DAY 1 | Monday January 24th 2011

Morning plenary session
Clarifying US government priorities for vaccines: Giving industry the direction and assurances it needs to respond effectively

• The impact of the Health Reform Bill: A realistic review of what it means for vaccine enterprises from research through to vaccine delivery
  • Clarifying the true impact of the Bill after all the compromises - review of legislative changes and impact on vaccine market:
    • 1st dollar coverage
    • Which recommended vaccines will be included in health insurance plans?
    • How will the expansion of Medicaid impact immunization rates and, therefore, vaccine manufacturers in US?
    • Tax credits for small companies: What impact have the awards had on vaccine R&D
  • Continued challenges of effective adult immunization - MediCare part D/B - how to move it forward from policy perspective?
  • Preventative measures are tied up in long term cost savings – will there be recognition of that in pricing and reimbursement and coverage levels?
• Update on the National Vaccine Plan: How will it impact the way industry does business?
  • Progress on NVPO and IoM discussions on the final plan
  • Clarification on which vaccines will be backed and pushed by government
  • Which emerging diseases are being prioritised from the NVP perspective?
  • What degree of assurance / certainty is there that they will get favourable recommendations?
  • How will NVPO deliver on the plan?
• US government funding and priorities for vaccines: Integrating and consolidating efforts across departments to provide clear messages for industry
  • What is the reality of government funding of vaccines in a period of financial deficit? How are departments working to streamline their efforts and initiatives?
    • Obama initiatives on infectious and neglected diseases: How much funding for vaccines versus diagnostics and therapeutics?
    • How do infectious disease vaccines fit the paradigm for low cost preventative prophylactic treatments? How do they fit in the new model of healthcare?
    • BARDA and DARPA priorities: What are the emerging diseases of concern? Where and how is this budget being refocused / diverted?
    • What is the future for the"1 bug 1 drug" / "1 platform 1 vaccine" approach?
  • How can government increase incentives for manufacturers to innovate, particularly to tackle smaller, riskier, niche markets?
    • Update on rapid approval technologies
  • Establishing networks to combine initiatives / objectives / resources / funding / risk share / benefit share and respond to major needs
  • What changes are afoot in government contracting strategy: Is it becoming increasingly prescriptive?
  • Has industry got all the answers and direction it needs in order to respond to government priorities for vaccines? Are the resources and assurances in place?

Followed by your choice of 3 highly interactive parallel sessions:

Focus session 1
(Shared with participants in the Cell & Gene Therapy Forum 2010)
Addressing the specific manufacturing, regulatory and logistical challenges facing autologous cell therapy products at commercial scale

• Learning lessons from the development history of autologous cell therapies: A series of presentations, each followed by an extended period for Q&A/discussion
  • What CMC/QA challenges did they face over the course of their full development history, and how were they addressed?
  • Ramping up to commercial capacity: What are the key strategic differences between operating at clinical and commercial scales?
• Examining the full process at commercial scale: From extraction of a patient's cells to reinsertion - defining the key steps and issues at each point
  • When and where do the key issues/challenges occur and how are they being addressed?
    • Transportation/storage/security - what methods are we using to track individual patients' cells? How are shelf life limitations impacting the business model? How would we address this aspect differently for future therapies?
  • Management of the clinical site - how to ensure that multiple sites comply to GMP requirements without the element of control provided by the clinical trial environment?
    • How are we educating physicians and patients alike?
  • How is product testing conducted at each step of the process, from pre-collection through final release, to post-therapy follow up?
• Panel discussion: What are the key lessons for the industry to avoid other players having to 'reinvent the wheel'?
  • How have enabling technologies developed since Provenge entered Phase III, particularly with regard to boosting efficacy/potency, and how can the industry harness these advances to accelerate the pivotal trial process?
  • In oncology, is Progression-Free Survival or Overall Survival the optimal pivotal trial endpoint?

