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UCB’s Women of Childbearing Age Program

UCB’s Women of Childbearing Age Program is a commendable initiative. Can you tell me more about it and elaborate on some of the program’s most successful strategies for encouraging the inclusion of women of childbearing age in clinical trials?

First of all, I’m going to start by saying when we talk about women of childbearing age, we define it as the period before, during and after pregnancy throughout the reproductive health journey. This could be a long period of a woman’s life, particularly for women living with chronic diseases that may have a longer time need a longer time to get pregnant. So UCB approached me years ago, with this idea of better understanding how to improve the information and the result for women living with chronic diseases. For me, it was really a no brainer, it was a great opportunity to use my expertise and experience in clinical trials and research ethics to help women were of childbearing age. And I want to say it was a bold, really bold move from UCB, because at the time, we were the first pharmaceutical company to be able to do that type of research and even think about that type of research. And this is how we establish the woman of childbearing age program to improve the lives and family planning of this women in this work is extremely meaningful to me personally.

So, as I said, 10 years ago, we made it our vision to empower and support women With chronic diseases to make informed decisions about the healthcare, and this is now embedded across all our development, early drug development, late stage and also in market, disease areas. And we stay and I say that women need to be protected through research and not from research. And this is why you CB was the first pharmaceutical company to conduct clinical research to generate strong evidence in women with chronic inflammatory disease during pregnancy and breastfeeding. So practically, what does that mean for us? Well, we have assembled a cross functional team of experts within our organization to systematically assess the woman’s unmet need, during their reproductive journey in all our therapeutic areas, where we design studies, we designed them with women in mind, in collaboration with our women, patient experts, we have operational remote enrollment model to reduce the burden of the studies on the women who may have already children and have, you know, busy life. Our clinical trial protocol template allows a woman who gets pregnant in a clinical trial, to remain in the study and not be excluded, which is what is usually done in what was done for decades in research. So that’s a little bit what we do internally. But I want to say we acknowledge the collaborative nature of our mission.

Now we recognize that a sustainable impact cannot be achieved by pharma in nicer in isolation. And this is why we partner we continue partnering with patients with scientific communities with regulators and policymakers to really advance the scientific understanding of women of childbearing age with chronic disease. And, on a personal note, I was very privileged to connect with key stakeholders this past year, on behalf of UCB, to present at different conferences and events panels, and including the opportunity to work with the FDA and provide feedback on their pregnancy safety study framework workshop. And moving forward, I want to say that I’m very pleased to share that I will be discussing how we can generate early data for pregnant and lactating women living with chronic diseases. At the DIA global meeting in June in San Diego, she has a fantastic opportunity to have this discussion with other with others. And finally, as a co-chair of the global independent commission bridge, with bridge stands for better research, information, and data generation for empowerment. I really look forward to continuing to help elevate this important conversation and delivers practical action-oriented solution to overcome information gaps that win about affect women’s health. And the first of which will be detailed in a report to be released in May 2024. So, watch for this report.

I just want to finish by saying that all women with a chronic disease should have access to reliable high-quality data, to help them understand the benefits and risk of disease management, from the point of diagnosis through their life and their reproductive journey. Ensuring women can make better informed decision based on facts and inclusivity.