[00:00:16] Speaker A: Welcome to the latest episode of the Few and Far between podcast. I'm your host, Chris O'Brien. As the biotech industry continues to grow, more competitive companies are looking for cutting edge tools that provide better perspectives and insight into clinical trials. My guest today has identified that solution as competitive intelligence, a strategy for trial tracking and reporting emerging trends that inform upcoming clinical studies and ensure they remain clinically meaningful and relevant in the market. Eileen Faucher is the founder of Brass Tacks Insights, a company that leverages subject matter, expertise, AI and streamlined processes to deliver competitive intelligence that distills all available study information into concise, detailed reports. On today's episode, Eileen and I discuss the unique approach of competitive intelligence as well as the importance of regulations such as the Sunshine act law. We'll also examine why diversity matters in clinical research and how individuals can locate resources to learn more about upcoming and current clinical trials. I hope you enjoy this episode and be sure to check out the show notes on your social and streaming platforms to learn more about competitive intelligence and other episode content. Okay, well, let's start the podcast.
Eileen, welcome to Few and Far Between.
[00:01:28] Speaker B: Chris, great to be here.
[00:01:29] Speaker A: It's a pleasure. I've been looking forward to this conversation. I have a bunch of questions, but maybe we can start with a little bit of framing about what competitive intelligence is in the pharma world.
[00:01:38] Speaker B: So competitive intelligence is a way of tracking emerging trends and it's super fun. If you like mystery novels or puzzles and you just like to take disparate pieces of information from different sources and connect the dots, I love it.
[00:01:53] Speaker A: So if you're a biologist who reads mysteries in your free time, this might be up your street.
[00:01:57] Speaker B: Exactly, exactly. You can learn a lot about a company's strategy by what they share in the public domain. If you're willing to put in some time and track that, fantastic.
[00:02:07] Speaker A: How different is, let's say, the pronouncement that you might hear in a quarterly earnings report or something like that. It's very high level. From the CEO to the specific kind of stuff that you track or find, I assume there are gaps that you're identifying there or additional context. Talk a little about that.
[00:02:22] Speaker B: I mean, great question. There really shouldn't be gaps, right? That would be a flag and the street would notice that and companies wouldn't be doing good business. But there are kind of leading indicators of change and that is what we're able to track. So we can if Companies quietly on ClinicalTrials.gov are changing their trial design, maybe they change their inclusion exclusion criteria, which is going to impact their label, which will impact how they enter the standard of care when they launch. You know, all of that can happen before some official announcements, but we can sort of stay abreast of where we see things headed and tell that story before it officially breaks.
[00:03:04] Speaker A: So when you detect something like that, a change like that, can that lead to like a change in the strategy for the label they're pursuing? Trial design? Talk a little bit about that, if you would.
[00:03:13] Speaker B: Yeah, it definitely does. And that's why it's fun because in oncology, you know, the guidelines get updated multiple times a year. There's so many accelerated pathways to approval. It's a really dynamic space. As an example oncology, there's a lot of smart people that we work with and we're basically thought partners. They could do it themselves if they had a lot of time. It just takes time. And so to save them that time so they can focus on their job, you know, focus on getting their therapy over the line, talking to the fda, running their programs, whatever it is, they'll hire us to, you know, take the 30,000 foot view of the landscape and help them understand what will be clinically meaningful when they're planning to launch their drug.
[00:03:56] Speaker A: I guess if you're working with outdated information on that stuff, you're putting tens of millions of dollars, maybe more, at risk.
[00:04:02] Speaker B: Yeah, it's crazy. It's so hard to do though, right? Registrational study takes time. Even if you do have a surrogate endpoint you can use and get accelerated approval, it's still going to take like a year, two years, three years maybe. And so in that time, if the standard of care changes and other therapies launch, it's possible, even if the study's positive, that it won't be clinically meaningful. So that's why you kind of have to multitask and keep track of where things are headed. And if everything is combination therapy by the time you're going to get to market, then you want to add that backbone to your study.
[00:04:36] Speaker A: Now, are you working primarily with like new product planning teams or who are the primary partners?
