Good morning, everybody. I'm Milay Louise Lam. I'm a clinical endocrinologist in Maryland, and I have the pleasure for this morning to introduce this session. Dr. Cherie Butt, who is in the industry, and Dr. Lynette Nieman, who works at NIH, and I'm gonna let them introduce themselves and talk a little bit more about their career and their journey. Thank you for being here. Perfect. Thank you so much. I have to say that I know that this topic is unusual for our community, but I'm really glad to see all of you, and I'm assuming that you're all trailblazers because you're thinking about this. So let me talk a little bit about my road, and then I'll let Lynette talk about her trailblazing. Like everybody, I wanted to be an academic because that was the only world that I knew. I did my postdoc at NIH, which introduced me to conducting research in the government, and one of the pivotal moments for me was this recognizing the key questions that I was answering in government versus academia, and where my first day of orientation was, we are a public health organization, so you can't do things that are this siloed, very narrow way of thinking. You have to think about how does it apply for all of the different patient profiles, and so that really, that's why you can't just look at one species. You can't just look at one strain. You have to understand how those strains translate to the different human conditions, and then I got the call to go from NIH to FDA, and here I knew how to do research. I'd been doing fundamental biology research for a while, and they had asked, would you also consider doing drug review, and I said, I don't know anything about that, but if you train me, I'm willing to try it out, and I was the immunogenicity reviewer and the CMC, which is chemistry manufacturing and controls, and again here key questions were different. Thinking about what is important when you're developing a drug versus what is important for public health versus what is important to understand fundamental biology. One of the things that bugged me about FDA was the, oh, I can't come up with a politically correct word, crappy applications. There were a lot of them, and so when I got the call to come to Biogen, I said, I want to understand why do these applications look so bad. We only have two questions. Is it safe? And is it better than what is standard of care, what's already out there, and when I transitioned, I did transition focusing on preclinical, and over a series of time, I said, okay, the one place I haven't been is clinical development, and so now I'm a clinical trialist, and again, as a scientist doing that, it really has been eye-opening because we design experiments very differently, but you can't be in Boston without this entrepreneurial spirit not hitting you. You cannot avoid it, and so thinking about how do we advance biomedical research from our different perspectives is something that really caught on to me and thinking about the Modernas and all of the other companies that you can probably name. I know some of those founders, and so thinking about how do we make sure those who are in academia or in government are best prepared to get it right and not because many of those founders will tell you they got it wrong several times before they finally got it right, so I'm really glad to be having this conversation with this group. So I'm Lynette Niemann. I began at the NIH, and I am still at the NIH, and I started there as a clinical fellow, and at the time I was there, we were immersed in doing things that led to drug development, and I don't know if, could I, can I control these slides? Oh, yes. Could we go to the third slide? Can somebody push it over to the third one? It's not working. Okay, and then keep, just keep going, keep going, keep going, and one more, and one more. There we go. So at the time I was there, we had, CRH had just been isolated and sequenced, and so we just, my boss just jumped right on that and got somebody to make it, and we started giving it to people, and listed on the right, you can see all the different things that were going on for the first, say, eight or so years when I was a fellow, so I was in a place where this was like normal. It's a little, sort of like what Cheri's saying. It wasn't very, very targeted. What is the mechanism of this or that? Although people were working on the mechanism of action of all of these things, but it was really much more towards, how can we bring these things to, to at least, if not commercialization, because the NIH doesn't commercialize things, and but how can we bring this to the human health people in the whole world? One of the lessons that I learned from all of this was in the very beginning, we didn't know anything about intellectual property. We knew zero. We just went, we were scientists, right? We were just giving out all of our ideas. You know, CRH, we never patented or anything with CRH as a test. We never patented a lot of this stuff, so then I got further along in doing these things, and so my own involvement of this list was, I was the first person to use Mifepristone for the treatment of Cushing syndrome, and as a fellow, I gave CRH to the first patient who received CRH, and so I was very immersed in this stuff, and then later on, you can see the last bullet. I don't know if those of you who are here recognize CDB 2914 or the word ELLA, but this is the emergency contraceptive that the FDA approved last, maybe six years ago now, and so we were very involved in the development of contraceptives, and which is a very tricky thing when you're at the NIH, which is a federal institution where the concept of abortion is not something we work on or talk about, and we avoid it in our patients whenever possible, so designing a trial to study a contraceptive in that, with that background, is very challenging. If I could just take one other minute, because I would like to, I'd like to make a background. If we could go sort of back, who has the slide? Could you, can you go back to the last slide? A clicker would be great. This one, yeah. So we, you just leave it like this. So what I wanted to bring out to people is that every body's situation is different. We're all different people, and we have different approaches and different strengths, and to me, as I was thinking about this, these are the three areas that really go into having success as someone who is trying to bring, thank you so much. I'm not sure I need this, but let me try. Yeah, no, I wouldn't do it. So these three different domains of what I'm gonna call the environment, where you're working, the ability, and the opportunity. So environment to me is the local stuff. Ability to me is an internal abilities that you have as an individual, and opportunity is what's external to you. So, so if we think about the environment, I just told you that for me at the NIH, it was the norm to do this kind of stuff. It never occurred to me that people weren't doing this or able to do it in other places, and I recognize how difficult it is. Now I recognize how this isn't, I was really fortunate to be in a place where you could do that kind of thing. But wherever you are, you're not going to get very far if you're in an academic setting without a very good tech transfer group, and most universities now and medical schools have that. So if you're interested in this at all, go make friends to your tech transfer person, and if they don't do a lot of intellectual property work with you, which is sort of referred to as IP, you want to protect your ideas for your university. You also want to protect your ideas in a sense so that when you partner with someone to commercialize it, if you do try to license something out, you want to have some control over how that's done. And so if you don't have a patent, if you don't have any IP, you've got no, you've got no claim in the game. So you need to learn about intellectual property, and also one thing I'd like to say to anybody who's got an idea, and this applies to basic scientists and clinicians, because remember Harry Mullen was the guy who thought about PCR while he was surfing and made millions of dollars for what was it, UCSF or SAMHSA or whoever, wherever he was. So our tendency as clinicians, as scientists, is to show me I have this great idea. I want to talk to you about it. Let's think about it. No, no. You have a great idea. It stays in your head. It stays there until you get your data. It stays there until you get your patent application in, and then you can disclose it. So any public disclosure will mean that you're not going to be able to have patent protection. So you've got to really, it's a very different way of thinking about stuff. And so and the companies you'll potentially hopefully be able to work with are not going to want you to disclose anything either. So you have to very much learn how, what part of your knowledge has to stay hidden, and what part can be talked about. So then feasibility, if you're at a place that has no place, no way to randomize a drug, you're not going to get very far with a randomized trial, right? So you have to be in a place that can give you the local environmental support to get something done. And you also have to have a team. In the old days, one person could maybe do some of these things, but nowadays you need a whole bunch of people to to work together. And so then just quickly, in terms of opportunity, there's a huge component of serendipity to our entire lives, right? Who do you meet? Who do you fall in love with? Who do you, where do you go to college? Where do you go to medical school? All that stuff. But the serendipity here