• Examining new strategies for raising the necessary funds
• How to build a winning management team to co-ordinate your strategic growth plans
• How critical is it to retain your top scientists?
• Future goals: paving the way for the transition from biotech firm to pharma company

• Barriers to entry in the vaccine business
• Portfolio decisions: preventative or therapeutic vaccines?
• Value chain decisions: how far can one go?
• Funding decisions: classic and new sources

• What do venture capitalists look for at various stages of financing?
• What vaccine technologies have investors backed?
• What does the market want?
• Overview of venture-backed vaccine companies

• Traditional model - venture capital
• Out-license non-core technology
• Partner core technology
• Secure other sources - government contracts, grants, etc

• Understanding the nature of the opportunity
• Evaluating the opportunity: assessment of benefits and risks
• Value drivers for establishing partnerships
• Structuring partnerships to maximise benefit and minimise risk

• Licensing in from and collaborating with academia – industry and academia perspectives
• Defining deliverables and transferring them successfully
• Finding the right partners – the German vaccine consortium, a virtual vaccine development company
• Managing the project(s) – a real challenge in communication

• New product development activities in the vaccine industry
• The role of partnerships in accelerating product development
• Examples of partnerships in the vaccine industry
• Keys to deriving value from vaccine partnerships

Partnering between big pharma and vaccine companies is increasingly important to both parties. But many vaccine CEOs want to know if Big Pharma has a coherent strategy, or are the companies acting opportunistically? How does a vaccine company plan their approach to big pharma? This panel will explain how they approach the deal-making process and explain what they see as necessary preparation for vaccine companies seeking to engage with them.

• The role of licensing and alliances in new and existing vaccines
• The technology components of a typical vaccine and the resulting potential for multiple licences and alliances
• Leveraging the respective strengths of each partner in an alliance

• HIV, Ebola, WNV and SARS – translation from bench to clinic and beyond
• Alignment of goals for successful partnerships
• Streamlining of development timelines

• Myths and obstacles in the fight against polio
• The need to develop products for the Global OPV Cessation Phase
• Gaining commitment and engagement from governments and vaccine manufacturers
• Financing global eradication efforts – where is the money going to come from?
• Public information and social mobilisation programmes for the 21st century
• A plan for dealing with conflicted-affected parts of the world

• Is wider and more effective use of voluntary licensing an option?
• The health economics of vaccination and pressure on vaccine pricing
• Addressing differential vaccine pricing world-wide
• The need for more global public private partnerships

• How well prepared is the Western world? 
• Ensuring a secure domestic supply of vaccine
• Can manufacturing problems be overcome using reverse genetics?
• Likely costs of the plan
• Priority lists for immunisation, plans for minimising exposure and recovery plans

• Enhancing influenza surveillance in the U.S.
• Enhancing influenza surveillance in Asia in response to outbreaks of highly pathogenic H5N1 avian influenza viruses
• Encouraging use of influenza vaccine
• Responding to the shortage of influenza vaccine in the U.S.

• Responding to a global public health emergency
• Accelerating the regulatory process
• A need for international harmonisation of regulations
• Regulatory co-ordination and co-operation

• Grandfathered flu vaccines
• Split/subunit vaccines
• Live cold recombinant vaccines
• New vaccine technologies explored

• Roles that the innate immune system plays
• Consideration of TLR biology in developing next generation vaccines
• Application to addressing the threat of pandemic influenza

• Non-invasive, non-replicating, nasal vaccine
• Adenovirus vector
• Cell-culture process
• Wave technology

• The reverse genetics patent landscape
• Actions of an IP stakeholder and vaccine manufacturer
• Impact on pandemic vaccine development by health authorities and vaccine manufacturers

• What are the main issues in pandemic flu preparation?
• Current and proposed production and distribution strategies
• Producing a vaccine for H5N1 – what if the strain becomes part of a pandemic?
• Who should pay for clinical trials development – government or industry?

• Impact of financing mechanisms on investment decisions
• Perspective on financing proposals for industrialised and developing world vaccines
• Challenges and opportunities in going forward

• Development and evolution
• Key components and cross-cutting themes
• Governance in a federal system
• Future challenge

• Cost as a fraction of average per-capita gross domestic product
• Analysis of the economic and epidemiological impact of a rotavirus vaccine
• Models to estimate disease burden and vaccine needs for manufacturers and the development assistance community
• The financial requirements for implementation of a new vaccine
• The expected disease burden reduction including treatment costs

• Challenges of R&D into diseases of poor countries
• Reducing the risks faced by firms by making an advanced price and/or purchase commitment for a future product 
• Using a conventional contractual law framework, and the existing international health regulatory and procurement systems
• Potential benefits for firms, sponsors and global health

• The scope of government investment today
• Emerging problems of the current financing approach
• Radical new approaches to financing like government voucher schemes
• Industry responses to the IOM report Financing Vaccines for the 21st Century

• How far have we come since 9/11?
• The importance of BioShield
• The unique and expanding role of animal models for biodefense research and development
• Complications and adverse reactions
• The need for expansion in the infrastructure for clinical testing and evaluation for new generation vaccines
• Future needs and opportunities

• Assembling the components of an expedited development programme
• Winning vaccine development contracts
• Accelerated product development in partnership with the government
• Establishing large scale manufacturing to meet stockpile requirements
• Negotiating a BioShield supply contract

• Animal rule
• Technology transfer
• Change control
• Vaccine development

• BioShield Act as funding source and enhancing IP values
• Federal grants and NIH SBIR funding opportunities
• Disease specific foundations and related venture capital sources
• DARPA and US military development opportunities
• Use of customised insurance products and mezzanine debt to reduce capital requirements

• How can the commitment to BioShield be made more tenable?
• How will the decision-making be allocated?
• Where will the centre of power be – at the government departments or agencies?
• How will companies/organisations be able to access the funds?
  What stages of development will be covered by the funds?

