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Darshan

Hey everyone, welcome to the DarshanTalks podcast. I'm your host Darshan Kulkarni. It's my mission to help patients trust the products they depend on. Which is why today's podcast is going to end up being really interesting, because we're going to explore what those words mean, how do you help patients trust the products they depend on. As you may know, I'm an attorney. I'm a pharmacist, and I advise companies with FDA regulated products. So if you think about drugs, wonder about medical devices, consider cannabis or obsess over pharmacy. This is the podcast for you stating the obvious because we're going to do a unique thing today. Everything we discussed today does not constitute legal advice that does not constitute clinical advice, and does not necessarily represent the opinions of the companies that that we work for. I do these podcasts because a lot of fun. And I'm because I find myself learning something new each time. So it'd be really nice to know if someone's actually listening. So if you like what you hear, please leave a comment, please subscribe, you can always find me and my dog Murphy on twitter darsan talk. So just go to our website at DarshanTalks.com. Our podcast today is actually really kind of interesting. We have talked about patient centricity several times we even had our guests on before, but the FDA has been paying a special attention to this. And there are new guidances in play. And we're trying to figure out what all this means. And so today's podcast is going to be sort of a role reversal. So I'm gonna land up being interviewed by Erica to talk about some of the issues that pop up, which should be really, really fun. I did. So if you're in clinical research, you probably want to hear what we're talking about. But I'm actually almost curious if we're going to get into things outside clinical research, because we're really talking about hardcore patient engagement, and patient centricity. And what does that mean, because that's not it. engaging patients in the context of clinical research is almost what we'd like them to do. But what do patients actually want? And that's going to be part of the discussion we're going to have. So our guest today is a pharmacist, she is a patient centric enthusiast. And is the patient experience patient experience lead at a large pharma, we're not going to name them they shall remain nameless, just so that they can be protected from the shenanigans we're going to engage in right now. So our guest for today, ladies and gentlemen, Erica divine. Erica, how are you?

Erica

Hey, Doris. JOHN, it's great to see you again.

Darshan

It's great to be here. And I'm as always impressed by all the certificates on your wall. Meanwhile, I have Batman. So I have I have to say that you win 100%. But But let's talk a little bit about where we can help patients when, and we can talk a little bit about what's been going on and how the industry is moving. And let's start with the beginning. In your opinion, your experience, has there been a change in the way industries engaging with patients? I mean, outside the lock, the lot of lip service we give, I've been really been a change.

Erica

Yeah, so I think that's a great question Darshan. And I think there is certainly an appetite to figure out ways to engage with patients. So let's just talk a little bit about the traditional model with pharma. So typically, we've really captured patient experience and caregiver experience through the lens of healthcare providers, and patient advisory groups. So typically, that's that's how we tend to approach understanding our patients. But what we're finding is is that that doesn't always tell the whole story. So how do we, how do we get that voice of patient directly from the patients and caregivers? So it was interesting, I was looking at a study that was published in June of 2020, by the BCG organization, and they had basically posed a question to patients, I believe, 3200 patients responded in the survey across five health care markets. So the US was included in that, but it was really a global study. And they said, what do you what do you want from pharmaceutical companies? I mean, it seems like such a simple question, right? And really, despite what market they were from, or what therapeutic area they were, you know, living with these conditions, the themes really bubbled to three main categories one, affordable access to treatment, so anybody who has gone to a pharmacy and experienced the sticker shock, probably not surprising that patients want to be able to afford their medications, but to They also wanted to make sure that clinical trial outcomes really reflected real world experience with treatment. And lastly, they were looking for more transparency from pharmaceutical companies. So when I look at two, and this kind of dovetails nicely into a discussion I was having with one of our health outcomes, colleagues around patient focused drug development, which I can talk about a little bit, just to summarize, it really got me thinking, you know, how do pharmaceutical companies really make sure that what they're studying with their products are really meeting the needs of patients. So to talk a little bit about that, and I know Darshan, you alluded to the guidances. So really, in a nutshell, in accordance with the 21st Century Cures Act, the FDA has launched this effort called patient focused drug development, to really be able to ensure that patient perspective is being incorporated not only in drug development, but also in regulatory decision making. So the outputs of this are the series of guidance documents, that is really to help sponsors and key stakeholders really understand it's a playbook essentially, on how they should go about making sure that the sampling is representative, to make sure that they're asking the right questions and using methods that will really make sure that they're getting organic representative data. But then the third, and the fourth is looking at the clinical outcomes assessment, and how do we really make sure that that's represented and utilized. And then lastly, the endpoint development, that, you know, we're looking at when we are incorporating that into really the regulatory decision making process. And there, this isn't new, as I'm sure you know, Dr. Shawn, you know, the FDA has, I think in 2009, they had the PR o guidance document, which isn't necessarily the same thing. I think it was really definitely wanting to understand patient experience. But it really was framed from the outlook of endpoint development. Whereas code patient focused drug development, it's a little bit more broader. And I think it takes us outside the scope of just endpoint development. So when I think about this, I for one, working in patient support, and really having really a focus to make sure that we are incorporating patient voice perspective desires once into everything that we do. This is exciting to me to see that there's momentum here to be able to make sure that that starts way earlier than commercialization of product. And really keeping in mind that pharmaceutical companies are now realizing Darshan that we aren't just drug makers, we're not just product makers, we are there to deliver an experience. And that will ultimately be a differentiating factor in how pharmaceutical companies better serve our patients. And so the question I had, and this is something that just is really interesting to me, and I would love to just tackle this from the legal perspective and and really get your insights is how, what are the considerations sponsors should be thinking about as we start to move into that space where we are directly engaging with patients and caregivers.