is things, like for me, CRH was sequenced, and we jumped on it. If that hadn't happened, I wouldn't, I would be in a totally probably different trajectory in my career. So it's really important to read broadly. Don't just read in your little field. Don't become narrow. Don't see how many angels can dance on your particular pin that you're working with. When I go to this meeting, I mostly go to things that I don't know much about. Because I find if I look at another field, and then I'm thinking about my own stuff, all of a sudden I get an idea. Well, I could put that over here where I am. So think broadly, look for ideas in other areas, and look at new things that are coming out that you might be able to jump on and use. It's important to have good collaborators, and the collaborators might be a company. It might be other people you know. It's really, as my husband, who has himself brought a drug to market, says, it's people work with the people they know. And so one of the reasons why I worked on CDP-2914 is that the person I worked with, with Miffa Bristow, who worked at the time with Roselle U. Clough, later on founded HRA Pharma. And when I became aware that child health was developing CDP as a series of antiprogestins, the internet had just started. So I was able to find him on the internet. I sent him an email and said, Andre, you know, what are you doing these days? You know, we've got some opportunities here in child health. Are you still doing these kinds of things? And immediately he writes back, yes, I've started this company. And that's how it all happened. So it's really important to reach out to people, know people, and figure out who your collaborators might be. And of course, funding is a perennial issue. And then just as your own stuff, you have to have not just knowledge about things, but you need to get experience. It's really that depth of experience in doing these things over and over that helps you learn how to avoid problems. And then again, I'll go back to something my husband talks about a lot. He says, fail early and fail often. Because that's how you're going to learn what works and what doesn't work, and how to avoid those kinds of problems. And don't be afraid of failing, because the person who fails many times is the person who ultimately succeeds. So embrace failure. It's actually a very good thing. And that's all I have to say. Yes. I will say that I agree that failing often and failing early gives you lessons. But let me say this, it's okay to let other people fail and you learn their lessons, rather than you reliving theirs. So something that's important to me, and what I'm going to do, Lynette, is probably give you this microphone, and then I'm going to be like Pat Donahue and walk around the room. I want to make sure, every time I give a talk, I want to make sure I understand what is it that the audience wants to hear. So what I would need from all of you is to tell me a little bit about what are you looking for? So are you looking for information on drug discovery? Drug development? How to start a company? How to, okay, how to partner with a company? Anything else? Okay, so it's starting a company and partnering with a company. And something that Lynette said that's very important is, I have worked with a lot of, I've worked with a lot of academic collaborators, as well as small companies. And probably the one thing that I've noticed that I'm going to ask of each of you is that they don't want to let go of their baby, right? And to Lynette's point, you're not an expert in everything. And so drug development, although I've had the privilege of working from concept all the way, I have an approved drug, and I was a regulator, like I've done that, but so few people have done that. You have to accept your own, this is as much as I know, I need to pass it off to someone who has this expertise. And so a lot of times our biggest struggle, at least at Biogen, but I hear this happens at Amgen and Pfizer and all of the others, is that you have a great idea, and you're working with the partner, but they don't want to let it go, and they don't want to respect the fact that you probably know how to develop it better than they do. And then that's where a lot of time is lost, frankly. And so what I want to do is I do want to make this as much of a deep dive as possible. So what I wanted to ask is for those of you who have questions about company creation, I wanted to get your questions. So I think you guys had indicated it. Is there something specific you wanted to know? No, I agree. I'll just say we're both post-baccalaureate research fellows at the NIH, so we're pretty early in the career, so I think we're just exploring right now. Okay, but to Lynette's point, you're in the right place, right? So, I mean, I remember when I was in NIH, it's a scientific candy store. Industry is also, but like there's so much that you, it's almost overwhelming, which is why they created the yellow sheet. But there's a lot of people, places that you guys can go to, but Okay, so is there anybody else around company creation? Like what specifically is your question? So I'm thinking about starting a nonprofit. So any tips on that? I'm in the process of writing a business plan for it. And so that's my, that's where I am. And then I'll get more board members and apply for nonprofit status and all of that. So that's where I am. Tell me a little bit why it needs to be nonprofit. I just, it doesn't really need to be nonprofit. But I don't want to charge for my product. I want it to reach as many people as possible. Yeah, so there's a lot of legal issues about being a nonprofit versus a non, not a nonprofit, a for-profit. And one of them has to do with whether or not you can get a salary. Some of it has to do with whether you can actually, nonprofits are designed to be educational. So you have to have an educational component. And if your primary goal, so it's really important to think about not what am I doing next, but what do I want to be in? What was my dream finished? You know, what's my real true goal? If your real true goal is to make a product and to sell it, that has to do with health, you're probably going to have an educational component to that, but that won't be your primary goal. It'll be really hard for you probably to set up as a nonprofit. And so you will most likely need to be, the easiest thing is an LLC to begin with, because you're going to be small to start, right? And then to get, you can always switch over to the bigger kind of, you know, you can always switch over to the bigger kind of incorporation. So talk to some people who know about putting a nonprofit together or a for-profit. If you are for-profit, you get to decide how you price. One of the things I loved about HRA Pharma was their approach towards, they sold Levo and Registro. So Levo was their money-making engine for the research, but they priced it at a price point that women could afford. And so you can decide to do that. You don't have to be charging $100,000 a year for some drug that costs you, you know, $50 to make for the year's supply. But again, you have to remember that I feel very strongly about pricing, but pricing is something that's done to enable further research in many respects and to pay back the venture capitalists, which some people call the vulture capitalists, that are required to get funding. So just think about how you're going to set things up. And I will say that all of our companies have a foundation. So to Lynette's point, there is always this arm that is social responsibility. But also to Lynette's point, there's bread and butter activities that help to feed into that. So if you are thinking about social responsibility, you can separate those and say, okay, I'm going to have this product that's made available. Every major company also has a free drug program. Everybody does it. So it's not going to be something that's not an option, but you should have some way to make sure that you can cover those expenses for what you give away. Yeah, and just keep in mind, I don't know if there's anybody here who's not U.S.-based, but we're talking from a very U.S.-centric perspective. Some of these concepts of how you incorporate and set up are very different in other countries. True. And I saw another hand. Yes. Yes, okay. Good morning, everyone. This is Joe Banning from University of Arkansas for Medical Sciences. So we know that when you do research at NIH, the interest is totally different from a company in terms of their interest, right? So how do you merge those interests when you're trying to develop a company? Yeah. Yeah, go ahead. That's a really good question. And one thing that I've been trying to help people appreciate is the drug development circle is, in fact, connected. What academia does is connected to what government does is connected to what industry does. And if we can get it right, then academia will do the experiments in the way that we understand, the way we need it to be understood for industry. So if you do an experiment one way, you're answering the question about the receptor and its activity. But if you do it another way, you're answering the question about its targets. Where is it? You know, where is it located? What are the off-target possibilities? And then that helps us with drugability. With government, and it depends on, like, intramural, the community, depends on what they're focusing on, there's a lot of partnership as well. Number one, the FDA is the regulator, so they need certain questions to be answered. And at NIH, understanding the public health aspect, where is this relevant, who is this