Women of Childbearing Age

International Women’s Day 2025: Accelerate Action

Andrea_Puletto — Fri, 07 Mar 2025 12:49:54 +0000

International Women’s Day 2025: Accelerate Action

Marie Teil, Special Patient Populations

Andrea_Puletto Fri 07/03/2025 - 13:49

International Women's Day is more than a celebration; it is a global call to #AccelerateAction and to acknowledge strategies, resources and activities that positively impact women's advancement. At ��ֳ�, we embrace this wholeheartedly, particularly when it comes to ensuring that women of childbearing age have equitable access to clinical research and, ultimately, the best possible care.

Historically, women, particularly those of childbearing age, pregnant, or breastfeeding, have been underrepresented in clinical trials. This gap in research has significant implications, limiting understanding of how treatments affect these populations and leaving many women without clear information on the risks and benefits of their medications.i It is imperative that we #AccelerateAction to address these disparities and drive meaningful change in clinical research, ensuring women are adequately represented.

In the past year, we’ve delved deeper into the experiences of women of childbearing age living with chronic diseases, shedding light on critical gaps in their healthcare journey. Through a social listening study analyzing over 1.2 million posts from France, Germany, Italy, Spain, the UK and the USA, we identified 2,600 posts from women navigating pregnancy and chronic illness. The results of the analysis highlighted four key areas of unmet need: lack of patient support, inadequate specialist discussions, suboptimal coordination of care pathways and the greater need for empowering these patient populations. We concluded that to bridge these gaps, ongoing collaboration is essential to:

Establish moderated online and in-person support services to reduce misinformation and provide platforms for communication between patients and healthcare professionals
Develop educational resources for patients and healthcare professionals
Create tools to enable discussion between women of childbearing age with chronic diseases and their healthcare professionals.

These partnerships and actions are instrumental in driving forward our shared goals so that all women have access to evidence-based healthcare. Collaboration is key to accelerating action. We are proud to partner with patient communities, scientific communities, regulators and policymakers to promote the inclusion of women in clinical trials. Within our work supporting women living with chronic diseases during their reproductive years, we successfully collaborated with the Epilepsy Foundation, HS Connect, IFPA, MG Holistic Society, Living Well with Epilepsy and Lupus Europe to support the development of a discussion guide to promote open discussions about reproductive health between these women and their healthcare professional. It includes background information and key conversation starters to support these discussions to help everyone involved prepare for the future. To read more, visit: /sites/default/files/2024-12/20598_��ֳ�_WoCBA_Discussion_guide%20B_AW0_0.pdf

Looking to the year ahead, the ICH E21 Guideline for Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials is expected to be available for public comment later this year. Additionally, we look forward to continued collaboration with the BRIDGE Commission (Better Research, Information and Data Generation for Empowerment) to provide administrative and communications support.

In my role at ��ֳ�, I am personally committed to this cause. I believe that by working together to champion the inclusion of women in clinical trials, we are not only advancing scientific knowledge but also honoring the fundamental principles of health equity.

On this International Women's Day, let us unite in our efforts to create a world where women receive the care and treatment they deserve. Together, we can make a lasting impact on women's health and wellbeing.

Follow me, @MarieTeil, on LinkedIn, and stay connected with ��ֳ�’s social channels for ongoing updates on our progress.

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Closing the Knowledge Gap: Including Pregnant and Breastfeeding Individuals in Clinical Trials

Chiara Vona — Mon, 18 Dec 2023 09:12:05 +0000

Closing the Knowledge Gap: Including Pregnant and Breastfeeding Individuals in Clinical Trials

Laura Shaughnessy, ��ֳ� Clinical Program Director

Chiara Vona Mon 18/12/2023 - 10:12

For too long, significant data gaps around the use of medicinal products during pregnancy and breastfeeding have impeded healthcare decision-making. This lack of information is particularly challenging for individuals living with chronic diseases during the stages of pregnancy and breastfeeding, as it does not all allow for an informed dialogue with their healthcare providers (HCPs) about optimal management and treatment of their diseases at those times.

As a member of the E21 Expert Working Group (EWG), a part of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), I am proud to be part of efforts to change this paradigm. It is high time all individuals, regardless of reproductive status, have access to the most effective treatments and information to make better decisions.

The E21 EWG was formed to create a new guideline for the inclusion of pregnant and breastfeeding individuals in clinical trials (CTs) – one that harmonises strategies and methodologies to ensure the appropriate inclusion and/or retention of pregnant and breastfeeding individuals in CTs.

