DAY 1 | Monday January 26th 2009

Morning plenary session
Vaccines at the tipping point: Where are novel enabling technologies and an increasing understanding of immunology leading us in an era of consolidation?
• Delivering integrated business models for large and small companies in the sector

• Analyst's introductory overview
  • o Assessing the global vaccine portfolio - what are the key areas of opportunity, both in terms of disease targets and populations, moving forwards?
  • What is our vision for an integrated technology platform upon which future success can be built?
• Big pharma perspective
  • How are we harnessing recent advances in technology and scientific understanding to build an R&D portfolio robust enough to withstand the increasing economic pressures confronting the vaccine R&D model?
  • What role will collaborative strategies play in shaping our future vaccines business model?
• Biotech perspective
  • Examining the strategic growth choices open to biotech companies in the current economic climate (acquiring technology from academia, strategic partnering, M&A) - what blend is optimal? What innovative funding pathways will be available to smaller companies in future, given the global credit crunch and what are the keys to capitalizing on them?
• Panel discussion
  • What blend of pharma and biotech business models will work in the marketplace of the future, given the uniqueness of traditional market dynamics and commercial models in the vaccine area, or is a brand new model required as new technologies and targets emerge?

FOLLOWED BY YOUR CHOICE OF 3 PARALLEL BREAKOUT SESSIONS:

Focus session 1
Weaving disparate value-adding technologies into a functional vaccine R&D platform

• VCs perspective: How do we currently assess novel technology platforms? What specific values-adding elements do we want to see in terms of their potential to deliver R&D efficiency and innovation?
• Case studies
  • Assessing recent clinical data from leading enabling technologies in development
  • What are the challenges in integrating them into functional platforms (particularly where multiple organizations are in collaboration) and how are they being addressed on an ongoing basis?
    • Novel adjuvants, applied both individually and in combination
    • Electroporation
    • Transdermal delivery
    • Temperature stable formulation
    • Chimeric vectors

OR | Focus session 2
What benefits are disposable technologies and other novel vaccine manufacturing solutions providing in practice?
• What cost savings are they delivering and how are the remaining technical and regulatory challenges being addressed?

• Introductory presentation: Summarizing recent progress in the development of innovative, low cost vaccine manufacturing solutions - what is available today and what is on the horizon?
• Regulator's perspective: What regulatory concerns remain over the utilization of disposable and portable manufacturing solutions and how might they be alleviated?
• Case studies: Practical experiences with the utilization of novel manufacturing solutions - assessing their performance
  • Why did we choose the technology/technologies in question and what challenges are we facing in terms of turning them into functional platforms?

OR | Workshop
Partnering workshop: Examining recent trends and deals to inform your business development strategy

• Opening presentation: Analyzing recent partnering trends in the vaccine sector and the impact on public market values
• Co-presented case studies: Exploring the strategic drivers behind recent collaborations within the vaccine sector from both sides of the deal
  • Big pharma-biotech
  • Biotech-biotech
  • Partnering with a foundation
    • Evaluation criteria: What were the specific values that attracted us in the first place and how do we plan to maintain and nurture them?
    • Successfully navigating the partnering process: How were the key decision made at each step?
      

THEN | Afternoon plenary session
How high will the vaccine safety ball bounce?
• How are regulators and industry addressing safety concerns over vaccines in general, and novel adjuvants in particular?

• FDA keynote address: What unique challenges are we facing as we assess new technologies for safety and how are we seeking to address them?
• Industry/regulator roundtable discussion: Debating a pathway to licensure for novel adjuvants - what are the next steps?
  • Comparing the real and perceived risks versus benefits of novel adjuvants - how much immunomodulation is too much in the current regulatory environment?
  • Adjuvant lifecycle management - what R&D strategies and tools can potentially improve the safety of adjuvants while not reducing their effectiveness?
  • Exploring the latest generation of immunomodulators nearing the clinic (eg nanoemulsions) - what are the potential risks and benefits of these technologies on the horizon from industry and regulator perspectives?

DAY 2 | Tuesday January 27th 2009

Morning plenary session
How sustainable are influenza, biodefense and pediatric vaccine markets long term?
• What long-term funding/commercial opportunities are available, and how will vaccination schedules and infrastructure in general accommodate new products?