relevant in, how global is this, what are all of the possibilities? And then for industry, all of our trials are global. So we actually need what the government work is, what they're doing, because we need to understand what's the applicability of what we're developing, so that we can say, okay, here's the epidemiology of it, this is how many people have this particular SNP or this particular version of it, this is how many people have early stage disease at this point, and therefore, this is probably how many people we'd be treating. So they're all, they're so interconnected, it's ridiculous. And if I can get this right, I can help, because I think government and industry get it, but it's academia where I struggle the most with trying to help them understand, what you do is just as critical to what we do, and if you do it, then that saves us time from having to redo your experiments. Does that help? Yeah, I mean, another piece related to that is that if you are involved with early work in humans, you're going to have to get an investigational new drug approval from the FDA. And to get an IND, so I've been an investigative sponsor on three of those. So you have to have a lot of preclinical work that relates to a lot of the stuff Cherie's talking about. You have to have done studies in a certain number of species of animals for certain periods of time, depending on how long you want to give it to people. You have to judge your dose for your first in human based on what is the tolerable dose in the animals that you've experimented with, or that your partners have done the studies on. So you actually learn a lot of this stuff that Cherie's talking about, in terms of what a drug company would want to know about, particularly regarding safety, by doing, by having to put an IND application together. So I don't think there's as much, I think once you really get into the stuff of first in human kinds of things, you overlap much more with the industry perspective than if you're doing some experiments, let's say in the lab with animals or cells, where you're very much able to control everything and get everything just the right way to answer that one main question that you're asking. Whereas when you're dealing with human beings, because people come to you, we're not all strain X of a rat, right? So we have different genetic backgrounds, we have all this other stuff. When you're dealing with human experimentation, you just have so much other messiness to the whole thing. And you can't do an experiment with six people like you can with six rats. And so it forces you in a way to have different approaches that are more like a drug company would be. Thank you very much. My second question is, does publication count as a public disclosure? And if somebody already publishes that, and later on discovers that kind of like discovery or novel finding, then what are the steps should we take to protect that? So the public disclosure is the actual thing that you disclose. But so a couple years ago, we had a late breaking session here about the use of mifepristone for the treatment of diabetes. And our lawyers were very slow in getting the patent application together. And it was like the most anxious thing because we were in the last week and it needed to get, you have to have that stamp of the date and the time that they receive your application. And so I called the Endocrine Society and I said, ahead of time, and I said, please, I want you to embargo my abstract. Nobody can look at it even online because that's a public disclosure. And so this year I was very happy to see they've embargoed everything until the day of, but it wasn't like that a few years ago. And so you have to be really, really careful. So any publication which has data that would enable somebody with skill in the art to reproduce your findings, and I'm sort of talking jargon of the patent people, is a full disclosure. And so you have to be very careful. Now, your point was, well, what if somebody then discovers something novel later? If it's truly novel, that's what a patent is. It's a novel, it's a new thing. So then you could take that knowledge and patent it if you can provide some evidence that it actually works. For most drugs, you actually have to have some evidence for other things in the patent world. You don't always have to have real data to support your claim, but for most drugs, you've got to have some data, not necessarily in people, but it has to be some indication that it would work. Yeah, and I want to emphasize something that's very important. I don't want to hamper the great science that everybody's doing, but Lynette is making a point is, do it, do whatever you're doing, but think a couple of steps ahead before you start to talk about it externally. And an abstract, I mean, that's exactly what our lawyers are always on our case about that. It's like, we're just so happy to talk about it. And they're like, stop doing that. Just send it to us. We will do the first to file paperwork, and then you can go out there. So you're not going to be limited from talking about it, but there are a couple of steps that you have to do to make sure it's secure in case. Look, how many of us know the horrible stories about someone coming to a meeting and someone took a picture of it, and then they went and published it? I heard those from graduate school on, actually from college on. It's really that, it's protecting your work so that if somebody tries to do something like that, you have a basis to which to say, okay, if you're going to make some money off of it, you owe me. This stuff happens all the time. So it's just thinking about this stuff ahead. Still do your great science, but protect yourself. The other thing is, if you work at a university, I'm sure that Arkansas would expect you to file an employee invention report, which is where you basically are making a claim that you have an invention, and they will then look at it and decide whether they're interested in what you think is your important invention. If they're not interested, you can get permission sometimes, depends on where you work, to have that invention be your own and not have to, but then you can't work on it anymore using funding from your organization. So many times it's worth waiting a little bit to have a little bit of data and then filing your EIR with your organization, but then once they get that, they own it because you're working for them, and they will help to educate you about when you can and can't talk about it. There's a lot of resources at all the, universities and schools want to protect, they consider it their property, right? You're working for them, it's basically theirs. So unless you're independent someplace else, they own it, they're gonna wanna make sure they want, it's protected. Thank you. I am a scientist, and by that I'm saying that I have no idea of business. I know, I see that certain knowledge that I have can become a business. So what would be the step-by-step that you can tell me how to go over and become that a business? Start with a patent, search for people? Okay, so I'm going to answer your question, but I want to come back to Lynette's last point. I will tell you that one of the most, the two of the most difficult institutions that I work with are MIT and Harvard. Why does, MIT is the worst, and let me tell you why MIT is the worst and why I understand it. The founders of Biogen came from MIT. The founders of Genzyme, which are now Sanofi, came from MIT. The founders of almost most, like most of the major companies you know about came from MIT. So MIT has figured out quickly, there's something about the knowledge that sits in the brains of our people that we better get on it because we're sick of seeing billion dollar announcements. Don't you think every university thinks like that? They would love to have the bragging rights to say their people, like the founder of Moderna, right? Like Bob Langer. He's across the street, he's from MIT. And of course, MIT gets to brag about our, you know, we have a faculty member who founded a company who basically saved the world. Every university wants bragging rights. So to your point, your institution, if you go to them and you say, look, I've been thinking about it, but I don't know how to do it. There should be, there's usually a team. I know in every Boston school, there's a team. So you don't have to make this stuff and figure this out yourself. They would love to be able to hail you and say, look at what our guy did. So don't think that you have to, there is a, I'm gonna speak about Boston because I know enough about it. Babson has this, Babson is one of the local colleges. They have a one week biopharma intensive. So I would have suggested something like that. So you're not like spending your time getting a full MBA. But your institution is probably gonna give you a lot of resources or help or maybe find a connection because they all want bragging rights. Except if you're in the government. So nobody in the government's allowed to have a company on the side. Many institutions will allow that and actually encourage it, like Cherie's saying. Some institutions, they're still sort of left in the dark ages where they want you to just, they won't let you spend something off and have, so the government would consider it double dipping. You know, we're not allowed to double dip. I can't receive honoraria when I speak to anyone because the government feels that I'm only able to speak because I work for them. And I would never know anything unless I had worked for them. It's an interesting perspective. But you can't get, you can't use your