Pre-conference briefing-biodefence
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| Separately bookable Monday 3rd October 2005 |
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| 08.15 |
Registration
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| 09.00 |
Chairperson’s opening remarks
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Klaus Neurohr, Head of Quality and Regulatory Affairs, Avecia Biotechnology
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| BIODEFENSE VACCINE DEVELOPMENT ISSUES |
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| 09.10 |
Leveraging the value of a single product to build a sustainable biodefense business
- Strategies for 'evergreening' of the existing product
- The development of next generation products
- Building a portfolio in biodefense vaccines and therapies
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| 09.40 |
Building a biodefense vaccine industry in Europe: what steps are required?
- What do companies require from NGO’s and governmental organisations in order to make this a viable option?
- What requirements are needed by governments to address the industry’s concerns: liability and IP protection?
- What incentives and assurances are in place to attract companies to develop biodefense vaccines?
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Kim Bush, President, Vaccines SBU, Baxter Healthcare Corporation
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| 10.10 |
Overview and update on Project BioShield
- What is the global importance of Project BioShield?
- What steps have been taken so far?
- Are the initiatives working?
- What is the next stage in the program?
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| 10.40 |
Morning coffee
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| QUALITY AND REGULATORY ISSUES WITHIN BIODEFENSE |
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| 11.25 |
Clinical development of biodefense vaccines
- The FDA's approach to clinical development and related policies
- New approaches being taken
- Considerations for fast-track
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| 11.55 |
Quality and regulatory aspects of biodefense vaccines
- Regulatory framework for Biodefense vaccine licensing in the US and EU
- Measures of Efficacy/Protective Effects: In-vitro and in-vivo assays
- Avecia's Anthrax and Plague vaccine programs
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Klaus Neurohr, Head of Quality and Regulatory Affairs, Avecia Biotechnology
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| 12.25 |
Lunch
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| 14.00 |
Panel session: will fast-tracking vaccines lead to greater problems down the line?
- What are the safety implications of fast tracking?
- What are the ethical considerations?
- What happens if the wrong decision is made?
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Klaus Neurohr, Head of Quality and Regulatory Affairs, Avecia Biotechnology
Trevor Marks, Business Development Manager, Health Protection Agency Porton Down
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| 14.45 |
Effective vaccine distribution strategies in the event of biodefense vaccine demand
- Lessons to be learned from the flu vaccine shortage
- When should the decision be taken to immunise?
- Are we prepared?
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| 15.15 |
Afternoon tea
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| BIODEFENSE VACCINE PROCESS DEVELOPMENT |
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| 15.45 |
Anthrax vaccine; past, present and future
- Current products - how long are they needed?
- The next generation - where are we?
- Beyond the next generation - what are the new products in development?
- Who is driving the development of these products?
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Trevor Marks, Business Development Manager, Health Protection Agency Porton Down
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| 16.15 |
Case study – Ebola
- What new developments have been made?
- Overview of ebola
- Current research findings
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| 16.45 |
Biodefense response – optimising manufacturing/delivery processes
- Necessity for regional/national stockpiles
- Stockpile formulary drivers
- Local planning for distributing stockpiles
- Rapid deployment at minimal cost-stockpile imperatives
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Richard Nolan, Senior Advisor to the Director Strategic National Stockpiles, Center for Disease Control
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| BIODEFENSE MODELLING STRATEGIES |
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| 17.15 |
Overview of the Animal Rule as a route to licensure
- Requirements for use of the Animal Rule
- Issues that should be addressed when designing the animal studies
- Approach to bridging the animal data to humans
- Update on animal models currently being used
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Mark Abdy, Veterinary Medical Officer, FDA-CBER
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| 17.45 |
Close of briefing
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| 17.45 |
Pre-congress registration and welcome cocktail reception sponsored by:
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