Darshan

So it's one of those interesting things where everyone talks about one into patient to do patient engagement, right? And you're the AMA, the FDA are all coming on saying we want this to happen. We need this to happen, right? Let's just talk purely from a US standpoint that the second from that standpoint, one of the key things you need to consider and you need to look at is this idea that what you're engaging in would not be construed to be promotional in nature. Because if you are engaging in conversations that are promotional in nature, there are a whole bunch of other rules that kick in. Number one, are you speaking off label, if you are speaking off label, what are the implications of that? You let's say you are engaging with them in a promotional way. And the real question is, Can you can you engage with them in a non promotional way? And if the guidances suggests that you can, so that's good news. The bad news is that the guidances at this moment are a little fuzzy. And what you start looking at is yes, the FDA is saying, these are different ways. These are different strategies you can use to actually engage with patients. But the second part of it is, what what do I pay a patient for being part of this? Because it's patients time. I mean, we think about clinical research. Already, like, we don't want to influence it, we think it's important that you just be part of the study, because it's for the betterment of humankind. Meanwhile, pharma companies are making billions off of these drugs. So we aren't going to pay you even, sort of all they'll pay us to offset your costs. But we aren't going to pay you to do much more than that, even though we're going to benefit significantly in to the tune of billions of dollars from this, you. So is that at some point, a level of exploitation, and no one's questioning that part of it because it's, it's, it's one of those third rails, we really don't want to touch, if we can help it, but but it's a reality. And I'll tell you why it's a reality. I got approached this week to be part of a clinical trial, because I have some medical issues that I need to talk talk to. And it's going to be a five year study in with 21 different visits. And the payment is will pay you up to things like 50 bucks for any costs you may incur. Well, what about all the costs that I have taken time off? Coming in all those things? So I think from a, from a legal perspective, do we have Well, from an ethical perspective, do we ever have a duty to offset that from a legal perspective? The next question becomes, okay, let's say you are going to pay them more, right? Because that'd be good. At that point is it a kickback can kickbacks happen? So theoretically, under the anti kickback law, that would primarily happen to physicians would be to healthcare providers in the light to influence prescribing behavior. However, this is that there's some great research done in Georgetown, where they actually talk about situations where patients will be targeted, because they it they strongly influenced the drug they'd be on. And they're an each in the case of that they were talking about there, they were talking about factors. So if you've worked in a large medical facility, like a level one trauma center, the light factors are incredibly expensive. I remember when I was working as a pharmacist about two years ago, a single dose of factor can be 15 $20,000. And you'd be giving them every two hours for three days. So a single hospitalization could be a million dollars. And if you could get if you get to influence which drug they're on, that's great. But at what point? Have you gone beyond that? So So the first question you start getting into is this idea of, are you providing kickbacks? Are you influencing the drugs that they will be on? And, of course, the point of marketing is to influence right, but but the question is, have you gone too far? And what is too far? I mean, if if they did go down that path? Isn't that just a successful marketing campaign? Or are you doing more than that? The second question you need to start thinking about is if you're doing offline, if you're actually engaging patients, and you're talking about the product, and you're asking them for input for a new indication, are you suddenly engaged in off label marketing. And if you are, is off label marketing, necessarily bad, the FDA has lost several court cases on whether you whether or not you can engage in affiliate marketing. So it goes to scope, it goes to how many people you're talking to, it goes to how much you're putting out, etc, etc, etc. So, so those become consideration, the next thing you start thinking about is privacy. So you start finding patients who are you have a certain rare disease state and you're going to engage with these patients. This is great, we're going to we're going to talk to them, we're going to ask them to help us and then we want to go back to them because we have more questions, or you have really interesting genetic data. Do I get to find you again? Or under GDPR? Or ccpa? Or HIPAA? just lose my information after you after use it? Or is it supposed to be de identified in the first place? So you never know who it was? Can I re identify you because you've got something that changes the world? So those are those are some initial considerations. Again, it starts getting more facts specific at that point.

