Risks, Rewards and Returns of Research
BRENDA BLANCHARD: I would like to wish you all a good afternoon and want to thank you all for coming. My name is Brenda Blanchard. I'm representing Novartis and I am very pleased to open our program today.
It's important that we have such a nice cross section of folks from the health care community and other sectors of the business community in the greater Tampa area who have joined us today.
The program today is first and foremost a Florida perspective on the risks, the rewards and the returns of research. Our distinguished line-up of speakers, as well as our panelists are going to share some good detailed information with you about those risks, rewards and the perspective on Florida.
My role is to welcome you on behalf of Novartis. We are one of the three primary sponsors of the program today. We're a global pharmaceutical company, committed to patients and to research. During 2005, the company invested across all business operations over 4.8 billion dollars in R&D, a figure that represents 15 percent of net sales.
This research is accomplished by over 3500 scientists around the globe. Our strategy is clear. We must first consistently invest in R&D. This will enable us to bring to market innovative and differentiated products that offer the patients clear therapeutic benefit. And we must develop promising new growth platforms like vaccines that reduce health care costs through disease prevention.
These strategies are working. Just today at our R&D day in London, Novartis announced that it has 138 projects in clinical development with most of those in second and third phase clinical testing.
In 2007, Novartis will launch four to five new products most to address the needs of the growing number of patients with cardiovascular and metabolic disorders.
The process of pharmaceutical R&D is time consuming and expensive. That's why Novartis is moving toward patient centric integrated exploratory research that spans from fundamental biological knowledge to early clinical trials.
Our scientists are asked to think carefully from the very beginning as they're working in fundamental biology which patients will most likely benefit from the new medicines we're researching and how can we establish quickly whether those medicines are safe and effective.
Our patient centric approach has also led to a strong commitment on a global level to provide better access to medicines for patients. In 2005, Novartis committed 696 million dollars to reach 6.5 million people around the world in need of life saving and life enhancing medicines.
These medicines treated malaria in Africa and other developing countries as well as reaching some 400 thousand low income people in the United States, some of whom paid little or nothing for life saving drugs.
And Novartis is a partner in Florida. Today, we employ over 550 people in the state, invest 15.4 million dollars primarily in clinical research and work closely with leaders in the state's Medicaid program with leading physicians in hospitals around the state and directly with low income patients through our patient assistance programs.
It's a great opportunity for us also today to work with Research!America as they strive to maintain and enhance the research environment in the US. Their strategy is effective. We need only to listen to the American public and their understanding that research is fundamental to improving health care. Mary Woolley, you have an outstanding staff. I've had the privilege of working closely with them. Cindy McConnell and Stacy Propst I know -- and Christine Brown, three people I worked with very hard with on this program. They put in a great deal of time and effort and they're to be commended.
I also want to say thank you to our other partner today, the University of South Florida: President Judy Genshaft and Dr. Abdul Rao who will be on the panel, for their commitment to the research enterprise to patients and to the importance of educating our scientific workforce of tomorrow.
Finally, a sincere thank you to my colleagues who are here. I'd like to mention Dr. Jorie Gatlin [Phonetic] who will be on our panel, sharing good information a little bit later. Jim Elkin is here from our DC federal relations office. Fran Mangiari [Phonetic] -- Fran, raise your hand. You're our on the ground guy in Florida. So, we're pleased that you're here and he demonstrates our commitment.
And, of course, Barbara Tombros [Phonetic] is here from our alliance building program with PhRMA, and a special thanks to our friend, Nancy Loving, with WomenHeart, the founder. Her commitment to women's cardiovascular health is critical. Thank you all of you for being with us today. And now, Judy.
[APPLAUSE]
JUDY GENSHAFT: It's really a pleasure to welcome everybody to Tampa and to the University of South Florida downtown here we are. This is very exciting for all of us. And this really represents a private/public partnership in so many different ways.
We're cohosting a dialogue on the future of research in Florida and as you've heard my partners include: Brenda Blanchard of Novartis who just spoke, and Mary Woolley of Research!America and I look forward to all of our panelists who will be introduced by Heidi Godman [Phonetic] of ABCWWSB in Sarasota.
And in the audience we have special guests from around the state. And we welcome you to ask questions of our panelists to join the dialogue. And I do say we have people from around the state and some of the people that are here we -- we have Randy Barrage [Phonetic] from the Florida High Tech Corridor. And we're glad that you're here.
George Gordon represents the Tampa Bay technology forum and Ann Duncan, who is here, was on our board of governors. And how many others are here from outside of Tampa? [A SHOW OF HANDS] Two people back there with both arms up. We're glad you're here. I can't introduce everybody, but we're certainly glad that everyone is here.
Just for those of you who are from out of town -- and we also know that our distinguished guest that is here, Dr. Zerhouni [Phonetic], is also a football fan. So, we are so pleased that you knew about the USF win over West Virginia.
[APPLAUSE] [Laughter]
JUDY GENSHAFT: We just always have to add something like that to spice up the afternoon. You know, for those of your -- the University of South Florida is approximately 44 thousand students and we view it as a very important research powerhouse in the state of Florida.
We have 310 million dollars of research grants and contracts and the second in the state in terms of our research funding that we're very proud of and we're going to be finishing our 50 year celebration this Saturday. So we're 50 years old. We're very pleased about the progress that we've just begun.
Today, we're going to really focus on research and research in Florida has grown like the state. Recently, it's young -- explosively and creatively. This is a state that really has embraced innovation.
Our Governor has created special funding for biomedical research at state universities including the 8 million dollars competitive grant that we've received this month at the University of South Florida for the --
[APPLAUSE]
JUDY GENSHAFT: Thank you. Thank you. I should say thank you, because our researchers are here. It's a multidisciplinary grant for the Florida Center for Excellence for Bio Molecular Identification and Targeted Therapeutics that was awarded to our university. And there were six awards given out.
And this is a public and private partnership of these kinds of awards. And, so, it was a very difficult competition and we're very pleased to be one of the award winners.
More importantly, Florida has used its investment in research to build partnerships for economic development. And USF is a perfect example. We provide the catalyst for growth in the Tampa Bay community.
If you take the Tampa Bay community and you combine the seven counties of Tampa Bay and you declare it a new state of the United States, we become the 25th largest state in the United States. So, it's a very large growth area in this population wise.
And I know that other public and private universities in this state can tell a similar story. And you can't think of future cities without also thinking of universities. Universities are really the economic development engine of growth in all states.
And as a result, this is a forum that gives us an opportunity to advance our dialogue. It's also a symbol. The cosponsors today include the university; they include Novartis, one of the country's major research companies. They include Research America which is the single most important advocate for research and the voice of our citizens.
So, I look forward to today's dialogue and I welcome the partnerships we can create and I want to thank you so much for celebrating the strategic focus on innovation that is a hallmark for research in America and for this partnership in selecting Tampa Bay. Thank you so much.
[APPLAUSE]
MARY WOOLLEY: [Woolley] I'm Mary Woolley, the President of Research!America. I want to add my welcome to those you've already heard and to thank President Genshaft and, Brenda, you and your colleagues at Novartis for all you've done to help us put together a first class program for you this afternoon. I also wanted to thank you for you leadership for research. It really matters. And the American public and the public here in Florida agree with that statement that research matters.
Research!America has been keeping our fingers on the pulse of public opinion about research, research based institutions and companies and the people who do research who conduct research for about 15 years now.
We commissioned a poll here in Florida to tap into attitudes among your colleagues, friends and neighbors and I have the opportunity this afternoon to take you on a whirlwind tour of some of that poll data, which is summarized in your program booklets in greater detail. We think it's really important to find out what the public thinks about research rather than just assuming that we know.
So, with that said, let me get right into it. First of all, I'm sure it won't surprise you to know that 90 percent or 96 percent, if you include very strong support and somewhat -- 96 percent of the population in Florida believe that Florida is now a leader in tourism.
Now, that, as I say, probably doesn't come as a surprise. You can read by glancing at the data here that Floridians also believe that their state is a leader in agriculture and to a lesser extent medical and health research, education and manufacturing.
This is a good time for me to add that this is a standard methodology for public opinion polling that we use with a theoretical sampling error of plus or minus 3.5 percent. This is a telephone call, very much similar to exactly the same kind of poll that you read about from politicians in the media every day on every imaginable topic. And this survey was conducted just a couple of weeks ago. So, it's very recent and it's the first time we're releasing the results.
Now moving on to potentials for expectations for the future, how important is it for Florida to be a leader, to become a leader. And in the following enterprise -- these are the same ones we saw before.