[00:04:42] Speaker B: Yeah, yeah, yeah. Yes, we are primarily working on the earlier, you know, clinical development side, which is technically the non promotional space. Right. So it's illegal to promote a therapy that hasn't been approved, so companies can't make any claims. But there are perceptions that stakeholders develop, physicians, patients, you know, about things in development. And so we just want stay grounded to what people are saying, what they're thinking, thinking what they think is clinically Meaningful and keep our clients grounded to that too, so that everyone kind of has a feel for where it's headed.
[00:05:17] Speaker A: So our audience includes lots of entrepreneurs, biotech, either CEOs or aspiring CEOs or CMOs, folks like that. If people don't have experience with CI, I'm sure sometimes you're selling in why this is important. Or do you find mostly you're working with companies that this is sort of a cost of doing business. They know they have to stay on top of this stuff.
[00:05:37] Speaker B: What's so fun about doing it as a consultant is to see how it's valued differently depending on the organization. You know, it's all about how much they value strategic planning. Some companies really value it. They'll invest in workshops, scenario planning, exercises, deep dives. And some companies feel like they don't need all that. And they don't necessarily. Not saying I agree or disagree. I think you can do a lot with. You just have a few key pieces of information to inform strategy. So officially, CI should be sort of informing things like what target should we choose? Should we pick this patient population or is that space already too crowded? You know, we won't have a chance to make a difference. Where is their unmet need that we can address with our therapy? You know, strategic questions like that. But also separately, I feel like a lot of what we do is just is really education, just keeping key stakeholders abreast of everything. Because in this information age that we live in now, it's just.
[00:06:41] Speaker A: It's overwhelming, isn't it?
[00:06:42] Speaker B: Yeah, it's like this unrealistic expectation, I think, on senior executives that they get up, you know, in front of investors and shareholders and have to know everything about everything. You know, like some potential competitor that isn't even maybe a high competitive threat. Just announced data. What do they think about it? Right. Have to sort of have all of that. A lot of people do. But you know, we definitely help with that because we distill it all down to sort of like that one pager and in real time alert so that they can just reference us and you know, speak to the key point.
[00:07:14] Speaker A: Yeah, so that's like another interesting use case. So that is. That's more defensive, right? That's like just being aware of being educated, as you said, about what's going on in the market. By the way, I can't imagine trying to stay on top of all of the things that are happening in cancer right now or even in a subset of cancers. There's just so much, so many things in motion right now, so that makes a ton of sense. And then the other piece is feeding into strategy. Can you give us an example of that? Where competitive intelligence changes. Either the endpoint you're aiming for in a trial or the sort of label that you're going for, that kind of a thing.
[00:07:46] Speaker B: Yeah, Chris, you're right. There's so much to keep track of. The slate is like mind blowingly cool, you know, but that's just one tiny piece of it. So I agree. We just operate under the assumption that, you know, our clients are like MD, PhD, MBA, like yeah, all the really smart people, they don't have time to study all this stuff. So we really try and make it easy to grasp. And that's kind of the fun part, is to take all the complicated mechanisms of action and clinical strategy and market dynamics and distill it down and so it's easy to grasp. It's really cross functional CI. So it's like this information and intel gets consumed across an organization. So if we make it easy to grasp, then different stakeholders and contributors can really feel comfortable engaging with the content and contributing, Contributing. And then that's where it gets used to inform all kinds of decisions like what the trial should look like, the label, the endpoints. So when we're able to inform about what trends are emerging, then it does sometimes lead to those types of changes and pivots and strategies. Yeah.
[00:08:50] Speaker A: And I guess at a minimum it tells you that if you're not going to change, it gives you more confidence in the decisions you've already made. Nothing in the environment has changed such that your strategy doesn't make sense.
[00:08:58] Speaker B: And that's actually a really good point, is that once the train has left the station, there's a lot of resources and the thinking that has gone into that. So there shouldn't be a lot of fire drills just because there's news here or news there. This development here, even though investors are like, what about this? What about that? A company that's set a thoughtful strategy generally should stay the course. Unless there's a few.
