Narrator: This is the DarshanTalks Podcast. Before this episode's interview with Christina D'arcangelo on clinical research with COVID-19, Darshan will introduce this episode with the recap for the week of Thursday, April 23rd, 2020.
Darshan: It's been a really interesting week again and COVID has done everything to make it more interesting. For example, there are some articles out there talking about how COVID is now stalling clinical trials for everything except COVID. There have been some discussions that patients themselves aren't even coming to the hospital because they're afraid of getting COVID, so the question is where are these patients going that don't have COVID-like symptoms. A lot of people are saying that they're actually either just passing away at home. Others are saying that this is impacting the actual clinical trials, so that's an interesting, unexpected result of COVID. So keep that in mind as you continue.
Darshan: This was also the week in which the Department of Justice announced that Logan Laboratories, Logan Labs, in Tampa, Florida, and Tampa Pain Relief Centers, Inc., a pain clinic also based in Tampa, agreed to pay, along with former executives, a total of $41 million to resolve alleged violation of the False Claims Act for billing Medicare, Medicaid, and Tricare for medically unnecessary urine drug testing. So again, keep in mind that performing a service is not enough. Was there a good reason for the service itself?
Darshan: This week, the EEOC, the Equal Employment Opportunity Commission, also put out some rules and put out some information around what they consider important for the purpose of the Coronavirus. So if you have some questions about that, feel free to reach out. I'd be happy to send you the link to that.
Darshan: This was also one of those weird weeks where they announced unusual things. In Nebraska, a pharmacist was arrested for an alleged conspiracy to use explosives, specifically Molotov cocktails, to firebomb and destroy a competitor pharmacy. That just seems unusual. That's sort of not the point of this. So I just thought that was interesting to note.
Darshan: Also, on April 16th, Novartis lost its bid to toss a former employee's revised False Claims Act suit after New York, sorry, a New Jersey federal judge said that the ex-worker's alleged conversation with his boss supported claims that he was fired for objecting to a potential kickback scheme involving express scripts. So stay tuned. This should get interesting. Is Novartis in trouble again is something we need to look out for.
Darshan: As usual, COVID-19 is keeping us interested. The FDA has taken the unusual step of allowing compounding of necessary hospital drugs for COVID-19 and this includes drugs like Cisatracurium and Precedex. There are a bunch of them, including Fentanyl and Furosemide, et cetera, so keep that in mind. That should be interesting as the days come through.
Darshan: Again, the FDA is also taking other unusual steps. They've said that developers can release digital products for psychiatric disorders without a 510 K Submission during COVID-19. That's going to be interesting because that changes the expectation of requirements around COVID-19. The guidance that came out and it says that this device availability may increase patient access to digital therapeutics while individuals are following stay-at-home orders orpracticing social distancing without the need for in-clinic business during the COVID-19 public health emergency. Remember, this basically is for a limited period. You may still need to go back, so stay tuned. You might be able to reach out if that's something you have, feel free to call us.
Darshan: April is also the National Minority Health Month and that actually talks about the importance of diversity in clinical trials. Obviously, when you're talking about people who are socially disadvantaged, economically disadvantaged or a combination of those two, that can have a pretty massive effect on representation and clinical trials, and that can actually, obviously, have impact on representation and on the efficacy that gets shown out in the population at large. Obviously, people are using tools, technology tools, to improve that, but we, as an industry, need to make better strides in this context.
Darshan: If you have any other questions, feel free to reach out. We hope to provide you with more interesting information as we continue.
Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshantalks.com.
Darshan: Hey, welcome. Christina, good seeing you again. How are you?
Christina: I am well. Thank you. How are you?
Darshan: I'm doing well. Thank you for being on the podcast. As you guys know, we're doing a whole podcast series, a whole podcast theme, around COVID-19. As everyone knows, that has interrupted our lives completely. And it's one of those interesting conversations, and everyone's been talking about clinical research and how that slowed down. I got someone who can speak to it, not only from the perspective of how has business slowed down, but actually hands-on, working with COVID. So this is going to be a really interesting conversation. Do you want to introduce yourself?