And you can see that now education along with medical and health research, which by the way go together especially at a university such as USF -- come out on top. And that is just reason number one that you can be sure that the citizens of Florida strongly support not only this university with its research emphasis, but expanding the research enterprise in Florida overall.
Now, we all know that health care costs are much in the news. And people understand that research is connected to managing health care costs which we must do in this country. It's our job, all of us who care about research to continue to connect those dots. To make it clear that health care based on evidence, which means based on research is the way that we are going to get our hands around the problem of runaway health care costs.
Now, that all said -- those are all pieces of good news. There's also some not so good news. Despite what we may want to believe, many people in Florida can't give the name of anywhere in the state where medical or health research is conducted. That's 54 percent saying they simply don't know.
Now, I want to caution you that your state is not different than other states in this regard. Some are a little bit better or a little bit worse. But we have a long way to go in terms of just simply self-identifying with research institutions and not assuming that the general public knows what you do and where you do it.
Now, we also learned as we have in other states that the public is a lengthy lead in. But the bottom line is that the public says they approve financial incentives, which by the way they're going to have to pay for one way or another to expand research in the state including attracting new scientific research either at existing institutions in the state or bringing in new institutions all together. Strong support here, especially if you add all the approvals, somewhat and strongly.
Now, further, people say that they understand and believe that it's important that medical and health research is important to the economy of Florida. And we know form the history of several other states that I'm sure you're familiar with -- that there's been a substantial stimulus to the economy by the state's decision to invest more strongly in medical and health research. And that's already happening here and is likely, undoubtedly, to continue with very strong public support.
Now, I said that people understand that ultimately these things need to be paid for. And here's one indication that people are ready to pay more. Currently less than six cents out of every health dollar is spent for medical and health research in the US. And we asked people how many cents they think we should spend. And 59 percent, almost two-thirds, think we need to be spending more.
Now, are they going to pay for it, yes. And the most difficult question of all, would you pay more in taxes, I'm not here to advocate higher taxes, but this is a way to really test people's commitment. Would you be willing to pay a dollar more a week in taxes if you were certain that all that money would be spent for additional medical and health research or not? And we see here 59 percent say yes. This is quite consistent with national polling on this question I might add.
Further, people say that Congress should support tax and regulatory policies that encourage private industry to conduct more medical research. You may not be aware but it's important to know that the R&D tax credit renewal is up for consideration in Congress. This is a pretty strong indication that the public wants it to pass. I would say that similar kinds of legislation in Florida would also meet with strong public support.
On a topic that's very much of interest to people at any age of life but certainly those of us in my cohort, we ask people whether they expect that heart disease will affect your life or do you think it will probably not. And 36 percent said, no they didn't think so, six percent don't know, but everybody else said, oh yes indeed. It's going to affect my life and they're right statistics tell us.
And people also tell us that they're quite optimistic about the power of research. Take a look at these statements, please tell me whether you think the following medical breakthroughs will occur: A cure for diabetes at the top, 70 percent; cure for Parkinson's, 63 percent. You can read the rest. People are quite optimistic about research. We believe that that optimism is well founded. There's lots more data in the handout I encourage you to take a look at.
That's a glimpse in a nutshell of what the people in Florida are thinking about and expect from medical research, those amazing outcomes and in short order. In a nutshell even in these fiscally challenging times for state and federal budgets, public expectations are high and the public's willingness to support research is strong. This is extremely good news since medical science is poised to deliver.
Our keynote speaker today understands all these realities, perhaps better than anyone else in the nation. He is compelling in his ability to communicate the benefits of medical research and in his ability to define and realize a compelling vision for the National Institutes of Health.
I do have the honor of introducing Dr. Elias Zerhouni, the director of the National Institutes of Health. The NIH as you know is the nation's medical research agency, the envy of the world. Approximately 83 percent of the NIH budget goes to support peer review research at more than three thousand universities, medical schools, hospitals and research institutions throughout the United States and overseas.
And of course the University of South Florida is among these and doing quite well in attracting NIH funds. Dr. Zerhouni has spent his career providing clinical, scientific and administrative leadership.
At NIH he has initiated the NIH road map for medical research. He leads the effort to emphasize translational research, as well as high risk research. Meanwhile establishing and supporting initiatives to reduce health disparities and insure broader public access to NIH funded research. He's also a leader in assuring strong partnerships between academia and industry.
Before being appointed Director of the NIH in 2002, he was executive vice dean of the Johns Hopkins University School of Medicine. He has received numerous awards, too many for me to name here, and his own research in imaging has led to advances in CAT scanning and MRI that have resulted in more than 150 peer reviewed publications and eight patents.
Dr. Zerhouni will speak to us briefly and then take a few questions. A representative from the University of South Florida will field those questions for Dr. Zerhouni from those of you here in the Tampa club as well as those joining us at satellite locations. Please join me in welcoming Dr. Elias Zerhouni.
[APPLAUSE]
ZERHOUNI: [Zerhouni] First let me thank Mary Woolley for her leadership and I have to say that when the opportunity came up to come to the University of South Florida and meet both the leadership of the university -- and hearing about the commitment Novartis support of this activity -- I became very curious. And Mary Woolley is probably the most effective person in Washington, D.C. to convince someone to take a plane and come to visit something I needed to visit and that was the University of South Florida.
I have to tell you that I actually like the Tampa Bay area. I have friends here. And the last time I came here was for the Super Bowl. [Laughter] Because I'm from Baltimore. I'm a Ravens fan and I like football.
I then heard President Genshaft say if you look at the Tampa Bay area in terms of population it would be the 25th State. So my proposal today is you secede [Laughter] and then we'll take you back as the 51st state, which will be the 25th. [Laughter]
I really enjoyed the morning visit with the leadership of the University of South Florida and I was actually very interested in looking at trends throughout the country and the history of Florida and its investments in both biomedical research and science in general.
I actually met Governor Jeb Bush at the end of 2002 and he was talking about his commitment to increasing sort of a third leg concept -- the presence of Florida in high technology and biotechnology in general.
And I have to say that it's happening. Because today Florida is a little south of half a billion dollars in NIH funding and the University of South Florida certainly has made quite an impression, especially if you consider areas of investment that really didn't exist here beyond the cancer at Lee Moffitt Center -- for example Alzheimer's disease which I will talk about.
But what I'd like to do is give you a synopsis of how we see things today from the standpoint of the NIH. I have to tell you that these have been the most interesting times for medical research. Every week we have a press release about a new discovery or a new breakthrough.
The pace at which science is advancing is quite remarkable. And, yet, at the same time we know that we have more to do and there is an enormous amount of challenges ahead of us, not the least of which in which I described in the paper in Science magazine last week is how do you adjust to a need for the population that is growing; and, yet, at the same time you have very difficult budgetary environments.
The solution is to be very strategic. And how do we envision the strategy is probably what we need to talk about here today in the context of partnerships.
The first statement I'd like to make is that it is hard for me to see a better investment than an investment in fundamental research by the federal government.
If you look at the NIH research -- and I'm just going to give you one example -- heart disease -- if you look at the curve on the left and if you had projected a straight line -- in other words, the research would not have happened and no impact would have been experienced in terms of mortality.
Today, we would have about 1.3 million people facing early death every year. There's been a 63 percent decrease in mortality from heart disease in the past 30 years. Same percentage in stroke. Due to multiple reasons: statins to control high cholesterol, high blood pressure controls, aspirin, many many reasons, but there's about a million early deaths that are averted per year because of this research.
And if you ask economists what is the value of this, the lowest estimate is 1.5 trillion dollars and then 2.6 is sort of the mid estimate in terms of economic value, avoiding early death but preserving the economic productivity.
And you can see continuing improvements in the statistics in heart disease. We still have to make quite a bit of progress for heart disease in women and that's why the National Heart Lung and Blood Institute has launched the red dress campaign and we need to recognize that this is still a challenge.
But I think the new effective treatments and prevention and new discoveries being developed with industry and by industry -- and I think Brenda Blanchard was mentioning the 148 molecular entities that Novartis is working on.
I know about the pipeline of what is coming down from industry. It is amazing, it is quite promising. Now, having a number of potential drugs is one thing. Having them approved and go through the whole process is much more difficult than people think about. But that was the investment that we at NIH made in cardiovascular research, coronary heart disease research over the past 30 years.
If I ask this audience the question: how much do you think -- we, each of us -- spent in funding cardiovascular research for the past 30 years, the total amount, out of our pockets a little bit like in the survey Mary talked about. When you ask people, would you spend a dollar a week on research and the answer is yes. Most people would say if you can guarantee me that it goes to science they're willing to spend a dollar a week -- how much do you think we spent to achieve this return over the past 30 years.