Erica

Wow, so so a lot to unpack there. Dr. Shawn? Because I'm thinking this just explodes a couple of different questions right. So you know, when we talk about what is what is fair market value, compensation for patients time and you know, we definitely work with that, you know, from patient. I mean, even if you're looking at market research activities, which are different, which are absolutely different than really patient voice activities. But the other part of that is, you know, when you talk about off label and on label, so in pharma companies, there are very distinctive swimlanes between when you can Talk off label and what function area controls that part of the engagement. And when you can talk only to on label claim. So, you know, does this. So So as we look at the way pharmaceutical companies are structured, they're structured in the way that they are for a specific reason. And so what happens is, the organization becomes siloed, because there's so many things you can't necessarily share. You know, speaking from a patient support perspective, we can only talk to patient patients, specifically when clinical conviction is established. So once the product is determined by the healthcare provider, that that is the right treatment for the patient. However, we know there's a bunch of other steps that are happening before before we ever get to that point. And so I think the question is, does this really set form up to become or stay or remain more siloed? Or do we see the healthcare landscape in the regulatory space evolving to be a little bit more accepting of some of the practices we acknowledge needs to happen? I think it also speaks to the question if we are not engaging patients appropriately. And we are not making sure that we are capturing the representative voice that is living with those conditions. And so I bring this up. Because I think it is a lot of times hard to make sure that you are getting the representative sample of patients that are absolutely or actually living with a diagnosis, you tend to get the more resource patients you get, you tend to get the more vocal patients and the ones that are a little bit more, they're further along in their treatment journey. And so, you know, I think there is a cost, maybe it's the risk mitigation, right? There's a huge cost to not capturing that upfront. But then again, how do we do it? How do we manage the risk with making sure that we're always keeping the patient's perspective in mind? So I guess the question darsan is, what is an acceptable level of risk? And how do you go about trying to change or get everyone on board within an organization? So not only the commercial teams? Maybe these remains separate with the development, the research and development teams, but then you've got this core group of legal and compliance and regulatory experts that absolutely have to be part of that discussion. Right? So what, how do you move the needle on that door, Shawn, because I feel like it's a catch 22? Right.

