Turning Clinical Trial Leftovers Into Global Impact

What happens to unused medical supplies when a clinical trial ends? For years the answer was simple: destroy them. Josh Kravitz (MedSurplus Alliance) and Greg Folz (Kits4Life) join Jimmy Bechtel to tell the story of how a stack of boxes, a looming Site Tank deadline, and a crisis in the Congo turned into a program that has now impacted over 6 million lives worldwide. Greg walks through the moment his research staff refused to keep destroying usable supplies, and how that frustration became an idea that won on stage and grew into an industry wide movement. Josh breaks down how trusted partnerships and strict chain of custody get donated supplies from a research site to a clinic or classroom halfway around the world. It's a conversation about waste, generosity, and what's possible when sites push their sponsors to think differently about what happens after a trial ends. 

Transcript

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Jimmy Bechtel 0:00

Hello and welcome to SCRS Talks provided by the Society for Clinical Research Sites. I'm Jimmy Bechtel, the chief site success officer with the Society, and today I'm lucky to be joined by my friends at the MedSurplus Alliance and Kits4Life. Josh Kravitz is the interim executive director with the MedSurplus Alliance, and Greg Folz is the chairman of the Kits4Life advisory council and on the board of the MedSurplus Alliance. And they're here to talk to us about how Kits4Life really is transforming and supporting the clinical research enterprise and really the broader medical enterprise and how we handle surplus medical equipment. So before we get into that and we learn a little bit about what the program is, I wanna learn a little bit more about the two of you. So Josh if you wouldn't mind, I'd love some introduction from you.

Josh Kravitz 0:49

Yeah, sure. So I've been working with non-profit organizations my entire career, beginning in 2000 and my focus has been on global health and what we call medical surplus since 2005, 'cause it's just such a simple way of helping people here in the US and around the world. And, it's just one of these really simple win-win, and it drew me in and it has kept me going for all that time. I'm also a a New Yorker, but I've actually lived most of my life in the South, and I'm in Atlanta, Georgia.

Jimmy Bechtel 1:30

Excellent. Thanks, Josh. Great to have you here. And Greg, please.

Greg Folz 1:33

Yeah. Thanks, Jimmy. Yeah, my background, gosh, I've been in clinical research for about thirty years overseeing, gosh, I, I would say maybe about eight hundred clinical trials. Started off into phase one, oversaw about an eighty-eight bed phase one unit, then that transitioned into-- I was acquired by a, a large site management organizations where we had about three hundred and sixty-five sites across the US, Europe, and Canada. That evolved into heading up a, a new research program for a very large multi-specialty group here in Southern Indiana that was acquired actually by a large health system. And been involved from the site side on clinical research, for about thirty-plus years. And today I currently consult with healthcare systems across the US in terms of auditing their systems and/or establishing new research operations.

Jimmy Bechtel 2:19

Excellent. Thank you both. Kits4Life Med Surplus Alliance, and SCRS go way back. So it's great to have the two of you here to share with our audience a little bit about what this program is and where it's headed. Guys, for anyone who isn't necessarily familiar yet with Kits4Life, can you give us an overview? What is the program, and what is the problem that it aims to solve?

Josh Kravitz 2:40

Yeah, that's actually a great question, Jimmy. I appreciate that, and I appreciate all of the support that SCRS has given us over the years. First I'll tell you a little bit about the MedSurplus Alliance. We are an alliance of various types of domestic and global health organizations, along with different types of in-kind donors of medical supplies and equipment, and of course, funders. At our core, we are an organization that facilitates conversations around these different stakeholders in the domestic and global health space, so that way everyone can work together and realize the greatest impacts in our respective work. And probably the most important thing that the MedSurplus Alliance was founded to do was to create a code of conduct to do this work at the highest levels of quality, particularly for the domestic and global health organizations that have an expertise in dealing with surplus medical supplies and equipment, and we actually accredit those organizations. Kits4Life is one of our key programs, and I love it because it has this simplicity of expanding healthcare access while reducing waste. The thing is that at the end of clinical research studies, sponsors often have a unused supply of medical supplies and equipment. And instead of destroying those items, Kits4Life is able to help them, and the research sites that they're partnered with, donate them to healthcare organizations as well as STEM education programs. And this is really solving two different really important problems. First, when we're talking about healthcare professionals that are working in low resource or under-resourced settings and communities, they often lack the basic supplies and equipment that they need in order to do their work. The donations coming in from programs like Kits4Life helps to close that gap. But beyond that, for items that aren't appropriate for clinical use anymore, we're able to get those to STEM education programs to use in their simulation-based trainings, and we are helping to train the next generation of phlebotomists, medical assistants, and other types of healthcare professionals. The other problem that we are solving is that research sponsors have to keep enough inventory on-hand at their partnered sites, and we've worked with over 1,000 sites at this point. But they have to keep the inventory at a level where they can deal with different types of situations, such as unscheduled patient visits. And what that means is that at the end of studies, there's often unused items, and Kits4Life provides this really simple, responsible way to move those items off the shelf and get them into the hands of people that can use them

