• The commercial opportunity / timing and cost considerations
• Upstream / downstream product development needs
• When it's better to partner than to go it alone
• Partnership strategies to accelerate timing and improve the probability of success
• Successful alliance management / realising the value from partnerships

• General issues
• Regulation and categorisation
• Manufacturing and control: quality, consistency and comparability
• Non-clinical aspects: pharmacodynamic models and preclinical safety
• Clinical aspects: efficacy and safety

• Is there an economic choice for developing one over the other?
• What are the manufacturing implications?
• Are there synergies to pursuing both areas at the same time or not?
• What are the similarities and differences between therapeutic and prophylactic vaccines?
• Clinical trials and manufacturing challenges for each sector
• What is the feeling within the industry?
• Examination of the prophylactic vaccines market which targets pediatric, the elderly and travellers

• Alternatives for vaccine production

• Strategies for recombinant protein production in alfalfa
• Biomass production in a controlled environment (BL2 containment) greenhouse complex
• Updates and results to date

• What are the benefits?
• The uses for hepatitis and others
• What developments have been made in this area?
• What is the feeling in the industry concerning these?

• How to ensure a smooth transition from research to production
• What factors need to be considered?
• Predictive and analytical risk assessment tools
• How to improve timelines
• New developments within this area

• Where vaccines for biological defense go after manufacture
• Why vaccine stockpiles are necessary for defense
• How vaccine characteristics influence the size and cost of vaccine stockpiles
• How vaccine characteristics may affect the amount of suffering and death that occurs from an attack

• International development to meet the millennium development goals
• What is the future of vaccine funding?
• Vaccine funding principles
• The vaccine fund initatives

• What support is being given for vaccine development?
• How widely available is this contractual funding?
• Are current initiatives actually working?
• How to overcome the cost of time and development over the public’s willingness to pay
• Funding of vaccine purchases

• Where is this money coming from?
• How is the selection made?
• Is this level of funding sustainable for the future?
• Funding principles: deliverables from industry
• Disease specific associations

• Similarities and differences in the needs of these distinct segments
• Priorities in disease prevention
• Criteria used to evaluate the usefulness of vaccines
• Vaccine development strategies to address these diverse needs

• Why children in the developing world are still outside basic vaccine coverage
• Vaccine pricing issues
• Development of vaccine manufacturing facilities
• The need for technological support
• Shantha, a case in point

• What is the strategy for pharmaceutical companies with regard to partnering?
• What are the necessary preparations for prospective partners, especially non government organisations?
• How pharmaceutical companies approach the deal-making process within the vaccines industry

• What is the role of partnerships in accelerating vaccine product development?
• New product development activities within the vaccine industry
• What information does government want from industry as vaccines are being developed in order to speed their adoption?
• Keys to deriving value from vaccine partnerships

• 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

• Are public concerns leading to unrealistic regulatory hurdles?
• Lessons learnt from pitfalls experienced in recent registration processes
• Defining pre-licensure safety profile
• Anticipating effective risk management strategy for new vaccines

• Are collaborations and public private partnerships the way forward?
• Is there true innovation and flexibility within regulatory authorities?
• How can a portfolio of products be used to reduce overall development costs?

• Steps to avoid common (and costly) technology transfer mistakes
• Implementation of strategies to maximise robustness and precision
• Case studies of logical approaches to bioassay development & validation

• Assembling a therapeutic vaccine biologics license application
• Process overview
• Development of the CMC package
• Lessons to be learned

• Enhancement of mucosal response
• Use of GelVac™ powder as a new delivery system
• Results to date

• What is the role of  health care providers in administering influenza vaccine and in improving coverage?
• What are the barriers that health care providers face when trying to immunise with influenza vaccine?
• How can some of these barriers be overcome and what partnerships need to be formed to achieve this goal?
• Is universal influenza immunisation a realistic goal?
• What logistically needs to happen before health care providers are ready for universal influenza immunisation?

• Phase III clinical results for FluBlØk™: a revolutionary influenza vaccine
• Validating a new vaccine technology platform: fits, starts and ultimate success
• Where to from here with the insect cell platform?