[00:09:22] Speaker A: Something really dramatic.
[00:09:23] Speaker B: Yeah, exactly.
[00:09:23] Speaker A: That makes sense to me. It is a train, but it's a big, expensive, slow moving train. I think you are very thoughtful about those decisions up front and obvious that CI is critical for that.
[00:09:33] Speaker B: One last point on that to just reinforce that or illustrate that is that I feel like there's sometimes this fear like what are we missing? You know, something's going to change, it's going to impact our strategy. So I feel like a lot of what we do Is like we discussed, track the news, share the news, and then here's what happened, here's why it matters. And then so what? And guess what? The so what is often this underscores the need for your therapy for this population. You know, that's often like, okay, everybody, just stay focused on your brand plan. You know, just because there's like new data around the world somewhere random, doesn't mean it's a fire.
[00:10:05] Speaker A: And that can be great. Right? You've also got stakeholders who are calling shareholders and investors saying, you know, does this change? Exactly, yeah. So being able to say we looked at it, there's nothing to see here, it's probably also pretty darn valuable. I wanted to ask you about the science. You said a minute ago, the science is really exciting. It really is. It's. I feel like in some ways, you know, coming. J.P. morgan was just a couple of weeks ago as we're recording this and you know, the feedback from there generally was really positive about the science. Not just in oncology, but certainly in oncology. And then, you know, come on everybody, let's get the investment side going and fund more of these companies. That's my Expert summary of JP Morgan 2025. How do you feel about the science in oncology relative to where it was a few years ago? Is your excitement level higher or lower? What do you think is on the horizon?
[00:10:51] Speaker B: It's a good question. So you're going to go with relative to where it was a few years ago, if you go back three or four years. So cell therapies, for example, have not made a ton of money in oncology as of yet, but what a cool idea and complicated, right? So I have to believe there's still a lot of potential there. But there's a commercial problem that we haven't solved yet as an industry, mainly in how to get them outside of the academic centers of excellence to the community centers so that they're accessible to more people. I'm hopeful that we stick with that because they do have a lot of potential. I don't think that story is done, but I do feel like JP Morgan, they were less popular in recent years and people are more interested now in bispecific antibodies. A lot of potential there. Of course, antibody drug conjugates are making a big splash now. It's kind of just a targeted chemotherapy. I don't think the modality is as mind blowing as what some of the cell therapies involve with their bioinformatics and neoantigens and donors and Stuff, So the science is cool, but then getting it to your patient, obviously, the easiest thing to give to a patient is a pill, right?
[00:12:01] Speaker A: Yeah, sure. Kind of. Delivery modalities matter.
[00:12:04] Speaker B: You know, as an industry, it'll be exciting to see us solve some key challenges around how to make these drugs cheaper, more accessible.
[00:12:12] Speaker A: Makes sense. Related, subtopic, I guess, on competitive intelligence, what's the Sunshine act? And tell us why it matters.
[00:12:18] Speaker B: Oh, yeah, I love it. So, yeah, I know this came up when we were chatting earlier. I brought it up because I feel like sometimes competitive intelligence gets kind of categorized as a little bit of a gray zone, you know, which. Which is frustrating to me because it's not. But it has been viewed that way in the past, and I would love to change that perception. Right. So as part of doing competitive intelligence, I think a really important part is to chat with physicians. We can just learn faster, pressure test our assumptions, stay grounded in what's clinically meaningful. Right. So the Sunshine act, to answer your question, is the federal law that requires manufacturers to report when payments are made to physicians on their behalf. That gets used as sort of a reason why manufacturers, pharma companies in particular, are afraid to do primary intelligence through CI. Drug developers are afraid that primary CI is somehow running afoul. Yeah, but it's easy to uphold the Sunshine Act. It's totally not a problem. There's a lot of value to be gained for the manufacturer from us as a neutral third party having these candid conversations with primary stakeholders. We never do it on behalf of a specific client. We're always just kind of doing it so we can stay sharp. We represent ourselves accurately. It's all compliant. We remind physicians not to disclose confidential information. So, yeah, I just. I brought up the Sunshine act because I feel like sometimes in explaining competitive intelligence, I just run into this perception. That it's a problem. Yeah, that it's like a compliance issue, but it's not great.
