Welcome To the Phacilitate Vaccine Forum Washington 2010

Agenda | Day 1 Printer friendly version - full agenda

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DAY 1 \| Monday January 25th 2010
7.30	Registration & buffet breakfast in the exhibition area
Morning plenary session How are we doing with pandemic planning? • Are we making the right decisions on vaccine strategy and funding to rapidly deal with outbreaks of new strains?
9.00	Chair's introduction WHO review of the spread and impact of pandemic H1N1 influenza to date Brief review of the epidemiology of the pandemic PAHO's response in the Region of the Americas Challenges and opportunities, including equity and access to vaccines Jon Kim Andrus, MD, Deputy Director, Pan American Health Organization (PAHO)
9.20	Questions & discussion
9.25	Australia as a retrospective case study: Dealing with the realities of pandemic H1N1 influenza How did it pan out with normal seasonal influenza about to hit? What was the epidemiology of the pandemic - which population groups were most susceptible? Was prior exposure a factor? What role did vaccines play? How have government and industry worked together to rapidly develop new products? Michael Greenberg, MD, MPH, Director of Clinical Development, Vaccines, CSL
9.45	Questions & discussion
9.50	Panel discussion Improving surveillance: How do we ensure rapid response strategy, infrastructure and technology are in place for tracking new infectious strains? How has the response to pandemic H1N1 influenza gone? How effective have the plans and preparations been in the face of a real pandemic threat? What lessons were learned from SARS and H5N1, and how have these translated into improved global surveillance systems? Could the Mexican situation have been detected earlier? Examining the linkage between surveillance, rapid response and vaccine manufacture Should capacity be expanded further? What have we learned from H1N1 and H5N1 about the potential for reassortment What should we be doing to pre-empt the next one? What models do DARPA use for their very aggressive identification of pathogens and for rapid vaccine development? Panellists: Melinda Wharton, MD MPH, Acting Director of National Centre for Immunization & Respiratory Diseases, Centers for Disease Control & Prevention Dr Michael V. Callahan, Program Manager, Rapid Vaccine Assessment, Defense Advanced Research Projects Agency (DARPA)
10.30	Keynote vaccine manufacturer’s perspective How responsive can manufacturers be to sudden demand without assurance of a market for an "emergency" product? How should a facility handle scheduling of annual and pandemic strains? Will there be a more modular approach to production capacity? How are vaccine manufacturers responding to the stability and ease of administration requirements of a vaccine stockpiling strategy? Nima Farzan, Vice President of US Marketing, Novartis Vaccines & Diagnostics Inc
10.50	Questions & discussion
10.55	Morning coffee in the exhibition area
What government funding mechanisms and procurement strategies are in place to accelerate vaccine development, and promote agile manufacturing infrastructure for future pandemic strains and emerging infectious diseases? What problems has the recent pandemic highlighted in terms of infrastructure and how are they being addressed through renewed funding, procurement and licensing strategies? What is best way to prepare for pandemic? Drugs versus vaccines or both What role will stockpiling versus pre-pandemic vaccine play? What have we learned from the H5N1 and H1N1 experiences? What new funding is being made available to stimulate agile manufacturing infrastructure to respond to changes in virus strain or new outbreaks of infectious disease? Is there room for both classic and novel manufacturing techniques? What new funding is being made available to drive R&D for biosecurity and emerging infectious diseases? What are the main areas of focus? What new products have been ordered?
11.35	BARDA/HHS Dr Robin Robinson, Director, Biomedical Advanced Research & Development Authority (BARDA), Office of the Assistant Secretary for Preparedness & Response (ASPR), US Department of Health & Human Services
11.55	Questions & discussion
12.00	NIAID/NIH Linda C. Lambert, PhD, Chief, Respiratory Diseases Branch, Division of Microbiology & Infectious Diseases, NIAID
12.20	Questions & discussion
12.25	Panel discussion
12.50	Buffet lunch in the exhibition area
OR	Lunch workshop sponsored by Preparing for the next pandemic: Exploring strategies to increase global pandemic influenza vaccine manufacturing capacity Speaker: Bill Helming, Vice President, Biodefense & Public Health Practice, PRTM Management Consultants LLC »Click here for more information
OR	Working Lunch (Very informal, optional discussion-based session for a maximum of 12 participants) From protocol to data lock - an operational perspective • A look at vaccine clinical development from a CRO, site, subject and recruitment point of view Moderator: E. B. McLindon, Chief Operations Officer, Accelovance
OR	Working Lunch (Very informal, optional discussion-based session for a maximum of 12 participants) Nasal administration as the preferred choice for vaccination - what would it take? Moderator: Hans Arwidsson, PhD, MBA, President & CEO, Eurocine Vaccines AB
Followed by your choice of 3 highly interactive parallel sessions:

Focus session 1 Clinical trial strategy and regulatory pathways for pandemic influenza vaccines
Please note: the exact content of this session will be adjusted depending on the situation at the time of the event.
2.00	Chair’s introduction Dr Hartmut Ehrlich, Vice President, Global R&D, Baxter BioScience
2.05	The epidemiologist’s perspective on the recent pandemic: Are there any clues to the timing of a new pandemic, and is it really possible to prepare for new strains in advance? How did the change of season affect the spread of the disease? What are the parallels, if any, between behaviour of H1N1 and 1918 Spanish flu? Which population segments have proved to be most resistant / susceptible? What does this indicate in terms of who should be vaccinated first? Assuming that the 2009/2010 influenza season will be bad, then statistically can we sit back for another 25 years? Melinda Wharton, MD MPH, Acting Director of National Centre for Immunization & Respiratory Diseases, Centers for Disease Control & Prevention
2.25	Questions & discussion
2.30	What has been licensed for pandemic influenza over the past few months? How do the regulatory pathways compare to those for H5N1 candidates? EMEA / FDA approaches: What are the scenarios for accelerating the approval of a new pandemic vaccine other than H5N1? Is there a pathway for accelerated approval based on post-licensure effectiveness? How do the regulatory pathways differ for pandemic and seasonal vaccines? In the absence of adequate animal models, what pre-clinical and clinical studies might be undertaken to convince the regulator that a new technology (eg DNA vaccine) could be used for pandemic? WHO recommendations for the Northern Hemisphere seasonal vaccine 2010-2011 - the consequences for manufacturers and regulators Can a trivalent vaccine be made quadrivalent? 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 (EMEA)
3.10	Questions & discussion
A comparison of the human data from pandemic influenza candidate vaccines available by January 2010 Use of adjuvants / ability to dose spare Need for 2 doses Data by specific age groups Safety / efficacy / effectiveness How do the different approaches compare? How might vaccine developers strategize to keep their clinical trials rolling by taking advantage of different seasons on a global basis?
3.15	Case study Dr Hartmut Ehrlich, Vice President, Global R&D, Baxter BioScience
3.35	Afternoon tea in the exhibition area
4.15	Case study Michael Greenberg, MD, MPH, Director of Clinical Development, Vaccines, CSL
4.35	Case study Bruce Innis, MD, Vice President & Director, Global Clinical R&D, Vaccines for Influenza, MMR, Varicella & Dengue, GlaxoSmithKline
4.55	Questions & discussion
5.00	Chair’s closing summary
5.05	Close of session followed by afternoon plenary session

OR \| Focus session 2 Optimizing your value proposition and positioning strategy for new vaccines • Case studies of recent launches
2.00	Chair's introduction Dr Ronald W. Ellis, Senior Vice President & Chief Technology Officer, NasVax Ltd, Israel
HPV vaccine positioning strategy: How is uptake and effectiveness in the field panning out? What data is coming from post-marketing surveillance?
2.10	Gardasil: Past, present & future Understanding the HPV disease burden Merck's clinical trials Young women, adult women and young men Post-marketing Second generation vaccine for HPV Gregg C. Sylvester, MD, MPH, Head of Adult & Adolescent Vaccines for Medical Affairs & Policy, Merck Vaccines & Infectious Diseases
2.30	Questions & discussion
2.35	Presentation and discussion A study of initial uptake of the HPV vaccine under Washington, DC's mandatory vaccine law How do payers and physicians make their product choice decisions? How do they assess value? What can industry learn? Eric Rosenthal, MD, MPH, FAAP, Clinical Assistant Professor of Medicine and of Health Policy, George Washington University Medical Center; Medical Director, Municipal & Regional Affairs, Child Health Advocacy Institute; Clinical Associate, Emergency Department, Children's National Medical Center Washington, DC Eric Faulkner, MPH, Senior Director, US Market Access and Reimbursement, RTI Health Solutions
3.10	Case study: Ixiaro Dr Clement Lewin, Head, Strategic Immunization Planning, Novartis Vaccines and Diagnostics
3.30	Questions & discussion
3.35	Afternoon tea in the exhibition area
4.15	Panel discussion What have been the unexpected outcomes from the introduction of new vaccines, and how might they influence positioning strategies as well as inform R&D paths to licensure for future products? Demonstrating ancillary impacts and benefits How to demonstrate the value of vaccines in antimicrobial resistance via epidemiological studies Cross protection potential Can you expect herd immunity from vaccines other than respiratory? The impact of vaccines on healthcare burden How is the concept of Patient Reported Outcomes being applied to vaccines – and with what effect? How might the evaluation of a new vaccine go beyond its direct impact especially when looking at vaccines for adults / elderly populations?
5.00	Chair’s closing summary
5.05	Close of session followed by afternoon plenary session

