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What can you still do to help in response to the COVID-19 pandemic? The National Institute of Biomedical Imaging and Bioengineering (NIBIB) announced that its Point-of-Care Technology Research Network (POCTRN) is soliciting proposals to further advance SARS-CoV-2 testing technologies to fill specific unmet national needs through RADx Tech II, a fast-track program that leverages POCTRN.
In this episode of the Global Medical Device Podcast Jon Speer talks to Mark Marino, Vice President of Growth and Strategy Development at VentureWell. VentureWell has been involved with the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Program.
Listen to this episode to learn more about the RADx Tech II program to fast-track eligible technologies to market in 2021.
“It’s labs, point of care, it’s antigen, it’s over-the-counter, really the full-range of COVID testing.”
“Now, we’re really starting to see some really rapid evolution with some really exciting technologies that are starting to come up in the pipeline of the market.”
“Everyone kind of knows, everyone has an expertise. Everyone has the same goal. People are letting go of both ego and showing up with tons of humility about what can I do to help? How can I add value?”
“We still understand that there are some unmet needs, particularly when it comes to screening, surveillance, diagnostics, and prognosis related to at-home and point of care tests.”
Announcer: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.
Jon Speer: This episode of the Global Medical Device Podcast, well of the content is good, well for awhile but there is an element of this that has a little bit of an exploration and let me hit on that real quick. So I had a chance to talk with Mark Marino. Mark is the vice president of growth and strategy development at VentureWell. You can learn more about VentureWell, venturewell.org. They've been involved with the NIH RADx Program, this is an important program that's been around for a little over a year in response to the COVID pandemic. Well, they're in the middle of soliciting applicants for the RADx Tech II Program and those are four technologies that have the opportunity to still get commercialize in the year 2021. And that application process is ticking, we're in the next couple of weeks, so by late June that's the deadline. So to hit on that real quick, but do enjoy even if the RADx Program doesn't seem like it might be something you're interested in, I think the content of this episode is really good because it highlights the importance of programs and initiatives like this. So enjoy this episode of the Global Medical Device Podcast. Hello, and welcome to the Global Medical Device Podcast. This is your host and founder at Greenlight Guru Jon Speer, and joining me today is Mark Marino. Mark is the VP of growth strategy and development. I think I got it right, at VentureWell. Mark welcome.
Mark Marino: Yeah. Thank you, Jon. Good to be here.
Jon Speer: Well, I'm excited about this because for a little over a year or so, I think Greenlight has been the premier QMS software provider for the NIH RADx Program. So I guess that might be a great place to start. What is that program all about and why should people be paying attention to that?
Mark Marino: Great. Yeah, so about a little over a year ago, just celebrating the one year anniversary in May. RADx the rapid acceleration of diagnostics initiative was launched by the NIH to really address the testing crisis happening in United States related to SARS- CoV- 2 testing. So with great deal of stimulus funds and some really insightful congressional leadership, they passed$ 1. 5 billion to address the testing initiatives here in the United States with four particular programs that were launched as part of this initiative, one was really new technologies that would potentially change the face of diagnostic industry of ways to detect the virus in other ways. One to address underserved populations called RADx- UP. One to just really take already commercially ready diagnostic tests and move them really quickly to the market. And then the program we've been really running and helping to implement the number of different partners is Radix Tech, which is to take pretty well- designed well- thought through early pilot and really support them with intense commercialization support to get them to the market faster, and in a year with a consortium of 900 experts and individuals from around academia government industry and 700 applications that came through, we ended up funding about 150 projects through a bit of a three staged intense shark tank like as described on the hill process to put them through due diligence, some funding, and then take them through the whole commercialization process from QMS systems to regulatory filing all the way to supply chain commercial and marketing and sales. And today we've produced around 300 million tests in the United States came out of this project, which is-
Jon Speer: It's crazy man.
Mark Marino: ...in a year, yeah.
