Episode 20: Daniel Perez, MACRO Trials

Daniel Perez is the Chief Operating Officer at MACRO Trials, a Site Optimization Organization (SOO) dedicated to providing the institutional infrastructure to perform the highest quality clinical trials across all specialties and private settings. At MACRO, Daniel combines his operational acumen with research and regulatory expertise to help bring its vision into a tangible reality. He leads MACRO’s operations by constantly challenging the status quo, and continuously evaluating the clinical trial process through the lens of the patient. Daniel also serves as a founding board member for Clinical Trials in Color, a 501(c)(3) non-profit foundation with a mission to improve health outcomes in communities of color by increasing diversity and access to clinical trials.

In this episode we discuss Daniel’s circuitous road to clinical research, the ability for lean organizations to better access underserved communities and the importance of self-development in clinical research.

Daniel Perez on LinkedIn

+Full Episode Transcript

Brad: All right. Daniel Perez. Thank you so much for coming on. I know like I had said before we started recording we've crossed paths a lot throughout the years, but I don't think we've ever had an opportunity to actually stop and talk and have a meaningful conversation. So thank you so much for coming on.

Daniel: Yeah. Thank you, Brad, for for inviting me on.

Brad: Very cool. So I'm going to jump right in. Same question. I like to always start with tell me how you got into clinical research. What's your what's your background story?

Daniel: So I love that you asked this question because I feel like most of us stumbled into research by complete accident. I don't, I don't, I mean, maybe now we're having a growing group of people that are deliberately seeking a break into the industry, but in my experience coming up, it wasn't that wasn't the case. You know, I always give people this visual of falling off a tree and hitting every branch on the way down. And that-that's a very funny visual that comes to mind, but that's what it felt like getting into clinical research. It felt like struggling to climb this tree that was a career choice and then falling off the tree and literally hitting every branch on the way down and then realizing, Oh, I will- I want to do clinical research. So a little backstory here. So I, from before I could even probably talk and walk. I've always wanted to be a physician. I wanted to be a clinician more broadly, but I wanted to be a doctor. And growing up as a kid, my mom's got home videos of me running around the room with a towel wrapped around my neck and they'd asked me, Oh, are you being Superman? And it was like, no, I'm, I'm a doctor. You know, and I was always mixing concoctions of baby oil and baby powder and putting them on people. And those were my elixirs of medicines growing up. So as soon as I had the opportunity to participate in a program, when I was in high school, I took it on and it was they call it an ROP program. I'm the actual acronym is slipping my mind, what it stands for, but essentially what they do is they take high school kids in high schools that are historically in underrepresented neighborhoods and they give them an opportunity for actual paid employment in hospitals and in professional settings. So my assignment was at Cedar Sinai medical center. So shout out to Cedars and the YED program or the youth employment and development program. And that was super important to me because I knew I wanted to be in the healthcare industry. I wanted to be a doctor I'm going to age myself. I was 16 when I was thrown into the world of the academic medical center and I didn't care what I was doing, Brad, honestly, I was just excited to be there. I was so preppy and naive "Daniel, and we need a Starbucks order for the conference room, you know, room B for all of these attendees. And these are all their Starbucks orders". And I was, I was so happy to do it, you know, because here are the superheroes, you know, th- these are the superheroes in healthcare. And so I realized very early on in my getting the foot in the door with Cedar Sinai, that it wasn't so much what I learned to do, and necessarily how I did it. That was important. It was the relationship building. It was my ability to connect with people. And so I knew that as I was finishing up high school and getting ready to go off to a four-year university, that it was the connections that I was leveraging with physicians and the exposure to the clinical realm, not the fact that I was running down a