OR \| Workshop Vaccines for major public health needs: Analyzing the latest clinical results for nosocomial infections
(Highly interactive workshop session for a maximum of 30 participants)
2.00	Moderator's introduction Dr Jan ter Meulen, Executive Director, Vaccine Basic Research, Merck Research Laboratories
Case studies from those furthest advanced highlighting Translation from non-human to human trials Regulatory interaction and pathways
2.05	The pursuit of a S. aureus vaccine: A review of Merck's V710 program Highlighting the medical need for a S. aureus vaccine (against MSSA and MRSA) and specific patient targets under active discussion Emphasizing Merck's general thinking into the identification of a proper target for a vaccine and the rationale for the chosen target in its V710 program Sharing the encouraging prelinical data with V710, thereby justifying the rationale for moving forward into clinical development with V710 Summarizing the available clinical data for V710 from the Phase I program Providing the rationale for the chosen patient population for evaluation in the Phase II setting Nicholas A. Kartsonis, MD, Senior Director, Clinical Research - Infectious Diseases/Vaccines, Merck & Co, Inc
2.30	Questions & discussion
2.35	Development of a broadly protective vaccine against Staphylococcus aureus Novartis' strategy to develop the S. aureus vaccine Preclinical results obtained with the Novartis staphylococcal vaccine Moving forward: Clinical trials Fabio Bagnoli, PhD, Associate Project Leader, Novartis Vaccines and Diagnostics
3.00	Questions & discussion
3.05	ACAM-CDIFF™: An active vaccine against C. difficile infection (CDI) The evolving CDI landscape Inadequacy of current standard of care treatments Prevention as a key approach to disease management Justification for a vaccine against CDI Rationale for targeting toxins A & B Current status of clinical development Dr Ginamarie Foglia, Clinical Director, Sanofi Pasteur
3.30	Questions & discussion
3.35	Afternoon tea in the exhibition area
4.15	Case study Preventing the spread of Norovirus infection Impact of Norovirus in public health settings Development status of Norovirus vaccines Human challenge studies to evaluate vaccine effectiveness Dr Robert F. Bargatze, CSO & Executive Vice President, LigoCyte Pharmaceuticals
4.35	Questions & discussion
4.40	Panel discussion What evidence is there that vaccines and monoclonal / anti-infective antibodies might be used in combination, or in sequence, or competition with each other, to fight nosocomial infections?
5.00	Chair’s closing summary
5.05	Close of session followed by afternoon plenary session

Then \| Afternoon plenary session How will pandemic influenza change the technology, manufacturing and economic landscape of the vaccine industry?
Please note: the exact content of this session will be adjusted depending on the situation at the time of the event.
5.10	Panel discussion What impact will the substantial increase in influenza vaccine capacity have on the industry? How will the economics of the industry change with cell manufacturing techniques come on-stream? How will the price/volume relationship relative to manufacturing capacity evolve? If cell culture vaccine does not have a promotable advantage for sales in the face of higher costs, how do manufacturers justify it? Chair: Dr Ronald W. Ellis, Senior Vice President & Chief Technology Officer, NasVax Ltd, Israel Panellists: Dr W. James Jackson, Chief Scientific Officer, Emergent BioSolutions Inc Philip R. Dormitzer, MD, PhD, Senior Director, Senior Project Leader, Viral Vaccine Research, Novartis Vaccines and Diagnostics Professor Alexander von Gabain, Strategic Advisor to the Board, Intercell AG Eric Victory, Associate Director, Business Development, MedImmune
5.40	End of day 1 followed by a themed cocktail reception in the exhibition area

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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