Darshan

So there are a few different things that are happening. And again, like you said, a few few seconds ago, that question sort of explodes into so many other breakdown questions that we can get into. Let's Let's start with the basic assumption you have, which is, well, let's start with the reality and the assumption that goes with it. The reality is, you're 100%, right. pharma companies are siloed. pharma companies are siloed. So that you'd have exactly that Chinese wall, if you will, between commercial and for lack of a better term clinical, it could be called non commercial, he or whatever you wanna call it, the commercial and other. The, it's based on this idea that FDA is 100% against, or it's illegal to promote a product off label. So that's the entire basis of that assumption. Here's the facts. The FDA has lost six court cases on off label promotion. The idea there, including sales reps, or directly promoting a product off label. So the FDA put out, I think, a 64 page memo, saying, here are some ways we could potentially go after regulating off label speech. But we honestly don't know if it will survive strict scrutiny from the DOJ or from from judges. So to your, to your conversation about evolution and regulatory changes. Times are changing. The question is which one of those 64 methods and I think it's like 2364 pages, sometimes 23 methods? But what will FDA choose? And I'm like, Well, one of the things in there, for example, was this idea that, can you regulate speech about the cases that came from? Can you regulate speech if it's off label if it's inherently truthful, and if so why does the FDA have the authority Do that. So if you if you are for example, um, let's let's I'm thinking of Marinol. Oh, no, let's forget, it's been a couple more years in pharmacy. Let's take a let's take semaglutide, which is a really good one right now. So my blue card was approved for diabetes. Turns out the evidence suggests it is incredibly good for weight loss. Is it inherently wrong for the promotion offs? And just recently approved so we can talk about it that way? Isn't it inherently wrong to promote semaglutide? For off off label use? If the evidence suggests works for that, and there's there is what you would call substantial evidence to support that claim? The FDA is position going back five years would be yes, that is wrong, because you never got that approved. The courts position of the courts response to that would be so you're you're agreeing the information is right, you just don't think that they have come back come to you and ask you to approve that. The FDA is position but yes, that is exactly the problem. And going back five years, the court in a similar situation to that said, and I quote, the FDA places too high value on its own importance, the idea that we need to get your okay to say or do something, it's hard, it's inherently paternalistic, and we're good at the fact that you can then find someone billions of dollars because of a technical step of just coming to you. If the informations either either false or misleading. That's absolutely go after them. But but the, the idea that you can go after them, even if it's not false or misleading is a problem. So that's one part of that evolution, that's going to happen. The second question you asked is, what is an acceptable level of risk? And how do you go after it? And how do you sort of address that question? Um, I think most pharma companies, especially large pharma, at this moment, are not going to take the step of going let's let's start promoting off label that's just not in the DNA of pharma let's let's be very realistic. There are smaller medical device companies and smaller drug companies who talk about it. But it it's not the smartest thing in the world to play with. With something like that without having a true understanding of what the implications could be. But if you're if you are saying that I want to engage with patients in a way that is compliant in a way that is putting patients first, and these different roadblocks we have created internally are preventing that. I think I think it starts by, first of all, going back to your own public statements. What What do you mean, by being patient centric, it goes back to seeing what your company motto and company values are, to see what those terms include and look at. It goes back to seeing what the newest regs are saying, for example, one of the issues you raised with this idea of the representative voice, and the FDA just put out guidance, as we know that that talks about how do you get a representative voice? You go back and you look at the maps, which are basically the FDA his own internal training manuals, what did they look for? You go back and you look at CIA's corporate integrity agreements, to see what are companies being targeted for? And what are they saying? You go back to OIG letters? And you see what are these opinion letters saying about when is something considered to be okay, when is when is it not? You go back to obviously, the laws and the regulations themselves? And then you go, how does all this come together? And and, and this is all the the external stuff, that you go back to the patient and go, What do you want? What what would that ideal scenario look like? Here are the limitations I know of, but what am I trying to accomplish? To meet that's where you do that gap analysis. And once you get that gap analysis of what we, what we do, where we should be, and what we're allowed to do, which is the laws and all those things that we just discussed, that starts charting your company's individual path forward. Does that does that make sense?

Erica

Absolutely. Absolutely. And I think that this is a discussion that's probably ongoing with many pharmaceutical companies, right? And I think that it's a beautiful thing that we have this push and pull, right? So, you know, for from my perspective, you know, what seems like the right thing to do for patients. There's oftentimes a legal perspective or flavor to that that says, But wait a minute, you know, you have to be able to consider it. From this particular angle to that, you know, even though you see it as doing the right thing by patients, in some ways, it could be inadvertently doing something that you may not want to you, you may not want to be engaging, you know, with them in that particular way. So I think it's, you need to have that robust conversation with the experts within your organization. And I think you bring up some really interesting ways to really be able to assess the landscape and where the evolution of kind of the the legal and regulatory space is sitting at any particular moment. So this, this makes me think just because, you know, that really is the that really is the the gatekeeper. You know, they really tell us, you know, we look to our legal regulatory compliance folks to really be able to share out how we work with patients, how we operationalize certain things within the organization. And, you know, before I jump into that point, you brought up something else regarding, you know, whether having an off label discussion, or whether it's factual, you know, I think the question becomes Darshan, who is having that discussion? I don't know that I personally believe any sales or promotional individual within the organization should be having that conversation. Typically, it is your medical folks that are having those discussions. But interestingly enough, most often, at least historically, your medical folks aren't having those discussions with patients and caregivers, they're having those discussions with health care providers, and sometimes payers, depending on what area of the organization they fall. So I think, you know, the question comes one, who is having the conversation? And to Who are they having it with? is a big is a big question. And do we need to reevaluate scope and roles? Where do we keep them kind of the way that they're already aligned today? It sounds like some of that's even changing, we're starting to see, you know, this kind of expanse, expansion in scope, and really kind of pushing the elements as to who, you know, certain representatives within the organization speak with. So you know, that could be even a slight change to the historical model that we have seen with pharma in the past. But I think this is such a great question. So the question I want to pose to you and maybe frame it out in a little different way. So Dr. Shawn, let's say you have just been hired to head the compliance department within a big pharmaceutical company. And there's a huge appetite, to really start making sure that the organization is moving more into the patient centric space. By doing that, we're reevaluating roles across the organization. But let's to keep it simple the commercial side. So let's talk about once the product is already FDA approved, and it's ready to be launched into the market. What do you need to know? How can function areas better position themselves or be able to show what information do you need to hear or understand from their perspective to make you want to re evaluate or maybe assess a situation a little bit differently? So in another way, instead of looking at it from pharma doesn't do that? We don't do that. So it's an absolute No. What? What factors would you consider from different functionaries that would say, let's see if we can figure out a way to make that work? Yeah.

