What a few days! Were you there? Game-changing R&D, emerging infectious diseases, DNA vaccines, influenza vaccines, cancer vaccines…you name it, it was probably covered somewhere! We hope you enjoyed the World Vaccine Congress USA 2013 – held last week, 16-18 April 2013, at the Gaylord National Hotel and Convention Center, Washington DC – with so many top speakers giving fascinating talks, and lots of networking events to attend, it was certainly a busy three days but we hope you found it useful.

Did you miss the World Vaccine Congress USA this year? Below is a list of Vaccine Nation blogs posts that cover some of the topics covered in each of the days, to give you a flavour of the event – and re-inspire you if you did attend!

Day One – Opening Plenary Session - Global Immunization Strategies and Initiatives

Day One – Morning Session (Track A) - Immunization Strategies for the Developing World

Day One – Afternoon Session (Track B) - HIV Vaccines – Novel approaches, funding, and clinical studies

Day Two – Opening Plenary Session - Game-Changing R&D Breakthroughs

Day Two – Morning Session (Track B) - Influenza vaccine landscape and development

Day Two – Afternoon Session (Track A) - Vaccines against Neglected & Emerging Infectious Diseases

Day Two – Afternoon Session (Track B) - Influenza Vaccines – Microneedle Patches and Antigenic Sin

Day Three – Morning Session (Track B) – Biodefense Vaccines – Overview, stockpiling and regulation

Day Three – Afternoon Session (Track B) – Lifestyle Addiction and Allergy Vaccines – Cocaine, smoking, alcohol and allergies

ViE Awards

On Wednesday night, the winners of the 6th Annual ViE Awards were exclusively announced to attendees of the Gala Dinner. Such was the calibre of the award nominees, a ‘highly recommended’ category was also included. You can read the list of all the winners here.

Did you attend World Vaccine Congress USA 2013? What were your highlights of the event? You can leave a comment in the box below, or on LinkedIn group discussion.

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There are more opportunities around the world to get involved with key stakeholders to realize sustainable immunization and vaccine research programs – attend World Vaccine Congress Asia, 17-20 June 2013, Singapore; World Vaccine Congress Europe, 16-17 October 2013, Lille, France; and World Vaccine Congress USA 2014.

In Track B of the second session of Day Three at the World Vaccine Congress & Expo USA 2013, Prof Juan Asenjo, Director, Centre for Biochemical Engineering and Biotechnology, University of Chile introduced the session on lifestyle addiction and allergy vaccines. He introduced the first speaker, Dr Ronald Crystal, Chairman and professor of Genetic Medicine, Lead Researcher, Weill Cornell Medical College, New York. Dr Crystal spoke about a novel vaccine, dAd5GNE, that curbs cocaine addiction by preventing cocaine from reaching the brain in rats. He also spoke about an anti-nicotine vaccine, HexonAM1, that raised anti-nicotine antibody titres in mice and mediated the prevention of nicotine-induced hypolocomotor activity. He also spoke about passive gene therapy approaches to curbing nicotine addiction, including AAVantiNic where an adeno-associated virus  gene transfer vector codes for an anti-nicotine monoclonal antibody, NIC9D9. AAVantiNic was shown to shield the brain from systemic nicotine, and immunization blocks nicotine-induced hypolocomotion.

The chairman of the session, Prof Juan Asenjo, then spoke about a “Vaccine against alcoholism addiction”. He spoke about attempts to induce a mutation in ALDH to slow metabolism of acetaldehyde. He spoke about proof of concept trials in alcoholic mice.

To conclude the session, Dr Rainer Henning, CEO of Biomay, spoke about “Third generation recombinant allergy vaccines based on a novel peptide-carrier fusion protein platform”. He spoke about allergen-specific immunotherapy, and the problems and factors limiting the broad application of specific immunotherapy. He spoke about BM32, a 3rd generation grass pollen allergy vaccine, which contains 4 fusion proteins. He summarized early phase clinical studies, and gave a summary of the study CS-BM32-002 and outlined CS-BM32-003. He explained that vaccines have been constructed for most aeroallergens, and highlighted a shift to a new paradigm of the way allergies are treated.

Were you at World Vaccine Congress USA 2013? Do you have any comments about Day Three’s Addiction and Allergy Vaccine presentations? You can leave a comment in the box below, or on LinkedIn group discussion.

