May 17, 2020

Could the screening process for cardiac drug approval be set to change forever?

Digital health
Digital health
Stuart Hodge
6 min
cardiac drug approval
Novoheart began with a passion for stem cell research and its impact on human health. “When you're sitting in the laboratory, making exciting discover...

Novoheart began with a passion for stem cell research and its impact on human health. “When you're sitting in the laboratory, making exciting discoveries, what you really want to be able to do is have that impact on society – to impact patients, impact the world in some way,” says Professor Kevin Costa, Chief Science Officer and co-founder of Novoheart.

The biotechnology startup believes it can do exactly that, as the first company in the world to have created miniature beating human hearts aimed at revolutionising drug discovery and the development of heart therapeutics.

Currently, a key issue in treating cardiac conditions is the difficulty of getting new drug candidates tested and approved using existing technology and parameters. Typically, the development of a new drug candidate costs $2-4bn and takes more than a decade, with failure rates for new drugs of circa 90%.

The primary cause for the withdrawal of any potentially lifesaving new drugs is heart toxicity. The conventional non-human, non-cardiac cell and animal models used to test potential drugs is poorly predictive of human responses, leading to false negative and false positive pre-clinical results which compromise overall successes.

These limitations, coupled with a shortage of available human hearts to test on, make it difficult for new drugs designed to treat heart conditions to get tested properly and in the past that has led to unsafe products entering the market – such as Flecainide, which was found to cause arrhythmias in patients even though it was originally designed to prevent arrhythmias. The same can be said for Vioxx, an alternative to non-steroidal anti-inflammatory drugs for the treatment of pain associated with osteoarthritis, which was subsequently found to increase the risk of cardiovascular disease and was withdrawn from the market worldwide after contributing to the deaths of thousands, perhaps hundreds of thousands, of people.

Both cautionary tales, but Novoheart has managed to design living heart tissues which deliver predictive accuracy of 90% or more and, as a result, could make the screening process far safer, faster and cheaper. The mini hearts act as advanced human heart surrogates and can be utilised in a variety of ways. The founders of Novoheart believe that the technology can be a catalyst in helping to fix a currently broken and expensive system for accurately pre-screening the effectiveness and safety of new drug formulas.

While Costa is deeply passionate about the science involved, he credits co-founder Professor Ronald Li with helping him to realise how this could be applied from a business standpoint to help save lives. Costa is a biomedical engineer and Li brought key expertise in electrophysiology – a “perfect marriage” of skills, according to the CSO.

“The heart's kind of a cool organ as it's really complicated in a way,” explains Costa. “You’ve got the mechanics of how the heart wall moves, there's fluid mechanics of blood flowing through it, there's the electrophysiology, so the electrical signals running through the tissue…

“Most institutions will specialise in one of these areas, but there are not a lot of investigators with the breadth of expertise to understand all of that, so it was a nice coincidence that Ron came in with the expertise in electrophysiology. I had the expertise with the mechanics, and we were both interested in a stem cell tissue engineering component.

“We started working together, and Ron had the vision that maybe this could be a company, something with commercial value. I'm really excited and inspired by the science part of it; I don't really consider myself that much of a businessman, but he had that vision, and it seemed like a really exciting opportunity.”

The third person involved was Professor Michelle Khine, who specialises in microfluidics and machine learning. Together, they founded Novoheart in 2014, with the company going public on the Toronto Stock Exchange in October 2017.

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Novoheart has developed not just healthy hearts for testing, but they are also able to produce diseased heart tissues, allowing not just the safety of drugs to be tested but also their efficacy in treating disease.

Being able to do this is a big step forward, in technological terms, from current methods of testing. “The way scientists test diseases is often by simulating that disease in an animal, normally in mice,” says Costa. “They call these ‘knock-out mice’, or ‘transgenic mice’, where you can change aspects of the mouse to kind of behave like the human disease.

“But the bottom line is, mice aren't humans, and especially with the heart, it's just fundamentally different, because the heart in a mouse will beat about seven or eight times a second, whereas a human heart beats about once a second.