Jimmy Bechtel 6:12

That's incredible and really exciting. It seems so basic, right? you used that same word, Josh. It seems so basic, but it's so powerful of an impact so broad of an impact that we can have with something that seems so obvious in what we can provide to the STEM programs or for other medical-based reasons. It's a really exciting opportunity for organizations to be able to take what is left over in research, at the end of research trials or during trials rather as well and provide them to, get a second life a second home and still be able to be used even if they are not able to be used inside of the clinical trial setting. Greg You were there, right? this was something that was talked about on the stage at an SCRS global summit many years ago. So take us back to the beginning. How did this idea come out of what was the program called Site Tank, and what did that early process look like to get off the ground?

Greg Folz 7:06

Yeah, I would love to share that because it actually started, Jimmy, with, with my research staff, the research nurses where, just like Josh said, at the end of every clinical trial you have these medical grade supplies. And our site at the time there at the large healthcare system here in Southern Indiana, is that we were probably doing anywhere from 80 to 100 active clinical trials. I had a huge staff. Our purpose for clinical research was to treat it as a care option, for those patients where they couldn't tolerate current drugs, those drugs weren't getting them to goal, so that's what we always looked at that innovation that the life sciences industry is providing. In addition, they were providing us, with medical grade clinical trial supplies. no different than with a patient who was receiving the supplies, or receiving, for their standard of care. At the end of every clinical trial, even though we were a high-performing site, we had to destroy significant amount of unused supplies. I believe our average enrollment rate was anywhere from 135 to 140%, but you still had that surplus. The staff kept saying, this was just a, a meaningless act, and it was wasteful, and why can't we donate that? And I said we're contractually obligated to destroy," and we had to follow a certain process to destroy, right? We had to make sure that any proprietary information was removed about the sponsor. We had to remove anything confidential about the study number, things like that, and we had to destroy every item properly, and then document that, which I guess I did a survey or did a kind of review of about 10, 15 trials, and we actually were spending anywhere from three to five hours after every clinical trial just destroying medical grade supplies and equipment. And the staff kept telling me, "Greg, you gotta figure it out," and they wouldn't take no. So one day they actually put in my office, I believe it was over 60 boxes of supplies that were going to be destroyed, and they had it stacked and they said, "Greg, please figure this out." At that same time, about that same period it was time to apply for a Site Tank. And so I kept, kept thinking, you know, there's gotta be a way, there's gotta be a way to prevent this. Even to provide the sponsors the opportunity for us to even to donate it to local animal shelters. And so I came up with the idea is can we create a secure environment that would allow those supplies to get in the hands of those in need? And so I dabbled it on a piece of paper and It was actually the weekend before the deadline for SiteTag. and that Saturday morning, I read an article where the Congo was battling yellow fever, and I believe there was already 186 lives lost. What the problem was, is that they received one million vials of medication, but they did not receive any syringes. They were, I believe they were short nearly six million syringes. that Friday before, we were notified by a sponsor that they were canceling a study before study start. And we had our kits that we had to destroy this following week, 'cause we had just scheduled it for the staff, had over 300 syringes. I found out that there was over 200 sites that were going to destroy each of their supplies of syringes and kits, which was 60,000 syringes. So I actually came up with the idea that week and submitted it by that Monday at the deadline And lo and behold, it was accepted for review on stage and the concept won. But there's a point right after that, it was nice to receive, the the applause. I started receiving texts from sponsors in the audience said, "Count us in." And from J&J. IQVIA came up on stage Kim Ray, and she said, "Greg, count us in." And so immediately it went from an idea to panic. And I said "Okay, now what do I do?"

Jimmy Bechtel 10:47

Sure.

