Marie Teil - Global Head of Special Patient Populations at UCB

Why are pregnant and breastfeeding women still so often excluded from clinical research, and what does that mean for real-world decision-making? In this episode, Laura Brencher, Leapcure's VP of Advocacy, sits down with Marie Teil, UCB's Global Head of Special Patient Populations, to unpack the long-standing evidence gap for women of childbearing age and what it takes to close it responsibly.

Marie shares why inclusion has to be intentional from the start, how earlier data generation supports more informed conversations between patients and clinicians, and what “ethical” truly looks like when patients are left without evidence. The conversation touches on growing global momentum, including evolving ICH guidance aimed at supporting the inclusion of pregnant and breastfeeding individuals in clinical trials and what leaders across the ecosystem can do today to move the field forward.

In this episode, we cover:

• Why excluding pregnant/breastfeeding populations creates real-world risk and uncertainty
• Designing inclusive studies as a default, not an afterthought
• Building trust-driven, evidence-based approaches that support patients and physicians
• Progress in the field and why upcoming global guidelines matter
• A principle to carry forward: protect women through research, not from research

Subscribe for more conversations on clinical research innovation that keeps patient needs at the center.

Creators and Guests

LB

Host

Laura Brencher

Vice President of Advocacy at Leapcure

MT

Guest

Marie Teil

Global Head of Women of Childbearing Age Program, Pediatric, Elderly at UCB

What is Leap Together Podcast?

This is the Leap Together Podcast, where we highlight top leaders driving breakthroughs in clinical research and life sciences.

Marie: 00:01

We have a long history of not first of all, excluding women, and then 20 more than about twenty years ago, we started including women in research, but definitely excluding women pregnant or breastfeeding women. We we often see that in even social conversation that you may have had, Laura. Right? When I I state what I do, very often people say it's not ethical to do that. Is it ethical?

Marie: 00:29

And my response is over. Is it ethical for pregnant women not to have data Yeah. And not to be able to have an informed decision?

Laura: 00:37

Hello. I'm Laura Brencher, and I'm one of the hosts of Leap Together, where we talk with leaders in clinical trials and patient advocacy to explore how medical breakthroughs come to life. In clinical research, there are moments where inclusion isn't just about numbers. It's about designing studies that reflect real life, real patients and real experiences. And when you start to see those stories come through, that's what keeps you pushing forward.

Laura: 01:00

So today's guest that I'm really excited about is Marie Teil, global head of special patient populations at UCB. Now Marie leads work that's changing how we think about evidence generation and trial design for women, especially during key stages like pregnancy and beyond for these populations. She's a leader who brings both scientific and deeply human perspectives to the challenge of inclusion in clinical research, and I can't wait to hear more about how that work is unfolding at UCB. So, Marie, welcome to the show.

Marie: 01:28

Thank you, Laura. Thank you so much for having me today on the Leap Together podcast. Really thrilled to be here.

Laura: 01:35

Oh, good. It's great to have you. And just to start us off, could you tell us a little bit more about your role at UCB and what inspired the special patient populations program?

Marie: 01:44

Yeah. Indeed. Thank you. So I would say it's it's interesting that we put these populations together, but the way we define it at UCB is women of childbearing age, pediatrics, and elderly. And why these groups together?

Marie: 02:00

Why these populations together? Because we believe and we know they need tailored considerations in the development, in the dosing, and the administration of pharmaceuticals. And today, they still face significant unmet needs, not really addressed fully at least by current clinical studies. And this is why we believe timely and consistent data generation for this population is essential. So just to give you an example, children and and young people have distinct unmet needs across different ages, age categories, and they are not included in the initial studies.

Marie: 02:38

Women of childbearing age, what do we know about them? About seventy percent of pregnant women use at least one prescription medication during their pregnancy. However, only about five percent have been adequately tested, monitored, and have data in the label. And if we talk about elderly individuals, they often struggle with multiple health issues. They have higher rate of polypharmacy.

Marie: 03:06

They're complex patients, and their response to treatments can differ noticeably from younger adults. Yeah. So this is why UCB is designed to advance science in chronic diseases for this population. And it it's a it's a true commitment that we have at UCB for those who have too often been left over or overlooked by convention conventional clinical study. We want to change that.

