The Thin Line Between Advertising and Misbranding with Darshan Kulkarni

Darshan Kulkarni: 0:00

The result however, was that the summary was incorrect. And the person who was targeted in that summary is is suing the journalist for libel. So it's going to become more problematic than not and the people don't know how to use it. People who are reckless are going to line up with egg on their face. It reminds me of

Harsh Thakkar: 0:21

What's up everybody. This is Harsh from cultivate.com and you're listening to the life sciences 360 Podcast. <podcast intro> All right, we're live, Welcome to another episode of Life Sciences. 360. My guest today on the show is Darshan Kulkarni. He is the life sciences attorney, entrepreneur, educator and speaker and consults live sides clients and many other industry organizations. Under his firm Kulkarni law firm, welcome to the show Darshan.

Darshan Kulkarni: 0:58

Thank you for having me Harsh.

Harsh Thakkar: 0:59

Yeah, I've tried. Usually I look at people's profile, and I do research and they they pick one lane and you sort of are doing a lot of interesting things. And I can't imagine how busy you are. So thanks for taking time to come on the show. First question I want to ask you right out the gate is growing up, you know, whenever you were in college or school or thinking about your career, did you always think that you wanted to end up into like the legal side of things or whatever you're doing today? Was it planned? Or were there a turn of events in your career that led to where you are today?

Darshan Kulkarni: 1:38

I think there's a saying that says humans plan and God laughs Yeah. So I think it's one of those situations where I'm not, I thought that I would be the manufacturing world, I thought that I would be running a pharmaceutical company because my my father owned a pharmaceutical company, his father owned a fossil company, and generations before that we own pharmacies. So I've always been in the life sciences industry, I thought I would be more in those directions. However, there have been other ways to me that he was always influencing and impacting how we take care of people. And that's why I knew that I would land up having the education that I did. So those people who weren't aware who I would see my LinkedIn and to the extent you missed Harsh's discussion a little bit earlier, I have a doctorate in pharmacy, I have a master's in quality assurance, regulatory affairs, I'm an attorney, I also have a fellowship in air professional geriatric care. And I did a clerkship from the Eastern District of Pennsylvania. So I did all of those because all businesses it doesn't matter what business it is runs off of three major legs, the technical aspects of the business, the legal aspects of business and the business aspects of the business. I have the technical down with my doctor and pharmacy, I have the legal doubt with my JD business aspects. I've done business work since I was probably about 15. Everything from final accounting to the like, and then I realized that my education really made me more of a clinician than a person in the pharma industry. So I went back got a master's in quality assurance, regulatory affairs, I originally thought I would use all of that to be in manufacturing, which is great. I help clients in manufacturing even today, which is great, but I found that there are other ways to do that software's one services and another. So that's how I get and then teaching is a third. So I do all of those.

Harsh Thakkar: 3:23

So yeah, I did. Thanks for bringing up teaching. So I did see on your profile that you are you're teaching at Drexel law school right now.

Darshan Kulkarni: 3:32

I teach in Drexel School of Law in their masters and jurisprudence program. I also used to teach to last year at the University of the sciences, formerly called the Philadelphia College of Pharmacy. I taught in their biomedical writing program for 10 something years

Harsh Thakkar: 3:47

USIP University of Sciences in Philly, okay. Yeah, okay.

Darshan Kulkarni: 3:51

Yeah. And that got merged into St. Joe's recently. So the school itself doesn't exist in the same way anymore. But I was excited to do that. And I've taught at numerous other universities, everything from Temple pharmacy to Jefferson Medical School to I think nursing schools and law schools and blah, blah, blah. So there have been a few.

Harsh Thakkar: 4:11

So how I have to ask you this, right, like with, I know, there's obviously a lot of conversations going on on social media about ChatGPT. And its role in education, or just even teaching in general and how it is done today versus how when I went into master's program, or even I went to school in India, so even in some cases, the concept of having a calculator in a math class was not considered fair. Right now you're talking about sophisticated tools like ChatGPT. So how, from when you were back in school, and now that you are an educator, what have you seen? How is the education system sort of changed? Have you noticed any takeaways?

