Developing a personalised approach to cancer treatments
Written by Dr. Hakim Yadi and Dr. Louise Jones
Dr Hakim Yadi is an expert in translational medicine at PA Consulting Group and Dr Louise Jones is Head of Translational Research and Stratified Medicine Service Delivery Lead at Cancer Research UK.
As our understanding of the genetics of cancer has developed, there has been much discussion about the potential to use genetic information for personalised or stratified treatments. However, for this to become a reality for all patients, the NHS in the UK needs to develop an effective national molecular diagnostic capability. Cancer Research UK has built a partnership with the NHS, healthcare industry, and the clinical and research communities to create an approach to large scale genetic testing for cancer.
The Stratified Medicine Programme
Phase One of the Stratified Medicine Programme will work with a number of hospitals and labs to demonstrate on a small scale how the NHS can provide molecular diagnosis for all cancer types routinely. It will also discover if this information can be linked to patient outcomes to build knowledge about the interaction between genes and treatments. The programme will focus on six different tumour types: breast, bowel, lung, prostate, ovary and melanoma. Patients will be asked their permission for surplus tissue from their diagnostic tumour sample to be sent to one of three leading NHS genetic testing labs, where DNA will be extracted and analysed for a range of molecular faults linked to cancer. This information will then be linked to details of their treatment and outcomes in a central secure NHS data repository, for access by researchers.
The programme is a partnership between Cancer Research UK, Astra Zeneca and Pfizer and the industry is interested in the potential of stratified medicine, and specifically the opportunity to identify patients for clinical trials and to develop new genetic treatment hypotheses. Alongside this, the government is investing in stratified medicine through the Technology Strategy Board (TSB), the UK's national innovation agency. The TSB’s Stratified Medicine Innovation Platform has committed to a £50 million investment over the next five years to drive the creation of new technologies to support the delivery of stratified medicine in the UK.
“Cancer patients deserve affordable, high quality tests delivered on time, and researchers need more information to link genes, treatments and outcomes,” says James Peach, Director of Cancer Research UK’sStratified Medicine Programme. “Our programme hopes to demonstrate both of these things and we have built a strong partnership across the main stakeholders: the pharmaceutical and diagnostic industries, the NHS, and the Department of Health.”
Challenges facing the diagnostics industry
Diagnostic products will be at the heart of the future of stratified medicine and have the potential to change the business model of pharmaceutical companies, as the era of blockbuster mass usage drugs is replaced by medicine targeted on specific populations. We cannot yet justify or afford sequencing every individual’s genome before a visit to the doctor. However stratification, based on common mutations, is already used in the treatment of the genetic subgroups in breast, lung and colorectal cancer. This approach to treatment will only grow as understanding of the genetic mechanisms of disease increases and James Clough, VP, Oxford Gene Technology believes that new technology platforms for genomic analysis offer enormous potential for the NHS to dramatically improve patient outcomes in cancer.
The challenge the industry faces is keeping up with the rapid pace of discovery of new disease indicators. Dr Paul Denny-Gouldson, from IDBS, believes that one way to do this will be to encourage collaboration within the diagnostics industry to ensure that the industry reaches a consensus, or at least drives interoperability around the technologies used to diagnose disease. Other issues will include the requirement for diagnostics to be more readily available at the point of care; have a rapid turnaround and provide easily useable outputs for clinicians to use during diagnosis. The challenges are daunting but the interest from the medical diagnostic sector is encouraging. Tom Burr, R&D Manager at Source Bioscience, appreciates that initiatives such as the Stratified Medicine Programmeprovide industry opportunities to not only test the current state of the art but also to work together to develop new tools.
The Future: Beyond oncology
Dr Cathy Kelly is the medical director of Aridhia, a healthcare informatics company currently working with the programme. She believes that similar approaches could be applied in the diagnosis of central nervous system and cardiovascular diseases. In both cases there is high disease prevalence and insufficient diagnostic tools for early illness detection or disease prevention.
The ability to develop tests to stratify patients in disease areas outside of cancer will require new business models that promote and appropriately reward collaboration between pharmaceutical, diagnostic and bioinformatics companies. Developing these models will be instrumental in allowing all the existing stakeholders to thrive in this new environment.
The Cancer Research UK programme is the first step on this journey, offering an opportunity to learn and develop these capabilities throughout healthcare systems, opening new market opportunities for medical device companies able to meet these challenges.
How healthcare can safeguard itself against cyberthreats
One of the most fundamental lessons from the COVID crisis is that health should always be a priority. In a similar fashion to the human body that frequently fights off viruses and foreign invaders that intend to cause it harm, the sector itself is now a prime target for another type of external threat: cyberattacks.
The figures speak for themselves: between December and January this year, hospitals in the UK were at 89% capacity, with 7,000 fewer available beds than there usually are. As the pandemic increased pressure on hospitals, clinics, and research facilities to create a treatment for patients globally, it has left the sector exposed to hackers who, like a virus, have been targeting it relentlessly and evolving their tactics.