When I ask that question people say thousands of dollars and the answer is $110. In fact, that was the total investment that each one of them -- each one of us put into federally funded research to achieve those results, about $3.70 per year over the past 30 years. There's no better return, I think, than supporting medical research and I think it is clear that it has a huge impact on the economy.
We have a more direct impact on the economy. NIH funds scientists across the US. You heard Mary Woolley tell you about the three thousand institutions we fund; we fund and support about 326 thousand scientists around the country. We used to support about 210 in 2001 - 2002. And all of them really look at both applied and fundamental research.
So, just to give you an idea, there were 3,114 new technologies brought to market by 185 US research institutions between 1998 and 2004. This is brought to market, not just patents apply for technologies. This is licensed and tested in the market place.
And when you look at companies that were founded, there were 4543 new companies directly funded from NIH research in the period -- 24 year period -- and of which 2671 are still alive and well today. So, quite a result in terms of economic impact.
As we've made progress in the controlling the mortality of heart disease and the morbidity of heart disease and other conditions, the other observation is that Americans are living longer and healthier.
And that's due to a series of improvements across medical research. And if you really ask people how do you know that -- there are two ways of knowing that and one is disability rates and what is amazing is that since 1982 the disability rates of Americans above the age of 65 has dropped by 30 percent.
And if you look at studies that look at chronological versus physiological age, they tell me that there is a 13 to 15 year gap that -- between physiological and chronological age. In other words, today if you're 75, you're more like physiologically 60 than 75.
So, that if you in fact look at life expectancy -- we've had a six year increase in life expectancy. But the likelihood of survival, if you reach 65 is actually 85 to 90. So, there's an enormous advance in terms of general health of the population.
But that has created new challenges. Because we have been so good at controlling acute diseases, we are now facing the challenge of long term, more manageable -- but more long term diseases, chronic conditions. And this is probably the number one change in the landscape of medical research over the past 30 years.
Chronic conditions account today for 75 percent or more of our health care expenditures. Seventy-five percent or more and growing. Aging the population is an issue that all of us know about. Health disparities remain a challenge and then you are dealing with emerging and re-emerging infectious diseases, because of globalization changes and other environmental interfaces and also dealing with new diseases that are emerging that are non-communicable and this is the shape of things to come. [Laughter]
This is the emerging non-communicable disease that we're all worried about, but we need to do new research and make sure that the implications of these new trends are controlled.
And the challenge for us as a society is the very fast rising cost of health care. If you look at the cost of health care in the United States relative to GDP, there was about 14 percent of GDP in the early 90's. It was flat for the 90's because the population was not aging during the 90's surprisingly, because the 90's reflected the depression and Second World War.
And there was not a baby boom then. The baby boom occurred after the Second World War. And, therefore, in 2000, you can see again the re-increase in the cost of health care and today we're about 18 percent of GDP, 1.8, 16 to 18 percent depending on who you believe, 1.8 to two trillion dollars of expenditures and in ten years it will be twice that. It's growing at seven to eight percent a year.
So, if you look at this and you look at that curve and you think as a citizen, as a policy maker, this is the elephant in the room and no one wants to talk about, but it is probably, in my view not just an elephant, it's a real dragon. Because it will reduce American competitiveness.
If you remember two weeks ago there was a meeting between the heads of the automotive companies in the United States with the President and the number one topic was health care costs, because of the implications of that on American competitiveness.
And my message is that biomedical research has to be the answer. Because today, we don't know what we need to know to be very effective in finding preventative treatments, preemptions, cures. We really are not as good as we think we are.
When I asked assemblies of scientists about how much do you think we know today that we need to know to be effective -- and most informed scientists will say we know about 10 percent of what we need to know, as compared to other fields of science where you know 50 or 60 percent.
And that tells me that there are both great opportunities and great challenges in front of us. The great opportunity for the University of South Florida or any region, which wants to take the risk -- is that there are still 90 percent of discoveries to be made. And therefore a huge potential gain.
At the same time, the challenge is we can't slow down because the discoveries we need to make have to happen at a pace that's commensurate with these rising costs of health care.
So, it is a race against time in many ways between our knowledge and our ability to influence our health. We have made tremendous progress.
In 2003 we completed the human genome. And in 2003 when I was director, just for a year, we kept asking ourselves what's next. So, we had the first complete draft of the human genome. The next think was to say, okay, how variable is the genome across humans. And this was called the Hap map.
So, the next project we did was to find out how different are we really from each other across the world. And we completed that in 2005, a year ahead of schedule. And the technology just exploded to the point where we could actually do studies in 2006 for comparing some -- a group of patients with a disease and a group of patients without the disease at a cost of about six - seven million dollars.
The same study in 2003 would have cost five hundred million dollars just because of the technologies that have advanced the nano-technology, high speed computing, micro circuits and micro fluidics. Just amazing. In less than three years something that was not doable became doable.
And this is what we're going to do over the next three years. We're going to use the new technologies -- very powerful sequencing technologies to identify the genetic -- not just the genetic roots, but the fundamental biochemical roots, or suspected biochemical roots of the ten most common diseases.
So, there is a transformation, therefore, in the way we look at research. We no longer look at research as let's try many things and let's hope for a magic bullet. If you look at the way we do research today, we need to understand the complexity of disease and disease pathways.
When you develop a chronic condition like diabetes you don't develop the disease overnight. You develop it over 20 years. Heart disease the same way. Alzheimer's disease the same way.
So, to be able to influence that, we need to understand what happens at the molecular level many, many years before the disease strikes. To do that we have to focus not on one magic bullet, one molecule at a time, but a system of molecules. It's what we call going from a single target to a system of targets.
In fact, in cancer you know that you cannot control cancer with just a drug. That's why we have these cocktails of chemotherapeutic drugs. Because we know that cancer is so complex that unless you attack it from different angles, you won't affect the outcome. Same thing is true of HIV/AIDS. We treat the patients with three drugs, not just one.
The same thing is likely to happen across all diseases and it's likely to happen because the focus is no longer going to be on Alzheimer's as a form of dementia or heart disease as a form of an organ disease, but we're going to focus on fundamental disease mechanisms.
Inflammation seems to be at the core of Alzheimer's disease, diabetes, heart disease, so we need to rethink as a society how we organize medical research. That means breaking barriers -- breaking traditional barriers between different areas of science that need to come together.
You're not going to study inflammation in Alzheimer's disease and in cancer or heart disease any differently, but you need to make sure you have a comprehensive understanding of it.
The same is true for protein aggregation. It's another mechanism that is invoked in both Alzheimer's disease and Parkinson's disease and other -- even in diabetes recently. This is again a cross cutting mechanism -- those underlying disease -- which in these concepts are novel. These concepts have been emerging over the past ten years.
So, these concepts are going to then lead us to reclassify our understanding of disease states in the first place. Where we're going to match the molecular signatures of disease with what happens to the patient, what we call a phenotype, and that will drive completely new strategies in health care.
And to do that we need much more precise, much more quantitative and much more accessible new research tools and that's why young universities can really make an impact by having the new investment in emerging areas.
I just heard about the 800 million dollars grant that you received on biosensing technology. Biosensing is right now at the leading edge, the most competitive area of science world wide. I visited Japan, China, Europe and here. Anybody who makes a breakthrough in biosensing is going to really lead the world.
So, these are the kinds of risks you have to take and take them now. Don't wait. Because that's how you dominate a field for the future.
So, the need in front of us is to transform health and medicine in the 21st Century. I don't think that we can use marginal solutions any more. I think that if we practice medicine the way we do today, 20 years from now, we will have lost the game.
And in -- whenever you have a revolutionary period like this -- it's like what the Chinese say, every challenge, every crisis offers opportunities as well as challenges. And the change is going to be [a] we have to intervene before symptoms appear, as opposed to what we did before.
We need to preserve normal function as long as possible and, therefore, intervene 20 years before Alzheimer's Disease develops, for example, and understand who is at risk rather than not knowing who is at risk and applying a one size fits all strategy in public health.
It's going to be very targeted, very personalized, very pre-emptive in nature. But that will require us to accelerate our discoveries at the fundamental level and to understand the pre clinical molecular events and our ability to detect, specifically, patients at risk. And it should be orders of magnitude -- more cost-effective than what we did today. No question about it. That's the vision.
