Pharma cos now demanding return on digital investments but some still risk being left behind, says DiMe Society's Jennifer Goldsack

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Talking the talk alone is no longer enough for pharma companies where their digital strategies are concerned—now they need to walk the walk, too.

Cajoled by the pandemic and ongoing challenges with clinical trials, including studies’ low rates of technical success, protracted timelines, recruitment and retention failures, as well as ever-increasing pressures to find new revenue streams as patent cliffs draw near, drugmakers now want to see digital investments bearing fruit.

That is the view of Jennifer Goldsack (pictured above), chief executive of global non-profit the Digital Medical Society (DiMe), which was set up in 2019 to drive forward the field.

Even over this three-year period, Ms Goldsack has seen a change in the way pharma companies view their use of digital tools.

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Growth in demand for DiMe’s resources—delivered via open-source channels and educational programs—is further evidence that companies are determined to gain maximum benefit from digitization.

Ms Goldsack believes that, until recently, to some extent the “tail wagged the dog”, with technology companies sometimes expecting their pharma colleagues to be takers of any product they were offering, while there was a paucity of knowledge and understanding among drugmakers around what they should demand from their partnerships.

“The tables are turning a little, and we’re starting to see leading pharma organizations have an understanding of what the value is and what good looks like, and they are now demanding that of their digital counterparts, of their vendors,” she told The Pharma Letter.

“We’re in a period where the cream is going to rise and a lot of the activity is going to drop out because it’s not actually yielding benefit, and we’re going to see more intentional use of digitization strategies.”

Upskilling must be a concerted effort

This change is being positively driven by drug companies that have invested in digital in their strategy and have appropriately upskilled their workforce.

“They’re the organizations that are able to be discerning and intentional with the digital partners that they work with,” Ms Goldsack said. “There’s a separation happening of those organizations that are raising their hand and saying “we’re all in with the digital strategy, and we’re supporting our teams accordingly,” and those who are not.”

Where previously there might have been a misconception that a single partnership or point solution such as a software product or interface would yield results, now it is understood that a comprehensive transformation is needed, appropriately selecting from all of the digital tools available to fundamentally change how new medical products are discovered and developed.

Making this transformation happen across an entire organization is an essential hurdle to overcome.

“We’ve reached a point in the industry where there is real experience and expertise within innovation, digital, data science and decentralized clinical trials (DCT) teams,” Ms Goldsack said. “There are pockets of expertise, teams who are ready to put their foot on the gas, but there are inadequate skills across the rest of the organization.”

Creating a shared understanding

The imbalance can lead to a culture across the broader organization of fear and uncertainty about what technology means to the industry, to scientific integrity and to job security.

This becomes a real issue, when, for example, a mandate comes down from senior leadership and, although innovation and DCT teams might be ready to implement it immediately, they meet inertia at every juncture.

Attempts to partner with a vendor mean going through legal teams that do not understand the value of an AI partnership, for instance. Those teams have to be educated, as do procurement, regulatory, commercial, health economics and outcomes research and other functions within pharma companies, all of whom harbor doubts and concerns about this technology and what it means for their work and their position.

“The broader organization outside of those core teams doesn’t yet have the fundamental understanding of why this is valuable and how it’s going to help them meet their key performance indicators as opposed to take their job, or cause them burden,” Ms Goldsack said. “And they don’t have the skills for successful implementation. That’s the challenge we’re seeing now.”

But this does not mean that the bottleneck cannot be overcome. Some companies are successfully adapting by making sure that all parts of the organization are on board.

Empowering innovation

Ms Goldsack names Takeda (TYO: 4502) as one example of such a company. The Japanese drugmaker has integrated its data science, innovation and DCT teams to create what she calls “a really nice structure of innovation.”

Takeda was the first pharma company to sign up for DiMe’s Digital Health Fundamentals for Pharma enterprise license, something that the firm viewed as “absolutely necessary for supporting its strategic priority around innovation in digitization as key to its organizational success, and ultimately speeding up the generation of new products and bringing them to market successfully,” Ms Goldsack said.

“I would call Takeda out as being leaders for its structure, its leadership, dedication to innovation and its commitment to getting every member of the organization trained on the basics—something we have partnered with them on,” Ms Goldsack added.

“This makes it easier for Takeda’s innovation teams to be effective. It’s much more enjoyable not to be educating people every day, but to be driving forward—it allows them to be much more agile.”

Companies that fail to pursue a similar approach to digitization risk falling behind in their drug development activities.

“We’re already starting to see a splitting, where some organizations—and Takeda certainly isn’t the only one—are moving ahead. Others are very busy with proof of concept studies and even implementing single point solutions. But by the time they try to get them into a trial, it’s too late, and there’s no leadership support to get it in, and so on.”

Manifold potential benefits

Over time, the gap to the organizations left behind could grow exponentially if they do not rapidly embark on a more holistic plan for digitalization as a core strategy.

“These innovations are not just helping molecules in the pipeline today,” Ms Goldsack explained. “For example, if you were to use a digital endpoint to support a label claim, it may allow you to reduce clinic visits and do some things remotely, reduce timelines, make enrolment easier, reduce costs. If it gets an additional label, a digital measure is more likely to reflect the most important parts of the patient’s experience of the disease. If that’s in the label, the hope would be that that’s reflected in reimbursement decisions and price points because this new digital data can show how it’s addressing patient need.

“In a large cohort Phase III, Phase IV trial where this measure is being used, you might start to see signals in the data that some people are responding particularly well to a drug. That’s what we would describe as a digital phenotype. Within a broad diagnostic criterion, we have started to identify a subset. That’s exciting because you can start to screen people based on that measure.

“Those companies aren’t just winning on that molecule, they are sending that information back to their discovery teams who now have better data to do hypothesis generation from. Their next molecule is going to come faster and have a higher rate of success.”

The need to embrace these benefits is so pressing that Ms Goldsack is unsure whether some organizations will recover if they do not start using digital endpoints soon.

Companies 'can't afford not to take the time'

A library of digital endpoints is one of DiMe’s open access resources, along with its V3 framework supporting the evaluation of digital tools, and a playbook on digital clinical measures.

“We encourage folks to use those resources, which are typically developed with input from our regulatory colleagues,” Ms Goldsack said. “We have hundreds of case examples of these resources in action so you can see how your peers in industry are successfully deploying them.”

Perhaps DiMe’s most important offering right now, given the education deficit across organizations, is the Digital Health Fundamentals for Pharma course. This interactive resource covers core language, global regulation and all of the different digital tools in the tool box, from AI and machine learning methodologies to digital clinical measures, companion apps, electronic informed consent, real-world evidence, social media marketing, telehealth and more. Examples help to show that these tools are not widgets but rather solutions that, where appropriately deployed, can bring transformational results.

“We are seeing top 10 pharma invest in this, along with leading CROs,” Ms Goldsack added. “They realize that they can’t afford, either for their business, for the retention of their innovators or for the patients that we’re all here to serve, not to take the time to back up their strategic priorities around digital, to make the investment to upskill and to prepare the rest of the pharma workforce. I think that is the most important thing that any leading pharma organization, anyone who is serious about their digital strategy, could be doing right now.”