This new efficacy guideline will provide a globally accepted framework and best practices to enable inclusion and/or retention of pregnant and breastfeeding individuals in clinical trials – including practical guidance for planning trials that include pregnant and breastfeeding individuals, as well as comprehensive communication and stakeholder engagement plans.

A global-level agreement is needed to improve the situation for pregnant and breastfeeding individuals who need medicines, and to be inclusive of all patient populations. This will help reduce the risk of prescribing medicinal products without adequate evidence in these patient populations. The guideline, based on globally accepted principles, will be implementable worldwide, thereby promoting inclusive patient care and ensuring ethical data generation in global trials.

This work is more than just a professional responsibility; it is a moral imperative. ��ֳ� is committed to improving the care for pregnant and breastfeeding individuals of childbearing age by addressing any gaps in knowledge. These individuals have often been overlooked in the past, but they are a crucial part of the patient population, and we believe that they deserve access to information that empowers them to make optimal disease management decisions throughout their reproductive journey.

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WoCBA Patients Women of Childbearing Age

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BRIDGE: Empowering Women with Chronic Diseases Before, During and After Pregnancy

Vanco Vlastimil (��ֳ� S.A.) — Tue, 21 Nov 2023 10:17:59 +0000

BRIDGE: Empowering Women with Chronic Diseases Before, During and After Pregnancy

Marie Teil, Women of Childbearing Age Mission

Vanco Vlastimi… Tue 21/11/2023 - 11:17

The decision to start or grow a family may be one of the most important moments in a woman’s life. Women around the world face many joyful, hopeful and difficult choices during these periods of their lives. However, for women living with chronic diseases, there may be additional challenges related to the management of their disease and their medication — including whether to continue or stop treatment during their reproductive health journey. These women encounter difficult decisions and uncertainties about their medications without access to reliable information on the benefits and risks involved in balancing their chronic condition with their pregnancy or the health of their baby.

Astonishingly, approximately 70% of pregnant women take at least one prescription drug, even though only 5% of medications are properly monitored, tested, and labelled for use during pregnancy. These significant gaps in data and research mean that healthcare professionals (HCPs) may not have the vital information needed to support clinical decisions for the management of chronic diseases during pregnancy and breastfeeding. These gaps may also severely restrict the ability of women with chronic diseases to have an informed dialogue with their HCP and to make shared choices about their health.

Today I am excited to announce the launch of a global commission named BRIDGE (Better Research, Information and Data Generation for Empowerment). BRIDGE is a voluntary, multidisciplinary group of physicians, researchers, patients, and women’s health advocates working to empower women with chronic diseases with evidence-based, accessible information to make shared decisions about their treatment during their reproductive health journey. BRIDGE aims to advance practical and action-oriented solutions to overcome information gaps that affect women’s health — the first of which will be detailed in a report due out in early 2024. As a co-chair of BRIDGE, along with Ngawai Moss, honorary research fellow at Queen Mary University of London, and Melissa Tassinari, former clinical advisor at the U.S. Food and Drug Administration, my ambition for BRIDGE is to help make sure that women with chronic diseases are equipped with high quality, timely data they can trust when making critical decisions about their treatment during these important moments in their lives.

Co-chair Ngawai Moss shares her perspective on why initiatives such as BRIDGE are needed.

Through our work, we want a world where women’s care — and their experiences of care — reflects what matters most to them. BRIDGE aims to catalyze a paradigm shift in the management of chronic disease during their reproductive health journey and as women decide to start or grow their family.

Find out more about BRIDGE and its members and sign up to receive updates and announcements by visiting the website: https://www.bridgeforwocba.org/

��ֳ� has a longstanding commitment to empower and support women of childbearing age with severe chronic diseases to make informed decisions about their healthcare. As part of this commitment, ��ֳ� supports the mission of BRIDGE and has supported the development of this website.

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Women of Childbearing Age WoCBA BRIDGE

Comment:

Posted by chris, 5 March 2024

nice info thanks for sharing.

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Empowering Women’s Health at RheumaPreg 2023 Conference

Vanco Vlastimil (��ֳ� S.A.) — Mon, 25 Sep 2023 12:02:07 +0000

Empowering Women’s Health at RheumaPreg 2023 Conference

Ágnes Koncz, Global Medical Affairs

Vanco Vlastimi… Mon 25/09/2023 - 14:02

The 12th International Conference on Reproduction, Pregnancy, and Rheumatic Diseases (RheumaPreg), chaired by Professor Catherine Nelson Piercy, was held in London from Friday, 8th September to Sunday, 10th September 2023.