Darshan Kulkarni: 4:56

So I went to schools just like you did in India, so I actually He was using things like log tables and anti log tables. And I don't know if you remember that I still have PTSD from some of those conversations and trying to remember how to use those. But I have always been a believer that you use the tools that you have, not the tools that people like to theoretically think you don't have. I remember teachers in school telling us, oh, you'll never have a have a calculator by your side. And I go, I'm never going to have a log table on my side, either, I'm more likely to have a calculator than have a log table by my side. So from that perspective, I'm a huge fan of using tools in ways that are unexpected. For example, I've actually conducted classes where my students would meet me and we do Twitter chats. So the idea was that I would talk about an issue, the students would interact with the conversation. But I had, I had about 6000 people following me on Twitter that time, and you'd get these world leaders responding to the conversation. So they weren't just leading learning from me, they were learning from these world leaders who disagree with me, which is exactly where you want to be. Right? Don't want to be learning in a sterile environment, you want to be learning, you want you want to get your basics down, but then be comfortable having a conversation in a place where people haven't fully thought out those ideas. And that conversation leads to wonderful educational experiences. I have students right now who this past semester, we've all been trying to figure out how AI is going to work. And that we know, I know, students, I know teachers who are saying, I refuse to let you use AI and I go, I know, first of all, I don't really believe the hype around, you can catch the AI write ups, I read somewhere on Reddit that oh, you can tell when something that AI right up versus what it isn't, I'm going low chance I can tell. The only real difference. Lanza being for me at least, the idea that number one AI seems to make up information, which is not true. And number two, the AI information for the most part so far, has been very, very generic and general, something like a 10th grader would write. And I would expect someone who knows what they're talking about, to have a better understanding of better write up. So that to me, is the big difference and the distinction. However, I think overall, I encourage my students to use AI right now i i wonder if it'll change in the future, I want to make sure that they take something from the experience. But unless there's an overriding reason, I don't want to take away the tools they will more likely than not use when they actually are in a working environment, because my students are all professionals most part.

Harsh Thakkar: 7:32

Yep. Yeah, I mean, I agree with you. So AI is from from where I can see it. It's a great tool for brainstorming or ideation, if you're just going to use it as a mechanism for putting in something and copy pasting the output. That's not a smart way to use AI. But if you're a writer, or if you're a consultant, or if you are in a Master's or PhD program, or you want to write a case study, or you want to write an essay, you can definitely use AI to come up with an outline or 20 different ideas, and then maybe a first draft, but then you have to actually put something into it right to make it more like you said, you know, otherwise, it's just going to be generic. Is somebody going to be able to tell whether you wrote it or AI wrote it? Maybe not. But then it's also doesn't have the personal touch to it. The humor, the emotion, the feeling? What what makes that writing better? Otherwise, it's just all works, you know?

Darshan Kulkarni: 8:33

Yeah. Yeah. I mean, you talk about something that got raised recently, or there were two separate cases where lawyers didn't check the work that they did. They just got AI to write the briefs. And then the AI made up a whole bunch of citations. Yep. And the judges are like, we can use this and the lawyers are being cited not only publicly where there, it's kind of humiliating. But also, I imagine there will be some level of these lawyers being targeted for disciplinary action as well. Additionally, I think there was also the situation of a journalist who used this AI tool to summarize an article and didn't do the research associated with it. The result, however, was that the summary was was incorrect. And the person who was targeted in that summary is, is suing the journalist for libel. So it's it's going to become more problematic than not the people don't know how to use it. People who are reckless, are going to line up with egg on their face. It reminds me of a couple of months ago, I want to say during COVID. And one of my favorite things that came out of that was this lawyer. I apparently follow a lot of lawyer stuff, obviously. But this lawyer who attended a conference with the judge, and his face was was a cat. And he's, he's like Judge, I can assure you I'm not a cat. He's like I picked judicial notice of this but my point is don't know how to use the tool. Don't use it first. figure out how to use the tool right before you start using it and more professional settings.

