“We need a biobank that is representative of the population”: Inside Europe’s first women’s health research tissue bank

Europe’s first Research Tissue Bank focused on women’s health is helping to bridge the gender health gap with the promise of new therapies and more representative scientific studies.

Located in the women’s health building at BioGrad’s 10,000 square foot facility in Liverpool, UK, floor to ceiling windows allow for a clear view through the diagnostic laboratories and into the biobank where hundreds of thousands of tissue samples are stored, waiting for their moment to contribute to science.

Specialising in laboratory testing, BioGrad is the company behind Europe’s first Research Tissue Bank, focused on women. It has been described as a ‘gateway to revolutionising women’s health’, which it aims to do by making it easier for scientists to study and advance therapies for conditions that impact women. 

BioGrad was founded by Dr Natalie Kenny in 2014. After spending several years as a scientist in the Amazon, Kenny is now a leading specialist in cell therapies and a multi-award-winning entrepreneur.

BioGrad Diagnostics was first-to-market with mass Covid testing in 2020, while BioGrad Education has 800 academic partners across 21 countries, training and up-skilling more PhD level scientists than any other organisation in the UK.

Dr Natalie Kenny, CEO, BioGrad

The drugs don’t work

It was through these research partnerships that Kenny noticed a trend in the clinical trials coming across her desk. 

“In a lot of the studies, the drugs weren’t working on women,” she says. 

“Higher fatality, higher toxicity and lower life expectancy” were seen among women in “almost every drug”. Why? Because they were only being tested in men. 

“We talk about the gender health gap, and the fact that research isn’t done in women, but it’s more than that, it’s a whole range of things,” Kenny says.

“In the UK up until last year, it wasn’t compulsory for medical schools to teach women’s physiology. Even now, women are generally considered by science to be small men, so we give them a drug designed for a man at a different dose.”

Working in drug discovery at Pfizer until 2010, Kenny saw firsthand how women of child-bearing age were excluded from human clinical trials. Even cellular research was predominantly conducted in male cells, due to a lack of women’s samples in the lab. The result of this is that the drugs and therapies that end up in development are less effective on women in the real world. 

One study in 2019 looked at 20 clinical trials on immunotherapies in 11,000 participants and found that in 19 of those trials, men lived for twice as long after the therapy than women. 

“They don’t have samples for women, or certain diseases are considered male diseases, not because women don’t get them, but because women don’t survive them, because the drugs don’t work,” Kenny continues.

“We’ve got all these ‘amazing therapies’ that come in on the market that can cure cancer and so on. They do, but they work better for men.”

Female scientists conducting research on samples. Photo supplied by Biograd.

A biobank representative of the population 

Having bootstrapped the company from the beginning, with no investors or shareholders “to answer to”, Kenny has been able to invest the profits back into the business to fund the critical research which is being overlooked elsewhere.

Outside of cancer, only around two per cent of public health research funding goes to female reproductive health. Meanwhile, only 1.9 per cent of all venture capital funding goes to women-led companies and femtech companies represent only one per cent of total health tech funding.

The BioGrad biobank, which banked half a million samples the first year, is Kenny’s way of taking matters into her own hands.

“What was really critical for me was if I’m going to develop cell therapies, I need to make sure I’ve got women’s samples and that they are going to work for women,” she explains.

“We’re creating a diverse network, and this isn’t just white women. Black and Asian women are hardly represented in clinical trials at all. For me, it was really important that if I wanted to reach my end goal of creating a therapy that actually works for people, we need to create a biobank that is representative of the population.”

Through the biobank, BioGrad is conducting research into treatments for women’s health conditions such as PCOS, menopause, and certain cancers through the collection of menstrual blood samples. This includes potential diagnostic tools, as well as new treatments for endometriosis, based on promising in vivo research into stem cell therapies. 

“We know there’s a huge need for an endometriosis test and it’s something that I think we’re perfectly placed to do,” says Kenny.

“We’ve got the biobank, we’ve got the donors and we’ve got all the diagnostic services. That’s something I can get to market.”

Female scientists observing liquid nitrogen. Photo supplied by Biograd.

New therapies within the next 10-15 years

Meanwhile, the Research Tissue Bank, its own entity, has already established partnerships with leading academic institutions and scientists, enabling them to include women’s samples in their studies. 

According to Kenny, some of the first requests have been from those investigating therapies for Parkinson’s, Alzheimer’s and other neurodegenerative diseases, where current treatments are known to be less effective in women. 

The site has full ethics approval, which can be conferred onto its partners to bypass lengthy applications to ethics boards, reduce costs and speed up the clinical pathway to allow women to access these treatments sooner. 

“It makes it so much cheaper and faster for the NHS and universities to be able to access these samples that previously they haven’t been able to,” Kenny says. 

While the process of getting a drug from concept to market is still a lengthy one, Kenny is confident that the UK will see an improvement in available therapies emerging within the next 10-15 years. 

In order to get there, BioGrad will soon be looking for women across the country to donate samples including menstrual blood, umbilical cord blood and tissue, peripheral blood, urine, saliva, nose and throat swabs, vaginal swabs, rectal or stoma swabs and breast milk, either through at-home collection kits or through BioGrad’s partner clinics. 

A nurse taking a blood sample at the Biograd site: Photo supplied by Biograd.

“Women deserve to know where their data is”

Kenny has partnered with Pregnancy Plus founder and app developer, Amber Vodegal, to create an app which allows donors to track what happens to their sample, without hosting any of their private data.

“Transparency in the science that you’re doing is absolutely case critical if you want to engage people in your research,” says Kenny.

“I thought it was really important that women knew what was happening with their samples. They deserve to know where that data is.”

The samples will all be stored on site at the BioGrad laboratory in Liverpool, with a process for notifying women if one of their samples is to be used in a clinical trial. They will also be informed of the condition, or area of research, and supplied with a copy of the research paper once it’s published. Donors also have the option to request their samples are destroyed at any point. 

With over 160 data points to collect from each donor, BioGrad is currently working with two maternity hospitals, including Arrowe Park Hospital, to build up samples gradually, with a view to expanding nationwide over the next two years. 

“We are streamlining our processes before we get thousands of samples a day coming in, but we are looking to ramp up quite substantially in the next six to 12 months,” Kenny adds.

“We’d be able to do a lot more if there was more funding for women’s health.”

Dr Sherin Pojar, Head of Scientific Operations at BioGrad, and Dr Natalie Kenny, CEO, BioGrad, with team of female scientists. Photo supplied by Biograd.