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SABIN VACCINE INSTITUTE 20th Anniversary Scientific Symposium Washington, DC April 25, 2014 Contents Opening by the Symposium Chair Welcome Remarks The Sabin Vaccine Institute: Twenty Years of Advancing Public Health Solutions The Evolution of Global Health and Vaccination 18 Paradigm Shift: From Dependency to Country Ownership 29 Evolving Health Technologies: The Next 20 Years 41 Panel Discussion: A Vision for the Future 55 Special Message 67 Chairman's Message and Thank You 70 Ubiqus/Nation-Wide Reporting & Convention Coverage 22 Cortlandt Street – Suite 802- New York, NY 10007 Phone: 212-346-6666  800-221-7242  FAX 888-412-3655 [START CD1 Track 1] Opening by the Symposium Chair DR PETER HOTEZ: If you would now please take your seats So we have an extraordinary lineup this afternoon, both as speakers and panelists, but actually the audience is equally amazing and distinguished So this is really a remarkable room, and I hope we get some pictures this afternoon So, welcome to our Sabin Vaccine Institute 20th Anniversary Scientific Symposium I'm Peter Hotez, the president of the Sabin Vaccine Institute I'd like to especially thank for this afternoon the Pan-American Health Organization of the WHO I think it's particular fitting that Sabin is having its 20th anniversary event here at PAHO because we've been working together for so long, and I clearly attribute a lot of the successes of the Sabin Vaccine Institute to our very close relationship to PAHO which I can say has been one of the very satisfying scientific relationships and personal relationships of my life I also want to recognize a special guest who I did not think was going to be here She still here? She'll be right back, okay So when she comes back then we'll recognize her So, we're thrilled to celebrate the legacy of Dr Sabin and the long history of progress in the field of global health alongside of an impressive list of leaders, from the WHO and PAHO, of course, and GAVI and UNICEF and the Bill and Melinda Gates Foundation, Harvard University, the National Institute of Allergy and Infectious Diseases, the NIH, the pharmaceutical industry and other important organizations And it'll be an exciting discussion today about best practices and preventing, treating, controlling and eliminating vaccine preventable diseases, neglected tropical diseases as well as prospects for the future The Sabin Vaccine Institute was founded to honor and continue Dr Albert Sabin's personal mission to reduce poverty and human suffering through public health initiates Dr Sabin had a particular passion for increasing access to preventative medicines to insure the next generation will be healthy and prosperous And today Sabin continues to tackle this mission through its programs and initiatives SABIN VACCINE INSTITUTE 20th Anniversary Scientific Symposium April 25, 2014 And now she's back, I just wanted to briefly recognize Carol Ruth Shepherd Carol Ruth, raise your hand please The wife of H.R Shepherd, our founding chairman of the board It's thrilling to be able to welcome her here Dr Ciro de Quadros, from whom you'll hear shortly, leads our vaccine advocacy and education tea which works with partners around the world to increase access to and promote awareness of underutilized vaccines We also, the key program for the Sabin Institute is also the global network for neglected tropical diseases that works to raise the awareness, funding and political will needed to control and eliminate neglected topical diseases And I have the honor to lead Sabin's product development partnership, known as a PDP, which now through association with Baylor College of Medicine and Texas Children's Hospital, is spearheading the development of safe and cost-effective vaccines for diseases that almost exclusively impact the world's poorest citizens But as I was telling some of the guests this afternoon, we in association with the Sabin PDP, we've also created a new national School of Tropical Medicine to particularly take on neglected tropical diseases in the mezo-American region and Latin America One of the real unexpected findings that we found is wide-spread neglected tropical diseases along the gulf coast in Texas, and not even ones that are imported but actually transmitted among the extreme poor, now that we have 1.65 million families in the United States that live on less than $2 a day Many people are surprised to hear that So, we've discovered a different part of America that not many people hear about Now, from improved access to vaccines and medicines to innovative new products, the global health landscape has changed dramatically in the past 20 years So, we'll begin this afternoon by hearing about how far we have come during that time From there, some of our distinguished speakers and panelists will examine prospects for the future, what the next 20 years look like for product development and access to vaccines in medicine, how will private and public partnerships play a role in advancing public health, and what does the outlook for meeting ambitious treatment and control and elimination objectives for various diseases Our exciting lineup is a diverse mix of experts that are uniquely positioned to lead this conversation So I think you're really going to enjoy this afternoon And then we'll have a reception to follow SABIN VACCINE INSTITUTE 20th Anniversary Scientific Symposium April 25, 2014 So, it's my pleasure now to introduce, I guess she's not so new anymore but I think of her as new The PAHO director, the director of the Pan American Health Organization, Dr Carissa Etienne, who will offer some remarks to set the stage for this exciting afternoon She serves as the director of the Pan American Health Organization following a very distinguished career in medicine She brings important insights to today's program, so please let's give a warm welcome for Dr Etienne, and to thank her again for inviting us into her house for this symposium Welcome Remarks DR CARISSA ETIENNE: Thank you, and good afternoon Really, it is a great pleasure for me to welcome all of you here today for this important symposium I am honored to have with us such a distinguished group at our PAHO home Really a group of luminaries, the who's-who in immunization We are very, very grateful that Sabin has asked us to host this, and that you have chosen this venue to discuss a subject that I'm sure you know is very dear to our heart and to our member states Today, you will be examining lessons learned from experiences in immunizations from around the world The region of the Americas has one of the world's most successful records in this