Transitions to Small Business Development Panel Discussion

Transitions to Small Business Development Panel Discussion

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Transitions to Small Business  Development Panel Discussion   Tuesday, December 6, 2022 Session Transcript:   >> Stephanie Fertig: Welcome back everyone  again my name is Stephanie Fertig,   and I'm the HHS Small Business program lead  here at NIH. this next panel is certainly near   and dear to my heart as we will be discussing  transitions to small businesses. I am happy now   to turn it over to the moderator Allison Hubble >> Allison Hubel: Thank you very much Stephanie.   I'll start by just a brief introduction  of myself. my name is Allison Hubble I'm   a faculty at the University of Minnesota. I am  one of the Co-PIs on the MN-REACH Hub that was   here at the University of Minnesota from the 2015  cohorts, and I'm a founder and CSO of Evia bio   and we just won the walleye tank business plan  competition on Friday so, we're riding high.  

Anyway, it's my honor to start the process of   having the wonderful members of this panel  describe their entrepreneurial journeys in a   certain extent. So, I have a question for you  folks. First please introduce yourself. Give   us a very brief description of your technology,  and a little bit of something about the Proof Of   Concept center that you interacted with and  provided you. with funding and or support.   so, Tracy why don't you start us off. >> Traci Lyons: Sure, can you guys hear me?  

Okay, hi my name is Tracy Lyons I'm a faculty  member at the University of Colorado Anschutz   Medical Campus. I'm an associate professor in  the department of medicine and the division   of medical oncology. I have recently  developed a novel monoclonal antibody   to treat breast cancer patients and my technology  was supported by funds from our SPARK|REACH   program here at the University. >>   Arash Kheradvar: Good afternoon, everyone my  name is Arash Kheradvar. I'm a professor of  

biomedical engineering and medicine at  the University of California Irvine. My   lab is focused mainly on technologies related to  structural heart diseases and in cardiac imaging.   I'm also the founder of Valvention Inc  which is a company that develops multiple   products which is a transcatheter aortic  valve it transcatheter mitral valve and   minimally invasive cardiac support system. >> Steve Soper: Yes, hello everyone it's nice to   at least be with you today if not in person. My name is Steve Soper and I'm sorry part of my   byline was omitted from the lead slide, I am  a foundation distinguished professor at the   University of Kansas in biomedical engineering,  and our work focuses on developing diagnostics for   a lot of different diseases, mainly cancer-related  diseases, but our Proof Of Concept project was   basically funded through the RADx redirect program  and we had developed and conceived of an idea for   at-home tests for COVID-19 that basically used  saliva as the input, and then tested for viral   particles in particular SARS-CoV-2 from saliva.  Now that tool is being repurposed for a variety   of other application scenarios so thank you. >>Allison Hubel: Well, that was great. It was  

wonderful for the community here online to get  a sense about you and a little bit about your   history. I've got a few more questions that I  would like to ask I would also like to have the   audience feel free to enter any questions  they may have into the chat. Hopefully as   we continue down this journey there will  be some questions that some of you will   want to ask this very distinguished panel.  So, I'll move on to the second question.  

Was there aha moment for you when you realize that  this was something that should be commercialized?   It may not have been a single moment  it may have been a series of moments.   And we'll go in reverse order this time  Steve do you want to jump on first?   >> Steve Soper: Absolutely, so the aha moment  well I think we all are very familiar with that.   in March of 2020 my university as well I'm sure a  lot of your universities shut down so we couldn't   meet in person, and what we decided to do was to  do some brainstorming on tests or technologies   that we could develop that would address the  pandemic issue in particular testing at home   or point of care testing. And what we did is we  repurposed a lot of our technology that we had  

developed as part of our NIH-funded biotechnology  resource center, specifically for a COVID-19   detection. So, a lot of work went into this with  brainstorming through zoom sessions believe it or   not, because we were quarantined at the time. And  what has happened now with this technology is that   COVID is still important for testing, in addition  RSV and other influenza viruses, so we've tested   this technology with those targets and have very  successful results. Now this technology is being  

commercialized by a company I founded in 2011, and  that is BioFluidica, that's stationed in in San   Diego. And the IP has been generated around all  this technology. see where writing papers writing   grants doing the work eventually, we got back in  person to do the work in mass conditions and then   trying to market the technology as well. >> Allison Hubel: Yeah, nothing like a real   hard example of necessity being the mother  of invention. Yeah, and the COVID pandemic   basically motivated the commercialization of the  technology and bringing it into the marketplace.  

