Expedited Pharma Publishing: Solutions, Struggles, and Strategic Importance

Expedited Pharma Publishing: Solutions, Struggles, and Strategic Importance

Speaker: Sam T Mathew

Independent Consultant

Speaker: Raghuraj Puthige

Function Head, Medical Communications, Enago Life Sciences

SPEAKERS

Speaker 1, Raghuraj Puthige, Sam Matthew, Garth Sundem, Speaker 2

Garth Sundem 00:00

Garth, welcome to this episode of the Medical Affairs Professional Society podcast series, Elevate. I’m your host, Garth Sundem, and today we’re talking about expedited publishing with experts from Enago Life Sciences. Joining us are Sam Matthew, Independent Consultant, and Ragharaj Puthige, Function Head, Medical Communications, at Enago Life Sciences. And this episode is sponsored by Enago. So expedited publications means many things, efficient publications, accelerated publications — Sam, what in the world are we talking about when we say expedited publications, specifically in academia or industry. What are we talking about here?

Sam Matthew 00:47

Hi Garth, first of all, thank you for thank you very much for giving this opportunity to discuss expedited publications in the pharmaceutical industry. Of course, this is a great question to begin the podcast. Expedited publications have gained prominence, especially after the recent pandemic and the introduction of new treatment modalities and emerging diseases. In general, there is no specific definition for expedited publications as such, but in the context of academic publishing, expletive publishing refers to the shift processing of a submitted people. This include the peer review process, addressing the comments and making the first electronic version available, all within the purview of the journey. The same time in the pharmaceutical industry, the acceleration of publication process begins within the company itself. So that means the expletive publication The pharmaceutical industry refers to the accelerated process of publishing research findings or criticize results or any other data in scientific journals or other various platforms. Again, that means this process aims to shorten the time between the completion of a study of or a research and availability of research to the broader scientific and medical community, basically in a pharmaceutical setup, this process actually involved rapid internal development of the manuscript draft by medical writing professionals, starting with the initial creation of the manuscript draft or a shell manuscript, often well before the studies even planned, or before the study is concluded. It also include accelerated review and approval processes within the company by various stakeholders, which will be usually followed by a submission to fast track pharmaceutical journals, which are already identified and exploited peer review, as we have seen in academic publishing within the journal purview and the prioritized production and formatting and then rapid online publication often, ah, much ahead of print. So that means, in conclusion, we can say that in academic publishing, exploited or activated publishing process typically begin once the article is submitted to the job. However, in the pharmaceutical industry, this process starts much earlier, and sometimes preparation even begin before the study is planned or concluded, with an initial draft undergoing various reviews before being submitted to the journal. And then I’m sure that this makes this process actually makes the executed publishing much more complex, as it involves coordination among multiple internal stakeholders, right?

Garth Sundem 03:21

It’s almost like we would say, building the plane while we’re flying it. It used to be that we would have the study data and then decide what to do with it. And that seems very clean. You could, you could take it, package it, send it off to the journal. There we go. But now it sounds like everything, you know, with accelerated publications, has to be developed concurrently. We’re writing the study as we’re doing the study, or not writing the study protocols, but we’re communicating, we’re getting ready to communicate the study as we’re doing the study is, is that a major change?

Sam Matthew

of course, that’s what you spotted on that. So basically, it depends on the planning. How good Have you planned with the publication?

Garth Sundem 04:07

Okay, so everything’s faster these days. You know, we expect fast data. What is driving expedited publications, or are there other factors that are pushing us to go from study to publication much quicker? Raghuraj, what do you think?

Raghuraj Puthige 04:33

Yeah, thanks, Garth. First of all, thank you so much for having this podcast on very interesting topic, and even for Sam, for, you know, being on the podcast. So thanks for this particular question, because this is extremely important, and we need to understand that why, you know, when do we need to publish things as quickly as possible? Let’s look into as a as a kind of a natural or an old thing, and why timing matters. Because. Is expedited publications basically addresses two critical needs which we need to note in the ever changing current research and no medicine which is dynamic and ever evolving, right? First and foremost thing is that they enable rapid dissemination of research findings, okay, which allows crucial information to reach quickly to several stakeholders, for example, scientists, doctors light health care professionals and policy makers. And this fast reaching of knowledge least leads to faster breakthroughs and also like helps in terms of making a more responsive decision making, right? This is one of the challenge. The other critical need is expedited. Publications play a very important and critical role in accelerating drug approval process. What do I mean by this? Saying this because by quickly communicating these important clinical trial results and especially safety data. These publications actually help in terms of streamlining regulatory reviews, which potentially brings new treatment to patients as soon as possible. Now looking at these two factors in the like nutshell, they are not just about rushing papers through reviews or publishing them, but the underlining, you know, meaning or the motive, is to that they are getting life saving information to the people who need it the most. That’s what I feel. It’s extremely important. And I ask Sam, if you want to add any more views into it and then provide more deeper insights, yeah,