Christina: Sure. Thank you so much. I really appreciate being here today and thanks for reaching out to me and having me on your show. I always like talking about clinical research since you know, that's my sweet spot. My name is Christina DiArcangelo. I am the CEO of Affinity Bio Partners, which is a clinical research organization. We work in both traditional biotech pharma and device, as well as, we work in medical cannabis and CBD clinical research. We've been doing that for the past four years. So I split myself in half and I go down the path as needed for my skillset.
Christina: And then I also am the CEO of a nonprofit called Affinity Patient Advocacy. We advocate for patients at no cost, both in the traditional space as well as medical cannabis and CBD.
Christina: And lastly, I have a tech company called AI Health Outcomes. We have two artificial intelligence Bots. One is called the DrBot, which is traditional-based, and then the other one, no surprise, is called the CannaBot. Right? And so they're both [inaudible 00:07:23]. We call them the BrotherBots. They work on the same AI platform. It sounds kind of funny saying I have BrotherBots, doesn't it?
Darshan: For now. One day that's going to become normal.
Christina: Yes. And so the cool thing about these little guys is that they're able to collect data from an electronic data capture standpoint like we do in traditional pharma, as well as electronic patient-reported outcomes. You may have seen that we published a white paper back in January on the cannabis side utilizing our CannaBot, basically reporting from the patients directly that are participating in the Pennsylvania program, how they're faring, what's working, what's not. And all that data was captured through the CannnaBot, which was through ePRO. So we're really excited that we have, between the three companies, they all work towards patients, and we've been helping patients on the biotech side, the patient advocacy side, as well as the technology side with the Bot.
Darshan: So, you're, obviously, in so many different areas, and you're, obviously, well-versed with both, as you put it, the traditional pharma device industry and/or the cannabis industry, as well. My first question to you is how's business right now?
Christina: Well, we've been fortunate because we split ourselves in half where we service both-
Darshan: Well, thirds.
Christina: Yeah. Right. Thirds, really. From an APA standpoint, Affinity Patient Advocacy, you can imagine we have been getting a lot of emails, calls from patients, not COVID patients, so to speak, that need advocacy help, but patients that are being impacted by COVID, in the sense that there are patients that have treatment plans and protocols and their rights are being violated by, say their landlord. There's all kinds of things that have been coming our way.
Christina: But then honestly, the cannabis sector, right? Because a lot of these patients are reliant on being able to take cannabis and/or CBD daily for their treatment protocol and just making sure that they still have access to the dispensaries, being able to go out and procure their medicine, as well as, if they're up for certification and they happen to be in a state like Florida, for example, that's not doing telemedicine, but Pennsylvania is, this is a problem for my patients in Florida because they're not able to re-up, so to speak, from a certification standpoint because there is no telemedicine going on down there.
Darshan: Right. That's been one of the conversations everyone's talking about that I've noticed where people that are saying, "Look, I need to get my hands on my medical cannabis."
Darshan: The issue is the medical cannabis industry is a nascent industry in many ways. And if that's true, they don't have the same reserves that traditional pharma might. That's not to say that anyone has the reserves right now. No one was expecting two months of no business. But in your experience, is there more clinical research happening?
Darshan: Is there more clinical research happening? Is there a lot of work around medical cannabis happening or are those industries pulling back going, we need to reserve cash?
Christina: Yep. The medical cannabis side, I can tell you, we had multiple contracts getting ready to ink to do various research, right? With the bot and everything, and everything froze from the cannabis side because people are afraid to spend, right?
Christina: I understand that perspective. But you also brought up a good point in the manner of, well, what about the reserves, right?
