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15 Key questions to be debated

Barcelona Vaccine
Forum 2009

  1. Multiple stakeholder 'debrief' on preparations for, and the response to, the 2009/10 H1N1 influenza pandemic: How we did and what have we learnt? How are recent experiences informing ongoing preparedness strategies?
  2. How are innovative partnering models and funding opportunities enabling vaccine market development on a global scale?
  3. What lessons can be learned from pneumococcal and HPV vaccine success stories to inform both R&D and market development strategies for potential future blockbusters?
  4. What were the drivers behind the activities of those big pharma companies that have recently entered the vaccine sector? Why did they choose their particular entry strategies?
  5. What were the experiences of regulators on both sides of the Atlantic regarding the approval of novel pandemic influenza vaccines? What were/are the similarities and differences between US and European regulatory approaches? How significant were these differences?
  6. What will be the impact of ongoing healthcare reform in the US and beyond on the vaccines world?
  7. What will be the successful business model for capitalising on R&D and commercial opportunities in the 'BRIC nations'?
  8. Can H1N1 pandemic 'flu provide opportunities for emerging companies to develop sustainable commercial models?
  9. Is there still a viable VC model in light of the scarcity of vaccine company IPOs over recent years?
  10. Can we sustain the funding of GAVI in its present form? How should GAVI be replenished? Where should the money come from? How should GAVI conduct its business in future?
  11. Are novel adjuvants realising their potential in influenza and other vaccine target areas?
  12. What were the claims and expectations for the various novel manufacturing platforms in development pre-pandemic? Which ones delivered on those promises?
  13. Reassessing the STEP and Thai HIV vaccine clinical trial data - what is the significance of these data in the final analysis and what pointers do they provide in terms of future directions for R&D?
  14. Establishing your preclinical rationale for animal models: To what extent can you trust mouse data?
  15. What are the PIPs (Paediatric Investigation Plans) really impacting? Have they made any difference to timelines, costs and success rates for the paediatric vaccine regulation process?

Active Immunotherapeutics
Forum 2009

  1. How do AI development and commercialisation pathways need to differ from traditional cytotoxic drug development? How to displace, combine with, or integrate the standard of care?
  2. What business models are most likely to succeed in AI?
  3. Case studies from companies approaching registration: What is required for registration trials? How is regulatory interaction in both US and EU being handled?
  4. Improving the efficacy of active immunotherapy: How can we make it work?
  5. What is big pharma / big biotech’s perception of the value of AI? How does AI fit into the strategic plans for the business portfolio? How are they evaluating, assessing and processing novel AI products?
  6. Have we hit the inflection point yet? Are we spending enough money in the area to have success? Are there enough biotechs involved?
  7. What progress is being made with the identification and validation of biomarkers in cancer vaccines? For genetic pre-selection of patients? For developing diagnostic tests? For labelling?
  8. From a business development perspective, how can we overcome the strategic development concerns with AI combination therapies?
  9. When and how should companies start dialogue with payor, physician and patient groups to assess reimbursability of AI products?
  10. Adjuvants and other agents: Do you need them? What is the regulatory viewpoint on adjuvants for AIs – what is the risk:benefit?
  11. What degree of flexibility are new statistical approaches achieving and with what benefits? In what circumstances is adaptive design likely to be most effective and when is it likely to be over-complicated?
  12. How is AI being applied to chronic infections that can’t be addressed by traditional vaccine approaches? Which areas are showing greatest promise?
  13. Immune monitoring for clinical efficacy: How do you measure and monitor the potency of AI response in the clinic? What potency is required for release of the product?
  14. What are the recent advances in B cell and antibody approaches to AI, and how are they being used to inform decisions in different disease areas?
  15. AI for allergy: What breakthroughs and barriers has this group encountered and what are their next steps?


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