Phacilitate Vaccine Forum Washington 2008

Agenda | Day 3 Printer friendly version - full agenda

DAY 3 \| Wednesday January 30th 2008
8.00	Registration & buffet breakfast in the exhibition area
Morning plenary session Delivering innovation globally through technology transfer, public-private partnerships, funding vehicles and licensing mechanisms
9.00	Chair’s introduction Dr Chandresh Harjivan, Principal, Life Sciences, PRTM Management Consultants
9.05	NGO perspective Innovation in science and technology: A critical path to addressing global health inequities Global health inequity - the problem Innovations in science and technology can contribute to health solutions Global access is the target Partnerships can drive solutions - industry is a key partner Carol A. Dahl, PhD, Chief of Staff, Global Health Program & Director, Global Health Technologies, Bill & Melinda Gates Foundation
9.35	Questions & discussion
9.40	Update on the success of the latest funding and risk-sharing mechanisms: What is the progress with the first Advanced Market Commitment, and how attractive are the alternatives? What are the risks of the AMC approach for manufacturers and how can they be minimized? Dual-market vaccines (PCV, HPV, Rotavirus) versus developing world vaccines (HIV, malaria, TB) Will AMCs be enough for developing world vaccines? How to manage the "tail commitment" What progress is being made with alternative funding mechanisms? ADIP Venture capital funded opportunities Private sector approaches Risk sharing by developing nations: What are the countries in greatest need of vaccines doing to share the risk with NGO’s, PPP’s and industry? What role are middle-income countries playing in funding and risk sharing for the development of vaccines nationally and globally? How are developing world manufacturers being incentivized to invest in R&D for new vaccines? Stephen M. Sammut, Senior Fellow, Wharton Health Care Systems & Venture Partner, Burrill & Company
10.05	Questions & discussion
10.10	Keynote address: Delivering innovative new vaccine products to industry through licensing and partnering mechanisms Analysing the different types of transaction that may be adopted to introduce innovation in vaccine development and delivery - what are the pros and cons of each? Licensing mechanisms Funding vehicles Collaborative R&D Options structures JVs Dr Allan P. Jarvis, Senior Vice President, Corporate Development, sanofi pasteur
10.35	Questions & discussion
10.40	Morning coffee in the exhibition area
11.20	How and where will new products for the developing world be approved? How can western agencies adequately assess benefit:risk in developing world populations? What is the benefit of Article 58 versus full marketing authorization? How appropriate are the standard data requirements and evaluation criteria to the developing world? How is the scientific opinion going to be used? How does it relate to the WHO qualification process? Why has the first AMC been applied to a vaccine that is already licensed? Building regulatory capacity in the developing world to enable licensure Overcoming the hurdles in the regulatory process for dual pricing / dual markets Is there a good pathway for hybrid trials with dual intent? How will FDA and other agencies accommodate this?
11.55	Questions & discussion
12.00	Panel discussion How is innovation being fostered, qualified and delivered by government, NGOs and private sector for international public health needs, pandemic influenza and biodefense? On what basis are industry, biotechnology, and non-profit partnerships making decisions about how to fill their pipelines? How sure are they that they are investing in vaccines that government and NGOs want? If there is a gap between the development of push and pull products, how can it be closed through better signalling between all parties? Using the guiding principles of portfolio management throughout the value chain to prioritize product development How are the problems with technology transfer being addressed and what more needs to be done to improve the chances of success? How are NGOs and government undertaking technology scanning and decision making to prioritise areas of innovation? A new paradigm of strategic partnering to improve vaccine development productivity Business environment: Big pharma's focus on reducing R&D spend Disaggregating vaccine development - a shift in R&D models Strategic partnering examples throughout the development continuum Evolution of the CRO industry Assuring a collaborative relationship Panellists: Peter J. Hotez, MD, PhD, President, Sabin Vaccine Institute & Walter G. Ross Professor & Chair, Department of Microbiology, Immunology, & Tropical Medicine, The George Washington University Dr Guillermo Herrera, Director of Global Medical Affairs, Wyeth Tom Privette, PhD, Vice President, Strategic Partnering, Covance Frank M. Rapoport, Partner, McKenna Long & Aldridge LLP
12.50	Buffet lunch in the exhibition area
Followed by your choice of 3 highly interactive parallel sessions:
Focus session 1 Best practice safety and risk management for early through to late stage vaccine development
