About Elizabeth Cormier-May
Liz has been in the biotechnology industry for nearly 20 years, with a focus on early start-ups and company creation. She started her career as a medicinal chemist for Novartis Institute for Biomedical Research, working in early discovery oncology. She quickly realized that her ability to create meaningful change in this space was limited, and she pivoted to creating novel markets within diagnostics, where she was able to have greater impact on patients’ quality of care and individualized journey.
Liz has spent the majority of her career in oncology and women’s health. She has focused on creating new markets, launching novel products, and building industry-disrupting companies from the ground up. Currently, she is Chairman of the Board, Co-Founder, President and CEO of her digital health start-up, Persona Health, Inc. and CEO and Board Director of an innovative women’s health, diagnostic start-up, Mammogen, Inc. Liz takes a novel approach to both product development and commercialization, always with an eye towards patient empowerment.
An entrepreneur at heart, she has found innovative ways to simultaneously add value to her companies’ end-users, as well as her investors. Liz is fueled by the notion that there is a patient, someone’s loved one, at the end of every decision she makes.
Mammogen is a female-led biotechnology company focused on meaningfully improving the detection, diagnosis and treatment of women’s health-related diseases, and creating an end-to-never-end community for women around the world. Mammogen is centered around its proprietary genTRU™ liquid biopsy platform. The company’s flagship genTRU breast™ program leverages novel messenger RNA (mRNA) technology to non-invasively detect and diagnosis breast cancer. The genTRU breast™ offering is positioned to unlock regular and reliable screening for millions of women around the world and eliminate many negative invasive biopsy procedures. The company’s proprietary multi-gene expression signature for breast cancer detection has been extensively validated in blood, as well as saliva, and has shown statistical significance towards providing measurable improvement upon current standards of care. Mammogen’s product pipeline consists of an array of non-invasive prognostics and diagnostics for additional diseases that affect some-, mostly-, or only-women. For more information visit www.mammogen.bio.
Medical Travel & Digital Health News (MTDHN): Tell us how you got interested in this incredibly important field.
Liz Cormier-May (LCM): I started as a medicinal chemist for Novartis Pharmaceuticals working in early discovery oncology. One of the programs that I worked on happened to be breast cancer.
I’ve always had a distinct passion for women’s health, particularly fighting breast cancer, as there is still so much work to be done in these areas.
Now, especially in a time when women are making the majority of household health decisions and handling the majority of the family’s finances, there’s no reason why a company shouldn’t put resources towards women’s health.
Women are far more likely to take a medical action, handle logistics and pay bills.
This is a unique time as we come out of the pandemic with shifting dynamics. All the stars are aligning and women are finding their voice, speaking up and demanding better healthcare. They want companies that are dedicated to improving their outcomes.
It’s just a really special point in time for Mammogen to be debuting with novel partners, novel products, and really focusing all of our attention on creating products that serve women.
MTDHN: Why is this a global message?
LCM: Very simply: It’s a global message because women are across the globe. Women make up half the world’s population meaning half of our world is not served in the manner they deserve to be served.
Though women’s health is underserved in the U.S., it’s grossly underserved in other parts of the world. There are still areas where women don’t even have access to healthcare and that has to change.
One of the things that makes Mammogen’s technology so exciting is that all our tests are liquid biopsy based, which means we are validating our easily administered tests on saliva, blood, and biofluids that are inexpensive to test and easy to ship around the world.
Imagine a time where women and other people around the world who may not have access to healthcare can order a saliva-based test to see if they have a breast cancer.
MTDHN: Tell us the role of diagnostics in this fast-emerging digital world.
LCM: Digital diagnostics are especially important and of interest in the women’s healthcare market.
The world is a busy place. We are 100% engaged with our mobile devices, and there is absolutely no reason why diagnostics can’t conform to this new era of digitalization, especially in a world where telehealth has taken an enormous jump over the last 18 months.
Diagnostics are exceedingly important. As hard as scientists in the medical community are working to eradicate cancer, I do not think that will happen in our lifetime. Our best bet is to get ahead of it and detect cancer in its earliest stages.
Early detection is important because:
- It allows us to get information to women at a point where they can intervene in a more meaningful manner. For example, early detection of breast cancer will create the opportunity to preserve eggs or start family planning for millions of women who, all too often, do not have that opportunity today.