Greg Folz 10:48

Christine Pierre, God love her, she came up to me and she g-goes Greg I know you're anxious," 'cause she could tell I was really anxious. And she says, Greg, this idea is too big for one of us, but it's not too big for all of us." And she gave me a big hug and she said, "Greg, now go get it done." And so that inspired me to get others involved. I started doing due diligence. I found out what a medical surplus recovery organization was, and I called up about a half a dozen of them. And I said, "Could you use medical grade surplus c-clinical trial supplies? And I believe I may have a perpetual source of those supplies for you." And they said, "Oh my goodness, yes." And what I found out is that they spent a majority of their time outside of shipping supplies, to these underserved communities and villages in fundraising. And I said, "What do you use the fundraising for?" We have to buy supplies." And I said, "Oh my gosh, so there's a huge demand there." And then I found out that they all had something in common, which was the MedSurplus Alliance. And so I always tell Josh and the team, I- I'm getting smarter after every phone call. And I found out that the MedSurplus Alliance, from my perspective, from the healthcare and research perspective, was it's like healthcare's joint commission or the clinical research industry's FDA, right? It's that regulatory body and that watchdog to make sure that gold standards are achieved and maintained by those who want to participate. And that's what I found at the Medical Surplus Recovery. They accredited these MSROs, medical surplus recovery organizations, to ensure that they were doing what they're supposed to be doing. And then I found out that the MSROs were using the exact same process my staff and sites had to follow whenever they destroyed, but the MSROs did it whenever they accepted the donation. They would process those supplies per the same standards that, that we had to, but we were throwing them into landfills. They were taking them and processing, putting them into inventory and sending them to recipient organizations. And then I found out that they also vet those recipient organizations, that make sure that those organizations are using those supplies appropriately and not selling them on the black market, and making sure that those supplies and equipment are used for the right reasons at the right time, for the right individuals. And so that's kind of the process and how it all got started. And and it definitely has taken a team approach. It's been humbling and I've been blessed with the number of individuals throughout the industry and also from the sites that have made it all possible today

Jimmy Bechtel 13:30

That's amazing, Greg. And what a journey, right? That you've been on here from something that was, as most great things start, it came out of a need that was identified. And almost like a pain or, like a dang, right? It was like, wow. I can't believe we're doing this. I, we have to destroy all this. And i- it, so then one thing led to another, as you just explained so eloquently, and here we are today being able to to help serve v- for a variety of different populations through the Med Surplus Alliance. It's and the Kits4Life team. It's really inspiring but also really exciting to, to hear about. 'Cause we don't often get to hear about these type of outcomes or even, philanthropic based pathways don't see themselves too often in our extremely regulated and controlled industry. So seeing that, a little light that, that has come out of it is really awesome to hear about. But I wanna talk about clinical supplies and lab equipment that don't usually, a- as we've identified, end up in the hands of these underserved communities. So what does it actually take to make that hand off happen, and who is involved in the logistics side? So I guess kind of Josh, help us understand kind of the the nitty-gritty or the complicated side of, how one might bring to life the vision that something like Kits4Life had.

Josh Kravitz 14:47

Yeah. It's a really complicated process that our accredited members make look really simple. But at the, the heart of it, it comes down to trusted partnerships. That's typically what makes anything really work combined with a strong chain of custody. Our members aren't the typical domestic and global health organizations. They do global health and domestic health really well, and they have this added- expertise around taking in surplus medical supplies, equipment, and medicines, and doing a really sophisticated job to sort these items to get them back into pristine condition and doing, of course all of the quality checks that are needed. In healthcare, there's no room for double standards because, an item that is going to be used on a patient that is in the United States and is fully insured has to be the same quality that is used on a patient in any type of low-resource setting, whether we're talking about a patient that's at a safety net clinic United States or it could be a patient that's in a hospital in a lower middle-income country, anywhere else in the world. So that's the, that's the core of who we are. And the other part of this work is to engage the programs teams of our members. So part of their work is to take in the supplies and equipment that are not needed for other purposes. And, this could be through the Kits4Life program. This could be from health systems. This could be from manufacturers or distributors. It doesn't matter. The items come in, and then they have these incredible program teams that are building long-term and deep relationships with a variety of different partners that they're working with. So these are the folks that are doing the incredibly hard work in the field. These are free and charitable clinics, other types of safety net clinics, a, a growing number of charitable pharmacies that are popping up throughout the country, and of course, healthcare facilities in low and middle-income countries. They develop these relationships specifically so that way we can understand what are their needs. They're the ones that are really in charge of the donations that they are receiving. And so through these close relationships, they're able to share, "Yeah, this is what we need," and then our members are able to match their needs with the shipments that they're sending them. And Jimmy, these shipments, they can be as small as a single box going to a clinic, or it could be as large as a 40-foot sea container that is going to another country. And that happens both here in the United States as well as in Australia, and an increasing number of other countries as the MedSurplus Alliance continues to grow. it's a complicated supply chain, but with the partnerships, with the expertise, it really seems simple. But at the end of the day, it comes down to, like Greg said, getting the right item to the right place at the right time. And what that makes me think about I always think about this young man, his name's Anush. He lives in Africa, and he had a treatable eye condition, but left untreated it was causing blindness. He had lost his sight. And the really tough part of the story is there's a medical facility in his community. There were doctors and nurses that were trained to treat Anush. What they were lacking were the proper supplies and equipment that the doctors and nurses needed to treat him. This particular facility was partnering with one of our members, SOS out of Louisville, Kentucky, and SOS was able to get this particular facility the supplies and equipment that they needed in order to treat Anush. And it's gonna sound like a miracle, it's just science, that they were able to restore Anush's sight. And when we last checked in on him, he was training to be a police officer in his community. And that is that butterfly effect that we all hope to achieve. Donations that start as, a simple lab kit or as something as complex as a centrifuge or a lab analyzer transforms into helping a person pursue their dreams, family dreams, career dreams, whatever it may be. But it started with that simple act of saying, "You know what? This can be used for a different purpose than we originally intended," and getting that item to the right place using the right partners