Starbucks and picking up coffee, although that was, that teaches you very valuable skills about not messing up orders and paying close attention to detail. But yeah, so I, because of my ability to nurture and grow strong relationships, when the time came to leave and go off to four year, I was able to keep my job. They offered me, you know, they offered me to stay on, which was very unusual for, for people rotating through this program. So I was able to work remotely, which back then was still very like, you know, cutting edge. Uh here's the VPN and here's the laptop work whenever you're in between classes and on the weekends. So that was great because all I was really doing was helping doctors with databases and becoming familiar with what is a database becoming familiar with what a research study is, and what's an IRB. And why does, why do they keep pestering me in my emails about the submission? And so, you know, my role at Cedars kind of evolved from Clara basic, basic clerical to more progressive administrative to more, Hey, Daniel's really good at Excel, and Daniel's really good in the medical records and why don't we give Daniel this project? And so my role started to evolve from there while I was at the four-year university. And the first opportunity I had when I was at UC Riverside to take on an actual clinical internship, not much admin, I took it. And in my first 12 hour shift, my very first 12 hour shift, I remember getting to the unit after having gone through, you know, two weeks of intensive orientation that leaves you, frankly, quite disoriented. Finally get into the unit at Riverside community hospital, where I did my clinical internship. And I remember hiding in the restroom for the last three hours of that shift, thinking to myself, Oh my God, I've made the biggest mistake of my life because I spent my entire life and very young life, but I spent my entire life chasing this, this thing about like, I want to be pre-med, I'm going to do everything that's medical related. And when it gets a four year, I'm going to kill it because I want to go to med school. And then I get out, I get actually put on the units and I realize I'm in trouble because I I'm not cut out for this work. All I really wanted to do was to sit in the elderly patient's room and watch say yes to the dress. In fact, there's a, there was a patient I'll never forget. She always wanted to have say yes to the dress on the TV. And all I wanted to do was to just sit there and watch it with her because she was lonely, you know, and to just have a conversation and tell me about your life and can I do for you? And the most fulfilling thing, wasn't me helping the nurses chart clinical notes, or helping to do wound vac care. It was really just connecting with the patient as a human being. So I was like, Oh, crap, I'm in trouble. And this was kind of in the beginning of my undergraduate career by sheer accident, I wound up in a research lab at UC Riverside. And I say by accident, because I was actually in the wrong auditorium for orientation, I had stumbled into the wrong room and someone, they said, you know, you're part of this program, right. I thought to myself, moment of truth. And if you know anything about the university of California system, you know, that the more senior you are in your undergraduate, the more priority you get to your classes. So me being like an incoming freshmen, there was no way I was going to get into some of the biology classes that I wanted that I really wanted to take. Like I had to put in my time and effort, if you will. So, so when they said you're in this program, right? I'm like, yeah, yeah, I'm totally in this program. And from that moment on, I was locked into this cohort where UC Riverside was piloting this innovative idea of hybrid undergraduate life science teaching. And what that means is they take students and they do the conventional lecture that you're used to a very large hundred plus student lecture hall. And then they take a cohort of students and they put you in a wet lab and this wet lab is designed so that you're able to do hands-on basic bench research and then walk right across the hall and attend the lecture. And so it's a very immersive learning experience. And I suddenly started to fall in love with the basic sciences from that moment. I was like, okay, maybe clinicals, you know, maybe being a clinician is not the path for me, but basic research is because I was really good at it. I was really good at being told, here's the objective, here's how you design a protocol and here's how you go to the bench and here's how you troubleshoot.

