Industry sign banking north carolina medical history fast
Thanks well thank you very much and when i first started thinking about this topic building career and industry sponsored projects i thought there are two ways we could go one was to think about well if you only want to do industry-funded studies and you know that's certainly one way to think about how you might build your career over time and I certainly have many colleagues who have done really important very impactful industry-funded studies and that's been the basis of their career and they've done very well for many many years but I think all of us would rather think about building a career on industry-funded studies is having this is a foundation and then finding out or figuring out a way to use this to build into using additional research Awards of NIH awards for example and this more mimics my career and I'll share some personal insights with you as we move forward here are my disclosures and on my disclosures I think it does show you that yes i do have industry support and i have an IH support and and i'll show you a little bit about how we accomplish this to start with I think it's also important to recognize where is the funding because at the end of the day a lot of this comes down to money and this slide demonstrates that total research expenditure is quite large you'll see that federal expenditure that we've heard about that we're all trying to obtain is quite substantial as well 30 to 40 billion dollars but industry funds a significant amount of us medical and health research in the United States this is data from fiscal year 2012 I looked at my home state and by the way if you ever need any kind of Statistics this research America which is a lobbying group has really good really good data they're all your states are listed so if you ever need information or preliminary grants etc you can find it there so i looked at my home state of North Carolina and you see that federal government funds about 2.2 billion dollars worth of health-related research and Industry 4.7 billion so almost double more than double what's actually being spent in North Carolina from industry than it is from federal government of course you have large research institutions in in North Carolina as well and you see the state ranking so numbers 13 an industry-funded number 17 overall and federal government research funding here I think also that the availability of research funds and who are going to think about applying for somewhat varies by your subject matter and I think for basic scientists and this is some data from the National Science Foundation and how the categorized science but basic science where activities aimed at acquiring new knowledge or understanding without a specific immediate commercial application or use so basic science if you will most of that has done it u.s. research institutions and a lot of that actually the vast majority is actually funded by the federal government but when you start thinking about translational research clinical research then you see where the business sector can actually drive a large amount of that type of funding as well I won't dwell on these NIH funding levels we've seen that over time the NIH funding levels have been relatively flat although we hope they're going to go up with some of the new budget negotiations and because of this because of the increase of people applying for the awards as well as the flat funding overall the pay lines for particularly the our awards and other project program project etc has fallen down to the fifteen to twenty percent level now I'm not showing this to be discouraging what I'm showing this is to make everybody realize that there are other sources of funding and we should be very optimistic to keep our eyes open to find other potential sources now we may ask ourselves why is there even a distinction between industry funded and nih-funded research and I think some of the discussion here has suggested that we've heard talked about promotions and things like that so I think there is an underlying a distinction that's given at major research institutions in this regard in 2014 the NIH delivered about 30 billion dollars to 50,000 competitive grants at over 2500 university in the US but why do we think a little bit differently about industry funded research well there is some perception of stature and top research universities are ranked by the amount of NIH dollars they're always lists whether it's similar to like the US News and World Report you can pull up go on the internet and try to find out where your universities ranked in terms of NH dollars and that's very important for a lot of a lot of reasons as shown here there's also perhaps some perception of value and it may come down to dollars and cents the overhead that for every dollar spent in your research study that ultimately gets returned to the institution is almost double that fifty to sixty percent of the grant actually gets returned to the institution to cover what's overhead costs industry-funded studies maximum usually about 28 to 30 percent and then there's this also perception of purity that I think we have to overcome a little bit but there's a lot of information out there that suggested industry study funded an industry-funded studies are usually positive they're usually the things that are cited heavily because they've demonstrated a positive result and to get around this of course we have clinical trials gov now where you have to register any study that you're doing to try to prevent publication bias and demonstrate that even if you have negative study results those are going to be available somewhere to people to to investigate but I also recognize that perhaps it may not just be bias it may also be that industry in some ways is making smarter choices they're liable or they have to be responsible to shareholders to their corporate board etc and they have to they're obligated to make smart choices they don't want to invest a ton of money going down a rabbit hole of research that's not going to yield things that we hope ultimately will improve health outcomes so there are two ways to look at this if you're a pessimist you're going to say it's all bias but if you're an optimist you're going to say well