Christina: I'm a Pennsylvania patient, so I have two auto-immunes and I take medical cannabis to help me with my auto-immunes. And I've seen in Pennsylvania, although we're fully functional, thank God, and we're able to go to the dispensary, and Wolf, our governor, allowed 90 days worth of product to be procured at one visit, which is fantastic, we're starting to run out of flower again. And it's, "Wow. If I was a flower patient, this could really put me in a bad spot." Luckily, I'm not a flower patient, I can take other things, but I'm seeing that happen, too.
Christina: It's not like the growers aren't working, they're working. It just can't keep up with the demand, and also think about the anxiety, right? That's one of the qualifying conditions in the state of Pennsylvania, and we've seen an influx of patients come into our program for anxiety, and some of these patients with anxiety and PTSD during COVID, this is not good for them, right? And so now we're worrying about whether or not we're going to be able to get the product supply to them efficiently, as fast as possible. But from a technical, clinical, traditional side of research, business has been great. We've been fortunate enough to procure a client that's working on COVID-19. They have two amazing protocols. We wrote the protocols for them, actually I did, not to toot my own horn, but you know. Got to give a girl [inaudible 00:12:47].
Christina: We've been working, honestly, 15-hour days because we're trying to repurpose, or our clients is trying to repurpose FDA-approved drugs for COVID treatment. And, obviously, there's not a lot of research out there on COVID right now, so we're looking at research and other like-type viruses that can support our potential at re-purposing these two FDA pre-approved drugs.
Darshan: And have you had any conversations with the FDA or have they mostly been [inaudible 00:13:23] say, quiet?
Christina: No, no. We've had a lot of conversations. I don't mean to giggle, but the client originally reached out to me from a cannabis standpoint, which is interesting, right? Because they also work in cannabis research. And then they said, "Hey, Christina, we have this COVID project. We know you're traditional biotech, really, for a long time, can you help us?"
Christina: So I've been working on this project for at least two weeks. I've talked to the FDA since I jumped on the project. I reached out to the medical cannabis side of the FDA because that's who I spend a lot of my time with right now, to say, "Hello, I'm coming in with some stuff for my COVID client." Right? "They've been responding. I feel like we could move things along a little bit more swiftly." And I see stuff out in the media that basically says, "Oh well, we have a 24-hour response time." That's not happening. And I don't know if it's because they're overwhelmed themselves because God only knows how many protocols they're receiving. I only know of the two protocols and that's what I'm worried about.
Darshan: It's funny you say that they're talking on a 24-hour response time because I'm working with a different client on a different issue... Well, two different things. I've got one client who has nothing to do with COVID and [inaudible 00:14:47] reach out to the FDA, and they've just been quiet. They haven't responded in a week and I have to call back today.
Darshan: I've got another client... Well, I've got two other potential clients who are coming in who need me to do Emergency Use Authorizations, and they're all sort of... It's interesting. You see people who have very little FDA experience thinking that if I come in today with a idea, the FDA [inaudible 00:15:10] approvals tomorrow, even if it's Emergency Use. And you're like, "That's not how this industry works."
Darshan: So they're like, "I'm expecting the approval in my hand by tomorrow." "When did you submit it?" "This afternoon at three o'clock." "No, there's zero chance of that happening to you."
Christina: Right. Our client was able to procure funding for this project. So we have a very, very, very nice investment guy who has a lot of contacts, has been traditional biotech the majority of their career, as well. So at least he understands that when I give updates because it falls on my shoulders because I'm the CRO, right? And so I have these guys asking me constantly what's going on.
Christina: The other question I get is, "Well, why aren't you trying to push into a hundred patients with this?" Our protocol was designed with 20 and the reason why I designed it with 20 is because, yes, we're using two FDA-approved drugs, but they're off-label use.