Brad: Sure.

Daniel: So I started to learn that I really love problem solving. I really enjoyed, Oh my God, my gel electrophoresis image. I don't see my lines. Where are my DNA bands? Oh, well you forgot to put the primer in. Okay. I love that kind of stuff. Right? Like, let's go back to the drawing board and validate these computational biological predictions that bioinformatics scientist is doing. And then you go to the bench and you actually verify, right. So that was fascinating. I think it was in my second year of undergrad, I scored a undergraduate research seat in St. Louis, Missouri at the Donald Danforth plant science center. And that was really cool. It was, it was an interesting experience that taught me two things. Number one, I really liked science. And and I, and I really enjoy it. And number two, that was very important is when the flight touchdown in St. Louis and on day one of arriving to the lab, I looked around and I noticed I was the only person of color in the room. And so those two things were quite impactful on me. Cause I thought to myself, okay, I'm here. I obviously earned my stripes with what I was doing at UCR. Somebody thought highly of me, but I'm like grappling to believe that I deserve to be here. I'm grappling with the lack of diversity in the space. And so I had an amazing summer that I was doing plant-based, you know, plant research, shout out to Dr. Tom Brunel, who made me believe that, Hey, you can do whatever you want coming back from that experience. I was like, all right. So I guess I'm not pursuing pre-med I guess I'm going to go the PhD route. I guess I'm going to pursue an academic routes. I want to do basic sciences. So right around then, I was really struggling in my coursework undergraduate. So one of the things that high school didn't do as it didn't prepare me for the rigor of academia. So in my first few, couple of years at undergrad level, I struggled with some of my basic courses. So by the time I got to organic chemistry, Oh my God, organic chemistry sucked so bad. I took it once failed miserably. I took it the second time failed miserably. I took it the third time. And the third time I was like, all right, this is the quarter where I'm really, I'm just going to kill it. Third quarter, we get a brand new instructor. It was her first year teaching. She had a very thick accent and I failed miserably. So three times I failed organic chemistry. And I remember sitting in the Dean's office being told, Hey, you were on academic probation. Why don't you try a humanities major? You know, we've obviously been working with you for the last year and a half. You really like the basic tactical, you know, actually touching the science at the bench, but you're not quite there at the academic level. So maybe we declare a humanities major and like the entire time I'm sitting in the office, my it's like my life was flashing before my eyes wanting to pursue medicine, wanting to pursue science degree, getting to the university, which was such a glass ceiling breaking moment for me as the first person in my family to get to a four year. And now here I am being told, maybe you're not cut out. You know, maybe you should think about being an art history major, which I loved art history by the way, can do an entire podcast on art history. And that was devastating. So I bagged and I pleaded to just give me, just give me one more shot. You know, it's not fair that it was such a struggle to get here and yes, I'm struggling academically, but please just give me one more shot. And it was the quarter where I had everything, like all the stars were aligned for me to make a big return from my academic downfall. I had tutors, I had scrounged up some money from my part-time with Cedars, and I had some friends that pitched in to pay for some tutoring and to really kind of get my act together. And that October of 2013 is when I found out that I had HIV. And so there was like there were, there were all these faults and cracks that just kind of fell apart when I received that diagnosis. And there are moments that I think really defined your trajectory and I've had a few of them, but that's certainly the first point where I thought to myself now what, you know, I wasn't very educated about HIV and there was, and continues to be such a high stigma about it. And I remember, I remember sitting in the parking lot of the Walmart in Marina Valley after picking up my first bottle of antiretroviral therapy. And I remember pulling out this pill and looking at it and thinking to myself, how the hell Did, how did, how did we get here? You know, how, how did we get to where I'm living with HIV? And I just take this one pill every day with lunch, and I'm being told I'm going to live a perfectly healthy life. I'm I'm, everything's going to be great. Like how did that happen? Because I remember growing up and seeing, you know, I had a friend, family, friends that were dying of AIDS and it was, it was people that couldn't afford medications and they had to take all these cocktails. And so that kind of, it planted a seed in my brain about, huh? I wonder if there's something there. Right?