Jimmy Bechtel 20:46

Thanks for expanding upon that, Josh. everyone knows that as great as something might sound, the amount of work that has to go in behind the scenes is usually tremendous, and this is no exception to that. And it, the coordination effort and the communication is really what stands out to me rather as being something that's super, super critical to the success of what we're trying to do here. It's not just a simple matter of pulling stickers off of tubes and shipping them off, right? There's so much more that goes into making sure that this is successful. so thank you for sharing some of the behind the curtain with what this is. And I wanna move on to my last question here as we're, we're unfortunately quickly running out of time. What does that impact look like, and where do you see Kits4Life and the team going from here?

Josh Kravitz 21:33

Yeah, we we're just blown away with what this program has done in terms of impact from the time that we started donations in 2020. Since that point, we have impacted an estimated 6.1 million lives throughout the world with simple items such as, needles and lab kits, to sophisticated items like lab analyzers, and that is making that real world difference through these incredible acts of generosity and kindness from the clinical research sponsors we work with, the over 1,000 sites in the United States and Australia, and other places around the world that we are working with. And we don't often see a program ramp up so quickly, but it happened with Kits4Life, and it happened in, at a time, during COVID, where we were all working remotely. We were just having Zoom calls as we were launching this, and it still happened. That's how important it is. As we look forward, we want to make donation the industry standard, so every clinical research study and trial from the outset should have a plan of how to convert usable supplies, equipment, and medicines into donations. So everything that is left over at the end of the trial but is still usable, either for clinical use or education, can and should be used. And what that means is bringing on more sites into this through their clinical research sponsors. So that means bringing on more clinical research sponsors into the program, but expanding this also to all parts of the clinical research ecosystem. So organizations like CROs have this tremendous role to play. And when we bring everyone to the table, we are going to achieve this really incredible set of mutual goals to support communities, expand health access for our vulnerable neighbors, and protect the environment while we're doing it. We can do it, and frankly, we have got to do this. This is one of those things that is just the right thing to do because it is making our world better. But Greg, I'm sure that you have a few thoughts also, and I'd love to hear where do you feel this is making an impact and going next?

Greg Folz 24:38

Yeah. I think what you said, that I would have never imagined after Christine said, "Go get it done," and then but focus on getting everyone involved and I'm just so thankful that from all the sponsors of the CROs that have participated today, I'm really thankful for, all the sites, now with over a thousand sites that have participated and encouraging their sponsors that they work with and say, "Hey, please, we want to make an impact. We want to continue to make an impact. And please, if you're not part of Kits4Life, consider that." And so that's a big, driving force. And and then also Jimmy at SCRS, without you guys, this would not been possible to create that initial opportunity to share an idea to encourage, that idea, to say, "Go vet it," and get everyone involved and it's humbling and like I said, I've been blessed to be part of such a an industry-wide collaborative approach to, to both not only humanitarian aid and impacting so many lives, but a sustainability effort that as Josh has referenced could be an industry standard going forward

Jimmy Bechtel 25:38

Oh, I couldn't agree more. And thank you both for sharing the vision there and how much impact this can have in so many different spaces. That's what I think is really one of the really awesome things about Kits4Life and the Med Surplus Alliance is we're not... josh, you said it so well, it's not just solving one problem. We're tackling a variety of different challenges in this space, so really exciting, and exciting to hear about the future. So I wanna say thank you to both of you for being with us here today, and thank you for sharing oh and pulling back the curtain, as I said on the work that is being done in this space.

Greg Folz 26:10

Oh, our pleasure. Definitely, Jimmy, our pleasure.

Josh Kravitz 26:12

Yeah. Thank you, Jimmy. And thank you, like I said, to SCRS and, to the sites. There is almost no call I get or email I get from CROs or a clinical research sponsor, a pharmaceutical company, where they haven't said something like, One of our sites has been encouraging us to learn more about Kits4Life." It's the sites, pushing this forward, and we really appreciate that incredible effort and generosity.

Jimmy Bechtel 26:47

And again, thank you both. And for those that are listening, make sure to check out other site-focused resources, like additional podcast episodes, webinar series, and opportunities to hear from our other partners and inspiring stories like this one on our website, myscrs.org. Again, thanks for listening and for tuning in. And until next time.