Christina: I'm not going to come out the gates like a big baller and try to make this a phase three study with research data other than preclinical cell data, right? I can't do that. I can't pretend I don't know what I know in clinical research, so I'm being conservative with my approach of going forward like we normally would with, "Here's 20 patients. Let's see what happens with these 20 patients." And I put stop gaps in a trial so I can look under the hood and see what's going on through the trial with the data and then turn back and say, "Hey, I have this. Do you want to take a look at the efficacy data?" And I built in a DSMB immediately. So I'm doing things like we do in traditional pharma, but I'm accelerating myself. I submitted the protocol in three days after I got the project and wrote it, researched and kicked it into the FDA in three days, which you and I both know that's unheard of.
Darshan: That's super-fast.
Darshan: So here's my question for you. How do you... So two questions come out of this as I say, the first one is everyone's talking about the cure for COVID and they're hoping like, "Oh, you know what, maybe you should have a cure in our hands." What's your take on that?
Christina: Hey look, I don't think there's a cure out there for anything, right? As I lean into the camera. Even when I'm working on the cannabis side where we're seeing some really promising results on certain things and certain indications, I think that there's an ability to slow down the virus in the body, and I think there's a way to lower the viral load. But what I'm seeing already in the approvals that have been received by other companies, is that they may see a difference over the last week or so of treatment for these patients, but how about 30, 45 days out when [inaudible 00:18:11] somewhere in the body and they don't know yet that it's hiding.
Christina: [inaudible 00:18:16] And so that's what I kind of worry about. When we designed our protocol, I purposely designed a 30 day... They will only be treated for four days and then 26 days later I have a followup visit so I can see in 30 days, one, is it still safe? And two, where are we with our viral loads? Are we okay? Has this patient truly improved? That's what I think is really important. I don't think we're going to cure this, but I think we should be able to stop it.
Darshan: Now, do you think we should be able to stop it within 30 days or within 90 days? Because the economy's come to a halt and they're depending on you to solve this problem.
Christina: I can't even tell you how many people bother me in my family that knows I'm working on this. They're like, "Christina, when is this going to happen? Are you going to be able to get this done? How quickly?" And I'm like, "Look, I'm doing my... I literally am working 15-hour days. I'm on the phone at midnight having teleconferences with Australia. You know what I mean? I have not slept. If I took my glasses off and you saw the bags, you'd be like, "Oh shit. Put your glasses back on."
Christina: I'm hoping that once we start going, we'll see the data pretty quickly. And based on the preclinical data that we have, I think there's a potential that we'll be successful. And if that happens, we've already preemptively talked to the original drug manufacturers, letting them know we're repurposing their drugs and can they help us out with distribution should the gates open, and they're already in. So we've done a lot of the... In this short period of time, we've done a lot of that in advance because we're ready to pull the trigger as soon as we can.
Darshan: Are you looking at things like adaptive studies or are you not?
Christina: No, no.
Darshan: Okay. To be fair, I recognize the fact that you wrote this protocol in three days, so there are limitations on what any human being can do. The second part of that question was, are you using biomarkers because you said that you're using surrogate markers almost, right?
Christina: Yes, we are. And basically also what we're trying to do is measure the viral load in these patients as they progress through the study because that's really where you're going to be able to tell if this thing is actually working or not.
Christina: This first protocol that I'm talking about right now that we're getting ready to operationalize is utilizing those two repurposed FDA products. The second protocol that I've already submitted the IND for is not just the two drugs. There's something else that we're adding that I can't say right now, obviously, but this additional thing that we're going to add, we've already done research on in patients internationally. The only reason why we didn't push it out the gates right now alongside the two FDA repurpose drugs is because this other thing has to be manufactured and it's going to take six weeks to get it ready.
Christina: So I figured it made sense for us to push out the two repurposed drugs, use those off-label, see what happens, because those two repurposed drugs sit with the other protocol with the other secret sauce thing that's being added. And that is pretty amazing because that secret thing lowers the anti-inflammatory issues in the person's body. And that's what we're seeing right now. So this virus just attacks these people's lungs, right? And knocks them out. Well, this other thing will help that lung issue and lower the anti-inflammatory issues that they're having throughout their body.
