Uncovering Small Pharma

Rob: For many publication and medical communication professionals, the idea of joining a smaller biotech or pharmaceutical company can be incredibly appealing. Less bureaucracy, closer access to leadership, and the opportunity to make a visible impact. But the reality of that path can look very different from life inside a large organization.

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.

To help us understand some of those differences, today we're joined by Robin LeWinter, Global Head of Medical Affairs at JCR Pharmaceuticals. Together, we'll explore the realities of building publication functions with limited resources, the many hats publication professionals are often asked to wear, but also the unique opportunities that come with working in a smaller organization.

Let's get to it.

 (End of Intro) 

Rob: This is a very timely conversation given that so many of our people are finding their ways into smaller companies. Um, as I look across the industry, I see so many folks just kinda jumping ship from the bigger companies and wandering into some of the smaller ones. And we thought maybe we'd have you, um, here to tell us about what it's like to be in one of these smaller companies 

So maybe that's the place to start, Robin. What do these, uh, what do these organizations look like when it comes to publications and medical communications?

Robin: I have worked in, I don't know, maybe four or five different small companies now, and I can't say that any of them look the same. They're all unique. Like any company, they're all unique. They're all a bit chaotic. Um, I think that is the underlying factor, and I don't mean that in a negative way. I just mean that, you know, the s- the structure that you are faced with in a larger company is often not in place or, not fully in place at, at every small company that I've been at.

Rob: Okay. So you don't have the full structure. So you don't have a publication department with 15 people, is that what you're saying to me?

Robin: Yeah, no, exactly. It's a small company. You don't have a department at all. Often it's just you, and if you're lucky, you have a couple people who will help you out.

Rob: All right. So I know there's no one set way to look at any given company. It sounds like you've had a couple of different experiences. Um, so does publications typically sit in medical affairs in a smaller company?

Robin: I have never been in a company that does not have publications within medical affairs, but, um, medical affairs is not always a fully established function as well, and sometimes it's part of R&D or development division or, something within the larger umbrella. Um, I have multiple times come in that publications is one of the first hires in the medical affairs team. So it's like you're starting the medical affairs team while you're starting the publications and the medical communications

Rob: Interesting. Uh, why would you say that publications is an early hire in the process? Why do you think that is?

Robin: Okay, let me take a step back. Maybe that's more medical communications than publications. Um, I don't think it's... It is often one and the same, where you have a publications team that often does medical communications in a small company. And a lot of that is because you're just starting to figure out how you wanna talk about your drugs or how you wanna talk about your disease to the healthcare providers, to KOLs, to, you know, the, the larger population of people that will be hopefully using your drugs. The medical communications will come in to help bridge the gap between the clinical development and, and the healthcare providers who might not have been in the clinical trials.

Rob: So I'm glad in particular, uh, right off the bat, you brought up the difference between publications and medical communications. And why do you think that the MedComms are so important? Is it because there's more functions contained within doing some of that work? Like, does publication medical communication people do more than just publish stuff in the smaller companies?

Robin: I mean, in an ideal situation, you will have consistent communications with your publications team, with your field force, with your regulatory teams, with all of the different functions within the pharmaceutical, you will be talking about your diseases and your drugs and your patient population in the same way. And that will be reflected in your publications, that will be reflected in your MSL material. It will be reflected in-- Ideally, it could be reflected in the protocols that are written by the clinical development team, where you are, focused on... You've identified what are the key drivers of success of the drug early on, and that's what your clinical team is using in their endpoints and your regulatory team.

That's ideal. In a small company, that is often not the case. What I've seen happen is all of a sudden you have a clinical study that reads out, and you need to publish a paper on it, and nobody knows how to do it, and nobody knows how do you get this sometimes fairly academic paper into the world where it's seen by the people who you wanna see it. And so they'll hire a publication person to help speak about, get the word out about your drug or your great results or whatever it is that you wanna publish about, out. And part and parcel in that is figuring out how to communicate the key points of your drug. 

So I think there are-- medical communications is often part and parcel with publications, um, by the nature of the work you're doing and by the fact that hopefully someone with publications has some sort of a skill set involving writing and communicating, and that also goes hand in hand with medical communications

Rob: Oh, so you said writing. You, uh, you expect the publication professionals to be writing the publications, in these scenarios?