Sam Matthew 06:44

Yes, yeah, thanks. Thanks, yeah, thanks. So if I make a little more deeper into this, so there are various scenarios so that can be considered as the need for rapid dissemination of research package. So if there is an urgency in addressing the public health emergencies that we have seen in pandemic COVID Recently, and if the clinical trial results impact any treatment protocols, or if the results significantly contribute to the evolving therapeutic landscape, or if the data is style sensitive, or any regulatory requirement for data disclosure is mandated, or in the other cases in which the data is related to the patient safety, such as adverse events, or if the data supports reimbursement and formula decisions. So in all these scenarios, it’s explicit publications are are recommended. But in addition to these scenarios, exploited, publication is also needed for faster drug approval process, as Riku has mentioned, because for accident drug approval process will definitely help in speeding up the drug approval process, streamlining the regulatory reviews and thereby improving the patient access to novel therapies. So we all have known about FDS breakthrough therapy designation. So FDS breakthrough therapy designation is mainly facilitated by the excluded publications. And in many ways, where in which the preliminary and ongoing clinical evidence which is provided by the excluded publication will be an important factor for the FDA to take these positions, okay? And in addition to this, not only in the beginning just one point, not only in this point, and when it comes to sustaining the FDA breakthrough therapy designation, that is also very important for the pharmaceutical companies to continuously provide the information that is available as quickly as possible to the FDA and the scientific

Garth Sundem 08:41

Oh, no, that’s great. So it expedited publications. It gets information to patients and healthcare providers faster, and it gets drugs to patients and healthcare providers faster. Is that how a company should identify a study for expedited publication? Should they look at possible patient impact, and that is the primary factor that would make them consider expedited publication. Raj, or or, Sam, what do you think is, is that how we know that we’re going to push the accelerator on a publication?

Sam Matthew 09:23

what I would say is, so always we should pay put patients first. And of course, the impact that the therapy or the new information is going to give to the patient should be given the prime importance. And if that is going to be the impact, then definitely we should go for expedited publications.

Garth Sundem 09:41

Okay, so we saw this in COVID. This was really what I think of as the start of expedited publications. And I know it wasn’t the start of expedited publications. That’s where it really came into into common practice, is, is it just COVID that benefited from expedited publications? Or are there areas beyond COVID That show public benefit from this efficient publishing? Raghuraj, what do you think?

Raghuraj Puthige 10:15

Yeah, I mean, you brought a very important aspect to this. Basically, it’s just not only the COVID, but if we actually go back to several, you know, important landmarks that you know, the medical and health care actually went through. It is important to note that it’s just not only the COVID, but there have been several other instances where the expedited publications became more important. Now, if I want to as as we have already seen, that the pharma world is basically changing faster than ever, because each time when the new actually medications that comes through from the various aspects, what is that they are targeting is basically to look into the unmet needs, and that’s where you get into the situation called the breakthrough therapies, right? And that basically merits more into the fast publication, or Accelerated publications. Now let us look into few examples. Now, as I said, one of the examples that I can think of is basically, is gene therapy, right? Which has completely changed the entire treatment strategy. Just to quote, one of the examples in the previous past is that, like inherited eye diseases, with, you know, treatment like luxt, you know, which came out, and then, you know, totally, you know, change the entire treatment scenario itself. And the publication was very crucial, because the doctors understood, and they started using these new approaches. Similarly, if you have to go back into the similar area, which was called chimeric antigen receptor T cell therapy, or car T cell therapy for blood cancers, right? And this also came out as one of the game changing treatment, and one of the earliest products which I can recollect is kimria Right, which shows very interesting results and also like promising results for patients who did not have any treatment options left during the time and publishing these findings actually helped more doctors to adopt These treatments and improve patient outcomes. Now, besides that, going back to the phase COVID, example, when the vaccines were not yet available, the symptomatic reliefs was also as equally important as life’s changing. And you know, publication that came out during that time, the time, like remdesivir or dexamethasone, was also very important for doctors to understand how these medications were also important in terms of, at least making a symptomatic relief for the patients. And another example which I can think of is basically the diabetic care, which is a lifestyle disorder like and one of the game changing, you know, medication that came through, which was basically like GLP, one receptor antagonist, right, which helped the update and tight treatment modality and also the guidelines, and helped millions of diabetes people much faster in the worldwide. So what is important here to consider is that the pharma industry deals with very time sensitive, critical data, right? Because the regulatory agencies like FDA and EMEA basically looks for such kind of critical data, and they make pharma companies mandatory to share the data and publish them, which basically helps improve patient’s life as quick as possible. Besides that, let’s also look into the few more, you know, recent past examples, which basically, like, you know, help everybody understand. And then go with what we are trying to say is that the COVID vaccines, right, as you have seen, like, you know, one of the first vaccine that came out from Pfizer biontech, or the moderna, right? And these vaccines were quickly published in the, you know, one of the High Impact Factor journal, like any JM, right, which actually, like, brought out very vital information in terms of providing the efficacy data and safety data, which was very important for the healthcare professional to take notice of it, and also, you know, implementing today treatment modalities as quick as possible, right? And going a little back into the timeline between 2014 and 2016 we also had Ebola epidemic, right? And even the vaccine that actually came out, which was published in Lancet in 2015 also was one of the important treatment in a modality that had to be, you know, urgently has to be acknowledged, right and also like, implemented into the treatment modality that was important then. And likewise, cancer treatments, again, they played very important role, because any any medication that actually like in a. Meets the unmet need and also increases the life expectancy, helps basically improve the, you know, treatment outcomes and also saving patients lives. So one of the products, like, you know, pembrolizumab, which came out, which published its phase one results right from the nhm in 2012 right? And even though it was just phase one, but because actually it, it came out with promising results, it actually gained the Fast Track FD status approval, and also, you know, designated as breakthrough therapy. And these are the few examples which we can go by from the patient first, because this is basically what helps us, ensuring doctors to have the most up to date information which can help them make treatment decisions. That is what I can just quote.