[00:13:52] Speaker A: Okay, glad we took care of that.
Hi, this is Chris O'Brien, host of Few and Far Between Conversations from the Frontline of Drug Development. We'll be right back with this episode in a moment. I personally want to thank you all for listening to our podcast. Now in our fifth season. It continues to be an amazing opportunity to speak with some of the top thought leaders in the drug development industry. If you're enjoying this episode, please leave us a review on Apple Podcasts. It really helps people discover the pod. And don't forget to subscribe to Few and Far between so that you never miss an episode. One last request. Know someone with a great story you'd like to hear me interview. Reach out to
[email protected] thank you. And now back to the podcast.
Let's talk a little bit about diversity in clinical trials. And I think there's news here. So will you talk about first, what's the news? And then let's talk a little bit about why diversity matters.
[00:14:49] Speaker B: Well, I mean, it's news, but I don't think it's like surprising to anyone. Right. There's been a shift in our world as of Martin Luther King Day that didn't have anything to do with Martin Luther King. So things have shifted. And with the new administration immediately, this action plan for expanding diversity in clinical trials that has been kind of in the works with the FDA in a while isn't available anymore on the site.
[00:15:17] Speaker A: Right. So the guidelines that were published are just not available anymore.
[00:15:21] Speaker B: Yeah, but you know, it took a long time for the FDA to draft this guidance and now it's not available.
[00:15:27] Speaker A: So one reason for diversity in clinical trials was compliance with FDA guidance. But you know, will you talk about the other reasons?
[00:15:34] Speaker B: Yeah, yeah, yeah. The carrot and the stick. Right, so that was going to be the stick was that there's going to be this expectation on a federal level that drug manufacturers be held accountable to enroll patient populations that reflect the real world demographic of the patients being served. Right. Like not that mind blowing of a concept. But right now on ClinicalTrials.gov sponsors have to disclose their target size of their study, like 100 patients. And I think the hope was that one day they'd also have to disclose their target demographic. You know, like if multiple myeloma is more prevalent in African Americans, then that's the number of African Americans they're going to try and proportionally have in their clinical studies. Right. Just like that idea. So that when you learn about how the therapy works, you also learn, okay, what is the genetic ancestry? Is it maybe more efficacious in these patients? A little more toxic? What? You know, you start to learn the things you need to know to market the drug. So that isn't happening. So, yeah, traditionally therapies are tested in white men and then marketed to everybody else.
[00:16:44] Speaker A: I think you believe, though, that that doesn't make any sense, that there's a strong business argument here, setting aside obvious ethical arguments.
[00:16:52] Speaker B: Yeah, right. The obvious ethical argument is obvious. It's obviously the right thing to do. But it's more than that. You know, I do think there's a Business case. And based on my experience, right when I started out in competitive intelligence, I came out to Seattle to work at a company called Dendrion, which was a great experience for me. And the interesting thing about Dendrion is they were developing. They developed a cell therapy for men with prostate cancer. And they ran into some issues when they were trying to get approval from the fda and it was denied init. And part of it was based on the efficacy. They needed to see more evidence of efficacy. And like most studies, like every study, black men weren't in a very, very small, like, maybe 5, less than 10% of that original study. So then Dendrin had to do another phase three study and finally got the drug approved. And once it entered the market, where prostate cancer is significantly more prevalent than black men, it turns out that black men derive a significantly greater benefit. Wow.
[00:17:50] Speaker A: Yeah.
[00:17:50] Speaker B: Yeah. So. So, like, if they'd been in the.
[00:17:52] Speaker A: Study, that would have been obvious up front.
