Challenges and Opportunities in Publications Leadership

Rob: When people think about switching companies, size matters. We hear it all the time. Some want to leave big organizations for the agility of smaller ones, while others are looking to move into larger, more structured environments. But what actually changes when you move between companies of different sizes, especially when it comes to leadership? 

This is In Plain Cite, a podcast exploring the biggest questions and trends facing medical publication and communication professionals. I'm your host, Rob Matheis, president and CEO of ISMPP. 

Today's episode is generously sponsored by Avalere Health.

On our leadership panel today we’ve got: Heather Abourjaily, Head of Medical Communications at Stoke Therapeutics, Suhaida Selamat, Senior Director of Global Publications at Kite Pharma and David Ginkel, Global Head of Publications at Astrazeneca. In this episode, we’re taking a close look at how leadership differs across small, midsize, and large companies—from organizational structure to decision-making, budgets, and even AI integration policies.

Rob: One area that I wanna start off with is, I think there's probably an assumption out there that in bigger size companies, there's more of a, I guess a focus on compliance and professional ethics when it comes to medical communications and publications, and that starts to wean off as the company sizes gets smaller. And I just, I wanna explore that with you guys a little bit and see, you know, what the ratio of strategy and execution to compliance and publication ethics is within your organizations. 

Heather: I've been at midsize and small biotech companies for a long time now, and I would say that those attributes are important even at small companies, but it's how you bring everybody along to try to get there and teach.

Everyone wants to be ethical. Everyone wants to follow good publication practice and our authorship criteria, and think about the data that we are publishing. But it's a lot of teaching and reeducation and reeducation to get folks there. So they believe in it, but it's just, um, hard to herd the cat sometimes.

Rob: Suhaida, how does that compare to, uh, your organization? 

Suhaida: It's very similar. For us, there's a lot of folks who have a very, um, academic background experience, which is very different than industry publications. That history with compliance isn't there. We also don't have a history of a CIA or an awareness of what happens, the consequences of not being compliant, for example. So that element of education is very important. 

Rob: So it sounds somewhat similar, but in some ways it actually sounds as though, um, Heather has a little bit more of a, uh, uh, folks joining in on the compliance side than you do, Suhaida, to some degree, but 

Suhaida: It's taken a few years, but I think we've moved the needle slowly but surely. And sometimes it takes the right leader in the right place to kind of bring the rest of the group along. Sometimes I work from the bottom up, sometimes I work from the top down. So it really is, uh, dependent on, on each group and situation they're in. 

Rob: That's a good point. I guess it really does come down to who you're actually working with, what their experiences have been, if they've been in a company that had a CIA, to the point you were making earlier, um, that will all impact most likely, whether or not there's an openness to professional ethics in publishing. Um, how about you, David? What are the thoughts over there from a larger size company? 

David: Uh, it's a large amount of our time spent on certainly good publication practices. And I was, uh, with the cross-functional team, was leading an effort to update our standards and SOPs. And I think the challenge we face in a, in a larger pharmaceutical company is just the ways the publication are somewhat different in oncology. Versus rare disease, which we also have through Alexion, our partner, and then the biologics, and then the early r and d versus, you know, trying to deal with something more of a phase three registration or, uh, real world data.

You know, it took, I would say we spent a full year last year just trying to align on how do we interpret the standards, how we can apply those in our company, and then how do we train, we do a lot of training also with markets and market companies on how they should be compliant. 

Rob: So I think to some degree all three of you mentioned training and education.

So staying with you for a moment, David, how much of your role is, is going across in just opening people's eyes and making them aware of what could happen when things go wrong and, and that, that training aspect? 

David: I'd say it's. One of the key things on our job description, probably one of the first things is, you know, compliance with good publication practices, making sure that people have qualified as authors, uh, that we have a appropriate approach to that and documentation.

So I'd say it's a huge amount of our time. We do webcast and we do all kinds of, uh, material that we support, and I'm like, next week I'm presenting to all them. Medical marketing company leads to give them an update on attestation and how do they understand how their authors qualify. So it's a, it's a big portion of the job.

Rob: Interesting. Suda, do you make the rounds too and and kind of go across the company and, and educate? Or is that a lesser part of your role, would you say? 

Suhaida: No, I do. We have a road show that we go in and, and, uh, not just educate folks within our companies, but also the folks that we collaborate with as well.

I. I would say when I train, one thing I try to do is not just talk about what the compliance rules are, but why, and I think people tend to be a little bit more open to following the rules if you explain why this rule came about or the horror stories that kind of got us there. 