Garth Sundem 15:49

Well, it’s so interesting to hear the the pre COVID, you know, applications or instances of expedited publications, because I think that we all, you know, peg our understanding to COVID, but, you know, with pembro is a great example. I mean, that’s 2012 so expedited publications. I mean, diseases don’t wait for our information to make its way landscape. And so patients, anything that actually, you know, saves the life of the patient, definitely, like you know, makes it absolutely well. And so saving patients lives is not only about drug approval or or communication and teaching them to use the drug in the most appropriate way, but there’s, there’s issues like market access, safety reporting, you know, these expedited publications are used beyond just the patient and their HCP. Sam, would you tell us a little bit about how expedited publications influence some of these aspects, beyond approvals and use?

Sam Matthew 16:59

Of course. Garth, so that’s, of course, definitely a great point such, because it is important to note that expletive publications are multiple roles beyond what has been discussed here. For example, expletive publications play a crucial role in reporting recent safety findings. So when these safety signals are promptly notified to healthcare professionals and regulatory bodies. It helps in timely updates to safety guidelines and warnings. So this can influence international regulatory decisions by aligning safety standard across different countries and geographies. For example, there was a case report which was published in any JM on thrombosis and thrombocytopenia syndrome related to Oxford AstraZeneca vaccine, which you all remember very well, which was submitted to any gym on March 29 2021 and this was accepted by April 9, that is, within 10 days. So that actually shows the importance of this safety information going out to the public. And another example is if we go back to pre COVID state. There was a meta analysis in any JM again concerning the risk of bio COVID infection with rocilio, which was submitted on June 11, 22,007 and which was accepted June 28 that means around 15 days. And in the same year, also, we all are aware of this Morbidity and Mortality Weekly Report from the CDC, which keep updating all the safety signals which they received during the course of the clinical trials or during the treatment phase. And another key reason, other than the safety reasons, for expected publication, is market access, which is actually aiding the reimbursement and formulary decisions. So of course, these fast track publications play crucial role in helping payers to access the value of a drug, actually by ensuring that they have necessary information to make informed decisions. So we first publish, in fact, offers first mover advantage in the market, impacting sales and profit positivity. But of course, more than that, patient is always in the front of I mean, should be given the prominent prominence in any of this, and keeping the decision maker informed of the benefits of a drug actually ensures that it remains a priority in healthcare settings when coming to payer discussions. And actually this expedited publications also provide some missing information quickly, if requested by the payers. So that is also one of the major areas where organizations submit explicit publications. For example, Kim diaphragm. It’s, which is a car T cell therapy by no artists for children. So this was published in the, again, it’s an adjm in August, 30, 22,070, so this was actually supported faster, 50. Approval, and also facilitated payer negotiations at that time. And from gliad sciences Sovaldi, which was actually used for treating chronic hepatitis C infection, which was published in Lancet somewhere in april 2030, was actually led to rapid formula inclusions of this trend that for the market access. So considering this, another reason for publication is to support accelerated drug approval process, which actually redu has gone in detail on that. So in addition, so that means these are the three other areas that we need to consider when we go for accelerated or expected publications,

Garth Sundem 20:44

okay, well, let me point out first to our listeners that I can see Raj and Sam are not reading the dates nor the names of those publications. Those live in your memories, and I’m very impressed. And let me also say so this, obviously, this sounds great. You have an expedited publication. It’s going to accelerate the access to information. It’s going to accelerate better prescribing better use market access, safety signals, unless you then go have to retract everything. So along with the benefits, there are risks, or at least challenges. So what do you both see as the hurdles of expedited publishing?