they're also making good choices now at the end of the day where are you trying to find funding somewhat comes down to economics and as NIH funding starts to decrease or that the pay lines are relatively low and industry funding is putting a lot of money into these phase 2 phase 3 phase for clinical trials universities are going where the money is and every one of your institutions I guarantee you when NIH funding was starting to be a little bit more difficult to obtain created very focused efforts to attract more industry dollars try to improve research efficiency develop new investigators for industry studded industry-funded studies and over all attempts to decrease the barriers that industry would feel by doing studies at research institutions that some of us have to deal with on a daily basis some of that frustration it reminds me of that old story there is that might be apocryphal but the bank robber when they asked him at a sentencing why did he rob banks he said well that's where the money is so the idea is that that's where we want to go to if the money is is there so there are several ways that you can get involved in industry-funded studies we have investigator initiated studies and these are things where there's mutual interest between the potential funding source the industry whatever company that may be and what you're doing either in your lab or from your clinical research and it can be basic science or or a clinically patient-oriented research and here an investigator-initiated studies the investigator develops the idea writes the protocol pitches it to industry and they may review it and industry liaisons may suggest modifications and I think we have to recognize it there are a lot of smart people working in industry actually most of them came from academia and ultimately migrated to industry they're they're rather intelligent they're very focused on their field and they often can make very good suggestions and modifying some of your investigator-initiated studies but what's important here is if the investigator owns the data and they own the analyses and they own the publications okay the only deliverables that you have to the company are just making sure that it's actually getting done that they may set some timelines for IRB approval making sure it gets listed on clinical trials gov defining when the study is going to be completed what your patient accrual milestones are so those are the kinds of deliverables that you negotiate for an investigator-initiated study you may provide them with a courtesy review of the manuscript and it's purely out of courtesy they have no editorial control over investigator-initiated studies and that's spelled out in the contracts that your institution will do with with the with the sponsors most pharma sponsors big pharma small sponsors support small farm actually welcome I is proposals they often have mechanisms on their websites that you can find what areas of research that they're particularly interested in that dovetails with their their interests and they also provide quick review and funding decisions which is really nice and I think this is key this is really important and useful for developing preliminary data for NIH grants you can do it fairly quickly and it's a good source of funding to keep in mind the other way you can get involved in industry funded research is the classic clinical trials right where they're testing drugs in different disease states that you're seeing in your in your practice here the farmer sponsor contracts with the pie and actually the University to perform the specific clinical trial the deliverables here are way different its regulatory rigor it's patient enrollment it's your obligation to closely monitor those patients keep them safe during the course of the clinical trial and provide them with clean and accurate data according to good clinical practice standards here that all the data is owned by the sponsor but what are the opportunities that you might think about if you're involved in phase 1 24 clinical industry-sponsored research well there's networking you get to meet a lot of other pis and investigator meetings who are like-minded as you interested in doing things that can lead to other collaborations you can start to develop your own research infrastructure because the money the funding that you get from industry sponsors of course can pay research coordinators research assistants research text start to fund the a serum bank and things like that there is the potential for impact publications we'll talk about some examples you can consider proposing ancillary studies from the data that's already being collected from the phase 12 for clinical trials and also important when you're thinking about grant applications is that it allows you to develop experience a track record and learn more about good clinical practices and good clinical practices is kind of described here it's really the the roadmap that we follow is call clinical investigators it assures that our research participants are are being cared for that all their rights safety and their well-being are protected within the standards of gcp whether from the beginning of the design of the clinical trial to conducting it to monitoring and appropriately recording analyzing the data making sure it's accurate reporting it out in manuscripts that all it falls under gcp and industry studies do quite a good job at following gcp and if you can learn gcp in the context of clinical trials and industry-funded studies it will tremendously help all your own industry investigator-initiated studies or your grant applications because everything that's mappable gcp is absolutely applicable everything you heard about writing NIH grants so another way is let's say you're participating in a multicenter phase three clinical trial they're collecting great clinical data they're collecting biospecimens and you're thinking okay how can i tap into that a little bit more not just enroll patients what else can I do well think about proposing an investigator-initiated translational study okay so maybe you have some specific lab expertise that you can take those samples those highly linked clinical data really detailed clinical data apply a unique aspect from your lab and