Darshan

It's actually a really, really well phrased question because it sort of brings a more airy, heady type of discussion into reality, what what would reality look like? So let's sort of explore the reality The truth is, a lot of what I said is theoretically true. But you put me as GC CHIEF COMPLIANCE OFFICER, if a large pharma small farmer, whatever my first thought would be, I don't want to put my neck out. I don't want to be first in line. I want to know, what have companies done and, and have sort of been blessed for doing that. So I'm currently a director of, of compliance for a group called factum AI, which is a lot of the big pharma companies and their medical affairs departments. And I'm helping sort of evaluate what the rules and stuff are. It's a volunteer position, but I'm just basically providing another voice if you will. The idea there being I'm surprised and impressed by the differing opinions of what people consider acceptable. So what would we think of as a monolith of no one's going to do this? No, people are doing things, you just have to go talk to them find out what they consider acceptable, then you find out what their logic is. So So when, when we say that we want to be more patient centric, let's define a patient centric means to us, let's and we discuss what that process would look like. Let's assume it's bringing in more patient voice. Okay, what are the risks associated with bringing in that patient voice? Is it that we're going to talk too much to them? Maybe. So let's keep that as one risk? Is it that we may end up having to pay them and that could be deemed an overpayment? Maybe let's keep that as a risk, is it that we're going to talk to them and promote the product in appropriately? That could be another risk. And we keep that in mind. So you identify the risks, you then go back to looking at your own training your own slps? And go What are we allowed to do already? Now it might be as a simple thing like fair market value? Well, you bring in fair market value experts and you go, what is a fair market value payment that is appropriate? And when is it appropriate, for example, you're bringing in patients to talk to you may be paying them an appropriate amount that could not be deemed to be sort of for the for the goal of influencing them. That's okay. Like you pay any other consultant, it's because that's what they are their consultants at the end of the day, but people don't work for free just because you ask them nicely, that's not okay. Okay, so that's the first thought. But we've got obviously bounced out, on the other hand, that same patient in the middle of a clinical trial, you'll never be able to get a clinic, get an IRB to approve something. If you're paying a patient, I'm making up numbers here, like 150 bucks an hour, that IRB is just going to go No, that's not okay. So, so reality is, you want to be patient centered, but you've got to recognize which bite of the howdy to an elephant one bite at a time, which bite you take first. So so you choose the bites are easier to take at that moment. So we talked about fair market value, then we talked about engaging with patients. Now you have a guidance out there. So you go back to the guidance. And you see, what does that guidance actually allow for? The guidance is, at the end of the day, the end of the day, the FDA is current thinking, now you might find that what you want to do is a step beyond where the guidance explains or the guidance hasn't really gotten into it. start engaging with the FDA, there are multiple ways to do that. One way is pick up the phone call talk to them. Now the problem is picking up the phone call and talking to them is it's not binding. So it was one dude at the FAA whose opinion was it's okay or it's not okay. So so maybe you want a more, more focused a more responsive, a more a more binding response. In those specific situations, you're going to do one of a few different things. One thing might be, you might file citizens petition. And you might call up the FDA and say, we need an opinion on this. And you've done that we've done that with the EMI wg the medical information Working Group they've done you had I think it was like at one point, it's off like 15 companies that became suddenly 35 companies who petitioned the FDA going, you have not given us clarification on these 10 issues. And there was a first citizen petition like 2012 there was one and there was like general counsel's and outside lawyers and stuff all coming together with with these questions. ftsi good to know, they file again in like 2015 or so. They said you have responded to those, we have some more questions, FDA knew that they were in business because these are these are not companies that are just throwing around money willy nilly. They have some backing, and it's not an individual company with an individual opinion. It's an industry wide representative. So in those situations, what you're doing is you're telling me These are real concerns, we need real answers. And you get the the FDA say we want you to commit that you want to go after us for a billion dollars if we do exactly what you want us to do, which is be more patient responsive. And and I think that's the next question. Next part of that discussion. You then take the next step and you go Okay, we've got both of those. What What else do we want to go after what we want to get a handle on sort of is the structure okay to do and I forget what three things I picked out. If you're looking at structure, you might go back and look at what the alleged opinion letters were. Because the Office of Inspector General puts out a bunch of opinion letters, and you'd go back to them and see which of them apply to pharma, which doesn't apply to clinical trials, let's say that's what you're trying to do, and say, in this specific scenario has has alleged to pine, because in the end, the FDA may have an opinion. But if it's not enforceable because guidance, Well, I'm glad you have an opinion, FDA, but you are willing to stand behind it because it's not a regulation, you by definition, are telling me it's a diamond, so it's non binding. So until you can bind yourself, I'm not bound by it either. But a YG. On the other hand, we'll actually back them up, and we'll actually sue you. So let's see what they've said. So So you look back at what that looks like, then you've got privacy issues. So you're gonna look at what OCI comes out and says, the Office of Civil Rights OCR, OCR is comes out and says, and and how does that play? So if people are thinking about HIPAA, which is great, but now you start doing studies that that involve bunches of patients of California or in Virginia, potentially, in Colorado, each of them have privacy implications that go along with it. So can I engage with patients? Like what was one of the questions we've talked about with with a company was what if we get what if we had a patient portal, and we gave them back the clinical study results so that they can access it? That sounds great and concept, and no one else has done it? But it's it's one of those things that I've seen discuss. That sounds great, and concept, but how do you actually know who the patient is? How do you give them back the results? And there are ways around and we've talked about those ways before? But the point is that that's a HIPAA consideration. And if it's not a HIPAA consideration, then you fall into ccpa. considerations. So so those are, those are the things you start thinking about. So let's say let's say those do happen. Okay, can I get a waiver? Because theoretically, waivers could work. And again, so you, you choose each chunk, each bite of the apple, go after it, and see how you can reduce the risks associated with that. So it's not going to be a I'm all for patient centricity. Let's just do blog. It's going to be what are the risks? Let's go after each risk individually. Is that responsive? Oh,

