How Biopharma Commercial and R&D Can Partner to Accelerate Digital Innovation

For biopharma, improved adherence is frequently the goal of a digital strategy. It has been for decades. And adherence improvement is the easiest business case to make to top executives or within your organization, says Paul Upham, Head of Smart Devices at Roche/ Genentech. In the case of higher price pharmaceuticals, a very small fraction of a percent increase in adherence rates in a given market is often associated with millions of dollars of additional revenue.

Saunders agrees that compliance and adherence are a bit of a holy grail in medicine. "There’s a very high percentage of solvable diseases that are simply not handled appropriately because patients don’t comply with their medications. Statins, glaucoma medicines, etc. are examples where patients stop taking the drug after three months or so, despite the fact that lack of adherence directly impacts quality of life. Adherence for these drugs are measured in hundreds of days, but should be measured in years."

Chris Easton, Senior Director, Global Commercial Lead, Personalized Health & Innovation, Innovative Patient Solutions, at Takeda suggests moving further upstream even before adherence.

"Currently, [in its simplest form] biopharma looks at where patients have a symptom, and provides a solution in terms of a drug. We need to move from treating symptoms to preventing episodes. Patients are worried about when the acute episode might come. For example, with hemophilia - how can I avert a bleed? Or how can I reduce a bleed? Digital innovation should be about being predictive, alert, informed and patient-outcome focused," Easton says.

Launching digital health solutions is all the more important now, of course, because of the COVID-19 pandemic.

"Digital health has advanced much further because of other sectors demonstrating how digital can provide you with a competitive advantage, especially during a global pandemic," Hassan explains. "Look at how online e-commerce has greatly taken over from the retail sector. Examining how other industries are adopting digital and differentiating – or not and suffering because of it – will dramatically move digital health forward in biopharma."

"You have to flip the pharma equation," Arora says. "In the typical business model it sometimes takes a decade for a product to go to market. But as your costs come down, your margin improves, and then you get a handle on the model that is the right fit. Digital health is sort of the opposite of that. You almost have to figure out the commercialization first and then work backwards. You must ask, ‘What must I do in terms of clinical proof points?’ How would I measure success? How will I scale? Who's going to pay for it? When are they going to pay for it?

What is the minimum viable product (MVP) that I need to build? You have to figure out your commercial model first, and then work your way backwards."

It’s also important to avoid complexity in defining the goals of a digital innovation strategy and establishing proper success metrics.

"Don’t over-complicate it. Keep it simple," Easton urges. "Use the language that your patient would understand to tell a story for all of the stakeholders. Speak the language of the internal customers you’re trying to convince."

STEP 3: Understand How Regulatory Requirements Impact your Digital Strategy

It’s critical that even from the start – in the development stages – that you are building your digital health products on a regulated infrastructure.

"Regulation should not be an excuse to not innovate. It is something that you should be aware of, and something you should keep top of mind when selecting digital health vendors. Having a platform that natively meets regulatory requirements is much easier," says Goldsmith.

Ensuring that your digital health products and their supporting platforms are compliant means a more seamless path to market and commercial launch. If you don’t pay attention to this up front, you can have huge delays.

"Tight collaboration with not only R&D and Commercial, but also medical affairs, government affairs, regulatory, quality and privacy is important, especially as the digital tools become more sophisticated and move up the regulatory maturity curve," notes Upham.

With that collaboration ensured, there is tremendous opportunity for regulated digital health products to improve patient outcomes and drive efficiencies. Dosing algorithms, patient engagement apps, connected combination products, and software-as-a-medical device are all examples of regulated digital health products that leading biopharma companies are developing. We’re beyond thinking about digital just as a channel for marketing and are seeing game-changing digital health products being built.

Hassan shares a few examples of compelling digital health use cases.

"You can monitor patients in real time through biomarkers. You can actually monitor a patient based on how they feel." Hassan says. "Real-time monitoring enables patients to provide frequent feedback that can be analyzed very quickly. You don't need to wait a year or two to find out if a drug is working or a treatment or disease management program is working. You can learn that much more quickly through digital."

Data collected from connected devices and digital biomarkers, etc. can also be translated into new intellectual property.

Data can be translated into new algorithms that help an organization know something about a patient population or about a disease that its competitors are unlikely to know, because they haven't been collecting the same data or doing the same analytics, explains Upham. "To me, that value can be greater and more meaningful, especially from a long-term competitive advantage perspective."

In addition, Kolodin recommends that organizations establish a cross-functional group to best determine what to buy versus what to build, and that they create a culture around digital strategies. Organizations should invest in technologies "that don’t box you in. Interoperability is key."

Easton also reiterates that organizations need a broad, cross-functional team when driving digital: "IT, regulatory and quality stakeholders, and commercial brand owners all need to be involved, since you’ll be driving support towards their brands."

STEP 5: Measure your Success as You Go

It is important to report back to the C-suite and expand your programs as you show results. Reinforce the original success metrics you set forth, e.g. remind the team that app downloads wasn’t the metric that you cared about, but actual improved patient engagement.

The best practice is to get quick wins, Saunders advises. "Get some momentum and you’ll find wind at your back. And then you can take on bigger and more complex projects."

Over-communicate the benefits of digital, Kolodin stresses. "Celebrate the successes. You can convert more champions when people can experience the benefits of digital and data, and remember that different stakeholders are going to be receptive at different times. How and when you approach the laggards versus the early adopters of digital varies. I recommend starting with the early adopters to build more digital champions internally."

Hassan notes that digital-enabled successes don’t necessarily need to be dramatic improvements in outcomes or something similar.

"If an organization is early in bringing digital innovation to their product and service offerings, the metrics are often different," Hassan says. "They're probably not quite as business oriented. They can be about showing success in building capability, showing success in gaining expertise, and showing success in learning."

The bottom line: demonstrate success and progress in advancing your biopharma organization’s digital capabilities.