WHO & CDC perspectives

• How did the processes for identifying/setting up the seed strain and increasing speed-to-market of the vaccines themselves perform, and how could efficiencies be built in to these processes in future? What novel technologies might help in this regard?
• How stable and secure was the vaccine supply on a global basis?
• How did we do at catering for high-risk members of populations, such as the elderly, on a global basis?
• Comparing the roll-out of vaccines in the Northern and Southern Hemispheres: What effect (if any) did they have on the epidemiology of H1N1?
• What is our current opinion on the feasibility and viability of a universal influenza vaccine? How much money could be saved if it becomes a reality? Will the 'one size fits all' approach be the successful model moving forwards, or will there need to be different vaccines for different populations?

9.00

Chair's introduction
WHO perspective
Global production of H1N1 pandemic vaccine and availability in developing countries

• Survey of estimates of global pandemic vaccine production capacity, June 2009
• Analysis of the quantity of pandemic vaccine produced since May 2009
• Objectives and status of the WHO pandemic vaccine deployment initiative
  

Dr Marie-Paule Kieny, Director, Initiative for Vaccine Research, World Health Organization

9.25

CDC perspective
2009 H1N1 influenza vaccination: Policy and programme in the United States

• United States vaccination policy and how it was developed
• Objectives of the programme and its various components - how it worked and what was achieved

Dr Beth P. Bell, Associate Director for Science, National Center for Immunization & Respiratory Diseases, CDC

9.45

Questions & discussion

Regulators' review: Comparing and contrasting FDA and EMEA legislation, guidelines, procedures and performance in response to the H1N1 pandemic

9.55

Presentations...
EU regulatory experiences on preparation, response and review of (H1N1) pandemic influenza

• Pandemic preparedness and the EU Mock-up licence approach
• Regulator interactions and operation of EU Network
• Review of safety and efficacy data and CHMP decision making
• Current situation regarding pandemic
• Implementation of lessons learned

Dr Peter Richardson, Head of Biologicals, Quality of Medicines Unit, European Medicines Agency

Pandemic influenza vaccines: US regulatory perspective

• H1N1 2009 vaccine: Lessons learned
• Preparing for the next pandemic

Theresa Finn, PhD, Associate Director for Regulatory Policy, OVRR, CBER, US Food & Drug Administration

10.35

...and panel discussion

• What were/are the similarities and differences between US and European regulatory approaches? How significant were these differences?
  • How effectively have Western hemisphere regulators dovetailed with the wider global regulatory environment?
• What will be the consequences for industry in terms of the regulation of novel technologies in future?

10.55

Morning coffee in the exhibition area

Updates from key US and European Government stakeholders

11.35

European Commission perspective
The public health response to pandemic H1N1 influenza: cooperation and coordination at EU level

• How did the EU support the EU Member States during the pandemic?
• What was the added value of the cooperation and coordination at EU level?
• Despite of the cooperation and coordination at EU level, why did the EU Member States take different policy decisions?
• What lessons can be learnt and what improvements can be made?
  

Dr Antoon Gijsens, Policy Officer, Unit SANCO C3 - Health Threats, European Commission

11.55

Questions & discussion

12.00

US HHS perspective

• Expanding domestic pandemic vaccine manufacturing infrastructure
• Development of next generation influenza vaccines and antiviral drugs
• Reinventing the countermeasure enterprise

Dr Robin Robinson, Director & Deputy Assistant Secretary, Biomedical Advanced Research & Development Authority (BARDA), Office of the Assistant Secretary for Preparedness & Response (ASPR), US Department of Health & Human Services

12.20

Questions & discussion

12.25

Roundtable discussion
How well did all of the stakeholders interact (Government public health agencies and funding bodies, regulators, WHO/CDC, NGOs, industry)?