Yeah, it'd be very interesting to do kind  of a retrospective analysis of what kind of   company creation resulted from this event  interesting, anyway Arash are you willing   to share a little bit about your aha moment? >> Arash Kheradvar: Sure, my approach is a little   bit different, so I basically didn't have  that classic aha moment in my research. So,   my lab is focused on clinical unmet need  coming back from my background in medicine,   we focus on unmet needs and then in order to solve  that sometimes you must deep down into the very   basic science and sometimes you need to do that  like some type of more translational work. So   I know that most university labs are basic science  research and then you know there's an aha moment   someone says or they think that oh you know this  particular song piece of science can have a major   application like for example in multiple things  in the Covid situation, or lab as I said is very   different so we are we already have few projects  in the lab that we are working toward that,   and you know obviously you have to develop  the infrastructure for that the basic science   for that but then you know when we get  to the level that we think that it has   enough it has produced enough preliminary  results that can be you know first of all   I m more comfortable on the results that  I can now and ask for investment so that   s the time that you know I would try  to get into the commercialization   and try to spin it off into a company. >> Allison Hubel: So, I think that s that   that is a wonderful story because different  there s going to be different paths through   commercialization and different motivations Steve  is a classic example of a very acute need you   however have gone through and used your training  to kind of frame your entire research program   around meeting unmet clinical needs. So, I can the  differences in those paths are important and yet   it maybe it will provoke people to think about  all kinds of different other motivating factors,   Tracy do you want to pipe in here? >> Traci Lyons: Sure, absolutely so you   know my lab has been studying what we call  postpartum breast cancer for over a decade.   And these are particularly nasty breast cancers  that are diagnosed in women who have recently had   children, many of these patients are my friends  and my peers, and so I've been very motivated   to try to figure out a better way to improve  survival rates for these women who are three   more three times more likely to develop breast  cancer or to develop breast cancer metastases   within five years of their diagnoses. So, about  three years ago along with one of my colleagues  

we had designed a peptide, that we were hoping  would generate novel monoclonal antibodies   in a mouse. That would target the particular  signaling pathway that we were interested in   and just prior to the shutdown actually we  got our first batch of purified antibody   three Decembers ago I guess, and I had my  graduate student put some tumors into mice and   then use the antibody to treat those tumors  and within four treatments and the animals   were tumor free completely, and we removed the  treatment for then a period of 45 days they did   not have any recurrence of their mammary cancer  and actually, when we re-challenged them with a   new tumor challenge they did not get a tumor. And  so that was my the best Christmas present ever   and that was when my clinical  collaborator Dr Virginia Borges said to me   you may just have the next her too and so that  was like the big moment and that I decided that   we really needed to do something so through the  SPARK|REACH program I was introduced to um a   Serial entrepreneur who became very interested  in the technology we licensed the technology I   Co-Founded a company called Perla Therapeutics  with him as the CEO and we are hopefully going   to be fully financed by the 20th. >> Allison Hubel:   Champagne for everybody right, yes so  what we're seeing here is kind of a   Balance, everybody here has talked about  an unmet clinical need I mean some of it is   driven by personal experience knowing people  who've developed cancer. Others of it's your   life work related to your clinical interest  and in others it's a pandemic. That everyone  

oh I shouldn't say everyone a lot of people have  been predicting for a long time that finally came.   So, there's always this balance between clinical  need unmet clinical need and the technology that   can address that clinical need. And so, both of  those elements seem to need to be present for   that aha moment to take place, so now we're going  to talk about some fun things, right fun because   we all know you're far enough along in this  journey that you've put in a lot of late nights,   and a lot of hard work. And so, my  third question and once again we are   soliciting any kind of input from the audience  is innovation is a path and not a destination.  

