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Join us as we tackle the essential factors that drive successful commercial products. Our team interviews industry thought leaders to explore regulatory compliance, market trends, and innovation. Stay ahead in this dynamic industry.
Announcer - 00:00:04:
Welcome to The Factor, a podcast series for the life sciences industry powered by Kymanox. Today's episode is hosted by Stefanie Johns, Director of Regulatory Affairs at Kymanox, who's chatting with Crystal Weber, CEO Group 31 Communications, a life science marketing agency that helps biotech or pharma companies get their message out and engage their audience, whether that's investors, healthcare providers, or patients. The challenge the life science industry faces in marketing is talking about the amazing things products can do without violating FDA regulations. That's exactly what Crystal and Group 31 can help with. So let's find out how. Here's Stefanie.
Stefanie Johns - 00:00:45:
Hi, Crystal.
Crystal Weber - 00:00:46:
Hi.
Stefanie - 00:00:46:
Thank you so much for joining us today. I'm so excited to talk to you.
Crystal - 00:00:50:
Thank you. I'm really excited to be here.
Stefanie - 00:00:52:
So I just wanted to give our viewers just a little bit of more of a background about yourself and Group 31 if you want to talk about what you do every day.
Crystal - 00:01:01:
Sure. So my background is I was in healthcare for a really long time. I'm an advanced practice nurse and worked at Duke University working in the pulmonary vascular disease center with patients with pulmonary arterial hypertension. And I switched over to medical writing and medical communications several years ago. I've been at Group 31 now for six years. We've been around for 14.
Stefanie - 00:01:26:
Wow.
Crystal - 00:01:26:
We are exclusively in life sciences marketing. So helping companies that are in biotech or pharma get their message out really helped make their science a narrative story to engage their audience and help drive the change that they need. Whether that's talking to an investor or a healthcare provider or helping a patient.
Stefanie - 00:01:48:
That's awesome. And I'm sure you're immensely helpful for a lot of small biotechs in particular who are trying to navigate the overall development of their novel products. And I know as a regulatory professional, you know, one of the things that my clients a lot of times will struggle with is, how do I talk about my product and not have issues with FDA giving me warning letters? And so it's always about, well, am I making a claim? And so I was wondering if you could kind of talk about, you know, what is a claim and what does that mean and how to navigate that?
Crystal - 00:02:21:
Oh, sure. Absolutely. So a claim is anything that is a number or something you can measure. It could be a comparison, even something as simple as having your brand name or logo in the same view as a disease process can be considered a claim. And a claim isn't bad. It just means that you need to layer in some extra fair balance to be able to make sure that the consumer is able to read and understand appropriately what it is that you're talking about. So claims are things that you're going to have in medical communications. And what you need to do is just make sure that you're balancing that out appropriately.
Stefanie - 00:03:04:
So if a company, wanted to make a certain claim, what would you recommend as far as like, let's say if they're pre-approval versus like post-approval, like how do you balance that?
Crystal - 00:03:17:
So, you know, best practice is always to start by thinking about what is the right thing for the consumer and sort of work your way backwards from there. You believe in your product, you believe that it's going to work, and you still can't promise that it's going to work for everyone, right? And you don't want to set that false hope or false expectation for somebody because it might not work for them. And so best practice would be to think about what is most accurate. And I think probably most of your listeners are scientists. They believe in science, they believe in what they're doing, and ultimately that's also protecting people. So if you start from that lens, that's sort of your safest bet. So functioning as if this is going to go in front of your neighbor, and would you feel safe giving them that information?
Stefanie - 00:04:18:
That's great feedback. And one thing I was kind of interested in, too, is as a regulatory professional, when I always start, even in early phase, I always ask clients, you know, what do you envision your label to look like?
Crystal - 00:04:32:
Such a good question.
Stefanie - 00:04:34:
So what types of things do you think companies should think broader about to make sure that they have what they need in their label when they go and do post-approval marketing?
Crystal - 00:04:44:
So that's a really great question. So a lot of it comes down to thinking about what are the different ways that you can imagine this product being used, even so you can structure your clinical trial appropriately, making sure that you're powering it right, that you've got your endpoints set appropriately. Because if you've got a product that you know works in X disease state, but it's not on label, you can't talk about it.
Stefanie - 00:05:08:
Exactly.