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The first session of Day Three, Track B, at the World Vaccine Congress & Expo USA 2013 was about biodefense vaccines. The chairman of the session, Dr David Walker, Executive Director, Center for Biodefense and Emerging Infectious Diseases, UTMB, introduced the first speaker of the morning – Dr Michael Kurilla, Director, Office of BioDefense Research Affairs, Associate Director for BioDefense Product Development, DMID, NIAID, NIH, DHHS. Dr Kurilla gave a presentation on “Biodefense vaccines – overview”, where he gave an overview of biomedical product development and product development paths. He listed some Phase I and II clinical trials involving small pox, anthrax, plague and tularaemia viruses, and discussed the desirable attributes of biodefense vaccines – including long shelf life, rapid onset of immunity, post-exposure prophylaxis and/or therapeutic capability, minimal necessary training, and surge capacity for production. He discussed some current funding opportunities of interest, and next generation concepts including stabilization excipients and novel formulations such as encapsulation methodology (where two vaccinations could be given at the same time, with the encapsulation giving a boost in a few weeks time).

Next to speak on biodefense vaccines was Dr Robert Brey, Chief Scientific Officer, Soligenix. He gave a presentation entitled “Stockpiling biodefense vaccines – technology innovation”. Here, he spoke about stockpiling vaccines and biologics for long term storage, and the sensitivity of vaccines to thermoinstability. He discussed the temperature sensitivity of marketed vaccines, and the cold chain management cycle. He spoke about addressing vaccine instability, including with lyophilisation. He gave a case study of Soligenix’s RiVax ricin vaccine – a vaccine based on the A chain of ricin.

To conclude the session, Dr Luciano Borio, Assistant Commissioner for Counterterrorism Policy’ Director, Office of Counterterrorism & Emerging Threats, Office of the Chief Scientist, Office of the Commissioner, FDA, gave a talk on the “Regulatory landscape for biodefense vaccines”.

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Is it ethical to test the anthrax vaccine in children?

In the final session of Day Two at the World Vaccine Congress & Expo USA 2013, Dr James Norman, Post-doctoral Researcher at the Georgia Institute of Technology, spoke about “A Microneedle Patch for Self-Administration”. Here, he described the delivery of a vaccine via a microneedle patch, applied through either thumb pressure or a “snapplicator”. He provided data to show that the microneedle patch could increase HAI titre and lower lung viral titre in a small study in mice. He discussed the advantages of a microneedle patch, which included improved coverage and reduced cost for both seasonal and pandemic influenza. He showed that there was a learning curve with thumb application of the microneedles, but there was drastically increased useability with an applicator dubbed a “snapplicator”. He also reported increased acceptability of the snapplicator versus simple thumb application.

To conclude the day’s talks on influenza vaccines (see more from the Day Two morning influenza sessions here), Dr Joshy Jacob, Associate Professor, Emory University, gave a presentation entitled “The wages of antigenic sin”. Here he described ‘antigenic sin’ as antibodies produced against an old strain in response to a novel strain, at the expense of producing antibodies against the novel strain. He noted that antigenic sin was not limited to influenza but was also seen in dengue and malaria. He spoke about overcoming antigenic sin in animals, using adjuvants such as pertussis toxin or CpG.

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Dr Navid Khan, Associate Director, North America Vaccines Segment, EMD Millipore, introduced the afternoon session of Day Two at World Vaccine Congress & Expo USA 2013. The session was on Neglected & Emerging Infectious Diseases, and Dr Alan D.T. Barrett, Director, Sealy Center for Vaccine Development at UTMB, was the first to speak on “Dengue vaccines: A landscape overview”. Dr Barrett gave an overview of dengue as a flavivirus, and outlined the 4 dengue serotypes. He described the complexity of developing a dengue vaccine, highlighting some issues such as the need to develop four immunogens, the poorly understood mechanism of protective immunity, and the interference between vaccine components. He spoke about antibody-dependent enhancement, and described the WHO activities and current efforts for dengue vaccine research. He outlined dengue vaccine candidates in preclinical development and clinical development, such as phase I-III tetravalent vaccines that include yellow-fever backbones, DENV-4 backbones and DENV-2 backbones. In terms of yellow-fever backbones, he discussed ChimeriVax and the Phase IIb of CYD-TDV. He also spoke about the NIH-developed TV003 that uses a DENV-4 backbone, Inviragen’s DENV-2 backbone vaccine candidate, GSK’s DPIV vaccine, and Merck’s envelope protein dengue vaccine candidate. Dr Barrett concluded by giving some estimates about the future of dengue vaccine development.