As you know, you have in Washington you have about 30 milliseconds of attention span for saying something. So, mine is the four P's, and what's the vision, it's the four P's, meaning that the future of medicine will move from curative to preemptive and will be predictive, P number one; personalized, P number two; it will be preemptive, P number three. But more importantly because we have to intervene when patients are relatively healthy, patients are going to have to participate much more in their care. And, therefore, organizations like the University of South Florida and your health care system is going to have to develop a completely new strategy to be able to take care of these chronic conditions in places and ways that are completely different from what we do today.
And that will mean that the system of the future is patient centered, not doctor centered. And the patient/doctor relationship is going to transform itself. But the predictive nature will come from science and research for us to find the biomarkers that identify patients who have the likelihood of developing Alzheimer's disease.
Personalized: We know that people don't react the same way to different treatments. Who reacts to what treatment? Those are the challenges today. And we already see results. We've this year found the ability to identify patients with breast cancer who would respond to chemotherapy versus those who do not. And that saves about 70 thousand unnecessary chemotherapeutic treatments potentially per year.
We found this year that people who develop macular degeneration, old age, which is the number one cause of blindness -- can be treated with a cancer drug. This is something that was completely unexpected.
But the key thing here is to understand the NIH needs to continue its fundamental mission and that is to pursue knowledge to improve health. And that means a balanced research portfolio.
I only say this because it relates to the partnership that we have with industry and academia. The NIH investment is about 28 billion dollars. And the way we manage a portfolio is this pyramid that I describe where about 60 percent of our commitment is on basic research and 40 percent interview what we call applied research. Twenty five is translational and clinical research is about 15 percent of our total dollars.
Why is that? Why can't we do more of applying a massive basic and so on, why is it that we settled on this pyramid -- of this shape of the pyramid?
The reason is very simple. It's because there is another component to it and that private sector research. You just heard from Brenda Blanchard that four billion dollars plus that Novartis does. And in the private sector which spends twice as much as NIH. Biotech and [unintelligible] included.
The pyramid is inverted. There is basic science but not as much. Much more in translational science and then very large phase two--phase three trials. And those to together really have to be coordinated in a seamless way. And that's why we think it's very important, especially in difficult budgetary times to maintain our investment, the fundamental discovery and this is what we want to do.
On the other hand, we have to also think about the challenges as we see them, not as we wish them to be. And we need to apply methods that are not those of the past necessarily but allow people to experiment.
But to do that you need to understand what the fundamental barrier is in front of us. And the barrier is what I would call our limited ability to study complex and dynamic biological systems.
If somebody asked me what do you think is the number one challenge for our community -- it's because we've discovered much more complexity than we knew as there 30 years ago. And that's good science. That means that we understand that cells are complex, tissues are complex, but we need to develop the tools to study that.
This is a picture called cellular metro. This is just a little piece of one cell and all the colors represent different proteins, different molecules throughout the cells, interacting together. This is one cell. It's about a million molecules -- types of proteins per cell, 25 thousand genes, 300 thousand proteins produced. And then there are modifications and that's just one cell.
And the signaling between the parts of the cell is not understood, we don't quite understand always how a particular receptor sends a signal, triggers a completely different program within the cell. And these multiple levels of [unintelligible] are being discovered at very high rates.
But to understand the complexity of the system you will need to have better resources, better tools, better experimental and theoretical concepts, which will be needed. And because of that we have been pushing NIH to invest more in the physical sciences to bridge the gap between physical and biological sciences because you need to have new tools.
At the same time, we've encouraged all the information to be publicly accessible to scientists. And one thing we've done, which I think is pretty novel, is we work with industry to develop what we would call a pre-competitive world. Where the people is really of such a nature that it is -- in the best interest of everyone to have access to that information.
So, for example, last year we created through the road map a data base called Pup Cam. It gives you all the molecules and all the known interactions of that molecule with cells and bio [unintelligible]. Something that was never available to scientists before.
You know by gene bank and [unintelligible] bank, we're continuing to do this in terms of developing enough tools and enough knowledge for scientists to ask new questions.
Those things are the future. My field is imaging and I'm amazed at the progress of molecular imaging. This is from an NIH scientist, Dr. Jennifer [unintelligible] Schwartz. And she has found a way to identify an image, one molecule at a time in the cell.
What you see on this image is the old image on the top, where you couldn't really distinguish the molecules and the new images with the new methods that she developed, where she can basically track the activation of one molecule at a time in its location within that cellular metro that I was showing you before.
And that's what we've been trying to promote. The risk taking, push new area -- new methods of discovery, organize research teams differently, make sure that you don't freeze things in place and allow high risk taking in research.
And I think the message for you today is how do you as a community locally combine the powers of the university, academia, the business community in the talent pool that you have to in fact, go to those groundbreaking areas.
This is the advice I used to give to my post docs. When I was in my lab they asked me what should I do. I said look you have two strategies you can sign up for the US Open and hope that you end up being a champion or you can invent a new game. And if you invent a new game, you will be the world champion for a few days for sure. [Laughter] Before they catch up with you. But inventing a new game and making a breakthrough that was not known to others is the highest risk, the surest path to reward.
So, I want to encourage that change -- I want to be a change agent. The agency wants to be a change agent. What's to encourage innovation in the way science is conducted, because the problems we're dealing with have changed at an enormous speed and we need to encourage that.
So, if -- encourage the concept of partnership -- we think that private/public partnerships are going to be key. They can't just happen at the NIH level. As you know NIH has multiple partners, the public, public advocacy groups, Congress, universities, industry and start-up companies.
And one message that I would really like to reinforce is that synergy between NIH academia and industry is going to be the key to the future. None of the parties can do it on their own.
And to make sure the barriers that we are erecting and the barriers are significant -- regulatory barriers -- intellectual property barriers, local issues -- those things I think leaders need to really focus on reducing that.
Because if we don't, I think the US could lose its leadership. If we don't sustain our research enterprise it's very hard -- it's very easy to lose an investment that has taken 50 years to get where it is. Not so easy to recover it.
So, we need to be very conscious of the fact that all of the parties have to come together. And I'm so pleased to participate in Mary Woolley's leadership activities that she does around the country. Because at the end nothing will happen because Washington says so. It will happen because the local communities like yours take a view of the future that is based on research.
If we don't do that, there is no other area of investment in the long term that can be more productive for our country. Thank you very much.
[APPLAUSE]
QUESTION: Tom Kline I'm at the department of molecular medicine and the college of medicine. I have a number of questions but I'll start out with health care costs and the cost of research. Do you have any idea? I'm sure there are statistics on this, what does regulation contribute to those costs both in health care and in research. And would the NIH be concerned in terms of cutting costs and looking into if regulation adds significantly to this and if there is increasing regulation which will tend to spiral health care costs. Is the NIH concerned about this? Is this a problem?
ZERHOUNI: There are two parts to that question. I think it's a terrific question. We actually are seeing an increase in what we would call transactional costs, both in health care as well in research. And just health care delivery -- and as well as research.
If you ask a number -- what is the number -- I've heard numbers as low as six percent of health care costs. As high as 31 percent of health care costs are transactionally related. How much of it is regulation -- I'm not sure I know that answer. But there's no doubt that there is an inefficiency. You know that very simply because you look at the percent of GDP that we spend in our country and you look at the percent of GDP in Germany and Canada and developed economies -- where you can perceive a significant statistical difference in terms of the health of the population and yet we pay 40 percent more than that.
So, if you use that, you'd say 30 - 40 percent, six percent -- I don't know what the number is, but I can assure you it's not as efficient as it could be.
The second is in research. Now, transactional costs and regulatory costs in research have increased as well as intellectual property issues -- and you can see that in the way research is conducted.
Clinical trials take longer than they should in being implemented and being conceived, approved, launched, patients recruited and the cost of that is just going so high that many companies, for example, find it more useful to go to other countries and to out source so many of that fundamental, not fundamental but applied clinical research, because of the regulatory costs.
One of the things we've done -- we have this process called the road map where we identified roadblocks. And one of them was just that. So, we've advanced in many ways. First I created an office within the office of the director of the NIH called the research policy harmonization group.
And it looks at working with FDA and CDC and CMS and all of the federal partners to lower the barriers, to harmonize policies across. One example is adverse event reporting in clinical trials. So, we've worked with FDA. Took us two years, but we did and have now a single computer platform, a single electronic form and we are now expanding this across the government. But I think the point you're making is that regulatory costs are increasing as a percent of our effort and we need to take those costs down.
QUESTION: George Blank, I'm a faculty member at the college of medicine. Thanks for the visit. As you know, the NIH pay lines are at very low levels these days. And also as you probably know far better than I, it's unlikely there will be large amounts of money forthcoming from Congress in the near future to adjust the budget upwards. Does the NIH have internal plans or strategies for dealing with the pay line issue?