Marie: 03:32

We want to prioritize inclusive study design, as you mentioned, and early data generation so that we can ensure all considered from the onset, not as an afterthought because we believe they deserve answers that are rooted in evidence and not just assumptions, which is often the case when you don't have data. So really our mission is to empower data driven decisions that improve health outcome for these populations for them and for their physicians so that they can have an informed discussion. And we're on an exciting journey there. Right? We continue to build out the program.

Marie: 04:14

We make this vision a reality. So I hope I come back another time for the purpose of the interview. But today, what I would like to do is focus on women of childbearing age because as you said in your introduction, pregnancy, breastfeeding is really a big question mark for women living with chronic diseases. So if you're okay with that, we could focus on that today.

Laura: 04:38

Yeah. That's brilliant. And thank you for the breakdown. It's such impactful work, and I'm really excited that UCB and and yourself are really focused on it. I'm really interested in in how you got into clinical research and what led you to focus on special patient populations as well.

Marie: 04:53

So I studied about twenty years ago Mhmm. Maybe a little bit more in academia, and I got different various roles in academia and clinical research, in ethics, in operations. And early on, I really noticed that many studies excluded pregnant and breastfeeding women or at least we're not asking the questions that matter to them. And, separately, personally, I had, witnessed friends living with chronic diseases who were struggling with family planning gestation and facing pregnancy while managing their conditions with almost no data to guide them. Yeah.

Marie: 05:36

But, really, the moment I remember where it truly hit me is when one of my friends lost a baby due to a flare of her chronic condition and and was totally, you know, left without, you know, what could I have done, this feeling of should I have done something differently? And this lack of information really struck me and and and fueled my determination to to bridge this gap between science and reproductive health, which was at the time huge. Still big, but was huge. Because indeed, women have been excluded. Pregnant and breastfeeding women have been excluded from participation in clinical trials.

Marie: 06:17

And and, practically, as as I gave that example, you know, I now have many more that this could have very serious consequences for for women and for those who are taking medications and still need to manage their disease. And most of the time with a chronic disease, you need to you need to continue

Laura: 06:38

Yeah.

Marie: 06:38

Taking care of your disease. And very often, unfortunately, the the health care professionals are are forced to make decisions without really robust evidence and more assumptions. And and the discussion with their patient is difficult because of that. So this is how I started. I started because of that.

Marie: 06:58

My background was in clinical research. I had couple of experience. One, really, really, I will remember always. And so when UCB approached me, it was clear that it was an important field, and I needed to do that at a time where pharma was absolutely not into it. I think we talk more now about that, but at the time, nobody was really interested in pharmaceutical companies into it.

Marie: 07:25

That. And so so I studied at UCB and we we truly committed to generating data, robust data to design inclusive studies, to collaborate with patients, and HCP, and to better inform ultimately, pregnant and breastfeeding women. And we believe that our studies are helping to build the evidence that is needed and that has been missing for for too long. Yeah. But what we do also is that we change the trial design.

Marie: 07:55

We, engage regulators earlier. We engage patients. We ask them what matters to them. Yeah. And we engage physicians as well to know what matters to them as well so that they can have this discussion, and they can make a more informed discussion.

Laura: 08:12

That makes complete sense to me. It sounds like for you, inclusion in this case and in many cases is about including every stakeholder in the decision and the process.

Marie: 08:23

Yeah. Absolutely. Absolutely. And and I think it's interesting to see how today, in a world powered by data, we all look at data.

Laura: 08:33

Yeah.

Marie: 08:33

I feel it's totally not acceptable that women and their health care providers must have to make really critical life decisions without these adequate data. So for me, it's more than a scientific issue. It's an ethical one. And this is why we always say at at UCB that women should be protected through research, not from research. Yeah.

Marie: 08:55

And this is kind of our motto. We we owe it to to our patients and these families so that they don't have to make a choice. They at least can, you know, back up their decision with by evidence, and every voice is heard. So this is really why we're doing that.

Laura: 09:16

Yeah. Something that always strikes me as well is that the data is so variable. I guess because there's not enough data, the care and the approach for women is so variable by region, by country, maybe even city to city, and that's that's a little bit scary as well. So there's just, you know, no consistency with the care and the options, and I think to your point, more robust data that can be kind of accessed globally is is really important to kind of battle that, I think.

Marie: 09:41

Absolutely. Absolutely. We see a lot of discrepancies in the data. As you said, region by regions and and and different levels, different approach to the data. And I think we need to think a little bit differently about these pregnant women and, you know, consider them as we would consider any patients that that we see and and think more about what robust research has been done to generate this data, really critically looking at at the data that are generated.