This highly anticipated event gathered medical professionals, researchers, and stakeholders from across the globe to cover all aspects of rheumatic disease in pregnancy, and presented a platform to discuss the unmet needs of women of childbearing age living with chronic diseases.

At ��ֳ�, we welcomed this opportunity to highlight the significance of timely family planning discussions, disease management, and optimal treatment for women suffering from chronic diseases, such as axial spondyloarthritis, psoriatic arthritis, and rheumatoid arthritis. Through our ongoing commitment to understanding and meeting the unique yet unmet needs of women of childbearing age living with such conditions, we were proud to support RheumaPreg 2023.

The conference featured a high-quality scientific program and a wide range of activities, including scientific lectures, panel discussions, and poster presentations. In the opening session, Prof Catherine Nelson Piercy empowered the audience with her visionary speech about the future direction for women's health. Similarly, to the previous RheumaPreg congresses, curbside consultations were popular sessions. This year, an unplanned pregnancy with lupus nephritis during the COVID-19 pandemic and a pregnant and unwell case with scleroderma were spontaneously discussed. ��ֳ� was present with a scientific symposium dedicated to highlighting the value of including pregnant women in clinical trials, from the perspective of both healthcare professionals and patients, considering the bioethical debate. Symposium presentations were followed by a healthy debate and an outstanding conversation between the panelists and the audience, which also urged the need to generate data for pregnant women with chronic diseases to facilitate confident decision-making.

The event also provided opportunities to engage with key stakeholders at international levels. Discussions were centered around the perspectives of patients, acknowledging the vital importance of first-hand narratives from women living with rheumatic diseases. We believe this approach is key to acknowledging the unmet needs of women of childbearing age and will pave the way for the formulation of patient-focused strategies to manage their conditions during reproductive years.

RheumaPreg 2023 played a pivotal role in enhancing the care provided to women of childbearing age living with rheumatic diseases, empowering them to lead healthier lives and navigate pregnancy with confidence and clarity. More information about the event can be found on the RheumaPreg 2023 website.

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RheumaPreg Rheumatology Women of Childbearing Age

Comment:

Posted by György Nagy, 27 September 2023

Excellent, congratulations!

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What is different for women living with epilepsy?

Chiara Vona — Fri, 01 Sep 2023 08:03:36 +0000

What is different for women living with epilepsy?

Andrea Wilkinson, Global Patient Engagement, Global Epilepsy & Rare Syndromes

Chiara Vona Fri 01/09/2023 - 10:03

From a young age and especially at the point of puberty, women are faced with societal and physiological experiences and decisions that are different from our male counterparts – such as planning for (or avoiding) pregnancy, the pregnancy months, lactation, post-partum and decades later, menopause. These differences are further complicated for a woman diagnosed with epilepsy. She has a different experience living with her disease than a man does.

Women need to consider their epilepsy treatments while preparing for the health of their unborn. They may be persuaded to undergo a C-section, and they may experience anxiety and fatigue after birth that can impact the frequency of seizures. Safety questions about breastfeeding may arise, along with so many other questions that a woman living with epilepsy must consider. Adding to these countless worries is the stress of finding accurate and relevant information during these pivotal and deeply personal moments.

The simple, but complex question of why is epilepsy different for women was the focus of a recent International Bureau for Epilepsy (IBE) event entitled ‘Women & Epilepsy’, in which I had the privilege of participating. As part of a project by IBE to empower women with epilepsy, experts from various fields were joined by women with the disease to share and discuss their lived experience of epilepsy. They shared clinical and social perspectives on how epilepsy has a unique and significant impact on women, especially once they reach childbearing age.

Neurologists, psychologists, researchers, human rights experts, industry colleagues and, most importantly, women living with epilepsy, who are experienced experts in their disease, underscored:

The clinical and ethical imperative to generate more and better standardized data to inform shared decision making on the use of medication during pregnancy and breastfeeding.
The need for intersectional solutions that go beyond medicines and include policy interventions and psycho-social support.
The importance of collaboration across the medical, academic, advocacy, and private sector communities to drive patient-centered change.
The need for a case team to enable effective communication between a woman’s neurologist or epileptologist team and gynecology team throughout pregnancy and maternity.
The lived experiences of women living with epilepsy must be foundational to any action taken.