I'd like each of you to talk about resources  that you took advantage of, during critical   points down your path of innovation toward  the marketplace. And please try to look at   a mix of resources that you may have taken  advantage of in both at your university or   your home ecosystem and then more broadly  out in the community, so Arash we haven't   made you go first yet and so it's your turn. >> Arash Kheradvar: Sure, obviously as you said   it's a journey not a destination. And you should  enjoy the journey because you know of destination  

comes very randomly, you have not much control  over that it's important that you accomplish   the journey to the best that you can. And you  know there's always a lot of good, unexpected   that's coming like as the Tracy just mentioned, so  yeah that's very true I have been fortunate that   UC Irvine has generally very much supportive of  innovation. We do have UCI applied Innovation   Institute that they are very focused on multiple  aspects of innovation and there is a real value   at UCI, if you can translate that technology  like a science into technology that can be   commercialized. So, I have been personally  very fortunate, and generally University of   California as you know every year the number  of invention disclosure you know forever it   has been the number one in the whole US so I've  been fortunate in that environment but I know   that there are a lot of smaller schools that you  know this culture has not evolved yet, you know   because of financial issues or because of you know  more traditional way of looking into the science.  

So, yeah that's my experience and then the other  thing is that like UCI is in Orange County you   know it's a hub of startup companies on  different grounds you know we wish we   had more VCs around us like in San Francisco,  New York or Boston. But we still have a lot of   companies a small and large and medium-sized that  you know basically accentuates this atmosphere   of innovation around us. Tracy it's your turn. >> Traci Lyons: Okay, great so I have been lucky   to have the full support of the SPARK|REACH  program here at the University it has absolutely   been crucial for me being able to do this. I  scientists don't know how to talk to finance   people and finance people don't know how to talk  to science people, and then just the sheer number   of acronyms that you have to figure out and so I  have a whole team of SPARK advisors we meet just   like this once a month, and talk over what's going  on what's coming next our CU Innovations office   has been extraordinarily helpful in making helping  me to understand you know contract negotiations   what to what to ask or what to not ask for. I  think one of the biggest things I've learned is  

to ask, no matter what it is if somebody uses  this acronym, and you feel stupid because you   don't know what it is just finally say what is  an IND I have no idea what you're talking about   out. Rick Duke and Claire McDonald head up our  SPARK|REACH program and they have been crucial   to our success in making this happen, in not  only by introducing us to the right people.   But just teaching us this process and it's been  very challenging, but it's been fun to learn the   business side of things. So, I've really enjoyed  that and other members of the community who have  

done this have reached out to me and helped me  as well we've also received some support from the   American Cancer society's mission boost program  which is similar in its goal to commercialize   successes in the lab. >> Steve Soper:   Great thank you, let me say this we're all  three professors starting a business is not   easy endeavor and it's never done by one person  I don't know what else to say and what that kind   of leads me into all the people that really were  instrumental in helping me bring this forward. And   let me start with just like Tracy said her SPARK  group I why we had money from the RADx program I   was it was administered through and I'm going to  make sure I say this right the Midwest Biomedical   Accelerator Consortium out of the University  of Missouri and I had weekly meetings during   the pandemic while we were developing this  technology with Steve Volpe. Who's at the NIH   who was it I think he's still at the NIH Jaya  gosh from the University of Missouri and Bill   Turpin from the University of Missouri, and not  only did they give me technical hints on what was   important especially Steve Wolpe in the Covid-  19 domain, but then also connections so we have   we talked at a couple venture forums about the  technology and raised quite a hoopla. I must say,   and that kind of got us going and it reinvigorated  the company that I found in 2011. that was kind of   having troubles because of the pandemic as a lot  of companies were but the CEO of the company Ralph   Mueller kind of put his faith in me. let's bring  this technology forward and getting it going,  