Dr Maria Elena Bottazzi, Associate Dean of the NSTM, Professor of Paediatrics, Baylor College of Medicine, gave a talk on “Anti-poverty vaccines”. She spoke about the neglected tropical diseases and their apparent link to povery. She discussed product development partnerships for vaccine development, and discussed the product development pipelines for vaccines against human hookworm, schistosomiasis, Chagas disease, leishmaniasis, and SARS. With regard to hookworm, she discussed anti-enzyme antibodies and developing GST-1 / APR-1 vaccines.

Dr Diana Valencia, CEO, Latam Clinical Trials, gave a presentation on “Testing NID vaccines”, and Dagna Constenla, Director, Economics & Financing, IVAC, concluded the session by speaking about “Vaccines against neglected diseases”.

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Dr Wayne Pisano, CEO of VaxInnate, opened the morning session of the World Vaccine Congress & Expo USA 2013. He introduced the first speaker of the session on influenza vaccines, Dr Robin Huebner, BARDA, who presented on “Flu vaccine landscape overview”. Dr Huebner spoke about he influenza vaccine landscape today and of the future, and gave a history of the influenza vaccine and how influenza vaccines looked in the US several years ago in 2004. He then spoke about the progress that has been made since 2004, including the move from egg-based production to cell-based, recombinant-based, and finally the next step of universal vaccine technology. He spoke about BARDA and their egg-based technology investments and preparedness contracts. He also spoke about contracts for cell-based influenza vaccines (e.g. Novartis’ cell-based vaccine facility) and contracts for recombinant-based & molecular technology vaccines (e.g. Protein Sciences’ Flublok). He spoke about more recombinant vaccines in the pipeline, and also about antigen sparing technology. He concluded by discussing what we want from vaccines in the future, including a licensed universal influenza vaccine, vaccine production year round, vaccines to cover pandemics, and perhaps the move to one flu vaccine that is effective for 10 years or even for a lifetime.

Dr Louis F. Fries, VP, Clinical & Medical Affairs at Novavax, gave a talk entitled “Clinical update on pandemic and seasonal influenza vaccine using Sf9-derived virus-like particles”. Dr Fries discussed the development of a VLP influenza vaccine manufactured in the Sf9/baculovirus system, and spoke about the Sf9/baculovirus manufacturing platform and the ISCOMATRIX adjuvant. Dr Robert Lins, Senior Clinical Adviser, Clinical Research, SGS Belgium NV, gave a presentation on “Set up of Phase I unit for viral challenge testing in vaccine development”.

Dr Eirikur Saeland, Senior Scientist at Crucell, spoke about “Universal protection against influenza: from antibodies to vaccines”. He spoke about the desire for a vaccine that ideally induces broadly protective antibodies, but cited that the influenza virus is very unpredictable. He described several antibodies that protected against influenza – CR6261 and CR8020 that recognise A strains, CR8071 and CR8033 that recognise B strains, and CR9114 that recognises both A and B strains. He discussed studies that showed these antibodies to be protective against a variety of influenza strains. He explained that we now need to use identified epitopes to protect against lots of different strains of influenza. He concluded by discussing new vaccine design possibilities.

Were you at World Vaccine Congress USA 2013? Do you have any comments about Day Two’s Influenza Vaccine presentations? You can leave a comment in the box below, or on LinkedIn group discussion.

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Dr Wayne Pisano, CEO of VaxInnate, opened the Plenary Sessions of Day Two of the World Vaccine Congress and Expo USA 2013, and introduced the first speaker, Dr Gregory Poland, Director at the Mayo Clinic, who delivered a presentation entitled “Vaccinomics: social and science systems in transition”. Dr Poland introduced the concept of moving from a blockbuster model to a personalized model of vaccination. He asked whether it makes sense in the 21^st century for us to give the same drug and dose to everyone – the answer was no, so why do we do it with vaccines? He explained that we are entering a 2^nd golden age of vaccinology – a new era of individualized vaccinology – and that we can move towards individualized vaccinology by looking at the immune response network theory and proposing a mathematical model for predictive immune response. He explained the benefits of vaccinomics, and explained the need to move towards understanding host genetics to understand the drivers of immune response and then apply this to the development of new vaccines. In the era of personalized “predictive vaccinology”, we might abandon the one size and dose fits all vaccine approach, and predict whether to give a vaccine based on likelihood of response. If we can understand how immune responses are generated across age, gender, race and medical condition, we can deliver a directed, rather than empiric, approach. If we can predict aberrant response – that is, adverse effects or no response – then we might not expose someone to the risk and cost of a vaccine if there’s no hope of a response. This can lead to ‘Vaccinology 2.0’.