Jon Speer: I was just going to say sometimes when folks think about... or at least, maybe I should say when I think about government getting involved and accelerating things, it doesn't always accelerate things but this is actually an example of true acceleration. A hundred... what'd you say? A 150, would you call these companies a more-
Mark Marino: Yeah. It was a mix, everyone. We had a really diverse range of applicants. You had an academic partner and some really good examples that came out of this that really expanded lab tasting. So the Brode Institute has been one of those that really wasn't doing this but then were. You had a lot of really large fortune 100 companies that had some type of tests, but were able to move in faster on the market. But the vast majority were small businesses. Those were the most successful companies that had... we're doing some diagnostics, had a little bit of a team assembled, but these are typically companies under a hundred people that were able to really rapidly utilize the resources to accelerate. So the government provided the funding and the framework. We had a number of different subject matter experts that supported the work, academia provided a lot. So there was a number of academic partners affiliated with this, Jons Hopkins, Emory really coordinated by a group out of MGH called SIMIT, the consortium of innovation and medical technologies. They were some of the backbone behind this process, and then you apply all of those business expertise to the academic partners that were doing verification to the government funding. You're able to get diagnostic tests, which typically take three to five years, we're going to get them on the market in less than a year, so.
Jon Speer: That's crazy. Crazy in a good way. So you talked about 300 million tests that have been administered as a direct result of the entities that have been involved in this program. Are these just all COVID tests? Can you give, I guess maybe some examples or maybe a little bit more details around that?
Mark Marino: Yeah. So this was really specifically addressing live detection of SARS- CoV- 2. So not really doing with antibody testing but it can be the full range of that, some of the other analytes. So lateral flow assays, antigen based tests. In the really early stages it was a lot of laboratory high throughput lab tests, in the very beginning getting those labs up to be able to get quick turnaround times and be able to build their capacity. So we focused on the labs and then really tried to move over to the point of care test and then slowly getting to over the counter. So the first over the counter test that was authorized in United States from a company called Illume was one of our projects and the first ever over the counter, even with an emergency use authorization respiratory detection and in the history of the United States. So be able to get that through was pretty impressive, but the spectrum is all over. So it's labs point of care. It's antigen, it's over the counter, really the full range of COVID testing.
Jon Speer: Yeah. And I've talked with a few other folks involved on various initiatives as a result of the pandemic and yes, of course the pandemic has been challenged and a lot of folks who have had unfortunately suffered and many people have lost lives, and at the same time programs like RADx and some of the other things have been really encouraging that... it's sad that it takes this type of event to spark that innovation and accelerating, bringing products and technologies to the market. But at the same time the outcome of this has been like, okay, at some point in time when we're through this whenever that is, it'll be interesting I think to look back and say," Okay, what are some lessons learned from this experience that we can apply as part of everyday life of bringing new medical technologies to market?"
Mark Marino: That's right. I think there was a really good article in nature about what does this mean now for the diagnostic industry. If we're able to do this in a short period of time, does it require really centralized lab system, which is not conducive really to this innovative responsive personalized type of diagnostic system that really requires a whole sorts of bureaucracy payment complexity, and years to get through. Can we flip that? And we showed that it's possible, right? It's possible with some pretty innovative technologies. It's possible when the regulatory environment aligns with those goals. And you're able to get really impressive. The whole of this talk of personalized medicine has happened where you were able to get some very specific targeted diagnostic devices that otherwise would not be available on the market. And now the next phase of that work is okay, so now what do you do with these variants that are evolving? Can there be additional structures and next genomic sequencing type of technologies that would really address the evolving virus as it goes? Can you do multiplex testing and start testing both COVID and flu AB at the same time using the same test? So now we're starting to really see some really rapid evolution with some really exciting technologies that are starting to come within the pipeline of the market.
Jon Speer: Yeah, that's really, really interesting. And you talked about RADx Tech being a shark tank ask type of program. Talk a little bit about that. There's different stages and companies have to demonstrate, I'm guessing some proof of concept or viability, I guess, talk a little bit about that process.
