9.10

What will be the impact of healthcare reform and increasing reliance on HTA for the vaccines world?

• Update and implications of healthcare reform in the US and other markets on the vaccines industry
• Overview and outlook regarding how Health Technology Assessment (HTA) agencies assess the clinical and cost effectiveness of vaccines

W. Neil Palmer, President & Principal Consultant, PDCI Market Access

9.30

Questions & discussion

How could paediatric schedules be changed to incorporate new vaccines such as Men. B in the developed world, and e.Coli and Japanese Encephalitis in the developing world?

9.35

Evolving vaccination schedules schedules and unmet needs: CDC perspective

• Status of US schedule
• Current context and environment
• Looking forward to the future
  

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

9.55

Questions & discussion

10.00

Industry perspective
Expanding opportunities to deliver vaccines for paediatric populations on a global basis

Yves Leurquin, Executive Vice President, International & Government Affairs, Crucell NV

10.20

Questions & discussion

10.25

Morning coffee in the exhibition area

Presentation & roundtable discussion
What are the most attractive targets moving forward in terms of potential market value and biological/technical feasibility?

• What progress is being made in their development/commercialisation and what challenges remain?
  

11.05

Case study
Latest developments in meningococcal vaccines

Dr Derek O'Hagan, Vice President, Global Head, Vaccine Delivery Research, Novartis Vaccines & Diagnostics

11.25

11.30

Roundtable discussion

• Nosocomial infections (Staph. aureus, C. difficile, Pseudomonas aeruginosa)
  • Passive immunisation or active immunisation - which is the best approach? Is it one or the other, or both together, and in which specific targets?
• Emerging infectious diseases
  • Dengue fever
    
  • West Nile virus
    
  • Chikungunya
  • Ebola
• RSV
• Herpesviruses
  
  • Herpes simplex V2
  • Epstein-Barr virus (EBV)
  • Cytomegalovirus (CMV)
• Is the time right to really start to push the development of vaccines for STDs? Has HPV opened up the market/opportunity sufficiently?

Panellists - speakers of the session, plus:
Dr Jan ter Meulen, Executive Director, Vaccines Research, Merck Research Laboratories

12.25

Lunch

1.25

Moderator's introduction
What initiatives are underway to improve our understanding of the Mechanism of Action of adjuvants?

• How do adjuvants work - do we know enough?
• Can we predict safety from preclinical studies?
• Can we develop safe and effective novel adjuvants?

Dr Derek O'Hagan, Vice President, Global Head, Vaccine Delivery Research, Novartis Vaccines & Diagnostics

1.45

Analysing the latest clinical data from both novel- and alum-adjuvanted pandemic influenza vaccines

• Is the HI assay effective for determining vaccine efficacy?
• Can a background cross-specific immune response be effectively induced by (adjuvanted) vaccines?
• In light of this data, how critical a role should novel adjuvants play in the future of both seasonal and pandemic influenza preparedness?

Dr Ernst C. Soethout, Senior Research Scientist, Netherlands Vaccine Institute

2.05

Addressing the challenges of developing a novel adjuvant as a technology platform – ISCOMATRIX® adjuvant case study

• Strategic approach
• Sound science: Understanding mechanisms of action
• Secure supply: Developing processes that meet commercial and GMP requirements
• Safety signals: Proactive, integrated, risk based approach to signal detection

Jillian Bennet, Vice President of Regulatory Affairs, CSL Limited R&D

2.25

Challenges in developing adjuvanted seasonal and pandemic influenza vaccines

• Recombinant antigen technologies will soon replace traditional inactivated influenza vaccines
• Adjuvants offer major benefits for both pandemic and seasonal vaccines but consumer opposition needs strong
• Pandemic requirements are fast moving so only those manufacturers with extensive infrastructure are able to benefit
• Governments prefer to contract large pharma manufacturers for pandemic supply rather than risk deals with smaller biotechs
• Vaccine stability and potency are paramount to avoid recall of pandemic vaccine where speed of delivery precludes extensive testing before release
  

Professor Nikolai Petrovsky, CSO, Vaxine Pty Ltd

2.45

Case study
What is the latest clinical data for adjuvanted vaccines aimed at elderly and immunosuppressed populations?

• How do adjuvants work in impaired populations?
• Can we develop safe and effective adjuvants in impaired populations?
• What adjuvants have demonstrated safety and effectiveness in these populations?
• What is the future for adjuvants in these populations?

Dr Tyler Martin, Chief Medical Officer, DynaVax Corporation

3.05

Panel discussion
What do we know, and what do we need to know, to help risk-averse health policy makers feel more comfortable about the safety of novel adjuvants?

3.25

Moderator’s closing summary

3.30

Close of conference followed by afternoon tea

1.45

Questions & discussion

1.50

Update on assessment of vaccines by the centralised procedure

• Issues on recent assessment of vaccines
• Considerations on PIPs and RMPs for vaccines

Dr Marco Cavaleri, Head of Anti-Infectives & Vaccines, Safety & Efficacy of Medicines Unit, European Medicines Agency

2.10

Questions & discussion

Paediatric Investigation Plans (PIP's): Exploring first experiences and lessons learned

2.15

Specificities in implementing the paediatric regulation for vaccines

• Topline overview of adopted Art. 7 & Art. 8 vaccine PIP's
• Some specific examples of possible challenges and learnings
• Do/did the resources spent on vaccine PIP's benefit the paediatric patients?
• What about the incentives?

Dr Frank Vandendriessche, Director, Regulatory Affairs, Europe, MSD Europe

2.35

Questions & panel discussion

• What is the PIP really impacting? Has it made any difference to timelines, costs and success rates for the paediatric vaccine regulation process?
• Comparing and contrasting the PIP and PREAs in the US - what are the key similarities and differences?

2.45

How are novel risk management guidelines evolving in the vaccine space in Europe?

• Have they/will they changed the environment?
• Should you adapt your R&D and business/commercial models to accommodate them and, if so, how?

Dr Jan-Willem van der Velden, Founder, Mesama Consulting

3.05

Questions & discussion

3.10

Panel discussion
Identifying and addressing key areas of disharmony with US FDA regulations: What are the next steps along the path to harmonisation?

3.25

Moderator’s closing summary

3.30

Close of conference followed by afternoon tea