Recently, DeciBio had the pleasure of speaking with Fanny Anderson. Fanny is a previous consultant with us here at DeciBio, and she now works with Illumina as a Global Market Development Manager with a focus on Reproductive Health & Genetic Disease. During our conversation, we discussed trends in women’s health, as well as Fanny’s experiences in leadership. Fanny has been promoted to senior manager since this Q&A occurred.
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Key Takeaways

1. Several exciting opportunities exist for molecular diagnostic innovation in women’s health, including endometriosis, contraceptive selection, and pre-eclampsia. 
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2. Endometriosis affects ~10% of women, yet no molecular diagnostic exists. This presents an exciting opportunity to innovate in the precision medicine space while improving care for millions of women. 
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3. Three key accessibility gaps – access to contraception, access to fertility and prenatal care, and access to menopausal education and supportive care – also present opportunities to improve women’s healthcare. Women’s healthcare is broad, extending from menses to menopause, yet innovation in the space is variable throughout this continuum. 
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4. Barriers to innovation and access in women’s health, such as lack of funding, exclusion of female participants from data collection and clinical research, and a tense political climate regarding reproductive health, are important to acknowledge when considering advancements that might be made in this space.

To start off, we’d love to hear a bit about your background in women’s health, including your experience and interest in reproductive health topics and your current position with Illumina.

Absolutely, thank you for having me. I have been passionate about women’s health since I was in middle school, when I had the opportunity to hear Melinda Gates speak about her work with the Gates Foundation. I learned that women’s health and girls’ education are paramount drivers of global growth and economic development. 

At DeciBio, I loved working with clients driving innovation in precision medicine and found that most were focused on oncology. I took every opportunity to work on projects pushing into new frontiers of precision medicine, including women’s health. Key areas of activity for genomics in women’s health include non-invasive prenatal testing, carrier screening, endometriosis, fertility, and adverse pregnancy outcomes. My interest in these topics is what ultimately led me to my position at Illumina.

In my current role in global market development, I identify emerging clinical applications for genomics and develop partnership strategies to accelerate time-to-clinic for these new innovations. Partnerships may be formed across the healthcare ecosystem, including pharma, biotech, academia, hospitals, biobanks, and payors. 

‍Thank you for sharing a bit about your background with us. You mentioned that women's health is a strong indicator of progress, which leads into our next series of questions regarding accessibility in women’s health. Do you see accessibility as a major issue in this space? 

This is such an important question. Looking across the continuum of women’s health from menses to menopause, I see three key accessibility gaps – access to contraception, access to fertility and prenatal care, and access to menopausal education and supportive care. In each of these areas, we see digital health solutions leading the charge to democratize and increase access to healthcare providers and information. 

Among these gaps, access to contraception is a huge issue and one that most threatens women’s health, especially in this country. In the U.S., almost 1/3 of women live in a contraceptive desert, meaning that they lack reasonable access to a health center in their county that can offer them a full range of contraceptive methods. Several telemedicine companies are working to fill gaps in access, like Nurx, Maven Clinic and TwentyEight Health.  There are even a few small pharma companies working to provide birth control over the counter, like HRA Pharma and Cadence. 

You’ve touched on the role of digital health solutions to improve access to women’s healthcare. Are there other initiatives or methods by which we might further expand access to resources and education in this space? 

Opening the conversation and educating others in our lives is so important. For those of us working in the precision medicine space, it is also important to recognize key opportunities for molecular diagnostics to transform standards of care and introduce objectivity in the healthcare system. There are several examples here. Endometriosis affects 10% of women, yet surgery is the only diagnostic tool and pelvic pain is often shrugged off by doctors. Pre-eclampsia affects 5% of pregnancies and is a leading cause of maternal mortality, but standard of care risk assessments predict less than half of cases. The American College of Obstetrics and Gynecology (ACOG) includes underlying racism towards black women as a risk factor for pre-eclampsia in their latest clinical guidelines. ~90% of lupus cases occur in women but the average time to diagnosis is 6 years. You get the gist. 

More broadly in society, we should raise awareness about disparities in women’s health. In the U.S., the maternal mortality rate is rising and much higher than in other developed countries. Mortality rates are three times higher for black women than for both white and Hispanic women. These are devastating realities that we need to increase awareness about. 

In that same vein, we’d like to discuss other barriers to widespread implementation of reproductive health technologies that you've noticed or that you think are important to address. For example, we’re curious about IVF technologies and NIPT.

