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Key Speakers Guido Grandi, Senior Project Leader, Novartis Vaccines and Diagnostics Dr Bassam Hallis, General Project Manager, Centre for Emergency Preparedness and Response, Health Protection Agency Alexander von Gabain, Founder & Strategic Advisor to the Management and Supervisory Boards, Intercell Dr David Kirke, Associate Director of Regulatory Affairs, ERA Consulting Dr Barbara Guinn, Cancer Sciences Division, University of Southampton Jean Marc Balloul, New Venture Development Director, Transgene Lior Carmon, Founder & CEO, Vaxil Biotherapeutics Conference Introduction Vaccine Research & Innovation 2010 2nd – 3rd September 2010 Dear Colleague, Increasing use of novel technologies has boosted the vaccines industry worldwide. Recent technological breakthroughs in vaccine research, manufacturing and delivery, promise a bright future for the new generation of vaccines, particularly for chronic conditions such as cancer, auto-immune diseases and nicotine addiction. According to recent report, The Global Vaccines Market, 2008-2023, therapeutic vaccines will significantly expand the vaccines market contributing to rapid revenue growth during the period 2008 to 2023. The cancer vaccine market, led by cervical cancer vaccines, is presently one of the most lucrative areas for vaccine manufacturers. Advances are also being made in almost all adjunct areas of vaccine research, such as the mode of delivery, use of combination vaccines, vaccine adjuvant, and vaccine manufacturing. Our Vaccine Research & Innovation conference is designed to implement successful strategies and innovative technologies to develop more effective vaccines. Gain insights through industry led case studies and discussions with key decision markers from the vaccines sector. Network and collaborate with global professionals to keep up-to-date with future trends and exploring business opportunities at the two-day event. By attending this conference you will gain insights on: • Overcoming challenges to cancer vaccine development • Evaluating the immune response to combination vaccines • Accelerating new vaccine introduction in the developing world • Monitoring High sensitivity T cell immune mechanism of novel vaccines, gene therapy, protein based drugs • Assessing the key immunological observations on clinical development of pandemic influenza A (H1N1) vaccines • Examining the safety challenges on new vaccine introduction • Implementing strategies for manufacturing and purification of conjugate vaccines file:///C|/Documents%20and%20Settings/user29/Desktop...0on%20Vaccine%20Research%20&%20Innovation%202010.txt (1 of 7)7/26/2010 2:19:04 PM
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• Good supply chain management practices for vaccine distribution Who will be there? Presidents, Chief Executives, VPs, Global Heads, Scientific Advisors, Therapeutic Area Heads, in: • Vaccine equipment and manufacturing • Vaccine application development • Vaccinology and molecular biology • Cell line engineering • Proteomics, recombinant protein/DNA biotechnology • Infectious disease R&D • In-licensing and out-licensing • Pharmacovigilance and safety testing • Regulatory affairs • Strategic product development • External research • Manufacturing/production • Chemistry manufacturing and controls (CMC) • Procurement & purchasing • Cold chain supply and lyophilisation • Strategic alliances • Clinical product resourcing • Supply outsourcing project management • Contract management • Process development • Business development • Drug discovery & delivery • Patent law • Investment and venture capital Sponsorship and exhibition opportunities: This event offers a unique opportunity to meet and do business with some of the key players in the pharmaceutical and biotech industries. If you have a service or product to promote, you can do so at this event by: • Hosting a networking drinks reception • Taking an exhibition space at the conference • Advertising in the delegate documentation pack • Providing branded bags, pens, gifts, etc. If you would like more information on the range of sponsorship or exhibition possibilities for Vaccine Innovation and Cell Line Development Conference, please contact us: file:///C|/Documents%20and%20Settings/user29/Desktop...0on%20Vaccine%20Research%20&%20Innovation%202010.txt (2 of 7)7/26/2010 2:19:04 PM
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Phone: +91 22 27578668 Email : raju@bharatbook.com Day 1 Vaccine Research & Innovation 2010 Thursday 2nd September 2010 09:30 Registration and refreshments 10:00 Opening address from the chair 10:10 Regulatory challenges in the approval process for novel vaccine adjuvants • Regulation and evaluation process of new adjuvants in vaccines • Differences in the global regulatory requirements and overcoming these challenges • Engaging with regulators and contributing to the evolution of regulatory framework • Integrating your global regulatory strategy and product development plan Dr. David Kirke Associate Director - Regulatory Affairs ERA Consulting 10:50 Evaluating the immune response to combination vaccines • High sensitivity T cell immune monitoring of novel vaccines, gene therapy, protein based drugs • Immune monitoring during pre clinical and clinical trials to detect adverse immune reactions to gene therapy and protein based drugs early Dr Thomas O Kleen Director, Business and Technology Development Cellular Technology 11:30 Morning refreshments 11:50 High-throughput stable cell line generation • Current-generation high-throughput sequencing • Establishing new assays for high-throughput screening • Optimised system for rapid generation of localisation and affinity purification-tagged mammalian stable cell lines • Stabilisation of cell lines
