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DAY 2 | Tuesday January 29th 2008
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| 7.30 |
Registration & buffet breakfast in the exhibition area |
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Morning plenary session
Vaccine economics and lifecycle management: How are financial markets, payers and pharma and biopharma companies assessing benefit:risk and the potential value of new vaccine candidates?
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| 9.00 |
Chair’s introduction
Dr Una S. Ryan, President & CEO, AVANT Immunotherapeutics, Inc
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| 9.10 |
Analyst perspective: How does the financial community assess value and benefit:risk in the vaccines sector and what investing trends are forecast?
- What do recent deals say about the value of vaccines?
- How do you value MedImmune at $15.6 billion?
- How have HPV vaccines altered the commercial value of vaccines?
- Assessing the risk profiles of
- Therapeutic versus prophylactic vaccines
- Paediatric versus adolescent/adult vaccines
- Analyzing the economics of niche markets such as the travellers vaccine market: Will they be sold as consumer products, prescription products, or reimbursed products and how will this impact value?
- In the face of increased consolidation how will the vaccine industry continue to grow?
- Licensing and partnering: The value of biotechs is generally increasing rapidly due to weak pipelines in Big Pharma – why aren’t we seeing this so much in vaccines?
- Is it because margins still haven’t reached the levels of therapeutics?
Dr Sharon R. Seiler, Vice President - Senior Biotechnology Analyst, Punk, Ziegel & Company
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9.35
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Questions & discussion |
| 9.40 |
Payer's perspective: how is the assessment of benefit:risk, value and price being approached for new vaccines?
- How should industry demonstrate value?
Dr Daniel Teper, Managing Director, North America, BIONEST Partners
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| 10.05 |
Questions & discussion |
| 10.10 |
Biopharma perspective: Building and managing a vaccine pipeline - considerations for development stage biopharma companies
- Prophylactic and therapeutic vaccine distinctions
- Importance of therapeutic focus
- Aligning licensing and acquisition strategy with pipeline strategy
Daniel J. Abdun-Nabi, President, Chief Operating Officer & Secretary, Emergent BioSolutions, Inc
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| 10.35 |
Questions & discussion |
| 10.40 |
Morning coffee in the exhibition area |
| 10.05 |
Keynote address
Industry perspective on economic pressures for new vaccine development: Demonstrating value to patients and payers through rigorous benefit:risk assessment, and applying lifecycle management to remain competitive
- The benefit/risk management in vaccine development
- The role of vaccine pharmacoeconomics in clinical development
- Lifecycle management in vaccine development
- Vaccine manufacturing: Opportunities and challenges in a global marketplace
Rajiv De Silva, President, Novartis Vaccines USA
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| 11.45 |
Questions & discussion |
| 11.50 |
Panel discussion
How are pharma, biotech and the VC community capitalizing on the business opportunities in vaccines?
- Analyzing market entry / re-entry strategies
- Technology transfer
- In-licensing
- Co-distribution agreements
- How is the value of vaccine businesses/franchise changing? What is pharma looking for from biotech?
- Building a venture financed vaccine company to appropriate inflection points for significant partnerships with pharma
- Balancing the benefits of a large pharma partnership against alternative relationships including with companies in Asia
- Integrating a vaccine business into pharma
- What is the perceived benefit:risk and value in
- Adult/adolescent vaccines
- Therapeutic vaccines
- Vaccines for global health
- Vaccines for biodefense
- Approaches to commercialization for remaining tough targets
Panellists:
Michael Lytton, General Partner, Oxford Bioscience Partners
Dr Douglas J. Pon, Assistant Vice President, Vaccine Licensing, Global Business Development, Wyeth Pharmaceuticals
Fuad El-Hibri, Chairman & CEO, Emergent BioSolutions
Raafat E. F. Fahim, PhD, Chief Operating Officer & General Manager, Nabi Biopharmaceuticals
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12.50
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Buffet lunch in the exhibition area
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Followed by your choice of 3 highly interactive parallel sessions:
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Focus session 1
Pandemic and seasonal influenza vaccines: Which new technology platforms and adjuvants are promising a significant impact on efficacy, dose reduction, duration of response and capacity?