so this technology that that I'm touting didn  t just start out of the blue it was filled off   technology that we had been working on for several  years. So, for example this biotechnology resource   center that I'm I have been directing for the last  five years, funded by the NIH the foundation a lot   of that technology and then the infrastructure to  build the devices that we were going to put out   onto the marketplace for Covid- 19 was built by  that grant, as well as the University of Kansas   and my colleagues at UNC Chapel Hill and Louisiana  State University as well. And then my colleagues   too at those two universities helping me with new  ideas how to build things quickly to get them to   market the Proof Of Concept and then technologies  only work as good as the answers they provide. And   that's the way that's treated at least from the  biomedical community is having access to clinical   samples to test the technology under different  clinical scenarios. And I had a colleague I have   a colleague at KUMC Andy Godwin, who went out  he was doing a lot of broad scale COVID testing   in the span of a week. He was able to secure  500 saliva samples for me. We could test the   technology to push it forward for an EUA approval  through the FDA. So, we also had advisors from the  

FDA helping us. Oh my gosh, I could go on and on  and on you know writing the patents getting those   through our technology transfer office quickly  and efficiently was another important linchpin   in all of this, and making this happen over  during the COVID period was not an easy endeavor   because most of this was done through zoom and  now it seems kind of commonplace to do zoom,   but not at the time even when we got in the lab  the students had to go through a lot of different   precautions, like wearing masks and social  distancing in order to get back into the lab   and they actually rose to the occasion, and got  a lot of the data that we needed to move things   forward so that's kind of my little Spiel on  that. Oh let me say one more thing Allison,   before we quit yet this is a platform technology  now testing demands for COVID is going down and   you got to ride the different clinical needs as  Arash said and what we're doing now is repurposing   this technology for different application  scenarios and one is the early detection of a   variety of cancers in particular we're working on  ovarian cancer right now using blood-based testing   for the early detection of that disease. >> Allison Hubel: So, these are just awesome  

nuggets of wisdom that you have  gained. And if I were to kind of   summarize this, at least through the lens of  my experiences is one of the hardest lessons   for me were to realize to know what  I don't know okay and if I don't know   a quality system that I need to do in my  business. I need to find someone to help   me with that and so one of the things that these  Proof Of Concept centers do is help connect you to   those mentors those people who know the thing  you don't know, and can help you move forward   the other thing I have learned is when you are  done networking you go back and you network some   more. So, it would be great if everybody could  comment a little bit on how and we do have another   question in the chat, Jaya I will get to it. It's  a wonderful question but I want one follow-up  

before we switch gears a bit it'd be great if  you could talk about the strategies that you   employed to expand your network to connect with  those mentors that helped you move forward so   why we don t we go back to Tracy again. >>Traci Lyons: Yeah, I think you know   my best comment for that is persistence and I  have been wanting to make this technology since   I first established my own lab in 2015. And I  had so many people tell me that it's too hard,   it's not possible, it's not going to work, and so  I really sought out people who had experience at   the university in tech transfer and developing  novel therapeutics. And so, I was just lucky   that we had the SPARK|REACH program. And that I  could seek out those people at the university,   and I mean I must credit them because beyond that  I feel like that's all I did. And then once that  

got rolling, they introduced me to all the right  people they found you know someone to finance the   company and so I really must give them credit  but also just say if people tell you no push   back and say you know I'm I think this could work  and go for it, if you really believe in it.   >>Arash Kheradvar: Yes, I fully  agree with Tracy, my experience   has been a little bit different as well given  that the research that I'm working on our old   class three devices so it adds another order  of magnitude of difficulties, because in the   lab you know it's so for medical devices you  really need to in like from the beginning intend   to develop those you know there's it's not that  you're working on a particular science and then   you know an idea of medical device comes to  you that would be very rare you usually first   focus on okay this device is needed and if that  device is going to be developed it will help that   number of patients and that number of patients is  quite important because it generates the market   of interest and that's very important to the  eyes of the investors so and then when you   have that moment or to understand that okay there  is absolutely no solution in that then you must   start thinking of the difficulty of designing  you need to know the anatomy physiology that   cellular problems everything you need to consider,  then you develop a first prototype you put it into   some in vitro testing it fails, and then you have  to go back and change and come back and then now   it it's okay, then next step will be the large  animal, you go to the large animal you know there   s sophistication to that so a hard drive that  we implant you know it involves like 15 people   view in the cat lab, for example we do have the  interventionalists, we do have Imaging people,   we need to have ultrasound, you need to have  a cat lab you need to have all those stuff and   they cost a lot of money, a lot of efforts  then you get through that you go you do the   acute animal study. Then you know chronic animal  study, sometimes your animal dies not because of   your technology because something just went wrong  completely Irrelevant to your technology. So,  