Sam Matthew 21:32

Of course, I mean, expedited publishing definitely comes with challenges. The first and foremost would be the regulatory hurdles, because we have seen FDA breakthrough dissertation. So if the expletive publication is planned for the accident under the approval process as defined any of the regulations, then the publications and the process should clearly be in line with those regulations. So we need to clearly provide all that data that is needed for those approvals in our publications, and any non compliance or wrong data in this framework can definitely result in delays in approval or even legal repercussions, especially when we go for fast track safety or efficacy information. Another point would be resources, time constraints and pressure the quality. So because of the time pressure, there can be a lot and lots of errors that can, by default, introduced into the into the publications, for example. And moreover, there can be the scientific environment of scientific and, you know, maybe get polluted or contaminated with duplicate publications. For example, if you see what happened during the COVID. The first paper, I think, was published somewhere in December 19, 2019, which actually talks about something happened in one and almost four months later, there was a paper that’s published that actually looks at the number of paper published on COVID. So they received around 2111 niche kind of papers they identified, which actually talks about COVID Within three months or three and a half months of time. Out of the they have identified, there are only 25% of the paper research. That is only 500 papers. Of that more than 100 papers are duplicates, so that shows how quality is impacted, how the scientific data is being contaminated by duplicate publications, because that will impact your evidence, which is available in the public domain. And definitely this activated publishing demands additional manpower, funding and infrastructure to be tight deadlines, and this can definitely strain the budget for an organization and definitely strain the personnel. Will lead to resource allocation issues and delays in other projects, because the prioritization may given to the we can do these projects, it can also lead to burnout, I mean, researchers and the writers and the people who are working on that due to long hours and high stress. And I’m sure that Riku and I, we all have sleepless nights when we had to have when we had worked on this kind of extended publications, absolutely. So yeah, these are some of the challenges that we have come across. And Raghuraj, you can definitely add some more examples or your experiences

Raghuraj Puthige 24:20

Thanks. Yeah, thanks, and thanks, and yes, you actually they can hit a very good point. And then besides that, if I may have to, like, stretch, some more important challenges, we have to think is that, you know, the quality control, the integrity of the research that you know leads to this experiment publication, and once the publication comes out, right, what happens to it? Because it is under, you know, post publication scrutiny and other ethical considerations. Let’s look into it in a systematic way. Okay? So note that like there is a pressure to publish, but only thing is that which can increase the risk of errors. And inconsistencies in data reporting, which we need to be mindful of. In extreme cases of this rush, there might be even like temptation in the researchers towards selectively reporting and other questionable practices. And this is, basically, is what is important to be considered. Because the challenge is, here is to find sweet spots between, you know, speed and scientific career, and compromising on quality is just not an option, because this is going to affect the patient’s safety and also affect the treatment decisions. Another challenges which we have already spoken is that what happens after publication actually comes out right, and because it is considered one of the fast tracked or Accelerated publication it is basically undergoes intense scrutiny by the public, because people wonder if rushing might have affected quality right, even a small mistakes or error can lead to public criticism, and now this will have a cascading effect once a criticism starts coming in, either you have to file an ER atom or calling in them. Otherwise it will have to be undergoing like possible retractions from the publications, and overall, it actually damages the reputation from both these researchers and the organizations. Now, what would happen, it basically happens in the public arena, is that the trust is lost from the doctors and the patients alike, because they don’t trust the product itself. What has been reported, and this is very hard, once the trust is broken, to rebuild. Now, looking into the ethical side of it, again, this actually adds another layer of complexity, because we’re moving like quickly. What is important is that the publication entire process needs to be remain very transparent. The data has to be reproducible, and also it needs to follow extremely good review ethical, ethical review process now, because we cannot take shortcuts, because, from the you know, designing onwards and obtaining informed consents or conflict of interest, and also reporting all results, either it could be positive or negative, needs to be done in a perfect, planned way. Now, the challenges here are not just to avoid publishing very quickly. The challenges are that because they are realities we need to address Through careful planning and having a strong processes, which is again towards total commitment of scientific integrity, because what we are doing is the stakes are just too high to mess this up. And once the damage is done, it is extremely irreparable. And this is what we need to be mindful of.

Garth Sundem 27:55

Okay, that is a great stuff. Great place to end. I hear planning, planning, planning, we can’t just do what we’ve always done in a more condensed way. We need to plan and have processes around what create an expedited publication, rather than just smashing the same amount of stuff into a smaller time box. All right, so thank you, Sam and Raghuraj for joining us today to learn how your company can partner with Enago Life Sciences, visit lifesciences.enago.com. MAPS members, don’t forget to subscribe. And we hope you enjoyed this episode of the Medical Affairs Professional Society podcast series, Elevate.