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| 2.00 |
Chair’s introduction
The next generation flu vaccines - the role of adjuvants
- Update on a mechanism-based understanding of how a vaccine works
- Fundamental biology – what are the targets for adjuvants?
- What are the lead products being explored in the clinic and what are the experiences to date?
- Is TLR the right approach? What are the alternatives? Other receptor agonists?
- What are the current (very significant) regulatory issues with adjuvants and how are they considered in the context of a fully licensed product?
- What are the risks of reactogenicity?
Professor Alexander von Gabain, CSO, Intercell AG
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| 2.20 |
Questions & discussion |
| 2.25 |
Moving towards LEAN vaccine manufacturing - lessons learnt from biopharma development and production
- Improving analytical tools as a dose-sparing strategy
- Combining disposable manufacturing technologies towards the mobile plant
- Applying lessons-learnt from biopharmaceutical manufacturing on vaccine production
Dr Catarina Flyborg, Leader, Vaccine Initiative, GE Healthcare Life Sciences
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| 2.45 |
Questions & discussion |
| 2.50 |
Update on VLP vaccines for seasonal and pandemic influenza
- Latest clinical results
- What is the potential for broadened immunity?
- What leadtimes and yields can be expected?
- How scalable will these techniques be in a pandemic crisis?
- How rapidly can they be adapted to new strains?
- How will they perform in crisis conditions?
- What are the regulatory hurdles and how are they being addressed?
Dr Rahul Singhvi, President & CEO, Novavax Inc
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| 3.10 |
Questions & discussion |
| 3.15 |
Update on universal antigen vaccine
- Latest clinical results
- What is the potential for broadened immunity?
- What leadtimes and yields can be expected?
- How scalable will these techniques be in a pandemic crisis?
- How rapidly can they be adapted to new strains?
- How will they perform in crisis conditions?
- What are the regulatory hurdles and how are they being addressed?
Dr Alan Shaw, President & CEO, VaxInnate Corporation
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| 3.35 |
Questions & discussion |
| 3.40 |
Panel discussion
Who is taking the lead in developing a surrogate assay than HI for existing and new influenza vaccines?
- Characterizing cellular responses and cytokine profiles in addition to antibody responses
- What non-HI-based antibody assays are being used, and how will they be validated for new vaccines not based on HI?
- Designing clinical trials to assess safety and immunogenicity of novel adjuvants
Panellists:
Dr Ronald W. Ellis, Senior Vice President & Chief Technical Officer, NasVax Inc, United States (a subsidiary of NasVax Ltd, Israel)
Dr JoAnne Bruno, Senior Director of Applications & Technology, Biacore Systems, GE Healthcare Life Sciences
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4.10
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End of focus session followed by afternoon tea in the exhibition area
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OR | Focus session 2
Minimizing cost of goods through effective capacity management, application of novel platform and technology solutions, and public/private partnerships
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| 2.00 |
Chair’s introduction
How is the increasing cost of goods affecting choices of platform and technology solutions?
- What is the new thinking behind bioprocess decisions to decrease costs of goods?
- Should platform innovations focus more on decreasing COGs or increasing efficacy? Is this trade-off reasonable?
Dr Hélène Pora, Vaccine Application Director, Pall Life Sciences
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| 2.25 |
Questions & discussion |
| 2.30 |
Production of the VRC HIV vaccine for efficacy trial: Public / private collaboration in vaccine development
- Establishing scalable production methodologies
- Working with public/private partnerships during development
- Aligning cGMP production with clinical timelines
Kimberlee Wallace, PhD, Director, GMP Operations & Process Research, NIH Vaccine Research Center
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| 2.55 |
Questions & discussion |
| 3.00 |
Live attenuated intranasal vaccine (LAIV) – novel process technologies and alternate delivery mechanisms’ impact on process development, capacity management and, ultimately, COGs
- The future prospect of developing LAIV through cell-culture manufacturing technology -- increases scalability and flexibility, removes the supply risk
- New manufacturing and delivery device technologies allow for a comprehensive strategy, not just for pandemic preparedness but also the ability to make seasonal flu vaccine accessible to larger populations and developing countries.