position in the government to get money in any way. But for those of you who are more free than I am, you know, you can, there are a lot of us in the Endocrine Society who have spun off. So I have Gary Hammer's one, Dan Drucker. I mean, there's just a bunch of people who've done this. So see what your local people do. If there isn't anything local that's helpful, then I would think about how your knowledge would be applied and then think about companies who might be interested. And then you can potentially, once you have a patent, you can license it to them. And many times they'll want to work with you to ensure that, I mean, they may not have the local expertise that your knowledge would bring to them. So they may work with you to develop it. It's not perhaps quite as satisfying as being in charge of it yourself. But starting a company and growing it and making this work, it's a huge commitment. It's your life. You know, you just basically, this becomes your everything. And it's the amount of knowledge it takes to go from being in an academic setting to running a company and all of the stuff related to that is, it's really huge. So it's almost easier in some ways to license it out and let someone else take over that burden of making it come ahead commercially. No, Lynette again raises some very important points. Number one, so I've always said, I want to be a serial founder, but I don't want to be a CEO. But I also am in a place where I can go and have a team that can do all of that for me, where I can have the idea and spin it out. And I'm perfectly fine with watching the baby grow up and win the pageant without me having to be involved. But again, this is a mindset thing. I'm comfortable with that, but a lot of people aren't. So you have to decide, do you really want to be involved in every nut and bolt? Or do you want to say, okay, I'm willing to, because even Phil Sharp, who was a founder for Biogen, he sat on our board. He wasn't involved in the day-to-day. So you could make a choice, like how do you want to be involved? But also the other critical point that she made is if your institution doesn't have that expertise, you definitely have among the 18,000 members of Endocrine Society and probably some of your other societies, there are people who've done this, ask them. And Gary is one who freely loves to share his ideas. But find people, send out a notice. I think we even talked about maybe having one of those scientific interest groups in this area. I think there's an entrepreneurship SIG, and occasionally they have emails that go around, so you could try that. Okay, so they did start. I know we had tossed around the idea. So that is probably a place where you could go and say, where would I get started? What are some lessons learned? Again, I'm one of those people who believes in lessons learned by somebody else. Don't do this when others have done it before you. And that's why I was talking to Bob Langer. I was like, tell me what worked, what didn't, what would you do differently so that I don't have to relive your past mistakes, and the other founders as well. So think about not trying to necessarily, but I call it efficiency. My family would call it lazy. But think about not trying to do everything yourself, but where would you best be able to apply after you have a better understanding of the landscape? Does that help? Yeah. We're recording it, we need to. Ideas don't sell very well. So how do you, I think the real question is, you've got this team together, and you've got an idea. What is the minimal, first of all, how do you go out and get funding for this thing? And secondly, what is the minimal viable product that you're gonna have to have in order to get other people interested in it? You said the magic word, target product profile. I've been working with several groups in academia, and that's usually what we say is, you have to have a target product profile, and then what experiments have you done to support it? To your point, there are a lot of organizations, like we have search and evaluation, everybody's got a search and evaluation department, which assumes that the package is already there, and then we buy it, which is what Lynette was saying about licensing it. Okay, we're just gonna buy this off of you and take it to the finish line. But there are a lot of organizations, Eli Lilly, there's several of them now, who create these gap organizations, which is, you're an academic, you have an idea, you need a little bit of help with trying to generate the initial data, and so these organizations will give you the seed money to do those initial experiments. Now, one thing I will tell you, it's a different way of thinking, and one of the biggest problems that I find with those in academia is timelines. We don't think five years, we think in quarters. So what can you get done in six months? So you could probably get money if you can say this is what I can achieve over the next year. Just from the idea, I've got this idea, I have some preliminary indications that it'll work. Could you give me a little bit of money? This is how much I would need to figure out whether that is. And then that way, in that way, the reason why companies are doing this is because they know that you all have these great ideas, but they also recognize you don't always know how to do it in a way that's useful for us. And so if they can see that and support that, then that will get us what we need to get it to the finish line. Does that help? Well, it helps, but, you know, really specific question is, how do you, you know, I'm not gonna call up Eli Lilly and say I've got an idea. I'm not gonna call up, you know, something like that. There's gotta be a, something you've got to show, you've gotta go through some steps with those things. And to your point, they did have a meeting, an endocrine meeting, where someone spoke about an organization, or it was an organization that helped people do those sorts of things. And they also talked about writing grant, government grants from NIH for entrepreneurial things and like that. But, you know, those aren't easy things to do. And what are, you know, what's, give me the easy way to do it. I mean, something, I'm not in an institution. I'm one guy here. I'm putting up my own money to do this thing. It isn't that easy. So you raised something that I've tried to communicate to people. And I hope that, I know I come across as chicken little. We have a new institute that was recently created called ARPA-H. And ARPA-H is basically an industry model. And what you said is a critical piece. The way that we work versus the way that is typically done with an academic, is you guys think of things as grants, but we think of things as contracts. ARPA-H is going to be contracts. And so you can apply to institutes like ARPA-H, and they're actually NIH institutes where you can apply with the idea and get a grant. And that's another way to seed and get some help as that one guy. I do not believe that you should be using your own money. There are way too many opportunities out there. Now, to Lynette's point, I do know a lot of VCs. So that's why it's easy for me to say that. And I live in a place where it's all around you. So there's always opportunity, but there are still mechanisms. There is the SBIR. So that's the NIH grants that help people toward commercialization, but they don't necessarily have to be commercializing everything. So there are a lot of federal funding opportunities that can be your first money so that you don't have to use your own. But I do think that it's really hard to get SBIRs and a grant without some pilot studies. I mean, everybody that, excuse me, basic scientists know that you do your experiments to get your pilot data that you put in your next grant. And you use this grant to fund the next grant. And so I think having some preliminary data and then being able to frame your idea in the context of an unmet need is what's really necessary. You know, what's the minimum? It's to basically project what, have that dream of the future, the end point, and say, what would that be doing for humanity? Because there's so much requirement now that every idea, even if it's very basic, be somehow linked to health. And so I think having some preliminary data that's very intriguing so that people will understand it and also being able to distill the importance of it down to, you know, it's the three minute speech, the elevator speech, the, you know, one minute worth of, somebody said to me, why was it important for you to work with CDB 2914? I say, because women needed an emergency contraceptive and women with fibroids needed to have their fibroids treated better. You know, so you get it down to that one thing that you think is gonna be useful. So I think, I don't know what your situation is and what it is you're trying to do, but getting some more data, sometimes getting some other people to work on the same project, convincing other people, is helpful. When my husband developed Profenadone, he sent Profenadone out, it's an antifibrotic that's now used for pulmonary fibrosis. He sent small quantities of it to basic scientists and said, maybe you'd like to try this, it's a TNF alpha inhibitor. And they did it and they, he's like Tom Sawyer, you know, he wasn't painting the fence himself. These other people who did all these experiments and then the clinicians started getting interested and then ultimately they, you know, had their IND and so then they would give it to the clinicians and it was like getting somebody else to, it was probably millions of dollars worth of stuff that other, that the NIH paid for