Next to the stage was Dr Jay A. Berzofsky, Branch Chief, Vaccine Branch, NCI, NIH, who gave a presentation on “Vaccine strategies for the 21^st Century for HIV and Cancer: Advances in basic principles and translation to human clinical trials”. He focussed on T-cell immune responses and how to optimise vaccine-induced T-cell immunity to improve quantity and quality (avidity, longevity, function) of immune responses. The four main areas he spoke about were: 1) Optimisation of vaccine-induced T-cell immunity; 2) Steering the immune response using IL-15 to mediate CD4+ T-cell cell help for CD8+ CTLs – and thus the possibility of using an IL-15 vaccine (and also TLR ligands) as a substitute for CD4+ help in humans; 3) Mucosal immunity using oral coated nanoparticles that can mimic the protection conferred by an intrarectal vaccine but not by the rectal delivery route; 4) Overcoming negative regulation using anti-TGF-β / GC1008, and the role of type 1 and 2 NKT cells in promoting and suppressing tumour immunity.

Marie Mazur, CSL Biotherapies, spoke about “Fostering access to innovation: commercial realities”. She spoke about the history of bioCSL and the 3 businesses of CSL, and discussed the work of bioCSL in the influenza vaccine market and how bioCSL fosters access to innovation. She explained the link between demand, supply and price of influenza vaccines, and outlined the realities of providing access to innovation in a commercial organisation.

To conclude the morning Opening Plenary session, Dr Rino Rappuoli, Head of R&D at Novartis Vaccines presented on “Vaccines for the future: Designing the next generation of vaccines for global public health”. Dr Rappuoli discussed the history of recombinant DNA, glycoconjugation and reverse vaccinology over the last 30 years. He spoke about next generation technologies – namely, adjuvants (including MF59), structural vaccinology and structure-based design (including engineering stable F protein for RSV vaccine), and SAM (self-amplifying mRNA) vaccines for RSV and HIV. He debated about whether it was time to retire the use of eggs in the manufacture of vaccines, citing that a high incidence of flu correlates with vaccine-strain mismatch, and that eggs are a major cause of mismatch as the passage in eggs introduces mutations. Therefore he suggested that we should look more towards producing vaccines in cells. He also spoke about the shipping of information over the internet rather than transporting physical viruses to produce vaccines around the world.

Were you at World Vaccine Congress USA 2013? Do you have any comments about the morning’s R&D presentations? You can leave a comment in the box below, on Twitter with the hashtag #wvcusa, or on LinkedIn group discussion.

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The afternoon session of Day One at the World Vaccine Congress USA 2013 got underway, with Dr Rick King, VP Vaccine Design at IAVI, chairing the session. He spoke about the hope and excitement surrounding broadly neutralizing antibodies, and introduced the first speaker for the session on HIV vaccines – Mitchell Warren, Executive Director at AVAC, who spoke about ‘creating sustained funding for HIV vaccine development’. In this presentation, Mr Warren spoke about the role of AVAC as an advocacy organisation, and introduced the concept of an AIDS-free generation – something which President Barack Obama had once stated as being within our reach. He spoke about the importance of ‘minding our language’ when discussing phrases like ‘end of epidemic’, ‘AIDS-free generation’, and ‘cure’. He gave an overview of all the HIV vaccine clinical trial milestones, including the results of AIDSVax in 2003, Merck Ad5 in 2007, and the hope conferred by the results of the 2009 RV144 trial in Thailand that showed benefit. He spoke about the hopes in 2006 – which included RV144, Merck Ad5, and PAVE 100 – and compared these to the realities in 2013 to show that the current vaccine landscape is now very different. He discussed the role of vaccination as part of a larger HIV prevention landscape that includes prophylaxis, microbicides, vaginal rings with antiretrovirals, and long-acting injectables. He spoke about HIV vaccine funding allocations from 2000-2011, and gave a list of the top HIV vaccine funders. He then went on to discuss the future of HIV vaccines, a list that includes the P5 (Pox-Protein Public-Private Partnerships), replicating vectors, translating Nab discoveries into vaccine candidates, and passive immunization. He discussed the preventive HIV vaccine clinical trial pipeline and the wide variety of pipeline approaches.