Following is an automated transcription provided by otter.ai. Please excuse inaccuracies.

Garth Sundem 00:00

Garth, welcome to this episode of the medical affairs professional society podcast series, Elevate. I’m your host, Garth Sundem, and today we’re exploring the intersectionality of medical affairs and Kardashian studies. Unfortunately, I don’t really know what intersectionality means, and I certainly don’t know anything about the Kardashians, which is why we have with us. Mike Taylor, Head of Data Insights at Altmetric, and Carlos Areia, Senior Data Scientist at Altmetric. This episode is sponsored by Altmetric parent company, Digital Science. So Mike, please, tell me how and why we’ve reached this point in our interactions and conversations today. Why are we talking about the Kardashians?

Mike Taylor 00:52

Wow. Well, we’re talking about the Kardashians because Carlos and I were invited to write a chapter about Kardashian studies in a rather splendid book called The Kardashians, a critical anthology. Now a chapter is called in the lab with the Kardashians. Oh, dear. This did. This started. That was 18 months ago, and I was in Oxford, Sheldonian theater, a library, sorry, Radcliffe camera, and I was, I’m researching part of my PhD, and I’m writing the introduction, and that’s really about the history of of research. And it goes back to 350, years. And I’d read this amazing chapter from a guy called uh Bishop, Thomas Spratt, who was writing in 1660 and he was wrote this book celebrating the first 10 years of academic publishing, scholarly publishing. I’m going to come back and talk about this in more detail. I’m enormously keen about this. But sprat realized, as did most of the Royal Society, that if you want people to engage with science and and understand science, then you have to make it interesting and entertaining and engaging and relevant and all of those stuff. And I like this. I’m going to come back, and I will, I will talk about this in great detail. But the point is, this was the message that we learned in 1660 you can’t just be this sort of dry academic and expect people like HCPs like doctors, because they were talking to doctors at that time, you can’t expect them to to not engage with things that are bright and boring and irrelevant. One of the things that they published, right at the very beginning of European scientific publishing was this was this post mortem of this notorious character, a real libertine guy called the Earl of Bauer Karis. You can go online his post mortem, published in 1665, or whatever it was. It’s got a DOI and they got all of this guy’s body, and they cut him up and they examined his organs. And you can read it as a morality story, if you like, but it’s also a story of like, what you do to your body. If you’re a notorious libertine, you drink a lot, you’re diseased all the rest. And I’m not going to suggest that the world of pharmaceutical Medical Affairs would be more attractive to a broader population if we did clinical trial studies on the Kardashians. But there’s, there’s a link here to how can we communicate, how can we instill the values of attractiveness in our in our research, to encourage people to engage with it. We know that publicity and talking about research has downstream effect on how people are treated. There was a fantastic study published in 1991 by Philips et al in New England, Journal of Medicine, that explored the effects of research being covered by the New York Times during the 1990s fascinating study. Happy to put a link in in the show notes to that what I’m saying. And we said this again with our podcast that we did with you at the top 10 publications in in the fall last year, putting a piece of research into a journal is fantastic, and that’s a really important thing to do, but you can do so much more to commit that to a broader audience. And in the case of the podcast, we found a couple of articles where the lead editor, the lead author, rather, had done a really fantastic and engaging video for I think it was for jammer oncology. I think it was and that you can see the effect of having that video has in the discourse around that article and I contributed another one in a rare disease. Area where there was a case study history of a family that that that was was used to to to pin that research. So I came out of the theater, out of the library, I’m so enthusiastic, and I bump into a friend of mine called Kath Burton. Kath for the K and she said, Go away and find out about the Kardashians, because she had just started writing, editing a book about the Kardashian studies and intersectionality and all that kind of stuff. I went away. There are 1000s of articles that use the Kardashians case studies and examples and illustrations and all sorts of other things. There’s, there’s, this is the second edition of the book. There’s even a couple of events called the conference, spelled the k of course, and Carlos and I were being invited to contribute this book. I wouldn’t have known a Kardashian if, if one of them stood up in my suit. I’ve got to be honest with you, Garth, it’s not my area of research. But what we found was really interesting. And I think that the approach that we took to to analyze this corpus, to analyze this set of documents, has a relevance to medical affairs that perhaps isn’t immediately obvious.

Garth Sundem 06:14

Okay, let’s get into what in the world we’re looking at here. Well, so first of all, 350 years of publication, science has now led us to what seems sort of a pinnacle moment where we find ourselves talking about the Kardashians, starting with sprout and the Earl of barrel of carrots, is what I heard you Say, which probably isn’t something like that Carla’s. So you were you were working on this book chapter about Kardashian science. There’s an article with some lovely visualizations. What are we looking at first or let me ask, What in the world did you do to make sense of the landscape of Kardashian science.