Crystal - 00:05:09:
And we saw that in some of the recent diabetes medications, right, that started getting used off-label before the label changed. I bet all of those companies would have loved to have that in their initial label.
Stefanie - 00:05:22:
Absolutely. Yeah.
Crystal - 00:05:23:
And so.
Stefanie - 00:05:24:
Great example.
Crystal - 00:05:25:
Exactly. Making sure that you've got, you know, that your clinical trial set up in a way that you can then talk about the science that you know is there.
Stefanie - 00:05:35:
Yeah, that's a great example, too, because I know a lot of companies, they want to pipeline everything out. And maybe sometimes they try and shoot for the stars, but you can only get so far at certain times of your program depending on what's the easiest for approval versus maybe it's a lifecycle management.
Crystal - 00:05:55:
Yeah. Oh, absolutely. And that's a tricky one, too, with a pipeline where you know you've got something that is potentially coming and you're going to be submitting. You still have to be really careful, especially if you've got this product is already out in market, not talking about it in a way that's not out there and approved already. If you're looking at a label expansion, making sure that you're talking only about the data. And it's so hard when you're super excited about the science to not be like, oh, my gosh, you guys, this is great. But it's really crucial to make sure that you're sticking with what it is the FDA has approved. And to be thinking thoughtfully about what their role is, right? They're they're not there to be punitive. Their job is to protect people. And so if you if you take it from that lens, everything that we do ultimately ladders to the person, right? And so all of the regulatory bodies, FDA included, are about protecting people. And if you can operate with that in mind, you're automatically going to be safer.
Stefanie - 00:07:11:
Absolutely. And I think working with companies like Group 31, you know, if you're not sure if it's a claim or if your data could substantiate that type of statement when you're talking about your product, I think that's always best practice because the lines are gray. And I think that's where a lot of companies can get themselves in trouble, you know, because they think that their data supports it. And then, you or I might look at it and I'll say, uh, like maybe not, you know?
Crystal - 00:07:39:
Yes, yeah. And it's really interesting because there are some things that you wouldn't even think about being claims. We had a client several years ago that their product was a skin care product that was for something like dermatitis. And it was only approved ages 12 and up. And they really loved images of people with young kids.
Stefanie - 00:08:08:
Oh, that's a great example.
Crystal - 00:08:09:
And that becomes an implied claim.
Stefanie - 00:08:13:
Yeah.
Crystal - 00:08:13:
And so you've got to be thinking about what is it that you're putting out in the world? What's the—if you're looking at the entire piece, what does that actually look like to a consumer who isn't every day in the science, right? And what they were trying to say was, if you've got your dermatitis under control, you can take your kids to the pool and have it not be a problem.
Stefanie - 00:08:40:
Oh, wow.
Crystal - 00:08:41:
And the product isn't for kids. And so you have to be really, really careful on everything. So imagery could also be a problem if you think about where do you put your logo on a piece. That has rules about it. The way that you set up your logo is also really crucial. There are rules about how big the font sizes need to be and what the font treatments are. And then also where that falls in relation to the important safety information. And so having somebody that can help with that, help guide you, because the worst thing that would be to get a letter.
Stefanie - 00:09:25:
Absolutely.
Crystal - 00:09:26:
And the downstream effect of that can be devastating for a company and especially for a younger company that doesn't have deep pockets to help mitigate. You know, it can be company ending.
Stefanie - 00:09:42:
Absolutely, because it's about trust, and you have to build that trust with your consumers and also your investors.
Crystal - 00:09:49:
Yeah.
Stefanie - 00:09:50:
And other stakeholders in your overall development program. And you don't want to lose that trust or damage your image, whether it's making claims that maybe are now disputed by FDA.
Crystal - 00:10:02:
Oh, absolutely. And I think it's important to remember that FDA isn't proactively reviewing and approving all the pieces that you're putting in market. And so what that means is they have empowered everyone to report anything that looks like it has overstepped the label. And the way that I think about it is if I were to put this piece in front of, like, my high school nemesis and they were holding a grudge, would this potentially get us in trouble with FDA? And so what can happen is somebody can call FDA and say, this is what I saw that could trigger an investigation by the agency. And again, their job is to keep people safe. And so it's in their best interest to investigate all of those. And as long as you're buttoned up, it doesn't matter what your high school nemesis did. Because as long as you've done everything that you're supposed to do, chances are you're going to be fine. But if there is an implied claim or if you do overstep your label, that does put you at risk. And it's pretty significant risk. It's not just like, oh, geez, I got a letter, no big deal. It's reputational damage. Your competitors can utilize that in their marketing and their communications. There's risk for piggyback enforcement with other agencies.