Dr Susan Barnett, Senior Project Leader, Senior Director, Vaccine Research at Novartis Vaccines & Diagnostics, spoke about a ‘Novel approach to HIV vaccine design’. She discussed two main topics – where are we now with HIV vaccines?; and where are we going in the future? She reiterated the hint of success with RV144 Thai trial that showed 31% efficacy – although the clinical efficacy had waned over time from 60%. She spoke about the P5 partnership established in 2010 to build on the RV144 results, with the aim to advance and license HIV pox-protein vaccine candidates, and she discussed the role of Novartis in the P5. She discussed the development of a vaccine using TV1 and 1086 gp120 monomers, and discussed the use of adjuvant formulations such as MF59, small molecule immune potentiators (SMIP), and TLR7 alum. She discussed a novel priming strategy using the newly-developed synthetic self-amplifying mRNA (SAM) vaccine platform to provide a non-viral vaccine delivery system. She spoke about SAM vaccines and how they work, and gave data on the use of an HIV-SAM vaccine expressing HIV-1 gp140.

Next to the stage was Dr Klaus Früh, Director, TomegaVax, Vaccine & Gene Therapy Institute, Oregon Health & Science University, who spoke about ‘Effector memory T cell-inducing persistent vaccine vectors’. Dr Früh explained how RhCMV/SIV vaccination can result in stringent, early control of highly pathogenic SIV challenge in monkeys, and continued to discuss the unique characteristics in CMV vector-mediated protection. What is so special about CMV vectors? Dr Früh explained that CMV vectors elicit high frequency effector memory T cells (that likely play the key role in controlling SIV), the unique ability of CMV to super-infect (and thus can use the vector in animals who already have SIV, and CMV can be used sequentially), the unusually and programmable T-cell targeting (the T cell response to CMV-vectored antigens is unusually broad), and the ability to maintain wild type-like persistent immunogenicity even when highly attenuated (and thus can develop safety-enhanced vectors as CMV causes many congenital defects and health issues in immunocompromised individuals).

To conclude the session on HIV vaccines, Dr Harriet Robinson, CSO at GeoVax, spoke about ‘DNA/MVA HIV vaccine, preclinical and clinical studies’. She discussed the results of a DNA prime, modified vaccinia Ankara (MVA) boost vaccine used in a serial challenge, rhesus macaque study. She continued to discuss the clinical trials with GeoVax DDMM and DgDgMM vaccines, and discussed results with the HTVN 205 DDMM regimen. Dr Robinson gave a schematic of the 2^nd generation GeoVax DNA/MVA vaccine, which comprises DNA co-expressing GM-CSF and VLP (virus-like particles), and gave reasons for the use of GM-CSF in the vaccine.

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The second morning session of Day One at the World Vaccine Congress USA 2013 started with Dr John Boslego, Global Program Leader, Vaccine Development at PATH, delivering a talk entitled ‘Driving the development of much needed vaccines for the developing world’. He spoke about the work of PATH, and introduced the 3 pillars of PATH – namely 1) Advancing technologies, 2) Strengthening systems, 3) Encouraging healthy behaviours. He showed a map of deaths from infections and parasitic diseases and compared this to a map of R&D – the global distribution of R&D seemed to be opposite to the distribution of infectious disease. He spoke about PATH’s vaccine development portfolio, the role of product-development portfolios, and how PATH bring technology and resources to collaboration. He gave a remarkable case study of the introduction of meningitis group A conjugate vaccine MenAfriVac into the meningitis belt. He spoke about PATH’s work meeting with public health authorities in Africa, approaching multinational vaccine companies, working with the Serum Institute of India, through to the vaccine licensure and introduction highlights of MenAfriVac. Since the introduction of this remarkable and successful intervention, there has not been one case of men A in a vaccinee in the men A in 2011, 2012 and 2013.

