Drug screening – improving the testing process
Ahead of an upcoming feature in Healthcare Global Magazine, Novoheart’s co-founder and CSO Kevin Costa gave us some insight into the issues faced when researching, developing and getting new drugs to market.
One of the big issues in the treatment of cardiac conditions currently is how difficult it is to get new drug candidates tested and approved using existing technology and parameters. Typically, the development of a new drug candidate costs US$2-4bn and takes more than a decade, with failure rates for new drugs of circa 90%.
The primary cause of drugs being withdrawn is heart toxicity. In testing, non-human and non-cardiac cells may be used which is not the optimal way to get an idea of human response and can lead to false negative or false positive clinical results, compromising overall success.
The limited number of human hearts to test on particularly impacts the proper testing of new drugs designed to treat heart condition and has in the past led to products entering the market which were unsafe.
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“The way scientists test diseases are often by simulating that disease on an animal,” explains Kevin Costa, Chief Science Officer at Novoheart. “They call these ‘knock-out mice’ or ‘transgenic mice’, where you can change aspects of the mouse to behave like the human disease… but the bottom line is, mice aren’t humans, and especially the heart is fundamentally different as the heart in a mouse will beat seven or eight times as fast.
“It’s not only faster and smaller, but there are obvious things about the heart that are different and 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 hear muscle… all in all, this means the mouse heart just isn’t predictive of how human hearts behave.”
Novoheart has developed living heart tissues which can deliver a predictive accuracy of 90% or more, which has the potential to make screening processes for new medication safer, faster and cheaper. The mini heart acts as an advanced human heart surrogate and can be used by drug developers as a solution to what is currently an ineffective system.
NHSX releases new data plans, experts call for transparency
Patients in England will get "greater control" over their health and care data according to new proposals set out by the government.
In a new draft strategy called "Data saves lives: reshaping health and social care with data", Health and Social Care Secretary Matt Hancock says that more effective use of data will deliver better patient-focused care. "This strategy seeks to put people in control of their own data, while supporting the NHS in creating a modernised system fit for the 21st century which puts patients and staff in pole position."
Under the new plans people will be able to access their medical records from different parts of the health system through different applications, to access test results, medication lists, procedures and care plans.
The strategy, published by NHSX, the government department that sets policies for the use of technology within the NHS, follows delays to the creation of a central database of patient records amid concerns over data sharing and a lack of transparency, with critics saying that only a small proportion of the public were made aware of the plans and the choice to opt out.
Kevin Curran, senior member of The Institute of Electrical and Electronics Engineers (IEEE) and Professor of Cybersecurity at the University of Ulster, says that moving health records online raises concerns. "The move to an online app does seem like a natural progression, however there is a difference between having computerised records within our healthcare IT infrastructure and having those records reside on a public facing server.
"Having records inhouse limits the range and type of access – it's far more difficult for remote hackers" Curran said. "There are techniques that healthcare organisations can use to reduce the risk of future data breaches. One way is to make it ‘opt in’, so patients have the choice to decide whether their medical information is moved to a public facing service so that they can access it.
"However, those who do not opt in or download the app instead should have their records hosted in a non-public-facing cloud service. This way, if a data breach does occur, those who never used the app, or not wanted to, will not have had their details released."
The new strategy has been welcomed by some, with an emphasis on the need for transparency. Adam Steventon, Director of Data Analytics at the Health Foundation, said: "Health data has played a critical role in the last year – from tracking COVID-19 outbreaks and developing treatments, to getting people booked in for their vaccines. It is critical that the use of data is accelerated if the NHS is to tackle the backlog of care and address the massive health challenges facing the country.
"It is particularly positive that the government has committed to building analytical and data science capability in the NHS and to improving data on social care. To ensure the full potential of data can be realised, the government must ensure transparency on how it will be used and the rights and options people have, as well as engaging with the public and health care professionals to build trust and show people how their data can improve the NHS and save lives."