World Vaccine Congress, Palais des Congres de Lyon, Lyon, France
11-13 October 2004
Day one Monday 11 October 2004Plenary session Accelerating global vaccine development and access 8:30 Chairperson’s opening remarks Michel Greco, Vaccine Industry Expert 8:45 Keynote presentation: progress on joint working for global immunisation · How UNICEF has progressed in its aim for every child to be immunised · Challenges of working with developed world manufacturers to ensure access to vaccines · Pricing and supply of vaccines – can we realistically set prices to encourage development? Carol Bellamy, Executive Director, UNICEF
9:15 Can public health needs overcome the scientific, regulatory and financial barriers to new vaccines? · How the needs of public health conflict with regulatory and industry priorities · How pharmaceutical scientists can contribute to the solution of public health problems · What factors drive large vaccine companies? · Are there too few of them to satisfy needs? · The role government will play in vaccine production, given no response from industry Dr Stanley Plotkin, Medical and Scientific Advisor, Aventis Pasteur 9:45 Key issues for vaccine development, supply and delivery for emerging manufacturers · Gaining international recognition for developing country manufacturers · Technology transfer to meet the needs of the developing countries · R&D efforts to meet the emerging vaccine needs in the developing world Dr Cyrus Poonwalla, Chairman, Serum Institute of India 10:15 Morning coffee 10:45 Accelerating vaccine development by working with emerging manufacturers · Running clinical trials in the developing world · Differential pricing and financing of essential vaccines · Scaling up production to meet supply needs Dr Teresa Aguado, Co-ordinator, Vaccine Development, Dept of Vaccines and Other Biologicals, WHO 11:30 GAVI and the vaccine fund: a strategic contribution to reaching the millennium development goals · The challenge posed by the Millennium Development Goals · GAVI and The Vaccine Fund: immunisation as an answer · GAVI: progress and challenges · A new international financial mechanism to help countries meet the challenge of sustainability Jacques-François Martin, President and CEO, The Vaccine Fund 12:00 Case study: partnering for a human trial of an AIDS/HIV vaccine candidate · Creating strategic alliances between NGOs, research networks and academic institutions · How to get IAVI on board to provide full financial support for research and development · How a commercial vaccine company became involved · Where did the initiative come from? · How the partnership was constructed and what challenges they faced · Perspectives for HIV vaccine development until 2010 Dr Jan van Lunzen, Consultant, Internal Medicine and Infectious Diseases, DTM&H 12:30 Panel session: how to increase access to vaccines in developing countries · Mechanisms for partnerships and funding · How can the industry work with global and regional NGOs? · Manufacturing in the developing world – a workable approach to access? · New approaches to addressing the distribution problems Panellists: Dr Teresa Aguado, Co-ordinator, Vaccine Development, Dept of Vaccines and Other Biologicals, WHO Jacques-François Martin, President and CEO, The Vaccine Fund Dr Robert Whalen, Director, Infectious Diseases, Maxygen Dr Cyrus Poonwalla, Chairman, Serum Institute of India Gordon Cameron, CEO, Acambis 13:15 Lunch Participants can choose from either: Focus group 1 Advances in vaccine pipeline and clinical development 14:45 Moderator’s presentation: making development worthwhile – balancing a portfolio · Modelling projected demand and life cycle of your product · Offsetting opportunity cost and product development costs · What is the profile of your target market? Gordon Cameron, CEO, Acambis 15:30 Investigator-operated vaccine trial network as an efficient tool for multi-state clinical trials · Conducting vaccine trials in healthy children outside the regular health care system, · Recruiting specialised, dedicated and GCP trained staff · Added value derived from academic institutional connection · Forming a strategic partnership with a CRO with distinct roles for each partner · Case studies of RotaTeq and Flumist: recruitment in Finland compared to elsewhere in Europe and the US Professor Timo Vesikari, Professor of Virology, University of Tampere, Consultant, Remedium 15:45 Transitioning from being a CMO to being a vaccine development business Ronald Brus, CEO, Crucell 16:15 Opportunities and challenges in research, development and commercialisation · What are the financial and regulatory incentives for the research and development of vaccines to treat orphan diseases? · A review of the US and European legislation on orphan drugs · What is the long-term pharmacoeconomic