• US Government agencies/industry/economists presentations & roundtable
  • BARDA keynote address: Defining the major points of focus - how are we coordinating with other stakeholders to rationalize the anti-biothreat portfolio and what does this mean in terns of funding opportunities for the vaccine industry?
    • Highlighting prioritized technology areas and targets
  • How many players will the influenza vaccine market support, given its increasingly commodotized nature? What is the balancing point in terms of the number of players that the sector will support?
    • Can the pandemic influenza market survive without a pre-pandemic element? What is the current view of the value of H5N1 stockpiling specifically? What should be done with current stockpiles nearing their expiry dates? What are the options for utilizing/converting spare manufacturing capacity?
    • What is the latest progress towards developing a 'universal' influenza vaccine?
    • What will be the next step in the influenza area - a quadrivalent vaccine?
  • What is being done to engage more vaccine companies in the biodefense space, particularly the larger companies?
  • How is the concept of post-marketing surveillance in the context of an emergency biodefense response evolving?
• CDC/payers/industry presentations & panel discussion
  • Where next for novel pediatric vaccines?
  • Vaccines for adult and adolescent markets - what is developing terms of target opportunities for the industry, and also the challenges in marketing and distributing these vaccines?
    • Exploring the ongoing roll-out of HPV vaccines worldwide and the evolution of adult and adolescent vaccination schedules
    • Addressing the key remaining challenges in installing the necessary infrastructure to conduct adequate post-market surveillance of adults and adolescents
    • 'Bundling' of vaccines to make schedules more efficient, particularly for adults - what initiatives are underway, and where do the authorities and industry see possibilities in future?
      

FOLLOWED BY YOUR CHOICE OF 3 PARALLEL BREAKOUT SESSIONS:

Focus session 1
Cell culture manufacturing and beyond: How are next-generation manufacturing technologies performing in the clinic?
• Are we seeing incremental improvements or major steps forward in terms of cost savings and increased yield/speed of production?

• Case studies assessing the pros and cons of emerging technologies in clinical development - what regulatory and product development challenges remain? How viable will they be in practice within a regulatory framework?
  • Baxter's cell culture technology
  • Insect cell technology
  • Protein expression systems
  • Plant-based manufacturing systems
  • Algae-based manufacturing systems
    

OR | Focus session 2
Update on non-cancer therapeutic vaccines in clinical development

• Introductory presentation: Round-up of key applications in preclinical development (diabetes, cholesterol, blood pressure)
• Case studies: Delivering the latest clinical data and ongoing clinical development and regulatory strategies for leading candidates in development in a number of application areas:
  • Allergy
  • Addiction
  • Alzheimer's disease
  • HCV
• Industry/regulator panel discussion: What might the pathway to approval for these new applications look like? How will they be regulated? (Which branch of the FDA would be responsible?)
  

OR | Workshop
Executive regulatory briefing

• A series of presentations and interactive discussions designed to provide an executive summary of key emerging regulatory legislation and guidelines from around the globe, pitched at a strategic level to provide insight into potential implications for your business. Topic areas to be explored to include:
  • A global summary of the latest developments in the regulatory environment for influenza vaccines and related technologies
  • Europe-specific:
    • Deciding when to take the national and when to take the centralized route - reaping the benefits of making the right strategic choice
    • Vaccine Antigen Master File (VAMF)
    • Navigating the Pediatric Investigation Plan (PIP) filing process
    • How will the recent Advanced Therapy Medicinal Products legislation impact the vaccine area?
  • A global summary of the latest developments in the regulatory environment for influenza vaccines and related technologies
  • Clarification of the latest developments in Chinese regulatory guidelines and legislation relating to vaccines
    

THEN | Afternoon plenary session
Reassessing the vaccine community's R&D approach to the hardest targets
• What future directions should NGO and industry alike take in areas such as HIV?

