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Agenda | Last update 09.05.08 | Printer friendly (complate agenda)
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Day 1 | Wednesday, May 14th 2008
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| 7.30 |
Registration & buffet breakfast in the exhibition area |
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Morning plenary session
Meeting the vaccine innovation challenge: How will industry, NGOs and the public sector overcome existing scientific and economic barriers to deliver vaccines for the world?
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| 9.00 |
Chair's introduction
WHO opening address
- Defining global unmet vaccine requirements. Which vaccines are really needed, and what initiatives are underway to facilitate their development and delivery, on a region-by region basis?
- How do these needs match up with the vaccines/serotypes that the local and worldwide vaccine industries are working on?
- Re-addressing the Big 3 - how will we seek to facilitate the discovery and development of AIDS, malaria and TB vaccines?
Dr Marie-Paule Kieny, Director, Initiative for Vaccine Research (IVR), World Health Organization
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| 9.25 |
Questions & discussion |
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Update on global public health priorities
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| 9.30 |
European Commission perspective
How will Framework 7 enable the discovery and development of vaccines for the world?
- How can the public sector support vaccines for neglected- and poverty-related diseases
- European vaccine landscape for vaccines
- Public private partnerships for vaccine R&D
- Building global partnerships for vaccine R&D
Dr Ole F. Olesen, Scientific Officer, Infectious Diseases Unit, DG Research, European Commission
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| 9.50 |
Questions & discussion |
| 9.55 |
GAVI perspective
Update on Advanced Market Commitments (AMCs)
Catherine Wangui Wachira, AMC Manager, GAVI Alliance
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| 10.20 |
Questions & discussion |
| 10.25 |
Morning coffee in the exhibition area |
| 11.05 |
Keynote industry response
The Novartis Vaccines Institute for Global Health - an approach to delivering vaccines for the developing world
- There is a substantial health burden in developing countries for diseases that could be met by vaccines
- Commonly, vaccines progress from vaccines developed for first world markets then subsequently used in developing countries: Vaccines for "neglected diseases" need to reverse this order
- Development of new vaccines for "neglected diseases" will depend on public sector involvement but weakness is the link between antigen discovery and proof of concept in humans
- NVGH aims to provide a bridge between research institutes with antigen discovery, field sites and manufacturers
Dr Allan Saul, CEO, Novartis Vaccines Institute for Global Health (NVGH)
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| 11.25 |
Questions & discussion
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| 11.30 |
Vaccine manufacturing: Integrating state-of-art technologies for affordable and efficient solution for emerging countries' needs
- Combining Plug 'n Play technologies to develop fully integrated manufacturing units for local production
- Building on biopharma experience to create new economical manufacturing platforms
- Implementing analytical tools to build in quality and safety
Dr Manuel Nyffeler, Program Director, GE Healthcare Life Sciences
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| 11.55 |
Questions & discussion |
| 12.00 |
Stakeholders' roundtable discussion
- Prioritising the most difficult, and most needed, vaccine targets - what are the latest funding, R&D and regulatory developments and initiatives against long-standing global health threats? What is the current technical feasibility of developing these vaccines, and what are the challenges to clinically evaluating them? (E.g., Defining appropriate endpoints)
- AIDS
- Malaria
- TB
- Fostering both antibody and T-cell responses - the importance of a balanced approach
- Diarrhoeal diseases
- Men. B
- Meeting the challenge of ensuring sufficiently broad coverage of strains
- polio
- Addressing the challenge of engaging the biotech sector in global health issues - how can the high risk and high cost of development associated with these vaccines be mitigated to encourage the involvement of small independent vaccine companies?