Harsh Thakkar: 10:03

Yeah, agreed, agreed, yeah, it's gonna evolve. There's already every week, every month, there's new ways. And I'm, I don't use it a lot. But I'm, I'm shocked at how good it is when when you try to use it. So like one example that I can think of which you might be able to relate a little bit is. So I had a operating agreement for my consulting business. And because it's a single member company, there's nobody else like, I'm the owner, I review and I update whenever I want to. So I was working with a lawyer, and you know, we're talking, I don't want to go too much into detail. We're talking about stuff like, Who do you want to give this to in? In cases, like if you die, or something happens to you? Like, do you have a trust? Like, how do you protect these assets, you want to change these language? So this lawyer told me like, Hey, here's the three sections that you need to change. And they need to provide some guidance around a, b, and c, I literally took that I put it into ChatGPT. And it gave me exact verbiage of how to put it. And I send it back to her and she was like, Who gave you this? Right? She said, This is not perfect. But this is really, really good. Where did he get this from? And I told her, I use ChatGPT. She's like, this is insane.

Darshan Kulkarni: 11:27

Yeah, I mean, I, I'll be honest, like lawyers use it all the time. Yeah. I mean, I've used it to improve some of my contracts the the piece, however, there, there are other elements that eventually will probably get improved. But for example, I think there's an element of let's say, you put an A clause into your contract, the big issue you have is, how does that does that cause conflict with something else you have in the contract? Right. And most people aren't thinking of that most people are going, this is a standalone statement. And no, it's not. It's rarely a standalone statement. It can be. But have you thought through, for example, a simple thing, like I'm gonna use Pennsylvania as my jurisdiction. Right? Why? Why Pennsylvania? Or why not? Well, have you considered the fact that your business operates out of Texas? Why would you choose Pennsylvania? Well, we choose Delaware. Well, Delaware has better corporate laws, you choose Delaware? Because if your business it makes more sense, you might choose Delaware, because they just have better judges, we're more use to corporate oversight. Well, what why not Wyoming? Well, Wyoming has other issues to consider. But they become advantageous as well. And you get get into that, like real estate, for example, where you can have blind trust, etc. But that's the point. I think, in the end, context is key. Understanding how you're going to use the technology to bring it all together. But it's it doesn't remove you doesn't divorce you from understanding your own duties. It just speeds up your referencing process and helps you clean up get some initial jump off points, which is great.

Harsh Thakkar: 12:59

Yeah. agreed. So I saw last week on LinkedIn, or for the last two weeks, you've been going on lots of events and speaking and talk shows, I think, last week, you were at an event talking about advertising compliance. So what what is it that you do? Are you like reviewing ads that life science companies put out? Or what are you what are you doing when you say advertising compliance?

Darshan Kulkarni: 13:23

So first of all, I was at two separate events last week, gave four talks last week on advertising compliance. So it was a busy week. But so let's start from the basics, as we all know, doesn't matter what you do in the life sciences, the point of a drug device or a biologics company is to make sure that your product meets two criteria and doesn't meet two criteria. The two criteria you must meet is that your product is safe and efficacious. And it is not adulterated or misbranded. So safe and efficacious is usually based on the testing you're doing. And adulterated misbranded is really how you're going to put the product out. Drug advertising is part of the MS branding component, generally speaking. So when you're talking about ms branding, there are several different ways to get into misbranding. But the one piece that we're talking about here is the difference between label and labeling. So most people think of those two words as being the same exact thing and they are not

