Terrapinn Ltd, Washington DC
20-23 March 2006
Day one Tuesday 21st March 200607.30 Registration and coffee 08.30 Chairman’s opening remarks Dr David Allison, Medical Officer, Health and Community Services Canada VACCINE FUNDING AND DEVELOPMENT 08.45 Keynote presentation: vaccine funding initiatives • International development to meet the millennium development goals • What is the future of vaccine funding? • Vaccine funding principles • The vaccine fund initatives Dr Julian Lob-Levyt, Chief Executive Officer, The Vaccine Fund, Executive Secretary, GAVI 09.15 Keynote presentation: government sponsored initiatives • What support is being given for vaccine development? • How widely available is this contractual funding? • Are current initiatives actually working? • How to overcome the cost of time and development over the public’s willingness to pay • Funding of vaccine purchases Senator Dale Bumpers, U.S. Senate 09.45 Funding from non government organisations • Where is this money coming from? • How is the selection made? • Is this level of funding sustainable for the future? • Funding principles: deliverables from industry • Disease specific associations John Dwyer, Counsel, Arent Fox 10.15 Morning coffee 11.00 Panel session: developing vaccines for soldiers, travellers and the impoverished • Similarities and differences in the needs of these distinct segments • Priorities in disease prevention • Criteria used to evaluate the usefulness of vaccines • Vaccine development strategies to address these diverse needs Moderator: Dr Tim Cooke, Chief Operating Officer, AVANT Immunotherapeutics Panellists: Fran Lessans, Chief Executive Officer, Passport Health Dr. Jerald Sadoff, President and Chief Executive Officer, Aeras Global TB Vaccine Foundation Dr Renata J. M. Engler, Colonel, Chief, Allergy-Immunology Department, Director, Vaccine Healthcare Centre Network, Walter Reed Army Medical Centre Dr Oren Cohen, Chief Medical Officer, Quintiles 11.45 Case study: vaccines for all - a prospective from the south • Why children in the developing world are still outside basic vaccine coverage • Vaccine pricing issues • Development of vaccine manufacturing facilities • The need for technological support • Shantha, a case in point Ranajit Sen, Business Development, Shantha Biotechnics Ltd 12.15 Lunch UNDERSTANDING VACCINE PARTNERSHIPS AND ALLIANCES 13.45 What are partners looking for? • What is the strategy for pharmaceutical companies with regard to partnering? • What are the necessary preparations for prospective partners, especially non government organisations? • How pharmaceutical companies approach the deal-making process within the vaccines industry Clement Lewin, Vice President United States Government Affairs and Strategy, Acambis 14.15 Developing tomorrow’s vaccines • What is the role of partnerships in accelerating vaccine product development? • New product development activities within the vaccine industry • What information does government want from industry as vaccines are being developed in order to speed their adoption? • Keys to deriving value from vaccine partnerships Dr John Gotto, Senior Director, Global Business Development, Wyeth Vaccines 14.45 Speed networking This is a revolutionary, exciting, quick and non-pressurised way to meet fellow conference delegates and industry peers in a one hour session. These brief meetings are the starting point for conservation and networking throughout the conference. This is where long lasting and fruitful relationships begin. Please make sure to bring lots of business cards! • Meet…move on… meet…move on…meet! • Exchange business cards with fellow conference delegates, speakers and moderators • The best networking session you’ve ever experienced 15.45 Afternoon tea
WORKING SESSION ONE: VACCINE REGULATORY ISSUES
16.15 Chairman’s opening remarks Niamh Kinsella, Associate Director of Regulatory Affairs, ERA Consulting 16.20 Risk management strategy in vaccine development • Are public concerns leading to unrealistic regulatory hurdles? • Lessons learnt from pitfalls experienced in recent registration processes • Defining pre-licensure safety profile • Anticipating effective risk management strategy for new vaccines Dr Luc Hessel, Executive Director Medical and Public Affairs, Europe, sanofi aventis MSD
16.50 Managing vaccine development costs: moving from the bench to phase I/II clinical studies • Are collaborations and public private partnerships the way forward? • Is there true innovation and flexibility within regulatory authorities? • How can a portfolio of products be used to reduce overall development costs? Dr Philip Gomez, Director Vaccine Production Programme, VRC, NIAID, NIH 17.20 Effective development and validation of biological potency assays • Steps to avoid common (and costly) technology transfer mistakes • Implementation of strategies to maximise robustness and precision • Case studies of logical approaches to bioassay development & validation Dr Ana T. Menendez, Senior Director of Bioassays and Biosafety Testing, Cardinal Health 17.50 Case study: uncharted territory - assembling a therapeutic vaccine BLA • Assembling a therapeutic vaccine biologics license application • Process overview • Development of the CMC package • Lessons to be learned Mark Leuchtenberger, President and Chief Executive Officer, Therion Biologics Corporation 18.20 Close of day one WORKING SESSION TWO: INFLUENZA VACCINES 16.15 Chairman’s opening remarks Michel Greco, Independent Vaccine Expert, former President Aventis Pasteur 16.20 Case study: novel inactivated intranasal flu vaccine • Enhancement of mucosal response • Use of GelVac™ powder as a new delivery system • Results to date Dr Kenneth Yates, President, DelSite Biotechnologies Inc. 16.50 Improving influenza immunisation rates – annual readiness equates to pandemic preparedness • What is the role of health care providers in administering influenza vaccine and in improving coverage? • What are the barriers that health care providers face when trying to