Pregnancy can be a notoriously stressful time, but no one should have to worry that having a baby might endanger their lives. Yet about 700 women still die in the U.S. each year as a result of pregnancy-related complications. And maternal mortality rates are higher here than in any other developed nation in the world.
BIPOC (Black, Indigenous and people of color) women face the greatest risk. Center for Disease Control and Prevention (CDC) data shows that they are two to three times more likely to die from pregnancy-related complications than white women. They’re also far more at risk of giving birth preterm or having an infant with a low birthweight, which puts the baby’s health in jeopardy.
The COVID-19 pandemic increased pregnancy-related adverse outcomes, especially for Black people. From 2019 to 2021, the maternal mortality rate for white moms-to-be went from 18 to 26 per 100,000 live births. For Black women, that rate surged to nearly 69 deaths per 100,000 live births in 2021, up from 44 deaths in 2019. Most of these deaths can be attributed to already existing health disparities exacerbated during the pandemic.
Making the maternal-fetal health disparity even worse is the fact that many immune-mediated diseases tend to have a more severe impact on BIPOC women. Those who live with such conditions, such as lupus, often have a harder time having a successful pregnancy, particularly if they’re not receiving quality medical and prenatal care.
In an effort to promote better health for moms and babies of all backgrounds and to shrink healthcare disparities surrounding pregnancy, Johnson & Johnson Innovation, in collaboration with the Office of the Chief Medical Officer (OCMO) Health of Women team, and together with Janssen Research & Development, kicked off the Maternal-Fetal Immune Disorders QuickFire Challenge: Innovating for Health Equity in March 2022.
Applicants across 18 states submitted their ideas for reducing the impact of immune-mediated diseases of pregnancy on historically marginalized communities. The QuickFire Challenges are designed by Johnson & Johnson Innovation as a crowdsourcing platform with the aim to inspire innovators to tackle some of the biggest healthcare challenges.
Late last year, Johnson & Johnson Innovation named two awardees for the Maternal-Fetal Immune Disorder QuickFire Challenge: Acclinate and NX Prenatal Inc. Acclinate is a digital health company that provides historically marginalized communities with relevant health information; it also empowers these same communities to make informed decisions about participating in relevant clinical trials. NX Prenatal Inc., a molecular diagnostics company, develops new tests to be used early in pregnancy that could predict the likelihood of adverse outcomes.
Awardees received grant funding from a pool of $500,000, in addition to membership in the global Johnson & Johnson Innovation – JLABS (JLABS) network and mentorship from across the Johnson & Johnson Family of Companies.
Take a look at the awardees’ innovative ideas and how they plan to put their funding to good use.
A Digital Platform Connecting BIPOC Users to Clinical Trials
When Tiffany Whitlow’s newborn son was hospitalized with asthma, he was given a drug found to be up to 47% less effective in African American children—information she did not learn until much later. She also didn’t know at the time that drug development was dependent on clinical trials, nor did she realize that BIPOC communities are drastically underrepresented in this process. Indeed, Black Americans represent only 5% of participants in clinical trials and Hispanic Americans just 1%.
So in 2019, Whitlow, an entrepreneur, joined forces with Del Smith, Ph.D., to found Acclinate, a company that aims to promote diversity in clinical trials.
The winning innovation: A digital platform called NOWINCLUDED, which gives BIPOC users community-focused health education to increase awareness about current inequities in clinical trial design and participation, with the goal of transforming the way medical research is conducted.
The goal is to make sure BIPOC women who live with an autoimmune condition hear from others with similar backgrounds, as well as gain exposure to information about clinical trials that could improve their health.
How it works: NOWINCLUDED is comprised of a series of web- and app-based “communities.” Each community is rich with educational content about a specific health condition and includes personal stories and videos from BIPOC patients and experts.
Through their software program called e-DICT, Acclinate generates a participation probability index designed to ensure that information about specific clinical trials from trusted partners reaches NOWINCLUDED members who are most likely to consider participating, and, in turn, help boost the diversity of trial participants.
How the QuickFire Challenge award could help: The funding has already helped Acclinate start building out a new NOWINCLUDED health community for people of color who are on their pregnancy journeys, and it will include specific information for users with immune-mediated disorders. The goal is to make sure BIPOC people who live with such conditions hear from others with similar backgrounds, as well as gain exposure to information about clinical trials that could improve their health.
