WoCBA

International Women’s Day 2024: Inspiring Inclusion

Andrea_Puletto — Thu, 07 Mar 2024 13:13:42 +0000

International Women’s Day 2024: Inspiring Inclusion

Marie Teil, Women of Childbearing Age Department

Andrea_Puletto Thu 07/03/2024 - 14:13

On 8 March, International Women’s Day (IWD), ��ֳ� will rally behind the global call to “Inspire Inclusion” – an important message that we proudly support across our organization. When we take a step back to think about what it means to be inclusive – one critical area that is lacking is the inclusion of pregnant and breastfeeding women in clinical trials. Current research tells us that an underrepresentation of women in clinical trials overall can have a significant negative impact on women’s health.

At ��ֳ�, we are steadfast in our commitment to closing the pregnancy gap and accelerating progress in the care of pregnant and breastfeeding women with chronic diseases. In partnership with clinical teams, we strive to address knowledge gaps, collaborate with and inspire physicians and patients around the world to identify potential educational needs.

I was honored to connect with key external stakeholders this past year on behalf of ��ֳ� at different medical congresses, industry events and panels, including the opportunity to provide feedback on the FDA’s proposed Pregnancy Safety Study Framework workshop.

As advocates for women living with chronic diseases who are navigating life changing moments for themselves and their families, we understand how important it is to resolve the lack of understanding about pregnancy and breastfeeding treatment decisions, ensuring women can make better informed decisions based on facts and inclusivity.

On a personal note, I feel very fortunate to be leading such an important initiative as ��ֳ�’s Global Head of Women of Childbearing Age, and every day I am driven to #InspireInclusion and contribute to meaningful progress in this space. Alongside a devoted team, I am embracing this IWD by advocating for and working towards a future where the inclusion of pregnant and breastfeeding women in clinical trials is the norm. In time, we hope that women can make more informed decisions and feel empowered at all ages and stages of their life.

As I look to the year ahead, I am pleased to share that I will be bringing this important conversation to DIA Global in June. I'm eager to talk about our work towards early data generation for pregnant and lactating women living with chronic diseases.

Also, as co-chair of the global independent commission, BRIDGE (Better Research, Information and Data Generation for Empowerment) – I look forward to continuing to help elevate these important conversations and deliver 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 in early 2024.
Follow me, @MarieTeil, on LinkedIn as well as ��ֳ�’s social channels for more updates.

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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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Empowering Women of Childbearing Age: A Patient-HCP Multidisciplinary Collaboration to Enhance Care for WoCBA

Chiara Vona — Wed, 29 Nov 2023 09:18:23 +0000

Empowering Women of Childbearing Age: A Patient-HCP Multidisciplinary Collaboration to Enhance Care for WoCBA

Ágnes Koncz, Global Medical Affairs Lead of WoCBA

Chiara Vona Wed 29/11/2023 - 10:18

Women of childbearing age (WoCBA) living with chronic diseases such as rheumatoid arthritis, axial spondyloarthritis, psoriasis, epilepsy, and multiple sclerosis continue to face significant healthcare challenges, despite rapid advancements in the medical field. More than ever, identifying how to enhance the healthcare experience of these women is a priority.

With that in mind, ��ֳ� partnered with patients representing multiple chronic diseases and specialist healthcare professionals (HCPs) spanning rheumatology, neurology, dermatology, psychology, and obstetric medicine across the globe. Together, we discussed how we can address challenges faced by women of childbearing age living with various chronic diseases and proposed comprehensive solutions.

Four primary unmet needs in the healthcare journey of women of childbearing age living with chronic disease were identified: a lack of patient support, insufficient specialist discussions, suboptimal coordination of the care pathway, and the need to better empower women.

To face those barriers, a powerful collaboration between patients and healthcare professionals across multiple therapeutic areas is the cornerstone of progress. Together, their combined efforts create a synergy that goes beyond individual therapeutic area, making the journey towards solutions for chronic conditions in WoCBA far more impactful. By actively working together, we not only enhance our understanding but also pave the way for tailored and effective solutions, ultimately elevating the standard of WoCBA patient care. In the dynamic workshop environment, participants pinpointed critical steps, including the development of comprehensive information resources for HCPs and patients. The focus extended to strengthening collaboration among specialist HCPs through a multidisciplinary team approach and the establishment of patient peer support groups.

At ��ֳ�, we are committed to continue collaborating with expert groups, patients, and HCPs. Our goal is to improve the healthcare experience for WoCBA who are living with chronic diseases.

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WoCBA Patients chronic inflammatory diseases

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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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#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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WoCBA

International Women’s Day 2024: Inspiring Inclusion

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

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Empowering Women of Childbearing Age: A Patient-HCP Multidisciplinary Collaboration to Enhance Care for WoCBA

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

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

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