these are like a system approach requires a lot  of patience, perseverance and you know the fact   that you know kind of be positive all the time  although you know there are a lot of negativities   around you. And I think that's kind of the  secret sauce to the success is to stay there,   and then in order to do that you need to enjoy  the journey until the success comes to you. So,   that's kind of my experience in general on  the device like a class three devices which   are I think very difficult, then like a class  one or even sometimes an Imaging modality that   we also work on Imaging modalities as well. >>Allison Hubel: So, it sounds like if I'm kind   of summarizing this, that when you must go through  all these series of hurdles you need whoever is   the expert in that to be part of your team and  help you get over that hurdle. So, it's almost   like a continual process of networking because  you're developing the team you need for your small   animal, and that may need to vary from the large  animal and that may need to vary from somebody   who's capable of submitting the IDE right. >>Arash Kheradvar: Absolutely, just to clarify  

like just a couple of weeks ago we had an animal  we were implanting some growth accommodating   pulmonary valve for young children in in some  mini-Pigs or baby Pigs, basically Piglets. And so,   like I asked my networks in Canon USA. Who they  brought their team and their machine to do the   Echocardiography you know we had a cat lab from  Phoenix, and I had the physicians and the nurses   from Children Hospital of Orange County. I had  my team, and we did have some other some we had   a couple of Veterinary surgeons, another one doing  the anesthesia. So, it's a major teamwork and you   know you must work with everyone and if every  one of these elements fails the whole experiment   fails, regardless of how good of a device you do  have known if the anesthesia fails for whatever   reason you're done that experiment is done. >>Allison Hubel: So, Arash I know how fraud it   must be and Steve you're an in vitro diagnostic.  So that's another challenging area in which  

the nature of the network is critical,  and you had the pressure of a pandemic,   making you compress the time frame. So,  if you can talk about that a bit and we're   getting increasing numbers of questions in the  chat, so we got some stuff to get through.   >>Steve Soper: Okay, I will make this short, but  in terms of networking know who to network with.   Do not try to be go beyond what you're capable  of doing so for example of well all three of   us are academicians of some sort I like to talk  to technology. I go to meetings I talk to people   both researchers and people and businesses about  what we're doing from a technical perspective,   but that's only half the battle the rest of  it is to talk about the business proposition   and that I'm not capable of doing I can't do  that so the CEO of our company he does that,   he talks about okay this is great technology but  what are we going to get out of it from a business   perspective. Are we covered with the IP he goes  to meetings like JP Morgan, which I just found out   about several years ago I didn't know about such  a meeting because I don't go to those meetings   so I think that's what my take-home message on  that would be it's great to have an expanded   network but make sure you know who your network  with, and that you're capable of effectively   networking with them and don't be afraid to  pass off some of this adventure to people   who are probably more capable to do that. >>Allison Hubel: And you know as scientists and  

engineers, it's not part of our training to do the  networking so this is something that really pulls   us out of our comfort zone. But it's extremely  critical and the Proof Of Concept centers can help   you by help connect you to that greater network.  And therefore grease the wheels for you moving   forward so Jaya has waited very patiently  so I m going to read her question for early   career scientists what best practices / mindsets  would you recommend so that they can be better   prepared to seek out the unmet medical needs  and intentionally develop technologies to meet   those needs? so is there anybody willing to. >>Steve Soper: I'll start, Hi Jaya, so for early   career scientists, I got a couple things to say  about that be very careful about what discipline   you're in, and promotion and tenure considerations  many times translational or commercial related   endeavors may hurt your promotion and 10-year  process. Believe it or not, and some disciplines   it's much more of a giving endeavor for this  commercialization process like writing SBIR   grants, writing patents, and I've seen a lot of  big difference between those two. And so that's  