Harsh Thakkar: 14:26

the same thing. I don't know the difference,

Darshan Kulkarni: 14:29

right? Most people think label is whatever is attached to the to the bottle, and that's great. That's that's your labeling as well. No, the label is what's attached to your bottle. Labeling, according to a Supreme Court decision is anything that accompanies the bottle. So what does that actually mean? What does the word accompany mean? So if you give a book along with your bottle, that's part of the labeling. Your sales rep talks about your drug. When you give the drug to someone. That's part of the labeling. You have a drug that goes out. That's part of the labeling. So my job is to make sure in that specific context, my job is to make sure that you are meeting labeling requirements as well. So what does that really look like that can come in several different flavors, one might be sure the FDA rules on what your advertisement can say. So it might just be a print ad, in which case, you need to have what's called fair balance for certain types of products. So you don't really need fair balance in the same sense for for a device as you do for drugs. But fair balance is one requirements, which means that your claims and your contraindications and the adverse events and stuff need to be appropriately balanced, or you need to disclose them. That's why you see those drug ads which say, this drug can be used to cure everything, like, sure athlete's foot, but here are all the problems associated with it. That's because the fair bouts, on the other hand, it also extends into things like clinical trials. So for example, if you have a doctor who's going to be speaking for you is, is he or she meeting your goals around fair balance? Is he a representative of the company? In that case, you look at FDA FTC issues. So it's not just FDA, that point, sometimes you might be involved from a compliance from a promotional perspective, in the area of a ship with this anti kickback False Claims Act violations. And those have a whole bunch of areas that come under question that come under pressure. So you might have a situation, for example, where you are telling the doctor that you know what we're going to do this clinical trial, we want you to be the principal investigator on it. That sounds great as a concept. But if the clinical trial involves 10 patients, this doctor is responsible for enrolling five. And if he doesn't enroll five, it doesn't matter if you pay the doctor$10,000. Well, that's not really for clinical research at that point. That's just to give a payment of $10,000. To a doctor, you're hiding it as a clinical research program. And there have been situations involved with promotional compliance that have popped up in that area. There's something called beneficiary inducements. So for example, you might have, you might go to a patient, and you might tell the patient, you know what, I would love for you to use this product bill, Medicare and Medicaid, your pharmacist, your doctor will build Medicare and Medicaid. And here's $10,000, you can intern at our company, well, that might wind up being problematic. And companies need to be considering that as they hire people. So all of these become issues in promotion appliance. For example, let's say you're trying to enroll a patient into your clinical trial. What can you say about your drug? When you tell them that we want you to participate in this clinical trial? At what point Have you gone from we want you to be part of this clinical trial to this drug will improve your care will improve your disease? Is that promotional? At that point? Can you say something promotional about an investigational drug, etc, etc, etc.

Harsh Thakkar: 17:58

So when you're looking at this advertising compliance, are you strictly focused on like the US market? Or have you had any clients that, let's say are advertising in us, but also in Europe? Then would you also advise them how to change the language or the labeling for like a different region?

Darshan Kulkarni: 18:19

So I'm born in Pennsylvania, New Jersey, so I do US law. Okay, so I stick to the US law, however, I've been asked to help in issues like clinical research, transparency issues, which is more of a global issue. So you're in Canada and some of these other countries, I've been asked to advise on those, but usually 99% of time, I'm trying to stay within the US. Okay.

Harsh Thakkar: 18:43

And then another question, as you were mentioning about the labeling that popped up in my head, is there a lot of instances where let's say you have, you know, a company that is, you know, that their product is not a drug device or biologic, it's maybe food or nutraceuticals. And they think it's food but you know, it has, it needs to meet certain requirements for drugs or biologics. So, do you also advise those kinds of clients to say, Hey, you're telling that this is a nutraceutical or food, but this, there is some components here where you need to, you know, also follow Drug Regulations, or because you're Missaying what your product actually is?

Darshan Kulkarni: 19:30

Yeah, so the difference between a food and a drug is not the product itself. It's the claims you make about the product. So if you are saying that, and there are examples of this, so for example, take fish oil. Fish oil has been available for years as a neutral as a nutraceutical. But it was approved by Amarin and also has a drug version of it. And the claims you can make as a drug approval are very different from the same claim the same product can make in the in the food world. Now Amarin would probably argue that it's not the same product, because there's a different level of testing, there's a different level of manufacturing requirements that are being met. But, but the point being, that there are these are deemed to be, it's not the product itself. It's the, it's the claims you make along with it. So for example, you can make something like will reduce your risk of heart attacks by 4% as a food, but you might be able to do that as a drug. So there's structure function claims, etc, which, depending if you're on whether you're a drug or a device you can make versus foods.