field The Americas has espoused a culture of vaccination and has become a world leader in disease eradication and elimination We were the first region to eradicate small pox and polio And we are in the process of certifying the elimination of measles and rubella We have also led the way towards equitable introduction of new vaccines By much of this year, 17 countries and territories of the Americas have added the rotavirus vaccine to their vaccination schedules Twentyeight have the pneumococcal vaccine, and 20 have the human papilloma virus vaccine Today, more than eight - - in the Americas live in countries with vaccines against pneumococcal infection, rotavirus and HPV in their regular schedules Obviously we owe this success to the hard work of immunization advocates like many of you who are gathered in this room, including our own Ciro de Quadros who pioneered our region's expanded program on immunization Yes, I know Ciro works with Sabin now, but we think Ciro belongs to PAHO But maybe more correctly Ciro belongs to the Americas and to the world Today, immunization is SABIN VACCINE INSTITUTE 20th Anniversary Scientific Symposium April 25, 2014 considered a public good throughout our region Not only governments, but also large sectors of society support immunization In most of our member states, it is protected by legislation This broad support has been translated into commitments that enable countries to provide quality vaccines free of charge to their populations A major difference between the region of the Americas and other regions is that Latin America and the Caribbean, more than 95% of vaccines are purchased with national funds Since 1979, PAHO has supported these efforts through the revolving drug fund for vaccines which procures quality vaccines at the lowest price for all PAHO member states The revolving fund was the brain child of Ciro de Quadros, who did everything possible to make sure that his idea would become a reality More than 30 years later, the revolving fund remains critical to the sustainability of our regions immunization programs Indeed, our member states have reconfirmed the fund's principle of solidarity, Pan-Americanism, equity, quality and transparency and have expressly called on the PAHO secretariat to continue to administer the fund just as it has been for the past three decades I also would like to mention just a couple of other components of PAHO's technology cooperation in immunization, because it is an important part of our region's experience in immunization A story that I think must be told and repeated and recorded for global consumption One of those is the ProVac initiation, which builds country capacity for using cost-effectiveness analysis in decision-making regarding the introduction of new vaccines Another is our work to strengthen regulatory capacity of our member states In addition, PAHO has also been working with member states to promote the use of electronic vaccination records Some countries have had these types of records for years, while others are well into the development and implementation stage Member states have made a commitment to share their experiences and to work together, which means that we project the use of digital vaccination records being spread throughout the region in the near future, promoting what we think is the use of quality data for decision-making at all levels In spite of all of our achievements in immunization, it is true that half of more than 15,000 municipalities in Latin SABIN VACCINE INSTITUTE 20th Anniversary Scientific Symposium April 25, 2014 America and the Caribbean have vaccination coverage rates that are under 95% I'm sure this would be a big achievement for many regions, but for the regions of the Americas, we recognize this is a continuing challenge To address this, each of our member states has developed a plan of action to achieve or maintain municipal vaccination coverage at 95% or higher, and to strengthen epidemiological surveillance In this effort, technical support from the Canadian International Development Agency, CIDA, and the US Centers for Disease Control and Prevention, CDC, have been key In addition to this tangible support for immunization, I cannot overstress the importance of continued work to strengthen health systems and advance towards universal health coverage as a vehicle for increasing immunization coverage in an equitable manner Indeed, the universal health coverage movement can learn from the successes and achievements in the immunization program Next week, our region will celebrate its 12th annual Vaccination Week in the Americas Since its inception in 2003, Vaccination Week has grown up to become the largest international health initiative in our hemisphere Indeed, it has become not just Vaccination Week in the Americas, but globally Vaccination Week Through the Vaccination Week initiative, more than 465 million children and adults have been covered, have been reached, and it has helped to keep vaccination high on the political and social agenda This year's slogan is Vaccination, Your Best Shot And this we encourage everyone to protect themselves against polio, measles and other vaccine-preventable diseases in anticipation of the World Cup to be held in Brazil So, Vaccination, Your Best Shot And we hope that everyone scores a goal We are very proud of our region successes in immunization, and of PAHO's role in supporting that success But we could not have done it without important partners like the Sabin Institute, with whom we have worked closely for many years In the area of vaccines and immunization, our partnership with Sabin have been critical to supporting research related to the introduction of new vaccines and strengthen epidemiological surveillance and maintaining immunizations as a top priority through the establishment of vaccine laws and the support of national immunization technology advisory groups Like the region of the Americas, the Sabin Institute has much to be proud of in SABIN VACCINE INSTITUTE 20th Anniversary Scientific Symposium April 25, 2014 its valuable work for a truly noble cause On behalf of everyone, certainly on behalf of the staff of PAHO, I sincerely congratulate you on the 20th anniversary, and I wish you many more years of success to come, and we look forward to continuing our work with you Thank you and welcome DR HOTEZ: Thank you very much, Dr Etienne, and again thank you to the Pan American Health Organization for hosting today's event And now it's my special privilege to introduce our first presenter, Dr Ciro de Quadros Dr de Quadros is a Sabin Vaccine Institute's executive vice president and director of its vaccine