ZERHOUNI: I just mentioned this Science article that I encourage you to read, if you have access to Science, because I'm providing data there about it. The issue is very simple, we've had almost a doubling of the number of applications and it's not like we're giving less grants, really. It's because there are twice as many people are applying and there's been a growth in the number of applicants of 85 percent.
And, so, what we are doing is obviously last year -- if you recall -- because of the Katrina hurricane -- we have the first effective cut -- even though when you have a flat budget in inflationary terms it's a cost, it's a cut.
We cut the non-competing grants by 2.35 percent. Some of you may remember that and -- from committed levels. And there was uproar about it. But we needed to do this. Why? Because I thought that the most important thing we needed to do was to preserve the ability of scientists to protect their laboratories and continue their research.
So, we've reshifted that into the RPG pool, research project pool. I think the priority right now -- because we have this increased demand in grants and lower supply for grants, we need to balance those two. So, our priority is to balance the main supply.
We did that. So, I know people have these quotes you there, pay lines at seven percent, and so on -- it's not true. The success rate for applications was 20.7 percent this year for our one level grants. And for investigators it was about 25 percent. So, it's not as bad as some people portray it to be, but it's not great at all. And if we continue to have flat budgets it's going to get worse.
So, we need to really restructure the way we think about our investments in science and our priorities. And that's what the NIH is doing. So, we will try to maintain that 20 - 22 percent success rate across the board. And that's true for [unintelligible]. It's not true across all institutes. It's true that some institutes have success rates in the 12 and 13 percent range, but across the board NIH has done what it needed to do.
Because remember that the pain, you know, became obvious in 2006, but remember the doubling stopped in 2003. And since 2003 we haven't had inflation corrected budgets. So, our plan is to continue the investigative initiatives research with slowdown since 2003 the number of RFAs trying to really make sure that the demand/supply is addressed and that, in fact, we protect new investigators -- not to increase the number of new investigators but to maintain their level.
Because my fear is that they'll get discouraged and leave. So, we're trying to maintain that level to special programs like the independence award and things like that.
But the key to me -- the vulnerability is, number one, new investigators; number two, scientists who have a good lab, very productive and may close the lab because they're missing a pay line by two percent -- that is the vulnerability. The third is the scientist who comes for his or her first renewal. That's when you have a lot of difficulties. So, those are the three things that I have focused on. How do I maintain a reasonable success rate for those individuals?
QUESTION: Barbara Hanson, from internal medicine and pediatrics and former member of DAK [Phonetic]. There's a natural tension going on that you've beautifully explicated in that Science review showing both what's being expended and what's being pulled and making the case for the increment of five percent a year or more. And I think it's an article that everyone should read, because the agony needs to be better understood.
A couple of layers below you -- your staff are actively discouraging program projects on the basis that it will be an N of one and they tell me they want to uphold the number of RO1's. Is there any way you can change the counting mechanism to count each of the projects in a program project. Because in my view that will help the road map philosophically and --
ZERHOUNI: Well, let's not -- this is a very good point you're making. But I have to say that what we look at is the balance between demand/supply.
And you look at the road map. The road map is not one initiative. It's a process that funds about as many scientists as you would fund if you had another way of funding them.
But where we see the most increase in demand -- and the -- a flat supplies RO1s -- and in program projects and large programs what we see is that sometimes there is an oversupply in some of them. The success rates -- some of them are quite high, because there's not a lot of competition there.
So, I think institutes and advisory councils are looking at balancing that right now. So, you will hear that. You will hear that we're not in favor of large complying grants into one PI because I think that impoverishes and lowers the risk taking potential.
But I think we'll reach a balance. I think we're not there, but almost there. I think in 07 will be -- I think 08 and 09 will be better and I think things will get there.
But here's the issue: the issue is what is the vulnerability. If you have a field of science or a lab that is doing well, has two - three million dollars worth of funding and can't sustain itself into that trough -- you have another one that has one grant and is going to lapse and has good research. I think we have to make those judgment calls and we have to sustain the new investigators, the investigators that are right at the beginning of their career. The weak but the good.
I told everyone that we should really prioritize what we do to maintain the largest number of excellent scientists in the vulnerable spots that we can.
So, that's the answer. I know it's not satisfying to many. But it's not a counting game. It's really a vitality of science game. IN a time where, you know, you have the ten percentile -- top ten percent of your people should be funded, I mean, automatically. And some institutes can't get there. I want them to get there to make sure that -- no questions that they will reach the 20 percent success rate, which I think is the bare minimum.
QUESTION: Samuel from the internal medicine pediatrics and molecular medicine. I think the United States has been the number one country in the world, as a leading country, because of its strength in research, strength in research and development.
But the issue that concerns me is the issue of competitiveness. As we have globalized more and more -- but it is through China, India, some countries in Europe -- becoming stronger in research.
So, does NIH have a long-term vision -- 10 years - 15 years down the road what pathway it's going to take. How it's going to retain it's competitiveness in the world.
ZERHOUNI: Well, first of all, I don't think we have been, we still are. And the has been -- I disagree with that. I think what you're saying is rise of other countries that develop their strategy and research to an extent that is greater than what it was in the past.
Remember still though that if you look at our commitment research, we spend about 50 percent of the world total in research at the fundamental level, NIH and so on. And, so, if you just look at the NIH budget it's as large or larger than the rest of the world combined.
So, I don't know that that's -- the risk is resource driven. The risk I think is more in the ability to take a chance on new areas of science, to not be conservative, to encourage limitation -- to reduce the transactional barriers. To reduce what stands in the way of good scientists doing good science.
And, to me, the more open we are, the more competitive we are, the more facilitating we are, the more we will succeed. And I think in the long run our competitiveness is going to be based on what I said.
This is my slide. This is the greatest risk. The greatest risk for us is that we stop taking risks. And I think for me as a scientist myself, as the director of this agency, my whole focus has been reduce barriers, remove the ability -- the inability of scientists to work together in different ways.
Remove the ability [SIC] of scientists to come up with novel ideas -- that's why we had the pioneer awards. I think that's how we will maintain competitiveness. Enter new fields like biosensing, nano biotechnology, do not hesitate to do that, even though it's not the beaten path.
I think our ability as a society to welcome also the best scientists from anywhere in the world and encourage merit is something that I don't see in other countries. Other countries, you know they may be spending a lot more money, but it's more bureaucratic, it's more government driven. It's not the way we have it.
So, I'm not at all as pessimistic as others where we haven't lost our leadership. We are at risk of losing it, I totally agree with that, especially if we do short term cuts that will damage us in the long term, which is really what I say in this Science article, that I think all of us need to understand you can't maintain while you're going below inflation for two long. And those are the things that have profound implications.
This is the answers. You know science is unknown at the edge of science everybody's ignorant. So, we are just as ignorant as the Chinese or the Indians or whatever, we just need to take risks. Thank you.
[APPLAUSE]
[END INTRODUCTORY REMARKS, ZERHOUNI PRESENTATION AND Q&A]
NAME OF ORGANIZATION: RESEARCH AMERICA
REQUESTED BY: EMILY BOHR
PANEL DISCUSSION
RISKS, REWARDS AND RETURNS OF RESEARCH/FLORIDA
WOOLLEY: We're so fortunate Dr. Zerhouni to have you leading the National Institutes of Health and expressing your vision so compellingly. We're going to turn the program now to what I'd like to call the fifth P. You talked about the four P's, the fifth P is a panel discussion. I know he's participated in many of these. We're very privileged to have Dr. Zerhouni join us for the panel. I am going to be introducing our moderator today and just mention how important it is that as we talk about the challenges facing medical research, we're very conscious of having the voice from the media helping us think through how we communicate to the American public. This is a voice that we know at Research!America as we work on communication to the public and to public decision makers -- that the media is one of the most important ways of getting that conversation going, that essential dialogue with the American public.
So, we're very fortunate to have a skilled member of the media with us today as the moderator. Heidi Godman is, in fact, an award winning journalist, anchor and medical editor for ABC 7 News in Sarasota.
She's the first TV broadcaster in this country to be named a journalism fellow of the American Academy of Neurology. She has in fact earned many awards for her work including two honors for excellence in cardiovascular communications from Florida's American Heart Association. And a Sarasota County government proclamation for her efforts to help less fortunate children find affordable health insurance. Heidi, welcome and thank you.