- When women under 40 get breast cancer, they often don’t have time to even think about setting up an appointment with a reproductive endocrinologist — they just start treatment. A lot of this is because women under 40 are often diagnosed with more aggressive forms of the disease, so time is truly of the essence.
The earlier we can catch this disease, the more time and options we give our patients. That is what this is all about.
MTDHN: How does digitized care impact this space?
LCM: When we combine that early detection message with the digitalization of medicine, we can think about easier ways to accomplish these goals. Maybe individuals can order a test from their mobile device, get their results on their mobile device or get an app that integrates with their Apple Health device.
All these things are coming together in a way that allows healthcare to be a part of one’s everyday life, not a once-a-year trip to see a physician.
MTDHN: Tell us about the role of artificial intelligence (AI) and machine learning in this brave new world of diagnostics.
LCM: It’s very important — but there are limitations. It is not a magic fix to everything.
When used properly, AI and machine learning allow us to comb through millions of data points in a way that the human brain could never do. Data gives us a more comprehensive view of the system biology behind a certain disease state.
For example, at Mammogen, our technology platform is exclusively licensed through a company called Liquid Biosciences. Their technology is based upon artificial intelligence and machine learning, but what makes it incredibly unique is that it uses evolutionary computing.
This means that it incorporates millions of clinical datapoints, generates millions and millions of corresponding algorithms and puts them into an ecosystem where they evolve, just like humans have done. These algorithms mate, mutate and migrate. This process is like natural selection, but probably more appropriately natural de-selection. All of the algorithms and biomarkers that are not associated with highest accuracy—and sensitivity and specificity—they all wash out and you’re left with a minimal set of biomarkers that have maximum accuracy.
That is a really intense and highly technical process. It’s unique to IV Bioholdings, which is the bio innovation studio that Mammogen is a part of and Liquid Biosciences is associated with. By approaching large datasets in this fashion, we’re able to get a far more robust understanding of the biology behind whatever disease state it is we’re looking at. This capability is disease state agnostic, it does not have to be oncology. This platform has been applied to Alzheimer’s, autism, Parkinson’s and addiction behavior.
However, for our flagship program at Mammogen, it allowed us to mine publicly available datasets in an extremely accelerated manner. It allowed us to see things that other people have never seen because we’re getting such a far more robust understanding of the biology and that’s very important.
Then secondary to that—if you put on your commercial brain—it allows us to create a very valuable intellectual property moat around what we’re developing, because this process is repeated over and over again. So multiple generations of evolution, which give us multiple sets of biomarkers that we move forward into clinical stage validation.
That protects our intellectual property, it accelerates our clinical development timelines, and it allows us to get products to patients in a hyper efficient manner. Statistically, the average diagnostic company takes five to seven years and about $18 million to get to the point where they have a set of biomarkers that have been analytically validated.
Mammogen did it in 22 days for a tiny fraction of that.
MTDHN: Wow. What does that mean for the future of Mammogen?
LCM: It means we are hyper efficient in our R&D process which translates to extremely reduced costs in development, and reduced costs in commercialization.
We don’t need to charge $3,000 for our tests to make a profit as a company. We can make a very reasonably priced test that is accurate, safe, sensitive, specific and get it into the hands of our women in a fraction of the time as compared to other diagnostic companies.
MTDHN: Your name implies mammograms for breast cancer, but what other medical conditions do you focus on?
LCM: Breast cancer is our flagship program. Beyond that, we are beginning development for endometriosis and other areas within women’s healthcare that have an unmet clinical need.
For endometriosis, for example, there is no way to definitively diagnose it except through a very invasive biopsy. The average woman suffers for 17 years before she’s accurately diagnosed. There’s no reason for that.
What we’re developing is a very simple liquid biopsy test that a woman can take to tell her whether or not she has endometriosis.
I’m someone who suffered from endometriosis. Having my family and living with the symptoms was terribly difficult. I was misdiagnosed over and over again. All of the time, resources, money, unnecessary spending and the physical and mental anguish that comes with being undiagnosed with a painful disease was very difficult.
Mammogen is focusing on areas like early detection of breast cancer, endometriosis detection and other issues that are traditionally very difficult to diagnose. These liquid biopsy tests are going to be simple to administer and completely noninvasive.
MTDHN: How will people go about getting this test when it is available? How will payers be involved?
LCM: People will be able to visit their provider who can order the test.