Harsh Thakkar: 20:45

Yeah, another example that came to mind is obviously, you know, something like a weight loss pill, right. So that could also be borderline, it could be a drug or something that, you know, hey, this will increase your metabolic ism or whatever, what have you, and then you will end up losing weight. But you can't really say you should use this, you know, as as a, you know, for as a medical, you know, statement that you will lose weight, right?

Darshan Kulkarni: 21:10

So, it's a decent example that pops up often enough. So you can say something theoretically, and again, you'd have to do, it would be product specific. But just to be clear, this is not legal advice. This is just general conversations, but and for educational reasons only. But the you might be able to say something that increases metabolism, that doesn't really mean anything. But you say will cause weight loss, that's potentially a violation. Because Because that's a disease claim. So anything that's used to cure, treat, prevent, mitigate a disease state will be a drug. That's the definition according the Food, Drug and Cosmetic Act of a drug. So are you doing any of those? If not, maybe you can get away with so you've got to be careful about what you say and what you don't say.

Harsh Thakkar: 22:01

Interesting? Yeah, that this is this has always been, you know, advertising, I don't know much about this area. So I really liked this last five or seven minutes of your insights on this topic, I want to jump into another topic that I come across a lot in my consulting experience, which is, you know, dealing with regulatory inspections, or dealing with FDA 483 is now I work in mostly in software and technology compliance side of things. So I've been with companies who were preparing for regulatory inspection, I've also worked as a consultant for companies who got a 483. But from your lens, you know, because you're in the legal side of things, for any startup, or a company that's, that has just, you know, got their first 483. What advice do you have for them to even? How do I say it process the fact that they received a 483? Before they think about responding, because there's so many startups in the last 10 years, who've, you know, come out in personalized medicine cell and gene therapy, a lot of areas. So what what is your take on that?