[00:17:54] Speaker B: I mean, it would have been obvious up front, and it would have potentially shortened the approval timeline. So, yeah, prostate cancer is over 60% higher in black men than white men. So, yeah, so it became more apparent in the real world. So that's maybe just one example that if they had been testing it in a patient population that reflect the real world patient population, maybe they would have gotten a faster approval. Another example is, you know, on the safety side, women have different immune systems than men, and so, you know, women, biological sex. And so that can change toxicity and safety. So if you kind of know that in advance, you can help. You can guide as to how to manage those toxicities and avoid label changes and withdrawals.
[00:18:36] Speaker A: I'll make a plug here, too. That I think sometimes sponsors think, well, we're just going to go where the patients are. So we're going to go to these primary research centers, and it is going to be disproportionately white. Disproportionately. But if you actually start with this kind of plan, your CRO partner can help you source patients who look more like the demographics that you think are going to respond to the drug. So talk to your partners, sponsors.
[00:18:57] Speaker B: Yeah, I'd love to hear even just a little more about doing that, because that's exactly it. You know, I'm not boots on the ground like you are in terms of how to get manufacturers comfortable with expanding and bringing on new sites. I guess it's fantastically hard.
[00:19:12] Speaker A: Yeah, it depends on the trial. Right? So trial complexity can drive that. There are some really complicated cancer trials that are hard to do. Outside of, you know, major medical centers. But even in those places, things like, you know, having minority doctors who are involved in patient recruitment can make a big difference. And people are much more comfortable saying yes to a study if they're being asked to do it by somebody who looks like them.
[00:19:33] Speaker B: Right.
[00:19:33] Speaker A: A minority nurse, a minority doctor can really help with things like that. And then sometimes you can add, you know, community hospitals or even full on hospitals in the same region, but that are just not primary place that you would have gone that might serve a different population. So yeah, there's tons that can be done there. The feasibility on that can be figured out before you start the study. So yeah, okay, end of commercial.
[00:19:54] Speaker B: I mean, that's just amazing. And then I just think that must go a long way in terms of market access, you know, like making sure to get the therapies to all the patients that need them and building trust and awareness, you know, like so reasons even beyond the science of just understanding any variations in benefit or toxicity.
[00:20:15] Speaker A: I think that's absolutely right. So I could talk to you about CI for another 45 minutes, but we don't have that much time. So I'm gonna flip to your other hat. You also sometimes work with individuals and in fact that's how I found you. Right. Is that I read an article where you're referenced and will you talk a little bit about your experience in working with that client?
[00:20:33] Speaker B: Yeah. So meaningful. So Beth Stillman, physician at the Mayo Clinic, reached out. So sometimes by word of mouth, we do get the privilege of working with patients because we're just all day looking at the proof of concept data, going to the conferences, talking to the physicians, following the companies. So it's what we do, looking at therapies and development to understand who are the front runners, who's moving fast, who's the most promising. You know, that's our job. Not many people have that job, you know, so even and oncologists, that's not their job. Right, right. Their job is to understand the evidence of therapies once they're approved and what companies can legally claim. But until they get approved, they're not on the hook. It's not their response. And they're busy. Right. So they don't have time to follow all the stuff like we talked about. So we have that job. So we like to share that information when we get the chance. So Jake Best husband had an advanced form of head and neck cancer. And so what I did for Jake was just, just look at all the clinical studies that were ongoing and kind of match them to what he was looking for in terms of risk reward ratio, likelihood of success.
[00:21:47] Speaker A: Yeah. And I think important to note again that his wife is a physician. And we will link to her article in the notes for this podcast. She writes very movingly about how overwhelming and confusing ClinicalTrials.gov is for a patient or an advocate for a patient who has an advanced form of cancer where standard of care is not going to provide a solution. It can be very, very hard to figure out what to do next. So that's the role that you kind of played here, Eileen, I think. Right.
[00:22:13] Speaker B: Yeah. Bess and Jake, both just like amazingly intelligent, prolific people that wrote a lot and shared a lot. So that was incredible to work with them and then have them tell so many stories and all their stories and share their experience like they did online. So just mind blowing. To realize, like we were talking about expanding clinical trials to include traditionally underrepresented patient populations is hard. It was hard for Jake, a white guy, to get into the clinical studies that we selected. And it was really hard. I mean, with a physician wife.