Brad: Right.

Daniel: And,uI came back to Cedar Sinai. So I did drop out of UC Riverside. I came back to Cedars and I started to apply for full-time jobs because guess what? Now I needed to be able to afford my medication. The university health insurance was not going to cover that. And so, you know, I, it was like, all right, well, I have to go back to work full-time and Cedar Sinai's got amazing benefits. So I was applying for the roles that I knew I was qualified for. I had all these years under my belt at Cedars. And the only thing I was qualified for was an administrative role because obviously that's what I've been doing all this time. And I remember there was an, the hiring manager and associate director, her name's Charlotte, Charlotte was looking at my resume and going, why do you want to be an admin? You know, you you've, you have UC Riverside under your belt. You did research. You had this amazing internship in St. Louis. Like why admin and me grappling with my diagnosis. I was not in a position or a place where I could just say it. So matter of factly, as in being able to do it now, but I was honest. And the honest part was I don't qualify for any other job without my bachelor's degree. You know, the ivory tower, academic medical center has a very rigorous process and you cannot bypass the HR rules, right? You don't have a bachelor's degree. You don't get the job.

Brad: Right.

Daniel: It's so happens that the physician that I was interviewing to work for had a research lab up on the ninth floor. And there was something about her saying, you know what, let me just gently guide you in this direction. Let me see what this doctor has to say. And to my surprise, I got an interview with this physician who asked me tell what you were doing in St. Louis, tell me what you were doing at UC Riverside. What type of technical skills do you have? And I told them, you know, I can do DNA. I could do RNA. I could do Q RTPCR like whatever, under the sun and these skillsets I can do for you. And then next thing, next thing you know, I remember getting a phone call and being told, you know, you're a great fit for that admin role. You're an amazing fit for that admin role, but we think you'd be a better fit as a lab manager. And I just remember my world's starting to spin because it was the first moment where I was like, what, you know, like a lab manager. Right? And so I started to then get into the basic sciences that touched on the clinical side with this role, because the research lab was investigating sudden cardiac death. And, and yes, I was still a bench technician, but they also leverage my skills as an administrator at Cedars all those years, which was important to a lab manager role, because you need to know about the accounting and accounts receivable and how to order supplies and how to move things-things through the procurement process. And you have to be good with people because you're onboarding lab members all the time. So I was excited, you know, I took on this role and immediately I knew that this wasn't a stopping gap. I needed to finish my degree somehow because I just knew it was important. So I started to go to school at night, working my job full time. I would sit and lecture Saturdays all day long. And I did the role for two years. And it, it was very fulfilling because I thought I finally found the intersectionality of science and medicine. And in fact, yes, I was working like my lab members were all physicians or MD PhDs, right. So I felt very much like I was contributing to something great, but I was still finishing my degree because I knew I had hit as far as I can go without my degree. So I complete my degree at some point. And by the time I complete my degree, I was in a point in my bench technician career. It was almost four o'clock in the morning. One night I was in the lab and I had run, I can't tell you how many 96, well plates that day I had started at like eight o'clock in the morning. It was a grueling day. And I remember pulling out this plate out of the equipment and looking at it and thinking to myself, why is, why am I getting no reads? And I realized, I forgot to put the enzyme in. And I pulled a chair at the bench and I sat down and I was like, I can't do this. I can't do bench. I can't do this. This is burning me out. I'm a social creature. I need to interact with like 96% of the patients that are in my day-to-day life are deceased. You know? And, and I know that the work is important, but it's not quite the full impact that I'm trying to have in the fulfilled, the immediate fulfillment. Right. So I, I turned to one of my mentors, Felicia Mayes at Cedar Sinai. And I'm like, Felicia, I am lost again. You know, I'm, I'm at another last point in my life. I don't know what to do. I love, I love what I was doing in the research lab. I know I want to do research, but like, help me guide me if you will, dear Oracle, I don't know where to go. And it was Felicia that looked at me and said, you know, you know what I think you'd be really good at. And I was like, what? And she's like, I think you'd be really good as a clinical research coordinator. And I just shot my arms up in the air. And I said, take me, put me out of my misery. I don't know what that means. I don't know what that is, but just please take me because I'm completing my bachelor's degree in about a months time. And I cannot work another day at the bench. I'm going to literally lose my mind. So there I was day one on the job as a clinical research coordinator, I came back to neuro. And so I came back to a very familiar family at Cedar Sinai, because this is a community of doctors and administrators that frankly watched me grow up. Right. And so now I found myself coming back to the same neuro ICU, where I used to staple welcome packets for patients and answer call lights. Now I was coming back as the clinical research coordinator for the stroke team and for the brain bleed team. And so it was a very kind of coming full circle moment for me in, in the beginning of my clinical research life. And I remember being handed a 100 plus page protocol and saying, well, here's your first study and thinking to myself, Holy crap, what did I get myself into? You know, like, I, I don't, I remember looking at my protocol for the first time and thinking, I hope to God, nobody gets hurt because I have this study and the trial was grueling. It was a phase three subarachnoids hemorrhage trial. And my task, my challenge, if I so dare to accept it was to take this protocol and bring it to life and to engage all the stakeholders needed to make this trial successful i'm talking about the neurointensivists, the general neurologists, the neuropsychologists that needed to do the battery of cognitive testing at the end the neuro ICU nursing staff the pharmacist investigational drug pharmacist. I mean, it was a huge undertaking and it was a role. Now looking back, I realized, of course I was perfect for the job. I didn't feel like that in the beginning. I felt like, Oh my God, Felicia, you made a mistake. But looking back at it, it was, it was actually a very, very good role because all of these people that I knew how they operated, you know, so when I went to the nursing unit and I said to the nurse manager Janita, Hey, we got to do a clinical trial. It wasn't, Oh my God, let me go battle the bureaucracy of nursing, right? It became let's collaborate. Right? Our mission is to be an academic institution. Our mission is to bring the cutting edge, innovative therapies and offer them to the patients that are served here at Cedar Sinai. And so I was able to unify people around that central point and get them behind collaborating, which is really difficult to do in academia. It's really difficult because we all kind of tend to operate in these silos. And so the trial was a success. I mean, we, we were, we became the highest enrolling center in the United States. I felt very excited. And that's when I knew that clinical research was it that's when I knew that this is what I need to dedicate my craft, what I need to dedicate my energy to. There's a love there for the clinical aspect. There's a love there for the research aspect. And there was an, there was this growing love for the fact that I remember there were patients that would come through who would have a brain bleed. And sometimes the visceral reaction is, Oh, well, they're not English speaking. So maybe we don't enroll. And I remember being the person in the room saying, why is that a barrier? Are they not, are they any less deserving to participate and potentially benefit from the care of the research because they don't speak English? And so the thing that I was most proud about is that the demographic of the patients I helped enroll at Cedar Sinai were for the vast majority communities of color. In fact, there was only white, Caucasian male in that total population. And so there was like this growing thing there that I couldn't quite put my finger on, but I knew that there was a passion to, to want to do more of that. And so, yeah, that's, that was my entryway into clinical research.