Rob: That's a good point.

Certainly giving that context, uh, helps to make the point. Um, Heather, how about you? What, uh, how does it go within Stoke? 

Heather: So I think I might be a little bit, have a little bit more luck than David and so Haida because when I come to a small company, they're usually, in the past there has been no process in place.

There have been no standards in place and no SOPs. And so I'm starting with a blank slate. And luckily people are hungry for it because they have trouble publishing and they want to publish their work. And so I'm able to come in and put a structure in place and within that I'll embed good publication practice, um, along all of the steps that happen within publishing, um, and getting a manuscript or abstract or whatnot written.

And so I'm continuously educating at each publication team meeting and almost with each email, with each review, this is why this is happening, and this is the next step so that they know what's coming. What's fascinating is. It takes a long time to get through a publication, you know, developing a manuscript and doing it in the right way, but it's faster than when you don't have a process in place and no one prioritizes it, and no one is the, the person who pushes it through.

So I think in that respect, I'm, I'm pretty lucky. 

Rob: And the truth is, you know, following good publication practice at the end of the day, will ultimately get you to a quicker deliverable than not following a good publication practice. 

Heather: Absolutely, yes. 

Rob: So, while you still have the microphone, Heather, you know, I'm curious about your internal review and approval process, and I wanna explore how that differs across these different types of companies.

So let's say you have a, a peer reviewed manuscript ready to go, where does it go next? 

Heather: So if I've done. My job correctly, the senior leaders have seen the paper throughout different points in development, and I think that is different in a very small company compared to mid-size and large, the CEO reviews.

Paper, the potentially board of directors review the paper appropriately. They are all interested to see how the interpretation has gone, how it's written. Is it clear? I have to continuously remind them that it's the author's work, it's the author's language. We cannot insert certain language, but that again, is part of the teaching process.

But with a small company. Every communication we have externally is critical to the survival of the company. And so the amount of reviews go up. I think when you're at a smaller. Company, everyone wants to see it. Everyone is so invested in what that paper says, especially those pivotal papers. 

Rob: Yeah, it sounds like it's all eyes on the publication and that certainly does heighten the importance of your role and the work that you and the team do, but it's gotta be somewhat frustrating when you're getting input from the board of directors or the CEO that you're trying to reconcile with your byline authors.

It 

Heather: is, and luckily, so far it's only been the pivotal papers that really want to, um, be reviewed and I let them. Note that it's the author's work and we need to respect that. I actually had to convince them that it was the authors who need the final sign off and no one can touch the paper. After that, they wanted it to go back to the CEO and I said, no pants down.

This is it. Yeah. It's like, it's education and, and making sure that it doesn't get held up by so many reviews. 

Rob: Yeah, it seems like it potentially could be very time consuming. 

David: Mm-hmm. 

Rob: David, how often are you sending your papers to the CEO and the board of directors? 

David: Hopefully not too often. Um, you know, unless they're an author on it.

Yeah. I think, uh, the challenge we have is obviously it's a large organization. We have reviewer lists, tables that they need to comply based on what kind of study it is. So that might include the franchise medical leave, the head of clinical, the head, the stats head, the IP. Um, the challenge we have is sometimes we get some turf battles between, you know, like let's say it's a Heon paper, it's globally led, but then the US team says we don't agree with the results, so they wanna weigh in.

So it's more like people wanna all get added on. We try to limit that to whatever the standard says and who should be reviewing that and not make it a free for all. That's kind of a challenge though, is a lot of people wanna weigh in on things. 

Rob: Certainly another good scenario where there's a lot of eyes on the publication, a lot of interest in getting it out and making sure that it, uh, gets the reviews that it needs to be, but still a bit different than the small companies where things are going way, way up the flagpole and, uh, and landing there.

So I'm curious, Sohi to how does it work in more of a mid-size organization where, uh, in terms of review and approval process. 

Suhaida: I think I'm somewhere in between David and Heather. We do have a rubric, depending on the publication, who gets to review it. It definitely doesn't go up to the CEO or the board of directors.

Um, but similar with the small company, I do definitely make sure the authors have the final approval. So it goes to us, but then it goes back to the author as the publication lead. We also keep track of all the author comments. So if anybody internally in that final business review has a comment that's counter to what the author wants, then I will overwrite that or I will go back to them saying, no, this is exactly what the author wanted.

Um, so we do have to keep a close eye on that. 

Rob: Do you find that happens a lot in your scenarios where you have to step in. 

