Phacilitate Vaccine Forum Geneva 2008

Day 1 \| Wednesday, May 14th 2008
7.30	Registration & buffet breakfast in the exhibition area
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?
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
9.25	Questions & discussion
Update on global public health priorities
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
9.50	Questions & discussion
9.55	GAVI perspective Update on Advanced Market Commitments (AMCs) Catherine Wangui Wachira, AMC Manager, GAVI Alliance
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)
11.25	Questions & discussion
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
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
1.00	Buffet lunch in the exhibition area
Followed by your choice of 3 parallel sessions:

Focus session 1 Adjuvant R&D and regulatory update: What progress is being made in terms of improving both safety and immunogenicity?
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
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)
2.50	Questions & discussion
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
3.15	Questions & discussion
3.20	Afternoon tea in the exhibition area
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?
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
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
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
5.05	End of session - all attendees to reconvene in the Main Conference Room for the afternoon plenary session

Or \| Focus session 2 DNA vaccines and viral vectors: After the hype, are they about to deliver?
2.10	Moderator's introduction Dr C. Richter King, Senior Vice President of Research, GenVec, Inc
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
2.35	Questions & discussion
Case studies: What are the latest clinical data for leading vaccine candidates and enabling technologies in the clinic?
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
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
3.20	Afternoon tea in the exhibition area
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
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
4.40	Questions & discussion
4.45	Panel discussion Panel to be comprised of the speakers of the session
5.05	End of session - all attendees to reconvene in the Main Conference Room for the afternoon plenary session

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)
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
2.25	Questions & discussion
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
2.50	Questions & discussion
Case studies: Exploring the latest progress with novel temperature-stable formulation technologies and delivery technologies in clinical development
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
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
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
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
5.05	End of session - all attendees to reconvene in the Main Conference Room for the afternoon plenary session

Then \| Afternoon plenary session Where next for AIDS vaccines?
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
6.00	Close of day 1 followed by a cocktail reception in the exhibition area

Day 2 \| Thursday, May 15th 2008
7.30	Registration & buffet breakfast in the exhibition area
Morning plenary session Anticipating and accessing emerging vaccine markets to secure long-term competitive advantage
9.00	Chair's introduction Where the public sector can play a role Research into existing and emerging disease Generation of IP Translational research – bridging the development gap Adding value for partnering Improving global health Dr Steve Chatfield, Director, Centre for Emergency Preparedness & Response, Health Protection Agency
9.20	Questions & discussion
9.25	CDC perspective Which indications will we prioritise and support? What is our current thinking regarding the adoption of a quadrivalent seasonal influenza vaccine? Dr Melinda Wharton, Captain, United States Public Health Service (USPHS), Deputy Director, National Center for Immunization & Respiratory Diseases, Centers for Disease Control & Prevention
9.45	Questions & discussion
9.50	BARDA perspective How will we drive vaccine innovation and market development through the coming decade and beyond? What strategic planning initiatives has the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) undertaken to increase transparency and promote partnerships? What initiatives does the PHEMCE plan to support in the near-, mid-, and long-term? What steps is the federal government taking to help bridge the "Valley of Death"? What advanced development and acquisition initiatives have BARDA undertaken, and what are the possibilities for the future? How has the U.S. Department of Health & Human Services (HHS) addressed barriers to industry engagement in biodefense? Monique K. Mansoura, PhD, Acting Deputy Director for Policy, Planning & Requirements, Office of the Biomedical Advanced Research & Development Authority (BARDA), Office of the Assistant Secretary for Preparedness & Response (ASPR), US Department of Health & Human Services
10.10	Playing your cards right: Managing investor expectations in biodefence The discussion will focus on how Wall Street and the investment community currently views companies pursuing biodefence funding through the United States Government, including both HHS and DOD. It will also provide practical tips, based on actual case studies, to avoid pitfalls that may create unrealistic expectations by the markets, as well as touch upon how the USG's contracting process actually works, in practice, as compared to a commercial transaction John M. Clerici, Partner, McKenna Long & Aldridge LLP
10.25	Questions & discussion
10.30	Morning coffee in the exhibition area
Keynote industry perspectives
11.10	Adapting the R&D organisation to drive the evolution of new vaccine targets and markets Merck has moved to a matrix-driven organization based around six franchises. Vaccines are part of the "Vaccines and Infectious Diseases" franchise This structure permits prioritisation of needs for vaccines, monoclonal antibodies and small molecule drugs on a pathogen by pathogen basis Prioritisation amongst new vaccine projects is based upon customer, commercial and technical inputs Dr Anthony Ford-Hutchinson, Franchise Head, Vaccines & Infectious Diseases, Merck Research Laboratories
11.35	Questions & discussion
11.40	Exploring issues and opportunities in developing and accessing the European vaccine market Vaccines: A strategic area for Europe Heterogeneous market access across Europe for vaccines Support for continued success of vaccines in Europe Dr Didier Hoch, President of the Board, sanofi pasteur MSD & President, European Vaccine Manufacturers (EVM)
12.00	Questions & discussion
12.05	Short presentations & panel discussion Assessing potentially key target applications and populations of the future What will be the next blockbuster vaccines? Case studies: What are the strategic drivers behind, and the keys to successfully instigating and maintaining, partnerships between West and East? How do you integrate such partnerships into your overall business model? How, and in what timescale, will the private sector vaccine markets in China and India develop sufficiently to present a significant opportunity to the global vaccine sector? How will the markets for, and prices of, vaccines develop in these countries? What role will local industry play in competition to, and in partnership with, US and European vaccine companies? Which existing and forthcoming vaccines (eg. traveller's vaccines) will gain new significance as global markets open up, and how will the challenges presented by potentially vast market expansion be addressed? Panel to be comprised of the speakers of the session, plus: Guy Buyens, MD, CEO, GENimmune NV Dr Jennifer Hannesschlager, Senior Advisor, McKenna Long & Aldridge LLP
12.45	Buffet lunch in the exhibition area
Followed by your choice of 3 parallel sessions:

Focus session 1 Delivering the latest market expectations and clinical data for vaccines against nosocomial infections
1.55	Moderator's introduction Examining the latest epidemiology data for major bacterial pathogens In light of the latest antimicrobial drug resistance surveillance data, how significant a role will vaccines play in countering the major nosocomial infections moving forwards? Dr Steve Chatfield, Director, Centre for Emergency Preparedness & Response, Health Protection Agency
2.05	Questions & discussion
2.10	Analyst's perspective The nosocomial vaccines market The antibacterial vaccines market – sales estimates & forecast, patient potential and key target groups Analysis of key opportunities and unmet needs – which vaccines will add significant value to current hospital practice? Overview of the late-stage pipeline Hedwig Kresse, MPhil, MSc, Senior Analyst, Infectious Diseases, Datamonitor plc
2.30	Questions & discussion
Industry case studies: What is the latest progress in the clinic for leading vaccine candidates against key nosocomial targets? Which approaches are optimal for discovering antigens for multiple strains? How are the specific challenges in designing and implementing clinical trials for these applications being addressed?
2.35	Case study Vaccines - a new strategy against multidrug-resistant nosocomial pathogens Professor Alexander von Gabain, CSO, Intercell AG
2.55	Case study Staphylococcus aureus; are we closer to developing an effective vaccine S.aureus background and epidemiology Vaccine targets and development status of leading candidate vaccines Nabi's new StaphVAX vaccine candidate Raafat E. F. Fahim, PhD, President & CEO, Nabi Biopharmaceuticals
3.15	Case study Clostridium difficile: An emerged disease with an emerging solution A threat from emergence and resistance A new target through an established approach Clinical development design and planning The importance of partnership Dr Michael Watson, Executive Vice President, R&D, Acambis
3.35	Questions for the speakers & panel discussion What are the technological keys to optimising the identification of antigens in complex bacterial pathogens? How are genomics and proteomics tools evolving to drive the discovery and development of effective antibacterial vaccines? Panel to be comprised of the speakers of the session
4.05	End of session - afternoon tea in the exhibition area