• What lessons can be learnt for each stakeholder and the vaccine community at large? Where can improvements be made?
• How were issues of 'over-supply' addressed and what lessons can we take forward?
• How well were vaccines evaluated in clinical studies to in terms of enabling decisions re. dose, etc. to be made in a timely manner?
• How well did we manage the immunization of mass populations and the management of public concern?
• Addressing the challenges in providing developing world access to pandemic influenza vaccines
  • To what extent were the poorest countries of the world catered for?
    How well did mechanisms designed to supply these populations with
    pandemic influenza vaccines work? How were decisions made by Western Governments in term of honouring commitments to supplying doses to the developing world versus making sure that everyone at high risk in the their own populations received vaccines
• How did the pandemic affect the seasonal influenza vaccine market/seasonal vaccine uptake?
  • Discussing the recommendation for inclusion of H1N1 with the seasonal influenza vaccine for 2010/11
  • Will H1N1 help improve seasonal vaccine uptake on a global basis? To what extent will the threat of further pandemics change recommendations for seasonal 'flu immunisation in future?

Panellists - speakers of the session, plus:
Dr Norbert Hehme, Vice President, Global External Relations GIO, GlaxoSmithKline Biologicals & Chair, IFPMA Influenza Vaccine Supply International Task Force
Dr Udit Batra, Head, Global Public Health & Market Access, Novartis Vaccines & Diagnostics
Dr Ernst C. Soethout, Senior Research Scientist, Netherlands Vaccine Institute

1.30

Buffet lunch in the exhibition area

2.40

Big pharma perspective
H1N1 pandemic - decision making under highly uncertain conditions

• Evolving assessment of public health risk
• Impact of this risk on the demand and supply balance
• Importance of execution - key processes and discipline

Dr Udit Batra, Head, Global Public Health & Market Access, Novartis Vaccines & Diagnostics

3.00

Questions & discussion

3.05

Clinical progress towards a universal influenza vaccine

• The Multi-Epitope approach – the concept and pre-clinical proof of efficacy
• Clinical trial results from recent Phase I/II trials
• Challenges facing universal influenza vaccine developers – an overview of the upcoming Phase II trial

Dr Tamar Ben Yedidia, CSO, BiondVax Pharmaceuticals Ltd

3.25

Questions & discussion

3.30

Case study
Safety and immunogenicity of a recombinant hemagglutinin influenza-flagellin fusion vaccine (VAX125) in healthy young adults and in the elderly

Dr Alan Shaw, Chief Scientific Officer & Chairman of the Board, VaxInnate

3.50

Questions & discussion

3.55

Afternoon tea in the exhibition area

4.30

Panel discussion
Looking to the future of the global influenza vaccine market and beyond

• What will be the impact on pricing and reimbursement for seasonal influenza vaccines of increasing manufacturing capacity on a global basis?
  • How will this affect various vaccine company business models? (eg. a US/European vaccine manufacturer versus one from India or China)?
  • How can coverage be improved on a global basis to help maintain prices?
• What lessons can be taken from the recent pandemic to help accelerate the development of novel vaccines in general?
• How do you put a value on a technology for in-licensing that is aimed at a pandemic outbreak?

Panellist:
Dr Jennifer R. Hannesschlager, Principal, Tiber Creek Partners, LLC

4.55

Moderator's closing summary

5.00

Close of session - all attendees to make their way to the main conference room for the afternoon plenary session

3.00

Questions & discussion

3.05

VC update
Is there still a viable VC model in light of the scarcity of vaccine company IPOs over recent years?

• Where do small companies go as a result?
• What is the model that will succeed in this environment?

Dr Philippe Pouletty, Co-Founder & General Partner, Life Sciences, Truffle Capital

3.25

Questions & discussion

3.30

Fundraising in a difficult environment - a biotech example

• Funding environment - past 12-18 months and now
• Alternative funding sources
• Elements needed for successful fundraising

Mustapha Leavenworth Bakali, President & CEO, Genocea Biosciences, Inc

3.50

Questions & discussion

3.55

Afternoon tea in the exhibition area

4.30

Case study: A recent pharma entry in the vaccine space

• Challenges and opportunities for new vaccine development
• What opportunities are there for small vaccine companies seeking partners/buyers?
• What are the keys to attracting pharma companies?