[APPLAUSE]
GODMAN: So the press would be the fifth P, the sixth P. Before we begin I'd just like to congratulate Dr. Genshaft on the big win at USF. I'm happy for you and as a citizen of Florida and a television anchor it's very rewarding. It's especially, personally painful though because I went to WVU. And not only am I a graduate but my roommate dated a football player who's now the coach at WVU. So it was quite a shock to us. We have a very distinguished panel assembled today. So, I'd like to go ahead and call up the panelists now. Dr. Zerhouni is here of course. Also we have Marjorie Gatlin, vice president US Clinical Development and Medical Affairs for the Cardiovascular and Metabolic Diseases Therapeutic area of Novartis.
Also, Nancy Loving, who is the founder and executive director of WomenHeart, the National Coalition of Women with heart disease. Dr. Abdul Rao, MD, senior vice president, University of South Florida health and medical director for clinical research at Tampa General. He will be representing our academic center of research.
Jay Roland who is a news editor with the Sarasota Herald Tribute which is the largest paper in the New York Times regional newspaper group. Also, Jack Sullivan, who is the president and CEO of the Florida Research Consortium. Why don't you welcome them all? Thank you very much for joining us today.
[APPLAUSE]
GODMAN: So, we've heard a great deal from Dr. Zerhouni about the government's perspective about the investment in research, but we thought it would be a good idea to start with the other research sectors and go ahead and ask what kind of investment your agencies are making in medical and health research as far as the time and energy, the number of people and patients that go into it. And what is your return on the investment. And let's start with Marjorie.
GATLIN: Thank you. It's a great pleasure to be here today. As Brenda said in 2005 Novartis plugged 15 percent of our net sales back into research and development, across our entire portfolio, which includes a focus on cardiovascular disease, oncology, respiratory disease and neuroscience.
We are running right now 430 clinical studies in the state of Florida alone including seven at the University of South Florida in various therapeutic areas. And that investment has led us to this portfolio again that Brenda mentioned of 138 late stage clinical products, 50 of which are novel molecular entities, so not just me, too, drugs.
We will have several that will be coming to market soon, including three agents for the treatment of hypertension and diabetes novel mechanisms. So we believe that the payoff on our investment is substantial for the patients because patients are at the focus -- the center of everything that we do at Novartis.
And getting novel treatments to patients to improve their lives and improve their outcomes for them and their families is our main focus.
GODMAN: Dr. Rao, the same question to you. What investment your agency is making, what's the return.
RAO: Good afternoon and again I am actually quite thankful for participating in this event and for working with Novartis and Research America in organizing this.
As Dr. Genshaft mentioned, the university actually topped 300 million dollars last year in extramural sponsored funding both from grants and contracts. That was not sheer coincidence. That was the strategic planning process which started back in 2000 to enhance the research enterprise of the institution.
And the payback of that strategic investment and strategic focus is now what you are materializing in 2006 and I'm hopeful we will continue to materialize in the years ahead.
Just to highlight a few areas where we have made very strategic investment, one of the areas which is a topic of today's discussion is health care and health related and medicine related research.
We have made a very, very strategic investment in that particular area. We are moving from a very in focused environment in creating signatures programs that we will fund in the future. We are creating intellectual and infrastructure capacities within certain areas of excellence.
Those areas have been identified not out of thin air but based on a number of factors, one of which was what is our current intellectual capacity in those areas. What are the needs of the community in those areas?
Everything is driven by disease process. It's not actually driven by the number of scientists we have or the number of award we have. It's actually what particular disease process is going to benefit the most.
We have looked at what the national and regional trends are in science in that particular area. We have done an extensive and I must say exhaustive analysis of the road map and of other long term plans that NIH has and NSF and other federal funding and state funding agencies have in those particular areas.
And based on these five or six principles and the return on investment we have actually identified four areas. Four signature programs, but a number of imaging programs.
That has actually allowed us to take whatever limited resources a state university has and invest them with the maximum return on investment. Instead of recruiting a faculty who is supposed to be [unintelligible] funded investigators in an area that may be remotely related to what our focus is, we have now started to actually recruit faculty only in areas which actually are going to enhance the capacity of that institution.
The ultimate goal that the President and Dean Glascow has is that the medical school would actually not just be the driving force behind bringing change, but would actually be the change agent for the critical care that we provide to patients in the community.
So, in the area of clinical research we have actually taken a similar approach. We understand that we need to be leaders in the Tampa Bay area in trying implement some of the -- or translate some of the findings in the laboratories.
We have started a process of transforming our clinical research enterprise through the courtesy of many in the room. We were successful in obtaining a CTSA planning grant application from NIH which allowed the institution to set up its first institute for translational and clinical research.
That had set the stage, almost like a catalyst to bring about a radical change in the way we look at clinical research. We have started bringing about changes in clinical research at one of our affiliate hospitals, only as a test case, because the ultimate goal is that once this flourishes, we will actually export this model to other hospitals such as the V.A. the All Children's Hospital and other regional hospitals in the Tampa Bay area.
Dean Glascow's vision which we are trying to materialize is that he would like the Tampa Bay area to have a clinical super site. So that if you were to come to Tampa Bay area and want to do research in diabetes we can actually provide you with 20 different physicians with three thousand different outpatients any given day. And that is the type of transformation that the institution is going through at the present time.
GODMAN: That has a little bit to do with collaboration. And we're talking about the investment on research. But how is the investment on research impacted when you collaborate. And I would ask Doctors Zerhouni, Rao and Gatlin to please answer this collaboration and who are you collaborating with and what kind of a difference is that making.
ZERHOUNI: As I said in my speech, we realize more and more that you just can't do it without collaboration across the board, with industry, with community, physicians. I'm pleased to hear the word catalyst for change that Dr. Rao used for their new Institute for Translational Sciences.
In fact the fundamental need there is to remove barriers to collaboration. So, for example, one of the things we launched last year we had a pilot program where you could have what we call multi PI. Traditionally in the US system, there was one principal investigator -- had all the money, controlled everything.
And this process allows scientists who want to collaborate from different schools, from industry, with NIH with somebody else -- basically collaborate freely. So, the point you're making and the point I think everybody is saying is that science has become so complex, the disease complexity, the cross cutting nature of some of the mechanisms we're talking about require us to eliminate barriers to collaboration.
GODMAN: And what are some other examples, Dr. Rao, of your collaboration.
RAO: Well, first of all, we have initiated a process of collaboration. Bear in mind that not the NIH lived in silos before Dr. Zerhouni joined the NIH. But we have institutions here who actually -- departments live in silos. And there are colleges which lived in silos.
So, one of the things that is happening is that those firewalls are actually being deconstructed as we speak. It is the President's mandate that there needs to be interdisciplinary research. He's setting up centers and she gave an example of a center, which was recently funded by the state, which is actually a collaboration of the college of arts and sciences, many departments, biology and chemistry, the college of engineering and the college of medicine, along with a private/public partnership of number of individuals out there in the private sector.
We have got a number of collaborations going on within our college, within the colleges of USF, but most importantly with the affiliate partners. We have this very very strong collaboration which we feel is absolutely fundamental to our success is with our affiliate health science centers.
The V.A. being one example. It is right across the street. A great resource for the medical school and for the medical center and we are building a strong collaborative relationship with them. So, I think the areas of synergy and collaborations extend beyond just public/private partnerships. They are actually now becoming a part of life at this institution.
GODMAN: Dr. Gatlin, can you give us some examples of how Novartis is collaborating.
GATLIN: Certainly. We have a focus as Dr. Zerhouni mentioned on developing novel targets, looking at novel targets for our new drug research. And as he showed that reverse pyramid that everywhere have in industry, it's not possible for us in our research facilities to identify all those novel targets.
So, we currently have 280 strategic alliances with academic institutions around the world in partnership to help develop these novel targets that we can use then to develop targeted therapies for the treatment of multiple illnesses.
We also work in partnership with NIH and FDA through the new critical path initiative. One of our great challenges that we currently face in getting new novel treatments to patients is that the process is becoming increasingly inefficient.
As an industry, we are investing more and more in developing new drugs. But the rate of new drug approvals has been falling off over the last several years and that's simply not acceptable to us. So, we in partnership with the FDA through their critical path initiative have our own internal process called the Delphi process to identify a new way of drug development that will be more efficient, more effective and will allow us to develop these therapies that are targeted for patients that have multiple utilities across patients and allow us to identify not only those products that are more effective early on, but also to understand the safety signals. So, that we can invest wisely and bring in new products to market.
And we could not accomplish this without our collaborations both with our academic partners and with our government partners to bring these new products to market.
One of the best examples of this partnership is Glevac [Phonetic], which is a life changing experience for all of us at Novartis which developed out of a identification of a specific target at the California Institute of Technology, which then Novartis developed specific compounds to attack a specific target.
And this compound would never have come to fruition had it not been for that initial collaboration with that academic institution.