Or \| Focus session 2 Therapeutic vaccines update: What is the latest progress with leading candidates in clinical development? • How and when will they reach the market?
1.55	Moderator's introduction Big pharma perspective: Examining a recent partnering deal in the therapeutic vaccine area What are the specific expectations and drivers that were behind it? Why is the therapeutic vaccine area suddenly so attractive to big pharma? Dr Karen J. Huebscher, Global Head of Business Development & Licensing, Novartis Vaccines and Diagnostics
Industry case studies Updates on the most advanced immunotherapeutic candidates for various indications in clinical development How are regulatory requirements impacting ongoing clinical trial designs and overall development strategies? What impact are novel adjuvants having on safety and efficacy? How might these vaccines fit into treatment
2.10	Case study Progress in the development of Sipuleucel-T for the active immunotherapy of prostate cancer Introduction to prostate cancer Background on Sipuleucel-T development Clinical trial results Discussion of regulatory milestones and path to market David L. Urdal, PhD, Chief Scientific Officer, Dendreon Corporation
2.30	Questions & discussion
2.35	Case study Therapeutic vaccines: Next therapeutic breakthrough Exploring the promising clinical responses Utilising new scientific knowledge for best advantage Identifying ways to improve efficiency Creating synergy with other cancer treatments Dr Jean-Yves Bonnefoy, Vice President, R&D, Transgene SA
2.50	Questions & discussion
3.00	Case study In pursuit of an Alzheimer’s therapeutic vaccine The impact and biology of AD The science underlying anti-amyloid therapies The initial clinical results with AN1792 Design and status of ACC-001, the second generation vaccine The future of immunotherapy James Callaway, PhD, Senior Vice President, Alzheimer’s Immunotherapy Program, Elan Pharmaceuticials
3.20	Questions & discussion
3.25	Case study Therapeutic vaccines for chronic infectious diseases: Will we get there? Need for therapeutic vaccines Rationale Lessons from the past Current status The future Guy Buyens, MD, CEO, GENimmune NV
3.45	Questions & discussion
3.50	Questions for the speakers & panel discussion What is the path forward to demonstrate sufficient efficacy with cell-mediated immunity approaches in the therapeutic vaccine field? What is the best/optimal method to induce CMI? Panel to be comprised of the speakers of the session
4.05	End of session - afternoon tea in the exhibition area

Or \| Workshop How can we improve immune response in elderly and immunosuppressed populations? (Highly interactive session for a limited number of attendees)
1.55	Moderator's introduction What initiatives are being developed and implemented to meet the challenges of prioritising and delivering novel, effective vaccines to special populations, such as the elderly and immunosuppressed? Dr Melinda Wharton, Captain, United States Public Health Service (USPHS), Deputy Director, National Center for Immunization & Respiratory Diseases, Centers for Disease Control & Prevention
2.05	Changes in CD8+ T cells in elderly persons and their impact for vaccination Dr Birgit Weinberger, Immunology Division, Institute for Biomedical Aging Research, Austrian Academy of Sciences
2.30	Questions & discussion
Industry case studies: Examining clinical trial design strategies for, and the latest data from, vaccine candidates in development against major health threats to elderly and immuno-compromised populations Are potential enabling technologies, such as adjuvants and alternative delivery devices, having an impact on immune response? What is the role of formulation in this context?
2.35	Case study FluBlok, a high dose recombinant hemagglutinin influenza vaccine Four ways to improve immune response in the elderly or immunocompromised Safety, immunogenicity and efficacy of high dose vaccine in various population Overall status update on FluBlok licensure Drs Manon Cox, MBA, Chief Operating Officer, Protein Sciences Corporation
3.00	Questions & discussion
3.05	Immunogenicity and safety of a licensed adjuvanted seasonal influenza vaccine in elderly and immunosuppressed subjects Dr Volker Brauer, Medical Manager, CRD & MA Northern/Western Europe, Novartis Vaccines and Diagnostics GmbH & Co. KG
3.30	Questions & discussion
3.35	Panel discussion Which vaccines in addition to those discussed previously should the industry target for the elderly population? How can we create a better understanding of why the elderly have a generally poor response to vaccines? What are the root causes and how might they be addressed to improve understanding of optimal dosage, for instance? Panel to be comprised of the speakers of the session
4.05	End of session - afternoon tea in the exhibition area