Mark Marino: So it is like a traditional VC, taking NIH funding and turning into a VC model to really have a funnel approach with a little bit of capital, but a lot of due diligence and technical support. So the first phase is really a bit of a deep dive. So there's an experts from across industry and government and academia reviewing the validity of the proposals in the first phase. So there is a review panel that is providing you with a set of criteria and assessment in a review, those teams then get some resources to go through a one to two week deep dive process where they are given that expert team of diagnostic former executives, subject matter expertise that know their technology coming from a variety of different places and a number of different projects support. Greenlight Guru being in some cases, if they need some quality management systems as identified or have a legacy system is one of those resources that can really help leverage that work. So they're getting these amazing resources from the very beginning, determined like can they meet the next milestone? Can they meet the technology development milestone? Can their tests stand up to the performance? Do they have the team in place to be able to execute? Are they fitting a unique need in terms of a use case, a clinical case. And then they get different traunches of funding as they go through the process. They go through some of our partners to verify in the lab, if their test holds up, if the sample collection and usability is feasible and then waiting at the end of them there's a large NIH commercial contract that really helps rapidly scale manufacturer. This work with a number of partners, BARDA, DOD, FDA, all a part of this large unified in some degree federal agency, helping to support them on that work to get them out into the market as fast as possible. And then we provide more resources as they need, if there's a autonec in the supply chain and cellulose and trying to find the right partner again, if there's a need of the right QMS system, then we've got partners ready and willing to really jump in and help support those teams to be successful.
Jon Speer: The supply chain, the logistics just coordinating all that, that's got to be a massive undertaking.
Mark Marino: Yeah. It's like, again, 900 individuals have been a part of this. What's been amazing, you can think of, wow, that's impossible to coordinate but everyone described as The Manhattan Project and I wasn't around when that was really happening. So, it's like everyone has an expertise. Everyone has the same goal. People are letting go of both ego and showing up with tons of humility like," Well, what can I do to help? How can I add value?" And so you have a whole group in their specialization, really just trying to be helpful, attach to the teams who they want to see successful. So there's no ownership, there's no feeling of turf wars. It's really about getting the best projects out to the public as fast as possible and with really a whole consortium ready to support.
Jon Speer: And I think that's the key point is that everyone uniting for a cause to help humanity, right? So I think that in and of itself it feels good to be able to do that, but to be able to make a difference because something like this could happen again or the... to your point, there's variant that this is an over yet and all that sort of things. So the need is going to be there and then some parts of the world are in dire need of these things now.
Mark Marino: That's actually right. So on a few different levels, one The National Institutes of Health, right? Which you think of in terms of your traditional research funder. They stepped up in a massive way to do things that the NIH historically has not done like stinking on translation commercialization, focusing on really getting products on the market not just really cool tech. Some of the techs really cool but they're really thinking about the success, which NIH hasn't done. So they've completely switched their model and they've said, it's going to be hard to go back to just funding a large academic research study. They want this to be the new way the NIH does business, which is again, as one of the largest life sciences funder in the entire world, that's a huge statement that they found so much value in the process that they're going to really want to prioritize this moving forward. So you can apply this to neurotherapeutics. You could apply this to a number of different med tech and healthcare related issues and see how it works. And like you said, the virus isn't going anywhere and you see it up with a number of different areas, and I don't think there still are unmet needs in the current testing landscape that this next solicitation called RADx Tech II is aimed to solve, focusing on better sample collection, particularly for pediatric populations or focusing on the quote unquote, perfect test, a cheap operating life performance of a lab but could be delivered in the point of care over the counter with really good results that's very easy to get by. So there's still some look at the search for the perfect test and point of care while also having a goal of being able to really identify variants as they become more prevalent and be able to address those with again, new technologies, new approaches to testing and identification.
Jon Speer: All right. I want to come back and talk about RADx Tech II and get more into the details of that. But before we do so I want to take a quick break, Mark I mentioned that you're with VentureWell. Talk a little bit about your role and what VentureWell does and above and beyond just the part they're playing in the RADx forums.
Mark Marino: Yeah. Great. VentureWell at 25 year old non- profit organization based here in lovely Western Massachusetts, we were founded with the basic premise to try to take science and technology, innovators, entrepreneurs, and ideas out of the university and into the market. By providing funding, support, structure, training resources. So we do this with student entrepreneurship programs. We do this with faculty and educators providing them funding. We do this with network convening and over the last few years, we've just applied that same model that works in higher education to a number of different federal agencies, whether it's the National Science Foundation iCore program, you have Department of State and a Global Innovation program as well as recently tapped to help administer and support the NIH RADx program. So my role is to lead some of the partnership work, identify areas of potential growth and development. Can be a bit of our healthcare related expert when requesting.