• Development of novel vaccines using infectious clone technology
• Use of a reliable vector (yellow fever 17D) for delivery of foreign genes
• Rapid development of a vaccine against West Nile
• Application to other emerging/reemerging virus diseases

• Vaccine production based on embryonated eggs is non-optimal
• Continuous cell lines are more stable systems for vaccine development
• The Vero cell line is widely accepted for vaccine production (Polio, rabies)
• This cell line is highly suitable for influenza H5N1, SARS, West Nile vaccine development

• Challenges of targeting major unmet needs with in-house expertise
• Pros and cons of partnerships with big pharma
• Answering investors’ questions about a high-risk, expensive business model

• The value of continuing to build the biodefense portfolio
• Strategy for developing a pipeline outside of biodefense
• The role of new technologies in building the pipeline

• Examination of the prophylactic vaccine market which targets pediatric, the elderly and travellers
• Examination of the therapeutic vaccine market which targets mainly cancer and HIV
• Insight into drivers behind current alliance activity in each area
• Clinical trials and manufacturing challenges for each sector

• The development pathway for therapeutic cancer vaccines is uncharted
• Optimising products through sequential clinical development of successive prototypes
• Leveraging this clinical experience to initiate late stage trials for two different products

• Investigation of CpG motifs as possible stimulators of innate and specific immunity
• Motifs that could stimulate lymphocytes in vitro
• Their ability to serve as therapeutics to prevent infection
• Ability as adjuvants to enhance immune responses in vivo
• Results from a second adjuvant based on polyphosphazenes

• Evidence that virosomes do not induce an antiphospholipid antibody response
• Specific studies on particle size showing consistency
• Toxicological studies
• Validation of incorporated antigen uptake
• Influenza antigens incorporated in the virosomes and their effect on the intended vaccine antigens

• Mucosal immunity
• Alternate route delivery
• Simplicity and safety
• Market needs

• Key components in development of the manufacturing process and safety evaluation of preventive vaccines
• Focus on the safety evaluation of novel adjuvanted vaccines
• Non-clinical safety data to be included in the original submission to a new IND
• Utility of the pre-IND meeting

• New developments in EU regulatory aspects for adjuvant quality
• Regulatory expectation regarding safety at pre-clinical and clinical stages
• The regulatory concerns and existing bottlenecks leading to slow approval of new technologies
• First experiences with scientific advice/licensing processes for vaccines with new adjuvanting systems
• Better immunogenicity, enhanced reactogenicity – how to perform the risk/benefit analysis
• What type of vaccine and which target groups would benefit most from new adjuvants?

• What are the main considerations in demonstrating safety, pharmacology and efficacy?
• Designing in silico, in vitro and in vivo studies to support safety
• Designing studies to assess systemic and local toxicity and immunogenicity
• Safety considerations for novel mucosal and parenteral adjuvants

• A discussion of bacterial vector vaccines in development
• What is their ability to provide for the onset of immunity as a major goal?
• How easy are these vaccines to produce and deliver?
• Manufacturing and purification technologies which are not costly and lengthy

• The need for potent alternatives to conventional vaccines
• Alphavirus replicon particles as a gene-based vaccine strategy
• Vaccination to protect against intranasal virus challenge
• Re-administration in the presence of vector neutralising antibody

• Vector development
• Seroprevalence
• Product characterisation
• Formulation

• A unique approach to maximising the breadth of the antiviral immune response
• Using a modified DC process with enhanced immunopotency as the antigen delivery vehicle
• Why this approach is compelling and how it differs from other vaccine strategies
• Proof-of-concept data and clinical trial plans
• Discussion on the feasibility of personalised antiviral vaccines

• What is the possibility of systematic infection in immunocompromised individuals?
• What is the possibility of reversion to a more virulent strain of the virus?
• Risks of a change of pathogenicity or host range
• Basic characteristics that promote strong immune responses
• How can you promote better immune responses without compromising safety?

• Novel assays to decode immune response
• A place for genomics and proteomics in immune monitoring
• Importance of standardisation in immune monitoring
• Importance of developing public databases of immune monitoring in vaccine trials

• Challenges to address in clinical development
• Speed to market
• Regulatory requirements particularly with new directive
• How disposable technology can help
• Available technologies and examples of application

• A new platform for vaccine evolution and manufacturing
• Advantages over conventional processes
• Impact of rapid vaccine production on civilian and defense applications
• Case studies, including product design, manufacturing scale-up, and regulatory experience

• The current interaction between vaccine developers and regulators – ups and downs
• Lessons learned from accelerating biodefense vaccines
• How these lessons can be used for other vaccines
• Gaining orphan drug approval by working with regulatory agencies
• The need and push toward international harmonisation of regulations

• Overview of guidances from both spheres of influence
• Risk management
• EU Clinical Trials Directive

• Theoretical concerns related to the cellular immune response induced by a vaccine
• Regulatory concerns related to the cellular immune response induced by a vaccine
• Merck’s approach on addressing these concerns