A Conversation with Compliance

[00:00:00] Hello and welcome to InformED, a podcast series where you will hear industry experts

[00:00:12] share their thought-provoking insights and lessons in the field of medical communications.

[00:00:18] This series is brought to you by ISMPP and is generously sponsored by MedTank Psycom.

[00:00:24] My name is Cassie Stokes.

[00:00:26] I'm the VP of Media Strategy and Audience Insights at MedTank, and I'm joined today by Mary Saba

[00:00:32] and Megan Weigel. The opinions shared here today are those of our own and do not necessarily reflect

[00:00:37] those of our employers. Welcome to the podcast. Mary, why don't you introduce yourself first?

[00:00:42] Sure. Thanks, Cassie. I'm happy to be here today presenting on this topic of compliance.

[00:00:48] Megan and I first spoke about this at the inaugural ISMAP Academy back in the fall of 2023,

[00:00:56] and there were some really good discussions surrounding this topic.

[00:00:59] And I actually learned a lot at that particular session. So just a little bit of my background.

[00:01:05] Currently, I am lead of publication standards at Santa Fe,

[00:01:10] and our team sits within the Chief Medical Officer Office. So I'm not compliance per se. However,

[00:01:19] we are responsible for the publication processes, publication management platforms and systems,

[00:01:26] and the publication SOP. And that is a company-wide. So we touch on all areas of the company.

[00:01:35] I have about 30 years experience in developing scientific publications for the pharmaceutical

[00:01:42] industry. I've worked in both the MECCOMS agency side as well as BARMA. So I'm happy to be here

[00:01:49] today. Thank you, Mary. And now Megan, if you would introduce yourself.

[00:01:53] I'm happy to be here with both of you today. My name is Megan Weigel. I'm a medical policy

[00:01:58] advisor focusing in medical communications at Bristol-Meyer Squibb. And I just wanted to note

[00:02:05] before I kick off that everything that I will mention or say today is on my own behalf and not

[00:02:12] on behalf of Bristol-Meyer Squibb. I started in the industry about 10 years ago working for

[00:02:18] medical communication agencies doing project management for a variety of different pharmaceutical

[00:02:23] companies. And I switched over to the pharmaceutical side back in 2019 in more of a publications

[00:02:32] compliance role doing monitoring and eventually switching over to advising on not only company

[00:02:39] policies and processes for good publication practices, but also industry best practices.

[00:02:46] I'm really excited to get the opportunity to speak to you both and have a conversation

[00:02:51] about compliance. So to start us off, can you tell me why do publications, compliance teams,

[00:02:58] exist within organizations? So I'll start off on this. First of all, if anyone wants a really

[00:03:04] more in-depth background on this, they can refer to the app, a cast that's being released. I think

[00:03:11] it was released in March, navigating the non-negotiables where there's a really good

[00:03:16] description of the history of publication compliance, what happened in the industry 20,

[00:03:22] 30 years ago that led to companies and professionals to recognize that there was a need for some

[00:03:31] guidelines and standards. And that was really the birth of good publication practice as well

[00:03:38] as integrating that with ICMJE. And so I think we've learned the lessons from the past

[00:03:45] where things were not always transparent, it wasn't always best practices being followed.

[00:03:51] So that's really why compliance I believe exists today and we're here to sort of guide the process,

[00:03:59] make sure that our colleagues are compliant, able to do their jobs, but also to do it

[00:04:05] compliantly. So Megan, I don't know if you have something you want to add on top of that?

[00:04:09] Yeah, I definitely agree with you. I think that as you mentioned 20, 30 years ago,

[00:04:15] there was a lot of misconduct that was happening in the industry. We know that there was ghost

[00:04:20] writing, guest writing, guest authorship, you know, there was no reporting of transfers of

[00:04:26] values to physicians and that led to a lot of misconduct. And our industry was under a lot of

[00:04:32] scrutiny and I think that folks who are new into the profession don't always know that background

[00:04:40] and know that history. And so compliance seems really exists so that they can protect the company

[00:04:46] and protect the employees of that company and make sure that the publications that are coming out

[00:04:53] are transparent and compliant and follow those best practices that the industry has really

[00:05:00] established. Great, you know, thinking about now 2024, there has been such an evolution

[00:05:07] in the role of compliance. So just wondering what are some trends that either of you have been noticing

[00:05:12] in the industry? Well, I think first I would say that the industry is moving faster than our SOPs.

[00:05:20] We have a lot of good guidance out there. I think that GPP that came out in 2022 tried to

[00:05:26] address a lot of the evolving topics but I think the foundation is there with GPP and

[00:05:33] but things like AI, when I think of not even a year ago when I was at the ISMAP annual meeting,

[00:05:40] the discussions there about AI and the use of AI, responsible use of AI, how that's evolved to

[00:05:46] what we talked about at the academy in the fall to now. You know, it's really, it's moving

[00:05:54] fast. So I think on a lot of these newer initiatives, whether it's preprints or AI or

[00:06:01] any of the other publication tactics and strategies that teams are eager to use and to explore,

[00:06:09] we have to really remain very agile. So I don't know, Megan, what your experience has been with this?