Day 3 \| Friday, May 16th 2008
8.00	Registration & buffet breakfast in the exhibition area
Morning plenary session Moving forwards, how can the industry best demonstrate the value of novel vaccines...
9.00	Chair's introduction Jan M. Reid, Senior Director, Vaccines Licensing, Wyeth Global Business Development
...to regulators?
European and US regulators' perspectives
9.10	EMEA perspective Experience, current and future considerations Review of evolution and experience in the centralised procedure Review what has been done with influenza pandemic vaccines, etc Speculation about future opportunities Dr John Purves, Head of Sector, Quality of Medicines, European Medicines Agency
9.35	Questions & discussion
9.40	US FDA perspective Defining the pre-pandemic vs pandemic influenza vaccine strategy from the US FDA perspective Considerations for evaluating the safety and efficacy of pre-pandemic influenza vaccines Regulatory challenges in evaluating adjuvanted pandemic influenza vaccines Considerations for licensing pandemic influenza vaccines that use novel technologies such as recombinant vaccines, non-egg based vaccines, non-HA vaccines, etc Dr Norman W. Baylor, Director, Office of Vaccines Research & Review (OVRR), CBER, US Food & Drug Administration
10.05	Questions & discussion
...to payers and patients?
10.10	Public sector perspective Discussing the evaluation process for novel vaccines in general, and HPV in particular Overview of vaccine evaluation in the UK The role of modelling and economic analysis Application to HPV vaccination: incorporating uncertainty in the evaluation John Edmunds, Head, Modelling & Economics Unit, Health Protection Agency
10.35	Questions & discussion
10.40	Roundtable discussion How can industry and public sector alike ensure that vaccines are best placed to drive the general shift in focus within the healthcare system at large from treatment to prevention? Panel to be comprised of the speakers of the session
11.00	Morning coffee in the exhibition area
Followed by your choice of 3 parallel sessions:

Focus session 1 What progress is being made in developing and harmonising regulations in key areas of concern for the vaccine industry?
11.40	Moderator's introduction François Verdier, Associate Vice President, Regulatory Affairs, sanofi pasteur
11.50	Perspective on the implementation of the EU Paediatric Investigation Plan (PIP) Clarifying the role of the 'Paediatric Network' - how will it facilitate the clinical development process? How will vaccines that are already licensed, but that are seeking broader applications/indications, be prioritised and addressed? What about the backlog for vaccines already in trials at the time of implementation? William M. Egan, PhD, Executive Director, PharmaNet Consulting
12.15	Industry perspective What are the main points to be aware of when designing a development strategy for a novel vaccine in Europe? Frank Vandendriessche, Pharmacist, PhD, Director, Regulatory Affairs Europe, Vaccines/Biologics, Merck Sharp & Dome (Europe) Inc
12.40	Questions & discussion
12.55	Lunch
Regulatory harmonisation for influenza vaccines
2.00	Industry perspective Overcoming the challenges in developing influenza vaccines in the US and Europe How do you balance the different timeframes for review and feedback within your overall development strategy? Dr Klaus Stöhr, Director, Influenza Franchise, Novartis Vaccines & Diagnostics
2.20	Questions & discussion
2.25	Presentations & panel discussion US and EU regulatory pathways for pandemic and pre-pandemic influenza vaccines Key areas of focus for harmonisation and progress Data requirements for pre-pandemic vaccines Speakers to include: Dr John Purves, Head of Sector, Quality of Medicines, European Medicines Agency Dr Norman W. Baylor, Director, Office of Vaccines Research & Review (OVRR), CBER, US Food & Drug Administration
3.10	Afternoon tea & close of the Phacilitate Vaccine Forum Geneva 2008