immunise with influenza vaccine? • How can some of these barriers be overcome and what partnerships need to be formed to achieve this goal? • Is universal influenza immunisation a realistic goal? • What logistically needs to happen before health care providers are ready for universal influenza immunisation? Dr Litjen Tan, Director Infectious Disease, Immunology and Molecular Medicine, American Medical Association 17.20 Case study: FluBlØk™ - a recombinant, highly purified influenza vaccine • Phase III clinical results for FluBlØk™: a revolutionary influenza vaccine • Validating a new vaccine technology platform: fits, starts and ultimate success • Where to from here with the insect cell platform? Daniel D. Adams, President and Chief Executive Officer, Protein Sciences Corporation 17.50 Case study: potential pandemic flu vaccine Virus-Like-Particle (VLP) • A new vaccine platform to address the urgent need for pandemic flu vaccine • Results of pre-clinical studies with an influenza avian (pandemic) H9N2 candidate VLP vaccine • Novasomes® – a safe, patented adjuvant to help address the need for antigen sparing • Rapid, disposable, scalable manufacturing process to meet vaccine needs for pandemic flu Dr Rahul Singhvi, President and Chief Executive Officer, Novavax, Inc 18.20 Close of day one
Day two Wednesday 22nd March 2006
08.00 Registration and coffee
08.45 Chairman’s opening remarks Dr Lance Gordon, President, Vaxgen VACCINES IN DEVELOPMENT 09.00 Case study: oral vaccines for biodefense • Pre-clinical studies for plague and anthrax • The advantages and disadvantages of oral vaccines • Overview of vaccines in development Dr Tony Mulcahy, European Director of Business Development, Cobra Biomanufacturing Plc. 09.20 Case study: second generation anthrax vaccine • Non injection mucosal delivery • What developments have been made? • Results and findings to date • The future of second generation vaccines Dr Stephen Bell, Vice President Research and Preclinical Development, BioSante Pharmaceuticals Inc 09.40 Case study: TB vaccines • Update on findings to date • Clinical results to date • Recent developments for TB vaccines Dr Jerry Sadoff, President and Chief Executive Officer, Aeras Global TB Vaccine Foundation 10.00 Question and answer session 10.15 Morning coffee 11.15 Case study: T cell Yin/Yang: focusing the Immune response • Immunoinformatics approaches to identifying vaccine candidates • Optimising antigens for immune system delivery (pathways and processing) • Monitoring immune response using carefully designed epitope arrays Dr Annie De Groot, Chief Executive Officer, EpiVax 11.35 Case study: towards the development of an effective HIV vaccine • Novel Env antigen structures • Neutralising antibody and T cell responses • Prime-boost strategies for broad immune responses • Results and developments to date • What are the next steps? Dr Jeffrey Ulmer, Senior Director Vaccines Research, Chiron Corporation 11.55 Case study: preventative HPV vaccines • Vaccine overview • What developments have been made? • Results to date • What are the next steps? Dr Richard Roden, Associate Professor, The Johns Hopkins University 12.15 Question and answer session 12.30 Lunch 14.00 INTERACTIVE ROUNDTABLE DISCUSSIONS The World Vaccine Congress Washington is the strategic platform for the vaccine industry to converge, discuss, debate and share insights of issues relevant to the vaccine industry. Delegates have the option to choose from 2 different topic areas with each topic lead by an industry expert chosen to lead the discussion. This interactive roundtable discussion is set up specifically for delegates to come away with different insights into issues that matter. Roundtable 1: Therapeutic vaccines • Recent hot news from the clinic • Looking at responses: tumor regression versus 'stable disease' • Autologous and allogeneic products: issues for big pharma? • Getting to market: the next 10 years Chairperson: Dr Tony Mills, Vice President Business Development, Biovex Roundtable 2: Biodefense • Where are we today in addressing the potential threats? • What are the key opportunities and challenges going forward for ensuring effective countermeasures are available? • What barriers need to be addressed to increase industry participation in the effort? • How can we create an effective public private partnership to research, develop and procure countermeasures? Chairperson: Clement Lewin, Vice President US Govt. Affairs & Strategy, Acambis VACCINE MANUFACTURING AND DELIVERY 15.00 Improving manufacturing technologies for new generation vaccines • Trends and requirements in downstream processing for new generation vaccines • Improved harvesting technologies • High throughput chromatography technologies • Addressing current process issues Dr Hélène Pora, Vaccine Application Director, PALL Life Sciences 15.30 How to define the best route of administration and dosing schedule • What factors need to be considered? • What new routes of administration are in development? • What are the issues concerning dosing schedule? • What regulatory issues need to be considered? Dr Patrick Squiban, Vice President Medical and Regulatory Affairs, Transgene SA 16.00 Afternoon tea 16.45 Case study: development of FluINsureTM, a novel intranasal inactivated influenza vaccine • Uses ProteosomeTM as adjuvant coupled to split-virus antigens • Preclinical and clinical safety profile • Induces both serum and nasal anti-HA antibodies • Induced protection against influenza in a Phase II clinical efficacy study and in challenge studies Dr Ronald Ellis, Senior Vice President, Development, and General Manager, ID Biomedical Corporation 17.15 Case study: development of a human protein T-cell adjuvant • Enhancement of T-cell responses for therapeutic vaccines • Use of sLAG-3 (IMP321TM ) as an immunomodulator in clinical trials • Results and findings to date Dr Frederic Triebel, Scientific and Medical Director, Immutep SA 17.45 Close of congress
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