Data security is an urgent concern for enterprises, but it’s even more important for firms processing patient data, Peter Ertl of Pregenerate explains.
Peter Ertl is the chief technology officer at Pregenerate, a company that uses scalable organ-on-a-chip models to replace animal testing in pharmaceutical research for arthritis treatments. The company uses human cells in its model and uses the technology to stratify patients into targeted treatment sub-groups.
He is also a professor for lab-on-a-chip systems for bioscience technologies at the Vienna University of Technology in Austria.
Here, Ertl discusses the unique data challenges present when dealing with medical data and the role he plays in ensuring the smooth production of his company’s technology.
‘In the patient realm, data security is of the utmost importance and is part of medical confidentiality’
– PETER ERTL
Tell me about your own role and your responsibilities in driving tech strategy?
The main task and challenge at this point is ensuring manufacturability of our micro-device. This means that my role and responsibilities include industrial prototyping, scale-up production and proper engineering documentation needed for regulatory approval.
Are you spearheading any major product initiatives you can tell us about?
I am involved in two microfluidic product developments as independent consultant, but I am not at liberty to disclose details at the moment.
How big is your team? Do you outsource where possible?
The team size varies according to engineering efforts and agreed time lines. At the moment, Pregenerate has two full-time dedicated team members as CEO and COO, with part-time lab support from two Imperial College students, and we are currently searching for a full-time biologist to join the team.
Additionally, we have a strong collaboration with the Vienna University of Technology, where our technology platform was invented. Of course, as a small start-up, we need to outsource some activities such as supportive services including marketing, regulatory as well as some data processing.
What are your thoughts on digital transformation and how are you addressing it?
Digital transformation is enabling us to change existing value chains in medicine and pharmaceutical research and, as such, will play a big role in Pregenerate’s future value-add of patient stratification as well as non-invasive measurable outcomes in patient monitoring.
For example, artificial intelligence and machine learning in diagnostic imaging provide advanced patient monitoring in arthritis progression over time, even independent of clinical symptoms. In turn, this improves Pregenerate’s interventional opportunities to optimise patient outcomes and generates much needed data for designing targeted precision treatments.
What big tech trends do you believe are changing the world and your industry specifically?
Microfluidics are revolutionising point-of-care diagnostics, tissue engineering and even gene therapies. We are witnessing an era where empowering patients and doctors together with innovative and iterative technologies is changing the way mankind approaches disease – ultimately, this will create a shift toward more prevalent, proactive, preventative care, as well as democratised medical technology available to more people globally.
Organ-on-a-chip technology heads the trend toward individualised medicine, personalised therapy options and precision medicine.
In terms of security, what are your thoughts on how we can better protect data?
In the patient realm, data security is of the utmost importance and, in Pregenerate’s opinion, is part of medical confidentiality. Anonymisation and strict adherence to HIPAA and GDPR are minimum requirements, and we aim to exceed these expectations by designing dedicated GMP/QC labelling systems and databases with the highest security available.
An integral part of this equation is internal auditing and self-reporting within a team environment. Outsourcing data processing to trusted partners can insure unbreakable firewall implementation and will be essential to small, disruptive start-ups including Pregenerate.
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