What IP does to help support the ecosystem here at Georgia Tech or in general in the bio science industry most particularly that's that's where I've spent most of of my career over the years. So if you can you can drop the lights on the front that's great because I think it'll make it easier to see. So Lisa told you a little bit about my background bunch of education formally and then twenty five years of what I call informal education in various aspects of the bio science industry both the United States and globally. I was very fortunate in my career and working for the American sub of European parents they take a very high interest in management and development where you get a broad exposure and an active way to the various functional aspects of the industry. So a little bit about one of my favorite quotes and this is from a friend Jeff Nicholson Jeff you may know as the person at three AM who invented the post it notes who went through the the numerous trials and tribulations in getting their management to accept them as a viable product and I think it highlights the difference between research which is the transformation of money into knowledge and we all know we all can spend lots of money but innovation is the transformation of knowledge into money. It's the transformation of those basic research discoveries into products and in the bio science arena. I would purport that that's the only and the only way to get products into the hands of patients in our case who can benefit from those products in their care of their own quality and length of life. So a little bit about Georgia Tech. I'm fortunate now and being responsible for helping our faculty commercialize their. Bio science discoveries for those of you who are maybe new to Georgia Tech Georgia Tech has a very long heritage in commercializing faculty inventions back. What's the school about one hundred twenty five years old now so the Early on inventions were in classical engineering disciplines sociate computer out. Software and the various hardware components that associate that and about over the last ten to twelve years Georgia Tech has made a huge investment in bio science related research just the bricks and mortar investment is somewhere on the order north of three hundred million dollars. And. The can comment faculty and research commitment that goes with that. So a little bit about what I call building an ecosystem ecosystem is an environment in which we can help nurture discoveries. Through products. This is my favorite circle the components that make up this ecosystem and I'm going to share a little bit of my view of each of these elements. First of all little bit about research dollars in two thousand and nine Georgia Tech landed on a little bit more than half a billion dollars in research and this can show you where the Friday of that money went. The major research support for National Institutes of Health comes primarily from the National from National Institutes of Health for Bio Sciences. Secondarily there's a fair amount of money for bio science related research that emanates from the Department of Defense and it's very sensitive. So a little bit about the nutrients Well first of all you need to have world class research talent. That's the key to any of this whether you're in an academic institution or in a private company interested in me. Being in translating innovative discoveries into new and competitively differentiated products. So we're fortunate here at Georgia Tech as are many of the other academic institutions like our sister program and biomedical engineering at every university in attracting significant research talent. That's been facilitated over about the last twelve to fifteen years by a public private partnership called the Georgia Research Alliance which is managed to attract eminent scholars world class scientists in various scientific disciplines from around the world to come to our various universities in Georgia. They've also managed to help supplement both facilities and equipment that are necessary to conduct research. So a little bit of is is occurring in academic in the academic world today when we think a little bit about how we reinventing academic disciplines and I think a joint program that we have between Georgia Tech which is a public institution and Emory University which is a private well endowed institution in biomedical engineering is a good example of that partnership. Of students get able to move and benefit from classes and research experiences at both institutions and if a ride a of tools are in place that help facilitate the interaction between the faculty and students and that includes all of the various kinds of social information sharing tools be they be physical library resources like Georgia Tech medical library at Emory for example and then things to facilitate the interaction of people like a shuttle bus that runs all day long between the sites. A little bit in terms of what helps these. Discoveries emerge. First of all is an increased emphasis on into disciplinary research a tremendous amount of collaboration. Georgia Tech alone has over one hundred we call research centers on campus these a collaborative endeavors. Between various departments and faculty members they cover a wide range of areas from biomedical engineering nanotechnology Microelectronics fabrication. Things like broadband regeneration. And it goes on and on also supported by some of our Georgia Research Alliance what we call phase hero initiatives. Disaster a natural selection process that occurs. In the bio science arena whether you're dealing with a medical device a pharmaceutical