advocacy and education program As this event is in celebration of Sabin's 20th anniversary, Dr Quadros will be providing some insights into the work of Sabin, an overview of where we started, and a look at our vision for the future So please join me in welcoming my mentor and my friend, Dr Ciro de Quadros The Sabin Vaccine Institute: Twenty Years of Advancing Public Health Solutions DR CIRO DE QUADROS: Good afternoon, and thank you very much, Peter, for the introduction First, Dr Etienne, thank you very much for your words and thank you for hosting the meeting I come back to my old house Before I start, let me also recognize some people in the audience Of course, Peter already recognized Carol Ruth But besides Carol Ruth, she has other generations of Shepherds, like her daughter, her son, and the young friend of her son, and you are all welcome here This is fantastic I want also to welcome our CEO, Michael Marine, Ambassador Michael Marine That's the wheel that keeps us on line And of course, Phil Russell, General Phil Russell was the founding president of the Institute And I also want to recognize Mike Whitham and - - who have been, Les was a member of the board and now he's with the Gates Foundation, and Mike Whitham is still a very active member of our board And I want to also recognize DA Henderson who has been my mentor and was the first saving gold medalist So, sadly, it's a pity because they set the bar too high when they gave you that So, it have been very difficult now, the committee to give that award And last but not least I want to recognize my wife, Susanna, and my two daughters, Julia and SABIN VACCINE INSTITUTE 20th Anniversary Scientific Symposium April 25, 2014 Christina This is new technology And besides that, I'm going to use a teleprompter because after President Obama came to town, it became the rule now that we have to stick with a teleprompter So, forgive me if I make some mistakes I think it was also important because what I'm going to present is a collective work of the whole staff of the Institute, and I want to thank all of them for preparing these remarks, and for really a fantastic job that has been done So, good afternoon again to all of you As we get into today's program I'd like to take a moment to acknowledge all of your presence I have known many of you for decades and we have been close partners in helping to overcome some of the worst health issues we have faced as a global society As a matter of fact, sometimes we even conspired to get things done So, this is very nice to see all of you And of course, my deepest thanks to the presenters of today, which are some of the busiest people in the world and they made space on their agenda to be here with us, and I think this is a tribute to the work of Albert Sabin to global health, as a matter of fact In many ways, I'm sure you will agree that world today is healthier than two decades ago And the prospects for even better health in the future are brighter than where they were only a few years ago This includes the prospects for the poorest communities among us Our conversation this afternoon focuses a bit on what has changed to make for such an improved outlook Just as importantly it also centers on what has not changed and how in the coming years we have an unprecedented opportunity to close some of the most stubborn gaps that persists, especially for the world's poorest people We begin by going back a mere two decades In 1993, the global health landscape represented stark conditions for the world's poor in many areas In the immunization field, roughly maybe 70% or even less in some areas of the birth cohort have access to the basic package of immunizations that allowed them to beat the odds and survive past the age of five years old Today we have a slightly improved picture, reaching about 80% of the birth cohort But we have to pick up the pace considerably to reach a primary goal of the global vaccine action plan of 90% coverage by national immunization programs, not only at the national SABIN VACCINE INSTITUTE 20th Anniversary Scientific Symposium April 25, 2014 level but in every community Twenty years ago, more than 100,000 people were contracting polio each year, and nearly 1.2 million cases of measles were found annually Those numbers have fallen dramatically As you know, there were no vaccines for some of the worst diseases such as rotavirus, pneumococcal and HPV And other vaccines remained prohibitively expensive for low income countries Few low income countries outside of the Americas had national immunization plans both to finance and to implement their progress In 1992, despite plague poor populations since Biblical times, diseases such as schistosomiasis, hook worm, trachoma and lymphatic filariasis remained classified as other diseases And you recall, in one of the MGGs, it talks about control of TB, HIV, malaria and other diseases And these were the other diseases that nobody knew what they were A coordinated advocacy movement dedicated to eliminate these scourges as public health threats, let alone next generation vaccine tools that may one day confirm immunization Today classified as neglected topical diseases, or NTDs, and thanks to the efforts of Peter Hotez, we are on the path to reaching control and elimination target for ten of these diseases within a decade and there are new vaccines in the development pipeline for severe other NTDs Finally, many of the organizations today are synonymous with global health such as the Gates Foundation and GAVI, did not exist or were fundamentally different than they are today It was within this context in 1993 that the Sabin Vaccine Institute was founded by the visionary HR Shepherd on the legacy and global vision of Albert Sabin to reduce needless human suffering Early on, we created the saving Gold Medal to spotlight some of the best scientist advancing research in medical practices that benefited poor and neglected populations Two years later, we convened the series, the first in a series of scientific conferences called the Cold Spring Harbor Laboratory Colloquium that examined various issues such as vaccine development, development for neglected diseases and performance improvements in immunization programs, and we formed the cancer vaccine consortium to advance development of cancer vaccines At the start of this century, Sabin's Product Development Partnership, PDP, was founded as the first and only PDP in the world developing a vaccine for human hookworm infection SABIN VACCINE INSTITUTE 20th Anniversary Scientific Symposium April 25, 2014 which is an issue that PAHO kind of resolved when they pulled procurement in the revolving