It’s interesting because NIPT and IVF workups, including carrier screening and pre-implantation genetic screening, have been beachhead applications for genetic testing in reproductive health. These technologies have seen growing uptake globally as the cost of testing continues to fall, though labs doing this testing still primarily exist in centralized settings with economies of scale. Widespread implementation relies on broader patient awareness, physician awareness, and ultimately insurance coverage. Fertility care is still largely out-of-pocket in most markets, and can require several failed lines of treatment before success. Personalizing fertility care may drive faster time to results and open resources to new couples. There are a few interesting innovations attempting to drive precision medicine in fertility, including AI imaging to optimize embryo selection and sperm DNA fragmentation analysis.   

To what extent do you feel that physicians are aware of, and comfortable with recommending, NIPT to their patients?  

Increasingly so. Clinical guidelines are key to driving clinician awareness and payor coverage. In 2020, ACOG endorsed NIPT for all pregnancies and risk levels. Since that guideline change in the U.S., we've seen growth in test volumes, clinician awareness, and payor coverage for NIPT. Outside of the U.S., there are a few other countries that endorse NIPT as a first-line screening test for trisomies, including Belgium, the Netherlands, and certain regions of Italy and China. But for the most part, NIPT is a second-line screening test contingent on traditional maternal serum screening. In those countries, awareness of NIPT exists among high-risk pregnancy specialists but less so amongst all OBGYNs. 

As we discuss timing, we are interested in hearing your perspective on working in the reproductive health space against the backdrop of a tough political climate. 

In your current role as a global market development manager, what has your experience been in navigating this climate?

Yes, this year has been deeply challenging to reproductive healthcare in the U.S. I was attending an international conference on prenatal diagnostics and therapeutics when Roe v. Wade was overturned. It was compelling to see so many leading professional societies, like ACOG, SMFM and ASRM, come together to stand up for reproductive healthcare. 

In terms of my experience, working in reproductive health has taught me so much that the political rhetoric ignores, including the impact of the SCOTUS decision on pregnancy care overall. Care for miscarriages, ectopic pregnancies, fetal anomalies, and even cancer diagnosed during pregnancy is all at risk due to this decision. 

How might this decision impact people who are living with infertility or are interested in IVF? Will these policies raise potential barriers to treatment and/or technology access? 

That's a great add on: what might happen with IVF, options to transfer multiple embryos, and the ability to store embryos? If embryos are treated as a person under personhood laws, you know, what will that look like in the fertility segment? Ultimately, there are a lot of unknowns. 

Speaking of future outlooks, we’d love to hear about current trends that interest you in precision medicine overall, and how they may intersect with women’s health ideals. 

In terms of precision medicine trends, it's interesting to see where pharma invests in R&D across therapeutic areas. Beyond oncology, we see growing R&D investment in cardio, neuro, autoimmune, and rare disease, including cell and gene therapy development. Pharma only invests about 1% of R&D spend in reproductive and women’s health outside of oncology. Within women's health, we see some interesting high-growth areas like in-utero therapies for rare disorders and novel treatments for autoimmune conditions that can occur during pregnancy. 

I hope these high-growth areas can build momentum and entice pharma to invest more in reproductive health. As we’ve discussed, there is a great need for development of molecular diagnostics, but treatments must be available that can be informed by these diagnostics. The two go hand-in-hand. Precision medicine brings together both the diagnostic and therapeutic so you can ultimately offer the right care to the right patient at the right time. 

That makes sense. What are the key drivers promoting R&D spending in women’s health? As players begin to participate and invest in the space, will this open up the floodgates for more companies to join?

Absolutely. I think as some pharma start to invest and see success in these areas, it will be a significant force driving others to do the same. There are great market opportunities in women's health. We are currently in the early mover phase, so we’re hoping that testaments to their success can provide momentum for others across the research continuum from academia to biotech and pharma to follow.

You already alluded to a couple shifts within women's health, but we would love to hear more about other trends or initiatives that seem particularly exciting to you.

Definitely! There are a couple of innovations that I’m excited to talk about, primarily in terms of diagnostics- I hope that these will drive future therapeutic development. The three areas of growth I’m most excited about are endometriosis, pregnancy complications, and pharmacogenomics for contraceptives.

Endometriosis is a condition I'm extremely passionate about. It affects 10% of women but has an average time to diagnosis of 7-9 years after symptom onset. There is a large burden of disease with no diagnostic technology or curative treatment besides surgery. A few interesting biotech startups, including Hera Biotech and NextGen Jane, are working on molecular diagnostics for endometriosis harnessing gene expression profiling. As they enable better understanding of molecular pathways, this may enable pharma to discover targets.

Within the pregnancy space, there's interesting research being done to understand and better predict common pregnancy complications like preterm birth and preeclampsia that we lack a solid understanding of today. Mirvie is using cell-free RNA sequencing to predict risk for those conditions earlier in pregnancy and allow for closer monitoring and potentially therapeutic interventions in the future. 