Robin: I mean, ideally you'd have help and a vendor, but in a-- the realistic space of small pharmaceutical where there's-- or a small biotech or, you know, a small company, there's very limited budgets. There's very limited understanding about what it takes to produce a publication. You have an abstract deadline that's next week, and you just don't have the time, let alone the money, to partner with somebody who is an expert writer.

So I don't necessarily expect my publication professionals to have English degrees, for sure. They're not writing the Great American Novel. But, I expect them to be able to look at an abstract and tell me what's good and what's not good. I expect that they can, you know, write five hundred words that are appropriate to the audience.

Rob: It's interesting, right? If you think about many of our publication and medical communication professionals within the ISMPP community, you know, we've evolved to a place where we do a lot of strategic planning, a lot of publication planning. Many folks do come with medical writing backgrounds, many do not. So it may be a little bit of a transition to wander yourself into a smaller company and then be asked to put pen to paper and generate those 500 words, uh, right off the bat. So it's, uh, definitely a transition. 

Robin: Definitely. It is, I mean, that's how it is at these small companies is you're wearing many hats, and if you come in as the publication expert for publication planning, the bulk of the team has no idea what that is, and they think that you will be doing the writing. And realistically, you have to understand what, what are the components of an abstract. Um, yeah.

Rob: No, makes sense. So some of the folks who are listening today, that may make them a little anxious if they don't have medical writing backgrounds or English backgrounds, whatever it may be. Some of them, you know, they grew up in many different disciplines. Should they be concerned about joining a smaller company, or is it eventually that you'll get an agency to help you? Like, what's the typical path that you see?

Robin: Like any company, but probably particularly in a small company, you have to be able to make the case for getting additional help. You have to start with the expectation that you are not the medical writer, and you have to start with educating your bosses or whoever is running the function you're t- working with as to what is the function of medical publication planning versus medical writing. You have to be able to make the cost-benefit analysis. So there's just a lot of educating as to how do you produce a publication that will actually be well-received and used by the people you want it used by. 

I don't necessarily think a publication planner needs to-- You don't necessarily need to be able to write the most polished thing, but you need to be able to guide the people within the company and your vendor. I mean, there's plenty of vendors I work with that could use some help with their writing as well. So I want you, like, I, I think it's important that someone in the publication field at least be able to read something and tell you if it's well-written. Whether you write it yourselves, that's another thing

Rob: Makes good sense. Now, we're not gonna knock on our vendors out there, but is it a different type of, uh, support that comes for the smaller companies? Like, is it, if you're a vendor, are you working differently with a company like yours versus one of the biggies out there?

Robin: I have so much empathy for vendors when it comes to working with small companies. You know, I, I actually started, with a vendor, so there's definitely some, some personal empathy there. But, we don't come in with a full publication plan that is going to be able to support one medical writer, a, a full medical writing team, let alone one medical writer for a year. You know, we have a couple abstracts here and there. We have a not very well thought out plan. We have not a lot of resources within the company where people understand how it's done. We throw a lot of stuff at the vendors, and we're like, "Write something." And often, and in my case, I've worked in a lot of the rare disease spaces, so you're asking somebody to write something really good in a disease state that they've never seen before or they don't have the expertise with. 

So just by the fact the vendors are ri- running a business as well, we're throwing not a lot of money at a vendor and then asking them to give us the full attention that they would for a large company, it's a lot to ask of them. And it's a lot to ask to get consistency. Like, you wanna be able to work with the same writers and the same medical directors at your vendor. And to get that consistency over the course of your publications and the course of many years can be really hard from a business case to do.

Rob: You know, earlier on in our conversation, you made a lot of reference to the clinical teams, and I think we spend a little bit more airtime talking about clinical and the relationship between the publication MedComm professionals and the clinical team. Maybe medical affairs is, is less relevant at this stage, um, any smaller companies. Is that an accurate statement?

Robin: I think it very much depends upon the stage of your drug. I mean, if you're doing phase three studies, you probably want your medical affairs team to be involved. If you're doing like a phase one study, I don't know. It's good to bring them in sooner rather than later.

Rob: It varies, especially if you have them. I'm asking because we're talking about vendors and agency support, and I just wonder if it's a different level of support because of the stakeholders that you're working with, uh, in this particular regard.