without knowing it because they gave out the drug and people did the experiments and. Yeah, but that goes back to my first thing that I've said, ideas don't sell. Ideas do not sell, you have to have data. And so you have to have this minimal viable product. Yes. And so I'm, that's the. So the minimal product is that you, let's say you have an idea that, you know, some drug is going to do X and you have a cell line and that cell line is a good model for X, that's minimal. So you have to sort of decide what's the minimum, what would satisfy you as the person with the idea as the minimum evidence that would suggest that this will go someplace and will work. I suppose my struggle here is that your idea didn't come out of a vacuum. There had to be, look, we're scientists. Everything is evidence and database. So there must have been some data that was generated by somebody, it doesn't have to be you. and that is just as viable to use as the ones that you use with your own hands and that's exactly what Lynette is saying is like you're not gonna pitch an idea and you've got nothing to support it so use whatever's been done but she raises another critical point which is the you don't have to do it alone and to be quite honest I've used that that style myself I'm like if you will do this for me then you can have the publication I needed the data I didn't care about the publication and I knew what I was going to use it for and so sometimes being a little bit creative and I always believe in the with in which it's a what's in it for me so if I ask somebody to do something I'm offering them something in the process they may not know what I'm using it for but they don't care because they got what they wanted but there is no idea that didn't have some kind of evidence to go with it so I find that hard to believe that you're trying to pitch something where you don't have something that says well this was done and this was done and this was done and that's why I think this will work but surely he may have some insight into it to a situation where somebody else did something in another area and then he's thinking about it for his thing and then it does get I think it's it's a tricky thing because you don't really want to disclose something that you think is really novel that you haven't been able to bring to some sort of a data set no they love they actually love getting it on the ground floor which is no I don't you don't have to have a full product but you do have to have if you think about saying or sequencing remember you know we now have little kits that we can sequence stuff in the old days we had those you know long gel things that we had to be doing and cutting out little bands so that then became a product a commercial product but if you have a techno technology that's unwieldy think about the closed-loop insulin artificial pancreas stuff you know that was very unwieldy everything turns out to be really big and then it gets miniaturized once you show it works but I agree with you completely VC doesn't want to give you any money for nothing you have to show them something but they also really love it when you give them something that's really early because it doesn't cost so much money and the farther along you can take it and have control over it the more if money is the idea to profit from it in the end the farther along you can get something it's reducing the risk of the person who's giving you money and they have to pay for that and risk mitigation and that's how you make the big bucks so you know if you can get something in a clinical trials and and you know through a phase two you're gonna get a lot more money than if you have some rat study so no completely agree now I know that we yes and then and then I wanted to make sure we answered the questions about partnering with companies so just to add something from my personal experience to this gentleman's query so if you have an idea there are two things like first you have to so I think everybody has idea but not everybody can manifest those right and we are not even sure like if that idea is solving a problem so if you go you have to go back if step back and you have to find out that what the problem is so if you can identify the problem and you have an idea then two things like you want to manifest that idea so bringing a product so there are a couple of ways you can do that you don't have to spend your money you can go for NSF I-Corps program and it starts from five thousand dollars and there is no liability even if you spend just you know if you spend it for your personal costs you're not liable for that but if you use that for five thousand dollars for interviews for example if you can have at least 60 interviews to discover your customer or market and you document those then you can if you submit those reports then you can go for $50,000 funding and that's the national competition if you win that so there's a conflict not one price they give like maybe 20 or 30 every year if you win one of those then you can go for SBIR which is for like $250,000 but I think if you want to manifest your idea then you should start with NSF I-Corps that's the best program so NSF I-Corps program yeah and I think it's national program they give I'm not sure how much money they give every year but there's a couple of million dollars yeah and there's no liability so if you just spend it for a pizza it's gonna come to National Science Foundation I-Corps I-Corps yeah and another thing is like if you want to if you have your idea you know that it's gonna work for your market and if you want to bring a product or something every university or every state has kind of like independent startup innovation center for example I know that University of Oklahoma they have kind of like Tom innovation hub so just contact them because you know I took one of those entrepreneurship course so just contact them they're just posting all the time just come to us if you have an idea we have a couple of bunch of people they're gonna help you out just share the idea for Arkansas from our state we have like UMS bioventures there's another like startup junkies they fund those thing like they evaluate your idea your product and if it's like you know something tangible or real they're gonna fund you and they're very serious about those startup junkies in Arkansas conductor another company they are looking for like those ideas and talking about like starting a company and I think I'm pretty sure every university is there by a venture office or innovation centers I mean but I do think that the real is there a lot of hurdles and bringing something forward right but the first biggest hurdle is to get enough information data that somebody's gonna believe you and I think that you know the gentleman's having that I think you've identified one of the major getting I'd like to get more funding right and I but I think funding there are all of these you know available things but what you have to do is have the mindset of you just gonna keep knocking on all the doors because it's not always easy to get even though this money is out there they don't always want to you're not gonna necessarily win the competition every single time and but I do agree with the idea of starting very small and then working your way up because SBIRs are really competitive and they you need to have a lot of oomph behind it so starting with something that's very small and maybe starting with something that's more local would be a way to be more likely to get the funding I I know in Maryland we have the same sort of a similar kind of thing through the state but the money involved is very small but it may be enough to get sort of jumpstart things right that so those are very good points there are multiple I course it's not just NSF so again I that's why I don't believe you should be using your own money and number two the point about the states every state I know they want bragging rights just like the universities so if your institution doesn't have that program it's highly likely you're right places like Maryland Massachusetts California where they've kind of seen the manifestation they have it and I'm glad to hear that Arkansas in Oklahoma I actually knew about our Oklahoma but I'm glad to see that other I know Kentucky has it so probably every state has some kind of startup group and you can call them and say look I have an idea but I need some help and the resources are there I mean I find that in Massachusetts it's ridiculous the wealth of resources but like you most people don't even know exists so I have to spend a lot of time teaching them okay just go here it's a website and then they find all of it so usually it's right in front of you you simply don't know that it's there and then once you look into it that to me is where a lot of the work has to happen thank you I'm trying to understand how to navigate a situation where my competitor has yeah they're never defined research competition has already applied for a patent for a product I'm using in one of my clinical trials how how do you handle that situation and they applied for a broad patent like all autoimmune diseases this is a cure for all autoimmune diseases and they're not even making the product it's a different company how do you navigate that do they have the patent already has it been issued as far as I know six months ago it hasn't been issued but they well if they just applied six months ago it takes years to get a patent they applied three years ago but when I last I checked through six months ago they had not received it so and there was even another group that was applying for it so there's