��ֳ� is working to advance science for women of childbearing age with chronic diseases and to empower them to make shared decisions about their healthcare. Our effort in addressing knowledge gaps in the care of women of childbearing age began in rheumatology, and we are now embedding an emphasis on women of childbearing age across our current and potential future medicines.

My ��ֳ� colleagues and I are seeking to better understand and apply insights shared by people living with epilepsy and rare syndromes to bring meaningful change to their lives. In 2020, we conducted a social listening project that tracked more than 200,000 public social media posts, across six countries in the European Union and United States, over the course of a year. This listening initiative explored two key questions:

What is the motherhood journey experience of women living with epilepsy?
What are the unmet needs of women living with epilepsy?

Based on the gathered insights, we convened a multidisciplinary community of patients, patient group representatives, and physicians from different therapeutic areas.

By convening this community of experts, along with partnerships with clinical teams, ��ֳ� strives to address knowledge gaps in the care of women of childbearing age through the provision of validated evidence and quality disease management tools.

It is fearless listening, continued collaboration, and a bias for action that will bring a paradigm shift toward protecting women through research — and not from research. Furthermore, this research is just one component in meeting the unique physical, emotional, and social needs of women of childbearing age living with epilepsy.

Mothers, daughters, sisters – all women – should feel confident to request the information they need to make shared decisions about their treatment options before, during and after pregnancy. At ��ֳ�, we are working toward a future where this is possible.

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epilepsy International Epilepsy Congress Patients women Women of Childbearing Age

Comment:

Posted by chelseymiranda932, 18 September 2023

This is my first time pay a visit at here and i am really impressed to read all at single place.

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Do advances in clinical trial diversity go far enough for women?

Vanco Vlastimil (��ֳ� S.A.) — Fri, 16 Jun 2023 11:06:38 +0000

Do advances in clinical trial diversity go far enough for women?

Marie Teil, Women of Childbearing Age Mission

Vanco Vlastimi… Fri 16/06/2023 - 13:06

The clinical trial landscape has evolved significantly in the last years – with a focus on more inclusive approaches to ensure medicines get to the right patients.

For example, the Consolidated Appropriations Act of 2023, passed by Congress earlier this year, makes it mandatory in many instances for drug sponsors to submit clinical trial diversity action plans, an action that was previously recommended by FDA guidance.

While diversity has become an increasingly important priority in clinical research, the inclusion of pregnant and breastfeeding women in clinical trials still falls short, leading to few available medications that have been adequately tested and labelled to inform potential use during pregnancy and lactation. Currently, 7 in 10 women may have to take at least one prescription medicine during pregnancy – with physicians and women with chronic diseases forced to face the difficult task of deciding whether to stop or continue a medication during pregnancy and breastfeeding, despite the unknowns.

In partnership with clinical teams, ��ֳ� strives to address knowledge gaps in the care of women of childbearing age through the provision of validated evidence and quality disease management tools. Our pregnancy and lactation trials that are completed or ongoing in four of our products provide evidence to support disease management and help clinicians and women with chronic diseases make more informed decisions around their health and family planning.

We are now working to address further knowledge gaps by systematically evaluating the opportunity to conduct pregnancy and lactation trials in each of our current and future therapeutic areas. We are also collecting follow-up data in infants exposed to our medications during pregnancy and breastfeeding, to identify potential risks and to help support patient decisions.

Additionally, we continue to work in close collaboration with our external partners such as the ConcePTION Consortium and Coalition to Advance Maternal Therapeutics (CAMT) on research specific to pregnant and lactating women, TransCelerate to collaborate on common drug development challenges, and as a member of a working group with the ICH initiative to enable inclusion of pregnant and breastfeeding individuals in clinical studies.

We hope to continue our collaborations with physicians and women around the world by identifying potential educational needs and seeking to offer important information regarding patient care before, during and after pregnancy.

Want to learn more about ��ֳ�’s ambition for women of childbearing age? Click here to learn more. Empowering Decisions for Women of Childbearing Age | ��ֳ�

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Patient Women of Childbearing Age clinical trials diversity

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Clinical Trials Day 2023 - Strategic Approaches in Pregnancy and Breastfeeding: Time for a Paradigm Shift

Vanco Vlastimil (��ֳ� S.A.) — Wed, 24 May 2023 14:34:52 +0000

Clinical Trials Day 2023 - Strategic Approaches in Pregnancy and Breastfeeding: Time for a Paradigm Shift

Marie Teil, Women of Childbearing Age Mission

Vanco Vlastimi… Wed 24/05/2023 - 16:34

This year’s Clinical Trials Day (May 20^th) serves as a timely reminder that much still needs to be done to make clinical trials more inclusive, particularly for pregnant and breastfeeding women.