for people who are pre that are not tenured yet  but those that are beyond tenure and are still   moving up the ladder what I would say is don't  be afraid to do translational work. I mean if   at least in the basic sciences, it's kind of built  on fundamental work and you know NSF for example,   but you can balance both of those translational  and fundamental research basic research work.   And I would encourage you to do that and look  into that the other thing I would say too is   don't think that you know what should or should  not be patented. I ve talked to a lot of people   and they say that I can t patent this, yeah but  again as scientists and engineers that's not our   forte we don't know that I would say take it to  your technology transfer office they have the   resources to decide what should or shouldn't be  patented, and if you are thinking about starting   a business patenting is the first step that you  want to do, and you can do that at the proposal   writing stage you can submit your proposals  as the foundation for either a provisional   or a full patent application. So I'll stop  there let the other people add something.  

>>Allison Hubel: So, once again just  to refocus we're talking about how an   early career scientist, can seek out those unmet  medical needs an intentionally develop something   that could have a therapeutic effect? >>Arash Kheradvar: If I may continue,   you know I do have a different perspective than a  Steve. So when I started as an assistant professor   my goal was not to get my tenure, I believe me I  never even thought about it until the six months   before like I got it. My goal was to be impactful,  I didn't mind to even have to leave academia if   I had to but my goal for those years was to  be impactful and that's what I didn't believe   me tenure just came with an acceleration  without even thinking about it. So, I would   suggest and I cannot recommend I always suggest  because everybody has a different a story and   an experience so my suggest the way what works  for me is I was always just focused on the impact   and what I agree with Steve is for every  everything that I was going to publish that   I thought it has some application, I would first  submit it as a patent in the background and when   I have the provisional stamped with USPTO then  I would submit that paper. This is you know  

so, in my lab every couple of months at  least we have one provisional submitting,   and then every now and then few of  those are combined into one patent,   so I started that as a rule you know from the  very first day of my career as an academics   and you know it worked for me. >>Allison Hubel: So, Tracy don't want   to cut you off, but we do have some questions from  David and their insightful questions so let's he's   getting down to the nitty-gritty here, I'm going  to combine a couple of his questions together,   when the best time is to bring in a sponsor  during a phase one or a phase two grant in   other words SBIR I m assuming. And his follow-up  question tothat is how many times where you turned   down from NIH funding? and I'm assuming this  is not related to RO1 research but rather your   commercialization of funding so does anyone  want to jump in on that I I'm also happy to   tell you how many times I'm rejected so. >>Traci Lyons: I can speak quickly just to   say that my REACH application was funded on  the second try, my Mission Boost Grant was   funded on the second try, my first SBIR  just got reviewed. It will not be funded   um and I think I did things a bit  unconventionally, because I had the sponsor I knew   through a mutual colleague, and he was actively  seeking new technologies. And so he came in early,   I think it's probably more traditional  to get the sponsor a little bit later not   like when you have the first experiment  done showing that this works but I'd be   interested to hear what the others think. >>Arash Kheradvar: I was just looking into how  

many grants I've submitted over 200 grants in the  team in 15 years that I have been in academics.   And you know I have raised about 20 million  dollars, in total with RO1 and others you know   I think every 45 days I put a grant in since  2007 that I started my career. I still do   that like this past couple of months I had to  submit 8 grants, was difficult honestly these   past 60 days. But you know sometimes happen so I  think in order to have the pipeline of innovation   there you have to be doing it there's  no time that you can just sit and relax,   you know and that's why I think we all agree  on that you should enjoy the journey because   that's the reality, and then one other  thing just that in the previous question,   so I think the academic entrepreneurs should be a  CEO a CTO a CSO a CFO. Not you know getting paid  

as all those positions but you need to be there  even if you do have a business partner. You know   I can tell you so many stories of the CEOs not  doing the best as they should I personally had   a very bad experience with the CEO that I had.  And you know it would basically ruin the whole   technology that could have been sold for 50  million dollars, so I learned to basically also   learn about their skills, because obviously you  need to have them you need to have a great one,   but you also need to double check some of things  or basically have a vision there's no way that you   can always say oh because you say that I agree, I  think that's that was my experience at least.  

