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The Women’s Brain Project

Published onJul 06, 2021
The Women’s Brain Project

Women’s Brain Project (WBP) is global, interdisciplinary, non-profit organization based in Switzerland which has spearheaded global efforts at the research and policy level to understand the role of sex and gender in brain and mental health and medicine in general as the gateway for precision medicine. WBP was created to understand brain and mental diseases from an individualized perspective, with the premise that studying patient’s characteristics is the path to better treatments and preventative strategies for men and women equally.

The WPB team is represented by 40+ members, including academic scientists, medical doctors, engineers, technologists, pharma leaders and policy experts who work together with patients, caregivers, regulators, and philanthropists to promote gender equality and precision medicine for brain and mental health. Numerous team members have also been patients or caregivers themselves (if not both). Currently, the majority of them work pro bono for WBP.

The problem

Men and women are different in their manifestation of diseases as well as attitudes towards health and access to healthcare. By studying and describing specific needs of men and women, and with dedicated policy activities to raise awareness on them, WBP is promoting gender equality in medicine, ensuring that each patient receives the best possible treatment. This is key to enable a patient-centric approach, and crucial to fight gendered stigma and discrimination. When talking about sex, we indicate differences driven by genetic expression of sexual chromosomes and the expression of sexual hormones 1; gender, in contrast, refers to the socially constructed norms that determine roles, relationships, and positional power for all people across their lifetime.2

Both sex and gender are recognized by the WHO as determinants of health.3

The concept of sex and gender medicine is gaining momentum, but at the time of WBP’s foundation, little data and minimal discussion existed on the role of sex and gender in mental and brain health. Sex and gender differences have been traditionally considered in epidemiological terms, i.e. whether disease burden or risk differs between men and women. Despite this, and taking the example from Alzheimer’s disease, it was seldomly recognized that more women than men were living with the disease, and most scientists deemed it not relevant for clinical research. Likewise, the sex of animals used in experimental research was often not reported, and in clinical studies, the sex and the gender of the individuals involved was often not described nor specifically analyzed. The burden of caregivers on the female population was not recognized nor addressed by specific policy actions. Thus, the pivotal role of WBP has been to interrogate and to generate evidence that sex and gender are indeed important variables that affect the course, risk factor profile, symptom presentation and treatment of brain diseases and beyond as well as specific care needs. This knowledge is key to develop research and policy strategies tailored to the patient, leveraging differences to promote health equality from a sex and gender perspective.

WBP also advocates for the representation of women in clinical trials and novel technologies design. For decades, women were excluded in clinical drug trials due to concerns about potential risks in women of childbearing age. Despite the NIH Revitalization Act of 1993, which mandated the inclusion of women in federally funded trials, concerns about gender inequality remain to this day. First, the reporting of sex-stratified results is not common practice and is not mandatory for failed trials. Second, women experience more side effects due to incorrect drug dosages or lack of testing in early R&D phases. Indeed, several of the currently prescribed drugs have been approved before 1993, when preclinical and clinical research focused on male animals and men only.

WBP in action

The goal of the Women’s Brain Project is to position sex/gender differences as the gateway to precision medicine. To this end, the organization has built valuable expertise, positioning itself as a global thought-leader in the field of sex and gender medicine. By publishing scientific evidence, building cross-discipline expertise, and raising awareness across multiple stakeholders, WBP is the leading organization raising awareness on how precision medicine, through sex and gender considerations, can transform the future of brain health.

WBP initially launched its efforts diving into the Alzheimer’s disease scientific literature available at that time, to collect information of sex and gender differences and provide recommendations for future studies. The result of this work entitled “Sex differences in Alzheimer disease - the gateway to precision medicine”4 highlighted several clinically relevant differences in disease presentation between men and women and numerous knowledge gaps. This work paved the way for the initiation of future studies into this direction opening the scientific debate on the importance of sex and gender differences in Alzheimer’s disease and novel technologies (which are the focus of numerous presentations, papers and three new books). Since then, WBP has put on the spotlight that sex and gender differences are the gateway to precision medicine, highlighting the importance of how patient heterogeneity and individual characteristics can influence risk factors, diagnosis, progression, treatment, prevention strategy and care. This approach is relevant beyond neurology and psychiatry, as it has been exemplified by the field of cardiology and oncology and novel technologies design where precise patient-centric approaches have led to numerous benefits in terms of treatment and prevention.

From a mostly dementia-focused group, the work has now grown to include other disease areas, such as migraine, Parkinson’s disease, depression, anxiety, neuro-immunological diseases, and maternal mental health, including a strong presence on the impact of COVID-19 in women and children and advocating to break the stigma around these diseases.

Also, the scope of the work has developed beyond clinical research and WBP’s activities tackle gender equality and precision medicine through a 360ª approach across four main workstreams that impact:

1) preclinical science,

2) drug development and clinical research,

3) social determinants of health and policy and

4) digital solutions and novel health technologies.

Becoming an international opinion leader

With a network of collaborators spanning across three continents, WBP is a driver of expertise and innovation in the field. WBP has been engaging several stakeholders to address these gaps, through different activities, including a strong global presence in the world’s most relevant forums, such as the World Economic Forum, Alzheimer’s Disease International, The Global Summit of Women, Women’s Health Access Matters, The Brain Forum, Alzheimer’s Association International Conference, TEDx events as well as the publication of scientific research, expert workshops, writing books and offering free and public webinars to educate and engage the general public on these relevant topics.