viability of orphan products? · Key factors in overcoming the complexity of orphan status, high unmet need, versus limited market size Dr Renu Gupta, SVP, Development, Antigenics 16:45 Afternoon tea Focus group 2 Developing new delivery methods for global immunisation Focus group moderator: Dr Noel Harvey, Director, Advanced Drug Delivery, BD Technologies 14:45 Needle-free and minimally invasive delivery platforms for biodefense immunisation · Immunologically-attractive benefits offered by cutaneous and nasal delivery · Complete protection against inhalational anthrax in rabbits by cutaneous and nasal delivery · Next steps Dr John Mikszta, Group Leader, Immunology, BD Technologies 15:15 Case study: live bacterial vectors for delivery of vaccines · Product development challenges for live vaccines · Optimisation of expression systems · Spectrum of immune responses elicited by a live bacterial vector · Latest clinical data Dr Steven Chatfield, Chief Scientific Officer, Microscience 15:45 Vaccine delivery via non-classical routes - selection criteria for delivery devices · Non-classical routes · Vaccine formulations · Delivery devices Dr Steven Bell, Vice President, Pre-clinical R&D, BioSante Pharmaceuticals 16:15 Stabilising high copy antibiotic-free vectors in live bacterial vaccines using ORT-VAC · Safe maintenance in vivo of plasmids without antibiotic genes · Improved antigen expression by increased gene copy number · Salmonella typhimurium colonisation in vivo · Protection from disease challenge after mucosal immunisation Julian Hanak, Director of Production, Cobra Biomanufacturing 16:45 Afternoon tea Plenary session
17:30 Panel session: regulatory issues and obstacles facing new vaccine delivery systems · The regulators viewpoint · The industrial viewpoint · The researchers viewpoint · Different delivery systems in terms of effectiveness, improved adjuvanticity, in vitro and in vivo stabilisation of antigens, safety from risk of infections and side effects Panellists: Dr Steven Bell, Vice President, Pre-clinical R&D, BioSante Pharmaceuticals Patrick Poisson, Director of Technical Services, Cardinal Health, Biotechnology and Sterile Life Sciences Dr William Egan, Acting Director, Office of Vaccine Research and Review, CBER, FDA Dr John Mikszta, Group Leader, Immunology, BD Technologies 18:15 Vaccine safety: a review of the MMR/autism debate in the light of new evidence · What probably does cause autism? · What is wrong with the theories that MMR might be a cause of autism? · How do we know that MMR does not cause autism? · Countering the damage done to public health vaccine programmes Dr David Salisbury, Principal Medical Officer, Department of Health, UK 18:45 Close of day one followed by speed meeting cocktail reception Day two Tuesday 12th October 2004 Plenary session Meeting the demands posed by re-emerging and new pathogens 8:45 Chairperson’s opening remarks Professor Ruth Arnon, Professor of Immunology, Weizmann Institute 9:00 Routes to expedite approval for vaccines to address new and re-emerging pathogens · Issues for pandemic flu preparation · Perspectives on the "animal rule" and its uses · Vaccines as orphan drugs Dr William Egan, Acting Director, Office of Vaccine Research and Review, CBER, FDA 9:30 Building a pipeline of HIV/AIDS vaccines for future development · The creation of new strategies for HIV vaccination from basic immunology and AIDS immunopathogenesis studies data · Vaccine clinical trials development: immunogenicity and mechanisms of breakthrough infection · HIV Phase I trials – what is the hope for the next generation of HIV/AIDS vaccines? · Some promising vaccine candidates from large-scale human trials data Professor Marc Girard, Honorary Director General, Fondation Mérieux 10:00 Case study: an approach to a HIV vaccine focusing on neutralising antibodies · Creation of HIV-1 envelope variants · High-throughput immunisation screening · Neutralisation testing and criteria for advancement · Product profile for a NAb-inducing vaccine Dr Robert Whalen, Director, Infectious Diseases, Maxygen 10:30 Morning coffee 11:15 Case study: developing a vaccine from a highly pathogenic H5N1 influenza virus · Update on human cases of H5N1 infection · Why can’t a vaccine be made directly from the H5N1 virus? · Regulatory and safety roadblocks to a reverse genetic vaccine · Will a candidate vaccine be safe and immunogenic in naïve populations? Dr John Wood, Principal Scientist, NIBSC 11:45 Flu pandemic preparedness: how well prepared is Europe? · The regulatory background in the preparedness plan for flu pandemics · Current and proposed production strategies · Batch release plans and availability of vaccines Dr Florence Fuchs, Director of Lyon Site, AFSSAPS 12:15 Panel session: influenza pandemic preparedness – are we prepared enough? · Mechanisms needed to respond to global public health emergencies · Challenges of producing vaccines for new flu strains · Evaluating their efficacy and safety Panellists: Dr John Wood, Division of Virology, NIBSC Dr Florence Fuchs, Director of Lyon Site, AFSSAPS Dr Bram Palache, Global Medical Affairs Director, Influenza Department Solvay Pharmaceuticals Denis Cavert, European Vice President, Commercial Activities, Baxter Vaccines 13:00 Lunch Participants can choose from either: Focus group 1 What is the future for adjuvants? 