Panel to be comprised of the speakers of the session, plus:
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
Wayne C. Koff, PhD, Senior Vice President, Research & Development, International AIDS Vaccine Initiative
Dr Una S. Ryan, President & CEO, AVANT Immunotherapeutics, Inc
Dr Michel Zaffran, Senior Adviser, Health Logistics Systems, Immunization, Vaccines & Biologicals, World Health Organization
Dr Wilfried A.M. Bakker, Senior Scientist & Project Leader, Process Development Department, Netherlands Vaccine Institute
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| 1.00 |
Buffet lunch in the exhibition area
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Followed by your choice of 3 parallel sessions:
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Focus session 1
Adjuvant R&D and regulatory update: What progress is being made in terms of improving both safety and immunogenicity?
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| 2.10 |
Moderator's introduction
WHO update on a public sector partnership focused on creating repositories of
knowledge regarding vaccine formulation with adjuvants
- What are the specific goals and timelines for this project?
- How and when do we envisage the industry getting involved?
Dr Martin Friede, Research & Product Development (RPD), Initiative for Vaccine Research (IVR), World Health Organization
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| 2.25 |
Questions & discussion |
| 2.30 |
How is the regulatory pathway for novel adjuvanted vaccines developing?
- What are regulatory concerns and barriers?
- What progress is being made in addressing toxicity issues?
- Are current EU regulatory requirements adequate?
Dr Dorothea (Thea) Sesardic, Principal Scientist, Division of Bacteriology, National Institute for Biological Standards & Control (NIBSC)
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| 2.50 |
Questions & discussion
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| 2.55 |
New approaches to study adjuvant mechanism of action in vivo
- New approaches to study adjuvant mechanism of action
- Signatures of adjuvant activity
- Can we predict toxicity?
Dr Ennio de Gregorio, Head of Immunology, Siena Site, Novartis Vaccines & Diagnostics
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| 3.15 |
Questions & discussion |
| 3.20 |
Afternoon tea in the exhibition area
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Industry case studies: How are novel adjuvants in clinical development progressing? What is the state-of-the-art?
- How are we addressing the remaining safety- and immunogenicity-related obstacles to gaining regulatory approval for vaccines incorporating these adjuvants?
- How is our understanding of MoA developing?
- What are the pros and cons of combining adjuvants in clinical trials?
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| 3.55 |
Case study
TLR9 activation with CpG ODN for enhancing vaccination
- CpG DNA that stimulate via Toll-like receptor 9 are effective vaccine adjuvants
- CpG motifs can be optimized for different immune effects
- CpG compatible and synergistic with other adjuvants and delivery systems
- Broad applicability and strong Th1 effects seen in animal models
- Strong enhancement of antibody and cell-mediated immune responses in human trials
- Platform technology resulted in numerous licensing deals with vaccine developers
- Novel approach of royalty-free licenses to permit use of CpG adjuvants in vaccines destined for developing world
Heather L. Davis, PhD, Site Head, Ottawa Laboratories, Vaccines Research, Pfizer Global R&D
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| 4.15 |
Questions & discussion |
| 4.20 |
Case study
Clinical and pre-clinical experience with novel adjuvant IC31
- Medical need for adjuvanted vaccines: What are our development directions?
- Translating adjuvant research into clinical benefit and licensure
Dr Kerstin Westritschnig, Medical Affairs Manager, Intercell AG
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| 4.40 |
Questions & discussion |
| 4.45 |
Panel discussion
Exploring the relative pros and cons of the next wave of adjuvant technologies
- What will be the next immunomodulators to follow TLR-targeting adjuvants into the clinic?
Panel to be comprised of the speakers of the session, plus:
Professor Nikolai Petrovsky, CSO, Vaxine Pty Ltd
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| 5.05 |
End of session - all attendees to reconvene in the Main Conference Room for the afternoon plenary session |
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Or | Focus session 2
DNA vaccines and viral vectors: After the hype, are they about to deliver?
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| 2.10 |
Moderator's introduction
Dr C. Richter King, Senior Vice President of Research, GenVec, Inc
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| 2.15 |
European regulatory update
Clarifying recent guidelines regarding plasmid DNA and live recombinant vaccines - what are the implications for your vaccine candidates?