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12.30 Development of avian cell lines dedicated to vaccines manufacturing • Human vaccine (Flu, Flavivirus, Recombinant Poxvirus) • Veterinary vaccine • Therapeutic proteins Jean Marc Balloul New Venture Development Director Transgene 13:10 Networking lunch 14.10 Biologics cell line and process development • Investigating a range of cell culture parameters • Cell line selection and delivery system • Vector redesign to improve cell line stability and clone selection • Automation processes for cell line development Karl Kreij Cell Culture Scientist Crucell 14:50 Manufacturing and purification strategies of conjugate vaccines • Conjugate vaccine (peptide/chemical hapten) development, optimisation and production • Production issues for conjugate vaccines • Overview of the novel purification approaches • Downstream processing parameters for purification • Analysing the challenges associated with purification procedures • Wide-scale adoption of disposable technologies 15:30 Afternoon refreshments 15:50 Safety monitoring in vaccine development and immunisation • How can you know vaccines are safe? • Challenges and risks with new vaccine introduction • Surveillance through clinical trials to manufacturing processes • Vaccine Adverse Event Reporting System (VAERS) 16:30 Challenges to cancer vaccine development • Overview of the main immune responses • Identifying targets for immune therapy • New vaccine development and current clinical trials Dr. Barbara Guinn Cancer Sciences Division file:///C|/Documents%20and%20Settings/user29/Desktop...0on%20Vaccine%20Research%20&%20Innovation%202010.txt (4 of 7)7/26/2010 2:19:04 PM
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University of Southampton 17:10 Closing remarks from the chair 17:20 Networking drinks Take your discussions further and build new relationships in a relaxed and informal setting. Day 2 Vaccine Research & Innovation 2010 Friday 3rd September 2010 09:30 Registration and refreshments 10:00 Opening address from the chair 10:10 Development of a pneumococcal vaccine comprising highly conserved proteins • Discovery of a novel class of highly conserved vaccine antigens • Approach for new-generation vaccines is the use of nonpolysaccharide antigens that are conserved among pneumococcal strains • Changing epidemiology of pneumococcal infection •Immunological considerations and correlates Alexander von Gabain Founder & Strategic Advisor to the Management and Supervisory Boards Intercell 10:50 From trial and error to rational design of adjuvant vaccines • Adjuvant need not induce side effects: A different concept • ISCOM, adjuvant for newborns and elderly • Antigen sparing an essential aspect • Broadening of immune response Bror Morein Department of Medical Sciences, Virology, Uppsala University Chairman of the Scientific Advisory Board, Isconova 11:30 Morning refreshments 11:50 Case Study: Key immunological observations on clinical development of pandemic influenza A (H1N1) vaccines Dr. Bassam Hallis file:///C|/Documents%20and%20Settings/user29/Desktop...0on%20Vaccine%20Research%20&%20Innovation%202010.txt (5 of 7)7/26/2010 2:19:04 PM
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General Project Manager Centre for Emergency Preparedness and Response Health Protection Agency 12:30 Vaccine development & early clinical research (Phase I) • Phase I study design • Managing sponsors • Managing the vaccines •Operational execution Andrew Nolan Senior Project Manager Phase I Therapeutic Area Head – Vaccines Quintiles 13:10 Networking lunch 14:10 Case study: Developing the next generation of therapeutic vaccines The case study will feature novel, therapeutic vaccines for the treatment of cancer and key intracellular pathogens via specific manipulation and augmentation of the patient cellular immune responses. Lior Carmon Founder & CEO Vaxil Biotherapeutics 14:50 Surface proteome analysis as a fast-track to vaccine discovery • Stripping away cell-surface proteins • Mass-spectrometry and in silico surfome analysis • Identification and validation of new targets for group A Streptococcus Guido Grandi Senior Project Leader Novartis Vaccines and Diagnostics 15:30 Afternoon refreshments 15:50 Challenges in adult immunisation • What are disease areas in adult immunisation? • Implementation of strategies to improve vaccination coverage • Indentifying and minimising the impact on accessibility and affordability of adult vaccines 16.30 Accelerating new vaccine introduction in the developing world • Meeting the challenges in introducing new vaccines: Logistics, supply and quality control issues • Overcoming shortage and delays file:///C|/Documents%20and%20Settings/user29/Desktop...0on%20Vaccine%20Research%20&%20Innovation%202010.txt (6 of 7)7/26/2010 2:19:04 PM
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• Good supply chain management practices for vaccine distribution 17:10 Chair’s closing remarks 17:20 End of Conference
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