Drug discovery and the International Day of Action for Women’s Health

International Day of Action for Women's Health

The International Day of Action for Women’s Health has been celebrated on 28 May every year since 1987. In 2023, DDW’s Megan Thomas looks at how the drug discovery industry is taking action in this arm of healthcare. 

Context

A 2023 McKinsey study revealed that despite the exponential growth in data generated across the healthcare ecosystem, notable gaps remain in women’s health. It states: “Gaps span the entire data value chain—from defining women’s health (pre–data generation) to diagnosing (data generation) to tracking at the national level (data collection) to translating data into insights at the global level through epidemiological studies (data analysis). These data disparities ultimately influence health outcomes for women globally by creating blind spots in the insights that drive research design, investment decisions, and pipeline priorities. Certain subsets of women, such as those of different backgrounds, sexual orientations, and gender identities, are more vulnerable to the gaps and negative effects of these blind spots. Furthermore, insufficient availability and analysis of women-specific health data undermine advancements in disease-state understanding and limit asset discovery opportunities across medical conditions with meaningful unmet need.”1

The study identifies four primary areas in which women’s health is being neglected, which include pre-data generation, data generation, data aggregation, and data analysis. In terms of pre-data generation, there is a lack of a consistent, aligned definition about what “women’s health” actually is, which leads to an uncertain foundation from which data generation can springboard. Moving past that, at the data generation stage, inconsistency and bias ‘generate blind spots in real-world healthcare data sets that inform public- and private-sector understanding of disease states’. When it comes to data aggregation, national data gaps result in an incomplete picture of women’s healthcare experiences, and therefore at the data analysis stage, the traditional metrics understate the true extent of suffering and experience of women’s health conditions.1

Clinical trials

Until recently, medicines and vaccines were mainly tested on men. GSK2 wrote: “Historically, it was assumed that there were no fundamental differences between men and women’s bodies other than size, weight, and reproductive organs. Instead, women were perceived as “little men”. Now, of course, scientists know better. They know that male and female bodies are genetically different, that they experience differences in the prevalence, course and severity of many common human diseases and metabolise foreign substances – like medicines and vaccines – differently. They also recognise that varying demographics – ethnicity, gender identity, social class, sexuality and more – have an impact on the health outcomes of patients. Yet until very recently, the male medical standard has stayed much the same.”

Kathryn Schubert, CEO and President of the Society for Women’s Health Research (SWHR), a US organisation founded in 1990 to promote research on biological sex differences and disease, told GSK: “Most people don’t know that still today you can be prescribed a medication that has not been tested on someone like you”. In a similar vein, Nivi Thyagarajan, global co-lead of the Women’s Leadership Initiative at GSK – a 9,000-strong Employee Resource Group that promotes gender parity – said: “We’re not a world of men – it is as simple as that. If we were a completely homogenous population where everyone on the planet was a white male, then we would be having a different conversation. But our world is incredibly diverse, incredibly heterogenous, there is such a broad spectrum, so clinical trials need to represent that.”

Lucy Radley, Senior Vice President, Head of European Regulatory Development at ProPharma Group, told DDW: “Everyone experiences diseases differently and has varying reactions to the same drugs, and so it is vital that clinical trials include those with a variety of racial and ethnic backgrounds, as well as gender, sexuality and ages.” She outlines the significance of patient-related barriers, which include lack of trust in the healthcare system among some communities, language barriers, cultural differences, and accessibility issues. She said: “Women may feel that their concerns about their health are not taken seriously, as found by a recent report for Women’s Health Strategy for England.”

Disease targeting

Stress Urinary Incontinence (SUI) is a very common bladder problem, which is thought to affect about one in three women during their lifetime. Despite the high prevalence of the condition and the debilitating day-to-day effects it has, there are currently no drug treatments approved that restore function and have a long-term effect. Versameb is a next generation RNA company taking action in the treatment of this unmet need, with a lead candidate programme in SUI. The company has developed a proprietary technology platform, VERSagile, which optimises the application of functional RNA in different disease contexts. Its lead therapeutic candidate, VMB-100, is currently undergoing advanced preclinical development activities and has demonstrated first-in-class potential for treatment of SUI in a pre-clinical animal model. These findings demonstrate regeneration and functional restoration of the urinary sphincter. Versameb aims to file for Investigational New Drug (IND) and commence clinical development later in 2023.