generate some very interesting preliminary data for grants or manuscripts etc the other way you can think about is there a lot of secondary endpoints to kind of go unexplored in these clinical trials other ways to mine these large clinical databases and I'll tell you that you can utilize your clinical research expertise and that industry is very receptive to these kinds of proposals to say hey let's let's see what we can do with these well there are some disadvantages to working an industry-funded studies at yep Thank You Barry talk a little bit about perception this perception also filters down that it may have a little bit less impact on promotion compared to NIH awards and I'll be interested in hearing other people's thoughts about that they're often short-term funding they're also study specific funding so they may only last for a year maybe two at a time and you have to if you're planning on doing I is studies investigator-initiated studies the investigator research agenda has to align with the potential sponsor studies so that's where their priorities so that's one thing but there are advantages as well there's rapid start up talking about weeks it pays for your clinical research infrastructure to get started start with the coordinators your tech things like that start your specimen bank that you can use from some of this funding it helps you develop that track record that I mentioned that ultimately can be used and leverage for federal funding residual funds is a term that other institutions call other things but if you have an money left over from an industry trial after you've paid all your bills after you've paid your coordinator paid for your salary support everything else most institutions will allow you to use that for other academic pursuits and how you can fund other academic things of interest see whether it's pilot studies or again paying for your research infrastructure and there's a potential for high-impact publications we shouldn't underestimate there's a whole field of study that util that looks at what are the impactful scientific journals what are the impactful manuscripts in various fields of study it's interesting they I guess make their own academic career studying the impact of other people's academic career ok let's do it and this was this came out in 2015 and this is the typeset the top cited GI and hepatology articles published in all journals ok as you see here ranked 1 to 50 and you'll see that the top 125 that z's top 5 journals for the five were actually funded by industry and I'll just I'll say that the number 5 is peg interfering alfa-2a plus ribavirin I was a first author on the New England Journal manuscript and this really set the stage for the standard of care for hepatitis C for at least a decade until the direct-acting antiviral agents came out and this was an industry funded study that had a wide-ranging impact on my career led to a lot of ancillary studies led to a lot of other other things so how else how can NIH study how could industry studies help NIH study at Grant achieving grant success with NIH funded studies well you've seen this the the five pillars of how your grant gets reviewed significance innovation approach investigator and environment and I think there are two areas where this may play a role particularly if you're an early stage investigator you can think about where where they asked do they have the appropriate experience in training well you can show if you're doing industry studies it yes you've developed experience you've developed a track record or enrolling patients you've learned about good clinical practice from these industry studies that that can only help particularly if you're thinking about clinical research or if you've done IAS studies relative to industry and
spin-off studies from that and similarly the environment the industry studies can help enrich your environment as I said by creating and helping maintain your research infrastructure while you are in between grants or waiting for additional grants so if we think about how we pursue NIH funding right if we think that this is the ultimate NIH award that we're trying to whatever type of award you're thinking about we go through kind of a set process that we've heard a lot about today we brainstorm this idea we have to come up with some preliminary data to show that we're serious about it we write this innovative application that also includes a way to highlight our track record and sometimes there are some barriers along the way that we may have maybe our track record might be a little thin if we didn't if we're only focusing on this one grant so I think there are ways that industry can help you can see where industry investigator-initiated studies can help you with preliminary data you can see where the clinical trials experience gcp enrolling patients developing an important cohort that you're subsequently going to study in your NIH grant can be important and the same thing goes for investigator-initiated studies with sample specimens translational research etc then I can help remove those battery barriers this just gives you an example early on in my career when when when I was just applying for funding for various awards these things were important in preliminary data sighting in incited preliminary data industry studies clinical trials that we were doing some interferon signaling studies that were interferon investigator-initiated studies and then subsequently we were able to start of course as you are acquiring more NIH grants you start citing those more but industry studies and investigator initiated studies always form some role in successful grant applications over the years now this is really important okay you got to think about your research career as your portfolio any of you pay any attention to your portfolio at your young age you know I remember there are people in residency who were they were reading the newspaper every morning looking at their stock portfolios and now I'm realizing they were the smart one okay because they're probably retired they may not have published as many papers as I have but they're probably retired by now by the way they don't have smart phones they're really looking up the that changes in the newspaper but you know that