9.05

Keynote address
Innovative approaches to accelerate vaccine development for low-resource countries

• The rich landscape of organizations and efforts
• How are we balancing efforts across low-resource countries?
• How are we prioritizing and selecting our investments in new vaccines?
• How can we leverage and coordinate among disparate efforts?
• What incentives and innovative policies can help us attract new investments and share risks?

Dr John Boslego, Director, Vaccine Development Global Program, PATH

9.25

Questions & discussion

Business models in action: Case studies of NGO, public and private sector investment in vaccines for global public health needs

9.30

Pneumococcal vaccine AMC: Is it the right type of mechanism to incentivize industry to supply the developing world, and if so, what other vaccines might it make sense for?

• What has been the response from global and local manufacturers?
• How are smaller biotechs being incentivized financially to get involved?
• How are risks being managed for manufacturers?

Sandy Wrobel, Chief Executive Officer & Managing Director, Applied Strategies

9.50

Questions & discussion

9.55

Emerging partners for emerging markets: Including non-western institutions in your vaccine business development strategy

• Introduction to NIH licensing practices and policies
• Identification of potential business development partners
• Case study – human-bovine rotavirus vaccine technology transfer
• Latest developments on the rotavirus story
• Further applications

Susan Ano, PhD, Chief, Infectious Diseases & Medical Engineering Branch,
Office of Technology Transfer, National Institutes of Health

10.15

Questions & discussion

10.20

A Product Development Partnership (PDP) model for new TB vaccines

• Need and goals for new TB vaccines
• Challenges to development of new TB vaccines
• PDP model: Aeras Global TB Vaccine Foundation
  • Relationships with partners
• Current status and plans forward
  

Lewellys F. Barker, MD, MPH, Senior Medical Advisor, Aeras Global TB Vaccine Foundation

10.40

Questions & discussion

10.45

Morning coffee in the exhibition area

11.25

Merck - Wellcome Trust joint venture and other approaches to challenges in developing and emerging vaccine markets

• Specifics of the joint venture – objectives / structure / roll out strategy
• Understanding what it takes to get into the emerging and developing markets eg being able to distinguish between private and tender markets
• Being torn in 2 different directions: What manufacturing technologies / policies are needed to enable vaccines to be distributed through WHO as well as being sold to the west?

Diana Lanchoney, MD, Executive Director, Vaccine Research, Merck Research Laboratories

11.50

Questions & discussion

11.55

Developing vaccines primarily aimed at neglected diseases of developing countries

• Most vaccines for developing countries were first made for Western markets - how do we reverse this paradigm for bulk of the global infectious disease burden for which there is no significant Western market?
• What are the gaps in the development path to vaccines for neglected disease?
• How can these be overcome?

Allan Saul PhD, CEO, Novartis Vaccines Institute for Global Health

12.15

Questions & discussion

12.20

Panel discussion
Realizing the potential of the structures that have been established to deliver vaccines to the developing world

Panellists:
Dr Michael V. Callahan, Program Manager, Rapid Vaccine Assessment, Defense Advanced Research Projects Agency (DARPA)
Jose Ochoa, Vice President Business Development, Emergent BioSolutions Inc

1.00

Buffet lunch in the exhibition area

OR

Working Lunch
What to consider on device selection for intranasal vaccination?

• Advantages of the intranasal route
• Cost/benefit perspectives
• Considerations on the device selection
• Limitations

Moderator: Degenhard Marx, DVM, Business Development Manager, Pharma Division, ING. ERICH PFEIFFER GMBH
(Very informal, optional discussion-based session for a maximum of 12 participants)

2.30

Case study
World’s largest HIV vaccine trial: Latest results from the RV144 Phase III trials in Thailand

Merlin Robb, MD, HJF HIV Program Director, Henry M. Jackson Foundation for the Advancement of Military Medicine, Deputy Director (Clinical), US Military HIV Research Program (MHRP)

2.55

Panel discussion
What do we now think a therapeutic / prophylactic vaccine for HIV would look like? What is state of the art in the field?

• What characteristics are required?
• What might the route to licensure look like?
• How would it be positioned in the market?
• Would it compete with or complement ARVs?
• What are the latest advancements with respect to
  • Potential breakthroughs in pre-clinical: Can a T cell vaccine work in HIV animal models?
  • What is the potential for using live vector delivery systems?
  • Therapeutic vaccines - how to cope with viral escape
  • Prophylactic vaccines - can non-neutralizing activities of Ab contribute to protection?
• How significant a role might mucosal delivery have?
• The role of passive immunity for HIV: In the absence of an effective vaccine could this be an option?

Panellists:
Dr Gary J. Nabel, Director, Vaccine Research Center, National Institute of Allergy & Infectious Diseases (NIAID), NIH
Harriet L. Robinson, PhD, Chief Scientific Officer, GeoVax Inc
Drew Hannaman, Vice President, R&D, Ichor Medical Systems, Inc

3.35

Afternoon tea in the exhibition area

4.15

What does a therapeutic Hep C vaccine have to do to get approved and compete with best in class drugs?

• How to develop an HCV vaccine in the context of current IFN-based therapies and evolving antivirals
• Clinical end-points required to get approval
• Case studies of trial design
• What is the latest data? What impact on viral load?
  
• How might it be used in combination with drugs?
• The role of passive immunity for chronic viral infections: If structural biology is not leading you towards immunogenicity then could this be an option?

Speaker to be announced

4.35

Panel discussion

• What can all these areas of research, combined with cancer vaccine research, learn from each other in terms of immune intervention and the common denominators that may help us identify vaccine approaches that are more broadly applicable?
• How much synergy is there between prophylactic and therapeutic vaccines in terms of going after difficult, intractable viruses?
• How are larger companies capitalizing on their infrastructure to access the different capabilities required?
  