From patient records being held ransom, to fake emails claiming to originate from the UN WHO, the NHS, or vaccine centres, through to attacks on the cold supply chain to find out the secret formula of the COVID vaccine, the healthcare industry is facing constant cyberattacks and struggling to cope. This threat is unlikely to go away anytime soon – and as such, the industry needs to take a proactive, preventative stance to stay safe in a dynamic digital world.
The responsive nature of healthcare – particularly of hospitals – means that efficiency is crucial to the industry’s standard operations. To support this, the sector has been embracing technological advancements that can improve the quality of work, enabling staff to meet pressing deadlines, and enhancing patient care. For example, the industry has been digitising records and improving its ways of working through digital means over the past few years.
This shift is critical to offer high quality patient care; yet, it also means the sector has become more dependent on IT, which can come with a risk if cybersecurity processes employed are deemed as inadequate.
Without the correct security measures in place, the desired efficiency gains realised, can be easily lost in a heartbeat. Simply put, an elementary glitch in the system can have a tremendous ripple effect on many areas, from accessing patient records and conducting scans, to maintaining physical security and protecting the intellectual property of experimental treatment development.
To prevent this, healthcare organisations need to ensure they’re considering cybersecurity as part of their overall digital transformation strategy – and setting the right foundations to create a culture where safety goes hand in hand with patient care.
Before implementing cybersecurity process, healthcare organisations need to assess the potential risks they face. Depending on how much confidential data the trust has, where it is stored, who has access to it and via which means, the cybersecurity strategy and associated solutions will change.
It’s fair to say that a medical device start-up where all employees have a corporate-sanctioned laptop and access data via a VPN will have radically different needs to a large hospital with hundreds of frontline workers connecting to the hospital’s Wi-Fi using their personal device.
These requirements will pale by comparison to a global pharmaceutical giant with offices in multiple locations, a large R&D department researching new treatments for complex diseases and a fully integrated supply chain. Considering the existing setup and what the organisations is looking to achieve with its digital transformation strategy will therefore have an immediate impact on the cybersecurity strategy.
Despite this, there are fundamentals that any organisation should implement:
Review and test your back-up policy to ensure it is thorough and sufficient – By checking that the organisation’s back-up is running smoothly, IT teams can limit any risks of disruption in the midst of an incident and of losing data permanently.
In our recent State of Email Security report, we found that six out of ten organisations have been victims of ransomware in 2020. As a result, afflicted organisations have lost an average of six days to downtime. One third of organisations even admitted that they failed to get their data back, despite paying the ransom. In the healthcare industry, this could mean losing valuable patient records or data related to new treatments – two areas the sector cannot afford to be cavalier about.
Conduct due diligence across the organisation’s supply chain – Healthcare organisations should review their ways of working with partners, providers and regulatory institutions they work with in order to prevent any weak link in their cybersecurity chain. Without this due diligence, organisations leave themselves exposed to the risks of third party-led incidents.
Roll out mandatory cybersecurity awareness training - Healthcare organisations shouldn’t neglect the training and awareness of their entire staff – including frontline workers who may not access the corporate network on a regular basis. According to our State of Email Security report, only one fifth of organisations carry out ongoing cyber awareness training.
This suggests it is not widely considered as a fundamental part of most organisations cyber-resilience strategy, despite the fact many employees rely on their organisation’s corporate network to work. By providing systematic training, healthcare organisations can help workers at all levels better understand the current cyberthreats they face, how they could impact their organisation, the role they play in defending the networks, and develop consistent, good cybersecurity hygiene habits to limit the risks of incidents.
Consider a degree of separation – Information and Operational Technology (IT and OT) networks should be separated.
Although mutually supported and reliance on each other, employees shouldn’t be accessing one via the other. This should be complemented by a considered tried and tested contingency and resiliency plan that allows crucial services to function unabated should there be a compromise. Similarly, admin terminals should not have internet access to afford a degree of hardening and protection for these critical accounts.
As the sector becomes a common target for fraudulent and malicious activity, putting cybersecurity at the core of the organisation’s operations is critical. It will help limit the risks of disruption due to cyberattacks, reduce time spent by the cybersecurity team to resolve easily avoidable errors, and ensure that institutions can deliver patient care, safe in the knowledge that their networks are safe.
Fighting future threats
With technology continuing to change the face of healthcare, the surface area and vectors available for attacks by malicious actors is constantly increasing. With the introduction of apps, networked monitoring devices, and a need for communication, the attack vector is ever expanding, a trend that needs to be monitored and secured against.
To prevent any damage to patients, staff, or the organisation they are responsible for, healthcare leaders must put security front and centre of their digital transformation strategy. Only then can the sector harness the full benefits of technology. Doing this should include implementing cybersecurity awareness training to challenge misconceptions around security, encourage conversation, and to ensure employee knowledge of the security basics and threats faced.
This ultimately allows healthcare organisations to do what they do best: provide the highest standard of patient care, safe in the knowledge that their operations, patients, and data are safe.