Or \| Focus session 2 Which vaccine manufacturing technologies hold the key to delivering reductions in cost and time-to-market?
11.40	Moderator's introduction Technologies for faster vaccine process development Integrated approach Process analytical technology High-throughput technology Disposable technology Platform technology Dr Leo A. van der Pol, Head, Process Development Department, Netherlands Vaccine Institute
12.05	Questions & discussion
Case studies: Comparing and contrasting cell culture manufacturing systems and technologies in development How are they performing in terms of yield, scaleability, flexibility (especially between normal and emergency demand situations) and the efficiency with which they can potentially be transported and established?
12.10	Case study An engineering approach to medium exchange process development A review of the Baculovirus expression system for vaccine production, An outline of media exchange process parameters Discussion on scale-up parameters and manufacturing considerations Colleen Sico, Manager, Upstream Development, Novavax, Inc
12.30	Case study The PER.C6 cell line - a rationally developed versatile platform for the manufacture of rAd vectors, classical vaccines and monoclonal antibodies Professor Jaap Goudsmit, Chief Scientific Officer, Crucell
12.50	Question & discussion
12.55	Lunch
2.00	Case study Large-scale vero cell culture for the production of influenza vaccines Serum-free Vero cell culture Platform technology Large-scale manufacturing Seasonal and pandemic influenza production Dr Manfred Reiter, Head of Upstream Development Group, Baxter BioScience
2.20	Question & discussion
2.25	Case study What progress is being made in the emerging field of nonculture, plant-based vaccine manufacturing systems? How are they comparing in performance to the traditional culture-based systems? Technical feasibility Environmental concerns Regulatory issues Business and market consideration The Center’s technology and its value in addressing issues related to safety, capacity, time efficiency and cost Technology transfer and implementation. Dr Vidadi Yusibov, Executive Director, Fraunhofer Center for Molecular Biotechnology
2.45	Questions & discussion
2.50	Panel discussion What challenges and opportunities remain in optimising disposable manufacturing and filtration technologies? Panel to be comprised of the speakers of the session, plus: Panellist: Dr Raf Lemmens, R&D Vaccine Program Leader, GE Healthcare Life Sciences
3.10	Afternoon tea & close of the Phacilitate Vaccine Forum Geneva 2008

Or \| Workshop What is the business/value proposition for your organisation in utilising a novel adjuvant? (Highly interactive session for a limited number of attendees)
11.40	Moderator's opening address: New paradigms and market opportunities in use of novel adjuvants to rejuvenate old vaccines Meeting the need for better vaccine adjuvants Detrimental adjuvant-antigen interactions Do adjuvants exist which don't cause excess vaccine reactogenicity? Successful navigation of FDA hurdles for new adjuvant-vaccine combinations Professor Nikolai Petrovsky, CSO, Vaxine Pty Ltd
11.55	Title to be announced Heather L. Davis, PhD, Site Head, Ottawa Laboratories, Vaccines Research, Pfizer Global R&D
12.20	Questions & discussion
12.25	Case study Examining the strategy behind a recent adjuvant deal - what is in it for both parties? The value and importance of adjuvants in new vaccines The features of Intercell's adjuvant IC31 Strategies to commercialise and partner a new adjuvant Case studies on adjuvant partnering deals Andreas Meinke, Head of Alliance & Grant Management, Intercell AG
12.50	Questions & discussion
12.55	Lunch
2.00	Panel discussion Defining the pros and cons of adjuvant use as a whole - what can an adjuvant do, and what can it not do, in reality? What impact will novel adjuvants have on the price of vaccines? Will their application price these vaccines out of the market for most of the world? How will we ensure an adequate supply of novel adjuvants in a mass-production scenario, such as a pandemic influenza outbreak? How easily can they be stockpiled? What about scaling-up issues? Panel to be comprised of the speakers of the session, plus: Dr Sarah A. Frech, Vice President, Clinical Development, IOMAI Corporation
3.10	Afternoon tea & close of the Phacilitate Vaccine Forum Geneva 2008