- What specific safety concerns do the regulators still have with regard to viral vectors?
- Should the industry focus primarily
- On stability?
- On ensuring there is no risk of recombination?
- On ensuring there is a lack of variation in genetic sequence?
Dr Michael Pfleiderer, Head of Section: Viral Vaccines, Paul-Ehrlich-Institut
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| 2.35 |
Questions & discussion
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Case studies: What are the latest clinical data for leading vaccine candidates and enabling technologies in the clinic?
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| 2.40 |
Case study
Complex adenovirus as a broadly effective multi-vaccine platform against lethal infectious diseases
- The complex adenovirus vaccine platform has demonstrated efficacy against a number of lethal infectious diseases, including:
- HIV
- Dengue virus
- Ebola/Marburg virus
- The advantages of the complex adenoviruses are their capability for antigen synthesis de novo to induce immune responses mimicking natural infection, their capacity for expressing multi-antigens to improve efficacy, and their capacity for multivalency to protect against viruses of multiple subtypes
- Complex adenovirus vaccines induce potent antibody and cellular immune responses
- Vector co-expression of cytokines with viral antigens further enhances immune responses to HIV
- In collaboration with the US Navy, dengue vaccine clinical trials are planned, with the possibility of human challenge studies to demonstrate vaccine efficacy
John Dong, MD, PhD, President & CEO, GenPhar, Inc
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| 3.00 |
Case study
RSV vaccine development based on host-range restricted vector
- The host-range restricted bovine Parainfluenza virus (bPIV) has previously been demonstrated to be safe and moderately immunogenic in adults, children and infants
- Surface glycoproteins from RSV and PIV3 were engineered into the bPIV backbone and designated MEDI-534
- MEDI-534 is immunogenic and protects small animals and primates against RSV and PIV3 challenge
- The addition of human adapted viral genes required confirmation of attenuation, tissue tropism and evaluation for propensity to cause RSV enhanced disease
- MEDI-534 was evaluated in adults and seropositive 1-9 yo children and the safety, viral shedding and immunogenicity profile was similarly to the bPIV parent strain
- Evaluation in seronegative children is ongoing
Dr Filip Dubovsky, Senior Director, MedImmune
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| 3.20 |
Afternoon tea in the exhibition area
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| 3.55 |
Case study
What is the latest progress toward proof of concept with the adenovirus-based vector system in clinical testing?
- Considerations for advancement of adenovirus vector systems: Key advantages and challenges
- What strategies are available to assure success?
Dr C. Richter King, Senior Vice President of Research, GenVec, Inc
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| 4.15 |
Questions & discussion |
| 4.20 |
Case study
Delivering the latest on clinical progress with electroporation based DNA vaccination
- Development of device technology for the clinical setting
- Overview of ongoing clinical studies
- Cancer applications
- Infectious disease indications
- Case study: Initiation of the first study of electroporation in the prophylactic setting
- Future directions
Drew Hannaman, Vice President, R&D, Ichor Medical Systems, Inc
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| 4.40 |
Questions & discussion |
| 4.45 |
Panel discussion
Panel to be comprised of the speakers of the session
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| 5.05 |
End of session - all attendees to reconvene in the Main Conference Room for the afternoon plenary session |
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Or | Workshop
Removing the cold chain - how are novel delivery and stabilisation technologies enabling the efficient and effective delivery of vaccines to the developing world?
(Highly interactive session for a limited number of attendees)
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| 2.10 |
Moderator's introduction
Opening address: Evaluating progress in the development of vaccine stabilisation and delivery technologies
- What challenges remain?
- What guidance is needed?
- What if the cold-chain is the only answer?
