'Letting The Data Lead Has Resulted In The Development Of Blockbuster Drugs'

Interview with Anna Villarreal, Founder and CEO of LifeStory Health


Ahead of our Chief Innovation Officer summit in San Francisco, May 7 & 8, we spoke with Anna Villarreal, the founder and CEO of LifeStory Health, a bio-science company focused on the female biology.

Anna's pioneering vision to map the menstrual blood proteome through a set of resolute, data-leading principles has led to extraordinary discoveries. These discoveries are the bedrock of a groundbreaking technology which is paving the way to novel diagnostic and therapeutic targets. The vast implications in the women's healthcare space are very exciting — from both a patient advocacy standpoint and a commercial perspective. LifeStory Health has the potential to materialize into a successful operating public company that would be both profitable for shareholders and positive for women's public health.

How are you using data to transform women's healthcare?

LifeStory Health is using data to drive the direction of the Company through a set of resolute, data leading principles that lead us to indications for novel diagnostics and potential therapeutic targets.

I define “Letting the data lead” as a term to describe the act of a judgement-free approach to letting results be the basis of one’s decisions. This concept exists in mathematics – think big data and the Bayesian approach companies take. Bayesian inference is a method of statistical inference in which Bayes‘ theorem is used to update the probability for a hypothesis as more evidence or information becomes available.

Within the pharmaceutical industry, letting the data lead has resulted in the development of blockbuster drugs, generating billions of dollars in sales. More importantly, these drugs have improved the lives of people around the world.

A great example of letting the data lead was in the discovery of Viagra – the first treatment for erectile dysfunction. Pfizer originally introduced the chemical slatternly, the active drug in Viagra, as a heart medication. While clinical trials proved Viagra was ineffective for heart conditions, the data led Pfizer to discover that the little blue pill worked for something much different. Viagra recorded $1.6 billion in global sales for 2016, and Pfizer is likely still relishing in their success of letting the data lead.

Insulin is another innovation from letting the data lead. In 1889, two Parisian doctors attempting to understand how the pancreas affects digestion removed the organ from a healthy dog. Days later, they noticed flies swarming around the dog’s urine, which was unusual and unanticipated. They tested the urine, and after finding sugar in it, realized they gave the dog diabetes. However, it wasn’t until the early 1900’s that researchers were able to figure out that what the pancreas produced actually regulated blood sugar. The researchers were able to isolate a pancreatic secretion that they called insulin, a discovery that would win them the Nobel Peace Prize. The pharmaceutical giant Eli Lilly went on to realize the value of insulin and began selling it within a year after the discovery.

The ability of these companies to improve the lives of millions is truly a result of letting the data lead. LifeStory Health is positioned to impact women on a macro level by letting the data lead; we have discovered the ability to stratify women into subgroups to improve prospects of gender-neutral clinical trials and continue to perform analysis on additional proteins to determine clinical opportunity, specific to degenerative diseases and oncology.

How is Lifestory empowering women?

As Founder and CEO of the bio-science company LifeStory Health Inc. (“LSH”), I am focused on empowering women to make educated decisions about their health. One aspect to this is by bringing awareness to the gender bias in healthcare and driving solutions for the scientific and medical community to better understand female biology. A solution that I have witnessed firsthand is the concept of “letting the data lead” in the scientific discovery process. This is a core principle of my company. Focusing on “letting the data lead” has resulted in truly groundbreaking discoveries that will play a significant role in the future of women’s health.

For LifeStory Health, letting the data lead has allowed us to discover more about female biology. It has also initiated surprising opportunities and has allowed LSH to impact a much larger patient population than originally thought. Unexpected sources of revenue have come to fruition including a data marketplace that will use blockchain, a rapid path to market is on the horizon, and inclusion in global standards of LSH’s practice of sex specific research is a reality.

How do you encourage a culture of innovation at Lifestory? Do you have any tips on how companies can have a more innovative mindset?

Everything we do is aimed at advancing women’s health through sex-specific research while discovering novel diagnostics and therapeutic targets. Nothing is off the table for us, if the data leads us to a certain unexpected endpoint.

Letting the data lead is slow and meandering. It needs time to percolate and permeate. It needs time to wander and explore, to discover. And sometimes it doesn’t want to stop at the intended destination or answer.

How important is workplace diversity to innovation?

Massively important. From a healthcare perspective, the data that exists on biological differences as well as presentation of disease symptoms between men, women and ethnicities is staggering. To not examine these differences at a biological level seems almost against public policy.

A shift in protocol is occurring and there is real time interest in women’s health. The FDA is beginning to retroactively change dosing standards, based on sex specific research, for current medications that have been on the market for over 20 years. The sleep aid Ambien is the case study for this increased attention of female pharmaceutical interactions.

Are companies having to innovate faster than they have had to before? If so, what tools are helping them do this?

There is certainly a race to innovate, but I’m not sure “faster” is the issue. I think companies need to innovate smarter. Of course, machine learning is a big part of innovating smarter and therefore faster.

In the biotech space, if innovation outpaces regulations, patient impact is affected. Patient advocacy is a tool that LifeStory Health relies on to drive innovation at both the regulatory level as well as in research.

An example of regulation working in collaboration with research is the recent guidance issued by The National Institute on Aging and the Alzheimer's Association came out with a  new definition of Alzheimer's disease based on biomarkers.

LSH is starting an early onset Alzheimer study this July and this new regulation will allow for our innovations to be better received.

How do you prepare for disruption?

I prepare for disruption by eliminating pre-conceived notions during research. This allows us to think outside the box and not miss things hiding in plain sight.

Evaluation biases on gender can be attributed to a centuries-long preconceived notion of menstrual blood being viewed as medical waste. A historical view of menstruation illustrates thousands of years of fascinating and unusual biases towards menstruating women.

LifeStory Health is the first company to recognize that menstrual blood (“MB”) may contain vital and unique clinical information and is not a waste product. LSH focuses on significant women’s health diseases unveiling the opportunity for macro and micro applications related to precision medicine.

How is the nature of innovation and organizations’ approaches to it set to evolve over the next five years?

It is hard to say. We can follow trends and make predictions but the beauty of innovation is you never really know what’s next.

See Anna's presentation 'Data-leading innovation in women's health: novel approaches to diagnosis and treatment of women’s disease' at our Chief Innovation Officer summit in San Francisco, May 7 & 8.

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