fund I understand that UNICEF is also working in that direction particularly for the Middle East or other regions What are your views on that? All questions will be a surprise DR CHOPRA: We definitely have to learn the lessons of PAHO, and of course as you know just transferring that model is not so easy and obviously there is like you said many of these countries quite rightly want to also their own procurement for their own reasons and so forth So we are having this balancing act of trying to on the one hand negotiate with companies around fair pricing but also understanding that we need a healthy market, so it is not just about getting the price as low as possible It is about also getting multiple players and the safety issues are critical as well On the other hand it is respecting countries' wishes to develop their own capacity to procure, to be in the market and so forth, so you know, we don't have the luxury of the strong political solidarity that you created in this part of the world and other parts, and so it is a balancing act of showing the advantages of acting together and having common pricing and so forth At the same time, being sensitive to the needs of industry as well, of the need to have some profit and some incentive to invest in capacity as well DR QUADROS: Thank you, Mick So the industry plays a critical role in the implementation of GVAP and you know, one part is that the GVAP has a chapter on research and development to improve vaccines to develop new vaccines so that is one important role of the industry and the other one in my view is to facilitate the introduction or those vaccines to all people that need so what are your views, Julie, of the manufacturers from the industrialized world in that respect DR JULIE GERBERDING: Thank you I feel incredibly humbled to be here at this meeting at PAHO with Sabin in the presence of two PAHO public health heroes Dr de Quadros and Dr Henderson, but it is a little bit humbling I am happy to try to represent my colleagues at the IFPMA and IC - - is here so I hope I'm speaking for all of us in my remarks I'm really struck with Julio's comments about solidarity because I was very surprised when I moved from public health where we are very solid in our support and advocacy SABIN VACCINE INSTITUTE 20th Anniversary Scientific Symposium April 25, 2014 58 in immunizations to industry to discover how much solidarity there is around this issue in the vaccine industry as well When we gather as CEOs in support of GAVI, which we are allowed to as part of the IFBMA process to talk about how can we step up, what have we learned so far, what is going right, what else can companies do, where we run into trouble, the unity of purpose in trying to solve the challenge is really heartening I think, and it gives me some optimism that we will be able to figure out how to this There are some indicators of success The fact that Mening and Prevnar got into the developing world markets almost as fast as they did into the developed world markets is a huge step forward from the many years that it used to take to move innovations in the developed world into the rest of the world We are learning There is a commitment, but if solidarity is the ying, the yang is sustainability, and this is where the challenge of securing affordable access and then sustaining it over the long run is going to be increasingly difficult, and the reason for that isn't lack of intent The reason for it is that all manufacturers are facing the same set of challenges, among them are competing priorities, a shrinking R&D base in the industry because of the longer timeframe and the larger amount of money that is needed to develop a vaccine It is at least $600 million to build a processing plant for a vaccine, and I can verify that it is usually more than that because we are in the process of opening one in North Carolina that was significantly more than that The R&D investments continue to expand The regulatory requirements are getting more and more expensive and I think my colleagues in the developing world are finding there is kind of a convergence We used to think of them as low-cost manufacturers, but their labor costs, their regulatory costs are going up as well So what happens is not that the vaccine presidents or CEOs don't want to have more products and more innovation and more opportunities to be relevant ot people everywhere, we are competing in our own companies against places to put investments, and so if we don't have a profitable business model and we can't compete successfully they will put their money somewhere else I think we are fortunate right now that the manufacturers who are in the business have good DNA and they believe that it is important and a responsibility to continue to this kind of R&D work and to their share in bringing vaccines SABIN VACCINE INSTITUTE 20th Anniversary Scientific Symposium April 25, 2014 59 to people not just in the GAVI markets but also in the lower middle income and middle income markets For the middle and upper middle income markets, the market model works It is the lower middle income markets that I worry about the most, particularly the vulnerable GAVI graduates, and that is what we need to collectively figure out and solve for, and I think you saw Seth put up the kind of five-year plan for graduating to a country being able to sustain, but there is no guarantee that countries are going to be able to invest and/or afford vaccines just because their average GDP has reached a certain benchmark And inside of these countries are lots of pockets where people will never get there, so we have to figure this out, and I think we need to it together DR QUADROS: Thank you, Julie Mahendra, what are the views from the developing country vaccine manufacturer, because if we look back to when the developing countries started producing vaccine and entering the market, there was a sort of revolution in the vaccine market, and prices generally went down I recall my experience with hepatitis B, which entered the market at more than $15, and a few years later it was at $7, which nobody could afford in Latin America, and then suddenly the Koreans started producing the vaccine and the vaccine came down to $1 a dose, and then everybody could introduce So now we know that some other vaccines that are quite expensive are being produced in the developing country vaccine manufacturer's infrastructure, and some of them have brought the price a little bit down What are your views, and how you see the participation of the developing countries vaccine manufacturer's role in the next two decades to achieve the goals of the GVAP in this respect? DR