• International development assistance to meet the millennium development goals
• What is the future of vaccine funding
• Funding principles
  

• What are the key areas lacking funding?
• Is this funding sustainable?
• Are the correct projects receiving money?
  

• Market drivers - impact on technology, manufacturing scales and costs
• Intellectual property rights - impact on innovation ability.
• Regulatory environment - new challenges and impact on costs. 
• Funding - prospects and ground realities.
  

• Protecting more people in a changing world
• Introducing new vaccines and technologies
• Linking immunisation to other interventions
• Immunisation and surveillance in the health systems context
• Immunising in a context of global interdependence
  

• What is the clinical spectrum and pathogenesis?
• What is the extent of bird-to-human transmission?
• What is the likelihood of human-to-human transmission?
• Treatment and prevention?
  

• The characteristics of current influenza vaccines
• The characteristics of new influenza vaccines in development
• What kind of research in vaccinology is further needed
  

• Was the panic justified?
• Was the response appropriate and have the initial enforced restrictions caused a decrease in vaccine uptake?
• What is being done with regard to surplus stocks in some areas and adequate stocks in other?
  

• What is the general feeling within the scientific community?
• What research needs to be carried out?
• What implications will this have on existing health care services?
  

• What advances have been made?
• Vaccines in development
• Decreasing timelines
• Increasing stability and chances of mutations
  

Sponsored by:

• Specific immune response
• Protective antigens
• Safety and drug master file
  

• New adjuvants in development
• Optimisation of immune response
• Challenges faced with regard to safety, efficacy and industrial production
  

• New developments in patch technology
• Mode of action
• Possibilities – travellers vaccines, cancer and infectious disease
  

• Have the new methods advanced enough?
• Overcoming the problem of working against a proven method
• What is the feeling within the industry?
• Can this be a reality?
  

• Delivery of large numbers of antigens
• Increased stability
• Implications for infectious disease prevention and treatment
• Overcoming problems of antibiotic compromised environments
  

Sponsored by:

• Has all the “hype” been justified?
• Updates on advances in this sector
• Do we have a full understanding of virus/host interactions?
• Do we have and understanding of their mechanisms of evasion?
  

• What are the current vaccines in development/on the market?
• What are the results so far?
• What are the timeline involved?
  

• HIV vaccines which way is best?
• What is the future of prophylactic vaccines?
• What new vaccines have come on to the market?
• Are lifestyle vaccines the more profitable option?
• New Japanese Encephalitis Vaccines
  

• What is the general feeling within the industry?
• Could these be the future? 
• Chronic viral diseases
  

• Is there an actual choice between developing a prophylactic vs. therapeutic vaccine?
• What are the manufacturing implications?
• When should the decision be made?
• Is it simply a question of cost?
  

Sponsored by:

• Methodologies for T-cell epitope discovery and enhancement
• CTL versus humoral response
• Development of "polypeptide vaccines"
• Presentation of selected cases
  

• Brief description of Merck's Rotavirus Vaccine
• Overview of residual DNA limits in vaccines
• Proposal for new oral limit for the level of residual DNA in an oral vaccine
  

• Barrier technology
• Level of automation
• Labeling and packing considerations
• Regulatory compliance
  

• Predictive and analytical risk assessment tools
• Ensuring a smooth transition from research to production scale manufacture
• How to improve timelines?
  

• Does the regulatory process hinder vaccine development?
• What impact does this have on cost and timelines?
• What improvements can be made to avoid conflict and allow development?
• The need for enhanced scientific expertise
• Risk/benefit ratio of public health intervention
  

• Overview of malaria vaccine field
• Update on RTS,S/AS02A clinical development & findings 
• Future plans
  

• Overview of rotavirus infection
• Updates on current findings
  

• AS04, a new adjuvant system for prophylactic vaccines
• Overview of adjuvant development
  

• Antigen discovery in the post genomic era
• The influence of delivery systems
• Animal models
  

• Overview on how the vaccine works
• Update on trial results
  

• Overview of HIV to date
• What is the current status?
• What is the future?
  

• Overview of LAG-3
• Preclinical studies with IMP321
• Results of two large randomised phase I/II trials with IMP321
  

• Strategies for 'evergreening' of the existing product 
• The development of next generation products 
• Building a portfolio in biodefense vaccines and therapies
  

• 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?
  

• 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?
  

• The FDA's approach to clinical development and related policies 
• New approaches being taken 
• Considerations for fast-track
  

• 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
  

• What are the safety implications of fast tracking?
• What are the ethical considerations?
• What happens if the wrong decision is made?
  
  

• Lessons to be learned from the flu vaccine shortage
• When should the decision be taken to immunise?
• Are we prepared?
  

• 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?
  

• What new developments have been made?
• Overview of ebola 
• Current research findings
  

• Necessity for regional/national stockpiles
• Stockpile formulary drivers
• Local planning for distributing stockpiles
• Rapid deployment at minimal cost-stockpile imperatives
  

• 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
  

Benefits of attending the workshop

This highly interactive workshop will allow delegates to put into practice negotiating strategies, enable them to identify problems in complicated legal documentation and come to mutually acceptable solutions.

Who should attend?

This workshop would be of great benefit to delegates who are new to contract formation and negotiations in the vaccines industry. It will also be of benefit to delegates that require a refresher course, to help stay up to date in this constantly developing field.

Your workshop leader:

Simon Portman is Partner and Head of Life Sciences Department at Hewistons. He joined in 1996 and specialised in commercial and intellectual property law, largely for life science clients in the UK, Europe and the US. He sits on the Intellectual Property Advisory Committee of the Bioindustry Association, is a member of the Eastern Region Biotechnology Initiative (ERBI) and the Oxfordshire Bioscience Network and regularly gives seminars in the UK and internationally.  He is co-author of the book “Commercial Issues for Lifescience Companies” and is currently co-writing the book “Intellectual Property: the Lifeblood of Your Company” with a colleague.

• Getting to the deal and picking the right partner
• Confidentiality agreements, materials transfer agreements, heads of terms
• The allocation of roles and risk between the parties
• Regulatory issues
• The use of management committees to coordinate projects, market products, formulate patent filing and defense strategy and solve disputes
• Intellectual property licensing, development, ownership and enforcement
• Different methods of payment – royalties, milestone payments, upfront fees, equity
• Sanctions in the event of a breach – built-in contractual remedies, damages, injunctions, specific performance
• When to terminate and what happens on termination
• Different methods of dispute resolution – mediation, arbitration, litigation
• Choice of law and jurisdiction
• How business practices and negotiating tactics vary from country to country –Northern and Southern Europe, USA, Japan, China, Middle East
  

• Delegates will be presented with the imaginary scenario of a drug development collaboration between a large US pharmaceutical company and a smaller European biotech company.
• It is proposed in the scenario that the US company’s drug delivery device will be sold in combination with the European company’s vaccine and joint developmental work will be carried out to make this possible.  
• The delegates will be split into two groups each representing one side of the collaboration.  
• Each group will be given a list of the aims of the collaboration from its point of view and a copy of the proposed agreement between the parties, drafted by US pharma.  
• The delegates will then review the agreement, discuss it among others in their group and formulate a negotiating strategy.
  

• Once the session is completed, delegates will give a resume of what they agreed and how they felt they did in the negotiation
• Delegates will be given a run-down of any other pertinent issues which they may have missed