Robin: Yeah. I mean, I think, by want of the fact that you are working on earlier clinical stage studies, the people in your company are not necessarily experienced with the pharmaceutical industry. They often come from an academic background. But then you're working so closely with PIs and, oftentimes with the people who have done a lot of the drug discovery. A lot of the people you're working with directly, whether within your company or externally, but the people who are working on the phase one studies or the phase two studies, your authors, they do not have the background and experience working with a pharmaceutical company.

They're used to, you know…The kind of publication that you do in grad school with a molecule and a cell model, it's a different type of publication than you are doing when you are trying to bring a drug to market. I'm not-- I mean, I come from an academic background, so I have a lot of respect for, for the work that I did in my PhD, but you can't just take the data and run a student's T-test and publish a paper. You need to have a biostats team. You need to have data that's been reconciled and cleaned and data that's been, you know, thoroughly vetted. 

And there is this intermediate space between a fully funded, well-run phase three study and a phase one trial where you're really just trying to prove proof of concept, where you're working with maybe not the easiest data set, but you want to appropriately share it out as you move the drug towards future development.

Rob: Yeah, I mean, it sounds to me, based on what we're talking about, it actually could be a very completely different experience for someone entering a small company versus if they were working very recently in a large company. The stakeholders that they're with, the type of data that they're working with, academics who are probably tenure track and yes, running student t-tests and, you know, maybe don't know how to do more sophisticated analyses and don't have a biostatistics team with them. Definitely a very different role for a publication medical communication professional to fit themselves into. Having said that, I mean, is it rewarding? Is it more challenging? Is it like…

Robin: I mean, it's both.

Rob: Working with small companies, what do you think?

Robin: It's so much fun to work with people who... I, I'm, I'm just thinking back to some of the times I've worked with academics who have worked really, really hard to come up with a treatment platform or a way to treat, in my case, rare diseases, and they really want to share it with the world, and they don't know how to. And you come in and you help them put together a publication that gets into a pretty decent journal, and that, you know, is, is seen by so many people. And there's this gratitude on their end but there's also this, like, pride on your end that you have taken this really cool new technology or approach or something and have brought it to the world. That part is really fun and really rewarding. 

Um, I mean, it's, of course, challenging because you're also telling these people that, no, you can't have 50 authors on a paper and everybody does have to review it. There's various aspects of publishing in a regulated world they've never necessarily had to consider before.

You know, just...I, I come from an academic background, and I've now been in the industry world for, like, 20 years, and I am still trying to figure out how things work in a pharmaceutical industry and who the different players are and who the different people are, and it's really unfair of me to expect any of these academics I'm working with to understand what clinical operations does versus what clinical development does versus what biostats does versus what I do, and they just see you as the face of the company. So you're, you're just, there's just so much education of everyone involved that it can be sometimes challenging.

Rob: So that was gonna be my very next sentence is, wow, you must be an educator among all the different roles you have because you're really responsible for making sure that these investigators, um, academics know some of the bureaucracy, know some of the process, or even if they don't have to learn it, you have to at least get them through the whole thing, and that really changes the role a bit.

So that makes me wonder a little bit, you know, we talk so much within, you know, our space about good publication practice and SOPs and, just following process compliance. How the heck do you ever accomplish that in a small company?

Robin: However you can. Um, I mean, I, I volunteer to speak at whatever meeting they will let me speak at. Every time we have a new publication, I try to educate again on the process. You know, you write policies, you try to get people to read them. I will do one-on-one meetings with people as appropriate. I mean, I just... Whatever way you can, you just keep talking about what it is. You can share GPP, you can share ICMJE guidelines, you can share all this stuff, but realistically, most people don't have time to understand what you're doing in the same way you do. You have to approach every individual in their own way and work with what works with them, but ultimately you have to use whatever tools you have in your toolbox to get people to follow the processes. 

Rob: So, you know, we talked a lot about, um, potentially industry people making their transition in and out of big or small companies and how it's, um, a different environment, different experience. And we also talked a bit about agencies and agency support and what a difficult challenge it can be to so- sometimes work with the smaller biotechs. When you're looking to bring on an agency, to go back to that, if you're going to market and you've got XYZ budget, are there particular things, if you're speaking to our agency partners who wanna work with smaller companies, what are you looking for in them?