“So it's faster and it's smaller. There are obvious differences which can have very fundamental consequences in terms of how the heart handles calcium, how the heart is susceptible to arrhythmias, how the heart contracts, and what the actual molecular interactions are within the heart muscle, which means the mouse just isn’t predictive of how human hearts behave.”

That’s where this product, which works by synergising the developed tissues themselves with the types of electric impulses that you would see in a human heart, offers something new and unique to the market. Costa is absolutely convinced Novoheart can be a success, citing the fact the company is already working in conjunction with some of the global pharmaceutical giants as evidence.

“I think this technology really has the potential to have a major disruptive impact on drug development,” adds Costa. “I think if we could shorten the amount of time that it takes to develop a drug to get approved, that would be a good thing.

“If you're going to invest in something, you need to have confidence that you're investing in the things that are likely to bear fruit, and if they're not going to work, then you want to know that as soon as possible so that you're not wasting time and effort.”

Part of the reason for the $2-4bn figure mentioned above, says Costa, is that the cost is averaged out over such a low success rate. “If we can increase the denominator, that’s got to be a move forward,” says Costa. “You're still going to be putting in a lot of money into this development, but if you can get it to pay off more and generate more effective drugs, costs will go down… and hopefully that'll also restore consumer confidence in the industry.

“You know, these examples like Vioxx and things like that happening in the market, it makes people rightly concerned that the process is a broken process,” Costa emphasises. “I think that is true, and I think Novoheart is a novel way to fix that process and hopefully, if the cost can go down, success rates will go up and we'll start seeing more drugs. The pipeline has been kind of drying out, because there's not enough companies that have the resources to invest in this process.

“Hopefully Novoheart can reinvigorate the whole drug development industry, and have a major impact on patient health.”

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May 13, 2021

Birdie aims to reinvent elderly care with tech

3 min
We take a look at homecare software startup Birdie, who are aiming to transform elderly care in the UK

British startup Birdie has announced it has raised £8.2 million to invest in innovation and scale up the business. 

The company's announcement is timely as it follows the criticism of the UK government over their lack of a plan for social care, despite acknowledging the sector is in crisis - around a quarter of the UK's home care providers are on the brink of bankruptcy due to a lack of funds and staffing. 

Birdie was born with a mission to  "radically improve the lives of millions of older adults", by using app-based solutions, IoT and machine learning to put preventative care at the forefront.  The company was founded by Max Parmentier,  after experiencing his own frustrations with the care system - his grandfather struggled with the impact of life in a care home, but lacked any other option. 

In 2017 Parmentier partnered with venture builder Kamet Ventures to  set up Birdie, in a bid to fix this problem. Since then, Birdie has partnered with almost 500 providers across the UK, and supports more than 20,000 older people every week. In the past 12 months alone the number of people Birdie supports has got six times greater. 

Birdie’s solution is an app to help care providers deliver more coordinated, personalised and preventative care, by giving them access to digital assessments, medication scheduling and planning tools. By using digital tools to take care of admin, staff have more time to spend with their care recipients. 

The new investment will be used to fund Birdie’s next phase of growth in the UK, as the company scales to meet the rapidly growing demand of the aging population. The company will also invest in product innovation, creating new features to address customer requests.

In addition, Birdie is piloting new care models, including partnering with the NHS to identify COVID-19 symptoms, building predictive pharmacy models with AI, and helping health authorities to detect early warning signs of patients’ health risks.

Internally, Birdie is committed to having a progressive company ethos. All salaries are transparent, and staff work asynchronously to maximise flexibility and equity. Staff members also volunteer in their local community during office hours, and the company offsets all its emissions.

These efforts have led to numerous awards, including having the best SME culture in the UK, an Honorable Mention in the Health category of Fast Company’s 2021 World Changing Ideas Awards, and innovation in care at the LangBuisson awards. 

“We believe the future of care for older people should be helping them to live at home for as long as possible through the delivery of personalised and preventative care" Parmentier said. 

"Birdie is already the partner of choice for caregivers up and down the UK, and this new funding will help us rapidly increase the number we partner with and what we can offer them - meaning more people benefiting from more affordable, quality care. We’re proud of our mission and the values we embody to pursue it.” 

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