more than one one group this is not uncommon CRISPR is a great example exactly in recent news you know it's hard to get a you know usually what happens you know people throw everything into the patent application they say I want to I'm patenting every single possible conceivable analog and every single possible formulation and every single dose every single kind of administration you know I mean all the things you can think of to amplify this is gonna work with Alzheimer's it's gonna work with autoimmunity it's gonna yeah the patent examiner just starts throwing all that stuff out so generally what happens is that it gets winnowed down to a few more concrete areas not so much the dosing business because that they usually give you leeway but the actual the the lead claim which is I it's going to be used to treat X is usually really very much winnowed down particularly these days more so than maybe 10 or 15 years ago so first of all they may or may not get that patent but what do you I guess part of the question is are you worried that you won't have access to the product or are you worried that you have a competing interest in terms of patentability yeah I do have a competing interest and I would like to take that to the next step and you know do a startup or something like that with so you need to think about whether you have something some in data that are novel that could be patented so I would take what you've got to your local tech transfer or IP whatever they call it office and disclose to them and and tell them what you know about your competitor you know until you get a provisional I don't even know if anything's you know out there in terms of whether there's any public information about what they actually asked for in terms of their patent but I think certainly you're the local people can give you an idea based on what they know you know oftentimes what they'll do when they're considering whether they'll write a patent for you is that they'll go ahead and do a patent search themselves and see what the literature shows and whether it seems like it's a viable it's a viable thing I mean I I sit across from my table my husband many times and he just came up with another idea he's on his fifth company so he was just came up with another idea and his own fifth company and he he came back to me the next way says well I looked it up somebody already patented that I mean so I mean having some sort of an idea about whether it's already been done it's the first step and the other piece of it and then I'll come over to you the other piece of it is I'm sure you have several ideas so don't be focusing on the one that you think somebody took and that's really the the lesson that Lynette is saying a she's absolutely right it's usually a narrow just like a drug label it's a very narrow this is what you get to claim but then also think about your other ideas and go for that and while they're doing this you can be doing that and moving things forward so yeah this is relevant also to some of the earlier comments so people typically think of patents as primarily to protect an invention that in fact is not what the Patent Act was written about 200 and some years ago it was actually written for the purpose to stimulate innovation to enable others to build off of the innovation that has already occurred and so it is it so first of all everything Lynette said about maybe it's not going to issue because maybe they are claiming things that are too broad that are not all novel non-obvious and enabled but also the publication of the patent which as you noticed happened before it was issued or denied is is meant to get the information out there and to and to spur innovation so I mean think you have to think about patents both of both of those ways both what are what are you able to protect and build a business off of but also that others patents are fodder for your own innovation yeah I I think is a really good point the patent when you're dealing with a patent office it doesn't feel like they want to foster innovation but that's what they're supposed to be doing and I think the patent office and you know and the pads are from across the world which now you can also are online pretty most places not every place there are a great source of information that I think many of us just we always think about a scientific literature but patent I mean the patents can tell you so much about some it's pretty if you're interested in certain class of compounds and you go into the patent archives and look at what's there because you know you'll see stuff that is very specific about well you know if you put the substituent on this steroid back one this is what you get and it's hard to find that in the medical literature so it's it's really worthwhile searching no I completely agree it is a treasure trove that most scientists don't even recognize is is available I remember a PTO patent and trade office officer who could first told me that when I was at NIH about why don't you dig into like what we've got because that probably he knew what I was interested in that probably is a place where you could find a lot of what you're looking for and then you don't have to restart okay so I know that there was also the other topic of how do I partner with a company so I want to make sure that I address those questions as well as I mentioned before we have each of the major organizations have a patent search and evaluation group and so they are tasked with going out into the different areas especially like conferences like bios where they do a lot of that stuff but looking not only at smaller companies to see what they they're developing that might be of use for us but also in academic settings again probably name you know the top 20 NIH funders are also the top place where a lot of companies go which is why I get a little bit frustrated that it's not really making it equitable so I'm hoping sessions like this you guys will have the knowledge you need to be part of that community as well but what specific questions do you guys have about partnerships everybody knows how to do it they know who to call it's not Ghostbusters okay so all right maybe we walk through this you have let's start with the gentleman I have an idea I think it might be something that's a value to a company you have to do your homework on which companies do you think this would be a value and I think to the point that you raise about product profiles is where a lot of people get tripped up because for each product profile it's you know what is it which most scientists can get that who would it be for most scientists could get that but what they fail to realize is what subpopulations is it relevant for and so this may be a little bit easier where you say okay is it early is it mild moderate or late-stage disease okay but answer that question the other piece is how is it administered if you have this idea how would it be given is it a technology where somebody lays on a bed and then it you know it's some kind of like what's the little copper tone copper fit is it that is it a device is it a is it an injectable okay if it's an injectable is it subcutaneous is it intramuscular is it intradermal like how is it being given how are you because one of the things that every company has to think about is it's not just because many companies can develop a really good drug but the delivery system is just as important as the drug itself because it let's take the pandemic all of those drugs that were need to be infused so people had to go to infusion centers that was an issue so most people most companies don't want IV infusions anymore they want something that's going to be a lot easier where the burden to the individual is is going to be lessened the other piece along the product profile is you know how do the patients access it is it going to be something and that was what Lynette was saying earlier if like even trying to get a little piece of insulin out of this you know pancreatic model is going to be so arduous that it's not worth it because the company is thinking about all of the places where something could go wrong and then they can't get the product out so you actually have to think beyond the science itself and you have to start thinking about the access because a perfect drug that has this long trip to get to the patient is not going to be something of high value to people but the easier you make it for the patient or if patients have caregivers for them to access it it's probably going to be of greater interest to people. So I have a different take on TPPs and fundamentally a root of the TPP there's sort of two roots what is the unmet need and so that gets into who are who are the patients who need this what are their options today what are the what are the things that they still need so for example a product I worked on a long time ago was being developed for type 2 diabetes and of course for type 2 diabetes there are a lot of available there's insulin and there are a lot of available non-insulin drugs and it got I mean this got quite a ways along into phase two clinical trials and turned out to be effective just as effective as metformin. Well metformin is one of seven classes of non-insulin anti-diabetic medications that all are equal or slightly better and there's no commercial need for an aid there is no there isn't any unmet need that a drug like that meets it fails. But then the other key route is what's the evidence that what you have whether it's a drug or a device or a diagnostic or some alternative health modality is going to you have has the potential to meet that unmet need those are those are