a vaccine or a diagnostic if you don't have IP You might as well not bother. The investments that are required. I'm going to show you some of that data just to lauch to guarantee a reasonable return on investment if someone's going to be able to come in and copy your discoveries. So intellectual property protection is key. That's not the same as in many other areas. People in our software departments may often tell you that everything should be open source and freely accessible that that doesn't work in the bio science arena. We have a program at Georgia Tech called Venture Lab. Which really helps bring business management and money to the table to help our faculty in first deciding whether an invention is worth commercialising And secondly how to go about that actual commercialization process. And that's supported by various early awards through Georgia Research Alliance Georgia Tech alumni Edison fund and increasingly in today's economic climate the importance of small be. And this innovative research rewards become a mainstay of getting these car companies bootstrapped and funded it until they can attract venture capital money. So what are some of our intellectual property goals here at the institution I think these are true of most academic institutions first one wants to recognize and reward faculty for the creation of valuable IP. Everyone will give you a different definition of what constitutes valuable IP. Valuable IP in my mind is something that ultimately gets vetted by commercial partner or potential commercial partner in terms of their interest in ultimately licensing or doing some kind of transactional deal with the company. It's also important in supporting innovation and strengthening the research programs in several dimensions. Those institutions that are capable of generating protectable IP of those that many commercial entities would like to come and work with They'd like to sponsor research at the institution. What programs they're in that's good for the institution overall it's another vehicle by which we can strengthen our global reputation and it also represents a quality stamp on the quality of the research that we do and I guess in two thousand and eight. I think Georgia Tech was number eight in academic patents worldwide. It also is important in attracting top quality faculty and students who want to see their inventions potentially applied and it want to be at the cutting edge of what's being done in the research arena years. It also helps create successful entrepreneurs. It's one tool in that tool kit if you will that's necessary to have certainly for bio science related discoveries. It helps strengthen our local technology community and Georgia. Has a keen interest and a governmental level in building its bio science related industries. We're certainly behind the coin as far as it relates to many other areas of the country such as the West Coast the northeast and even Florida. Right now is not the time to ask the state to spend a lot of money. But there is a strong interest in strategically supporting bio science companies in Georgia. So recently we landed as a state a new pharmaceutical company called Dendreon which recently had approved a very very unique individual lives therapeutic for treatment of prostate cancer. So it's based on in part the revolution that's occurred in biotechnology. But it basically involves taking the individual patient cells. Shipping them to Dendreon where they go through a sequence of immune boosting exposures that then packaged up and shipped back to the doctor who then has to infuse them into the patients. So that was kind of an interesting thing to land here. Unfortunately we didn't land the research organization that remains up in the northwest. And importantly we strongly believe in the bio science community that in order to translate these discoveries. Into products that can help humans IP is an absolutely essential requirement. So what are some of the challenges we face both as an institution and as an entity to try to commercialize things first of all as the research infrastructure at Georgia Tech is grown dollar wise people wise facility wise and you name it wise that places an increasing demand on our various services in the institution which have to evaluate these invention discoveries or invention disclosures. And to. Well you wait those adequately requires a fair amount of time and intellectual effort. Also as we know the world is increasingly flat. And maybe in the past you could could have gotten by with just a U.S. patent since clearly in the bio science area. The US is the single largest and most profitable market but increasingly the companies that are looking at these discoveries are global. And they are often turned down one product in favor of another even though the second product may be inferior because it has global IP protection for an institution like Georgia Tech. As are bio science efforts and discoveries associated with them have exploded over the last particularly five years that places pretty good strain on the institute's resource budgets for patenting in particular and as we patent globally as many of you people in this room know it gets pretty expensive pretty fast. And unlike the industrial world where we can keep our discoveries close to vest until we for example file our first regulatory filing. The academic world is driven by different measures. You know so publication is key in communication of those results. That means we file an earlier. That means this whole process in Tottenham starts earlier. Now the actual product development cycle is no shorter. So the net result