-- [tape cuts off] --
SULLIVAN: I'm in a room with people -- I am the highest handicap, lowest net worth and lowest IQ. Again, I'm the every man, the comic relief. What the FRC does and is, is more of a facilitating role than it is a direct funding role.
We have three goals in life and that is to improve the quality and quantity of university research in the state, to insure that more of that research gets commercialized and finally to insure that our legislative and other leadership understands why those two things are important.
And we can't do that alone. So from my perspective backing up a little bit, collaboration is absolutely important for us to insure that we have folks like the Tampa Bay partnership, High Tech Corridor Council, the Florida Chamber, Enterprise Florida and others involved and understanding and communicating this message. So, from a bigger picture perspective, collaboration is very important to me.
It is certainly important for our universities and my role in trying to insure that that would be done right is to probably give you a story that I've heard described at universities as a collection of feudal lords.
And if you think about it in that light, what I try to do is insure the king -- the king being the legislature and the executive branch -- recognize that collaborations need to be -- occur based on where the king puts money, as opposed to being a command and control kind of collaboration. So, that's sort of my perspective on collaboration and our role relative to it.
GODMAN: Can you tell us where the king's putting the money? [Laughter]
SULLIVAN: Well, in this past session, we were very fortunate that 103 million dollars was put forward for a variety of initiatives, one of which was just recently award centers of excellence of which you heard the number one institution both graded in the written presentation as well as the oral presentation and in terms of the funding was the University of South Florida.
Five awards were made for a total of 30 million dollars. So, again, the king put the money out and said, here it is, here are the rules. We want you to come and competitively work to obtain these awards. And our universities did put their best foot forward. And as a result Florida will be better because of that.
We also put funds in recruiting imminent scholars, 20 million dollars which is allowing our universities to go out and recruit talent from across the world, which will take us to the next level.
In addition, there was an additional 53 million that went forward for a variety of other purposes that included helping recruit SRI, I believe into the Tampa Bay area.
GODMAN: Ok, thank you. So, it sounds fabulous and collaboration is the way to go. But what do the patients think. Let's go to Nancy Loving now for the patient perspective. What do you see as the benefits of research and all this collaboration and some of the weaknesses too?
LOVING: Well, I think, don't overlook the power of patient advocacy in developing your programs. We developed an alliance with the Society for Women's Health Research with a lot of patient groups as well as with the women political leaders in Washington.
And we developed a strategic plan for research priorities. We called it the ten-Q report and what this did was identify the top ten unanswered research questions affecting women and heart disease. Such as: why is a younger woman more likely to die of a heart attack than a man? Why are women more likely to die after bypass surgery than men?
So, again, I would urge you to engage patient activists as well as your political leaders as well as your political leaders in helping you build your research capacity and also developing a strategic focus.
GODMAN: Alright, so you see that research is working but I know you feel there is some weakness in research and from the patient advocate point of view --
LOVING: Well, I think that the challenge is that there have been huge advances in research and medicines -- but not everyone is benefiting. Certainly women, in particular ethnic and minority groups, are not included in research studies. So there are huge gaps of knowledge about the physiology and diagnosis and treatment of heart disease in these communities.
And, clearly, not only we all need to be more included, but any gender specific or ethnic disparities need to be recognized and further explored. So, I think there is wonderful progress, but a lot of work still to do.
GODMAN: It's very interesting to hear the perspectives of those directly involved in research and from the patient point of view. But what about everybody else, the public. So, let's go to our media panelist, Jay Roland. Tell us how much do you hear about research, collaboration, synergy.
ROLAND: Well, I think the slide we saw earlier spelled it out as well as anything. There's a vast, huge percentage of people who don't know where this research is going on in Florida. And that to me is indicative of the kind of information that we get or the lack of information that we get typically from universities and from government as well.
There are a few universities that arte pretty good about providing updates and informational breakthroughs they make. The University of Florida is pretty good. Duke University we hear from a lot and there's I think a couple of others.
But for the most part, we really don't hear a lot about what's going on. And in government also too there -- so much information that goes out goes out through the medical journals and in a lot of cases, you're sort of speaking to each other. The public are not the ones who are going to be reading Science or the Journal of American Medicine.
If you look in the newspaper or watch the local news stations, most of the stories that are about research and health related fields you'll see in the second or third paragraph as reported this week in "fill in the blank" journal.
And what happens is the national media, the AP wire, New York Times wire, those reporters, they'll comb through those journals and they'll report them. That's basically news that we get.
Throughout the country, I would think there's not nearly enough direct communication from the universities and from the government, from the states to the local media, the newspapers and TV stations there.
On the other hand, I think the private industry does a fantastic job. Pharmaceutical companies -- we get stuff all the time, news kits and how they make doctors and researchers and patients available for interviews and stories. And that's great.
The only tricky part there, though, is that sometimes those things are -- they accompany a new product on the market and we have to walk a fine line between advertising and a straight news story.
That's not to say that the new products on the market aren't life saving breakthroughs and are not going to improve the quality of life for people, but it's -- when it comes to editorially deciding what's worth a story, what's worth our efforts, it often seems to be a very compelling case that this is really something different and special and not a similar product to what some of the things that are already out there.
I would say one other thing too though, the advantage that you have was also shown in the slide. There is a craving for information about medical and health related issues and our newspaper is a participant in the National Leadership Institute, done all kinds of studies throughout the years about what people want.
Every time in every market, one of the top two or three issues that people want to hear about or read about are health related issues and that's only going to get more as the baby boomers are getting older.
We crave information. You have a ready market out there. The newspapers realize that, that's what the readers want and we can help provide that too.
One other thing, a lot of newspapers now [unintelligible] just to create a [unintelligible] and a lot of the stories he's starting to do now are health related, too. As the boomer's go we'll slowly try to catch up and do what we can to recognize that need. I think the agencies need to be, if possible, more aggressive and take a cue form the pharmaceutical companies to help get the word out.
GODMAN: I would echo that as a television reporter, medical reporter. I've been in the OR dozens and dozens of times. And I'm the one that everyone calls with the story. And it's always the pharmaceutical companies. It's very rarely USF, I'm so sorry to say. It's very rarely any of the universities in our state. Duke is probably the best one at it. But we're not talking about fancy marketing kits, media kits; all it has to be is an e-mail. Put us on your mass email.
And if you can tell any of your colleagues about it, go ahead and tell us about it and maybe in Albuquerque this is happening or Seattle, it doesn't matter. It might affect folks in Florida and the local media would be interested. So, it doesn't matter where the research is happening. If it can affect all of us, everyone wants to know. Thank you.
Research is very big business. So, let's talk about the economic impact and go to Jack Sullivan. Tell us what's the projected economic impact sponsored by the FRC and does the state offer economic incentives?
SULLIVAN: Let me start and back up and talk about the economic impact of research at the state university we serve. It is a 1.5 billion dollars enterprise which is huge. And if you look at that in terms of what that translates by the time it filters through the economy several times, it's about a 5.8 billion dollar impact.
That returns back into the state tax coffers over 224 million dollars a year. So, just purely from the standpoint of looking at the direct and induced spending from research it is a major factor in Florida's economy.
But there are two ways that you can look at this. One is what I would call a static view, which is what I just did, taking spending whether it be on capital facilities, whether it be on sponsored research, whatever it may be, putting that through an economic model and coming out with what the impact is.
The other would be what I would call a dynamic impact which is what happens to the knowledge economy. What are we doing relative to cutting edge technologies and devices and things that are going to work their way into the economy, as well as our productivity, which is critical to Dr. Zerhouni's comments earlier today.
If we can be more productive that line hopefully won't continue to go through the roof and our productivity as a nation won't be impacted negatively by what we're spending on health care.
So, that's sort of the bigger picture. And if I go back and sort of describe to you -- I was asked by the former Speaker of the House as we were coming forward with legislation -- well, tell me what this is going to mean in terms of economic impact and jobs, which tells you a lot about how they perceive research and the economic development impact and what they think sells to the voters.
And in doing that, we developed a small model that said of that 103 million dollars, we expect over the next ten years that we're going to get 618 million dollars research, based on the investments and the infrastructure of research, again, facilities, equipment and talent.
Out of that we're going to get activity that's going to generate patents, those will generate licenses. Those licenses are going to generate economic activity. We expect there to be about seven thousand jobs supported as a result of that 100 million dollars.
We reasonably expect seven start-up companies. I think we'll get more. And we expect a 1.8 billion dollar increase in the gross state product of Florida and a 71 million dollar increase in tax revenues for the state. So, that 103 million dollar investment over the next ten years will virtually almost pay for itself on a very conservative level.