Carlos Areia 07:03

So yeah, thank you, Garth, yes. I just thought it was funny to see like the pinnacle, everything lead to our Kardashian research so curiously and again, tying all of this with medical affairs, I use the pipeline that we usually use for most of our customers, and we use a known technology that’s been around for a for for a while, which is clustering. So we’ve matched like the basically we feed it the the algorithm with the information from the publications and created clusters that we can then split, slice and dice and analyze and describe throughout the chapter. And this, again, both me and Mike, we love clustering because sometimes, more often than not, usually allows us to find emerging topics and by looking at co occurrences between titles and abstracts or inside publications, and that usually highlights trends and signals. So this is a technology that we usually use with our customers in a completely different context, of course, but in the case of the Kardashians, it allowed us to identify, identify five clusters that we could then explore the individual publications and later the social media attention tied to each one. And very broadly speaking, was, I think we split into five clusters, wealth, influence, social networks, one another. Was about feminism, politics and social change. Another was around celebrity, celebratory fame and public identity, sexuality, gender and mental well being. So those are like, very briefly, speaking, the five people can go and read the chapter if they wanted, but these would then allowed us to split. And you can think of it like we usually what we do for our customers, like split by therapeutic areas or products or anything else. And the analysis was quite similar to what we usually do, and yes, and we found some very interesting insights for the Kardashians, but that’s like the in terms of the methodology. This is something that me and Mike, we’ve been doing for the past two or three years. Okay, so

Garth Sundem 09:32

looking through a very similar lens at very different data than you would usually be looking at, okay, so we’ve got these five clusters. And first you look at these clusters in terms of what the research is writing about. Great, you know, it’s the title the abstracts. You’ve got these five clusters that people are writing about now. Is that, is that the same as what people are citing and tweeting, you know, is what the researchers are writing about, what people, beyond the researchers, actually care about, are those the same thing?

Carlos Areia 10:16

Well, it does, it does differ a bit, and I think that’s another thing that was quite curious and sometimes similar to what happens in medical affairs, that sometimes what companies put out there, and the expectation that how it was produced is not the same as how it is received by the consumer and by the reader. So the there was some patterns, some interesting patterns emerging when we started linking this research to their citations and and the social media, okay? And I’m not going to do all the spoil around the Kardashians, because we want people to read our chapter, of course, and, but, but yeah, but asking your question, yes, there was some different, yeah, different results between what was published and what was

Garth Sundem 11:07

cited and what was tweeted. So, I mean, just, just to put a peg in that, it’s, it’s a very stark demonstration that what the researchers chose to write about is not necessarily what resonated in the external landscape, and you can see that in these clusters about the Kardashians, but you could also see that about a disease state, or about a therapy, or things that may be even more relevant to medical affairs than the Kardashians.

Carlos Areia 11:40

Yeah, especially so when we started, I think we’ve talked in another podcast about how we created, like demographic groups and some things that are completely unexpected resonate to a particular public, like, for example, a group of rare diseases patient or a group of cardiologists. So and well, here in this chapter, the Kardashians, we kept it quite broad, like an overall lens. But usually when we dig in with with our with our partners, we start focusing on specific, like demographic groups or specific and see what resonates. And again, similar when we use like clustering, and that’s why we like it so much, is sometimes what we find is quite different from what we expect,

12:30

absolutely. Yeah,

Garth Sundem 12:31

well, that’s interesting. So again, and we’ll link this from the podcast, but we started with what the researchers are writing about in the terms of their title and abstract, and then we look at how that’s received in or amplified in terms of citations and also in terms of tweets. But you’re saying that for most medical affairs applications, it wouldn’t just be everyone who’s citing this, or everyone who’s tweeting this, but let’s look at what people are talking about in certain demographic groups. Let’s look at let’s look at how this is received, not across the entire landscape, but received by the people who matter. And that’s what more often in medical affairs,

Carlos Areia 13:20

exactly. And then did something that we actually did for the Kardashians as well. We we can start to use some qualifying, not only like what that they are talking about it, but the sentiment behind it. So we and even for this chapter, we’ve applied and things, and we saw some patterns in terms of polarity of sentiment when we did a sentiment analysis to the to this data set and on the clusters

Garth Sundem 13:52

right, because in Kardashian studies, perhaps any publicity is good publicity. But in the world of medical affairs, perhaps we would like positive publicity, rather than just the fact of a lot of conversations taking place in a lot of places. So what did you see in the Kardashian landscape when you looked not only add the volume of people talking about these five clusters, but how they felt about these five clusters?