of that is that the residual patent life at the time of approval of that device or drug is actually shorter when it comes out of an academic institution in a general sense than it would be coming out of an industrial organization. We also find getting increased competitiveness for both research partnerships particularly from overseas universities that historically had been kind of quiet. But they suddenly realize they can make money but by working in the right. Way with industry. And then as any other thing we have constant changes going on in terms of patent trademark changes not only in the US but also worldwide. And some of those are good for the industry and some of those perhaps are not so good. And you know time will tell. Will those go importantly for the industry is knowing what the rules are. We don't know what the rules set is and we have a product development cycle that's ten to twelve years. It's really difficult. A little bit about the process we use that TAC It is rather formalized to evaluate IP. It begins with an invention disclosure. Which really is the faculty members. Discussion of what are the research findings importantly what do they see as the commercial implications of those. Usually they're on the cutting edge knowing what all of their colleagues and collaborated at other institutions are doing in similar areas. So we also ask questions around. What is the competition that you're aware of that that goes through a technology kind of assessment and analysis which really results in a decision about do we protect the IP now in the United States we're fortunate we have a provisional patent application process. So we basically file a provisional on almost anything. OK that gets it out the door does kind of limit things a little bit. If you don't think about what you're doing in terms of spend. But generally you can live with that and gives us a year to figure out what it is we really want to do here. And if we do decide to protect that IP. We go through various IP protection and filings oftentimes using X. Journal counsel resulting in formal patent application. Sions traditionally first in the U.S. of course we also support that with a detailed market analysis by commercial experts and one of the things that's rather unique about Georgia Tech is its staff to its commercialization services with industry experts specific to the domains of the various technologies. So they actually have people who've worked in industry who've been there for many years who have networks of contacts in industry that are actually doing their commercial market assessment of their technologies. There's a business development process that begins to move forward in this where we really look at. Is this opportunity of forming a start up company. Is the technology broad enough that we can gets potentially several products out of it such that we don't put all our eggs in one basket. Or is it something that we may be better off licensing to a potential industrial partner. And if that's the case we will still do some technology marketing ultimately seeking the licensee which would gains the rights to that product. In the case of a start up. It runs through we call a Venture Lab process internally. But basically it's a means by which we assist faculty and the other founders. In in all of the aspects of commercializing those discoveries. And ultimately helping them find the right kinds of management and money that are absolutely essential if we decide the Institute doesn't want to pursue commercialization of that technology they can actually give the rights to those discoveries to the faculty members and that happens a fair number of times as well. So really at the heart of this is where this Venture Lab program sits. It's at the intersection between our various technology assessment process sees and business assessment process sees around that technology. It was first founded in about two thousand and one here at Georgia Tech. It is now a model used for by many of the universities and if you go to websites like the Association of University technology managers it's replete with references to the venture land program at Georgia Tech several of those institutions have significantly enhanced the price of the program we've learned from that make corresponding enhanced Mincey here. And it's part of a larger group of tech which is called the enterprise innovation institute. But importantly the staff has really substantial private sector experience. And so besides the bio science side we have expertise in separate functions dealing with computer hardware and software general electronics mechanical engineering. Well and who are people who have a fair amount of industry experience have an F. in them sound started companies. In those kind of general areas and been successful in attracting funding to grow those companies. I process is very faculty focused. It really involves working on the risk identification in mitigation process sees around that technology and assuring that this technology will be able to be backed by external funding vehicles that are non-governmental so that we get a fair amount of industry and experience venture capital vetting subsequent discoveries and and commercial start up companies. But the Gulf. Is building successful startup companies based on Georgia Tech and throughout Georgia type research that. Venture Lab really deals with these. Five factors. This is what's essential to any start up company I don't think that's particularly new or novel but it's the market in the protections you can get in that market place the milestones are you going to be able to measure