Brad: Yeah. That's a, that's an intense story. And my question is who's plays you in the bio pic because I think that's a, that's a perfect for a, for a script right there,

Daniel: You know, one day it's, it's funny. I know you interviewed Edye the other day and I look around some of the players in the industry. And I always think to myself, like with this conversation about clinical research in the spotlight, in the limelight with the COVID-19 pandemic, I almost feel like we have an obligation to go to the media and say, Hey, how do we better portray clinical research out in the media? Because you guys are getting some things right. But for the vast majority of it, there's so many untold stories there and the community needs to hear them. The community needs to identify with it and know that this industry needs more talent. You know, we need to diversify the talent pool. And if we look back at kind of my trajectory into clinical research, I could pinpoint the one thing that would have not made any of this possible. And that was my bachelor's degree, right. If I had not completed my bachelor's degree, I would have never been able to take on a clinical research role. And frankly, I'll be the first person to tell you, I have never once drawn upon my organic chemistry abilities or my biology abilities, or my statistics abilities in the day-to-day with clinical research, because what it is is critical thinking stakeholder engagement, you need to have strong communication skills. You need to have expert, you know, attention to detail. And so I have to really wonder in question the paradigm of what are we actually doing to create the bottleneck for the lack of talent in the industry. So I wonder with you, you know, who plays me in the, in the biopic? I would, I would love to, you know, have some role in B-being able to tell that story at a much larger scale.

Brad: Well, yeah. And you bring about a good point. I mean, when I started, I was sort of in the same situation, I did not have a bachelor's degree. You know, I had to start at a very sort of low level research assistant role. But it's like you said, all of those skills that are brought to there. I mean, look at the people who are in clinical research, it's ridiculously broad. I mean, there are people with art history degrees, and there are people with advanced degrees as well and everything in between it's, it's you know, probably unnecessary for there to be so much barrier to entry when it's just seems simply unnecessary for the most part.

Daniel: Yeah.

Brad: But you know, that's something I think is changing, especially as, like you say, there's a, there's a lot more spotlight, there's a lot more people talking about these issues. Now you see that you can be successful in clinical research without being a PhD, you know? I think that'll only continue to grow. So all of that brings you now to macro trials.

Daniel: Yeah.

Brad: Tell me a little bit about macro.

Daniel: Oh man. Where do I start? Macro has been, it's been a labor of love. Macro trials has been like everything that I just said with my story has felt like the birthing process to get me to what macro, first of all, what macro is the promise that we have with our vision and, and just frankly, what, what are we're trying to do in the industry? So macro trials was initially founded by two physicians in Beverly Hills. Okay. You've got a dermatologist and you've got a facial plastic surgeon who were very much passionate about advancing their field of expertise. And one of the things that they struggled with was why should I only be able to do this within my academic medical center infrastructure makes no sense. And the other thing that they were trying to scratch their heads and wrap their mind around is we've got a community of patients that exist beyond Beverly Hills. Why can't we do that? Why can't we democratize clinical research and make this a little bit easier for folks, but I'll tell you that doctors are really talented at clinically, right? Just broadly speaking every now and then you get a superstar physician that's kind of great at the operations, great at the business acumen kind of home run on all fronts, but the physicians had a vision, right. And that's all they really had from 2009 up until about 2016 or so when they brought in a third party player and that was Jonathan cabin or current CEO and Jonathan cabins saw the vision that the founders had for macro. And he said, Holy smokes, we've got a huge opportunity here. If we can just spin this a little bit more innovatively and give this some structure. And so John having had a background in, in help incubate and launch startups as well, put that touch into the equation. And they were doing, you know, up until this point they've been, were, they had been doing investigator initiated trials, kind of publishing proof of concept projects with pharma, or maybe taking on one or two phase three trials here and there. But it was nothing super big in scope until one of their colleagues came to them and said, you know, I'm having a really hard time getting this trial started at I won't name the academic medical center, but I'm, I'm having a really hard time pushing this through, like, why is this so difficult? You know, I, I can't get a study coordinator. I'm dealing with the bureaucracy of, of the department. And then once I break through that, it seems like there's only 17 other layers of bureaucracy to get the IRB approved. Like, why is this so hard? Right? And so that's when Jonathan cabins light bulb went off and said, well, screw them, bring it to us. And the, the rest was kind of history from there because they bootstrapped and they figured it out, but they managed to pull it off to do a very critical pivotal phase three biologic trial. They jumped into conducting this clinical trial without really having this background in operations and regulatory compliance. They just figured, you know what, we'll figure it out. You know? Lucky for them, they had a pharma sponsor that was like, all right, well, we'll, we'll take you on for the ride. We'll figure it out with you. Because at this point we're desperate of the fact that that academic medical center is not moving we'd much rather move and figure it out, then not move at all. And at that point I was reached out by Jonathan cabin. I had a full-time job at children's hospital, Los Angeles. And you know, his big question was, I can't quite tell if this is a clinical trial complexity problem. If it's a personality misfit, if it is the lack of infrastructure, like help me understand what's going on because this clinical trial business is a lot harder than it than we thought. So I started consulting on macro on the side, frankly, because I was bored. I was really bored. I loved my nine to five, but it wasn't stimulating. I went from one ivory tower to seemingly another one that was kind of way too structured for my creative mind. And so I got involved with macro trials in that regard, and it was like letting a kid loose in a candy store, everything that I had under my skill stack under my belt from people, engagement, people, management, leadership, operations, regulatory, all of it was kind of just put on my desk and said, here you go. If you have questions, let us know, let us know how we can support. And I was doing that as a side gig and there came a point where I realized I need to be all in, or we're not going to be able to do this. You know, the w-we're not going to be able to actually pull this off.