Stefanie - 00:11:37:
Yes, that's usually what I see.
Crystal - 00:11:39:
Yeah. Yeah, and if you get a letter, then is the state attorney general going to start looking to see? And we've seen that happen nationally with a couple of companies. And so what we do at Group 31 is, yeah, we're marketing. But first and foremost, we are risk-averse science nerds that love to help take really interesting science and communicate it, right? And within the guardrails of the regulatory agencies that we live in.
Stefanie - 00:12:18:
No, I love it. I think it's perfect. And you reminded me of one facet that always kind of surprised me as social media has emerged as not just a platform for communicating with friends. It's now communicating everything, especially products. And it's something that we have to be aware of.
Crystal - 00:12:39:
Oh, absolutely.
Stefanie - 00:12:40:
You know, as regulatory and marketing professionals in the pharmaceutical space, because it's not just putting something on social media about your product, like you can get a warning letter if you tweet something that is not appropriate.
Crystal - 00:12:54:
Well, and also need to remember that I know of a client that—
Stefanie - 00:13:00:
Do you?
Crystal - 00:13:01:
I do. That— They felt like their marketing team wasn't being aggressive enough and went out and did their own social media ads without thinking about the regulations. And they didn't know. This was somebody who was just like trying to get the word out.
Stefanie - 00:13:23:
Passionate.
Crystal - 00:13:23:
Yeah. Passionately trying to get the word out. They felt very strongly their product makes a difference and then didn't think through what that could look like and ended up getting smacked around a little bit.
Stefanie - 00:13:33:
That's sad.
Crystal - 00:13:34:
Because they didn't include fair balance. And all it had was the product logo and the disease state. And got smacked around for that a little bit. And so unfortunately, we don't have super duper up-to-date regulations for all the different types of communicating with people. And so you do need to lean into your med legal team, making sure that you've got strong people around you that understand the regulations to help keep you safe. And ultimately that protects you in the science. And it's not just sort of what you think of with social media. It's also Google ads are getting a lot more prominent things like Reddit. You're seeing a lot more ads there. And so thinking about what is actually in view, what might trigger a claim, and what is the best way that you can reach your audience that you need to.
Stefanie - 00:14:31:
Yeah, that's great advice. And I think the overarching theme here is that it's complicated. It's not a very straightforward, you know, I have some data. I can just say whatever I want with this data. It's very word selective, how you present it, the images, the logos, it's everything together.
Crystal - 00:14:52:
And that even starts pre-label when you're talking to investors, right? You've got that forward-looking statement that you have at the beginning of all your presentations, and you can be positive and excited. And there's still rules that you have to follow. So, the best time to start thinking about marketing is before you have a name for anything.
Stefanie - 00:15:16:
Yeah, that's great.
Crystal - 00:15:18:
You're rolling your product out of your academic institution. You're beginning this, be thinking about marketing then and how you can be proactively keeping your company safe.
Stefanie - 00:15:29:
Yeah.
Crystal - 00:15:30:
In the same way that you're thinking about your IP protection.
Stefanie - 00:15:33:
Yeah, especially as you interact with patient groups because they get very excited and they want to talk about it. So, like, you have to make sure you're giving them appropriate information so you're not overpromising.
Crystal - 00:15:45:
Yes, absolutely. And then remembering that FDA is just one regulatory body, right? So, thinking about information that you put out in the world and sticking with digital for a second, having to think through the rules around ADA compliance. So one in five people has some sort of disability. And with the rules with the ADA, your job is to make sure that everything that you put out is accessible to everyone, regardless of their abilities. And so, when you're creating a website, when you're sending an email, thinking about what if somebody is using a screen reader, when you're creating a chart, even for a poster. Would this poster work for somebody who's colorblind?
Stefanie - 00:16:35:
Wow.
Crystal - 00:16:36:
Because your data is only as good as you can communicate it.
Stefanie - 00:16:39:
Oh, absolutely.