the deliverables and the advancement of both the company and of the technology. It's a matter of management and money that help faculty realize the fruits of their inventions. Now Money Money is a big topic these days after the last few years of venture capital funds while they all have lots of money. And not rushing to spend it. And you'll hear it described as well we've shifted towards later term discoveries. That's just another excuse for not spending money. OK And that puts the venture capital community if they truly late stage in heated competition with the established medical device and pharmaceutical industry and I can tell you is going to win out in that battle. And so what's the message is happening is we're creating a hiatus in the funding of early stage opportunities. We do have three vehicles that are accessible to us runs the drug your research alliance which will give grants and loans to start up companies typically up to three quarters to a million dollars to help them get off the ground in the early stages. Since it does represent state money can't be used for certain things like paying patent attorneys. The best you know so we get all the money to do that job to check out ison funding as alumni fund which will take equity investments in these companies and S.P.I. our money which is really the small business of the federal government through its various funding agencies that can assist with small business grants from the various federal agencies. And they will pay for patent money by the way. So so that's really the summary of loops where we go in here. So a little bit about S B I R Because it is. The most valuable tool today you get sizable amounts of money when you get into phase two S B I R grants it comes from the primary federal agencies and for most of our discovery work places like NASA. And I said sure very interested in funding new discoveries that are aligned with their research interests. These are grants not loans or equity and hence they what we call non diluting financing they don't dilute the ownership stake of the starters of the business venture capitalists will come in and for relatively small contributions and of money they want large percentage ownership and control of the company. And it's always a balancing act because he says the good V.C.S. bring with them a heck of a lot more experience than just money to the table. So they absolutely can add lots of value. Georgia Research Alliance I already talked about this new information there. If you like it but but the importance of these things are it really provides in essence about a four to one leverage in non diluted financing. So between I.G.R. a money and smearing the monsoon friends and family money that usually you can land we can get a sizable amount of money into the company for what still an early research discovery and hence doesn't require lots of amount of work. We do several things to help the what they ate this process at the Institution for example Georgia Research Alliance money is exempt from university overhead. So every dollar really goes to work to work on the research. And it doesn't matter if I'm a Georgia Tech faculty member whether I'm spending G R A money at Georgia Tech or let's say Emory or Georgia state throughout the state system public and private institutions overhead is waived. So when you look at what that is percent. That's actually is a sizable turnaround in dollars. It's a little bit about the incubation Philly's. At Tech we have a group called the Advanced Technology Development Center. We affectionately call it eighty D C. It basically helps incubate new start up companies and we have specialists aligned there based on the domain expertise of the technology. It also is a means to access what we call G.R. a Phase three loans which are loans that gap to get matched one. Three four one I guess. We have access to George's Seed Capital Fund which is a small state venture funded I venture fund to make investments in companies. We operate in in collaboration with the minority business enterprise center. We've managed to attract a lot over the years of about thirty years National Venture Capital type attention primarily in our more computer hardware and software and electronics areas which are you know traditional areas of strength. And more recently in the bio science arena years and then the state of Georgia has various centers of innovation which are state wide technology areas that the state supports. A.T.C. offerings in a nutshell are really focused around providing strategic business advice in the form of consulting free community interaction with entrepreneurs connections to people and resources that can help get our start up companies the kinds of information and solutions to problems they need. We do have physical facilities for startups on the Georgia Tech campus we have a wet lab incubating and anybody who knows Georgia knows that. Well labs are in short supply. So right now we have sixteen companies in that incubator with the exception of one. They're all based on Georgia Tech technologies. They're all by. Science related with the exception of another one which is biofuels related and these are just basic right laboratory spaces nothing fancy in which these companies can grow and exist in avoids the issue of who owns the IP because they're not working in the university labs officially. And it brings a lot of external recognition to startups that have grown through the detail kind of mentoring formal and informal processes we offer a T.D.C. as a commercial was just recognized a few months ago by Forbes as one of the the top ten technology incubators