“When you’re pregnant, you have so many questions about your health and the changes within your body; sometimes you don’t even know what to ask,” says Whitlow. If you also have an immune disorder, you may be even more confused and overwhelmed. And if you’re a BIPOC woman, you may be skeptical of doctors and the healthcare system in general, she adds.
“Clinical trials provide options, but for a long time people have been left out,” says Whitlow. “I’m not trying to persuade someone to participate or not, but I really want them to be in a position to make an educated decision and for industry to learn what potential modifications they need to make in their protocol design to ensure that their trials are truly inclusive.”
What success will look like: “We’ll know we have been successful as soon as moms start to give us the feedback that they didn’t know this information before interacting with our brand, and that they were afforded the opportunity to become more educated.”
A First Trimester Test for Detecting a High-Risk Pregnancy
When someone is first diagnosed with cancer or a heart condition, they’re typically given tests designed to make predictions about the course of their disease so their care can be guided accordingly. Brian Brohman, CEO of NX Prenatal Inc., believes that pregnant women deserve the same kind of information about their health—and that they ought to have it as early in pregnancy as possible.
NX Prenatal wants to empower pregnant women and promote better maternal-fetal health by developing early warning blood tests that aim to assess the risk of preterm birth and other adverse pregnancy outcomes.
The winning innovation: Time 2 PrepareTM. That’s the working name of NX Prenatal’s potentially groundbreaking menu of tests, which are designed to advise moms-to-be about their likelihood of experiencing serious pregnancy-related health problems like preeclampsia and preterm birth. Both preeclampsia and preterm birth are more common in women with autoimmune disease.
Preeclampsia—characterized by dangerously high blood pressure—typically crops up after week 20 of pregnancy. Preeclampisa occurs in 5 to 8% of all pregnancies, but for Black women the rate is 60% higher than it is in white women.
Preterm birth is also more common in Black women. More often than not, it catches both the mom and her healthcare provider by surprise. “Preterm birth is labeled spontaneous 65 to 75% of the time,” says Brohman. “The mom might be driving to work at 32 weeks and her water breaks, and all of a sudden she’s in labor.”
NX Prenatal’s blood test, which would be given to women at the same time as other first trimester tests, is designed to predict the risk of preeclampsia and preterm birth long before these problems arise.
How it works: Time 2 Prepare utilizes a process called proprietary exosome-based liquid biopsy platform.
“A single cell might shed thousands of exosomes in a single day,” explains Brohman. Scientists used to think exosomes were solely waste vehicles, a way for cells to “take out their trash.” But in the past two decades, they have discovered that these particles do much more, he says. Part of their function seems to be to provide a fetus with protection from the mother’s immune system so that it is not attacked as something foreign, says Brohman.
We may be able to reduce the rate of preterm birth and preeclampsia more substantially in BIPOC groups, numerically speaking. A simple blood test like ours might provide an opportunity to level the playing field.
How the QuickFire Challenge award could help: Studies already indicate that Time 2 PrepareTM may be able to accurately predict whether someone is at high or low risk of adverse pregnancy outcomes. The QuickFire Challenge award enables NX Prenatal to explore how the technology might be used to serve historically marginalized women in particular.
NX Prenatal plans to recruit women from different racial and ethnic groups to test the accuracy of Time 2 PrepareTM, then determine if the test needs to be modified for different populations. The current version of the test uses specific biomarkers to identify whether a pregnant woman is at a high risk for preeclampsia or pre-term birth. “There may be a handful of different biomarkers that arise within a particular racial or ethnic group,” Brohman explains. If so, identifying them will help make the test more accurate for everyone.
What success will look like: The hope is that all pregnant women, including women of color, will be administered the test as part of their standard first trimester lab workup. If the results show that their risk of preeclampsia or preterm birth is elevated, they can then seek additional medical care or personalized guidance designed to keep them and their baby as safe as possible.
Because adverse pregnancy events are more common in BIPOC women, “we may be able to reduce the rate of preterm birth and preeclampsia more substantially in those groups, numerically speaking,” he says. “A simple blood test like ours might provide an opportunity to level the playing field.”
