• New medicines in the wider context of addressing the diseases in the developing world
• Vaccine prioritisation from public health professionals in the developing world
• Development, evaluation and addressing future availability of preventative vaccines

• Biotechnology offering new tools in the fight against neglected diseases
• Market, funding and information barriers that impede scientific and industry progress
• Improving the value proposition for companies to pursue developing world products

• Identifying the scientific and economic hurdles for industry addressing neglected diseases
• Sources of risk in the R&D supply chain and how the situation differs in each market
• Mechanisms during vaccine R&D to address the key obstacles

• Creating effective global partnerships in support of vaccine R&D
• Analysing best partnership models for vaccine development efforts
• Debating the partnership and business development strategies of smaller companies

• Advance market commitments encouraging companies to invest in R&D
• Key principles guiding the development of any advance market commitment program
• Concerns raised by industry in the development of an advance market commitment

• Key innovative financing initiatives debated in the development of the public health community
• What are the elements of the International Finance Facility for immunisation (IFFIm)?
• Potential relationships between different innovative financing mechanisms and pros and cons

• Update on long-term vaccine procurement strategy development
• Principles in the vaccine procurement program and identifying the ultimate goals
• Effect of adjusting the timelines of procurement contracts and multi year contracts

• The developing world vaccine markets and their distinct characteristics
• Key business drivers and strategies for business
• Key success factors

• Outlining critical areas in which demand forecasting creates a positive impact
• Committing to demand forecasts prior to clinical studies or significant manufacturing capacity
• Good forecasting; identifying methodologies and mechanisms to address forecasting challenges

• Market trends and market growth; anticipating future movement
• Recent headlines underscoring the current concerns related to vaccines
• Solutions to problems in the vaccine market that threaten to undermine availability of existing vaccines and hinder the development of new products
• Policy interventions; the economic dynamics of vaccine markets and the financial calculus of vaccine manufacturers

• FDAs role in facilitating development of new vaccines
• Regulatory criteria attaining to the development of new vaccines
• Funding and procurement update from US Government – what are the current strategies and priorities?

• Ethical considerations illustrated by smallpox and HIV vaccine programs
• Rare adverse events and vaccines; intussusception and rotavirus, myocarditis and smallpox and oculorespiratory syndrome, Guillan- Barre Syndrome and influenza
• Robust safety surveillance to minimise risk and harm

• The vaccine business in emerging markets
• Mapping of the regulatory and legal frameworks that may represent a barrier to the registration of vaccines
• Supporting the preparation and implementation of regulatory strategies for the assessment of clinical trial applications
• Establishing regulatory mechanisms for thelicensing of new vaccines
• Collaboration with US FDA, EMEA and other NRAs to develop new regulatory strategies to facilitate licensing of novel vaccines

Moderator to be confirmed

• Who are the new players in the vaccine industry? What does the future hold for them?
• Developing the means of bringing new products to launch and maturation
• Opportunities and constraints for new players
• Must your company be acquired to survive? What are the survival strategies?

• Business design choices; making explicit or implicit choices about the design of the business model
• Developing creative, proactive go-to- market strategies
• Global market opportunities; evaluate the impact of different product designs on the likelihood of successful development, time-to- market, and the value of first mover advantage
• Alignment of product development with operational strategy

• Case studies of vaccines in development
• Driving manufacturing strategy with commercial considerations in mind
• Reducing time to market

• How are R&D partnerships driving new product development in the vaccine industry? – for both developed and developing- world needs
• Partnership strategies to accelerate timing and improve probability of success
• Debating the partnership and business development strategies of smaller companies in the vaccine value chain
• How to optimise links with antigen-focused traditional vaccine companies

• Developing a master plan to manufacture and formulate influenza vaccines
• An update on H5N1 flu vaccine development
• Pre-clinical and clinical studies for seasonal and pandemic-like vaccines
• Adjuvant development

• Designing risk management plans for pandemic vaccines; spontaneous reporting and safety exchange, signal detection, safety studies,  post- licensure commitments
• Pre-pandemic approaches; are they scientifically supported? How can they be implemented? What data should be required to license pre-pandemic vaccines?
• Which areas of regulatory policy still need to be addressed, and how can the regulator respond?

• Moving flu cell culture vaccine manufacturing closer to a commercial reality
• Pioneering innovative technology bringing reliability and flexibility of the manufacturing process
• Flu cell culture vaccine manufacturing technology advantages over traditional egg- based production
• Future timelines and outstanding developments

• What are the prospects for improved influenza vaccines?
• Approaches to developing new vaccine strains and not just stabilising existing ones
• New platforms to address the needs of a pandemic flu vaccine
• Predicting the utility of recombinant vaccines / novel adjuvants and immuno modulators

• What are the main issues for vaccines development and manufacturing?
• Can some modern technologies contribute to help?
• What would be the implications on validation and impact on development time?
• What could be the benefits; time, robustness and costs?

• MF59 adjuvant for pandemic flu vaccines
• New generation formulations for vaccine delivery
• Optimising potency and safety for vaccine adjuvants
• Discovery of novel vaccine adjuvants

• Adjuvant development and formulation
• Characterisation of adjuvant mechanism
• Application of adjuvant for infectious diseases

• What are the new discovery areas for adjuvants?
• Defining what immune response it is that we want an adjuvant to elicit
• What advances are there in formulation?
• Modulate an immune response by formulation: influenza virosomes

• Characteristics of Rotarixâ„¢
• Results of Phase III studies – efficacy / safety
• Current environment and future studies of Rotarixâ„¢

• Rationale for development of a pentavalent humanbovine (WC3) reassortant rotavirus vaccine
• Characteristics of RotaTeq®
• Design of Rotavirus Efficacy and Safety Trial (REST) and other Phase III studies
• Results of Phase III studies – efficacy / safety
• Current environment and future studies of RotaTeq®

• Conjugate vaccine research needs and the path forward
• Development and evaluation of a new vaccine candidate
• Scenarios for the conduct of a pneumococcal conjugate efficacy trial in adults
• Defining the trials that might be necessary to move a new or existing pneumococcal vaccine forward to approval

• Progress in the private sector regarding HPV vaccines
• HPV vaccine trials - updates on vaccine evaluation programme to date
• Ongoing phase III trials and vaccine efficacy
• Assessing the route to licensure and outstanding issues

• Desired product profile
• Flexibility of product platform
• Challenges for development and commercialisation

• Novel Env antigen structures
• Neutralising antibody and T cell responses
• Prime-boost strategies for broad immune responses
• Results and developments to date

• Challenges for vaccine introduction in developing countries
• Global research currently being conducted in endemic diseases
• Recent achievements; overview and highlights of progress towards vaccine development
• Short, mid and long-term goals of vaccine development

• Gaining international recognition for developing country manufacturers
• Technology transfer to meet the needs of the developing countries
• R&D efforts to meet the emerging vaccine needs in the developing world

• 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

• Lessons learned from use of licensed vaccines in the private and military sectors
• Understand the challenges for vaccine deployment
• Implementation of mass immunisation for military deployment
• Understanding the need for concurrent use of vaccines
• Understand how costs impact vaccination rates in military / private sectors
• Understanding vaccine storage issues

• Exploring ‘risk based management’ as an emerging tool for biodefense R&D portfolio
• Considering the risks of technology versus produce development
• Industry structure and dual sourcing
• Market assurance versus SNS management
• Suggested approaches to portfolio management and governance

• What new routes of administration are in development?
• Making decisions on modes of delivery, number of doses, use of adjuvants
• Demonstrating safety and efficacy
• Technology applications to enhance deliverability
• What are the regulatory issues needed to be considered?