>>Steve Soper: Yes, let me I always like to  give you a little bit of a person perspective   on things. And my comment would be for all these  all of you who are academicians don't think you   can write an SBIR grant by yourself, they have  a little bit different format and I think Tracy   will tell you that phase one maybe not so but  phase two you have we've had with Bioflitica   we've had great success with SBIR grants, and  the reason for that is it's very simple we've   hired a firm that's really specialized in writing  SBR grants to help us. And their success rate was   high so again bringing people who know how to  write an SBIR grant they are not like RO1 grants   I'll tell you that right now, it was beneficial  to get that to move forward and yeah, I know you   might have further questions on that but yeah  that's kind of my little two bits on that. So   we can move forward I see there's still a couple  more questions we may want to try to get to.   Oh we did we kind of addressed them they were from  David so, well let me just let me just add one   to build on what Arash said I think this is very  important, when to bring on a CEO for a company?   I can tell you right now I've had experience in  doing this both one way and the other. The best  

Proof Of Concept data on the technology you're  touting for commercialization I think is critical,   after that it makes sense to bring on a CEO to  help you move that forward in terms of funding   and commercialization. I've tried it with help  getting a CEO early on for a Proof Of Concept data   was collected fundraising was difficult, if not  impossible, not just from SBIR but other venues as   well Angel funds and VCs so it's that's not always  true but boy that in my experience be careful   when you bring on a CEO that it may or may not be  successful and be very selective too. Those people   are critical they're just as important as the mind  behind the technology wow you got to work with   them too that is the inventor and the CEO, you  got to be thinking on the same page as well.   >>Allison Hubel: So, we have one last question,  because we're getting close to the end, and it's   meant for Arash. Many of the translational  product development funds come with tight   milestones and budget use restrictions? what is  the distribution of translational grant proposals   versus hypothesis-driven research grants that  you have submitted? what would you say to those   academic researchers who think applying for  product development grants is a lot of work   and funding is tied to deliverables? >>Arash Kheradvar: I would say 50% were   hypothesis-based 50% were  kind of development based,   you know you could submit a translational grant  that is also still hypothesis based overall I   think in the past five years the vision of NIH has  changed more toward the translation. I remember in   2011, 2010 you know it was very difficult for a  developmental grant or a clinical unmet need to   get good reviews from the panels. Right now there  are several panels in NIH that are focused on  

translation even at the RO1 R21 ones you know not  just the SBIR, so I think it's just a matter of   like kind of try you know and don't give up.  That's the most important thing I would say   I do have a I do have a philosophy that you  know if you don't apply 100% you won't get it.   If you apply there is a potential that the  randomness helps you but obviously you know   it depends on who are the 3 people who are looking  into your grants, and you know who are competing   with you on that same day, which you know it's  85% of the chance that you may get it funded or   not. So, you shouldn't take it on your side and  say oh you know I got this this is horrible no   you shouldn't look at it that way. At least I want  you know I said okay you know I'm happy that I had   the opportunity to get some three people opinion I  may not agree with none or I may agree with some,   but you know the most important thing is to learn  from there from that, take those negative points   as the challenges as opportunities to improve  and then resubmit and you know if you are if   you have the perseverance to kind of stay on like  against the road, and against their negativity,   at some point good stuff going to happen. >>Allison Hubel: So, I would like to thank  

all the panelists for their great  contributions to this day's meetings.   If somebody wants to reach out David had  another question, but we've run out of time,   and I want to keep Stephanie happy, got to keep  Stephanie happy. And so thanks to all of you and   it's been my honor to serve with you. >>Arash Kheradvar: Thank you very much,   it was really a pleasure and if anybody from the  audience would like to like to have a different   conversation later, you know I will be very happy  you know just looking to just Google my name you   know my contact information coming and you know  I would be happy to help as much as I can.

2023-02-14 19:45

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