Meanwhile, MinervaX is pursuing the development of a maternal vaccine for the prevention of adverse pregnancy outcomes and life-threating infections caused by Group B streptococcus (GBS) for the prevention of adverse pregnancy outcomes and life-threatening infections in newborns during the first three months of life. GBS is estimated to be responsible for some 320,000 cases of neonatal invasive disease, 60,000 stillbirths, 3,500,000 preterm deliveries, and 10,000 babies suffering from long-term neurological damage annually world-wide. Current preventive strategies are insufficient and there is an urgent medical need for a maternal vaccine to reduce the global GBS burden. MinervaX’s maternal GBS vaccine is based on adjuvanted protein antigens covering close to 100% of clinical GBS isolates. MinervaX’s GBS vaccine received Fast Track regulatory status by the FDA which is designed to facilitate the development of investigational treatments with the potential to address unmet medical needs in serious life-threatening conditions.

Institutes, associations and programmes

A number of institutes and programmes within bigger organisations are dedicated to taking action in the field of women’s health. The BioInnovation Institute, for example, is dedicated to improving women’s health by supporting and accelerating start-up companies working in the space. Its Women’s Health Initiative aims to strengthen the European ecosystem for innovative translational research and start-ups that address the high unmet medical needs within women’s health.

The American Associtation for Cancer Research (AACR) is equally dedicated to this arm of healthcare with its AACR Women in Cancer Research (WICR) programme. While not all the spotlighted women are working specifically in women’s health, we can’t hope to tackle these issues without representation in the field and so the AACR’s programmes and activities committed to supporting the professional development of female investigators are significant. This is why other initiatives such as SciPro’s Women in Discovery roundtables foster a professional ecosystem of open communication.

The AACR programmes at the 2023 meeting included: The WICR Career Development Forum, which is intended to provide important and useful tools and information to support the professional development and career advancement of women scientists in the cancer research field; The Professional Advancement Series, the sessions of which are organised to provide important skills to investigators at all levels, from junior faculty to high school students and which are organised in collaboration with the WICR, Associate Member Council, Minorities in Cancer Research Council, and the AACR Science Education and Career Advancement Commiteee; and finally the Nursing Mothers’ Suite, where annual meeting attendees who are nursing mothers are welcomed and provided with privacy and a secure environment to nourish and nurture their children.

Awards and funding

The steps forward when it comes to improving women’s health depend on a number of variables, but perhaps the most significant is funding. Where is the money coming from to enable the necessary change?

Earlier this year, an article in Nature revealed that women’s health research lacks funding3. The article draws on the work of Arthur Mirin, a US applied mathematician and an independent researcher. It states: “Although other public funding agencies outside the United States don’t provide such granular detail, one team of researchers looked at almost 9,000 grants awarded by the Canadian Institutes of Health Research, the country’s main funder of such research, from 2009 to 2020. They found that 5.9% of grants looked at female-specific outcomes, although the grants were worth more on average in 2020 than in 2009.”

In England, £25 million of new funding has been allocated to create new women’s health hubs, as part of the Women’s Health Strategy for England4. Minister for Women’s Health, Maria Caulfield said: “Women make up 51% of the population and should not be an afterthought in healthcare. Better access to specialist services is key to tackling health inequalities – the £25 million funding will create new women’s health hubs providing specialist care and advice to women across the country. “We are making excellent headway to meet our commitments set out in England’s first ever Women’s Health Strategy, aiming to boost the health and wellbeing of women and girls.”

Meanwhile in Australia, Franklin Women, a professional community dedicated to supporting women across the health and medical research ecosystem, has secured a two-year grant from NSW Health. The boost in funding will enable the grassroots social enterprise to build the team and systems needed for their sustainable growth and ongoing impact in the sector.

In Canada, there is the National Women’s Health Research Initiative, a joint initiative between Canadian Institutes of Health Research (CIHR) and Women and Gender Equality Canada has plans is to advance a coordinated research programme that addresses under-researched and high-priority areas of women’s health. The National Women’s Health Research Initiative will help to ensure new evidence improves women’s, girls’, and gender-diverse people’s care and health outcomes5. This initiative is comprised of two funding streams: The Pan-Canadian Women’s Health Coalition and the Innovation Fund. The first Innovation Fund funding opportunity consists of one-year Biomedical Discovery Grants, and the second funding opportunity will consist of operating grants to support three-year research projects in two areas of women’s health: first is translational research in healthcare diagnostics, therapeutics, and devices; and second is healthcare implementation research to remove barriers to accessing healthcare.

References

  1. https://www.mckinsey.com/industries/life-sciences/our-insights/closing-the-data-gaps-in-womens-health
  2. https://www.gsk.com/en-gb/behind-the-science-magazine/men-women-gender-diversity-clinical-trials/
  3. https://www.nature.com/immersive/d41586-023-01475-2/index.html
  4. https://www.gov.uk/government/news/25-million-for-womens-health-hub-expansion
  5. https://www.researchnet-recherchenet.ca/rnr16/vwOpprtntyDtls.do?prog=3878&view=currentOpps&org=CIHR&type=EXACT&resultCount=25&sort=program&next=1&all=1&masterList=true

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