your portfolio changes over time you might take higher higher risk when you're younger less bonds more stocks a little more volatile and your investment portfolio changes over time where you may be a little bit more conservative and less stocks and more bonds around the age of retirement well I think the same lessons apply to your research you want to diversify your research portfolio in order to max minimize risk and maximize your returns and early on your research may come from very early in your career may come from pilot awards and i think as i showed you industry can play a role in this we talked about some of the important pilot awards and funding opportunities from ASL DNA GA and there are a lot of other foundation grants that you could think about applying for a little later in your career but still early you still have some industry background there but then you've been successful k 23 Kos taking 75% of your time you still have a little industry and maybe other foundation awards and then subsequently over time you can still think about having industry studies but you've been successful now with independent research awards ro ones yoooo ones and a fantastic grant which oh you should keep in mind in the future as the k24 that is a mid career mentoring award and allows you to help mentees at your institution so I think if you try to diversify your research portfolio over time yet you might have the most benefit so what are the keys to being successful in this endeavor well you want to get your foot in the door we'll ask your mentor to make some introductions for you and don't be afraid to pound the pavement ok you can whereas some shoe leather doing this and I will tell you the first industry garant that I got was directly because I was a new faculty member at Emory in 1998 I knew I want to do some industry-funded studies and at my own expense I flew up to to be a mess met with medical director and explained to them who I was where I was very interested in industry studies and clinical trials and that led to some subsequent funding opportunities so don't be afraid to try to make these opportunities for yourself respond to invitations and requests in a timely manner we're all really busy but if someone is reaching out you don't don't ignore them and prioritize study performance you want to develop a reputation for clinical research excellent embrace gcp some of it sounds a little cumbersome but it's really an important cornerstone for clinical trials your research staff is going if you if you have this commitment your research staff will memmer will mimic that same level of commitment and it will help you tremendously focus on study startup times it's an important metric that industry does look at over unworn you additional studies cast a wide net keep your eyes open look for opportunities make opportunities be aware the changing research environment in your chosen field obviously if you're just starting out today and you wanted to study hepatitis C therapeutics that may not be the best career choice at the moment I'm I'm thinking Nash maybe a little bit better and also you have to moderate your concern for being overextended right all these grants say seventy-five percent protected time but is John showed that the earliest yesterday that's seventy-five percent is a little nebulous how you characterize it so you have to be willing to cast a wide net and work on other things because at the end of the day if you're k award doesn't work out you still want other things to to pick up the slack be patient but persistent submit investigator-initiated study ideas to medical science liaisons that all the companies have and network with medical directors tell them that you're interested in opportunities to be in writing groups they like I said they want interested dedicated investigators and you never know it could lead to one of the highest impact publications in your field so I'm going to stop here and I'm happy to take any any questions in part of panel thank you yeah we're a pal for just about 10 minutes that's all we have so if this previous speaker is David Rhonda hashem Nick can come up so so I thought that was an excellent talk and understanding that that was great so I'll start off with a question just to kick things off so this is for David so just for our audience are our awards from industry or the NIH made to individuals or who are they made out to so yeah so they're made to your institution so you put your application package together and the your institution submits it on your behalf and we we did interact with your institutional grants management office really i mean i can have one-on-ones with you of course as well but for official documents or anything like that it goes through the official channels and the award is made to the institution okay and and perhaps for Michael the same thing for industry yes the awards are made to the institution they're the ones who administer for you but of course you have to sign off as the pie nice a moment there such hi Michael David we're seeing of course a desire to have more academic and women participate and the cable it happens at a time when you know biologically some women would want to have their children their families we had an experience where a young investigator had taken three years to have her two children sort of academic leave then came back in the system and then the time clock had ticked too far and then she was no longer eligible to be a que awardee is that something that we can work on so that we can continue to encourage women to be able to participate in the curve I don't know about other Institute's but I can say at least for the NIDDK that the time out away from the research would typically we look at it and it wouldn't be held accountable I mean a part of the the clock it's really the time at the bench Anor in the clinic doing the research the KO one is the only mechanism that explicitly states a time range post terminal degree to 25 years KOAT and k23 actually don't state that so our heuristic is we would like you the end towards the end of your k period to still have ESI early early investigator status so that you get that bump in the pay line when you go for your ro 1 so in general know that if you took time away from