[00:06:15] You had such a great point that things are moving so much faster than the SOPs and the

[00:06:21] standards and the guidance documents can really keep up with. You know, a lot of the issues

[00:06:27] that I've observed are around, I mean copyright is always a big one. That's not new,

[00:06:34] but it's always there like you mentioned the use of preprint servers and that can have copyright

[00:06:41] implications tied in with it. I think that there's also new challenges we see with different

[00:06:48] kinds of publication extenders, whether those are digital enhancements that are offered from

[00:06:54] a congress or journal, as well as even things like the plain language summaries and the involvement

[00:07:01] of patients as authors and things of that nature. So when communicators are coming to you with this

[00:07:08] extender ideas, are there common issues that you're seeing that you're running into that's

[00:07:14] hindering them from being able to use them? Or is it a bit of a variety of considerations?

[00:07:19] I think from my perspective, we would always want to ensure that whatever those digital

[00:07:25] extenders or enhancements when they're being used that they're always reflecting the content of the

[00:07:31] original publication. We never want to add extra data or extra things into those extenders that

[00:07:39] are not originally in that publication and that you know they're already following the

[00:07:45] appropriate review and approval steps within that company. Yeah, and I think that's one of the

[00:07:51] things that I see too that there's some questions for the themes right there just building their

[00:07:56] experience doing these. There are questions about what's the right review process for this?

[00:08:02] You know who do I have to involve in this? Where can this live? You know how can people find it?

[00:08:08] Those are the kinds of discussions that we often have. So thinking about you know preparing

[00:08:13] for those kinds of conversations and those discussions, that dynamic between medical

[00:08:18] communicators and compliance. What are some ways that maybe medical communicators could think

[00:08:23] differently about that dynamic and how they come to compliance? Well I would say you know bring

[00:08:30] us in early and have a discussion about these things because as I indicated you know and I

[00:08:37] think this is true probably for Megan as well we are not doing publications ourselves right so

[00:08:43] we're the compliance people. So I need to understand what some of these initiatives are that people

[00:08:51] are want to pursue or are considering pursuing so it helps to have that discussion early on

[00:08:57] so we can talk about what the risks may be to doing certain activities so that I can fully

[00:09:05] understand what they want to deliver and to whom and how. So I think it's really important

[00:09:12] to have those discussions up front. I think sometimes people look at compliance as the police

[00:09:18] so they don't necessarily want to talk to us first. They figure maybe we'll catch them downstream but

[00:09:27] you know it's always better to have those early conversations because I think we're you know our

[00:09:32] goal is to help our colleagues to be a resource to sort of have that expertise in publications

[00:09:39] and good publication practice and share that with them and they can share their knowledge about you

[00:09:45] know all the current trends in different types of publication extenders and different places that

[00:09:52] they plan to you know sort of go with their publications. Yeah Mary I think that we've

[00:09:58] laughed a lot about how sometimes folks can view us as the compliance police or you know that

[00:10:05] we're going to try to get them in trouble or catch them in something and that's really not

[00:10:10] not the role of a publications compliance person in a company you know I think that they really exist

[00:10:19] in order to help their colleagues find a way to move forward compliantly with what they want to do

[00:10:26] not not to hinder them in doing something. We know that there's a lot of risk around

[00:10:34] you know the pharmaceutical industry as a whole and publications can be under extra scrutiny and so

[00:10:41] viewing your compliance counterparts as you know a resource to use rather than someone who's going

[00:10:50] to hinder you from moving forward I think is a really good mindset shift to have. Agreed

[00:10:56] I actually have some experience working with some of my clients on the agency side where we

[00:11:01] were trying to get some new and novel extenders or channels approved we saw lots of success by

[00:11:09] starting early and going in and talking to compliance. One of my goals was to just understand what those

[00:11:14] guardrails are from compliance so that we can go back and make tweaks and we did have to make

[00:11:21] some adjustments and I think that's important you know to keep an open mind you know go in

[00:11:25] with the mindset that you want to collaborate and the role of compliance you know we saw them as

[00:11:32] someone who's going to help us do what we want to do but do it compliantly. And so we had some success

[00:11:38] with that approach and we're able to work together to really adjust what we wanted to do to make

[00:11:45] sure it's compliant and then get it approved and after we piloted that one channel with one

[00:11:51] you know asset we now have a success that we can build on for other assets or other manuscripts

[00:11:58] as they come across and we know we have a better idea now from the beginning of what our guardrails

[00:12:03] are and what we need to do to stay within those and then again that dialogue has been opened now