Dr Thomas P. Monath, Adjunct Professor at the Harvard School of Public Health, talked about ‘New vaccines needed for pathogens infecting animals and humans: One Health’. He spoke about the impact of zoonotic diseases, highlighting the fact that they account for 75% of emerging diseases. Dr Monath explained that about 1/3 to ½ public health emergencies are zoonoses, and used SARS, Ebola and Nipah viruses as diseases that all have zoonotic cycles. He also spoke about the new coronavirus – H7N9. Much of the rest of his presentation focussed on how to prevent disease in both animals and humans, and Dr Monath highlighted some key approaches to achieving this. He gave examples of vaccinating domesticated animals to prevent disease in humans and domestic animals, and vaccinating wild animals to prevent disease in humans and domestic animals. It seems that co-ordination across the human and animal health sectors in biopharma is essential.

George Adams, Vaccine Program Manager, Asia India Japan Market Manager at EMD Millipore, gave a presentation on ‘Providing global access to vaccines in a key effort’. He highlighted that this was the decade of vaccines, and that in 2012 there were 1700 vaccines in development and 700 viral vaccines in development. He spoke about the work of Merck KGaA and how EMD Millipore fits in, and also about employing EMD Millipore technology in a collaborative fashion.

Following on from this, and concluding the morning session, Lois Privor Dumm, Director, Alliances & Information at IVAC, spoke about ‘Disease prevention in low and middle income countries: The role of vaccines’. She spoke about Millenium Development Goals and the need to prevent 5.6 million childhood deaths. She spoke about the impact of Prevnar on admissions of children under 5 for invasive pneumococcal disease in Kilifi, Kenya, along with the introduction of the pentavalent vaccine on invasive Hib, again in Kilifi. She spoke about the work with GAVI to make sure vaccines reach the places they need to reach, and also the benefits of vaccines which include increased lifetime productivity, education, and positive impacts on families. She spoke about the challenges and opportunities in vaccination, including cold chain strategies – highlighting that equipment is often neglected in the plan. Accountability is also often overlooked, but it is a must-have that countries need to take accountability. There is also a need to build public confidence and trust, and we can’t forget to communicate the impact and benefits of vaccines. If industry is willing to supply, donors and countries willing to pay, and countries willing and able to introduce vaccines, then diseases can be prevented and lives can be saved.

Are you at the conference? Do you have any comments about the morning’s Immunization Strategies presentations? You can leave a comment in the box below, on Twitter with the hashtag #wvcusa, or on our LinkedIn group.

>>Read more>> Day One – Opening Plenary Session – Immunization Strategies for the Developing World

Day One of the World Vaccine Congress USA 2013 got underway with an introductory speech from Neil Darkes, General Manager of the Life Sciences division at Terrapinn. Neil introduced Dr George Siber, Executive Chairman of Genocea, who welcomed us all to the 13^th vaccine congress, and gave us some food for thought by asking the question: which 3 interventions have saved the most lives? The first is clean water, the second is adequate nutrition, and the third is the reason why we have all congregated today – vaccines.

Dr Siber’s opening remarks were followed by Aurelia Nguyen’s presentation on ‘Investing in immunization through the GAVI Alliance: the evidence base’. Aurelia Nguyen is the Director of Policy & Market Shaping at the GAVI Alliance. Her presentation focused on the work of the GAVI Alliance and the importance building of strong partnerships between the public and private sector to widen the portfolio of vaccines, meet vaccine demand and minimize costs. Aurelia Nguyen highlighted the GAVI Alliance’s three market shaping goals – that is, 1) Ensuring sufficient supply of vaccines, 2) Minimising costs, and 3) Ensuring quality and innovation. She discussed levels of vaccine supplies between 2001 and 2012, and also the price evolution of vaccines. She explained the importance of increased competition reducing vaccine prices, and informed us about tiered pricing, giving some examples of the pricing differences between GAVI-eligible countries and the US market. She also spoke about the importance of Advanced Market Commitments for pneumococcal vaccines and how these can help accelerate the manufacture and delivery of vaccines. In the Question & Answer session, topics included Advanced Market Commitments for other vaccines, bridging the gap between education, social mobilization and vaccination, and whether reduced price would reduce quality.