the bench I don't we wouldn't all venues okay and we actually had a situation where the stands people at the NIH said exactly what you said now and it went to study section and the reports of the reviews were in time this person is eight years out of medical school finished you know fellowship so many years ago so it may be something that I'd asked to to look at the details and make sure we can implement it that's important so just just as a fall to a question which you alluded to can you mention about the early investigator status because I don't think anyone's talked about that what makes you eligible what makes you ineligible when you go from a que tu an hour simple it's a clock so it's ten years post terminal degree so PhD or MD PhD at the end of your your final degree and it's a regardless of how much clinical time you're doing and so forth it's really ten years you if you're beyond that point I'll say what means no second but if you're beyond that point you can apply for a sort of extension there's a formal process but it has to be due to things like you know you were away from doing all research because family things like that and they can then they can look at that and extend it so what does it mean it means having ESI status is fantastic when you're going for RO once and so forth because for example for this year for fiscal year 2016 for an iddk we publish this it's in my slides that actually if you look at the end the pay line for our ones is thirteen percent but if your ESI early stage it's eighteen percent to five percent bump and that's significant so it's something you don't want to trifle with losing before you're going for your ro on can you clarify the new investigator this is ESI and yes so a new investigator is you basically have never had a RPG as a p as a p.i so you've never been list as a pie or multi pie on a significant large man as an RO on a p.o on for example the smaller grants ro threes k awards those do not adulterate your investigator status and what break ki get is a new investigation none right so so in michael's talk he taught i mentioned about the what could be the impact or we want to get information on impact of industry funding for promotion if anyone was little comment on it so in other words you know NIH NIH rankings that institutions are determine about how much in nitra dollars come in per year to the whole institution and at least historically that getting an ro1 or having an ro1 it was a criteria for promotion so what about industry sponsors for that I one thing that is you know detrimental if you would is that is hard to get on the authorship of industry studies anesti are really engaged active as you mentioned you know have a close relationship or have medical directors by n you know participating in an industry study you're lucky if you're in the back of the paper in the acknowledgments section so one could have millions of dollars in funding but no publication out of those so lack of publication will is what will negatively affect the promotion if you have the same amount of funding and you know get a new england your paper i don't think that you get a significant not because you you divide your funding from industry yeah I would agree at our institutions it's been much more accepted that if someone has you know a half million dollar grant or a million dollar grant from industry as long as that's identify and they're publishing that's that hasn't been a big not at our institution we also have really quickly call clinical scholars and how we promote them to so might be what category and for kok rd is the mentors have to have significant significant funding doesn't have to be current are one finding it just has to be significant any other sources it just has to be real and they still have to have demonstrated a strong mentoring track record and david on that same thing you mentioned a loan repayment program you didn't mention if they have to have a grant or not it doesn't hurt so yeah we look at everything case by case book having being on a t32 is very good having an individual f is better having a k is best and but that's not the only parameters we look at publication record in the in your field you know we just want to show you're not going to take money and bolt two years and do something completely off of the NIDDK reservation so we want to make sure that you're you know you're really committed to doing research you're not going to go into private practice and is there a payback provision two years for the two year funding terrific i'll just say that's one of the most innovative things and we've had mentees who've benefited tremendously from that loan repayment program it's really fantastic so it's you should all be applauded for that and its really i and i wish we had it when I was doing it yeah I akula I my own personal bias is that medical school debt is one of the major major impediments to people choosing an academic career and this is a game changer you know 35,000 for two years you can renew it a couple of times I mean that is a significant help and it may get better because there's talk that probably will go up to 50,000 yeah that's right 35 to 50 it's great it's great I almost want to go back to melody so so Hashem mentioned pakora grants RP Corey grants counted in as NIH grants are they III know the answer I'm asking you guys yes I certainly believe they are they're federally awarded grants so I think they sort of fall in that same category yeah III agree with you but they actually don't least from I understand they don't count towards the institution's NIH fun now so they're they're federal grants but if what you get directly from NIH counts toward UNH ranking epic Ori because it's outside of that is technically doesn't counter them that's that's what I understand unless you're the sum is a question the question where are you talking about yes I status it's 10 years yeah you can you can send me an email I can show you though so I think you might be some fifties there's two different things this early investigation Attis or what it was caught early stage investigator and then there's the new investigator when you apply for a very first are one right so those are two different things understand everything I think that hungry you you