2.00	Chair’s introduction How are we assessing vaccine risks in clinical trials? What are the new challenges pre- and post-marketing for risk assessment and risk management? How does risk management change over time? What are the hot topics for pre-market and post-market safety studies? What is the new CBER Vaccine Safety Team and how does it function? Establishing appropriate risk management plans When is a vaccine risk evaluation and mitigation strategy needed? What is the current regulatory view of new and evolving safety issues facing vaccines? Dr Florence Houn, Deputy Director, Office of Vaccines Research & Review (OVRR), CBER, US Food & Drug Administration
2.25	Questions & discussion
2.30	Case study Building safety and risk management into product lifecycle Role of risk management in early clinical development strategy Safety & risk management at the transition from Phase II to III Risk management in post-marketing to end of lifecycle Dr Adrian Dana, Senior Director, Clinical Risk Management & Safety Surveillance, Merck Research Laboratories
2.55	Questions & discussion
3.00	Panel discussion Moderator: Jeffrey J. Stoddard, MD, Vice President, Medical & Scientific Affairs, Risk Management & Post-marketing Programs, Covance
3.40	Afternoon tea and close of the Washington Vaccine Forum 2008
OR \| Focus session 2 Innovations in dose sparing and delivery devices: To what extent are they inducing a broader and more protective immune response, as well as reducing cost and increasing manufacturing capacity
2.00	Chair’s introduction Update on intradermal vaccination to meet pressing public health needs in pandemic preparedness and disease control What does the 200+ year history of the ID route reveal about safety and efficacy? Recent experience with seasonal and avian influenza antigens by this dose-sparing route Potential needle-free and high-speed delivery methods for mass campaigns and pandemic preparedness Exciting future technologies to take advantage of skin as an organ of the immune system Dr Bruce G. Weniger, Chief, Vaccine Technology, Immunization Safety Office, Centers for Disease Control & Prevention
2.25	Questions & discussion
2.30	Case study Update on the safety, efficacy and benefit:risk of a non-standard delivery mechanism for vaccines - Vaxfectin™ as a novel adjuvant for DNA- and protein-based vaccines Vaxfectin™ as a dose-sparing adjuvant for a pandemic influenza DNA vaccine Protection against H5N1 challenge in mice and ferrets with a Vaxfectin™-formulated DNA vaccine Safety - toxicology of Vaxfectin™-formulated DNA vaccines Effect of route of administration (ID vs IM) of a Vaxfectin™-formulated measles DNA vaccine on long-term protection in a macaque challenge model Comparison of a needle-free ID or IM injection of Vaxfectin™-formulated DNA vaccine to electroporation of DNA vaccine Vaxfectin™ as dose-sparing adjuvant for protein-based influenza vaccines Alain Rolland, Pharm D, PhD, Senior Vice President, Product Development, Vical
2.55	Questions & discussion
3.00	Panel discussion How are innovations in formulation, dose reduction and delivery impacting capacity, distribution and sustainability of vaccines for global health? Progress with temperature stable, orally administered vaccines Progress with single dose vaccines To what extent will these innovations affect purchase decisions? Panellist: Dr Ronald W. Ellis, Senior Vice President & Chief Technical Officer, NasVax Inc, United States (a subsidiary of NasVax Ltd, Israel)
3.30	Afternoon tea and close of the Washington Vaccine Forum 2008
OR \| Breakout session Manufacturing vaccines on a global basis: Tackling quality, efficiency and economics
(Highly interactive workshop session for a maximum of 30 participants)
2.00	Moderator’s introduction How are new developments in formulation, dose reduction and delivery impacting capacity and distribution of vaccines for global health? Progress with temperature stable, orally administered vaccines Progress with single dose vaccines New developments for nasal and other routes of administration To what extent will these innovations affect purchase decisions? Jan Delaere, Director, Manufacturing Strategy, Flu Pandemic Vaccines, GlaxoSmithKline Biologicals
2.25	Questions & discussion
2.30	India as a manufacturing hub: How can we achieve consistent quality and compliance with the world’s regulatory authorities? Formulation of a quality strategy for the product under discussion. Due diligence exercise to: cGMP gap analysis between local regulatory requirements and global standards cGMP compliance ability analysis Infrastructure status and up-gradation needs Formation of formal intra or inter-organizational management structures & teams Extensive scientific / regulatory dialogues followed by implementation team’s creation Adoption of WHO pre-qualification guidelines wherever available or being developed Import / export permissions to be addressed Opportunity to access newer markets through such exercises Specific examples to be provided for 3 vaccines under global partnership Sai Prasad, Head, Business Development, Bharat Biotech Intl Ltd
2.55	Questions & discussion
3.00	Case study – title to be announced Speaker to be announced
3.25	Questions & discussion
3.30	Afternoon tea and close of the Washington Vaccine Forum 2008
	Gold Passes Would you like to attend sessions during both the Washington Vaccine Forum and the co-located Cell & Gene Therapy Forum? Email team@phacilitate.co.uk or call +44 (0)20 7839 6137 for more information on our Gold Passes.

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