Darshan Kulkarni: 23:22

So I think, if you have a 483, or the like, whether it's a title, Untitled letter of any kind, whether it's a warning letter, the key piece is first of all, don't judge. So I think the issue of a 483 starts before the 483 is issued, you've got to start from when 483 is not a it's a result. It's a preventable result. So you've got to start off by going, what of the which of these issues really needs to be addressed? How should it be addressed? So for example, do you have a policy on how to deal with the FDA walking through your door? Number two, what documents are you going to provide to the FDA? Not all documents need to be produced? Just because the FDA asked for it doesn't mean that you use it? For example, does the FDA have any reason to look at your financial numbers? The FDA is a quality organization, their job is to make sure that you're they're looking at the quality of your processes, and appropriately so we want to make sure that patients are healthy. Or you're only providing safe and efficacious products. How does me giving you my numbers telling you how much I paid? My consultants addressed that question at all? So those types of issues? Can they take photographs within your institution? Do you have trade secrets to worry about? For example, if I'm an FDA inspector, am I allowed to go in and take photographs in a Coca Cola and try to put together their formula of how they make things? Well, no, that will be a violation of the Trade Secrets Act. I don't care whether whether you're the FDA or not. So from My perspective, I'm not coming at it from a quality perspective, I'm coming at it from legal perspective who's informed by quality. So to me in my world, the FDA is just another player who's doing its duty to make sure that patients are being appropriately protected. And that's appropriate. But my job is to protect my client as well. And the FDA has his own lawyers to help protect them and protect people, which is great. And I think we're all collaboratively working to help protect people. But I think you need to have clear policies in place. The next question, so once you have clear policies, who's going to be in the room? So are you going if you have a 483 that might get issued? If you have an inspection going on? Do you put the chatterbox in the room while the FDA is taking its notes? Now, you probably don't want the chatterbox in that room. You want someone who's going to take notes. Why? Because the FDA might ask you a question, this guy who doesn't know anything, is suddenly telling things that they probably shouldn't be speaking about. So is there a spokesman? Should that spokesman be the CEO? Maybe maybe not? Should the spokesman be the lawyer? Maybe maybe not. Sometimes I just like someone who's well versed and just having a having a conversation? That becomes a question. So you might have the actual place where you do the inspection, review the findings. And you might have a separate location where you are actually responding to the 483. And that might be if the FDA says, give me the Batch Records from XYZ period, it might make sense to go Could you tell me a little bit more about what you're looking for? Sure, we're looking for this. So this way, you can narrow down the scope of what you're giving to the FDA, you don't want to be in a situation where you're just giving out documents. And the FDA then is looking for x, but you give them a b and c and now they're looking at a b and c. Yeah. So that's just in the preparation in the writing the next time and you can't always prevent everything. And that's not the point of this. The point is, you are limiting. You are responding to the FDA appropriately to the question that they're asking you, it's important to ask the scope of what you're asking. So now the FDA has come in, they've done the inspection, then you've got to decide how you respond to the findings of the 483. What are the key things people do is that people get worried and they should be worried if the FDA has pointed out some flaws, but not worried so that you respond inappropriately. So you'll get people who come in and say, Oh, the FDA had this problem. We're gonna fix things, FDA, everything will be ready next week. Mostly people aren't here. They're on vacation. It's summer. They're at a conference, you can do it by next week. Why are you making promises you can't keep? So what the FDA wants. And this is why the FDA, I like to say the the FDA will give you enough news to hang yourself. They're not asking you, they won't tell you what to do, they will tell you what do you want to do, because you know your processes. And as a result of that, they will hold you to your own promises. So look at what is a reasonable promise to make. If you're going to train a 500 person staff, you're probably not going to be able to do it by next week. Two person staff, maybe three person staff maybe. But what even that I would go, Well, how are you going to get that together? You've got to get your policies together. You've got to reconcile those policies with everything else you have. You've got to get buy in from appropriate stakeholders. Can you do all of that within a week? And then train everyone? And then record that you've done the training associated with it? And then, and that's just the corrective action? How are you going to do the preventative action, this is one of the key pieces, people seem to forget this all the time. It's cat paw. So corrective action and preventive action. FDA says you'll have to test you outside the fridge. People said, I've had this happen, which is why I say this. Oh, we took the test too, and put it back in the fridge. Yeah, that's not that's a corrective action. What's the preventative action for a preventative action might be something as simple as we make sure that all tests use or pulled out or logged in. And then we have a system that beeps if you haven't logged it back out. If you haven't put it back in. Or the idea being that you need to have a clear program to make sure that you have appropriate corrective and preventative actions. But again, you're seeing this from the perspective of Well, what did the FDA actually notice that the FDA actually noticed? The, the syringe that's that's out or the test tube that's out? Is that what they're concerned about? Or did they come in because they were worried about the lack of cleanliness in your facility? And now you're talking about this, this test you when they didn't even ask about that you're suddenly blabbing on because you're nervous about that. Right?

Harsh Thakkar: 29:48

Right. Yeah, it's definitely an area where there isn't like a clear cut, answer, right. And many other cases, you have sort of a blueprint of hey, here's how you act. for, let's say, whether it's clinical trials or whether it's manufacturing GMP GLP. But this area of dealing with an inspection, responding, there's never, you can't I mean, yes, there are some parts that are common across all inspections. But every inspection has its own unique story. Because the people are different, the company is different their history or nonexistence of a history, if it's a new company, with the FDA, there's so many moving parts that it's hard to say do X, Y, and Z, and you will be good. Because you really have to think in that moment, what's the right decision, like you walk through different examples? So I myself had been nervous many times, you know, dealing with agency, and, and I'm sure many other people who are immensely talented in their jobs, might unintentionally, you know, say something that they shouldn't have said, or might make a reckless decision or a promise like, so it's always an area that I dislike, I always lose sleep every time I hear like, oh, we have we have an inspection or we have this agency audit that's happening. So thanks for that. Absolutely.