  • Leveraging across technologies on the vaccine / biologics side, and commercial weight on the pharma side

4.55

Chair’s closing summary

5.00

Close of session followed by afternoon plenary session

Case studies
Hurdles and benefits to switching strategy from egg to cell based manufacture: How are they being overcome and realized?

• Fully realizing the potential of flu cell culture requires multi-institution cooperation to generate and test cell-derived influenza virus vaccine seeds
• The response to H1N1v pandemic influenza highlighted advantages of cell based manufacture
• Cell based manufacture is a starting point for future improvements
  

2.20

Case study

Philip R. Dormitzer, MD, PhD, Senior Director, Senior Project Leader, Viral Vaccine Research, Novartis Vaccines and Diagnostics

2.40

Questions & discussion

2.45

Case study
Mammalian cell culture based 'flu vaccine preparation: Advantages and challenges

• Introduction to MedImmune 2009 Influenza A (H1N1) vaccine (egg-based)
• Benefits and challenges of switching from egg-based to cell culture based production of influenza vaccines
• Potential using MDCK cell for LAIV production and safety control strategy
  

Kun Yao, DVM, PhD, Associate Director, Manufacture Science & Technology, MedImmune, Inc

3.05

Questions & discussion

3.10

A fast track vaccine made in insect cells

• Rapid response to H1N1 emergency situation
  Support from regulatory authorities to change the mainstay of egg-based manufacturing?

Dr Manon Cox, COO, Protein Sciences Corporation

3.30

Questions & discussion

3.35

Afternoon tea in the exhibition area

4.15

Fast tracking the development of - and path to licensure for - a novel manufacturing platform by utilizing it in pandemic influenza efforts

Dr Rahul Singhvi, President & CEO, Novavax, Inc

4.35

Panel discussion
Application of cell culture technologies to influenza vaccine manufacture: Opportunities and barriers

• How did influenza cell culture technologies impact your organization's response to the H1N1 pandemic?
• The biotech industry has already developed robust cell-based manufacturing technologies that should be able to pave the way for vaccine industry to piggy-back - why then has progress been so slow?
• What can be adopted from the regulatory processes and pathways already in place?
• What examples are there of crossover technologies to help vaccines which come out of the drug / device / diagnostic / clean-tech fields?

4.55

Chair’s closing summary

5.00

Close of session followed by afternoon plenary session

Case studies of novel adjuvants: What has translated and what have we yet to find? Translating from mice / non-primates into humans

• How efficacious will they be in specific vaccine formulations with an antigen?
• What translational and clinical data backs this up?
• How are biomarkers being used?
• What does the development pathway look like?

2.25

Vaccine adjuvants comprising combinations of TLR agonists and/or delivery systems

Dr Heather L. Davis, Executive Director & Ottawa Site Head, Vaccines Research, Pfizer Global R&D

2.45

Question & discussion

2.50

Mice do not always lie: Translating preclinical results into novel vaccines

• How to identify protective antigens
• To adjuvant or not to adjuvant – that is the question
• How to find the proper formulation?
• How to decide on surrogate markers predicting efficacy in an early stage
  

Professor Alexander von Gabain, Strategic Advisor to the Board, Intercell AG

3.10

Question & discussion

3.15

Designing smarter viral vector delivery of vaccines: What has translated successfully to humans?

• How can adenovirus delivery proceed at this time given the bad result with HIV?
• Can animal studies predict the immunogenicity of different adenovirus vectors in humans?
• Is there a better alternative to the currently used cell substrates for adenovirus vector production?
• Are there better vector combinations for vaccine delivery?

Dr Alfredo Nicosia, Chief Scientific Officer, Okairos

3.35

Afternoon tea in the exhibition area

4.15

Panel discussion
Addressing regulatory concerns for licensing new adjuvants and delivery combinations: What impact are translational science and biomarkers having?

• Comparing EU/US approaches to benefit:risk
  • How do the regulatory pathways compare for adjuvants and combination products
• What are the concerns around mechanism of action / systemic response / chronic inflammation/ long-term effects?
  • How can they be mitigated at an early stage?
• How is it influencing big pharma’s interest in novel adjuvants and delivery mechanisms?

Panellists:
Dr Norman W. Baylor, Director, Office of Vaccines Research & Review (OVRR), CBER, US Food & Drug Administration
Dr John Purves, Head of Sector, Quality of Medicines, European Medicines Agency (EMEA)

4.55

Chair’s closing summary

5.00

Close of session followed by afternoon plenary session

5.25

Panel discussion
Examining the commercial potential of therapeutic cancer vaccines

• What are the next promising candidates and what stage have they reached?
• From a commercial standpoint what are the pros and cons of cancer vaccines versus other treatment modalities?
• How is big pharma assessing opportunities in the field: What are they looking for next?
• If cancer vaccines must be used in combination with other therapies, how will this impact trial design, regulatory pathways, and the ability to raise capital?
• Raising capital for the development of cancer vaccines: If survival is the endpoint then very few VCs will have the capital required for long clinical studies - how will the gap be filled?

Panellists:
Dr Allan P. Jarvis, Vice President, Corporate Development, sanofi pasteur
Dr Joyce Frey-Vasconcells, Executive Director, PharmaNet
Dr Nicole Frahm, Associate Laboratory Director, HVTN, Fred Hutchinson Cancer Research Center

5.50

End of day 1 followed by a themed cocktail reception in the exhibition area