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  • Organoids for Health Equity! Diversifying Preclinical Research (International Women's Day)

AMSBIO Achieves ISO 9001 Certification for the Netherlands
May 7, 2024
From Basics to Brilliance: AMSBIO’s Lab Glow-Up with BioPORTER®, Detachinâ„¢, and SoluLyseâ„¢
February 13, 2024

Organoids for Health Equity! Diversifying Preclinical Research (International Women’s Day)

It’s International Women’s Day on 8th March, and this year, we’d like to highlight the importance of women, not just behind the microscope, but under it. Until 1993, the majority of clinical trial participants in the US were men of European descent, leading to a lack of data on the safety and efficacy of treatments for women and diverse populations. Since then, a federal law was introduced mandating the inclusion of women in clinical trials and awareness of the importance of diversity has gradually increased. This has been crucial for improving the safety and efficacy of treatments across all demographics.  

Although attitudes may have begun shifting in clinical trials, inclusivity in preclinical research has often been overlooked, leading to gaps in our understanding of how drugs and treatments affect different populations even before they proceed to human trials. Addressing this oversight is essential to advancing our knowledge and ensuring that drugs and therapies are universally beneficial.  

Figure above is a 3D image of a kidney organoid stained for podocytes (red), proximal tubules (cyan), distal nephrons (green), and nuclei (blue). The picture is kindly provided by Drs. Ken Hiratsuka and Ryuji Morizane, Massachusetts General Hospital and Harvard Medical School.

The Importance of Inclusivity

Understanding how our bodies respond to treatments is like solving a fascinating puzzle for better healthcare. Genetics, physiology, and demographics all play a role in this complex equation. However, there’s a missing piece in many studies: diversity.

Inclusive research practices ensures that everyone, regardless of background, gets a seat at the table. That’s why the Medical Research Council (MRC) in the UK made a bold move in 2023. They told researchers to think about diversity when conducting studies, making healthcare research a bit more like a party where everyone’s invited.

This step from the MRC is a nod to the importance of embracing the rich tapestry of human diversity in research. By including a wider range of participants, we can unlock valuable insights into how treatments work for different people. And that’s how we pave the way for healthcare solutions that are not only effective but also fair and inclusive for all.

Inclusive Drug Development through Intestinal Organoids

In an article published in Advanced Biology in 2023, Dr. Julia Y. Co, Dr. Jessica A. Klein, Dr. Serah Kang, and Dr. Kimberly A. Homan from Genentech Inc. advocate for the incorporation of diverse human populations into preclinical drug development using intestinal organoids. They emphasise the importance of representative model systems to enhance predictive power in early-stage drug development.  

The proposed solution involves using primary human intestinal organoids as in vitro models for research and drug development. Intestinal organoids are three-dimensional (3D) multicellular structures derived from stem cells, and they offer advantages in recapitulating physiological complexities while maintaining donor-specific characteristics. These organoids not only replicate tissue functions and disease states but also retain the genetic identity and epigenetic signatures of the donors, making them an ideal model for capturing human diversity. Dr. Co and coauthors call for an industry-wide effort to actively integrate diversity into preclinical drug programs using intestinal organoids.  

However, the integration of intestinal organoids as an inclusive model into research and drug development practices is not without its challenges. To facilitate inclusive research, Dr. Co and her fellow scientists suggest establishing intestinal organoid biobanks to enhance accessibility and address sample acquisition and data availability issues. Additionally, they emphasize the need for scalable and automated culture protocols to enable broader research and adherence to FAIR (Findable, Accessible, Interoperable, and Reusable) data principles for meaningful outcomes.  

By implementing these strategies, Co et al. (2023) believe that intestinal organoids can be effectively utilized as an inclusive model to enhance the predictive power of preclinical drug development and ultimately improve patient outcomes.  

Even in the midst of the COVID-19 pandemic, the World Economic Forum’s report, “Closing the Women’s Health Gap 2024,” brought attention to the pressing issue of global gender disparities in healthcare. Despite comprising the majority of healthcare workers, women continue to face significant barriers in accessing leadership roles and equitable healthcare services.

The report underscores the imperative of prioritizing women’s health as a fundamental human right and integral aspect of sustainable development. However, an alarming finding emerged regarding the development of COVID-19 vaccines: while women participated in trials, the consistent reporting of sex-specific data was lacking. Shockingly, only a small fraction of studies provided such data, and an even smaller percentage planned for sex-disaggregated analysis.

This oversight is critical, as it impedes our understanding of how vaccines affect women differently and undermines efforts to ensure their safety and efficacy. With less than 5% of researchers considering sex-disaggregated data in their studies, there’s a clear need for action to address this gap. The report’s findings underscore the urgency of integrating gender perspectives into healthcare research and policy-making. As we navigate the challenges of the pandemic and beyond, it’s imperative to prioritize women’s health and work towards a future where all individuals have equal access to quality healthcare.

Diversifying Preclinical Models with AMSBIO and ScreenIn3D

That’s why here at AMSBIO we are dedicated to assisting you in diversifying your preclinical models effectively to help bridge the gap of between gender discrepancy in research. Our biorepository boasts an array of tissues from reliable sources, including a comprehensive selection of healthy tissues as well as a variety of disease states and genders. For specific research needs, we provide custom tissue procurement services, allowing us to acquire samples not readily available in our extensive biorepository.   

In collaboration with our partners ScreenIn3D (S3D), we leverage the combination of organoids with their proprietary lab-on-a-chip technology. This results in cost-effective, high-quality, large-throughput, and data-rich assays. S3D collaborates closely with you to ensure that your desired outcomes are achieved and that you maximize the potential of your data.   

Diversifying Preclinical Models with AMSBIO and ScreenIn3D

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Further Reading

  • Toward inclusivity in preclinical drug development: A proposition to start with intestinal organoids.  

Co, J. Y., Klein, J. A., Kang, S., &; Homan, K. A. Advanced Biology, 7(12). https://doi.org/10.1002/adbi.202200333 

  • MRC urges researchers to consider diversity in experiments 
  • Why preclinical research models must reflect diverse populations 
  • WEF_Closing_the_Women’s_Health_Gap_2024.pdf (weforum.org)

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