Suhaida: Not a lot. I do try to train our internal reviewers like, this is not the time for you to be making editorial reviews. It's not your language preference time. You know, you're really looking in terms of is this aligned with what the company wants to say?

And is it accurate, fair, balanced, and for me, did it follow good propagation practice? So this is not the time for you to opine. Um. Really, all the authors have already done that, so. 

Rob: Right. No, that makes good sense. Just switching gears a little bit, um, so how do you guys use agencies? Do you have one agency of record?

Do you have a bunch? What's your R-F-I-R-F-P process? We could spend a whole podcast on that, but maybe just an overview. Heather, we'll start with you. Do you use agencies and, and how does that work? In a very small company. 

Heather: Yes, at Stoke we do use agencies. I've been at other small companies where they have not believed in agencies, and that's a really hard, um, mountain to climb and convince them that we do need agency support because once a publication person is hired, they said, well, we have you.

We don't need a publication agency. Not understanding all of the work that goes in behind developing a publication. So how I have it set up at Stoke is I have an agency that helps with the strategy development and the publication plan development, congress plan development, and then I have an agency that that just focuses on execution.

I. And then I have a third agency for creative. I wanted to bring out the best in all agencies that I am working with, and that's sort of where that all fell out. There's plenty of work for each of those agencies to have, and so this seems to be working well for me right now. 

Rob: Good. Where do you go for your budget, for your agency work?

Like do you go right to marketing for it? 

Heather: Yeah, so directly from, um, medical has their own budget and so I have the majority of the budget within medical, given a scientific communications workload, and luckily it's been at Stoke, it's been very easy to, to get the budget. 

Rob: Excellent. Sohi Hapa in your organization.

How does it work? 

Suhaida: Um, as a former agency person, myself, I'm very pro agency. I have two who help me. I don't have as clean of a division between them as Heather does. They both kind of work on the plans and they both work on executions. I have over the years figured out that one group is a little bit better with, um, more heavy preclinical work.

The other group is really a lot better at, um, time sensitive work. So I tend to divide the work. Based on that and our budget letters up to medical. So definitely not for marketing. 

Rob: Okay, excellent. David, how 

David: about for you? Yes, we use agencies at a, uh, a company like AstraZeneca. I mean, we're doing publication volumes in the thousands each year, so we have to have agencies to support us and develop that volume of work.

I'd say the advantage of the agencies is they tend to be the ones with the long-term view. Like they've been on some of these brands for 5, 6, 10 years. They have a lot of people have worked on it and seen things come and go, so they understand the combative environment very well. You know, we don't have medical writers internally.

That's not the real goal. Our people internal are alignment, developing the plans, making sure it's aligned with the scientific narrative. You know, we manage the internal teams to make sure we know what should be going forward, but they actually really help us operationalize each of those individual manuscripts, oral abstracts, whatever we're doing.

So they're critical. And yeah, we use about probably five or six very consistently, and then some others here and there. 

Rob: You mentioned thousands of publications, and that actually creates a segue to one other area I wanted to explore, which is metrics. So David, what type of metrics do you keep in a large pharma company who's asking you for metrics and you know, that type of uh, dialogue I.

David: I think you're gonna get asked a different question depending on which therapeutic area you're in. So oncology is very different from the biologics, which is very different from rare disease and rare disease. I think you're looking at, uh, some of these things like alt metric scores and dimensions wouldn't be as valid or useful.

Um, and obviously we're trying to get our teams to move away from impact factor. Really use KPIs more around the broader value of a publication, meaning, yes, okay. What was dimension scores and all that, but also, you know, getting into like how. Important. Was this in that journal? Was it the third most read?

What about the digital content? Was it used? Were MSLs using it was in me Medin info request happening? Was it used in training? So we really try to focus our KPIs on also on just a few of the key big readouts, like what are the major ones, and try to prioritize, that's our key word now, prioritize. Try to do less volume based.

Um, which is historically where people have been and trying to get into more of the value of that publication. 

Rob: It's looking more at the impact and how it's influencing the rest of the world as opposed to just counting the beans day in and day out. Um, Heather, how about you with metrics? 

Heather: I. Did you see me taking notes?

Um, so right now, thanks David. Right now, um, I am just setting that up and just starting to put together some very basic metrics around impact. And I really like what you said, David, about seeing where the publication is used versus just impact factor and reach. It's fun to think about how I've, um, developed metrics in the past and how I can take the best practices and set that.

Up well for Stoke. 

Rob: So how about you with metrics and how are they being used in your organization? 

