Digital Therapeutics have the potential to help millions of people who have unmet medical needs. But of course, you know that!

In our conversations with you, the topics that come up time and time again are adopting the right commercial model and ensuring that digital therapeutics (DTx) can meet a rigorous standard for quality. The Digital Therapeutics Alliance (DTA) has been leading the way in exploring options for quality standards and they recently met for a roundtable with USP.

USP is advancing quality to help build a healthier world. They recognise the challenges faced by the introduction of technology. Michael Levy (1) recently wrote a great article on the question of quality following the DTA/USP roundtable.  He says:

“The answers aren’t simple and require a robust discussion among experts in this area. For example, USP standards are used to confirm the identity, potency, purity, and performance of medicines. But what is the meaning of the “identity” of a digital therapeutic? For a chemical medicine, this question focuses on the chemical composition and structure that is unique to the substance. For a digital therapeutic, which involves computer code, the definition of “identity” will have to change, but it is difficult to know exactly in what way it needs to evolve.”

I recently watched a documentary on the life of Madam Marie Curie. A pathfinder in the field of Science, she remains to this day the only Female to have been awarded two Nobel prizes for separate disciplines. When she discovered a new element in pitchblende, the full weight of scientific knowledge had nothing for Madam Curie to reference. It was so new that for quite some time the effect of this new element was un-named until Marie herself came up with the name ‘radiation’. This new phenomenon was so exciting that manufacturers rushed to add Radon to their products, including toothpaste! Of course, we can look back at this now and ask ourselves ‘what were they thinking?‘ But to be fair, regulation of medicines and therapeutics had yet to be normalised. I am not suggesting that DTx has the same inherent dangers as radiation! However, we do have a robust regulatory framework for medicines but this framework is not relevant to DTx. As Michael says, DTx are so new, so different, that they will have to consider a whole new way of validation.

This conundrum highlights the importance of the work the DTA are setting out to accomplish.

The DTx event series is the dedicated meeting place and forum to help all the stakeholders advance the conversation. At the East Coast event on Sept 25-26 in Boston, the programme focuses upon quality assurance and business models. I cannot wait to see the conversation develop.



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