Darshan: Do you foresee based on the response you're seeing with essentially... I'm going to call it the pandemic response. But the response we're seeing, if this happens in a year again or in two years, do you see our infrastructure being ready for it again?
Christina: Oh, I hope there's a lot of lessons learned here. Not to knock the FDA, but I'm sure there were hundreds and thousands of people trying to submit into the portal. And I can tell you from my own personal experience, it came down twice on me where I couldn't submit my IND and I couldn't submit my supplemental data to support the IND because everything came crashing down. So that's a little bit of a problem. Owning a tech company, I can't have my bots come down in the middle of the study. I need to be able to run efficiently. And again, I'm not knocking them, but even the school system. I have a kid that's seven years old that's now at home and so I'm dealing with homeschooling.
Christina: I'm not a fricking teacher. What the hell do I know? He's learning a lot of life lessons, let me tell you.
Darshan: Do what you're good at.
Christina: I try to do it, but even the system they use for online teaching, that broke a couple of times and it was like, "Okay. Well, you knew that we were leading up to this." Right?
Christina: I would think. And so why wouldn't you have pressure tested the systems to make sure that they could uphold to all of these kids climbing into it to be able to do their homework?
Darshan: Well, to be fair though, I'm going to push back a little bit on that. Zoom, for example, has crashed so many times and that's the entire business model. I'm going to give them some credence, but it goes back to that question of what's going to happen in the future. I think the answer is no one knows, obviously, but it looks like everyone's going to take some lessons to be learned and [inaudible 00:24:12] there.
Christina: Oh, yeah. Even in our businesses, I'm sure there's certain lessons you've learned.
Christina: There's a lot of lessons we've learned on our side. Even with the nonprofit, I didn't foresee that we were going to have all these patients rolling in as much as they have been and still are. I get patients every day and a lot of these require the high-touch approach, so I'm taking them on along with everything else I'm doing, so it's very hard to straddle these multiple hats we're wearing right now, right? We're doing stuff that is out of our norm and it requires a lot of different thinking to be able to get stuff achieved.
Darshan: So we're past where I thought we'd be on time-
Darshan: ... but this was as always a really, really good conversation. Any last parting words? What would be a happy ending as you see it to all of this?
Christina: Well, I think a happy ending is to see some success in some of these companies' treatments, right? Our clients, as well as others that are trying to repurpose previously approved drugs, hopefully. Or somebody who comes up with something else. But time is of the essence, right? We don't have a lot of time to play around with this because I'm sure you're watching the numbers. I watch them every day. And I can tell you three weeks ago when I worked on this protocol, there were 268,000 cases of COVID three weeks ago worldwide. And now we're over 1.4 mil and here we are three weeks later.
Christina: I'm hoping that we have some success and some of our other colleagues in the industry are also having success. I love the fact that people are coming together truly to work on projects that they otherwise wouldn't have. You know? Even my client, they're medical cannabis, and they said, "Oh, wait a minute. Let's put the brakes on. We need to focus into COVID right now because we already know that if we don't, we're never going to get anywhere with our cannabis side. So we need to get something out there and help these patients because at the end of the day, that's what we're supposed to be doing is helping patients.
Darshan: Exactly right. Well, thank you so much again for being on. I'd love to have you on again, if you're available.
Christina: Sure. Absolutely.
Darshan: This was great. And next time I won't have my growling dog next door.
Christina: Mine's locked in the kitchen.
Darshan: Thanks again. This was great. And we'll be talking.
Christina: Thank you. Okay. Sounds good. Be well.
Narrator: This is the DarshanTalks Podcast. Regulatory guy, irregular podcast, with host Darshan Kulkarni. You can find the show on Twitter @darshantalks or the show's website at darshantalks.com.