but in fact is changing the world in their language. Now this only works if you have a cycle of renewal. So we wrestle service a bridge to other resources in Georgia Tech and services that may help propagate the next stage of advancement in that technology. Is there's a logical progression here because the faculty member we don't want them to leave the university. Right. That would be a terrible loss so but as you've had one success that tends to build the interest in future successes and there's a network amongst faculty who have successfully started companies that have done it several times the tend to talk to one another and that builds additional interest. We offer seminars workshops technology briefings and we offer access to be able to kind of test out the concept around whether the technology should be company a company or be licensed. We have the research labs we talked about and we helped bring access to the kinds of unique and expensive equipment that no small startup company could afford to go out and buy on their own. So you know these successful companies that spin out from universities and this is not unique to Georgia Tech. But what you know. They often turn times turn around and sponsor research back at the institution which point they do pay our overhead charges. Importantly they serve as a source of employment for many of our graduates and that's really good. If they themselves oftentimes will spin off new companies. So and then what happens with our successful graduates they do things like give money to the institution help our endowment. That's a good thing. They oftentimes if they're successful will turn out to be angel investors. These are people who make relatively small but still meaningful investments in technology companies they oftentimes understand the technology they were offered their free time and advice to you know people who are emerging as entrepreneurs for startup companies to help them avoid some of the same mistakes that we all inevitably make going through this process. And that provides further nutrients for the ecosystem because the more of this you have around you. The easier it is for a new start a company to emerge and be successful. So so that's kind of my cycle of ecosystem life around commercialization. I want to turn turn the tables a little bit and talk about the importance of patents. Now the data I'm going to show you is based on pharmaceuticals and that's only because the data on medical devices realm trending in many of the same directions is just not as solid or the data and pharmaceuticals is pretty solid. This was from a survey done in one thousand nine hundred six by Mansfield published in management sciences and it talks about it. Asked a variety of companies in a survey format. By industry types. What would happen if you didn't have a patent and case of pharmaceuticals sixty five percent of the the products that they have developed wouldn't have been developed. That's a pretty high percentage stands out amongst all the end. Stree medical devices pretty much approach those numbers chemicals are a bit longer and you can see where the more industrial type industries go yet at the same time in the last twentieth century. We've had tremendous scientific driven explosion. In knowledge which is fueled a whole variety of different kinds of innovations. Everything from new agents to treat disease to new approaches to eradicating disease in the developed world and undeveloped world and this just highlights a few of those for you. Now this song gets paid for by somebody which I guess is changing. The but I thought it was important to put in perspective. Where does your health care dollar go today and point out that despite all the rhetoric we constantly hear about pharmaceutical prices only ten percent of the total health care dollar goes towards pharmaceutical costs. This is data through two thousand and nine. So it includes the benefit of the Medicare drug benefit that was introduced in a rare in two thousand and seven two thousand and eight. I also want to emphasize the fact that this is what's happening to health care spending. Now. That's a reality. And it's probably driven by the increased cost of most of the new discoveries. And importantly it's also driven by the fact that the population is living longer. So thirty years ago when I knew my grandparents they died in their fifty's. Nowadays we have people living into their eighty's and ninety's quite routinely now what's happening however is these chronic diseases. And now kept at bay being hyped. Tension Diaby East even cancer to a large extent. And so they're living longer and they get to get more chronic diseases and they want to have more problems and that's going to cost you in hospital bills physicians bills and drug bills for that matter. But I do believe in my my little commercial. That these advances in medical care is something that for the American population. I would call it a right. But. Some people call it an expectation but but one of the things we do very well in this country in supporting this is we have parallel round roles that are quite distinct between that of the federal and academic institutions and that of industry so on the left you can see from I guess this was two thousand and seven data and I H spending was around thirty one point two billion dollars. OK in the major emphasis it and I H. is on basic research on those fundamental discoveries increasingly we're hearing and I each talk about translational research. Everybody has also a different definition of what translational research means to me it means taking the discoveries from the