Bioelectronics, a new field to guide the treatment of chronic diseases.
When you combine GSK’s drug development expertise with Verily’s low-power miniaturised devices, you get Galvani Bioelectronics – a pioneering developer of bioelectronic medicines. MedTech Engine catches up with president Kristoffer Famm
MedTech Engine: How would you describe the discipline of bioelectronics?
Kristoffer Famm: Bioelectronic medicine is an emerging scientific field, aiming to use tiny implantable devices to change precise electrical signals in nerves to treat a range of debilitating chronic diseases.
Do you feel the work of Galvani Bioelectronics is more closely linked to pharma or to medtech? Or does it require us to think in terms of an entirely new category of medical innovation?
Galvani Bioelectronics represents an important step change in the research and development of these medicines, combining GSK’s discovery and development expertise and deep understanding of disease biology with Verily’s world leading expertise in the miniaturisation of low power electronics, device development, data analytics and software development for clinical applications.
What are some of the greatest challenges in this brave new world?
Two key scientific obstacles to overcome are:
1) The body’s hugely complex electrical wiring. We still don’t fully understand which neural circuits control a given organ function. The need for a “map” of the nervous system is widely recognised and is the subject of comprehensive research efforts – for example the US National Institute of Health’s SPARC (Stimulating Peripheral Activity to Relieve Conditions) and DARPA’s (Defensive Advanced Research Projects Agency) “Electrical Prescriptions” (ElectRx) programme.
2) The need for extreme low-power miniaturised devices to deliver bioelectronic therapy: the development of such devices that can function for decades without damaging the delicate biology of the human body is a key objective of Galvani.
What has Verily brought to the mix that GSK would have struggled to achieve independently?
Verily has a singular focus on developing cutting edge technologies to improve human health. Their expertise lies in using low power, miniaturised devices and data analytics, which will be invaluable as we embark upon this critical next phase of research. Their whole mission is built around bringing together technology and life sciences and their culture already relies on multidisciplinary teams working in areas similar to bioelectronics.
How do you see the role of bioelectronics fitting into the wider horizon of medical innovation? Will it be driving the forefront of new health solutions? Or will it simply be one of a group of drivers?
While we’re confident that bioelectronic medicines will be used to treat a broad range of chronic diseases in the future, we see these medicines sitting alongside and complementing pharmaceutical and other therapies, rather than replacing them. We believe its initial appeal will be to patients with chronic disease that is not well controlled or in disease areas where there is still unnitial work is centred on establishing clinical proofs of principle in inflammatory, metabolic and endocrine disorders, including type 2 diabetes, where substantial evidence already exists in animal models; and developing associated miniaturised, precision devices. When we started our work in bioelectronics in 2012, we predicted that it would be a decade before devices would be ready for regulatory review. That estimate remains accurate
Which regulatory system(s) will they need to go through? (ie. pharma, medical devices, etc)
In Europe, the device would be regulated as a Class 3 active implantable device.
Who else is moving into this space, and do you see partnerships there?
Over the past four years, GSK has built up a global network of around 50 research collaborations in the bioelectronics space, many of which are with world-leading academic institutions. These collaborations will continue and Galvani will continue to seek out partnerships with other external experts in the field.
Original article by MedTech Engine
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