Brad: Sure.

Daniel: And so it felt like standing on the edge of a cliff when it came to time to leave my cushion, you know, well, salaried operational budget role, because it wasn't a job that was being funded by soft funds. It was funded role. And I remember people telling me like, you're crazy, you're going to jump over to this thing. Like w-what are they even doing over there? And there was just something in my gut that said, I'd much rather jump and regret it than to not jump and regret, not having the creativity freedom to express myself in something that I'm so passionate about. So I did, I eventually left the academic medical center and I came on board a macro full time. And that is where things really started to take off, because we now had this trifecta, we had, we had the clinical vision of the founders. We had the innovation and startup know-how of Jonathan cabin. And then we combine that with the operational and regulatory acumen that I brought to the table, and we just, we just kicked off. And what it came to was, well, what are we, are we a site? Are we a site management organization? What the heck are we? And it was very deliberate that I did not want us to be a site management organization, even though we function quite similarly because the SMO model is, it tends to be very top down, like, all right, who's in my Rolodex of physicians, how do we get this trial assigned? And then, you know, Hey, good luck type of approach, right? For me, it was more of how do I take all of these learning experience? All of the things I had a front row seat to within the ivory towers, all of the things I wish could be done better differently and apply that into clinical research in a private setting. And I mean, that's when magic started to happen, because we started bringing in and leveraging technology, bringing in and leveraging talent, bringing in leveraging expertise. And so, yes, in a lot of ways we do function as a traditional site where a physician in private practice can say, Hey guys, I want to do a retina study, or I want to do a diabetes study, or I want to do a Nash trial, but I literally don't know where to start. And so we bring them in and we say, tell us what you want this to look like. You know, do you want it to integrating into your practice? Do you want to come onto our clinical, you know, space and, and have it completely outsourced? And so that's one element of our business. The other elements were a business that has been increasing in demand more so during the pandemic is more traditional site optimization, which is what we encoded in our entity. We're a site optimization organization. And what that service really entails is really partnering with pharma and saying, what is, what are some of the, what are some of the bottlenecks what's going on, where the rubber meets the road for your sites, and how can we help? How can we actually scale emotional intelligence and bake that into your operations and SOP so that you can actually conduct a really darn good trial. And we started to see an uptick in that because of the pandemic, when we saw that all non COVID 19 research was essentially halted and hospitals had to shudder and shut down, and suddenly there was no market to be able to do non COVID 19 research, unless you were in private practice or unless you were in and outside of this ecosystem type of environment. So that's where we're at with macro trials is really offering these two kind of a very traditional site level clinical operation for physicians, but also kind of signposting and working with pharma to say, Hey, we're, you're not thinking about this because you really shouldn't, you should be focused at the, at the protocol level and your responsibilities as the holder of the I and D but Hey, guess what? We bring the site level expertise,

Brad: Right?

Daniel: And so I remember one time somebody asked or somebody kind of, matter of fact, we said, Oh, so you're a CRO, and we're not, you know, we, we are very much not a CRO. We don't offer CRO services. We offer site level services of optimization, whether that means we're functioning as a traditional clinical trial site, or we're partnering with you to touch down and expand maybe satellite site footprint to help bring these trials into a more diverse, underserved community. And so now what we're doing at macro is we're really trying to wrap our mind around, okay, we've, we've managed to figure all of this out, our secret sauce and all that good stuff. How do we continue to break down the structural regulatory, logistical and cultural barriers that prevent the underserved communities from participating in clinical research? And so certainly one part of that is access, like literally just being able to access it. Another part of it is more effective outreach and patient engagement. Another part of that is just language barriers and technological barriers. So that's where we're working at now with macro trials is in the scalability side of really how can we increase our reach to the underserved communities?

Brad: Yeah. And that's, I would like to, you know, have a whole other conversation about that topic. I know it's something that is very near and dear to you. I've seen a lot of your content and posts about that topic, you know, I think, and to go backwards a little bit, I think the, you know, we operate in very much the same way that you do. I think the future is not in the future is in being agile, being able to serve the people the way that they want to be served.

Daniel: Exactly.

Brad: You know, we're the same way we have a standalone site we're integrated within private clinics. We're integrated within a hospital system, but it's just like that. Just like you say, it gives you the opportunity to go out into the community. And especially again, communities who do not have access to novel treatments, they don't have access maybe even to good healthcare at all.