bench and moving it to the bedside getting it into a person where I can test it. And I support some of that but certainly not to the extent that you find most of the industry doing. Well a private sector is focused on the later stages they want to take these discoveries and translate them and reach a decision on whether that discovery has applicability to the treatment of or diagnosis of human disease. So I don't forsee is tends to be more in the translational research aspects and the clinical research that ultimately supports the approval of that. But this ecosystem between the federal and the private indeed. Stree is rather unique in this country and the United States really stands out in the world in terms of how that information moves back and forth. A little bit about medical research and gentlemen the U.S. just to give you an idea of number of compounds in development. This is data that covers from ninety seven through two thousand and nine. And the top line shows you that that most of the compounds in development be they by industry or by the academic world are emanating out of the United States. While areas like the European Union in Japan have either been flat or slightly deep declining and this red line represents some areas like the Soviet Union and some of the Third World countries but the lion's share of discoveries are driven out of the United States. Goes hand in glove with this is now I have a discovery I've got to get it approved. You've got to go through a process that's called drug development. It's a regulated process in this country as well as overseas. But but fundamentally despite the advances in science. Very few of the compounds we start off with make it through these various steps. Some are on the order of twenty percent make it through all the way if you're lucky. And most of those fell out in the various forms of preclinical research around efficacy and importantly safety a small number make it into clinical trials and the clinical trial phase is have been increased in terms of their duration and scope and hence cost ultimately resulting in an approval in our case by the F.D.A. or in the European case by the European Medicines Agency and there's an ongoing period of post marketing surveillance that legally is required to monitor your product. But but if you look. This in just add up. Even the minimum numbers you're talking about nine have to ten years. If you're lucky. And at you filed your I P somewhere over here. So how much is really left. When you get out over here. You know less than half. Now in the United States. There have been various patent extensions rules and regulations put in place which allow you to recover some of the time consumed in the regulatory process but not all of it. And I'll give you incentives for for example doing studies and pediatric patients but none of those show. Well come anywhere near to the cost of developing a drug. This is data from Henry Duke and this is already old two thousand and five it cost on average one point three billion dollars to develop a drug to commercial markets. Hoops. And as I mentioned a small fraction of the make it freely through and since few of these are actually a commercial success. With every one of them you're rolling the dice a C.E.O. of a French pharmaceutical company who I know pretty well actually used to say they were very successful in central nervous system does disease drugs like depression therapies and used to say we never seem to be able to follow on but we still spend almost three billion dollars a year doing research in developing this area fundamentally because we can't tell what's going to make it but if we do make it with one. We'll make an awful lot of money to cover the sins of many other programs. But this gives you the after tax average return on those of course and you can see very few drugs managed to to meet the mark. So that obviously raises the question of the question which is what I'm going to leave you with. Which is how could anybody consider doing this without the sense of security which property rights give you. And a property rights significantly get reduced. I would propose that the land much like his nascent seven hundred seventy three will rapidly become uncultivated and will also suffer. So I thank you very much and I guess I'll try to get through any questions if we have time when I'm going to be you know. Well you know. My. Just my own yeah absolutely. I would say. You find a lot of these things as I call a laboratory tools. Well they would be good little businesses for example for selling to other researchers right someone has developed a unique method toolkit right protected or not you know because it's just not going to be much competition along those lines. The the other part that sits there. Unfortunately actually and I would argue most institutions in this country have. Are under resourced in the technology transfer efforts. So what they have websites right. So they think putting it on the website which regurgitates what's in a faculty invention disclosure is going to attract industries interest and they're going to come marching in and licenses stuff. Well first I don't work that way. Right. You have to like most other things you have to kind of market him in the first stage of that for most research discoveries you have to translate them into something the world can understand and where they're going and then you have to market them to selected targeted audiences. I think if you do that you know the investments that really come from are dollars right in the form of and I each dollars when I have a higher likelihood of being recouped.