Erica

absolutely. And, you know, it makes me think of when we were talking about patient centric mindset change within an organization, you know, I think you have to also be deliberate about what changes you're essentially making. So you can't be great at everything, you have to look at a couple of key critical elements, or moments of truth within that patient journey to really be able to make sure that we're, we're precision targeting, where those pain points are, and taking the feedback we're hearing from them and being able to deliver and optimize that part of the the experience, and then we build on that. But you raise a really good question. And I think it's, it's also, am I hearing that ensuring that we have a risk mitigation strategy around that is essential also. So that has to always be part of the conversation, when we start to explore ways that we kind of, you know, stray a little bit from the way we've historically worked. You know, the bigger question to and maybe the overarching question is, and I still, you know, I think we are in a really good time period with with kind of this appetite and momentum to really not only appreciate the patients, patients should be involved, it's not really a question of whether they are, we absolutely have to make sure that we are capturing their insights and their needs and their perspectives in everything that we do. And what is what is the you know, the, the endgame here, right? So like, if we don't get that, right, what are the ramifications? And, you know, I look at it, you know, from a pharmaceutical company, we potentially stand to create a product that takes billions of dollars to get the market and time and resources and then really not nail it on the head because we didn't really capture what a patient really wanted. And we've seen examples of this in the past darsan, where, you know, we didn't incorporate that feedback early enough. So you know, when the product came to market, we find, huh, you know, maybe we didn't assess the appropriate endpoints that really matter to patients. So while we want to make sure we of course extend life, we also want to make sure we're extending quality of life and I think sometimes we're not now necessarily capturing that. So, you know, I hear there's really it looks like it's a, it's really a pendulum, maybe it's a balance, where we're looking at one we it's it's not a question, we have to do this. But we have to consider always, what are the risks in the way that we're looking to approach things. And I think you really lend that legal perspective that I certainly don't have. And thank goodness, we have people dedicated to looking at this specifically to really frame out to really frame out, you know, the data and the evidence that supports, hey, this is something we shouldn't move forward with, or this is something we can consider, but we may have to make a couple of tweaks along the way. So yeah, it's it's, it's fascinating. I think it's really fascinating. And you mentioned before, I can agree, you know, no pharmaceutical company wants to be a headline, you know, and what we have, but the most important thing is, you know, we risk not putting patients and caregivers needs first. And we have to be very considerate about how we frame those programs and initiatives out to make sure that that is always top of mind. And maybe that is that's that that's the key pillar to patient centricity is that we have to always approach what we're doing with that mindset first, but then also looking at it from the perspective, okay, we're looking to implement programs. But what kind of discussions need to happen before we go forward with that, again, we may need to be first because if everybody doesn't want to be first, then how do we move the needle in a space that really expands this a little bit better?