With payers there is still a huge disconnect with diagnostic innovation and recognizing the value of said diagnostics. It can be difficult for diagnostic companies in the beginning to span that gap, which is why I think it is so important to consider non-traditional models that get valuable diagnostics into the hands of patients on an accelerated timeline.
Now, I want to be clear I am not saying that we will not do all of the clinical trials, and all of the scientific validation necessary to satisfy payers and physicians and publication needs.
What I am saying is I believe there are other ways to bring a product to market aside from the traditional go through the payer route, which we will do, but we are also actively exploring other safe meaningful ways to get this product into the hands of patients.
MTDHN: Are you working with any advocacy organizations?
LCM: A big part of what we are building at Mammogen is based around community.
I’m a big believer that community engagement fuels market adoption and market adoption fuels the community.
We are actively engaging with other companies that are also focusing on innovative ways to treat either breast cancer and or the lasting effects of breast cancer. We are connecting with creators of everything from exercise routines to a company called Brilliantly, that just launched a breast warmer that fits right into breast cancer survivors’ bras after reconstructive surgery.
We were featured on a podcast that the founder of Mammogen and I did with Matthew Zachary, who is a tremendous advocate for all things oncology. We’re spending a lot of time working with him and his company called OffScrip Media to engage with our community, patients, survivors and advocacy groups.
MTDHN: Are you connecting with women in underserved communities?
LCM: Yes, that is a huge part of our organization. There are underserved women under 40 who struggle to get mammograms, which are important because women under 40 have the fastest growing rates of incidence.
There are also underserved communities where access to healthcare is not available because of age, race or ethnic background.
We are spending quite a bit of time to make sure those communities are represented fully in our clinical stage validation work so that we can, if necessary, create a test that is specific to certain populations. Currently, however, our science has proven effective for all women, regardless of age, ethnicity, stage of disease or genetic predisposition.
These are all things that we’re thinking about every single day as we prepare to bring these early detection tests to market.
MTDHN: Can you tell the readers how the company is funded, what your plans are, the size of your organization, etc.?
LCM: We are privately held and we just closed our $2 million seed round. That $2 million gets us through the next 12 to 18 months.
Mammogen is part of a bio innovation studio called IV Bioholdings, founded by Marty Keiser. IV Bioholdings has just opened the first round of fundraising at the studio level, as a means to provide capital to the three child companies below it.
Our process is hyper efficient, not just at Mammogen but across the other companies within the innovation studio. With this efficiency, the bottleneck is not R&D like it is for the rest of the industry, the bottleneck can then become financing. This approach eliminates that issue for the 3 companies within IV BioHoldings by providing capital to reach specific inflection points, which, in turn, make traditional fundraising more successful.
Mammogen will be raising a Series A round as well, of which planning and outreach has already begun.
MTDHN: How do you differentiate yourself from some of the other companies that are focused on women’s health?
LCM: Mammogen is proud to be a women’s health company lead by women, which is something unique in the industry.
I can use my healthcare experiences as a woman to help others. Knowing what it feels like to have endometriosis, to struggle for years to get diagnosed, and then to have lived the entire journey through hysterectomy is an advantage.
Another differentiator is our technology. We are looking at RNA when most of the rest of the world is looking at DNA. That is exceedingly important because RNA—the language of cells—is the key to early detection.
When you can listen in on what the cells are doing, as they are healthy, living and thriving, and or adapting to the introduction of disease, then you get earlier information. When information comes from the tumor not the patient, as is the case in DNA, you can’t collect any of that information until the tumor cell is dying, which is why DNA technologies have been wonderful at later stager applications like patient stratification or targeted therapy, but struggle in screening or early detection. RNA, however, is being released by all healthy living cells, as well as disease cells within a patient’s body all day, every day. You get earlier, better and more information, which is a huge distinguisher. RNA allows us to learn about the biology of the patient, not just the tumor.
Finally, Mammogen’s engagement with the community is a competitive advantage. The first thing I did when I took this job was spend over 50 hours talking to breast cancer patients and survivors and their families to understand the patient population I’m serving.
Sitting with these patients and hearing their stories, identifying the gaps in care and crying as they talk about it, is not the same as market research.
MTDHN: What does your growth pattern look like?
LCM: We are pre-revenue. We are in clinical validation stages right now with our strategic lab partner, P4 Diagnostix. This collaboration extends from assay development through commercialization, and further preserves our hyper efficient model.
The goal is to have this test launched in 2023. That would be less than three years from the inception of the company, which is tremendously impressive.