Daniel: Correct.

Brad: And again, I think that really is the future. We're starting to see, I think, more pockets of that happening in different parts of the country. So that's a beautiful thing. And again, I, I would like to have you back on to have a more specific conversation about inclusion and diversity, because I think that's frankly, something I'm not very well educated on.

Daniel: Yeah.

Brad: Uh somebody who operates with the same problem, I think like we call ourselves integrated site network, or, you know, any number of different things, but really we all have the same goal here. You know what I mean?

Daniel: Yeah, exactly.

Brad: Um so I want to put a pin in that a little bit, because I would like to have a more detailed conversation about that. Yeah. absolutely. So, you know, going from there, you know, what's, what are some best practices you personally have sort of picked up throughout your time, especially at macro

Daniel: You know, there's a, there's a few books that are always on my desk and I'm looking at them right now. The first one is crucial conversations. It is the tools for talking when the stakes are high. And I think it's FranklinCovey. The other one is the five dysfunctions of a team. And another book that I'm looking at here is daring greatly by Bernie Brown. So in terms of best practices that I've encountered, it's one of the most important things that we do at macro trials is we're always finding new ways to run towards connection in an industry that tends to be quite fragmented and disconnected. And here's what I mean by that. We always have these parties that need to come together towards the same common goal of delivering safe clinical trials. You've got the sponsor, you've got the CRO and then you've got the site. And then you can further divide that into the site level operations, where you've got the physician investigator, you've got the study coordinator. If you've got some kind of management in the mix, then you've got that players involved. And oftentimes what I've noticed at least in my career upbringing is there was never really a focus on connecting. There was never really a focus on soft skills. There wasn't that much of a emphasis on developing communication in your ability to communicate effectively. And so one of the things that has grown to be a very important cornerstone of what we do at macro trials is to develop every team member's ability to function as a stakeholder engager, being able to communicate effectively, being able to a heightened sense of self-awareness because the more self-aware you are, the more effective you are at managing yourself. And that's important because you need to be able to meet people where they're at. You need to be able to meet the patient where they're at, meet the investigators where they're at, and certainly meet the sponsors and CRS where they're at. This is an industry that is very much, has been very much cookie cutter model mentality, meaning you've got the bachelor's degree, you've got one or two years of clinical research experience. Great. You're qualified, here's the protocol and go, right?

Daniel: Right.

Brad: And so best practices for me, honestly, has been doing a lot of self-development work that frankly has nothing to do with the subject matter of clinical trial that is important. And that's going to come quite organically by just nature of moving through the clinical trial career path, but really focusing on some of the other supplemental, critical tools that you need to have to F- to frankly, work with people, right. And being able to connect with people. And when I say we, we run towards connection, we are able to take a stance when we interact with a grumpy investigator, or maybe we have a grouchy CRA, or we have a grouchy sponsor, we're able to look at that and identify it for what it is, you know, and as students of Jim Collins, and Bernay Brown here at macro, we look at that and we go, okay, that's just the mask. You know, that's just a shield. That's just an armor. We know better. And so therefore we should do better by meeting that person where they're at and the outcome ends up always being stronger relationships, stronger working relationships with sponsors, CRS, and investigators, increased trust, and frankly, more fulfillment and more work satisfaction. You know, I, I, I hope that if you were to independently interview the team at macro, that they would all kind of resonate with the fact that they look forward to coming to work. Not just because they love their trials. Of course they do, but because they have a place where they feel like they can connect and belong. And that's, that's really critical in driving a culture. That's different from the historical narrative of clinical research, where, and I'll quote, my colleague, ed, you've got such astonishingly astonishingly high levels of staff turnover at the CRC and CRA level. And one of her metrics that I am borrowing from her is comparing the staff turnover rate in clinical research versus the fast food chain industry. And it's a problem when the fast food chain industry has better retention rates than the clinical research industry. It's an industry where you, we, all of us are, we need to not be asleep at the wheel of driving these trials that ultimately are going to signpost to the FDA questions about safety, efficacy, efficient, you know, for patients, ultimately these are patient lives, right? So if you've got an industry with high s.taff turnover rate and you are touting what we've got standardized clinical research principles and training, well, I don't know how effective that is unless we're really paying attention to the soft skills and developing the emotional intelligence of the people in this industry.

Brad: Yes. I could not agree more with that sentiment. I mean, I think it's, you know, you can't, this can't be a thoughtless job.