OR | Focus session 2
Improving immunogenicity, efficacy and safety through innovation in clinical assay development and trial design

• Identification, validation and standardization of clinical assays to enable more direct comparisons of efficacy, quality and immune response between trials
  • Comparing results in the clinic between different vaccines for the same disease: What is the current regulatory approach to clinical assay specification?
  • Industry approach to clinical assays: What are the validation strategies used to ensure we are making good decisions?
• What will it take to establish the gold standard for clinical assays for important targets beyond flu?
• Pushing the boundaries in vaccine clinical trial design
  • Vaccine genomics in the context of clinical trials: How is gene sequencing being used:
    • in early trials to detect why they are failing?
    • to design and/or modify vaccine antigens to improve their immunogenicity and safety throughout their lifecycle?
  • What innovations in clinical designs can be used to obtain valuable information regarding safety and efficacy from release through to end of shelf life?
• Stepping up to a tough challenge – designing better clinical dossiers for testing vaccines in the elderly

OR | Workshop
(Highly interactive session for a maximum of 30 participants)
Post-mortem: Pandemic influenza preparedness and response
• What has changed in a quantitative way post-pandemic in terms of policy, industry and regulatory review procedures, and benefit:risk judgement and communication?

• Working Party A: Areas for discussion:
  • Re-examining the criteria and procedures for pandemic flu: When is a pandemic a pandemic?
  • Feedback from the countermeasures review processes
  • Benefits of pandemic vaccines: How severe does a pandemic have to be to warrant immunization?
  • Efficacy of pandemic immunization: Balancing risks and benefits
  • Should we expand the criteria of pandemic to include disease severity and societal impact?
  • Getting the timing right: With hindsight what’s the appropriate trigger to announce a pandemic?
  • Ensuring that all interested parties understand the same messages and communicate in the context of each of their own, but different responsibilities
  • Regulatory lessons: How good / appropriate were the test mechanisms? What has been learned regarding correlates of protection?
  • Drivers for vaccine up-take: Was the pandemic too mild or did the vaccine come too late?
  • What are the true costs and lives saved?
• Working Party B: Areas for discussion:
  • Supply and demand
  • Despite seasonal over-production capacity, pandemic vaccines were too little-too late: What technical solutions are in sight to change this global dilemma in the next 3-8 years?
  • Was the projected US seasonal influenza production capacity enough for timely supply of pandemic vaccine in the US?
  • What are the access projections for developing countries? How to encourage more capacity and access globally, especially in the developing world
  • Industry must invest in pandemic vaccine development without knowing if the pandemic becomes severe. Governments are compelled to purchase vaccines with the same uncertainty. Will this remain a reality and what has to be done about it?
  • How do we make manufacturing more flexible?
  • Pandemic vaccines seem to be as safe as seasonal vaccines: Could one use them before the pandemic?
  • Reflecting on what should be done on an annual basis with seasonal flu to facilitate acceptance of vaccines both seasonally and in the event of pandemic
• Conclusions and further action points from both Working Parties in terms of:
  • policy, criteria and timing
  • regulatory review procedures and benefit:risk judgement
  • information sharing and surveillance / inter-agency cooperation
  • technological priorities
  • global access
  • communication and public perception to facilitate greater acceptance of both seasonal and pandemic vaccines

Then | Afternoon plenary session
What PR lessons and skills does the vaccine industry need to learn?
• How can the communication of B:R be improved?
• How can vaccine hesitancy be reversed?

• How would a PR expert ‘sell’ the benefits of vaccination?
  • What influences public perception? How to prevent the misinterpretation of facts
  • Honing your corporate communications skills to deal with public fear and media frenzy
  • How to combat bad / misleading PR: Do you ignore it or jump into the arena?
• Panel discussion
  • Advocacy: Delivering a consistent line in educating the public on vaccines - whose responsibility is this?
  • Influencing the influencers: Getting buy-in from the entire medical and healthcare environment to be advocates for the benefits of vaccines
  • Examining the psychology behind the fear of vaccination: How can behavioural research help?
    • Quantifying the effects of human behaviour on vaccine efficacy
  • Learning lessons from pertussis, MMR and pandemic ‘flu: What’s the PR action plan going forward? How should we communicate B:R to parents?