Following on from Aurelia Nguyen’s presentation, Kim Bush, Director of Life Sciences Partnerships, Global Health Program at the Bill and Melinda Gates Foundation, delivered a talk entitled ‘Investing in Global Health’. His talk covered the history and work of the Gates Foundation, highlighting some figures regarding the Foundation’s investments in global health. He provided a remarkable graph that showed the decline of mortality in the under 5s from 20 million in 1960 to 6.9 million in 2011. Great progress has been made, he said, but more still needs to be done. Thus he continued to highlight the priority diseases and conditions in health, specifying that the Foundation’s number 1 global health priority is creating and delivering vaccines for infectious diseases. The Gates Foundation will continue to work closely with expanding donor bases and partnerships. He highlighted the fact that developing countries bear 90% of infectious disease burden, but only 10% of global research and development is geared towards these diseases. Only 3 countries have wild-type polio, but the Gates Foundation hopes that the disease will be eradicated within 8-10 years. He highlighted the importance of industry engagement and successful collaboration models to achieve global health success – and as such a focus of the Foundation is to get partners to invest in global health.

Dr Olivier Raynaud, Senior Director, Head of Healthcare Initiatives & Healthcare at the World Economic Forum, delivered a presentation on ‘Immunization today: a global public health perspective’. He told us about he role of the World Economic Forum in vaccines, stating that the aim of the organisation was to contribute to health and improve the state of the world. To achieve this, the World Economic Forum look at four key factors:

1) Health as an economic issue, and making health make economic sense

2) Collaborative solution and action is critical

3) Engaging with the private sector in global health

4) Involving other [non-healthcare orientated] industries to contribute to health

The motto of the World Economic Forum is entrepreneurship in common public interest, and Dr Raynaud highlights to us importance of data and the aggregation of information. Data, says Dr Raynaud, has no value if it isn’t shared. If you wondered what the World Economic Forum has to do with vaccination, the Forum’s goal is to ensure access to healthy and productive lives, and quality and affordable care.

Next to the stage was Dr Jesse Goodman, Chief Scientist at the Food and Drug Administration (FDA). Dr Goodman delivered a talk entitled ‘Moving R&D into the future’, and spoke about vaccine research and development for the 21^stCentury. The science is getting hard, says Dr Goodman, but the opportunity is getting great. Dr Goodman explained to us that the common approach is investigator/sponsor driven, where R&D leads to a plan for use, which leads to purchase and therefore demand. He highlights, however, the importance of a changed demand-driven approach. Demand should lead to a plan for use, which in turn leads to R&D and then purchase. This approach is a very different paradigm, with developers and advocates needing to ask the tough questions upfront of whether the vaccine is a high priority, what needs are required to be met, and whether input from organizations has been sought. These questions need to be asked now, not several years and millions of dollars down the line.  Dr Goodman also highlighted the need to build a bigger pre-competitive space for vaccines. He signaled several opportunities for collaboration, including pre-clinical, product manufacturing, clinical trial design, surveillance, and social and behavioural factors in provider and consumer decisions. He wrapped up his presentation by declaring that there are new ways forward for R&D, but we can make this a “decade of vaccines”. Only together we can do this, he said, but we can. Questions from the audience included what steps are we taking regarding H7N9 in China, why the FDA are not pushing more for universal influenza vaccines, and whether Phase III trials can be eliminated.

Dr Guru Madhavan, Senior Program Officer, Institute of Medicine, National Academy of Sciences, concluded the Opening Plenary session with a talk on ‘SMART Vaccines: A decision-support tool for prioritizing new vaccines’. He explained that SMART Vaccines was an innovative product of the Institute of Medicine, and was a decision-support tool but does not make decisions itself. Users are offered a choice of up to 29 attributes drawn from broad categories including health burden considerations, economic considerations, demographic considerations, public concerns, scientific and business considerations, programmatic considerations, and policy considerations. SMART Vaccines integrates computed attributes with qualitative attributes entered by the user to provide a value score that compares one vaccine opportunity against one or more other candidates. SMART Vaccines is expected to be used for facilitating discussions about attributes and values among diverse users, helping them to converge upon mutually beneficial priorities and collaborations. You can read more about SMART vaccines here > Dr Madhavan highlighted three expected benefits of SMART vaccines:

1. Increased transparency

2. Discussion facilitation

3. Decision-making tool

Dr Madhavan concluded by asking for feedback on the Phase II of SMART Vaccines.

Are you at the conference? Do you have any comments about the morning’s Opening Plenary presentations? You can leave a comment in the box below, on Twitter with the hashtag #wvcusa, or on our LinkedIn group.

>>Read more>> Day One – Morning Session – Immunization Strategies for the Developing World