I am proud to have presented at Regulatory Affairs Professionals Society (RAPS) Euro Convergence 2023, discussing strategic approaches in pregnancy and pediatrics alongside Dr Solange Corriol-Rohou, Senior Director of Regulatory Affairs and Policy at AstraZeneca, and Corinne de Vries, Head of Translational Sciences at European Medicines Agency.

Today, although 70% of pregnant women take at least one prescription drug during pregnancy, only about 5% of drugs have been properly monitored, tested and include label data to inform use during pregnancy and breastfeeding. This reflects a widespread tendency not to include pregnant and breastfeeding women in clinical trials – often driven by public attitudes about risk, as well as outdated approaches to research.

Due to the lack of inclusion of pregnant and breastfeeding women in clinical research, women around the world continue to be subjected to misinformation and misconceptions. The global clinical trial community needs more discussions like the one we had at RAPS Euro Convergence 2023, seeking to drive actions that ensure women have access to timely information about the safe and efficacious use of medicines.

New efforts are urgently needed to change the mindset when it comes to benefit-risk considerations. We should stop focusing solely on the risks to the unborn baby and consider the benefits to the mother of being treated – as well, of course, as the consequences to both the mother and baby of not being treated.

There is a clinical and ethical imperative to generate more and better standardized data, informing decision-making on medication use during pregnancy and breastfeeding. Such a change can only be achieved through collective action from all relevant stakeholders.

At ��ֳ�, we remain committed to addressing such health disparities and closing gaps in clinical trial diversity. No woman should ever have to choose between managing her health and starting a family. So, this May 20^th, let’s rally together and call for better representation of pregnant and breastfeeding women in clinical trials.

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Clinical Trials Day Women of Childbearing Age Euro Convergence 2023

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#EmbracingEquity in clinical trials for pregnant and breastfeeding women living with chronic diseases

Vanco Vlastimil (��ֳ� S.A.) — Tue, 07 Mar 2023 14:09:34 +0000

#EmbracingEquity in clinical trials for pregnant and breastfeeding women living with chronic diseases

Marie Teil, Women of Childbearing Age Mission

Vanco Vlastimi… Tue 07/03/2023 - 15:09

On March 8, millions will unite to observe International Women’s Day (IWD) with its theme #EmbraceEquity – encouraging us to take strides to address gender disparities and create a more diverse, equitable, and inclusive world.

A vivid example is the collection of clinical data and research. A recently published paper in the US by researchers at the Brigham and Women’s Hospital found that women were underrepresented in clinical trials, which can negatively impact women's health. This lack of equity in clinical trials is even more pronounced for pregnant and breastfeeding women. during and after pregnancy. The COVID-19 pandemic further demonstrated this “pregnancy gap” in data and information with only 1.7% of clinical trials including pregnant women.

��ֳ� is committed to closing the pregnancy gap and #EmbracingEquity in the care of pregnant and breastfeeding women with chronic diseases. In partnership with clinical teams, we strive to address knowledge gaps, collaborating with physicians and patients around the world to identify potential educational needs.

And, in 2023, our collective effort involves working with experts – as part of a new global commission – to resolve the lack of understanding about pregnancy and breastfeeding medication decisions, ensuring women can make decisions based on facts.

On this IWD, we are #EmbracingEquity in clinical trials for pregnant and breastfeeding women living with chronic diseases, advocating for a future where there is parity in care and outcomes for all.

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International Women's Day WoCBA Women of Childbearing Age Equity

Comment:

Posted by Jean-baptiste MIQUEL, 8 March 2023

Thanks Marie and the Team - What a real gap and unmet needs!

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Women of Childbearing Age

International Women’s Day 2025: Accelerate Action

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Closing the Knowledge Gap: Including Pregnant and Breastfeeding Individuals in Clinical Trials

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BRIDGE: Empowering Women with Chronic Diseases Before, During and After Pregnancy

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Empowering Women’s Health at RheumaPreg 2023 Conference

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What is different for women living with epilepsy?

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Do advances in clinical trial diversity go far enough for women?

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Clinical Trials Day 2023 - Strategic Approaches in Pregnancy and Breastfeeding: Time for a Paradigm Shift

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#EmbracingEquity in clinical trials for pregnant and breastfeeding women living with chronic diseases

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