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.