Crystal - 00:16:40:
And if it's getting lost because people don't have access to it, you might as well not have communicated.
Stefanie - 00:16:46:
Yeah, absolutely. No, that's a great point. You know, you just touched on a great topic. Are there other regulations or standards that companies need to be aware of just beyond FDA and ADA compliance?
Crystal - 00:16:58:
Yeah. So, I think ADA compliance gets overlooked a lot. And there have been, since 2020, the American Bar Association estimates about 10,000 lawsuits a year, specifically with digital ADA compliance. And that includes some pretty significant players in pharma. So, Novan, AstraZeneca, AbbVie have all been hit with lawsuits about compliance. And just like you don't want to get a letter from FDA, you don't want to get sued for not having a compliant website. So building from a mindset of making accessibility there from the beginning means it's going to help keep you safe. And again, a huge lawsuit that could be company ending. Especially thinking about that when you're going to have a landmark of you've got a press release that's coming, when you're going to have a poster, when you're going to be launching, making sure that you're layering in all your ADA compliance. Because now you're going to have all these new eyes visiting the website. And it's really, really important to make sure that you're making the data available for everyone and not taking unnecessary risks.
Stefanie - 00:18:26:
No, that makes sense. You know, I think that's a great point that probably a lot of companies are not thinking about right now. Are there any other regulations that you find problematic in this space?
Crystal - 00:18:40:
So, there's some stuff that seems sort of basic, but ends up tripping up people a lot. And just as an example, so you want to send out an email. You want to put your product name in it. You need to have your registration mark. You need to have the generic name. You have to be careful about what's in the rest of your subject line, because in that one view, you have to be incredibly careful. And then other things like the regulations of the space that's allowed. So thinking about Google ads, if you've got to fit something in a certain amount of characters, that's really key to make sure that when you're thinking through your claims, that you're going to be able to get the information across in a way that's not going to get you in trouble. And thinking about other agencies would be like FTC, SEC, all have a stake in making sure that whenever you're communicating to folks, you're doing so in a way that follows all the rules. You know, there's ways that you're allowed to talk to investors. There's ways that you're, yeah. So it's good. And I don't feel like I sound like a broken record a little bit. But it's so key to have people around you that actually know this stuff. So that way you can focus on doing the science and bringing this product to market. Because, you know, the reason that most people in biotech get into it is they've got something personal about it, right? Maybe one of your parents died of pancreatic cancer or you have somebody who has CAH in your family. And trying to find ways to make life better for people living with that disease process. That's the best reason we're here. Absolutely. And so if you can hand the regulatory piece of it off to people to help keep you safe, help protect the company, it's like an insurance policy.
Stefanie - 00:20:47:
Absolutely. I mean, that's definitely on the forefront at Kymanox. You know, our company slogan is because patients deserve better. And that's why we're here. And I'm sure that's why Group 31 does what you do and here to support clients. So obviously, like for best practices, as you just said, it would be beneficial for companies to work with experts. But when is the right time? Because a lot of these smaller biotech companies it's hard. Because they're trying to pour all their attention and funding into actually generating data. But then how do they talk about the data safely? So what's your advice to kind of balance that and interacting with companies like Group 31?
Crystal - 00:21:32:
So I think some of it comes to finding the company that's the right fit for you. If you're very, very early stage, you don't need to go to a huge Manhattan-based company. Those are great, but they're not going to be able to scale to your budget. And so, honestly, I think the best time to start thinking about it is as soon as you're going to be putting stuff out into the world. I think the place where we fit in best is you're getting ready to come out of stealth mode, and then we can help you move toward the next step safely. And to give you an example of sort of our favorite clients to work with, we have a client that we met four years ago. They had enough money at that time to update two slides in their investor deck. We have since helped them grow, go through seed funding, and they are next week signing the closing papers for a $65 million Series A.
Stefanie - 00:22:34:
That's amazing.
Crystal - 00:22:35:
And we've been with them that whole time. And so the way to partner with that is you know that this is something you have to do. You know you need to do marketing. You know you need to do it in a safe way. So getting somebody who's a part of your team that you believe in them and they believe in you. And so what we will do, and I suspect several other companies function this way as well, but I do have a Group 31 bias. What we will do is sit down and say, okay, let's talk about what are your goals for the next six months, what's your budget, and then try and come up with how do we get that information out to the right people in a way that accomplishes what needs to be done within the regulation of the space. And then because I'm cheap, we also look for how can we spend that same dollar three ways, right? So some of it is finding that right partner who's interested in protecting your bottom line too.