Jon Speer: All right. And how can folks learn more about VentureWell, what's the best way to tackle that?
Mark Marino: Yeah. Head on venturewell.org and yeah, we've got a number of different opportunities, funding that we're providing. Training programs we're offering and a number of different... just we also are a bit of a convener for resources, strictly in innovation entrepreneurship around the country. So check out some of our events opportunities even more.
Jon Speer: All right. Awesome. And while we're taking this break, want to remind folks me and Greenlight Guru, we are the premier QMS software provider for the RADx Program and if you're in the RADx Program and you need the QMS is great, we're here to help you. If you're a medical device company or an IVD company and you're looking for a QMS solution, well, we can help you with that as well. This is our focus. This is our market. This is what we do for a living. We help companies through design and development, risk management, document management, as well as managing quality events, things like campus complaints, nonconformances. So if you'd like to learn more about the Greenlight Guru medical device success platform, then go to www.greenlight.guru to learn more. And if you'd like to have a call with one of our solutions consultants and account executives to learn more about your needs and your requirements to see if we have products and services that fit your needs, well we'd be happy to have those conversations with you as well. So Mark, you mentioned RADx Tech II. How is this the same or different from the RADx Tech I? Where are we in that process and that sort of thing? So I guess maybe unpack that a little bit so that folks can learn if they have criteria to be a part of this program.
Mark Marino: Yeah, we've learned a lot in the year plus of doing RADx Tech work and again, seeing the portfolio and some really, again, really exciting examples, whether it's over the counter point of care. When the NBA wanted to reopen one of our tests is medical was able to provide their point of care for the bubble that happened last year, seen a lot of tests be applied to a number of different communities, small businesses, reopening of schools, labs and in over the counter. So, no, we still understand that there is some unmet needs, particularly when it comes to screening surveillance, diagnostics and prognosis related to that home and point of care tests. So we're really focusing on two particular areas to address some of the national gaps that may still exist. The home- based point of care tests are looking for technologies that really have some superior performance characteristics where you can get that lab like performance, except to getting it in point of care time, right? Like it usually less than an hour, can you get the same PCR standard that you would get in a high throughput lab would get it in a point of care over the counter type of test. Looking at multiple different respiratory pathogens and doing multiplex tests, looking at pooling again, a way to really address a large group and test a group at one time. So tests that are really conducive to pooling that allows for better surveillance and infectivity and some of the prevention efforts that testing has provided. And also looking at just really where the gaps are, particularly as the world and has the United States in particular goes in through an increased number of vaccinated population. There's still going to be a gap in the pediatric population, particularly back to school when we started talking about the fall and even the summer through summer camps. So if there are novel approaches to testing in pediatrics, either in sample collection and ways to allow that, if you were to think about the perfect test, right? It's one where a five- year- old able to collect his or her own sample and be able to have someone just test and read it and get a result back almost instantaneously. But maybe with results that you can really rely on. Great sensitivity, great specificity, a grade limit of detection numbers that may be like a dream, but we still got to solicit the academic community, the private sector, anyone who got an idea or some approach to really look at submitting. So that is one big category where again, it can be anyone in any part of the world. They didn't have to be the United States. So the ideas can come from anywhere. We are looking for getting those commercialized in this year, right? So it would be really hard to not have any kind of concept or any type of validation at this point to try to get an emergency with authorization by the end of the year. So there's still a goal to see if we can be as fast and as rapid this year as we were last year, and get things on the market by the end of the calendar year. So that's one pretty sizable chunk that we're looking for. The other is really to address the barrier. We've done a lot of work across a variety of settings to just understand how our tests are holding up to the variant, the various types of genomic lines that do not seem to be changing and all of the variability but those that are and how we can adjust, modify tests and still be as responsive. So new approaches to dealing with varying capabilities, whether that is again, innovative, next gen sequencing or other technologies that are capable of this rapid identification and performance that they're really focused on the variant testing or other ways for screening and surveillance to identify how the variants are evolving over time, and ways that our test performance can maintain their current standards in that. So really those are the two main areas of focus and prioritization to address some of what we see as the current and potentially future gaps in the testing landscape.