Robin: I'm looking for a company that has consistency, like has medical writers that are, there's not massive turnover. There's a lot of turnover in the pharmaceutical and the agency side, don't get me wrong. There's turnover everywhere. But, um, there are some companies where you've had relationships with them for a long time, where you know that the medical writer might turn over, but the medical director will be stable. You can trust that there is some consistency in understanding of your disease or being able to figure out what the key points are in the space. 

Um, and then I look at price. You often get what you pay for, and there are, the agencies that I most like to use are the ones that often charge more, but they charge more for a reason. But on the flip side, there are some agencies that charge more that maybe aren't necessarily charging what, you know, I'm not getting the value from them. You know, so I will say I've been at companies where I've said, "I wanna work with X agency, and it costs this amount of money to do this project," and they will say, "That's way too much money. We have another agency that will do it for half the price." And it's, it's a dance to get them to come around to the agency or the people you want to work with. And it can be challenging to deliver a really good product using an agency that you don't necessarily want to use, but you also wanna make sure that there is, you know, that what you're delivering looks good. 

So I mean, that comes back to where I'm saying I do want my publication planner to be able to read something and know if it's good or not, and to be able to provide feedback to the agency. And I try to provide a lot of feedback. I mean, I'm acting as a publication planner, but also a pubs manager where I will send something out for review, and then I will be the one collating the comments and giving direction to the agency. "This is how we should address it. This is, what I do and I don't wanna see." And there's just an immense amount of time kind of on all levels of creating the publication. But, there's definitely some agencies I'd rather work with than others, and I don't always have the opportunity.

Rob: So, you know, we talked a lot about the differences between the large and the small companies, but definitely a similarity, the dance with the agency partners and figuring out which is the best mix and, convincing stakeholders when there's more expensive options and so on. Certainly putting the patient at the heart of what we do is a similarity. But if you asked me to read the transcript of our discussion, probably two phrases come to mind, throughout our discussion, and one is it varies and it depends. And when we f- first started our conversation, you said, you know, "Rob, there's two things we're gonna talk about today. These companies are unique, and they're chaotic." And I kept that in mind as we had our discussion. I think we covered a lot about the unique. In the time we have left, tell me about the chaos. What goes on in these places that makes it so chaotic?

Robin: I mean, there's... you're trying to get a drug approved. There, there's not that kind of window to, to spend time putting together a very strategic plan. So a lot of what we do by just nature of where things are at is very reactive. Like, oh my gosh, this big meeting's coming up, and the deadline for the abstract is in three weeks. We better put something together. You know, it's not easy to go to an agency and say, "I need you to write an abstract in three weeks." This is where it's really helpful to have somebody who can write an abstract in-house, or if your publication person can write an abstract, that buys you a little time. It's hard to get that dedicated strategic planning time. Um, it's hard to work with an agency to put together a strong strategic plan. It's hard to have communication statements when, I mean, you hear all the time, and I've heard this in large companies too, but you're building the plane while still flying it.

And I think that is fairly consistent across most of the pharmaceutical industry, but you definitely feel it more in a small company. 

Rob: Yeah. so I think we've had a great conversation, so far. I, you know, I have just one more question for you. We have a, um, a number of our listeners who are out there working in big companies, they may be thinking, "I don't want the bureaucracy anymore. I don't want the red tape. I don't want five levels of management. Wouldn't it be great if I could just sit myself down in one of these smaller companies and make a difference?" And if you had to give one or two pieces of advice to someone who has those shoes on, what would you say to them, and, and what would that advice be?

Robin: I do think you're a lot closer to making a difference at a smaller company. There's a lot more resting on your shoulders, but with that comes the ability to make a lot more difference, whether it's patients in getting drugs to market or, educating on the drugs, or for the company. You definitely can affect change in a way in a smaller company that you can't at a larger company. I mean, you also don't have that structure, and some people really thrive with the structure, and it-- there's some sort of, safety in having that structure. That's a great place for some people. 

Rob: Well, it sounds very re- refreshing. I think what I hear you saying is before you jump ship, and it's not a bad thing to do necessarily, just make sure you have your mindset in the right place and that you recognize that it's gonna be different, but there's the opportunity to do a lot more and maybe even be closer to the patients depending on, on the company they end up working for

Robin: Yeah, that I agree with. And you also, you get closer to, um, leadership in a way that you don't at a larger company, and being closer to leadership is another way to affect change that can be really rewarding.

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.

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In Plain Cite is a production of ISMPP, the International Society for Medical Publication Professionals. 

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