• Presentations and panel discussion
  • What lessons may be taken from recent setbacks in areas such as HIV?
  • What will be the long-term impact on other adeno-vectored vaccines, and viral vectored vaccines in general?
  • Have we adequately tested CMI in HIV vaccines yet?
  • Should the community concentrate solely on funding basic research in the most difficult target areas such as HIV, or on getting into the clinic, or on a blend of the two? If the latter, what is the ideal balance moving forwards, given the economic pressure on vaccine companies to proceed to human trials as quickly as possible?
  • In light of recent setbacks with novel technologies, is it time to reassess the severity of safety concerns over 'tried and tested' technologies such as live attenuated vaccines?
    
    

DAY 3 | Wednesday January 28th 2009

Morning plenary session
Vaccine market sustainability on a global scale: Capitalizing on the business opportunity presented by unmet needs...

...in the developing world

• Analyst's perspective: What are our current assessments regarding the value of key second-tier nation vaccine markets? What are the vaccination priorities for the public sector in each case?
• China
  • India
  • Korea
  • Russia
• Industry case studies
  • What is the optimal entry strategy for a Western vaccine company seeking to access Chinese and Indian R&D and commercial opportunities?
  • Pursuing a vaccine target endemic to a developing nation or region - what are the technical hurdles and funding/commercial opportunities?
    

...in the undeveloped world

• Keynote address: Update from the Bill & Melinda Gates Foundation
  • Now that the vaccine industry is fully engaged with previously neglected diseases such as TB, what are the next steps in these applications? What emerging diseases and technologies are we particularly interested in for the future?
• R&D updates: Delivering the latest results from advanced clinical trials of malaria, TB and multi-valent pneumococcal vaccines. What are the ongoing product development strategies?
• NGO-industry-regulator panel discussion
  • How to make vaccines more affordable for the global marketplace while retaining the business case for industry?
  • How are regulatory pathways in the US and Europe evolving to enable the development of vaccines predominantly for the developing and undeveloped worlds?

FOLLOWED BY YOUR CHOICE OF 3 PARALLEL BREAKOUT SESSIONS:

Focus session 1
Employing novel characterization tools and techniques to improve decision-making at each stage of the R&D pipeline

• Preclinical case studies
  • Which preclinical models correlate best to humans? How are ex vivo studies and other translational medicine techniques and technologies accelerating progress towards First-in-Man studies in the vaccine field? Is there evidence that human cell data is more valuable than animal data in vaccinology?
  • How acceptable is this data to the regulators as an alternative to, or in support of, animal data?
  • What results have been seen with humanized or transgenic mouse models?
• Clinical case studies
  • How are novel high-throughput assays improving clinical trial design and decision making through the phases?
  • Case study and panel discussion: Gardasil - exploring the successful development of a vaccine using modern lab techniques and technologies. What lessons are there for other vaccine developers?
    

OR | Focus session 2
Update on therapeutic cancer vaccines in clinical development

• Opening overview: Examining the 20-year history of therapeutic cancer vaccines
  • Analyzing set backs and progress to date - what trends have we seen and what lessons can be taken forward to assist in the ongoing development of these products?
• Big pharma perspective: Why are the strategic drivers behind our recent investment in the cancer vaccine area?
• Case studies
  • Analysing latest clinical data from leading cancer vaccine candidates (both individually and in combination with chemotherapy) in phase II or III trials. What are current expectations in terms of time-to-market? Addressing ongoing regulatory concerns - how is the pathway to market evolving?
• Panel discussion
  • How do you make development decisions for products in a novel class with no 'roadmap'?
  • How can we realize the potential of various novel immune modulators (antibodies, checkpoint inhibitors, etc) to boost immune response to cancer vaccines?
  • Can immunoassays really be trusted for clinical development decision-making in the cancer vaccine area?
    

OR | Workshop
Global health as a 2-way street: What opportunities are available to both Eastern and Western vaccine companies to access novel markets and populations?

• Western company perspectives
  • What are we looking for in an Eastern partner?
  • What is the latest information on the development of regulatory systems for companies seeking to conduct clinical development in the Far East?
  • Case study: In what scenarios are Eastern CMOs of potential benefit to Western vaccine companies?
• Eastern company perspectives
• What are the specific strategic goals of various Eastern vaccine companies, how are they evolving their business models to achieve them and what opportunities are there for partnering with Western counterparts?
• Panel discussion: In what timeframe will vaccine manufacturers be able to meet evolving bioequivalence requirements and to what degree will this impact the global vaccine sector?