Suhaida: I think we're trying to figure out what we want to measure. We can measure a lot of things. The question is, what does that actually mean? We can measure activity that's very simple, you know, metrics or the other things.

But I also find at least what we are struggling with is, for example, global might think, oh, this doesn't really have an impact. And then suddenly some country will come to us and say, actually we need this for an HTA submission. We're not gonna get reimbursed in country X, Y, Z if you don't have this in the peer reviewed.

Publication. So how do I measure that individual country impact and impact directly to patients, uh, in that country? So I think it's, it's a more complex issue. And then some things like a clinical trial that failed, you know, the metrics that it's not gonna look very sexy. However, to me that's an ethical responsibility that we need to publish that in a peer reviewed manuscript.

Those are patients who participate in our clinical trials. So. The metric for that is not gonna look great. However, you know, what does that impact of us in terms of our scientific reputation and commitment to patients? So I think I struggle with metrics. 

Rob: Yeah, it is interesting though. I was surprised by the responses that it does seem to be that there's, across the board, across all three different size companies, some evolution towards more than just counting things, or at least an openness to it, which I think is a big change and shift in our, in our profession over time.

So that's, um, that's great to hear. I. Uh, you know, so one other area I was hoping to explore was the utilization of artificial intelligence AI across companies. I know there's lots of different thoughts and opinions about how it can be used in medical communications, but I'm wondering if it varies across different size companies.

So, uh, Soha, I, why don't you start us off. 

Suhaida: It is quote unquote not recommended. In our company, we have developed an internal closed loop tool, but it's mostly for internal communications and not for publications yet. 

Rob: Interesting. And Heather, how about for you in a small company, are you guys using AI to any extent?

Heather: No, but our head of Medical is very keen on having some trial runs with it. I think where we'll start is with SSLs and see how it works around standard response letters and then move over to publications. 

Rob: Got it. How about you, David? AI in a large, uh, company? 

David: Yeah. We have launched the tool, which is uh, for plain language summary, first draft development.

It's worked quite well. We are exploring other tools to help me with poster development. That's more challenging, by the way, 'cause that involves. Visuals. It's very exploratory. That would be the opt operative word. Lots of exploration. I'd like to see if there's AI tools that could help us reformat a rejected manuscript.

I'm not yet in the camp of, we should go do manuscripts yet and submit those. 'cause I'd like to hear a little more from the journals first of. What they're willing to accept, what they won't, uh, for first drafts, what's the language we'll use in terms of transparency to make that make it appropriate? So I would experiment on that last, but I think there's lots of areas we could use it, maybe even to improve some of our internal reviews, just looking for errors, like something that's missing on disclosure.

So we're exploring. It'll be, I think, at least a two year journey to find tools that work and, and make it more efficient. 

Suhaida: I have a question. So did you adjust your author agreement? To acknowledge and get their consent to use AI for the publications. 

David: Well, right now we're not using it for manuscripts outside of plain language summaries.

We do discuss that with authors for posters. They're aware of it. They review it themselves too. So there's always a human that reviews it. So again, we look at these as more first drafts where a, a large language model works quite well, which would be like a plain language summary is a natural. But I, I have concerns around what authors will think if we went to the next step of doing full manuscripts, and that's why I kind of would rather not be a first mover in that area.

Suhaida: So that's always my question. Like do I have to then, you know, adjust my author agreement letter so that everyone is aware and okay with the use of ai, but we're 

Heather: not there yet. But I think it's important what David said is that it doesn't take the human out of it. It doesn't take the authors out. It's just to help with that first draft development and get something written.

And so that, I think, yes, we would want to make the authors aware, but it's not like that's the only. Person AI writing the manuscript. 

Rob: Well, it sounds like we need to set up another podcast, uh, specifically for AI across different size companies and use cases. I always say there's a, we should just set up meetings and if we just had AI the whole time, we'd sell like hotcakes.

So it's such a hot topic, but um, I wanted to thank you guys for taking time, uh, today to chat. Yeah, thanks. It was fun. Great. Thank,  

Rob: Well, that's us for today. Thank you all for listening. Please take a minute to subscribe to In Plain Cite on your favorite podcast app. Share with your colleagues and rate our show highly if you like what you heard today.

In Plain Cite is a production of ISMPP, the International Society for Medical Publication Professionals. This episode is generously sponsored by Avalere Health.

Our production partner is CitizenRacecar. Our producer and editor is Hajar Eldaas. Post production by Alex Brouwer. Publication and promotion by Candice Chantalou.

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