9.05

Funding vaccine research: Advocacy for a sustainable funding structure - the case of malaria vaccines in Europe

Dr Odile Leroy, Executive Director, European Vaccine Initiative

9.25

Questions & discussion

Making the business case for developing world vaccine R&D

• Comparing and contrasting innovative partnering/corporate models aimed at developing novel vaccines and vaccine markets on a global scale - how will these initiatives impact R&D/commercial models and opportunities for each partner?

9.30

FioCruz - GSK

Dr Akira Homma, Chairman of Policy & Strategy Council, Bio-Manguinhos / Fiocruz

9.50

Questions & discussion

9.55

Facilitating vaccine R&D for developing country health through win-win collaborations between the public and private sectors

Dr Ted Bianco, Director - Technology Transfer, The Wellcome Trust

10.15

Questions & discussion

10.20

Biotech case study
Ixiaro: Moving a novel JEV vaccine to global markets for travelers and endemic population

• Features of a novel attenuated, inactivated and Vero-cell based JEV vaccine
• Registration and manufacturing strategies for different customers
• Commercialization through partnership selection

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

10.35

Questions & discussion

10.40

Roundtable discussion
Assessing ongoing and future funding and delivery solutions for developing world vaccines

• What is the latest clinical progress of leading malaria and TB vaccine candidates? What role are PPPs playing in making these projects financially viable?
• Can we sustain the funding of GAVI in its present form? How should GAVI be replenished? Where should the money come from? How should GAVI conduct its business in future? (Eg. One vaccine at a time, or with multiple projects ongoing?)
• With the potential for a number of novel vaccines for primarily developing world diseases to be approved for the market over the coming decade, how will GAVI and others get the funding and build the infrastructure roll them out globally? How will the logistical challenges in the supply chain be addressed?
• How to deliver developing world vaccines that aren't currently on the paediatric schedule, such as typhoid and cholera? What alternatives are there if they don't fit in with current schedules?
• How will the community address issues derived from the actual physical route of delivery to ensure that those populations who need vaccines the most receive them? (Eg. the potential loss of efficacy of oral vaccines in the developing world where malnutrition has an impact)
• How might companion diagnostics dovetail with vaccines and global health moving forward?
• Assuming that poliomyelitis is eradicated in the coming few years, what happens next? What will be the path forward for developing and delivering the doses that will still be required post-eradication?

Panellists:
Dr Allan P. Jarvis, Vice President, Corporate Development, sanofi pasteur
Dr Wilfried A. M. Bakker, Senior Research Scientist, Netherlands Vaccine Institute

11.30

Morning coffee in the exhibition area

Case studies: Update on novel vaccine technologies and platforms that have been developed for the influenza market

• How did they perform in the H1N1 pandemic and what were the lessons learnt?
• How will they impact 'flu vaccine market economics in the long run? How will they be developed further?

12.20

Second generation cell culture technology

Dr Alexandra Löw-Baselli, Director of Clinical Development, Vaccines, Baxter BioScience

12.45

Questions & discussion

12.50

FluBlok - made in insect cells

• Update FDA licensing process
  
• VRBPAC meeting experience
• BARDA contract activities

Dr Manon Cox, COO, Protein Sciences Corporation

1.10

Questions & discussion

1.15

Buffet lunch in the exhibition area

2.25

Novavax recombinant H1N1 VLP vaccine

• Lead time for vaccine manufacturing including release testing
• Surge capacity considerations
• Clinical testing and registration of product not under "strain change" pathway
• Commercial production of recombinant vaccine

Dr Rahul Singhvi, President & CEO, Novavax, Inc

2.45

Questions & discussion

2.50

Case study
HEK-293 cells is an efficient platform for large scale manufacturing of influenza vaccines

Dr Amine Kamen, Head, Animal Cell Technology, National Research Council; Canada

3.10

Questions & discussion

3.15

Panel discussion

• Regulator/industry perspectives: What were the hurdles that prevented technologies from achieving licensure during the H1N1 pandemic and how might they be overcome next time?
  • How will the processes by which novel manufacturing technologies were tested and approved (or otherwise) during the H1N1 pandemic impact the future development of vaccines and vaccine technologies in general?
• What is influenza doing for the vaccine sector as a whole?
  • What impact will the new manufacturing/processing technologies that have largely grown out of the pandemic preparedness effort have on the vaccine sector in general?
  • What are the pros and cons of these platforms in terms of how easily they might be employed in both developed and developing worlds for 'flu and also for other types of vaccine? How could these technologies be utilised to impact global unmet needs?

Panellists:
Dr Peter Richardson, Head of Biologicals, Quality of Medicines Unit, European Medicines Agency
Theresa Finn, PhD, Associate Director for Regulatory Policy, OVRR, CBER, US Food & Drug Administration

3.45

Moderator’s closing summary

3.50

Close of session, followed by afternoon tea in the exhibition area

Case studies: Examining recent deals and partnerships between Western big pharma and biotech companies and counterparts from the BRIC nations

• What were the drivers behind the deals in each case?
• How do such deals impact prices and the development of markets in these developing countries?

12.30

Establishing a presence in India: Shantha Biotechnics

• Vaccine opportunities in the developing world
• The local vaccine landscape in India
• Shantha Biotechnics, its assets and strengths
• The rationale for combining forces with sanofi pasteur
  

Dr Allan P. Jarvis, Vice President, Corporate Development, sanofi pasteur

12.50

Presentation to be announced

1.10

Questions & discussion

1.15

Buffet lunch in the exhibition area

How are Chinese and Indian vaccine companies reacting to the expansion plans of Western pharma and biotech?

• What are their current and planned activities in vaccine research, development and manufacturing, and also deal-making?

2.25

Indian perspective: New paradigm in vaccine development

• India as a major supplier of vaccines in developing countries
• A global approach: Gennova and MVI PATH partnership in malaria vaccine development
  

Dr Sanjay Singh, CEO, Gennova Biopharmaceuticals Limited

2.45

Questions & discussion

2.50

Chinese perspective: The future of the vaccine business in countries with newly developed vaccine markets

Dr Zheng Haifa, Chief Scientist & Vice General Manager, Beijing Minhai Biotechnology Co., Ltd

3.15

Panel discussion

• What are the drivers behind the re-balancing of developed and developing world manufacturing capacity, and what does it mean for the vaccine sector as a whole?
• Do global partnering opportunities offer more chance of a 'win-win' situation for Western biotechs than traditional deals with big pharma? Do they create more incentive for both parties than traditional big pharma-biotech deals?

3.45

Moderator’s closing summary

3.50

Close of session, followed by afternoon tea in the exhibition area

5.40

End of day 2 followed by a themed cocktail reception in the exhibition area