the two pieces you need to put together and then the I mean the third part which isn't part of the target product profile is how do you move along the path to get there and those are really the three things that you need to start attracting resources whether that is grant funding through SBIRs and yes SBIRs are competitive but they're a lot less competitive than R01s so if you manage to get an R01 you already know how to write grants and you're actually then entering a less competitive pool So think about it that way. Whether it's, you know, investment, which isn't necessarily venture capital investment. It could be initially angel investment if you need, you know, a few hundred thousand dollars to start something down a path. So there are a lot of options out there. However, if you are looking for an easy way, don't try to become an entrepreneur, because there's nothing easy about it. Yeah, how do you find angel investors? There's a lot of different mechanisms. I don't know if you want to talk about your experience. Yeah, so there's something called the Angel Capital Association, which maintains something of a directory of angel groups. But, you know, often you can, I mean, it may take some creativity with your Google searching, but if you start with angel investing or angel investor and probably put in your locality, because angel investors often do like to invest in entrepreneurs whom they can visit or have lunch with, then, you know, and then it's networking to find the people. So, and that might be through your state bio association. So if they have, you know, events, often there are angel investors there. If you know people who are, who have started companies or who are at startup companies, they probably know angel investors, because they've had to get money from them. Or they might, you know, the scientists who are at a small company might know the business development people or the CEO of the company who has had to interact with angel investors and small funds and such. So basically we're hearing from one of those people right now. So, I mean, a lot of you guys are here at the meeting and a lot of, there are reps from a lot of the companies that are, used to be pretty small and now are smallish, you know. So there, I'm talking about people who are at this meeting, people who, there are booths, people at the booths are not going to be the people you want to talk to, but you could leave a card and, you know, see if people can get back to you. So, I mean, I think, you know, tapping into people that have had the real experience themselves in the company side of things is, you know, you've got a lot, there's just a lot of folks around here who have a second life that you may or may not know about. It may not be official that that's why they're here, but talk to, again, as I said before, it's the people you know and the more people you talk to, the more people you know. The other thing is, I think the SIG group still does have an email with people or a chat that people aren't using very much. So it might be worthwhile just putting out an inquiry over that, saying does anybody know, you know, you know, to be nice at the endocrine society could provide some resources of this sort as well. Yeah, that was, yeah, that was going to be one of my take-home messages, but I do want to say something, double-click on something that you said that's really important. So for me, I know bio very well. I don't even think people know, like, has anybody been to bio before? Exactly, like very few people even know what that is. So it's biotechnology innovation organization and it's very different from, like, JP Morgan, which is, you know, the established companies. It's that, it's that space where you have a lot of startups or people who are new to the, to the industry and every state has a chapter. And so you could go to whatever you're stated. Again, this goes back to state resources that people simply don't know are out there, but you can go to your local chapter and, or the state chapter and say, I want to do something but I don't know how to do it, can you help me? They will have all of those resources, a website, a toolkit, they will be able to give you that. And that's their business, that they're an association and all of us, you know, the larger organizations and even the smallish ones feed into it. We pay dues to educate the community. So again, I don't, you all should never have to use your own money for anything because there's so much out there to educate you, to help you, to seed money. And to your other point about SBIR, yes, so let's take the ends, right? N equals. How many, how many millions of people are applying for an R01 versus the number of people who are SBIR applicants? So yes, it's relatively competitive, but you, the number of people that are applying is limited because again, you guys are mavens. You guys are thinking about something that most scientists are not and therefore you've already called and you've set yourself apart from the rest of the group. So that, that's going to be, but please go to your local or your state chapter of BIO and they're going to be able to give you a lot of this information. I think you're really oversimplifying this. First of all, you know, the only thing that, I mean, having talked to these angel, to people and whatever, the only thing that they're interested in, once you've convinced them you have an idea, which isn't all that hard to do because usually they don't really know exactly what you're talking about. You have to explain it to them, is how do you monetize it? That's the only question they ask. How do you monetize it? And they make their decisions based on those things. And you know, I think that's the, you know, really, you know, what it comes down to. I mean, I think you're mistaking venture capitalists with angel fund. Like GoFundMe is not about how are you going to make money on it. And that's GoFundMe is an angel. No, that's the whole point of being an angel. Like, you're not looking for the return. You want to help the community. It's about social responsibility, but you define what society that is. Venture capitalists, you're absolutely right. Just to give it to you, since you're talking about the angel investors, so I think Reddit has a group, a specific group for angel investors. So if you go there, you'll get like daily to daily life, you know, their thoughts, what they're thinking, what kind of ideas they're funding. So that's a very real life resource. Thank you. I just wanted to take up one of the comments that you made, and that is not only finding the unmet need, but also a source of funding. And that is potentially go to the patients themselves. They're the ones with the unmet need. I've worked with patient foundations very closely to help develop drugs that they feel they need, and they actually do a lot of the basic research and fund a lot of the basic research. So they often have small grants to get academic or possibly even non-academic research done, and then build on that. And one example that I have is of a drug that was an academic investigator, was funded by a patient foundation, wanted to do some research, acquired a sample of drug from a larger pharma company. The pharma company said, oh this is great, and I like your data, but we're not going to patent it. You go ahead and do whatever you want. He patented it. I saw a presentation later from the company saying that it worked in a disease that had a super high unmet need, and we started negotiating, started moving that forward. The company had to buy the license from them in order to use their own drug and develop it, and ultimately it was successful. So going to patients for funding and to validate the unmet need, and also potentially repurposing drugs. Because in this case this was a indication that was for a rare population of patients, not the one that the pharma company was interested in, because they want big big dollars usually. But those niches where the unmet need is highest, may be the best place to foster this kind of research. Yeah, no, you're absolutely right. I remember in graduate school I was doing ovarian cancer research, but this is a Texas thing. This is another place where it's not normal. And there was a foundation, and they came to me and they offered me $300,000 to support my research. I was nowhere on this radar of entrepreneurial, but you're right. There were all these foundations in Texas where patients, they had the money, but they didn't know what to do with it. They wanted to support the scientists. That is really a good place for you to go in terms of, again, local. But I think I've just lived in these states where all of it, I mean Lynette makes a good point, if I had never been at the NIH, I would have probably never gotten to where I am now, because it was simply the way I was raised professionally, and even being at MD Anderson, it was something that was all around you all the time. Any other questions or comments? But I really appreciate the fact that you all have raised some very good ideas, and I hope that the rest of you are taking notes, because this is a lot of where the funding sources for the work and the ideas you have can be coming from. I just do want to make one comment about Reddit. There are predators there, so be careful if you go out there. But you know, crowdsourcing platforms like GoFundMe, you know, typically those are not going to ask how do we monetize this. Well, I actually know someone who just raised two million dollars on GoFundMe. Yeah, it happens. Not a med tech company, but it was a technology company. You know, yes, angel investors are going