[00:22:53] Speaker A: Yeah. At a great place and all the.
[00:22:55] Speaker B: Stuff and leveraging that privilege of physician. Physician communication. It was still like, you know, you'd have to have no job, enough resources to fly around the country, establish care, then come back, get in the clinical study. You know, there wasn't. It was hard.
[00:23:11] Speaker A: I found very moving the point that clinical trials, clinical research is not set up to serve a patient. It's designed to serve patients broadly by getting us to answers that lead to better medicines.
[00:23:22] Speaker B: I'm not split on that point, but that's the really important point to make. Right. I mean, as far as oncology goes, I mean, in general, clinical research is for the benefit of society and it's not for patients. But in oncology, there are a lot of single arm studies where, you know, you're not going to get the placebo.
[00:23:37] Speaker A: True. Yeah.
[00:23:38] Speaker B: Like we were talking about earlier, all these just cutting edge, amazing new technologies emerging and then you hear anecdotally a lot about these cures basically happening for some people that have very advanced cancer. So when that's what's on the table, you know, when that's the situation, it does seem like getting into a clinical trial has really a lot of upside for the individual patient. In oncology.
[00:24:03] Speaker A: Yeah. Yeah, I think that's. I think that's absolutely right. So I know you have a little bit of advice also for someone who's trying to figure that out for some resources and some places to Start if they're looking for a relevant clinical trial. So you want to list a few things that were on your mind that you've shared.
[00:24:18] Speaker B: Yeah. So ONC Live is a really cool tool that's relatively recent and it shares a lot of just tiny articles from oncologists about what data they're excited about or new data that's worth noting. And so if it was me and I didn't know where to start, I would just go to that website and search for my type of cancer and see what the latest buzz is, especially around asco, which is always at the end of May, beginning of June, or esma, which is the European Society of Medical Oncology, which is in the fall. But of course, the first step, I think would be to get. And I don't have them off the top of my head, maybe we can add them in the notes, all the places where you can get some biomarker testing if there's any genetically targeted alterations or anything upregulated in terms of tissue markers. Because the thing is, if it doesn't match with something that's already approved, it could match with something that's in development, and then that can be a really promising thing. Oh, and the last thing is the patient advocacy groups. Of all the stakeholders I've had the privilege of working with in my career, I'm always just blown away by the patient. Advocates are so smart. They know everything about the regulatory environment, the science, the data. And so they really do passionately care about guiding patients to the right resources and the right studies and the right investigators.
[00:25:40] Speaker A: I think that's a great list. So I'm just going to summarize it again. So find a great research hospital, get your biomarkers tested, research the results. When you've got a diagnosis, look on ONC Live for signal for indication that exciting things are happening. Do general disease research and contact patient advocacy groups that are active in your specific. That specific cancer that you're targeting. I think that's a really phenomenal place for folks to start. And obviously this is for folks where standard of care doesn't look like a great answer.
[00:26:05] Speaker B: Yeah. And, you know, can I just add one thing that might not be loved by all stakeholders involved, but I would advocate for just reaching out directly to people. You know, don't be shy, you got nothing to lose. So if you see somebody on ONC Live that said something of value, or if there's a drug that you wanna get compassionate use, which means getting to use it before it's approved, that a company's developing. It's not hard these days to figure out people's emails. Send an email, maybe they don't reply, reach out.
[00:26:31] Speaker A: Yeah, yeah, yeah, I love it. Can't hurt to ask. Okay. If you get in trouble for that later. We never had that part of the conversation. All right, now I wanna flip to something that we always try to include, which is a little bit of career advice. So for people who are interested in getting into research, what do you think folks should do? If somebody's in undergrad or in grad school right now and likes mystery novels, to your point, what should they do?
[00:26:53] Speaker B: Well, for competitive intelligence, you need two things, right? You need to be able to understand the complex science and then you need to be able to communicate that concisely. Not everybody is going to be strong in both areas.
[00:27:05] Speaker A: That is true.
[00:27:06] Speaker B: Like we were talking about earlier, you know, the part of the value of what we deliver is that we take all the information, distill it down, make it easy.