14:30 Moderator’s presentation: utilising both the adaptive and innate systems for vaccine development · Innate immunity and toll-like receptor signalling · Prophylactic vaccines and immune therapy based on combined innate and adaptive responses Dr Carlo Russo, President and CEO, VaxInnate 15:00 Recent advances with new vaccine adjuvants : from preclinical to clinical development · Safey of subunit, and recombinant subunit approaches to vaccine design · How has the understanding of the role of effector cell mediated immunity changed? · Novel adjuvant systems able to induce such cellular responses · Ordered antigenic arrays as natural adjuvants for boosting antibody responses · Targeting the adjuvants to the dendritic cells Dr Martin Bachmann, Chief Scientific Officer, Cytos Biotechology 15:30 Case study: virosomes – a suitable parental delivery method for vaccine antigens? · Immunological background · Structure and composition of virosomes · Adjuvant properties of virosomes · Applications of virosome technology in licensed vaccines · Key issues Dr Reinhard Glück, Chief Scientific Officer, Berna Biotech 16:00 Panel session: adjuvant/delivery systems requirements of prophylactic vaccines versus therapeutic vaccines · DNA/genetic vaccines · Viral vaccines · Cancer vaccines Panellists: Dr Michael Buschle, Chief Scientific Officer, Intercell Dr Martin Bachmann, Chief Scientific Officer, Cytos Biotechology Dr Reinhard Glück, Chief Scientific Officer, Berna Biotech Dr Zeil Rosenberg, Worldwide Business Leader and Medical Director, Beckon Dickinson 16:45 Afternoon tea Focus group 2 Identifying and utilising novel antigens 14:30 Moderator’s presentation: identification of protective antigens for recombinant vaccines · Epitope-based vaccines · Identification of protective epitopes · Salmonella flagellin as a vehicle for candidate vaccine · Epitope-based broad-spectrum influenza vaccine Professor Ruth Arnon, Professor of Immunology, Weizmann Institute 15:15 A novel genomic approach for the rapid detection and validation of bacterial antigens · A novel, comprehensive genomic approach to identify bacterial antigens · Human sera as selective agent · Rapid validation of antigen candidates by serology Dr Michael Buschle, Chief Scientific Officer, Intercell 15:45 Case study: developing a group-common pneumococcal protein vaccine · Coverage for all pneumococcal serotypes · Unique fusion protein as vaccine antigen · Development challenges · Biological data with vaccine-induced antibodies Dr Ronald Ellis, Senior Vice-President Vaccine R&D and General Manager, Shire Biologics 16:15 Multiple antigen targeting in cancer vaccines using autologous DC · Clinical development of melanoma and colorectal cancer DC-based vaccine candidates · Current scientific and development challenges of cell-based cancer vaccines · Combination therapies: the future of cancer vaccines? Dr Margarita Salcedo, Director, Discovery Research, IDM Research Laboratory 16:45 Afternoon tea Plenary session 17:30 Progress report on a Men A conjugate vaccine for developing world, specifically sub-Saharan Africa · Update of the development of an affordable vaccine · Outline of clinical trials envisioned in India and Africa · The NVP development model Dr Marc LaForce, Director, Meningitis Vaccine Project, PATH Europe 18:00 The promise and potential of meningococcal c conjugate vaccines · Another conjugate vaccine success story: Hib, Pneumo, and now MeningC · "Designer" MeningC conjugate vaccine: protective epitopes, targeted immune response, broader potential · The road to commercialisation: avoiding the potholes and challenging the speed limit Dr Joan Fusco, Vice President, Technical Affairs, Vaccines, Baxter BioScience 18:30 Close of day two followed by cocktail reception Day three Wednesday 13th October 2004 Manufacturing for late stage clinical trials or commercialisation 8:45 Chairperson’s opening remarks Lisette Mermod-Cox, Managing Director, BDKT The Consortium for Life Science Technologies 9:00 Keynote presentation: regulatory issues for an emerging manufacturer in becoming global vaccine supplier · The need to build an appropriate national regulatory authority · Gaining potential manufacturing capacity to supply to global markets · Specific