to ask you how can you monetize this, but it's really, they're looking to see that you have some, the question really isn't so much out of strict avarice, but that a big concern for angel investments is that not to invest in something that's going to become a lifestyle business for a person, and that is just never, you know, even if it's successful, they're not going to make any money. And so what they're really looking for is the orientation of the would-be entrepreneur to say, okay, if this is successful, you're going to make some money out of it. And it can be as vague as, you know, if this is successful, a large medical device company is likely to buy it. That's a good enough answer. But then particularly, if this is successful, I want to sell it to a big medical device company, not I want to, you know, keep this as a business, and I want to ultimately, you know, become the salesperson and go around and talk to doctors and sell it and just have everything come back into the business. Yeah, that's a really good point. And our foundation, and I know Novartis does it too, and some of the others, we will, I guess the word is we do angel investments, but it's exactly to your point. The one thing that our grants office will question is, if we are the only ones that are funding it, there's a problem because we don't want to be the sugar mama or daddy for something. And that really was the basis of why some things are told no, it's like, you're not getting any other funding from any other place. No, because we don't want to, we don't want you to keep coming back to us. And you've got no way to sustain this without us. So I just thought of this, and this might be a question for Lynette. So we know that your institution might be one of, might want to be part of a startup. And there's rules around that. But what if the NIH is funding your research? I know you're supposed to credit them in publications and whatnot. But do they, is there anything around that? No, the restrictions that I have is that I'm an NIH employee. So typically, the rules go, and if somebody has a different relationship with their institution, you should speak up. But my understanding of it is that in most places, when you're an employee of whatever group, and you come up with an invention, while you're working within your daily official work job duties, that that is owned, in a sense, by the organization, in a sense, is allowing you to come up with an idea. Now, if you come up with an idea that you don't reduce the practice within your organization, and you go someplace else, nobody knows what was in your head if you haven't disclosed it to someone, right? So I mean, you don't have retroactive responsibility if you haven't reduced, tried to work on it during your duty hours. But so I would imagine that anybody anyplace else, if even if you're funded by the NIH, that you don't owe the NIH, you don't have to pay retribution to them, it's more your employee. Your employer actually isn't giving you a grant, right? I mean, NIH isn't giving you a grant, they're giving the grant to your employer, and then your employer is the one who is responsible if there is any responsibility at NIH, and there typically wouldn't be. Thank you. So, out of the government have come some really great successes. I mean, one of, one that was a favorite of mine when I was there was Gardasil, that came out of NIH. We know that the platform that the vaccines was developed on, that was work not just out of the Vaccine Research Center at NIH, but it was funded by DARPA. This is a 20-year-old technology that's been waiting to happen. Exactly. It's been looking for, it's been looking for, you know, it's time to shine. And so there is a lot of work that's been done out of the government and with government support. So you're right, the government doesn't want to stifle innovation. It also, similar to what you said about the PTO, it wants to foster it. And so, but to Lynette's point, it's really your institution that just wants to Yeah, I mean, I mean, the list of the drugs that I had up here, I'm sorry, maybe it won't come back up. But at any rate, I mean, CRH, PTH, LHRH for precocious puberty. I mean, there's been so many different things that have come right out of the endocrine people at the NIH, and that, you know, none of us are getting any money for, because we're not getting any money for it. But I mean, just look at all that stuff on the right. I mean, huge amount of stuff from one governmental agency that, and basically, you know, some of it has been sort of taken over and not monetized, I would say, in the way that I would approve of, because it's, you know, making companies, you know, because it's, you know, making companies big money. But a lot of it, I mean, you know, faring, hopefully they will get their OBRA and CRH back to us again sometime, fourth quarter, I hope, of next year. But, you know, these are important things for us, and other very equally important things have come out of academicians in all places. So I really think that most institutions really want to have these kinds of things happen. I think the difficulty is that a lot of institutions do not do a very good job of educating their people about, you know, just, you know, you've got great ideas, how can we really partner together? There are more, in some ways, a lot of more passive in some institutions, so that it's the investigator with the idea who has to sort of seek this knowledge out and the support. But I really think, you know, talk to the people around you who've been doing this and are successful, because you, there are so many lessons you can learn from that. And we should also make it very clear that pharma, one company to the next, and places that make devices, they're all really different companies. They're very, very different. They have different trajectories. They have different ethos, one to the next. So you'll get a different flavor. And when you, when you collaborate with different companies, at least my experience has been, it can be night and day in terms of the relationship. The best relationships are where there's really good mutual respect, and it's a true collaboration. The worst ones are where you sort of feel like the company is using you so they can get to their next milestone. And so be careful who you choose, and if it doesn't, if you don't care what the relationship is, it's fine. But if you, if it matters to you, you've got to find the right person you want to be with, or right group. Yeah, that's a, that's a really critical question. Culture is different at every company. This is where I would strongly suggest your local chapter of bio is going to be helpful, because just like at FDA, we had a, we had a list of bad actors. Bio will also have the, okay, I think, you know, I think this is relevant for this company, you know, I'm new to this, am I going to be taken advantage of? They're gonna have some information on them, because they have to interact with all these organizations, but it's true. I mean, to your, to your point, like, don't, if you get a no the first time, don't leave it at that, because, so two things out of that. If you get a no the first time, ask why. Use that why to go to the second one. Don't think that because this one said no, that nobody in pharma or devices in the ecosystem will want it. It's simply that this company, probably for X, Y, and Z, and, and they move on. Like, sometimes they cared about it last week, but then they decide they want to go into a new area. So don't take it personal. Please don't take it personal when you get a rejection, but the why is critical, because maybe you didn't give a good business case or value proposition, and so then when they say that to you, you're like, okay, I'm gonna build this up, and then I'm going to go to the next one with that information. Don't do this alone. You've got bio, you probably got your university. I do think that, in my experience, the institutions, usually medical school type institutions, they have CEOs versus the ones that have presidents, have a tendency to be more savvy. So if, in your area, there is a, an institution that has a CEO, I bet you they have a good tech transfer and business development office, and that might be where you can go to get some information. But I do want to say that this is for everyone, no matter where you live, so don't limit yourself because you don't live in Boston or DC or, or in San Francisco, and the resources are out there, so I do want to encourage you to keep, keep doing what you're doing and thinking about it, and I'd also really like to encourage you to infect your colleagues so that they also are thinking about this as well. To the critical point about the PTO patenting was not only intended to protect, but also to foster innovation, but so few scientists think about things this way that they're not appreciating that that innovation is, is waiting there in that treasure trove of the Patent and Trade Office of databases. So I think we're almost at the end, so I do want to, I want to thank you all, and I hope this was useful, and I agree about the Entrepreneurial Scientific Interest Group, that probably is a good place for you to sign up, and again, I bet you the resources are right in front of you at your institution, in your state, and, and with bio, the local version of it, so please feel free to use that. Thank you. Thank you very much Dr. Butts and Dr. Nieman for this really informative session.

video

Dr. Cherie Butt

Dr. Lynette Nieman

medical industry

research

NIH

FDA

patient profiles

drug development

funding opportunities

entrepreneurship

grants