• The cancer vaccines business
• Will the promise ever be reached?
• An industry perspective

• Product development challenges
• Time to market

Biology: DNA vaccines and gene therapy

• Manufacturing and control issues
• Current regulatory framework
• Possible regulatory methods for seeking marketing authorisation
• Emerging developments

• Current and future challenges of the application of such new cancer vaccines
• What is the future for cancer vaccines? Therapeutic or prophylactic vaccines?
• Drug discovery, development, and approval process issues
• Issues in clinical trial design

• Development challenges for whole cell vaccines
• Process development and manufacture of complex biologicals
• Past and present clinical trials  
• Immunological evaluation of treatment

• Prime-boost vaccines - clinical experience
• Monitoring immune responses in cancer vaccine trials

• Potential uses on breast cancer
• What are the other potential areas?
• What developments have been made?
• Combinatorial therapies

• Breast cancer update
• Latest developments
• Results to date

• Business issues in general: big tendencies in the business, renewed interest for vaccines from big pharma 
• Innovation, opening a discussion towards new vaccines, new technologies, adjuvants, as well as a view on therapeutic and cancer vaccines
• Access: featuring the real progress made in the last year with the different initiatives (but also their limits), financing, particularly for newer vaccines, production issues, including in developing countries and the infrastructure issue (health systems)

• The story to date: who's left and who's coming onto the stage
• Status of big players, status of smaller players
• Consolidation drivers including technology, pricing, hungry big company mouths to feed
• Thoughts on possible future plays

• Market structure
• Key business drivers
• Innovation ability
• Cost and profitability issues
• Regulatory aspects
• Success factors

• Assessment of the opportunistic behaviours in the market place
• What are the pharmaceutical companies’ strategies in this area?
• How companies approach the deal making process

• Latest developments in this area
• Results to date
• New technology applications

• Current issues in vaccines development and manufacturing
• Available technologies: from cell culture to filling and formulation, example of applications
• Validation aspects: what needs to be done, effects on implementation time
• Reduction of manufacturing costs

• Facts, figures and background information
• The changing role of the animal model in vaccine development
• The consistency approach in vaccine quality control
• The principle of replacement, reduction and refinement (thee Rs) in animal use
• Three Rs: present possibilities and future prospects

• Meet…move on… meet…move on…meet!
• Exchange business cards with fellow conference delegates, speakers and moderators
• The best networking session you’ve ever experienced

• Role of regulatory T cells in infection, cancer and autoimmunity
• Pathogen-derived immunomodulatory molecules as adjuvants
• Using adjuvants to manipulate regulatory versus pathogenic and effector T cells

• Influenza virosomes: a new adjuvant on the market
• Clinical experience
• New generation of influenza virosomes

• Introduction to transcutaneous immunization (TCI)
• Efficacy of the Posintro^TM adjuvant formulation and the TransVac^TM patch for TCI
• Comparison of i.m. administration with TCI using commercial and experimental vaccines.
• Activation of langerhans cells
• Development of assays for determination of neutralising antibodies

• Technologies for immunogenicity assessment: in silico methods, experimental methods
• Immunogenicity testing in vaccine design
• Assessing immunogenicity for lead selection
• Immunogenicity in pre-clinical and clinical development
• Optimising the population coverage of vaccines

• Fill-finish manufacturing
• The use of bulk plastic pellets
• Mold tooling and form-fill-seal technology
• The use of all operations performed on one compact machine
• Scale-up and manufacturing of the bulk cell culture based vaccine

• Factors to consider while evaluating outsourcing of buffer solutions
• Comparison of set-up costs versus outsourced products
• Benefits of using disposables - options and sizes available

• Intellectual property rights
• What barriers are faced?
• What new challenges will regulation have on cost?

• Who’s going to pay for the new vaccines we’re developing?
• Stockpiling
• Decreasing costs

• Development needs for products in different markets
• Production issues and collaborations

• Public health considerations that may be unique to vaccines
• HIV
• Bioterrorism
• Emerging new infections
• Advantages in industry-government collaboration in vaccine development
• Potential drawbacks
• Experience with technical collaborations with governmental agencies
• Impact of multiple governmental agencies’ involvement in vaccine development
• Lessons learned from HIV and bioterrorism vaccines

• Is there a real interest in achieving this?
• Commercial implications for companies
• Who is going to pay for the new vaccines?
• Is vaccine funding sustainable?

• What approaches are being taken?
• Are the preparations adequate?

• Stockpiling vs. flexible and fast processes
• Bottlenecks in production and immunicity of avian flu vaccines
• New adjuvants, route of inoculation and other improvements

• Rational for cell culture, whole virus and Wt strains
• Safety, immunogenicity and protection pre-clinical studies
• Clinical plans and timelines
• Manufacturing capabilities

• Results from Phase I study
• Plans for Phase II studies
• Importance of herd immunity for optimal public health impact

• The high cost of production of cell culture-derived rabies vaccines.
• Production at low cost for room temperature storage versus tissue culture – derived rabies vaccine
• Enhancing the potency of DNA vaccine preparations with inactivated rabies. Development of a novel combination rabies vaccine (CRV) and examination of its potency in mice as well as cattle
• Marketing as DINARAB in India after completion of animal trials and securing the  necessary regulatory approvals