People say smart fast, they save time because they can just grab that, what they need to know. So it's kind of both. It's like stem, but then also being able to write. I guess you can use tools now, right? I mean, I suppose you could just ask ChatGPT to write up your, like how to describe something. If that works.
[00:27:31] Speaker A: If that works great. I think your point about, first of all finding the nuggets of value in a large amount of information and then figuring out how to communicate that concisely is really great. And you're right, it's a mix of sort of STEM and classic logical thinking, liberal arts, rhetoric type expertise that I guess you have to bring together. Is that right?
[00:27:52] Speaker B: Yeah, yeah. And then the last thing too that I want to highlight is that I feel like in academia a lot of times the emphasis is on sounding smart and knowing everything.
[00:28:02] Speaker A: That's such a good point.
[00:28:03] Speaker B: But. But in reality, I feel, especially in this line of work where we're really trying to get down to the core truth of what a therapy is and what is happening with it. There's no bluffing.
So the point here is if you have a question, ask it and don't be afraid. Because it's all about identifying knowledge gaps. I mean, it's this iterative process that we go through with our clients. Here's the narrative, here's the story. And then together we recognize this is what we don't know about what the competitor's doing or this is what we don't know about, where the field is headed. And That's a really, really valuable piece. So I find sometimes when people are starting out, they of course don't feel confident raising their hand and saying, but I don't know.
[00:28:47] Speaker A: Yeah, right.
[00:28:47] Speaker B: I don't understand how this connects to that or I don't understand why that's important. But the more that you do that, the faster do you develop that understanding. And it just. The rising tide lifts all boats. Right. When people raise their hand in these conversations and say, what is that? Or I don't get that. You're never alone. It's better for everyone.
[00:29:06] Speaker A: Yeah. So that's great. That's probably general advice in lots of places to be willing to admit I don't understand something or I need something explained. You're probably not alone. If the person can't explain it to you concisely themselves, they probably don't understand it very well either. I think those are words to live by. But you made another point too, about academic. The sort of objectives of academic research versus research in the practical world and the business world. Will you talk a little bit about that? About being expansive? And I think you said maximizing use of vocabulary versus oh, right, all that stuff.
[00:29:38] Speaker B: Yeah. Yeah, right. So my mother was the consummate intellectual. She had her PhD in the history of medicine and she always used the biggest words possible to describe anything, which is one way of being in the world. And then I learned there's alternatives to that when my sister got married and her husband works at a hedge fund and speaks in like very short sentences with like one syllable words and then rakes in money. So I thought, okay, I need to figure out, you know, the middle ground here. But I think the point I'm trying to make is that in academia there's value, I guess, or the idea is to become an expert about a very specific thing and stay very high level. But in this line of work, especially in competitive intelligence, and because it's so cross functional and because the idea is to get information and communicate it, there's so much value in just keeping it really simple.
[00:30:31] Speaker A: Right. Make it simple, move quickly, get to the insight that kind of thinking people are bluffing.
[00:30:36] Speaker B: If you get a lot of people together on a call and go through some complex stuff and there's no questions, either they're not listening or they're just. There has to be questions and it has to be simple. Yeah. That's the direction that we want to go, Eileen.
[00:30:48] Speaker A: Words to live by. Okay, so if people want to get in touch with you and brass tacks, what's the best way for them.
[00:30:53] Speaker B: Email is the best way. Eileenrasstaxinsights.com Fantastic. Taxes like T A C K S. Yeah.
[00:31:01] Speaker A: Getting down to brass tacks. I love it. It's exactly what you said folks need to do in their communications. Right. Get to the point of the matter.
[00:31:07] Speaker B: Yeah. I thought when I picked the name that my tagline would be let's get down.
[00:31:13] Speaker A: I don't know. Maybe. Maybe. We'll see. All right, Eileen, thanks for joining us today on Future and Far Between. That was really fun.
[00:31:20] Speaker B: That was fun. Thanks, Chris. Thanks for having me.
[00:31:26] Speaker A: Welcome, producer Adam.
