you can control the chain
• Learning the success and pitfalls through live case studies

• Addressing the issues of heat and freeze damage to vaccines
• Overview of technologies to monitor the exposure of vaccines to damaging temperatures during storage and transport
• Vaccine vial monitors, freeze indicators and electronic temperature monitoring devices

Key issues to be addressed:
• Commissioning and Qualification – Industry Guidelines
• Planning & implementation of Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification.
• HVAC System/ WFI System commissioning and validation
• PIC/S and FDA compliance: Case study.
 

Benefits of attending:
• Approach for designing, engineering, commissioning, and validation of pharmaceutical/biotechnology facilities
• Integrate commissioning into the validation process: bid documents and overall project control
• Compliance strategies for regulatory requirements while optimizing the cost and efficiency of facilities and their utility systems.
 

Who should attend:
• Quality Assurance managers and supervisors
• Logistic managers and engineers
• Process development head and supervisors

Regulators worldwide are moving towards a Risk Based Approach to the manufacture and control of Therapeutics. The FDA 21st Century cGMPs initiative, ICH Q9 and the recent publication of ASTM E2500 have all added significant weight to this shift. This workshop will provide hands-on opportunities to demonstrate how risk management is applied, develop risk based strategies and apply risk assessment to the manufacture and quality
assurance of Vaccines.
 

Key issues to be addressed:
• Defining risk management in relation to ICH Q8, ICH Q9 and ASTM E2500
• Need for a risk based pragmatic approach to manufacture and distribution of Vaccines
• Application of risk based principles to QA, compliance, product design and validation
• Application of risk tools
 

Benefits of attending:
• Evaluate the principles and practice of risk management in vaccine operations
• Make compliance-based judgments based on risk management principles
• Utilise risk evaluation techniques to analyse vaccine products, operations and compliance
• Propose control strategies to mitigate unacceptable risk and loss to organisations
• Use risk tools in a regulatory and compliance environment
 

Who should attend:
• Bioprocess, manufacturing and production scientists
• Quality assurance and control professionals
• Compliance and Validation managers
• Research and viral safety scientists