Jan Reid, Senior Director, Vaccines Licensing, Pfizer R&D Business Development

4.50

Questions & discussion

4.55

Moderator's closing summary

5.00

Close of session - all attendees to make their way to the main conference room for the Afternoon Plenary

12.00

Using an alternative animal model for toxicology of a novel Alzheimer’s disease immunotherapeutic

• Overview of the AD product candidate
• Preclinical rationale for animal models
• What are the alternative models for AD vaccines and immunotherapeutics?
• Do we need to be more open-minded regarding safety testing in other species?
• How do we allow for differences in immune systems and markers?

Dr Ronald W. Ellis, Senior Vice President, Research & Development, NasVax Ltd

12.25

Questions & discussion

12.30

State of the art in vitro systems: What novel approaches to predictivity are being adopted in AI?

• The XPRESIDENT platform: pre-clinical identification, selection and validation of relevant tumour antigens for cancer immunotherapy
• Identification and selection of clinically relevant antigens using human tumours as source material
• Predicting and benchmarking immunogenicity in vitro by an artificial APC approach
• Validation of immunogenicity in early clinical trials
• Validation of clinical relevance of antigens in mid-stage clinical trials

Dr Harpreet Singh, CSO, immatics biotechnologies GmbH

12.55

Questions & discussion

1.00

Case study
Immune interventions for chronic viral diseases - examples of CMV and HIV

• New antigenic targets, vaccine deliveries and immunologic endpoints
• Preclinical proof of concept - inferences from orthologous animal model systems
• Immune-based therapies and combined therapies to improve upon standard of care
• Considerations for the regulatory package moving forward

Dr Susan W. Barnett, Senior Director, Senior Project Leader, Viral Vaccine Research, Novartis Vaccines and Diagnostics, Inc

1.25

Questions & discussion

1.30

Buffet lunch in the exhibition area

Moderator: Professor Nikolai Petrovsky, CSO, Vaxine Pty Ltd

2.40

Case study – prophylactic vaccine
Establishing your preclinical rationale for animal models: To what extent can you trust mouse data?

• Identifying and utilising alternative animal models for preclinical efficacy in the prophylactic vaccine setting

Professor Dr Claire Boog, Scientific Director, Netherlands Vaccine Institute

3.00

Questions & discussion

Case studies
Revisiting the hardest targets - how are recent technological and scientific advances enabling fresh attempts to tackle major, long-standing unmet medical needs?

3.05

Case study – prophylactic vaccine - challenges for an RSV vaccine

• Attenuated virus vs. subunit vaccines
• Circumventing the effect of maternal antibodies against developing an immune response
• Approaches for avoiding potential immune pathologies associated with immunization

Dr Jan ter Meulen, Executive Director, Vaccines Research, Merck Research Laboratories

3.25

Questions & discussion

3.30

Case studies – prophylactic vaccines
Remaining vaccine challenges demand novel approaches

• Traditional vaccine approaches have been unsuccessful for diseases such as HIV, hepatitis C, and shigella
• Potential solutions may lie in better antigen or adjuvant selection, delivery route, or dosing regime
• Alternatively, these disease may only succumb to radical new vaccine approaches, examples of which will be discussed

Professor Nikolai Petrovsky, CSO, Vaxine Pty Ltd

3.50

Questions & discussion

3.55

Afternoon tea in the exhibition area

4.30

Panel discussion
Reaching a common understanding of which – and how much - data you need to do to get into the clinic: Is there a consensus?

• How to get regulatory buy-in earlier?

4.55

Moderator's closing summary

5.00

Close of session

6.00

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