manufacturing challenges around quality, risk management and compliance Dr Suresh Sakharam Jadhav, Executive Director, Quality Assurance and Regulatory Affairs, Serum Institute of India, President, DCVM 9:30 Scaling up production for a new influenza vaccine – challenges and opportunities · Cell-line selection criteria · From concept to factory · Cell-cultured flu vaccine and pandemic supply Dr JCG Preusting, Director, Cell-culture Influenza Vaccine Production, Solvay Pharmaceuticals 10:00 Case study: producing vaccines in the developing world – costs and considerations · Key drivers of this phenomenon and how they compare to developed world drivers · How much lower costs are in manufacturing and research and development? · What is needed for prospective global suppliers of vaccines to gain regulatory and licensing approval? K V Balasubramaniam, Managing Director, Indian Immunologicals 10:30 Morning coffee 11:15 Challenges in achieving room temperature stable oral vaccines · Regulatory issues with oral GMO (Genetically Modified Organisms) · Cost effectiveness of production and distribution/storage Dr Mary Nicholson, Senior Director, Operations, Fall River, Avant Immunotherapeutics 11:45 Quality issues for late-stage clinical vaccine manufacturing and commercialisation · Compliance issues: the roles of GMP, GLP and GCP · Integration and interfaces between quality and regulatory affairs, process development, manufacturing, non-clinical and clinical programmes · Assay development and validation issues · Quality management of third parties and sub-contractors · Auditing (GMP, GLP, GCP) Dr Klaus Neurohr, Head of Quality and Regulatory Affairs, Avecia Biotechnology 12:15 Panel session: how to develop manufacturing processes and facilities to achieve global approval Despite the best efforts of manufacturers and regulatory agencies in developing global harmonised standards such as the CTD, there still remains real barriers to being a global vaccine supplier. This panel session will discuss the real problems that manufacturers face when trying to get approval for their vaccine on a global scale and to license it for sale in another country. Panellists: Dr V A Srinivasan, Executive Director, Indian Immunologicals Dr Suresh Sakharam Jadhav, Executive Director, Quality Assurance and Regulatory Affairs, Serum Institute of India, President, DCVM Dr Mary Nicholson, Senior Director, Operations, Fall River, Avant Immunotherapeutics Dr Klaus Neurohr, Head of Quality and Regulatory Affairs, Avecia Biotechnology 13:00 Innovative primary packaging systems for vaccines and biologics utilising Blow/Fill/Seal · Advantages over conventional aseptic processing · Cost savings from automation · What impact has product volatility and viscosity on viability? Patrick Poisson, Director of Technical Services, Cardinal Health, Biotechnology and Sterile Life Sciences 13:30 Lunch Therapeutic vaccines clinical trial challenges 15:00 Developing a vaccine: clinical challenges in a small company · Defining endpoints - surrogate endpoints, trial design, regulatory interactions · Developing a world-class scientific advisory board · Gaining funding to move through clinical trials of NeuroVax(TM), a T-cell receptor (TCR) peptide vaccine designed to treat MS Dr John Bonfiglio, CEO, The Immune Response Corporation 15:30 Case study: clinical challenges for Transgene's MVA-HPV-IL2 vaccine · Medical need for therapeutic HPV vaccines · Characterisation of candidate vaccines · Preclinical evaluation · Clinical development strategy · Progress in product development of MVA-HPV-IL2 gene-based vaccine Dr Patrick Squiban, Vice President, Regulatory and Medical Affairs, Transgene 15:50 Designing Phase I/II for the APC8024 programme, a therapeutic vaccine for breast and other Her-2 expressing cancers · Immunotherapy of breast cancers · Induction of therapeutic immune responses in cancer patients · Regulatory and development strategies for cancer vaccines Dr Reiner Laus, Vice President, Research and Development, Dendreon 16:10 Results of a randomised Phase II B trail with the liposomal MUC 1 vaccine BLP 25 in NSCLC · Patient selection for vaccine trials · Clinical outpoints · Immunological markers Dr Andreas Harstrick, Head, Medical Sciences Oncology, Merck KGaA 16:30 Cancer vaccine regulatory challenges in clinical trials – hope for the future? · Upcoming changes related to Directive 2001/20/EG · Quality and preclinical issues in clinical trial applications to the Competent Authority · Major requirements for registration of cell-based cancer vaccines Dr Thomas Hinz, Head of Laboratory, Paul Ehrlich Institut 16:50 Panel session: Q&A session with the case study presenters on challenges of therapeutic vaccine clinical trials 17:30 Close of conference
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