Marie: 10:13

Yeah. Absolutely.

Laura: 10:13

Yeah. That makes complete sense. And I was thinking about how communication can be really important to engage individuals with research opportunities and, you know, how they can help maybe themselves potentially, but also how they can make an impact on others through research and that data collection piece that comes from research. So say say someone becomes pregnant and isn't sure whether to continue their medications or, you know, is worried about what they can take or should take for acute issues, how do you guide that conversation, and where do you kind of point them for trustworthy information?

Marie: 10:44

Yeah. So it's very difficult today. I think a place where we always go is the label.

Laura: 10:50

Yeah.

Marie: 10:51

Because this is the drug label. This is where, ultimately, we guide the patients. Right? Yeah. However, there's in addition to that some research that is done and there may be some publications, and this is where it becomes really hard.

Marie: 11:06

So for us, we guide them to the label. However, I truly believe that the responsibility extends beyond us, beyond pharmaceutical industry. It encompasses every the entire ecosystem. I think the health care professionals, the media. Yeah.

Marie: 11:26

It's an advocacy group, public health institution. Everybody has a part to play, right, in ensuring that women are receiving the accurate, the timely, and supportive information that they need when navigating, their chronic diseases and their family planning and their reproductive journey. Yeah. So when a woman is planning a pregnancy or is pregnant, really, it's important to have conversation about her medication as early as possible and, ideally, I would say prior to being pregnant.

Laura: 12:00

Yeah.

Marie: 12:00

So when you're pregnant, it's already a little bit, you know, you you're missing a little bit of the early conversation. It's really important that if this woman is not sure, the first step is speak speak to a health care professional. Yeah. Speak to your doctors. Mhmm.

Marie: 12:18

This conversation is critical. It's grounded in trust. It's empathy. It's evidence based guide guidance, but which also make is sometimes difficult for physicians too. Yeah.

Marie: 12:30

But I also wanna say most women will turn to social media, online forums Mhmm. Peer communities when they feel, you know, they are concerned or when there's enough not enough data out there.

Laura: 12:46

Yeah.

Marie: 12:46

And and I believe the media could be a powerful tool for education and for bringing this information out, but it also can be a source of confusion. Right? Sometimes you see unclear, contradictory reporting. You mentioned that, Laura, earlier. This difference in or unclear information really lead to fear very often.

Marie: 13:13

Yeah. So whether it's it's, you know, a click or online or support group, it's really important to share information that it's really consistent Yeah. Because this is how women get a better information and a better decision. And, what another important point is to make it really easy to understand at least what really matters to them. Yeah.

Marie: 13:38

And I'm insisting on that because we can be very you know, put a lot of data out there, but we need to be clear about what is this information that that they want to hear. Goal is to help their decision to help them feel supported, informed, and make sure they actively participate in this process so that they feel more confident about speaking about their health. It's interesting because there's a report. I don't know if you saw that report, the prescription for change. It's a report by the World Economic Forum and Kearney.

Marie: 14:13

Right? And they really highlight this critical gap in women's health research in general, but particularly pregnancy and and medication safety. Good. Right? I think it's it's clear that in the context of pregnancy, this report at least underscores the importance of empathetic conversation with health care professional.

Marie: 14:34

The need to direct individuals to trusted and science based resources, not just beliefs, because we all have our own beliefs. But let's go back to the data. Yeah. And an important point is to to get this robust and science based evidence, you need to encourage participation in clinical trial or in reserve at a minimum. Right?

Marie: 15:00

Because this is how you get your robust data. Right?

Laura: 15:05

It's a yeah. The the daily challenge that we're working on over here as well.

Marie: 15:09

Exactly. And and I know you're very familiar with that. We we have so something else we did, last year is we developed with patients Mhmm. Discussion guides that were really designed for these important conversations with with HCPs so that patients would feel equipped with the questions because sometimes you don't even know what to ask. Yeah.

Marie: 15:33

Right? And and when to ask it and what to ask it. So there are discussions guide discussion guides that are available on the website, on the UCB website for I'm planning a pregnancy. I'm thinking maybe I wanna have a baby and I have a chronic condition. Mhmm.