Carlos Areia 14:26

Yeah, so I think it’s like everything else. So there are some topics that are more controversial than others. So I think if I remember correctly, in the Kardashians like clusters, like the wealth influence in social networks and fame public identity were at the most positive slash neutralish sentiment, whereas, as one can expect, like sexuality, gender and the identity surrounding it at the most polarized sentiment in the discussions. So

Mike Taylor 14:57

yeah, you’re right. I’m looking we’ve seen. Hmm, we’ve seen polarization in in in many different areas. It’s always really quite interesting, because, broadly speaking, most medical affairs related research is, is, is, is weekly positive. So people are going on to social media and they’re saying, Oh, interesting paper coming out, something like that, you don’t get that much negative attention. When you do get negative attention, it’s really interesting. There was an example of a drug that was released a couple of years ago. Sorry, it had approval a couple of years ago. I’m not going to name the name the drug. I’m sure everyone could figure it out. But when it was released, there was a lot of positive sense. It was considered to be a breakthrough in a particular area. But within a week or two, people were digging into the numbers and saying quite a lot of adverse effects here. Actually, the effect isn’t quite as strong as we thought it was. And then you can actually look at the timeline, if you section it so you’re just looking at what HCPs, what medics are thinking about it, you can see that they were very positive to start with, and much less positive. They weren’t negative, but they were that positivity sort of rose and then dropped over time, whereas the broader population continued being really quite positive about it. So you see this sort of segmentation of discourse by demographic. I can say that without sounding like a social scientist, you see it quite often. It’s not just in areas of controversiality, such as Carlos is talking about, oh,

Garth Sundem 16:40

when’s the next edition to the book? You guys gotta, you’ve gotta, you’ve gotta tie the Kardashian sentiment to the news cycle. And you could maybe see these clusters go positive sentiment when, I don’t know, someone adopts a puppy, and negative sentiment, when, when they all do the evil things. Oh, sorry, I’m editorializing. But you could look at not only the snapshots of of how this information is received, both in terms of volume of conversation and the second conversation, not only broadly, but within certain demographic groups or certain interest groups, and not only Kardashians as a whole, but these five clusters that you’ve negated. But you could also look at how that is affected by different actions, and I wonder if that presents an opportunity to use a metric like this to keep an eye on the impact of medical affairs activities. If we do see we have a publication, is that a is that a place in time that changes the volume and changes the sentiment. Yeah, it can

Carlos Areia 18:03

be, for example, like if a particular Kol shares their opinion on it, and then can trigger action of positivity or negativity, depending on

Garth Sundem 18:17

right or you have a new, I don’t know, phase four study, or something come out, or real world. And so you’re looking at something that changes the landscape, or it does get something in the popular press, it gets attention, yeah, well,

Carlos Areia 18:30

we’ve got additional index as well that you can use.

Mike Taylor 18:33

Oh, boy, oh yeah, that’s another hole we’re gonna dive down. Okay, I did want to, if I can, just briefly mention the the effect of of using the Kardashians as an example, because I think it’s really interesting. So we, we’ve benchmarked our clusters against this, the similar set of publications. And so for example, we you might look at articles that mentioned the Kardashians in the context of inter intersectionality, which is this merging of the private and the personal. And if you compare it with a baseline, you find that the they get twice the amount of impact, twice the amount of citations. I think this is a really good example of and it kind of goes back to that 1991 article in ng that if your research has a higher profile, then it will get more get more attention. Kind of see this actually, it looks like we’re seeing this in clinical guidelines. So you know, if you look at those longitudinal studies, when you get approval, you get a jump up in attention when you get mentioned in the guideline, you can, you can see jump jumps as well. It’s almost more interesting when you don’t see the jump shift. I mean, what’s going on there? You know? What? Why are you not getting the attention? I think this is the thing that really starts opening up. You know, we’re on the verge of being able to use some really clever technologies to get real insights out of the data of our publications. You know what? What Carlos hasn’t mentioned is that normally, when we’re doing clustering, we kind of know what we’re looking for, right? So we we know that we’ve got h e r studies in the mix, and we know that h e r studies don’t get as much attention as a phase three trial. In this case, neither Carlos and I knew anything about the Kardashians, so we were taking this approach of running the data through the analyzer and then seeing what clusters popped up, but you can tune into algorithms, and there’s going to be more of this with increasing use of AI. So this idea of sort of ad hoc understanding of what’s finding attention, you know, how does and not just in sort of subject clusters, but even what language is working, how how you talk about things, what publication extenders are doing, how that is interesting. I think there’s I’m so excited about the future of medical affairs and the sort of the science of communications, because it’s all about trying to get better treatments to the patients. And, you know, winning the winning, winning, not just the minds of the medical profession, but the hearts as well. You can only do that through good communication. And