GODMAN: Alright, thank you very much. Nancy Loving, what can you tell us about the economic impact of heart disease?
LOVING: Well, we recently did a survey of all federal health care dollars spent on women's health and it comes to about 75 billion dollars. And we found that half of those dollars were spent on treatment of heart disease in women. Not research, not prevention.
And I think one of the reasons that figure is so high is because there has been such limited research on women and heart disease. So, there's huge gaps in knowledge and money is being wasted quite frankly on treatments and diagnostics that have not proven effective or safe in women.
We found that NIH puts about half a billion into women's health research, but CDC puts 31 million. You know, the numbers should be the exact opposite. We shouldn't be putting half of federal money spent on women's health on treatment of one specific disease. It's appalling really.
GODMAN: Thank you. Dr. Gatlin, can you tell us how much of a roll did the payers have in Novartis' decision to bring a drug to market.
GATLIN: We work with payers closely to guarantee access. Payers don't play a role in what drugs we bring to market. However, what we do do is when we are developing a drug, we make sure that we are developing the information that demonstrates the value of that medication. Because that's what we're dealing with with payers. What is the value propositions -- as we call it -- of them putting that particular treatment on their formula so the patients can have access.
I think it's a good development that it's not just a matter of, well, yes this drug is better than a placebo. Because doctors aren't using placebo but we do a lot of trials comparing to other therapies that are already out there to demonstrate the value so that patients can get that true value, not just the benefit on the efficacy side, but perhaps a better side-effect profile, perhaps a compound that's easier to use so the patients don't have to go to the doctor that often.
So, that is a collaboration that we have payers to demonstrate the value of medications and the value of treatments to patients and in some cases, for example when we're dealing with Alzheimer's or other things, the value also to their families and their care givers.
GODMAN: Dr. Zerhouni, how does NIH translate NIH research into new pharmaceutical drugs?
ZERHOUNI: Well, I think you heard part of the answer in the fact that many of the targets that eventually end up being targeted by pharmaceutical research are usually discovered in fundamental research.
It's typically a scientist who really was looking for something unrelated to any potential application. So, basic research is usually the richest source of insight.
I'll give you an example. The Nobel Prize this year was given to two scientists, Craig Mellow and Andrew Fire [Phonetic]. Who discovered a process which was unknown to us six years ago, maybe a little more, maybe eight years ago, called RNA interference.
That process was completely unknown to pharmaceutical or academia, anyone -- or the agency -- he was doing an experiment where he was trying to repress the activity of RNA which is molecule that sends a message to produce a protein.
And for years people thought that you could suppress the RNA with what we call anti-sense [Phonetic]. And he did the experiment and lo and behold he found that you needed double message, double stranded RNA to do that.
Well, all of a sudden, in hepatitis B today and hepatitis C in HIV/AIDS -- and I can tell you the other diseases -- there are very, very promising programs that industry -- I know Novartis has done that. I know other companies have developed libraries of RNA interference tools to be able not only to understand the disease process but develop treatments.
So, we have had experiments in animal models, where you can in fact control hepatitis -- the damage of hepatitis through RNA interference injections. Here's an example of the transfer from a research that had absolutely nothing to do with therapy, a discovery that was fundamental in applications that you see in the sector.
So, generation of knowledge, discovery of completely new insight, the ability for us as NIH to do research where industry may not be interested; in doing for example, vaccine development. We have our own abilities to develop vaccines. We developed the vaccine for the [unintelligible] which was the cause of 50 percent of all cases of mental retardation in this country. We had 11 thousand cases in 1995; we had less than three last year. That's the kind of research we do.
The safety of the blood supply. All of the research that was done NIH -- Harvey Alter [Phonetic] is the person who did it to detect the HIV contaminated blood supply and so on. And if you look at the safety of that, in 1967, you had about a 30 percent chance of contracting some disease through transfusion. Today it's .003. It's one of the safest things we do.
So, NIH has a role in rare diseases where there isn't a lot of the market; vaccines with prevention. That's a very hard one to economically sustain and public health and safety, as well as fundamental discovery.
GODMAN: With the economic troubles that government funding is experiencing and maybe throughout the country though -- how do you attract the high caliber individuals to research. Anyone want to address that?
ZERHOUNI: I'll address it, because I think you absolutely put your finger on the number one issue. And I think somebody was mentioning is that going to affect national competitiveness in the long term our ability to -- and this to me is the one thing I lose sleep over. I have other things but this one is the most common one.
And that is the fact that if you look at the young scientists today, the training period is longer than it ever was. What you need to know as a molecular biologist or a translational -- or any type of science -- you need to do a PhD. They usually are six - seven years long. You need post doctoral fellowships, six - seven years long.
And you don't get your first grant until you're 38 years old and maybe your tenure track position at 38. So, when you're 25 years old and you say, I want to go into science and you compare that to your colleagues who are going into banking or investment or whatever other branches, law -- and you say, by age 35 I may have two kids and a very low salary and no guarantee that I will succeed, that to me is something as a country we have to tackle. And provide career pathways for scientists that are different than the one we've generated over the past 50 years.
GODMAN: Dr. Rao, what are you seeing among the young researchers?
RAO: Well, the recent data came out of the National Research Council and the data suggested that there has been in the past three years a gradual increase in the number of graduates who are actually coming out from the doctoral program in science. And particularly stem.
And it's largely because of the doubling of research dollars at NIH, the increase in NSF funding, which has given some hope to these students that perhaps this is field that they can go into and graduate and get a half decent life.
This trend is changing. And this trend changing and it is most palpable at the level of the departments and the programs, because what we are witnessing is a decline not only in the number of applicants but in the number of qualified applicants who are applying for doctoral programs.
More students are actually opting for a masters or perhaps into areas which are other than stem. So, I can give you specific numbers, but -- of our own biomedical graduate program at University of South Florida -- that the numbers of students who have applied this year for our doctoral program in integrated sciences dropped by about 33 percent.
And the number of qualified applicants -- and there is a certain bar below which we do not go -- was actually even more. So, we are seeing a downward trend. It's going to come and haunt us a few years down the line.
And there needs to be -- I'm glad that you raised this issue because one of the most important engine other than the faculty obviously is the graduate students. And if we do not create an environment which supports and continues to invite the attention and engagement of young minds to come into research, it's going to become a very difficult -- to fulfill our needs in the future.
GODMAN: Thank you. And from my perspective -- and I'm sure Jay's also -- this is where the media really can help. This is where we can make a big difference but we can't do it without you. And I know we have a lot of researchers and pharmaceutical people in here. So use us. Tell us Jay, what do you think is the role of the media.
ROLAND: The one advantage I think you have when it comes to health related issues is that it doesn't have to be a big sensational controversial story. I think newspapers and I think mainstream media in general see their roll as really kind of a conduit for this kind of information. They realize that what people want is news you can use.
And they want hope too. They want to see that there are breakthroughs coming down the road, that there are things -- that work is ongoing that will help them down the road as they age or will help them or the next generation of children and grandchildren.
And, so, we typically are -- the shortage of the flu shot -- we got called all the time, where can we get it, how can we get it. And we posted this information on our web sites and we run things as often as we can.
The nice thing is it doesn't have to be really flashy kinds of stories. It can be straightforward news. This is going to help you in your life and I think it is somewhat the same for television.
GODMAN: Well, I see myself as an educator. And I find myself in the position of being a go to person. If I do a story on heart disease or some new treatment or some new surgical procedure happening in town, people call me not only about that, but my second cousin in Idaho has X. What should I tell him to do? So, I've become sort of a referral service.
So, I really need to do a lot in educating and I take it very seriously. It's a big responsibility -- a privilege that we have, but also a great responsibility.
Alright, we're almost out of time for the panel questions but I'd like to end it by asking each of you. Dr. Zerhouni talked about breaking down barriers. So, I'd like to ask each of you, what are you doing to break down the barriers?
GATLIN: Breaking barriers. We break barriers at Novartis all the time in the interest of delivering better medicines to patients. And one thing I'd like to address is what Nancy brought up, which is the inclusion of appropriate populations in our clinical studies.
I'm very proud of Novartis' track record in that area. As I said, we have two new products coming to market quite soon. One for the treatment of diabetes called Galdis [Phonetic] and I'm very pleased to let you know that 45 percent of the patients enrolled overall in that clinical program were women. In the United States twenty percent were Hispanic and 17 percent were African American.
Same for our new drug for hypertension; 47 percent of those patients were women, 20 percent African American and 18 percent were Hispanic.
So, one of our major goals while we break down the barriers between the different parts of our company and have a mor