[00:31:27] Speaker C: Thanks, Chris. Thanks for having me on again. I'm excited. I have a couple questions for you about this podcast episode.
[00:31:33] Speaker A: Sure.
[00:31:34] Speaker C: So let's talk about competitive intelligence. Why is it so crucial to biotech starting clinical trials?
[00:31:39] Speaker A: Yeah. I think Eileen's point, which is really important, is that unless you understand the solutions that are working their way through the clinic, you might be aiming for the wrong endpoint. You might be developing something that is going to be a solved matter by the time your drug gets there, or you'll have trouble explaining to the FDA why your drug is differentiated. So if you're looking carefully at all of the things that are in flight in phase 1, 2, and 3 trials, your likelihood of choosing a target that's appropriate goes up.
[00:32:05] Speaker C: Yes. And to go along with that, you mentioned it. What happens if a competitive intelligence report identifies the study as not being clinically meaningful? What do you do next?
[00:32:14] Speaker A: Well, I think that's when you go back to the drawing board and think hard about the endpoint that you're designing for. We see this a lot in oncology trials with people picking quite narrow endpoints, being trying to be very specific and generate meaningful signal that the FDA will respond well to, and then potentially expanding from there as time goes along. And it's a lot easier to do if you really understand what else is coming.
[00:32:34] Speaker C: One thing that you and I lean discussed during the podcast is how the core of clinical research is to benefit society, not individual patients. That's very conflicting, isn't it?
[00:32:44] Speaker A: Yeah, it really is. I think this is an important point. It's one that people outside of the industry definitely don't understand. And, you know, the more time you spend in it, the more sense that it makes. In order to run these studies effectively, of course, we need patients, and we need those patients to be consented into trials to understand what they're doing, et cetera. But really, the focus is in the app aggregate. Can we get enough data to indicate whether or not this treatment is safe and valuable. That really is the focus of the clinical trial industry.
[00:33:10] Speaker C: And going on to another conflict. You were talking about merging complex science with concise communication. Can you explain the value in that?
[00:33:18] Speaker A: Yeah, I think Eileen's really good on this. In the podcast, she is a very clear communicator. And unfortunately, it's not true of all scientists. Not all scientists have had that kind of training or have that kind natural tendency. So part of what Eileen does, high signal to noise ratio, you're getting. You're getting a lot of insight and a lot of clarity when she tells a story, and I think it's very valuable.
[00:33:39] Speaker C: Just one final thing. You guys talked about Beth Stillman's story, which Eileen Faucher is very involved in, and it brought to mind a question of why it's so hard for people to get into clinical trials that could potentially save their lives.
[00:33:53] Speaker A: Yeah, I think this gets back to the point that you raised earlier, Adam, and you're absolutely right. Beth Stillman's story is heartbreaking. The death of her husband and her frantic effort to try to find an effective clinical trial that could have potentially saved his life. It's a really sad and tough story to hear. This gets back, though, to the point that Eileen made. The industry is really aimed at trying to get signal from these trials. It's not really aimed at helping an individual. That sounds kind of cold to say it that way, but I think that's the reality. And so someone like Eileen can help people potentially find their way into a trial when they might otherwise not be able to identify that trial as a need. I think that's laudable. I think we need more tools that help people who are very sick to find these kinds of options. And I would love to see the balance shift slightly in the direction of more patient centric than it is today.
[00:34:41] Speaker C: I definitely understand that. Thanks, Chris.
[00:34:43] Speaker A: All right, Adam, that was a pleasure. What a fun one.
Thank you for listening to the latest episode of Few and Far Between Conversations from the front lines of drug development. Our podcast is now available on Apple Podcasts and other streaming services. Please take a moment and leave us a user review and rating today. It really helps people discover the podcast and we read all the comments. Those comments help us make Few and Far between better and better. Also, be sure to subscribe to Few and Far between so you don't miss a single episode. Got an idea for a future episode? Email us at fewandfarbetweeniorrosti.com or contact us on our website at biorasi. Com. I'm your host, Chris O'Brien. See you next time.