Garth Sundem 21:34

going back to knowing what you’re listening for, we’ve talked about this in the context of insights before where you have your listening priorities, you have your five things that you’re going to listen for, but then you also have the ability to open your ears and see what emerges. And it seems like that’s what you did with this Kardashian study to find these five clusters you didn’t know from the start that you were going to be looking at wealth, celebrity, gender, mental, well being you, you asked the landscape to return. What is interesting and and these are the clusters that that came out of it. I mean, is, is emergent insights compared with listening priorities, one of the uses of this kind of clustering that you see,

Mike Taylor 22:33

I mean, I think that in some ways, it’s like using an old fashioned kaleidoscope. I don’t know if you’re old enough Garth to remember those cardboard tube who look down for this crystal. You turn the thing to the bottom, and you see different patterns. And as you turn it around, so that pattern changes, and using AI and doing clustering using algorithms is a little bit like that. You have to have the eye of the beholder to use that, because sometimes you focus it and you can see one kind of cluster, and you turn it around a bit when you see a different one, you have to know what makes sense to you. And this is where, and you know the people you’re working for that this is where I think that the humanity comes into AI, that it’s a tool that gives us lots of different variations and lots of different ways of under different ways of understanding the data, but it doesn’t give us the answer. We have to recognize that. And again, you know, to talk about the heart. What resonates with the heart and what is going to resonate with the people who are consuming the the research? Okay? So from this point of view, we found five clusters the way that we looked at it. We looked at it a different way. We might have found one or three or 14, but for five, felt like it’s an interesting gel. And in fact, if you look at the graphs that we use an application called boss Neil, which is free and you can download and play around with it, there are four main clusters, and there’s another cluster that spreads around them. That’s the fifth cluster. It sort of spreads all over it. It’s sort of all in it’s pretty much all in those four. It’s really interesting. It’s like cluster that joins all the other clusters, but it’s a weakly defined cluster. And for me, I think it’d be really interesting to do this in therapeutic areas, to to take a sort of a neutral look, if you like, to be the observer of what’s going on within the within a field, and then to see, well, what’s working, what’s connecting with people. How are people? How are different HCPs reacting to this, this miasma, this cloud of research

Garth Sundem 24:44

that’s being put out around and this. We should do this. We should do this. We should do Yeah, and this cluster seems to be very, very tight and obvious, whereas this other cluster seems to be an underlying theme of all the other. Clusters. It’s never only represented in one place, but it’s an underlying information or sentiment that seems to that seems to underlie all the clusters. Okay, we’re almost out of time, but we can’t leave without learning what the Kardashian index is Carlos, what in the world is the Kardashian index?

Carlos Areia 25:21

Well, the Kardashian index is basically a measure of measure that measure, basically a metric that measures the balance between citations and followers. So the Kardashian index will tell you if you are a highly cited researcher but lower in terms of social media, in terms of following, or if you are a unicorn with both, or if you are just like a digital opinion leader with not a lot of research yet, basically, will Capture and encapsulate these three or four personas between Kol, Kol and unicorn. That that one can measure it is a satirical metric, but, but, you know,

Mike Taylor 26:11

I wonder whether we shouldn’t put a paper on this and find out whether it correlates with Kol status as as as defined by their peers. That would be really interesting. I also think you’d be really interesting.

Garth Sundem 26:26

I also think you should trademark this and put it alongside impact the I wish

Mike Taylor 26:30

someone else came up with the cake the Kardashian index, sadly. Yeah, we come up with a come up with our own. But interestingly, I mean, it is really interesting that you say that. I mean, there are so many ways of looking at how well form on social media. Carlos done some great work looking at networks of communication. We found, for example, now, if you look at some leading KOLs, you can see that the people that they are following, and they interact with our people, who are scientists. You know, they’re doing the cutting edge science, but the people who are following the KOLs are tend to be lower, seniority, earlier, various stage, medics, scientists. So you you kind of have that. You think, Okay, well, that’s quite a lot of noise, but essentially, what it means is that the Senior KO wells are acting as a bridge between the science and the the other population. So if you flip that around, because I know that these people are senior KOLs, you might say, well, who are the people who look like bridges but aren’t KOLs? Yeah, who aren’t senior Kol and this is where you might start thinking, Oh, are they influencers? What does that mean in the Medical Affairs context? I think there’s so there is a world of research to be done in this space and practical findings.

Garth Sundem 27:51

And that is your Kardashian index. All right. Well, we we are out of time, despite the fact that we could talk about the Kardashians for hours and hours and hours. Mike and Carlos, but thank you to learn more about how your organization can partner with Digital Science, visit digital-science.com. MAPS members, don’t forget to subscribe. And we hope you enjoyed this special episode of the Medical Affairs Professional Society podcast series, Elevate.