Jon Speer: All right. As far as the tattoo program is concerned will it also be a phase based approach similar to Tech I?
Mark Marino: Yeah, very similar. So having an initial screening process due diligence conducted small amounts of capital deployed for the teams to really embark on that, one to two week deep dive shark tank like process, and then being able to make pretty quick decisions to move them fast through the process. Move them through to NH contracting, move them through the commercialization pipeline, attach resources to them. So similar to what we learned in last year, part of it is the funding. Part of it is the infrastructure you can help build with these companies in these projects. So having the availability of companies like Greenlight Guru to continue to provide those QMS systems and support when needed the regulatory advisory services to supply chain issues, working through all of that in a similar way to get them to a place of commercial readiness, allow them to deploy by the end of the year.
Jon Speer: Okay. And I assume there is a place that we can direct folks if they're curious about applying our learning more, what would be the best place? What would it be go to VentureWell site or another location?
Mark Marino: Yeah. You can go to VentureWells site, where the solicitation will be connected. The easiest way, so the infrastructure for a lot of RADx is leveraging, NIH is existing investment in point of care technology research has been 10, 15 years in the making. So some of academic partners called the Point of Care Technology Research Network or POCTRN as we love our acronyms. So P- O- C- T- R- N they are really providing the backbone support for both the grant applications for the process. So if you go to a P- O- C- T- R- N.org, and then backslash RADx dash tech dash 2, or just go to POCTRN.org, you can find this solicitation on there. It'll take you through all of the criteria we're looking for. The frequently asked questions and a little bit what a review process looks like and be able to apply directly there.
Jon Speer: And folks we'll provide the link that Mark just mentioned, and the notes that accompany this episode. So and look at for that but POCTRN, P- O- C- T- R- N, if you didn't find it and I guess you mentioned something a moment ago, and I don't mean to put you too much on the spot here, but you talked about EUA, Emergency Use Authorization. I know that's something that has been really important for a lot of technologies and it seems like it's almost like a must have for the RADx initiatives to be successful. A lot of folks ask me like," Jon, how long is this EUA been going on?" And I'm like," I don't know," but any insights that you're hearing? Because to your point, there's a lot of government that have to collaborate and work collectively together on this and the FDA is a key piece of that.
Mark Marino: We have a very special relationship with the FDA, as it relates to RADx weekly meetings to review some of the... whether the pipeline portfolio ask specific questions, get guidance from the FDA. They really have been pretty incredible throughout this whole pandemic. We're getting willing to adjust, willing to be responsive, willing to really have the data and the science guide how they're making some decisions, whether that's pooling or whether it's getting the over- the- counter guidance needed for these tests to be able to get on the market. So we have very special relationship with them and I don't know too much about when the EUA is going to have to translate to the 5, 10K process and needing that. But I do think that is coming, right? So having the right systems and structures to get that EUA so then you can have a product on the market, while critical now that is the RADx goal. We are funded through COVID stimulus funds to really specifically address the COVID 19 pandemic. So a lot of this is that the EUA goal for getting these companies to get those tests and get on the market. However, those companies longterm sustainability need to go through that traditional process in this... the method does not guarantee that that process will happen. So we're going to start to see that I think particularly as the year winds down and as next year picks up a bit of... the FDA has been really good at communicating with relatively decent notice, whether is going to be a shift in transition. I would anticipate they would do something very similar of allowing a bit of a bridge that goes from EUA to 5, 10K to think whether that's Genova or other types of classifications. I think they're considering it. There's processes there. And I think they're being very methodical about how they're going to not want to lose the momentum of all these companies that are now able to get some commercialized products on the market and not want to... just that to just disappear immediately just because a bit of change in EUA status. So I think it's early and we're still... we're not through, we're certainly in a lot better shape than we were a year ago but there's still a lot of work to be done. So I don't anticipate that's going to happen anytime in the near future. And I think the FDA is willing to really work with teams, work with companies to ensure that that happens in a pretty similar way.