Darshan Kulkarni: 31:15

I think it's also important to not just see things from the perspective of one agency. So for example, I think you mentioned that you're in looking at it questions, right? And you might have it findings. I come out of the perspective, well, what agencies looking at why, why are we worried? For example, you might be thinking about part 11 compliance, because that's what the FDA is thinking about? Yep. But the fact is that part 11 compliance is just the FDA, if you're talking about patient privacy, which is the case in a lot of like clinical trial documentation. Now that point, you're thinking of OCR, Office of Civil Rights, because they're looking at HIPAA, well, you've got HIPAA going on, you've got part 11 compliance going on. There's also the FTC that is looking at the question of privacy, then you've got state laws, you've got CCPA, BDPA, you've got all these different states with their own version, their own flavor. And then if you've started going internationally, about GDPR, how does all of this reconcile in a way that makes sense for your company, there was a recent law, I want to say Montana, but I could be wrong, one of the states came out recently. And they said, we're trying to fill in the gaps between what all these different states are saying. So we want to go after things that everyone else is missing. So there are there will have to eventually be some level of reconciliation, because there are so many different versions of this. But I've had sponsors, I've had pharmaceutical companies, I've had medical device companies take the position that we're not subject to HIPAA. Well, here's a really easy question for you. Why are you not subject to HIPAA? Well, because we don't collect patient data. So you don't collect patient data. But do you own that patient's data? Oh, yes, we own the patient's data. So you own data you don't collect? Yeah, so how does that work? So these are the conversations you get into?

Harsh Thakkar: 32:58

What do you so this is something I don't ask people a lot, and I should, because every person has a really amazing answer for this. What do you love about your your role, like, you know, working with companies working with clients? And what is kind of one thing that you don't like that you someday wake up and think, why why did I choose this career?

Darshan Kulkarni: 33:22

I think I'm very, very lucky. I grew up in a time when I thought that. I mean, I spent the first 20 years as a clinician, I help patients every single day, I've been in a situation where I've, I think it was like $12 and 12 medications, and each medication costs $12, which medication should I take? And that was horrible as a pharmacist, to have to choose what is right for the patient? I'm lucky in that I think the industry makes an effort to say, You know what, if you can't afford the medication reach out to us, we have programs that will help you. So I think that the tension of the industry is good. And I'm lucky to be part of that. I think there are downsides to that, for example, I think people do get greedy. I think the cost of drugs is incredibly high. And pretending otherwise is silly. I'm not getting into the value of the of the drugs when I'm talking with the cost. And I think that there are efforts being made to address that. And there are lawsuits going on with to those efforts being made to address that, I think, was it I don't I can't remember their two drug companies right now suing CMS for its efforts right now. So those would be my the parts if you're lucky about. I think from an entrepreneurial perspective, I think I one of the best parts about doing what I do is you have some really big highs and really low lows. I agree. And those are scary. I think Harsh. You actually had a post yesterday before where you talked about in April, you're going why am I doing this and today you sign the contract with a large pharma company, top 24 My company, and that that makes me kind of go, yeah, that's my experience like you're going, what am I doing? Every time a new client signs are excited every time that client leaves, you're terrified. And that cycle just keeps repeating.

Harsh Thakkar: 35:12

Yep, yep. Yeah, it's definitely a great industry to work in. I don't know what I would be doing otherwise, if I if I wasn't in pharma, but you are right, you know, there are some weeks and months where it's literally like, I, I don't even make an effort to get new projects, or I don't even make an effort to hire people. But it suddenly feels like seven clients want me to do seven different things. And then all of a sudden, five people appear that I can bring on the team. So it's like, it's never planned. It's not like, oh, in July, I'm going to have three new clients, but it just happened so fast, that I almost have to be ready. Because tomorrow, it could, like you said, it could be either or I could lose five clients next month, or there could be five more that come in. And it's just that thrill of sometimes, you know, with personal, you know, obviously, I have a toddler at home. So, being a father being spending time with him. And also being there for my family. My family lives in India. So challenges to you know, meet with them and then running a business. It's like, I can't drop a ball, right. I have to hold all at the same time. And for me, that's that's one of the challenges. Yeah.

