Regulatory Focus™ > News Articles > GSK Bets Big on Bioelectronic Medicine as Regulatory Questions Loom on Horizon

GSK Bets Big on Bioelectronic Medicine as Regulatory Questions Loom on Horizon

Posted 08 August 2013 | By

Back in April 2013, Focus covered a rather futuristic-sounding announcement from GlaxoSmithKline regarding its funding of a new field of medicine the company was calling "electroceuticals"-more formally known as bioelectronic medicine-an emerging field of medicine that might one day use the body's own electronic signals to treat patients. While the initial funding was small-just $1 million, a miniscule fraction of GSK's $40 billion in annual revenue last year-the company has just announced this funding is poised to increase substantially in the coming year.

Background

GSK seems to be betting that electroceuticals might one day revolutionize the medical field. At present, it is envisioned that an electroceutical could trigger nerve fibers to restore vitality to organs or other functions. GSK observed in a statement in April 2013 that, "The functions and organ systems of our body are, to a significant extent, controlled by electrical signals that travel along the nerves."

Bioelectronic medicines would, in theory, treat diseases by controlling those electrical signals, manipulating how the body communicates with itself.

"One day, such 'electroceuticals' could potentially coax insulin from cells to treat diabetes, regulate food intake to treat obesity, and correct balances in smooth muscle tone to treat hypertension and pulmonary diseases," GSK speculated. "We believe this is a vision now worth pursuing. And it is why we are seeking to grow and integrate a research network that will become a new bioelectronics community."

"We are confident that this field will deliver real medicines, and we are mobilizing resources for this journey," the company's researchers wrote in an accompanying editorial in the journal Nature.

A $50 Million Fund

In light of this potential promise, GSK said it now plans to launch a $50 million strategic venture capital fund to invest in companies developing the new technologies and medicines that could benefit from electroceuticals. The fund will reportedly operate under GSK's own Bioelectronic Research and Development unit, which the company established in 2012.

"We want to help create the medicines of the future and be the catalyst for this work," said Moncef Slaoui, chairman of R&D, in a 7 August 2013 statement. "GSK can play the integrating role that is needed to drive this new type of medical treatment all the way from the bench to the patient and this fund is a key part of our efforts."

GSK added that it hopes the fund will be able to build a portfolio of five to seven companies within the next five years.

How do you Regulate Electroceuticals?

All of this investment, however, raises a tangential question: Are global regulators ready to review these new types of combination products?

The products would represent a potent combination of challenging reviews: nanotechnology, medical devices and potentially even medicine contained within micro-capsules activated when certain conditions are met.

US, EU and Asian regulatory bodies have all been slow to issue guidance or regulations regarding nanotechnology, which are notoriously difficult to manufacture. Among the regulatory considerations: How do you assess and ensure the quality of devices you may not even be able to see? And how do you assess the safety of a product that could accidentally be inhaled by a person working in a manufacturing plant making the product, or even by the intended patient?

Electroceuticals, then, could stand to benefit from regulators taking a longer and more in-depth look at how they regulate nanotechnology products-something already likely to happen over the coming decade.

But complications become myriad once medicines-either chemical or biological-are introduced into the regulatory equation, raising a key question: What is the primary mode of action of an electroceutical?

While many combination products (i.e. a pre-filled syringe) have a primary mode of action that is medical in nature, GSK's explanation of bioelectronics medicine makes clear that some products might not have just a single mode of action, instead relying on both electricity and medicine in tandem (electricity to activate a site and the medicine to access it).

For the purposes of regulatory review, then, it could become difficult to determine which center has responsibility for the product. In the US, that could also affect the dates by which the agency must respond to certain user fee-required response dates.

For now, all hypothetical questions, but it's no longer the $1 million question-now it's worth $50 million.


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