- How to leverage these advantages to strategically balance the need for pandemic preparedness with the traditional mantra of "do not expand without demand"
Drs Ben Machielse, Executive Vice President, Operations, MedImmune, Inc
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| 3.25 |
Questions & discussion |
| 3.30 |
Panel discussion
- Projections of capacity improvements to be gained through innovation
- Handling post-licensure manufacturing changes that take the manufacturer outside the license
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4.10
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End of focus session followed by afternoon tea in the exhibition area
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OR | Breakout session
What is the direction of vaccines for biodefense? How are they now positioned alongside broad-spectrum technologies, and how will markets be developed beyond government procurement?
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(Highly interactive workshop session for a maximum of 30 participants)
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| 2.00 |
Moderator’s introduction
Biopreparedness: Vaccines for prevention or therapeutics for response? Where should industry focus?
- What is preparedness?
- What is the role of vaccines in biodefense in the short- and long-term?
- Examining the intersection of vaccines and therapeutics
- Where are we with respect to products to answer Category A bioterrorism agent threats?
- Where do vaccines sit with regard to broad-spectrum platform technologies?
- Can a market be made without a government purchaser?
- Dual use vaccines – how to transition to a commercialized product
Dr Michael G. Kurilla, Director, Office of BioDefense Research Affairs, Associate Director for BioDefense Product Development, DMID, NIAID, NIH, DHHS
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| 2.25 |
Questions & discussion |
| 2.30 |
Enabling the future acceleration of biodefense product development: How can we ensure a robust manufacturing infrastructure to respond to public health threats?
Thomas R. Fuerst, PhD, Director, Vaccines & Biologics, Office of Research & Development Coordination, Office of Public Health Emergency Medical Countermeasures, Office of Public Health Emergency Preparedness, US Department of Health & Human Services
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| 2.55 |
Questions & discussion |
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Case study
What checklist should companies use before embarking on biodefense vaccine product development programs
- Funding and procurement issues
- Partnerships and outsourcing – where do the risks lie?
- Regulatory hurdles to be aware of
- Development issues - how large do trials need to be to power the study?
Robert V. House, MSPH, PhD, President & Chief Scientific Officer, DynPort Vaccine Company LLC, A CSC Company
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| 3.25 |
Questions & discussion |
| 3.30 |
Panel discussion
- How to develop more effective public-private partnerships in the advanced development and acquisition of countermeasures for significant public health threats
- Broad-spectrum platform technologies - anti-virals / antibiotics – are they a practical reality? What will the regulatory hurdles be?
- In the absence of public funding for these products, what approaches can be taken to develop a sustainable market?
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4.10
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End of focus session followed by afternoon tea in the exhibition area
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Then | Afternoon plenary session
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| 4.50 |
Keynote Address
Rebuttal to the anti-vaccine movement: What approach should the vaccine industry take?
- How can the public be reassured about vaccine safety? What role can pharmaceutical companies play in the public debate about vaccine safety?
- How to influence the media
- Update on latest US litigation
Dr Paul Offit, Chief, Division of Infectious Diseases, The Children's Hospital of Philadelphia
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| 5.30 |
Questions & discussion |
| 5.35 |
Close of day 2 followed by a themed cocktail reception in the exhibition area
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Gold Passes
Would you like to attend sessions during both the Washington Vaccine Forum and the co-located Cell & Gene Therapy Forum? Email team@phacilitate.co.uk or call +44 (0)20 7839 6137 for more information on our Gold Passes.
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