A final area of interest is precision medicine for contraceptives. There are a few startups, like Adyn and Dama Health, that are using genomics to personalize birth control selection. I think this is a fascinating space with lots of potential to alleviate side effects and simplify the lines of treatment used for contraceptive care.

Those are all exciting innovations to keep an eye on. Do you anticipate any barriers to accessing these innovations? For example, we have heard about issues surrounding female inclusion in research and data collection in the past.

Inclusion of women in research and data collection has and continues to be a serious bottleneck. A key data point is that from the 1970s until 1993, there was FDA guidance in place that recommended women of reproductive age be excluded from all clinical trials.

Many drugs were developed and approved during that time, and a lot of research being conducted completely excluded women. There's a long way for us to go to catch up in terms of female inclusion in these datasets and establishing more diverse datasets. This pertains to all women and especially women of color. We need to better understand the biological differences that exist between men and women and, additionally, the molecular pathways of disease in women's health. This data gap is much bigger than I ever imagined, and the correct way to solve this problem remains unclear.

This issue even trickles down to important data points like drug dosing. A study in 2020 found that over 80 drugs have doses that should be adjusted for women, but very few actually have sex-specific dose recommendations.

I also want to highlight the term “bikini medicine” because it is relevant to the conversation surrounding comprehensive research and care for women. Bikini medicine illustrates that oftentimes we may think about women’s health in terms of solely breast and reproductive health. However, heart disease is the leading killer of women in the US in many developed countries. Autoimmune disease also disproportionately affects women. There are many challenges and unknowns women continue to face, not only in terms of reproductive health, but across all disease types and therapeutic areas.

Interestingly, pharmaceutical companies indicate that they look to diagnostics and biotech companies to elucidate molecular pathways of disease, after which they can develop treatments leveraging those pathways to block certain disease mechanisms. On the other hand, diagnostics companies feel that if no treatments are available, it is hard to offer value through diagnostics. Many of these companies are spun out opportunistically from academia through tech transfer programs. All fingers then point back to academia and nonprofits to act as engines for basic research. In these settings, problems arise when a lack of grant funding impacts women's health research. There is not yet an alignment of incentives across the discovery ecosystem. Some companies are working to bridge that data gap, but I haven't seen any of them reach a scale yet that can really move the needle.

These trends can pose serious problems; without data to elucidate underlying pathways of disease, any given stakeholder's research timeline is made longer and riskier, and may run a trickier course to return on investment.

We’ve spoken extensively about different trends, and their benefits and challenges. We’d like to zoom out and discuss your global perspective. Are there any global trends in women’s health that you would like to highlight? 

With regards to NIPT, we are seeing accelerated growth and adoption in countries like Australia, Brazil, and South Africa to name a few. We have seen positive indicators of broader payor coverage in just the past few months in Germany and Japan. On the research side, the Netherlands conducts a lot of fascinating industry-leading research on topics from genome-wide screening to viral DNA fragments detected in NIPT data. 

We also see countries like France, the UK, and Japan stepping up to set national research priorities on key women’s health issues like endometriosis.  

We’d love to hear about your growth into management roles, how you may have overcome challenges in the workplace, and any advice you have for women seeking to attain leadership positions. 
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My best advice is to push yourself outside of your comfort zone by taking on as many stretch opportunities as possible. Along the way, try to be a sponge, learning from leaders and mentors as much as possible. Try to remember moments when things clicked for you, so that you can pass on those learnings to your mentees one day. 

When I started managing analysts, I tried to accelerate the development of my team by sharing key learnings I gleaned in my own experience in their position. I tried as much as possible to share my screen and teach by example to help the team learn faster. I also made it a priority to discuss strengths and development areas with my team at the start of the project and to emphasize that the project could be an opportunity for them to pursue their professional goals. 

I have had some amazing female mentors who have shown me, by example, that women supporting other women enables accelerated growth trajectories and inspires female drive toward leadership positions. I try to emulate the inspiration and strength they have instilled in me in my work and mentorship of others.

As a woman in leadership, what do you do and what can companies do to create safe and productive spaces for women to discuss ideas such as the ones we have covered today? 
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Companies need to establish mentorship programs and prioritize diversity at the executive level across gender, race, etc. Data suggests that when people identify with leaders and mentors, they will be more likely to envision themselves in positions of leadership in the future and pursue these opportunities. As we have discussed, there are many areas of growth in women’s health and in precision medicine more broadly, and an important part of the solution will be fostering and encouraging the development of future leaders who will drive innovation in these spaces.

Thank you so much for your time, Fanny!

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