SUHARDONO: Thank you very much, Ciro Thank you for inviting me in this very prestigious meeting and to be also a panelist in this forum We are from developing country manufacturing networks, and up until now we have 40 manufacturers in this association from Mexico In this area we have Mexico, Brazil, and also from Argentina You are right this has actually not happened to the business of vaccine, and this is like generic rules, more competitors come usually price will come down, but of course it is a little bit different as a business, so usually learning from for example, one of the target in the - - eradication SABIN VACCINE INSTITUTE 20th Anniversary Scientific Symposium April 25, 2014 60 of polio You know that the last—this month Ciro is also certified and this is - - virus because India is the last country in the region free from polio, and then this is also his contribution from Sabin polio, so mostly in our members and - - have been - - , and then this with very, very affordable price, yeah, because and also the second learn with the Pentavalent, when UNICEF introduced Pentavalent then the price around $4 or $5, and then usually developing countries manufacturers like to 15 years behind the multi-national company in terms of Pentavalent when our group joined the price also come down and then now the price approaching $1, one point something, so actually why the price become more affordable, of course because this has been like generics world and more competitors will come down Then usually most manufacturers in developing countries is partly owned by government, and then of course it is not really based on business approach to produce the vaccine, and then because we are followers of course we have to be more competitive, and then because we produce a huge amount of doses, so we really have to reach economies of scale, so if the volume and also the cost of course will be more affordable We have—and then that happens with - - vaccine that until now supplied through UNICEF Until now ten of our members are also pre-qualified and also already supply more than 30 vaccines to U.N agencies, so coming back to the - - 20 years from now, so you know that the vaccine development is very, very risky and very, very expensive and time consuming so it was very interesting, I agree in the future it should be interdependency is not just south to north, but should be also - - So the role of the Sabin institute and also the biotech company and also GAVI and then if we have like really a mutual partnership and also with the multi-sector collaboration so we hope that still we can reach more affordable for the new vaccine that currently is - - very expensive From our experience, learning, lesson learned usually will come to the affordable, is not very cheap, but should be affordable, and - - still should have the - - for growing and also development Thank you DR QUADROS: Thank you very much So Lance, last but not least, you know, you are now one of the major players in global health, so the figures of the Gates Foundation are all over the map and the architecture of global health SABIN VACCINE INSTITUTE 20th Anniversary Scientific Symposium April 25, 2014 61 But there are two areas which I think are very critical for the things that are dear to the Sabin Vaccine Institute One of course is the introduction of the GVAP, and the other is what we with the neglected tropical diseases because you know the Gates Foundation has investments in that area, and we want to see what are your views for the next 10, 20 years in this area of neglected tropical diseases and how can we tackle that challenge? DR GORDON: Thank you, Ciro Thank you for the breadth of that question, so it really starts with the passion and evolved mandate of the Gates Foundation The passion in fact I think I would probably - - as an ethics statement that drives everything we Which is, and I quote, every person deserves the chance to live a healthy, productive life Everything that the Gates Foundation is engaged in derives from that statement, so we getting a little more granular invest in change, and improvements both in health and in societal development In the case of health as I think many people know, Bill and Melinda started with a particular interest in vaccines but it was a very specific analytic and considered focus given that vaccines in many, many ways are the most cost-effective health interventions, possibly short of, but I'm not even sure short of sanitation So, the next really great thing about working with the foundation is that it is consistently agnostic as to solution sets for the diseases, so we start by looking at what is the relative global disease burden for the different diseases I'm part of Global Health, so that is where my group focuses, and those span infectious diseases that could be considered vaccine-preventable diseases but many that are not, so we select specific disease objectives, disease initiatives, based on relative disease burden, the opportunity for transformational change, the opportunity of partnerships and what we consider our strategic advantage, that is what institution the Gates Foundation and what role we play, or can we play in the world or should we even try to So, through that set of filters, we focus down and we pick specific diseases Out of the 47 neglected infectious diseases that we started thinking about in developing our neglected infectious disease strategy, we focused on 17 Some of those—well, we looked at every one and we asked ourselves what was the SABIN VACCINE INSTITUTE 20th Anniversary Scientific Symposium April 25, 2014 62 solution set? What were the weaknesses? What were the opportunities? It was different for each disease Each disease is unique It has a different geography, a different demographic, different microbiology, pathobiology, different clinical consequences, so breaking it down to the two broad categories and trying to stick through to the question you asked, for the vaccine diseases we have an interest in malaria, HIV, TB, a range of enteric diseases, a range of respiratory and everything else seems to fall into the neglected infectious disease, which is my read We really work on a global advocacy basis In many cases, we work with the developing country manufacturers, providing sometimes technical assistance, sometimes working on market incentives, sometimes partnerships, cofunding development of products, really to create an affordable supply of vaccines We the same with the major pharmaceutical companies Merck has been a great partner, as has Takeda, and Sanofi, GSK and others, in the vaccine arena In some cases countries either have a preference or even