Darshan Kulkarni: 36:31

Yeah. But it's that's the fun of it. Yeah, yeah, it is.

Harsh Thakkar: 36:35

Yeah, this has been a great conversation. I have a few closing questions for you. Any book recommendations? I outside? I know, you read a lot of regulations and documents from clients, but when you're not reading them, do you have any books to disconnect? of the life sciences?

Darshan Kulkarni: 36:52

I should have thought of this question. I'm sorry. Let me look at my audible list. But I don't read books anymore. Oh, no. read so many books. I listened to so many books, and I read so many regulations, I avoid reading books, which is a terrible thing to admit. But let's see, what did I finish recently. So this is gonna sound terrible. And this? Well, I don't think sounds that terrible. There's a book called Jaya. So if you grew up in India, you've all heard of heard of the story of the Mahabharata, which is the story of good over evil. It's sort of it's sort of like a Marvel movie, but not quite yet. But I think that it's a great story. But then about 2013 2014, I landed up taking two months off and backpacking through a piece of the world. So I went through the east coast of the world. So I did Japan, Korea, Vietnam, Laos, Singapore, Australia, and someone had me fly to Berlin and give a talk there. And when I was doing that, what I discovered is that the Mahabharat, even though it originated in India, as we understand it, now, there are all these different stories in Vietnam, and in Laos. And in Thailand. I was really cool to understand that these stories have other other chapters that have never read. And I felt like Jaya brought all those stories together. So for me, that was a really interesting book. This was one of my favorite ones to read. And I try to go back to it every so often. So it starts with components. I didn't even realize what part of the Mahabharata things like another mentee and stuff, which, again, for those people who have no idea what I'm talking about, I'm sorry, I'm sorry, I lost you. But it's kind of interesting to see them all connect together.

Harsh Thakkar: 38:33

Interesting. Yeah, I've read obviously, even growing up in India, I read bits and pieces of it when I was in teenager and in school, but I don't remember much of it. So I don't want to see I want to I don't want to misspeak and offend anyone that knows my heart. So but yeah, it's Listen, this has been really amazing conversation. I know you also host a Podcast, right? Do you want to talk about that? Just so if anybody wants to hear more about you, or the guests that you chat with? You want to put a plug for that?

Darshan Kulkarni: 39:04

Absolutely. Thank you for letting me do that. So I host a Podcast called the darshan talks Podcast. And it's at this point, it's only on YouTube and interviews with people impacted Life Sciences. But I've been focusing more and more specifically on people who are in who impact legal regulatory compliance. So I have lawyers, I've had bio ethicist. I've had CEOs, I've had regulators there are probably about 650 interviews so far, probably on there. So you might find it interesting if that is your jam.

Harsh Thakkar: 39:40

Interesting. I've already checked out a few episodes. I think that's how I first heard about you because you were doing a LinkedIn live stream and you were talking to somebody about AI and I saw the notification I started listening to it. So yeah, I've listened to a few of those. So where can people find you after the show if they want to connect with you or work with you?

Darshan Kulkarni: 40:00

So you can always find me on LinkedIn. I'm Darshan Kulkarni. I don't think there are too many of me but there are a few. Yeah, I'm an attorney based in Philadelphia. You can just go to my website Kulkarni law firm.com Or you can find me on Twitter at Kulkarni law firm. And I'd love to hear from you. Or you can actually reach me, you can email me Darshan@Kulkarnilawfirm.com. That's KULKARNI law firm.com.

Harsh Thakkar: 40:27

That's, that's great. So and any closing thoughts before we wrap this up? I love this conversation today.

Darshan Kulkarni: 40:33

This was a great conversation. Thank you for having me on. I appreciate your help. I appreciate you putting this message out and I'm excited to see what what more you have as we continue.

Harsh Thakkar: 40:44

Thanks, Darshan. Thank you so much for listening. I hope you enjoyed today's episode. Check out the show notes in the description for a full episode summary with all the important links. Share this with a friend on social media and leave us a review on Apple podcasts, Spotify, or wherever you listen to your favorite Podcast.