• A new vaccine platform to address the urgent need for pandemic flu vaccine
• Results of pre-clinical studies with an influenza avian (pandemic) H9N2 candidate VLP vaccine
• Novasomes® – a safe, patented adjuvant to help address the need for antigen sparing
• Rapid, disposable, scalable manufacturing process to meet vaccine needs for pandemic flu

• Immunoinformatics approaches to identifying vaccine candidates
• Optimising antigens for immune system delivery (pathways and processing)
• Monitoring immune response using carefully designed epitope arrays

• Pre-clinical studies for plague and anthrax
• The advantages and disadvantages of oral vaccines
• Overview of vaccines in development

• Non injection mucosal delivery
• What developments have been made?
• Results and findings to date
• The future of second generation vaccines

• Update on findings to date
• Clinical results to date
• Recent developments for TB vaccines

• Reliable detection and characterization of immune responses
• Identification and characterization of vaccine candidates
• Kinetic binding assays for better quality control
• Reducing costs in development and production
• Strategy for meeting current GxP requirements

• Novel Env antigen structures
• Neutralising antibody and T cell responses
• Prime-boost strategies for broad immune responses
• Results and developments to date
• What are the next steps?

• Vaccine overview
• What developments have been made?
• Results to date
• What are the next steps?

• Recent hot news from the clinic
• Looking at responses: tumor regression versus 'stable disease'
• Autologous and allogeneic products: issues for big pharma?
• Getting to market: the next 10 years

• Where are we today in addressing the potential threats?
• What are the key opportunities and challenges going forward for ensuring effective countermeasures are available?
• What barriers need to be addressed to increase industry participation in the effort?
• How can we create an effective public private partnership to research, develop and procure countermeasures?

Roundtable 3: Avian flu

• What are the latest developments?
• What approaches are being taken globally to stop the potential spread?
• Where are we today in addressing the potential threat? Are we prepared?

• Trends and requirements in downstream processing for new generation vaccines
• Improved harvesting technologies
• High throughput chromatography technologies
• Addressing current process issues

• What factors need to be considered?
• What new routes of administration are in development?
• What are the issues concerning dosing schedule?
• What regulatory issues need to be considered?

• Enhancement of T-cell responses for therapeutic vaccines
• Use of sLAG-3 (IMP321^TM ) as an immunomodulator in clinical trials
• Results and findings to date

• To provide information that aids in design and conduct of clinical trials that will support marketing approval
• To provide insight into conduct of cost-effective and time-effective clinical trials
• Provide templates and examples of trial related documents to facilitate successful outcomes

• Preparing a Clinical Development Plan (for regulatory agencies and investors)
• Selecting the appropriate indication(s)
• Planning clinical trial vaccine manufacture to support pre-clinical and clinical needs
• Considerations for manufacture changes and comparability through development
• Differences in the development of prophylactic versus therapeutic vaccines
• Novel vaccine and adjuvant development issues
• Special population issues
• Use of Clinical Advisory Boards

• What are the basic and necessary elements of a clinical protocol?   
• Selecting the appropriate trial endpoints
• Considerations for Inclusion/Exclusion criteria
• Protocol development and sample size considerations
• Safety monitoring and data collection
• Design of Phase I studies, Phase II studies and Phase III efficacy studies
• Statistical Analysis Plan and use of interim analyses 
• “Intent to treat” analysis versus “per protocol” analysis
• Practical Exercise – Development of a Clinical Trial Outline (CTO)

• Development of Case Report Forms (Phase I through III)
• Use and design of Diary Cards
• Overview of the Informed Consent Form and process
• Contents and preparation of the Investigator Brochure
• Development of SAE reporting forms and procedures
• Product shipment, storage and disposition forms and procedures
• Preparation of Site Manuals and special documents

• Site Selection and subject recruitment
• IRB issues and procedures
• HIPAA issues and considerations
• Conducting an “effective” investigators meeting
• GCP and special training for study sites and staff
• Selection of a DMC/DSMB for pivotal studies

• Basic considerations for trial monitoring
• Use of CROs for conduct and oversight of clinical trials
• Data collection, data management and data integrity
• Development of a safety database
• When, who and how to conduct audits
• Development of audit plans and when to lock the database
• Practical Exercise – Preparation of an SAE report (or other) for regulatory agencies

• Preparing the Clinical Study Report (CSR) according to ICH-E6
• Regional regulatory forms (FDA form 1572, financial disclosure, etc.)
• Reporting requirements for regulatory agencies (safety and annual reporting)
• European Union Clinical Trials Directive
• Preparing for a marketing application
• Preparing for meetings with regulatory agencies
• The CTD format and preparation of Module II