To transform knowledge into actions, WBP organize recurrent regulatory roundtable with key stakeholders to learn from the experience of the US Food and Drug Administration (FDA), which has a dedicated Office of Women’s Health (OWH), to see how women’s health, sex and gender considerations, and diversity issues can be prioritized in other regulatory agencies.

Importantly, the Women’s Brain Project founded the International Forum on Women’s Brain and Mental diseases, a yearly reoccurring event. In 2020, the Forum held its third edition with a focus on sex and gender analysis as the gateway to precision medicine across our lifespan.

This flagship event is much more than just a conventional scientific meeting. This event’s main goal is to bring together experts and representatives from a wide range of scientific disciplines and various fields of practice contributing to the study and improvement of mental and brain health. Moreover, the inclusion of patients, caregivers and other individuals impacted by brain and mental health issues in their daily life keeps the ongoing debate relevant and focused.

By actively involving medical professionals, technology experts, life and social scientists, industry, policy makers, researchers, caregivers, and patients, WBP strives to facilitate an open and transdisciplinary collaboration. In this way, all stakeholders have an equal voice in the constructive and actionable discussions on considering the influence of sex and gender in brain and mental health research. Further extending our transdisciplinary approach, we are now collaborating with the Organization for Economic Co-operation and Development’s new Neuroscience-inspired Policy Initiative (NIPI). NIPI is hosted by the New Approaches to Economic Challenges Unit. NIPI aims to reimagine our work around issues of the brain and asks the question ‘Brains are indispensable drivers of human progress, so why not invest more heavily in them?’. NIPI is pioneering the new asset of Brain Capital, which prioritizes brain health and brain skills in the brain economy. Brain Capital will be quantified, tracked, then leveraged to drive policy and investment innovations. WBP CEO, Dr Chadha, is co-chair of the Women’s Brain Health Gap Working Group. This Working Group highlights and frames inequalities in all areas across the translational spectrum from bench-to-bedside and from boardroom-to-policy and economics. Closing the Brain Health Gap will help economies create resilience and prepare our systems for future global shock

The future: Women’s Brain Project call to action

Moving forward, also based on the lessons learnt during the pandemic, WBP’s call to action is to reconsider the way we develop drugs and other solution for health, towards a sustainable model based on AI-powered precision medicine. In WBP’s vision, this can be achieved by the concerted action of researchers, patients, caregivers, drug developers and policy makers. To this end, the WBP is currently planning the creation of the first sex and gender-based precision medicine institute in Switzerland.

The work of the Women’s Brain Project during the COVI-19 Pandemic, the Chinese learnings

Since the beginning of the COVID-19 pandemic WBP has been heavily involved in its management, both from a healthcare-system-perspective and a scientific one. In February 2020 a WBP member, went to China to bring medical aid and scientific knowledge to the first COVID-19 outbreak region.4 In doing so, she acted as a relevant source of scientific information for the team of scientists at WBP. The work of WBP has been crucial to the establishment of a COVID-19 hospital in Italy within a record time, resembling the concept of the Chinese “fever clinic”. This helped the local Italian community to contain the spreading of the infection and manage severely affected patients.

Additionally, WBP launched a series of educational webinar events on the pandemic and published a large number of scientific publications on the topic of sex and gender differences in the COVID-19 infections and vaccination strategy.

Currently, the organization is writing a book with the Elsevier publishing group on how to apply precision medicine approaches to the management of pandemics.

With the COVID-19 pandemic, the topic of precision medicine and sex and gender differences has finally hit the spotlight. WBP has been among the first to highlight sex differences in Sars-CoV 2 effects, as well as important gender imbalances and risks for women in the pandemic. The vaccine approval has exposed a number of issues related to sex and gender differences (in safety as well as its use in pregnancy), which need to be addressed. The team is currently working to raise awareness on these issues and promote ad-hoc policy changes in drug development.


Dr Antonella Santuccione Chadha is a medical doctor with expertise in clinical pathology, neuroscience and psychiatric disorders. She is head of stakeholder engagement for Alzheimer’s disease at Biogen.  She is co-founder and CEO of the non-profit organization “Women’s Brain Project” which is addressing the influence of sex and gender on mental and brain diseases. As a medical doctor, Antonella has decades of experience in preclinical research, patient treatment, clinical development, medical affairs and setting up the international regulatory framework for Alzheimer’s disease.

Always focused on solving the puzzles related to Alzheimer’s and other psychiatric diseases, she has worked with Swissmedic, the Bill and Melinda Gates Foundation, several European universities, the EU Commission Directorate for Health and Food Safety, the World Health Organization, the CEOi and several Alzheimer’s’ disease Organizations. Since 2018 she is listed among the top 100 Women in Business in Switzerland and in 2019 she has been elected Woman of the Year in Switzerland by the Magazine "Women in Business".


References

1. WHO | Gender and Genetics n.d. https://www.who.int/genomics/gender/en/ (accessed May 10, 2021).

2. Health TUC for G and G. Gender and Health resources hub n.d. http://www.ighgc.org/the-hub (accessed May 10, 2021).

3. Manandhar M, Hawkes S, Buse K, Nosrati E, Magar V. Gender, health

4. Ferretti MT, Iulita MF, Cavedo E, Chiesa PA, Dimech AS, Chadha AS, et al. Sex differences in Alzheimer disease — The gateway to precision medicine. Nat Rev Neurol 2018;14:457–69. https://doi.org/10.1038/s41582-018-0032-9.

5. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7373121/#

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