Marie: 15:50

Or I'm pregnant. What should I ask? Or I wanna breastfeed. What should I ask? What is interesting is that when we the patients design these guides along with physicians, and there's also the guides for physicians who wanna be equipped to ask the questions at the right moment because sometimes in a busy practice, they don't have time to ask these questions.

Laura: 16:12

Yeah.

Marie: 16:12

So it's it's for both of them. Right? It's this discussion guide. It's I think it's one small tool to help everyone, you know, have this conversation early on and start thinking about how do I generate data. Oh, I we had a patient head of patient association a long time ago who said, you know, if every woman was willing to share the data and to participate in a registry in research, we would have tons of data to help us being more informed.

Marie: 16:47

So something we haven't thought about for decades. Right? We actually avoid it for decades. I think we need to rethink the way we're looking at it.

Laura: 16:57

Yeah. I totally agree with you. And, you know, something that I wanna come back to that you mentioned as well in terms of, like, where patients and women get their information from and where they go to for information is advocacy and something very close to my heart and a core part of LeapCure as well. But I really wanted to delve into it because a lot of what we're about connects to advocacy and how they communicate out. And so you've been, I know, closely involved with Bridge, and I know advocacy groups like Bridge can be really meaningful to so many people.

Laura: 17:29

So could you talk a little bit more about, firstly, what Bridge stands for, Bridge's mission, and and how it helps close information gaps before, during, and and maybe after pregnancy?

Marie: 17:38

Yeah. Yeah. Thank you. So I'm a co chair of Bridge, and I work with really very closely with this group, this multidisciplinary team Yeah. That is really committed to transforming how we support women's health across the reproductive journey.

Marie: 17:57

And so BRIDGE first of all, I want to say BRIDGE stands for better research, information, and data generation for empowerment of women with chronic diseases. It's an independent initiative that focused on closing the information gap that affects women, as you said before, during, and after pregnancy because the delivery is not the only thing that happened in the life of the woman. You have the after pregnancy that could also be challenging. And we often talk about breastfeeding, but it's not necessarily breastfeeding. It's regardless of the breastfeeding situation and willingness.

Marie: 18:35

And what BRIDGE does so so it's it's a group of independent passionate physician, atheist, patients, ex regulators. It's global. Mhmm.

Laura: 18:45

It's a

Marie: 18:45

group that is global and really calling for a paradigm shift in the pregnancy and breastfeeding journey for women, you know, during their reproductive journey. Yeah. And the goal is to elevate women's women as a as a a guardian, if you want, of their own health in partnership with their health care team. So what is unique about Bridge is that we have a patient head of patient partnership as a co chair, and the voice of the patient is here from the beginning

Laura: 19:19

Good. Yeah.

Marie: 19:20

Of everything Bridge is developing. And the core principles, if you wanna bridge and of the what guide our work is access to relevant information is a fundamental right for women. Yeah. Women living with chronic illnesses should be at the forefront of the decision making about their health Mhmm. And their reproductive health.

Marie: 19:44

And decision making must be individualized for each women's needs and preference. Yeah. Right. And, one of its core goal is to change mindsets within the pharmaceutical industry, but also among clinicians and even among women themselves about what truly inclusion in research means. Because as we said, we have a long history of not first of all, excluding women, and then 20 more than about 20 ago, we started including women in research, but definitely excluding women, pregnant, or breastfeeding women.

Marie: 20:21

You know, we we often see that in even social conversation that you may have had, Loran. Right? When I I state what I do very often, people say it's not ethical to do that. Is it ethical? And my response is, is it ethical for pregnant women not to have data Yeah.

Marie: 20:40

And not to be able to have an informed decision? Yep. And so as we're talking about Bridge, just to to finish up on that, there's a Bridge report that has been issued last year and and published last year, and the goal is to provide practical action oriented recommendations for industry. So I think we we all know there's a data gap. I think a lot of your audience, you know, there's a gap.

Marie: 21:06

But what are the actions? What are the recommendations? What can industry, to regulators, researchers, policymakers, and patients do Yes. To help closing this this data gap. So UCB so why we're there?

Marie: 21:21

UCB is proud to be the first organization who sponsored and provided administrative support and communication to to Bridge. And and now we have more interested into into Bridge, and and we wanna make sure that all of us together, we collaborate to ensure that women have access to the evidence they deserve.

Laura: 21:43

Yeah. I was gonna say, actually, everything you shared really does point towards collaboration. I guess the question on that is why is working together across patients, advocacy groups, and industries so essential for progress?