Jon Speer: Yeah. I should clarify for the lay person listening, EUA is not a substitute for the work. It still requires good science, safety efficacy, sensitivity, specificity as far as the many of the tests are concerned, so you still have to have good science behind it and you still have to present the case with objective evidence. So it's just a different vehicle to get the clearance, get the product to market. So it's not a substitute for cutting corners or anything of that nature. Sometimes people hear that though and it's like," Oh, wait time out."
Mark Marino: And it's nervous, I don't like it either or people even thinking like," Oh, that's going to be an easy process or I don't need the system." This seems like an elaborate system to build just for any EUA and you forget all of your indications. For you to still need to be there your compliance needs to be there. You're still going to be audited. Your evidence has to be there. It's just like maybe less samples and you wouldn't like in a large clinical trial to get your ideal. You maybe need a little bit less than a sample size, at least 30 positive samples. So it's less data. So they're not having you to go through as much rigorous clinical research, but the data still has to hold it up. It still has to stand. You still need to get methods and you're still going to be scrutinized pretty heavily so.
Jon Speer: Well, I think too if I recall once you are commercialized, there's a responsibility to continue to collect data, right?
Mark Marino: Exactly right. You're still subject to the audits. You still have to get your systems in order to be able to retrieve it and you can still subject to FDA visits. There's all of the things that now come great responsibility when you get EUA. So the work doesn't stop. And work in some cases, I think we get easier. And the FDA has been really clear about that. They've been pulling away those EUA designations for not really as much the diagnostic pretty significantly on the antibody tests. But yeah, you'll see when things are flagged, they do their own verification to make sure that holds up. So yeah, you still got to have the right systems in order. I think what we're telling our companies is to be a viable company in a post COVID world, you got to do it right the first time, right? Here's your opportunity. Here are the resources, here's this infrastructure, here's the software to use to make sure that this is applicable beyond this particular window that you have with us.
Jon Speer: Absolutely. Mark, I appreciate all that you've shared with respect to the RADx Tech and RADx Tech II Programs. Anything else that you think is important for listeners to know before we wrap up this episode of the Global Medical Device Podcast?
Mark Marino: Yeah, I think we covered a lot. That was a lot of detail. I really appreciate you having me on. And I do think there... as we said in the beginning, this is meant to both prepare for potentially the next pandemic. Some of us view this as a trial run for what would happen if you had a particularly lethal version of some type of go pandemic, whether that was an influenza or something else. And this was a test while devastating and horrific and incredibly impactful. We know that other pathogens are out there that we don't know yet. And so really getting the systems, having the whole community be able to rally like we saw last year. We set a precedent for what we could be doing in the future, and if the whole of government works really closely with the private sector with startups entrepreneurs industry, we can accomplish an amazing amount. So this is again, another opportunity for anyone with those ideas to come forward, see how they work and get access to this great network and resources. And yeah, really just appreciate the opportunity to share the work that we've been doing and yeah, happy to have the Greenlight Guru as a partner in this work.
Jon Speer: I know we've enjoyed the partnership and working with you and the VentureWell team and all those involved at RADx as well. And it's really exciting to see some of these things, it's thoughts and ideas and tests and technologies that get to market in a rapid period of time. So, the part that we play and this is just... we're happy to do our part and glad that Greenlight Guru is the premier QMS software provider of the RADx Program. Folks, Mark shared a lot of information today and a couple of places that in summary that to go venturewell.org, also POCTRN, P- O- C- T- R- N.org. And again, we'll provide links to those in the show notes, but I want to thank Mark Marino. Mark is the VP of growth strategy and development at VentureWell, and you've been listening to the Global Medical Device Podcast. Thank you so much and we're still the number one on the medical device industry, and that's because of you. So, if you're listening to us wherever you're listening to us, that's great. We're also on YouTube now, so you can watch many of our episodes. So go check that out and be sure you subscribe to the channel so that you can see when the new episodes are being published. Of course, if you need some help with your quality system needs reach out to us, www.greenlight.guru and as always, this is your host and founder at Greenlight Guru, Jon Speer, and you have been listening to The Global Medical Device Podcast.
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Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...