Darshan

100%? I agree with every single thing you said. We usually do these as you know, for about 1520 minutes, 41 minutes. So

Erica

it's been a great discussion, or Shawn, I should do

Darshan

more fun. Here's my question for you, Erica, how can people find you?

Erica

They can find me on LinkedIn. I have a personal email. It's Brahman, vru. Mmm, I TT period [email protected] But you can always catch me on LinkedIn. I'm on LinkedIn all the time.

Darshan

Perfect. And just to summarize what we spoke about, we actually ended up having a pretty broad conversation, we landed up talking about the the pharma and when we use the word pharma, we include medical devices, we include biologic companies, if you as well, but they have an appetite to engage at but but for the most part, people, companies have used a HCP and patient advisory group formulation to do that. But to do that, we really need to do a better job. Bringing in the voice of the patient. You talked about the BCG study with 3200 patients, asking them, what do you want from pharma, they came back with three distinct things, affordable access, clinical trial outcomes, representing the reality, if you will, and transparency, I'd love to get into each one of those that sounds like a conversation for next time for sure. Because I would argue that, that the police, the last one is more done than people think the transparency component. But the first two, I think we definitely have room to improve on. You talked about 21st Century Cures Act, he talked about patient focused drug development. But going back all the way in 2009. When you were talking about patient reported outcomes, and the implications there off, we talked a little bit about what laws regulations, issues can pop up, we talked about the anti kickback law of fair market value off label privacy, I didn't get a chance to really get into False Claims Act or sunshine act issues. But we really came back to this idea of the interest of the patient, and the quote unquote, Representative voice. The The other thing I probably should have talked a little bit more about but didn't get into was this idea that if you're going to engage with patients, probably make sure you have an agreement in place, probably make sure you have a confidentiality agreement in place, and the actual engagement agreement so that it's very clear that this is not a marketing outreach. But it is a consultative outreach where you're actually talking to patients on a one on one basis. You also we also got into this idea of how do you evaluate an acceptable level of risk? And who should be having these conversations with whom and we did a breakdown of how you evaluate risk, and how do you evaluate which direction the company should be going to be more patient centric. So we we spoke about both sides of it, how do you look forward? How do you identify what is quote unquote, patient centric, and we talked about everything from looking at company values, looking at the regulations, maps, the ESOP, etc, etc, etc. to see which direction we should go But also looking backwards to see what would stop us. And that includes 43, warning letters, maps, use of citizen petitions and the like. We also talked about how do you push that forward, and that was where we talked about the use of groups and the like, as well. Um, and we talked about the Chinese wall between commercial and research, and when do you have to, quote unquote, be consistent with the label? Did I miss anything? Erica?

Erica

No, I think that was great. And I'm glad you added the part about having the non disclosure. The consent, that is also a primary focal point of discussion is is patient consent.

Darshan

100%. This was a really fun switcheroo. So we've got to do this again. But any last parting words before we go?

Erica

No, this was great. It was a it was informational. And it was certainly a great learning experience for for me so thank you so much.

Darshan

Thank you will do this again. For those of you want to reach me. You can find me on Twitter darsan talks, or find me on my website at DarshanTalks calm. Thanks, everyone. Thank you, Erica.

Erica

Thank you.

Erica

This is the DarshanTalks podcast, regulatory guy, irregular podcast with hosts Dr. Shaun Kulkarni. You can find the show on twitter at DarshanTalks or the show's website at DarshanTalks.com

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