Stefanie - 00:23:35:
Yeah, that's great.
Crystal - 00:23:36:
Because ultimately, when our clients succeed, we succeed.
Stefanie - 00:23:40:
Yeah. I mean, I've never really considered how marketing can also be huge for investor relations. Especially when you're doing the early stage funding because you have to get your name out there because you're competing with so many different companies.
Crystal - 00:23:56:
Exactly. And even, you know, if you're going to go to a big meeting like BIO or, you know, like a SETC kind of meeting. You might not have the money for a booth. You might not have the money to attend the whole meeting, but you still need to have a presence there. So thinking strategically within your budget of what can you do to continue to get your name out and get things moving in the right direction for you so you can meet the right people.
Stefanie - 00:24:25:
That's a great application because I think a lot of times when companies think about marketing, it's huge, like huge campaigns. But it could just be more strategic communications to get them noticed by larger companies for partnering.
Crystal - 00:24:41:
Absolutely. So we have a couple of companies that were not able to attend BIO just from a cost perspective. You know, it's a spending meeting.
Stefanie - 00:24:53:
Yeah, it's an expensive conference.
Crystal - 00:24:54:
And what we have helped with is do Google ads before the meeting that drive to their investor page. We can target that based on geography.
Stefanie - 00:25:06:
Wow.
Crystal - 00:25:06:
For other companies, we've set up like a virtual booth. So you can come in and have that same sort of interaction, but have it be digital. All of that can cost less than sending your entire team to a very expensive city for five days.
Stefanie - 00:25:20:
Absolutely.
Crystal - 00:25:21:
And, you know, a lot of it, a lot of marketing is about just getting that name recognition, right? And so the more often that people are talking and thinking about your brand, the better you're going to be able to get your KOLs to know who you are when a potential investor calls them and say, hey, can you vet this science for me? You want people to be bought in on the science. It starts with name recognition.
Stefanie - 00:25:49:
Absolutely. Well, you know, it's all about who you know. I mean, it's making connections, building connections. And that could probably be influenced just by having really solid communications, as well as having help from Group 31 or other companies that can help you make those connections.
Crystal - 00:26:09:
Yeah, absolutely. And that's a big part of what we do is play a matchmaker for folks. You know, I love learning about the different companies in our space and who are the great people that I can connect my clients to because we can't do everything. I am not your person to write your PI. We're not going to help with your clinical trial. But, chances are we know somebody who can. And so just sort of leaning into that relationship building, it's so key.
Stefanie - 00:26:43:
Absolutely. I mean, when you think about all the steps that it takes to get a drug or a combination product, drug device, whatever product it is, across the finish line, it's a lot. And there's a lot of different hands and facets, but it's just nice to have comfort and having solid connections to get you across the finish line.
Crystal - 00:27:04:
Yeah, absolutely. And if you've got that good team around you, then you can focus on doing what you actually want to do.
Stefanie - 00:27:12:
Absolutely.
Crystal - 00:27:13:
And not have to worry about wordsmithing in a way that, you know, keeps you on the good side of the FDA.
Stefanie - 00:27:18:
Absolutely. No, that's, I think, a great point to end on. And I just wanted to say, you know, thank you so much for joining. Is there anything else that you want to... Say is like in conclusion of our chat today?
Crystal - 00:27:32:
Absolutely. So thank you very much. I've really enjoyed this. I think the key thing is remembering that our job as scientists and science communicators is to tell the truth, which means making sure that you're not over-promising, even if you're really excited.
Stefanie - 00:27:56:
I think that's a great point. So thank you so much, Crystal, for joining us.
Crystal - 00:28:00:
Thank you. Appreciate your time.
Announcer - 00:28:07:
That was Crystal Weber and Stefanie Johns. For more on Group 31 Communications, visit group-31.com. That's group-31.com. Thank you so much for listening to or watching this episode. Please subscribe or follow this podcast in whatever app you're using right now, or follow Kymanox on LinkedIn for all updates. This episode was edited and produced by Earfluence. We'll see you again soon on The Factor.