Healthcare is in the midst of a digital shift. Artificial intelligence offers physicians providers an new resource when making decisions, new data streams promise hyper-personalized treatments and digital therapeutics evangelists see are hawking the novel treatments as a companion, or even a replacement, to traditional biologic treatments. All in all, it’s a future that hopes to empower the individual while streamlining care and cutting costs — but only if pharma and other established players can identify its challenges and properly embrace what’s to come.

“The ecosystem has shifted, and it’s put more power into the hands of people who give the data, more power into the hands of the patients,” Dr. Ameet Nathwani, chief medical officer and chief digital officer at Sanofi, said yesterday to a packed room at BIO 2019 in Philadelphia. “[That] is a good thing, but we in the industry have to find out what is our role in that journey.”

Avoid mistakes from the past

Nathwani said that pharma has often fallen short with most promising innovations because it did not consider the ecosystem into which they would be introduced — take, for instance, the industry’s development and launch of therapies that required multi-hour infusions prior to infusion clinics becoming commonplace in health systems. The modern equivalent, he explained, is uncertainty as to whether or not the biologic treatments currently undergoing clinical trials will still make sense within the data-driven care ecosystem to come.

“Ask yourself, ‘Are people treated the same way that they are in your trial by the time the drug is actually approved and priced in the markets?” Nathwani advised. “Try and predict within three or four years after your product is available, how are people going to be treating their disease, how are patients expecting to be managed, and is that the same way that you’re developing your drug. Because if it isn’t, more people are going to ask the question: Well, this is great, you did your trials in five or six years in a very traditional manner, but in those five or six years … [patients] managed at home, there’s digital biomarkers, there are new devices that are probably used, the patient’s journey is probably completely different. If you have a more traditional approach, will your data still fit in that new model? I would ask yourself those questions now, and have those scenarios built in as you develop your drugs.”

Another consideration is growing presence of AI in everything from drug development to clinical decision support, he continued. On the one hand, there’s no reason for pharma not to lay the groundwork for tools that can address its biggest drivers of cost and inefficiency.

“My first message to everyone who is in our industry right now is to use technology to enable your trials, your conventional work,” he said. “We should be looking at that — how do we find patients, how do we codify them, how do we do the trials a completely different way? The technology is not there today, but we should maybe look at conducting trials more efficiently because the cost of R&D is still huge across our industry, and I think that’s ripe for disruption."

Much like other industries, however, healthcare is not immune to the broader threat AI and automation bring to the traditional workforce. Even beyond careful data governance, thoughtful system design and other efforts toward building responsible and transparent AI, Nathwani said it was important for pharma to begin preparing its people for the culture shift.

“The question is, how do we retool a generation to become more data driven, much more oriented to that,” he said. “We have a big program that we just kicked off internally to get our organization digitally literate to start with, and then we have to focus on building new capabilities. We certainly cannot hire everyone we need to, there’s already a shortage in the world of data engineers and data scientists … It’s a major problem, I don’t have a solution. It’s a society problem as well.”

Friend, not foe

And then there’s the question of the new kid on the block: digital therapeutics. For Nathwani and Sanofi, the maturing sector doesn’t necessarily represent a threat to the traditional business of biologic-based medications. Rather, he said, pharma companies should be carefully watching these smaller digital companies for signs of which parts of its business could be disrupted or replaced.

“We just have to be mindful. It’s the same as any other competition coming in, except it’s just very different and we have to have a different mindset,” he said. “A digital therapeutic can be a friend or a foe, we just have to open our eyes to the fact that competition is coming from new angles that we otherwise would not have considered. Our approach and response should be equal: Let’s embrace it, understand what it can do. If the patients are going to benefit in the end, that’s great for everyone. If we can’t differentiate our drug from a digital therapeutic we have a different problem, because I think digital therapeutics will be faster, they’ll be quicker, they won’t have the same safety burdens that you would encounter with our own drugs.”

That’s not to say that adopting these new modalities will be simple. While many digital therapeutics lack the adverse events of biologics and therefore may seem low risk to develop, there are are a number of logistic and regulatory unknowns that won’t be easy to untangle.

“The number one [risk to pharma] is just the complexity of developing these technologies,” he said. “Just imagine, when you develop a biologic drug and you make a slight modification, you have to go through this whole process. Just imagine that in the software world, where software changes over time. What’s the IP of it, can you IP a software? Well, actually, the regulations are not that clear and so there’s software’s copyright, and then what’s the generic version of it?”

Again, Nathwani said that pharma companies need to put more effort into investigating and anticipating which digital therapeutics or tools will drive the paradigm shift. To do so, he suggested that organizations should take a deeper look into the platforms being developed by tech companies in and out of the immediate space and, if it makes sense, follow their lead.

“There’s a number of tech companies working in this space. Take a scan of it and see how many other people are actually interested in those disease areas and see what they’re doing,” he said. “We’re very good at scanning [for] other biological competitors and understanding who’s developing similar products and similar drugs in the same ecosystem. We’re not very good at anticipating what are the technologies that are being developed that could fundamentally shift the ecosystem.”

Cutting costs, providing relief

Beyond simply keeping up with the changing landscape, Nathwani said that preparing for and embracing these new patient-friendly technologies is all but mandatory to combat ballooning price tags. As the cost of managing chronic conditions and delivering treatments is threatening to prohibit the development of novel treatments, he explained, any opportunity for pharma to remove costs from the system can’t be overlooked.

“I’m not sure that digital health is going to solve the fact that pharma is still regarded as just above the tobacco and oil industry in reputation. But I think what we do have is a responsibility right now … to actually manage chronic diseases more effectively, and more cost effectively,” he said. “Do you want to see a world where genetic therapy or cell-based therapies cannot be delivered? I think in order to afford that, we have to find a redress in the balance, take healthcare costs out in other ways, and be responsible in doing that. … And we can’t control everything — there’s also other infrastructure costs we can’t control — but at least we can play a role in that, and I think digital health is one way that can help us address the balance.”