Dr Peter Fusco, Vaccinology Consultant
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| 2.25 |
Questions & discussion
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| 2.30 |
Project Optimize - immunization systems and technologies for tomorrow
- Project Optimize a new WHO/PATH collaboration- funded with a 5 years grant from the Gates Foundation envisions a radical transformation in the way that vaccines and other essential health products reach underserved populations throughout the world by working towards two complementary goals:
- Apply innovative systems and practices for management, distribution, and use of vaccines and health products and
- Optimising the characteristics of high-priority products for use in LMI countries
Dr Michel Zaffran, Senior Adviser, Health Logistics Systems, Immunization, Vaccines & Biologicals, World Health Organization
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| 2.50 |
Questions & discussion
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Case studies: Exploring the latest progress with novel temperature-stable formulation technologies and delivery technologies in clinical development
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| 2.55 |
Case study
Patch technology for vaccines: Coming of age
- Patch technology is well-suited for developing world vaccine delivery
- Needle-free, simple application
- Patch formulations are dry, eliminating instability due to an aqueous environment
- Solubilisation of patch formulations occurs by transepidermal water loss from the skin
- Patch formulations can be designed to provide ambient temperature stability
- Ambient temperature stability for distribution and use has been established for LT patches for ETEC diarrhea
- Clinical field efficacy for ETEC diarrhea has been demonstrated
Dr Sarah A. Frech, Vice President, Clinical Development, IOMAI Corporation
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| 3.15 |
Questions & discussion |
| 3.20 |
Afternoon tea in the exhibition area |
| 3.55 |
Case study
Formulation stability of novel protein vaccine candidates
- Developing a stability formulation for a protein based vaccine
- Evaluating an in vitro potency assay as a characterisation stability indicating assay
- Studying the effect of surfactant on the stability of the formulation
Bounthon Loun, PhD, Director of Drug Product Analytical & Formulation Development, Wyeth Vaccines
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| 4.15 |
Questions & discussion |
| 4.20 |
Strategies for the development of stable vaccines
- Rational design of vaccine formulations with enhanced stability based on identification of degradation pathways and the use of novel excipients
- Case study covering the development of adenovirus-based vaccine candidates
- Approaches for integrating stability testing into vaccine R&D/process development
- Use of Arrhenius analyses, animal and accelerated stability testing to guide formulation development
- Impact of adjuvants on stability testing strategy
Speaker to be announced
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| 4.40 |
Questions & discussion |
| 4.45 |
Panel discussion
Exploring vaccine stability issues in the context of stockpiling
- What qualifies a vaccine as being capable of being stockpiled - what does its stability profile look like?
- What sort of replacement schedule might be needed for stockpiled influenza vaccines on a global basis?
- Is this economically viable and, if not, how can we solve this issue?
Panel to be comprised of the speakers of the session
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| 5.05 |
End of session - all attendees to reconvene in the Main Conference Room for the afternoon plenary session
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Then | Afternoon plenary session
Where next for AIDS vaccines?
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| 5.10 |
Panel discussion
- What is the path forward for the AIDS vaccine field?
- What gaps still exist in our knowledge and understanding?
- What is the future for CMI in this area? Is the pendulum swinging back to antibody-based approaches to AIDS vaccines?
- Are we designing trials properly to enable a balanced global approach to targets like AIDS?
- What is the industry's role in an area as difficult as AIDS on an ongoing basis?
- What initiatives are required to ensure that the industry remains engaged long-term?
- How can the global R&D pipeline for AIDS vaccines be managed in future to ensure that one failure does not have such massive repercussions for the field?
- How do we keep the balance in the clinical pipeline to ensure that product candidates keep progressing?
Chair:
Wayne C. Koff, PhD, Senior Vice President, Research & Development, International AIDS Vaccine Initiative
Panellists:
Dr C. Richter King, Senior Vice President of Research, GenVec, Inc
Julianna Lisziewicz, PhD, President & CEO, Genetic Immunity
Dr Una S. Ryan, President & CEO, AVANT Immunotherapeutics, Inc
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| 6.00 |
Close of day 1 followed by a cocktail reception in the exhibition area
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View Day2» | View Day 3» |
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