a legal requirement for domestic manufacturing, so we actively engage in that, and that is all part of the Vaccine Action Plan, very specific activities but broadly supporting the vaccine program The neglected tropical diseases are a different category It breaks down into two parts really, what we call the PCT diseases and the IDM diseases So one of the great things that we have been engaged in together with the Sabin Vaccine Institute, but outside of the vaccine arena, and certainly you, Ciro, and Peter Hotez, have been great champions of the way we use drugs, as if they were vaccines So, there are about 750 million people last year who received drugs as a public health measure without regard to the status of infection or disease They are used really as PCT, which is preventative chemotherapy so by treating whole populations and clearing the infectious agents, the parasites, it obviously prevents transmission if there is no one to transmit it from So we support the London Declaration for that The London Declaration is a group of 10 diseases where there were substantial partners for each SABIN VACCINE INSTITUTE 20th Anniversary Scientific Symposium April 25, 2014 63 of those Now that is a subset out of the WHO roadmap for NDT, which is coincidentally another 17-disease subset, not the same 17 that I work on So, the London Declaration much like the Global Vaccine Action Plan is a call to action, and somewhat of an organizing platform to advance solution sets So the London Declaration, I just had done a big review We had a major meeting in Paris celebrating the second anniversary of that program, but that is an area where again using drugs as if they were vaccines The pharmaceutical companies, and Merck certainly an enormous load carrier through the Ivermectin donation program 1.4 billion doses of drugs were donated last year That is not low cost That is donation programs, and their commitments are for as long as they are needed in many cases, and it is having an enormous beneficial impact on global health We have truly gotten to the point because of these broad initiatives where the supply of the medicines to treat, cure and in some cases potentially eliminate infectious diseases is not a limiting factor There is as much drug available as is needed to handle these diseases, and it is not really —you might think, well this is somehow excess capacity or it is just leveraging off of their commercial markets, but the great thing is they are also participating in research for new products They have opened their compound libraries to not-for-profit product development partners, who are mining those compound libraries looking for the next drug for neglected disease Some of the recent changes, so Merck very, very long involvement, a company with a similar name but actually separate, Merck KGA in Europe had been donating another drug called praziquantel, 25 million doses since 2007, but as a result of these kinds of initiatives, the London Declaration, very similar to the vaccine action plan, they stepped up their program from 25 million doses a year to 250 million doses a year, and they didn't stop there They also committed to develop a safer pediatric version of the same drug One of the products that we are very excited about right now is for sleeping sickness and this is an old line drug currently owned by Sanofi, which was developed for an entirely unrelated purpose They have invested in developing that for sleeping sickness and we are particularly excited because it looks like it can be a SABIN VACCINE INSTITUTE 20th Anniversary Scientific Symposium April 25, 2014 64 stage independent oral cure replacing ridiculously difficult to deliver drugs I don't mean to expand on this too much except I am terribly excited by it Sleeping sickness is a disease that is uniformly fatal It is - because it is always fatal if untreated as one of the higher neglected tropical disease burdens When someone is diagnosed and by the way it takes nine-person teams to go out into remote, isolated places and the diagnosis, screening, but when they are shown as positive on that diagnostic, you've got to confirm it with a microscopy and then you have to a lumbar puncture, and if they don't have parasites in the CNS you can use an oral drug, pentamidine, but if they have CNS penetration, you have to take them out of the village, transport them long distance to a hospital where they can receive twice a day IV infusions for a week and every eight hours an oral companion drug, prohibitively expensive, difficult and cumbersome, so through the kinds of participation we are seeing from the pharmaceutical industry, there is a new drug in the very near-term horizon, which is oral, which is stage independent, no more lumbar puncture, no more transporting people, so the CEOs, the companies have gotten together, and I know that Merck is a core member of something called the CEO roundtable, where the largest pharmaceutical companies have really gotten together to contribute to global health, so where I think the world is going? I had the great pleasure, we launched a new program about two weeks ago, together with CIFF, the Children's Investment Fund Foundation and other donors, committed $120 million to the cell transplant - - field And I sat on the panel with major donors and stakeholders and at the end I was again the last speaker, and as I had listened to each of the other speakers I kept thinking, Margaret Chan is right, we've got to take the neglect out of neglected infectious disease, but in this case I really meant something a little bit different Many of these diseases are not neglected today, 1.4 billion doses of drugs committed, vaccines rolling out in enormous scale, the GAVI program, the developing country manufacturers both addressing their own needs and those of other countries I think it is a time we might start thinking about changing the name of the NTD or NID to the infectious diseases of poverty They are not as neglected as they used to be, and I am thankful, I think we are all thankful, everyone in the room and all of the partners SABIN VACCINE INSTITUTE 20th Anniversary Scientific Symposium April 25, 2014 65 MALE VOICE: That was excellent A common theme that I am hearing, which I propose and many people are engaged with this concept that going forward we don't work in one area, there is such an opportunity as vaccinologists to work in the field that will have an impact on diseases of poverty, and I was going to recognize Ande Gay [phonetic] I don't know if she is still here of the U.N Foundation and the alliance that some years ago worked together to reduce measles mortality in Africa, Mark Grabowski [phonetic] I saw him here as well, but they went out and in about six or seven years averted more than 10 million deaths in Africa, and if you think in the history of public health that is an amazing milestone, I can't think, I mean smallpox contributed, but over such a brief period of time but to avert that many deaths and when you learn more and tease out lessons learned, they didn't it with measles vaccine alone, they went out with bed nets, they went out with anti - - , and so we need to be thinking more like that going into the future DR QUADROS: - - ? DR GORDON: I just want to make one additional comment because this is the 20 t h anniversary of the Sabin Institute I want to thank them both personally, but I think my experience is probably common for a lot of people, so I started in the commercial vaccine industry I had 10 or 15 years developing vaccines principally for the U.S and European markets, and that was although I knew the vaccines got used in other countries, that was really the focus, but it was really thanks to H.R Shepherd and Phil Russell who invited me during the very first years of the Sabin Institute to attend the Cold Spring Harbor colloquia and some of the other things, and H.R Shepherd invited me onto the board of the Sabin Institute that started broadening my horizons and thinking more about first vaccines for the world, but now Bill Gates has taken what the Sabin Institute helped develop as an interest and passion for the vaccines in global health and broadened it out to as I said at the outset agnostic as to solution, but really committing and I think a lot of people because of the work of the Sabin Institute, and your work, Ciro, and H.R.'s and Phil Russell and D.A Henderson and so many other people, I think part of removing the neglect really accrues to the work done here SABIN VACCINE INSTITUTE 20th Anniversary Scientific Symposium April 25, 2014 66 DR QUADROS: You are our ambassador to the Gates Foundation We are running out of time, but does any panelist want to make a last statement or any comments before we ask Margaret Chan to answer my question? Anybody want to make a final comment No? So let's ask Margaret Chan to —this is an interesting thing let me tell you because I had dinner in the house of - - with Dr Chan and during the conversation I told her that we were having this event, and she said I want to be there I said oh yes So that's the date, she said unfortunately it's impossible, but can I send a message? I said only if it's an answer to a question that I'll send you She said, yes, ask me the question So I hope that she will you know, refer to my question before she answers because I didn't see her tape yet Thank you very much to the panelists That was really great [applause] Special Message DR MARGARET CHAN: It is a great honor to be introduced by one of the giants of immunization, the leader of polio eradication in the Americas and now a designated public health hero of the Americas Your personal history goes back to the smallpox eradication campaign in Brazil The extended program on immunization is a legacy of smallpox eradication Over the past 40 years, EPI has remained true to its privileged birth place, never forgetting the importance of constant research, innovation and clear goals that help unite the work of multiple partners Your work at the Sabin Vaccine Institute, especially on new vaccines continues a tradition that you personally did so much to establish You asked about my views on three barriers; country ownership is the first At the policy level there is clear consensus that countries must take the lead They absorb development cooperation through a tremendous mobilization of their own usually very limited resources They deserve to have the first say about priorities, programs and the best implementation strategies In reality, the situation on the ground is very different Many partnerships and implementing agencies continue to pursue their own objectives resulting in fragmentation, duplication, high SABIN VACCINE INSTITUTE 20th Anniversary Scientific Symposium April 25, 2014 67 transaction costs, and multiple sometimes impossible reporting requirements on health indicators In my view, one of the best ways to honor country ownership is to streamline and simplify operational demands on programs EPI in partnership with industry has introduced new products and formulations that are simple and safe to use in resource constrained settings where skilled staff are scarce This contributes to country ownership by making implementation much easier with existing resources The challenge now is to persuade development partners to use this system as well Second, you asked about access to new vaccines and technologies The WHO Constitution regards the enjoyment of the highest attainable standard of health as one of the fundamental rights of every human being, every child, regardless of where it was born or the income status of its parents deserves the very best science and medicine can offer Developing countries usually have to wait at least a decade until new technologies gradually trickle into their health systems Not any more, GAVI and other partners, including the Sabin Institute and WHO have made it possible for the introduction of the newer and more expensive vaccines to take place almost simultaneously with introductions into wealthy countries The WHO prequalification program has contributed to another uplifting statistic Today quality assured vaccines are used in the immunization programs of 97% of all countries, again every child deserves the very best that medicine and science can offer Finally, you asked for my views on the sustainability of national immunization programs This is certainly an issue of concern in many of our member states More and more countries are graduating to middle income status This means they are also graduating from eligibility from GAVI support At the same time the map of poverty has changed Middle income countries are now home to 70% of the world's poor Can these countries sustain high coverage? Especially when the more expensive vaccines are included? The goal as set out in GVAP is 90% national immunization coverage by 2020 with 80% coverage in every district I am personally optimistic GAVI, UNICEF and WHO have already demonstrated their capacity to change the dynamics of the market for public health vaccines, making supplies more SABIN VACCINE INSTITUTE 20th Anniversary Scientific Symposium April 25, 2014 68 abundant and predictable and getting prices down In the Americas the revolving fund for vaccines crated under Dr Ciro de Quadros leadership, let's countries pull demand and buy vaccines