[00:12:09] with compliance and we can bring them in early. So yeah we have seen success and so I hope that

[00:12:16] others would also give this a try go in with the open mind and hopefully you would see success

[00:12:20] as well. As I mentioned earlier I don't I'm not within the compliance department per se but I'm

[00:12:26] sort of the pubs process right expert so a lot of times these discussions you may need to pull

[00:12:33] in different people you may need to have someone from legal you may need to have an RK someone

[00:12:37] from compliance and you know just to make sure that everyone's aligned that you know it's

[00:12:44] great to get the different perspectives because what I might perceive as a risk you know

[00:12:50] someone else may not then be able to talk me out of it based on their experience or just bring in

[00:12:56] different different ideas so having those discussions early on and I'm finding that more and more

[00:13:03] we're seeing that with our with our publication leads within the organization where they

[00:13:08] reach out proactively to try to understand how they can move forward with certain things given

[00:13:15] the various things that are in our RSOP and knowing what the environment's like.

[00:13:22] Yeah that's such a good point because there are certain times where if folks come too late

[00:13:29] in the process that's when sometimes the answer might be a no when folks come early on and

[00:13:37] they bring the compliance person in from the beginning and you have those discussions

[00:13:42] you can kind of shape the process moving forward to be compliant but when you come too late sometimes

[00:13:49] you might be too far in the process so it makes it much more difficult to find a path forward.

[00:13:56] So I think like you both been stressing coming early and coming with all of the details and

[00:14:02] coming with an open mind is the best the best way forward. Yeah and we even had success

[00:14:09] treating it a little bit as a concept review where you're coming in with here's the channel

[00:14:13] here's the asset here's our concept that we want to do and then think through all the

[00:14:19] considerations and make adjustments. So definitely understanding all the details so you can answer

[00:14:24] all of the compliance questions but also kind of keeping a little bit loose understanding

[00:14:30] that there may be opportunity to make adjustments in the actual asset. That was a situation

[00:14:36] we ran into we wanted to use a different publication and we had to go back to the original manuscript

[00:14:42] instead and so that was just we needed that flexibility to understand compliance's view

[00:14:48] but then also still fulfill on our goal for the project. So if we were going to talk about any

[00:14:54] key takeaways or words of encouragement for our listeners what would you offer from your

[00:15:00] perspective? What we talked about early on understanding sort of a little bit of the

[00:15:05] history of scientific publications within the pharmaceutical industry is important so

[00:15:12] you know it's good to be educated on that so that you understand why compliance exists.

[00:15:16] You know we're not here to keep you from doing things right we're here to sort of facilitate

[00:15:23] keeping everyone on the quote unquote right path right so I think first of all understanding

[00:15:30] why compliance exists and then also knowing within your organization because every company and agency

[00:15:39] who set up differently know who the publication process experts are within your organization

[00:15:45] so that if you do have a question you know who owns the SOP so you know who to reach out to

[00:15:51] with if you have questions if it's not crystal clear to you. So I think knowing who those

[00:15:56] experts are within your own organization will help quite a bit and then of course know your own

[00:16:03] companies SOP. I don't think there's a lot of difference I mean from company to company there's

[00:16:08] a lot of similarities because I think that the SOPs at least the ones that I've seen

[00:16:15] are all built on good publication practice, the ICMJ, EME and all the industry

[00:16:22] guidances for publications but there will be slightly minor differences right so maybe

[00:16:29] some little change that you know that's different from the company let's say you worked at another

[00:16:34] company previously and you find something a little different but they're all very similar

[00:16:39] but really know your company's SOP and I have to say on a personal level I really

[00:16:45] enjoy it when I get an email with a question and they've sent a screenshot of the section of the SOP

[00:16:53] and they're asking for clarification on that because it shows that first of all they're doing

[00:16:57] their due diligence they have a question about it it might be something that we need to look to

[00:17:02] update in our SOP so for me it's very gratifying to have people refer to the SOP and then of

[00:17:10] course knowing BPP and ICMJ, EME keeping up to date on those for anyone who's developing

[00:17:18] publications or leading a publication team I think those are critical. Yeah Mary I think you hit most

[00:17:24] of the top points that the only thing I would add is just to say view those publication compliance

[00:17:32] folks as a resource not as someone who's going to hinder you or who's going to get you in

[00:17:38] trouble really utilize them go to them early go to them often they would rather have you come

[00:17:46] and ask the question then come later and ask for forgiveness so really create that relationship

[00:17:53] with them from the start and bring them in whenever you can. Thank you Megan and Mary this has been

[00:17:59] a very interesting conversation but we are out of time for today if you're interested in more

[00:18:04] information about the compliance aspect please listen to the Navigating the Non-negotiable's

[00:18:10] Informed podcast released in March. Thanks for listening to Informed for medical communication

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[00:18:40] to learn more I'm Cassie Stocks