Marie: 21:56

So I believe that we all have, and we see that very clearly in which we all have our ways of looking. We see through our background, through our local environment. And then when I say your local, it's your function. It's what you do. It's what you've learned.

Marie: 22:14

If you're a researcher, you see problems through your researcher eyes. The patient has its own. Regulators have their own, you know, look at at things, which is normal. This is how we we are trained. This is how we function, and this is why we're so expert each of the fields that we are in.

Marie: 22:35

Yes. However, it's very difficult if you tackle a problem through one aspect to impose it to others. Actually, nobody wants it. Everybody wants to understand and see and bring their vision and their point of view to a a challenge. Yeah.

Marie: 22:53

And this is why to me, collaboration is the because from the start, and this is why Bridge is so unique, from the start, we have included patients in this discussion. So from the start, we hear them. We listen, and and we hear what the needs are, and they're actually part of the solution Yeah. And the action oriented recommendations, which I think is essential talking about patients. But same for regulators, for researchers.

Marie: 23:21

We all need to do it very, very early. Otherwise, it's one bringing it to another group, and you miss you always miss something when you do.

Laura: 23:31

Yeah.

Marie: 23:32

So this is a little bit why we continue to to collaborate with with others, and and we want to contribute this collaboration and want to expand as much as we can. We have more and more groups being wanting to join Bridge or to collaborate with Bridge, and I think it's can only be a plus to be bring different perspectives Yeah. To the to this topic, which is a complicated one, and it's not an easy one to tackle.

Laura: 24:00

No. So much of it is about just listening and and properly hearing, isn't it?

Marie: 24:05

In the world, share the ICH E21 guidelines that are being designed for inclusion of pregnant and breastfeeding individual in clinical trials. And I think this is gonna be it's gonna become in the coming years a true help and support for all of us to generate more data, but also have more data Yeah. For these discussions. So I just wanna I I think it's a it's a fantastic, work that this the ICH, is doing. And I know these groups are working really very diligently on on this, and I'm looking forward to seeing the guidelines in, hopefully, end of next year, '27.

Laura: 24:49

Yeah. Feels like we're really on the edge of some change and and good progress here, so I'm really looking forward to the next year or so as well to see what happens.

Marie: 24:57

This is true. It's it's really interesting to see, and I've been in that field for more than ten years, almost twelve years. And and I see the progress. I see what has happened from at the beginning, even the lack of awareness, very few. We were small group talking about it to now, you know, more and more interest in the field, more and more reports, more and more documents, and this ICH guidelines coming to to help all of us in terms of data generation.

Marie: 25:28

So it's really fantastic and really encouraging to see what's going on in the field. Yeah. Truly. Yeah.

Laura: 25:37

I was thinking, we've talked about a lot today, and I'm wondering before we wrap up, the one simple idea you hope that all the listeners remember from this conversation today if you have one.

Marie: 25:48

So, yeah, I'm gonna I'm gonna say for everyone to remember is something that that I mentioned already, which is remember that we need to protect women through research and not from research. And to me, this is what should stick to all of us.

Laura: 26:04

Yeah.

Marie: 26:05

It's about protecting women. And, of course, we need to have the data, preclinical data, clinical data to have the decision, but this is what we should all aim for.

Laura: 26:17

Yeah. I love that. Thank you.

Marie: 26:18

And I'm hoping that initiatives like your podcast Mhmm. To help raise awareness, the bridge initiatives, and a lot of others are gonna help getting there.

Laura: 26:30

Yeah. Like we said, there's progress happening. I can feel it and see it, which is amazing.

Marie: 26:34

It sounds great.

Laura: 26:35

Well, thank you so much for joining us and for the work you're leading to kind of redefine how research includes and, like, truly supports women around the world. And, yeah, thank you to everyone for listening. This has been another episode of Leap Together where we explore the stories behind clinical research and the people bringing medical breakthroughs to life. Thank you, Marie.

Marie: 26:55

Thank you very much, Laura. Thank you all.

Leapcure: 26:59

That wraps up our conversation with Marie Teil from UCB. Her leadership underscores a critical truth: inclusion in research must be intentional, evidence driven, and centered on real patient needs, especially for pregnant women, children, and aging populations. We're grateful for her work advancing the principle that women should be protected through research, not from research. Thanks for listening, and until next time, stay informed, stay engaged, and keep pushing for better health outcomes for all.