Daniel: No,

Brad: Really, you know, it's, it's impact is greater than, you know, pen on paper, you know, it's there's a lot more to it and, you know, small things that, you know, even I've done within my company is I tried to start a book club, you know, let people give people the opportunity to learn and reflect and bring those things to the table. Just like you said, things that aren't related to clinical research at all. I mean, this is, this is beyond again, a simple job, or it should be, you know, if your, if your heart's in the right place and you're, you're doing the right thing. So, you know, I think that is a beautiful sentiment. And unfortunately there still are the sort of large, you know, at this point, I, you know, I refer to the academic institutions as sort of the dinosaurs. I mean, not that there aren't good people within the system because of course there are.

Daniel: Right, right.

Brad: But, you know, if anything, they're making it more difficult and, and more,usort of, I don't know, just, I can't think of the word I'm looking for here, but it's like you said, it's a cookie cutter, you know, it's just become, so it, you know, you, you lose the ability to really help people because of that bureaucracy and because of that sort of siloed cookie cutter mentality. So I'm, I'm always super encouraged. I've, I've, you know, I've been keeping up with you for awhile and with macro and I love what you guys are doing. I feel like we're a very much sort of in line,uphilosophically. So that's awesome to see that there's people out there, you know, with that same, same mentality

Daniel: Yeah, the other day, I got everybody in the conference room and I, you know, I said, well, today we're, we're going to do today. We're going to do an exercise that will arguably completely changed the trajectory of macro trials. And everybody got sitting up straight and they're like all excited. And they're probably thinking I'm going to unveil the integration of this new technology or something. Right. Super disruptive. And instead, what I had was I had these easel post-it pad things all over the conference room, and I had these these markers. And I said, everybody grab a couple of markers. And I pick somebody at random. And I said you know, my team member. I said, you are going to describe to the room, your perfect wallet. And I wish I could take pictures of the facial expressions in the room. Cause everybody was what the hell does a wallet have to do with clinical research. And,uand I, and I facilitated and moderated the team through an activity of design thinking. And the reason why that was so transformative for us at macro is because it taught everybody the value of knowing that everybody has their ideal. Everybody has their ideal, whether you're a study monitor or a study coordinator or a sponsor, you come into the arena of clinical research with an ideal in your mind, same thing for every stakeholder, every physician, how we deliver on that ideal depends on our skillset and our ability to design that experience from scratch.

Brad: Sure.

Daniel: And by the end of the activity we had, frankly, macro, we, we design the ugliest wallets. You can ever think of,uI include myself because I designed a wallet with the, with the team, but the whole point of the exercise was how do you draw out from folks what's important to them? What, what are their values? What motivates them? And then how do you design and cater a completely innovative,uexperience around that? And so there are so many, there's so many implications of that particular activity. There is the designing of the patient experience. There is the designing of the CRO experience through the study startup practices that you have in place at your site. There is the sponsors designing the sponsors experience, designing the investigators experience. So,uthat was a very interesting activity, but I, I remember walking away from that and I had a team member say, you know, when I woke up this morning, I could have, if somebody had told me to bet money, we were designing wallets at work. I would've, I would've totally lost.

Brad: Right. But no, that's, that's a very, I mean, obviously that's a microcosm for all the things you just mentioned. I mean, it's a very thoughtful experiment, you know, I, I love that kind of stuff. And I very well may steal that idea from you and I'm calling it right now.

Daniel: Please do. It's such a, it's such a great, it's such a great activity because you hit your team out of left field with somebody totally not expecting

Brad: Come up was something different than a wallet. So at least I'll, I'll put my own spin on it. How about that?

Daniel: Absolutely.

Brad: Well, awesome. Anything else you want to hit us with before we wrap up here? Again, I would, I'm going to insist that you come back and we, and we have some further conversation about some of these more sort of cultural issues within clinical research. I know that you're doing a lot of that kind of stuff now, but I, I, I'm going to have to, I'm a force you have basically to come back and talk to me about it.

Daniel: Yeah. I forced me please. Volun- tell me to do whatever you want. You know, the, the takeaway thing I think for me is is just be courageous. You know, this industry is extremely risk averse. I get it. The stakes are extremely high. The stakes are extremely high and nobody wants to be the first to create a mistake that then becomes the case study for some IRB meeting at a hospital seven years from now. Right. But my biggest takeaway is, is, and I hope, and I think I'm starting to see more and more of that because of the pandemic to be courageous, to go out there and try something new, obviously in close consultation with the regulatory North stars that we, that should be guide posting us. But we, we need to have more courage in what we do because the stakes are even higher for what we can get wrong. If we don't.

Brad: I agree, Daniel, where can people find you online?

Daniel: Linkedin if few include my LinkedIn link, that would be the best and quickest way to find me. And I, I'm always happy to talk to folks as much as I, as much as humanly possible,

Brad: Right on. Well, again, thank you for coming on. I'll post your contact information on our show notes. And again, thank you so much.

Daniel: Thank you, Brad.

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Episode 19: The Energetic Edye Edens