in bulk, lowering prices and stimulating secure vaccine supplies The benefits of immunization are immense and measurable, and this is another powerful motivation at a time when words like transparency, accountability and measurable results are part of the development vocabulary World Immunization Weeks such as the one currently underway help meet another global vaccine action plan goal and that is that people understand the vaccines and demand immunization as a right and responsibility High population demand corporation make a major contribution to sustainable programs The increasingly wide use of vaccines against hepatitis B and human papillomaviruses raises the exciting prospect of preventing two of the most common cancers in the developing world This too is a powerful motivation to expand immunization and not just sustain it In conclusion, the future of immunization looks bright EPI with its early emphasis on universal access has been a pathfinder for solutions that can help countries move towards universal health coverage This too looks certain to ensure a bright and sustainable future as we together build on so many foundations pioneered by Dr Ciro de Quadros Thank you and my best wishes to Ciro and the Sabin Vaccine Institute [applause] DR HOTEZ: That was a great panel discussion and we deeply appreciate Dr Chan's remarks What I would like to is end by just having a brief video from our chairman of the board, Mort Hyman, who unfortunately couldn't be here this afternoon because of a family emergency, so Mort is going to give us a few remarks Before we close, I would like to just a shout out to some people from Sabin who haven't been recognized, of course the whole staff of the Institute participated in this, but we didn’t acknowledge a very important man, Niraj Mystery [phonetic], is Niraj here? He is managing director of the global network for NTDs whose work you heard about Brian Davis our chief operating officer Brian, raise your hand, and a special thanks to two very important people who helped organize this, Richard SABIN VACCINE INSTITUTE 20th Anniversary Scientific Symposium April 25, 2014 69 Hatzfeld and Debra Ellison [phonetic] sitting in the corner here, and Nicole who did a lot of work for this event It was a really nice afternoon and very meaningful as well Let's hear from Mort, and I will just end by reminding everybody that on Tuesday, next Tuesday the 29 t h , we will have our annual Sabin Gold Medal Event at 5:30 at the Marriott Hotel When I was living here it was called Rockville Now they call it North Bethesda, I don't know quite what that means, but I still think of it as Rockville But it's North Bethesda, near the White - Metro I hope many of you can join us for that Thank you again for an extraordinary afternoon What can I say it is such an honor to be linked and have the ability to be mentored by Dr Ciro de Quadros, and we are also thrilled to hear about your recognition and the award this afternoon Thank you [applause] Chairman's Message and Thank You DR MORTON HYMAN: I regret I was not able to welcome you and cannot thank you in person for participating in this symposium which celebrates the legacy of Dr Albert Sabin, those who worked with him, and those who came after While many of you may be far too young to recall the terror that gripped America and other industrialized countries at the height of the polio epidemic in the 1950s, I remember it well For a detailed and gripping description if you have not already done so, I urge you to Polio by David Oshinsky, which won the 2006 Pulitzer Prize for history It is a fascinating story of triumph Thanks to the work of Dr Sabin and others polio was eliminated in the wealthiest countries, and in the decades since we have applied the epidemiologic lessons that we learned in the process to other countries, enabling the word community to vanquish or control that terrible disease as well as many others We have witnessed significant success in our efforts to improve the health of the world's poorest people, but of course more must be done The partners who have spoken today and those of you in the audience have a large stake in this effort Collectively you represent a vast group of SABIN VACCINE INSTITUTE 20th Anniversary Scientific Symposium April 25, 2014 70 organizations, companies, and governments working tirelessly to close the health gaps that have eluded us for so long But still we know we must better We cannot accept that 1.2 million children around the world die every year from vaccine-preventable diseases Surely not when there is a clear road map the global vaccine action plan to help us overcome the lingering obstacles to full immunization coverage We must continue to challenge conventional models for vaccine development by creating the power of partnerships to develop vaccine solutions for some of the most pervasive diseases affecting the world's billion poorest When we have the very real possibility of controlling or eliminating many neglected tropical diseases by 2020 thanks largely to the generosity of a number of pharmaceutical companies and private philanthropy with the Gates Foundation in the lead we must embrace this undertaking and invest the resources that are required to see this effort through to success I give special thanks and congratulations to my friend and colleague Ciro de Quadros whose achievements and dedication to this cause are world-renowned Ciro has devoted to working with Dr Sabin and other giants in the field and is widely regarded as a giant himself He has been and is in the forefront of working collaboratively with partners around the world to improve the health of its poorest communities He is an inspiration and leads the way through his example We honor him today and his extraordinary achievements in bettering the lives of untold millions We at Sabin remain committed to this urgent task We are optimistic and confident that working in concert with all of you and your colleagues and counterparts around the globe success will be achieved Thank you for all you and for being with us today Now before adjourning for some refreshments please join me in expressing our thanks to our panelists and speakers [Applause] DR HOTEZ: Thank you very much for coming this afternoon Please join us for a cocktail reception downstairs, and I look forward to talking to you more Have a great weekend SABIN VACCINE INSTITUTE 20th Anniversary Scientific Symposium April 25, 2014 71 I'm sure it's going to be a beautiful weekend Bye-bye Thank you [END CD3 Track 2] SABIN VACCINE INSTITUTE 20th Anniversary Scientific Symposium April 25, 2014 72

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