The distinction between pharmaceuticals and technology continues to get blurry as companies partner to create high-tech devices combining biology, software and hardware to treat chronic diseases. Bioelectronics—miniaturized, implantable devices—can modify electrical signals that pass along nerves in the body, and potentially may be used to treat conditions such as arthritis, diabetes and asthma.
Earlier this week, GlaxoSmithKline (GSK) announced an agreement with Verily Life Sciences LLC (formerly Google Life Sciences), an Alphabet company, to form Galvani Bioelectronics to research, develop and commercialize bioelectronic medicines. GSK will hold a 55 percent equity interest in the new jointly owned company and Verily will hold 45 percent. The company will be headquartered in the UK.
The new company will leverage GSK’s drug discovery and development expertise and its deep understanding of disease biology along with Verily’s technical expertise in the miniaturization of low power electronics, device development, data analytics and software development for clinical applications. Initial work will focus 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 miniaturized, precision devices, according to GSK.
“Many of the processes of the human body are controlled by electrical signals firing between the nervous system and the body’s organs, which may become distorted in many chronic diseases,” says Moncef Slaoui, GSK’s Chairman of Global Vaccines, and chair of Galvani Bioelectronics’ board. “Bioelectronic medicine’s vision is to employ the latest advances in biology and technology to interpret this electrical conversation and to correct the irregular patterns found in disease states, using miniaturized devices attached to individual nerves. If successful, this approach offers the potential for a new therapeutic modality alongside traditional medicines and vaccines.”
Kris Famm, GSK’s vice president of Bioelectronics R&D, and now president of Galvani Bioelectronics, has pioneered work in both large and small molecule drug discovery and worked for a decade developing and delivering R&D strategy with a recurring focus on emerging technologies. He believes one of the benefits of bioelectronics is the ability to gain real-time feedback on how patients are doing.
“It will really help us hone the intervention,” Famm says in a Reuters article. “This is almost the epicenter of convergence because the technology is not only helping you to monitor a disease but it is also actually the therapy.”
Other companies are also working in the field. For example, biotech firms Setpoint Medical and EnteroMedics are developing bioelectronics as a means to tackle inflammatory diseases like rheumatoid arthritis and suppress appetite in the obese. Swiss-based Novartis also is working with Alphabet on a smart contact lens with an embedded glucose sensor to help monitor diabetes.
Novartis Chief Executive Joe Jimenez has said that the combination of pharmaceuticals and technology will eventually be “front and center” in disease management.
Nonetheless, there are numerous challenges for these companies, including, as the Reuters article notes, the need for multi-year clinical trials to prove that the new technologies are safe, effective and can deliver the type of benefits to overall clinical outcomes that proponents expect. Regulators such as the U.S. Food and Drug Administration (FDA) also need to be convinced of the case for radically new ways of treating and monitoring patients.
“The challenge will be to make sure that regulators are on board, although the FDA is much more innovative now than it was 10 years ago about accepting different endpoints for treating disease,” Hilary Thomas, chief medical adviser at KPMG, says in the article.
It will be interesting to see how supply chains are created for bioelectronics.