Q&A: Scaling digital dividends for biopharma R&D

Efforts to digitalize healthcare systems across the European market are reaching an inflection point, as leaders there have seen some success with high-value digital use cases. However, these victories have been small and on a regional scale. We asked ZS leaders serving that market, Principal Bazgha Qutab and Associate Principal Pameljit Kalra, to reflect on how biopharma companies are scaling the value of digital initiatives.

ZS: Despite putting so much energy and effort into digital transformation in biopharma R&D, most companies are still running programs that aren’t scaling the few things that create meaningful and measurable value. Why is this happening and why should biopharma focus on the idea of value—or scaling for value—in R&D?

Bazgha Qutab: We have seen waves of uptake in digital transformation programs. There are hype cycles followed by periods of “We don’t know what happened on the outcomes of the transformation.” I believe the miss on these programs is embedded in the miss in the design phase and how the programs are adopted to scale, for a couple reasons:

• Digital is a mindset—a culture. It needs to transcend organizational boundaries. We often see companies bring digital into specific areas, such as R&D design, where it’s piloted across a few studies. But the superseding study, portfolio or disease area approach is missing. Transformation needs to fit across all levels of the portfolio and value chain.
• Scaling across core markets on the program roadmap is an afterthought. This is missed in the design itself, where it’s assumed that other markets or functions can adopt the standard blueprint from the first market or first launch.
• How value is defined, measured and planned for is also often missed. There may be some focus on KPIs, less on value and almost negligible attention on adoption.
• Digital is a connected ecosystem. So, healthcare professionals (HCPs), patients, sites and healthcare organizations should be considered as part of a single customer or stakeholder ecosystem when enabling change. Across healthcare, organizations are paying lip service to a patient-first mindset, but they haven’t fully adopted it.
  

When it comes to workstreams and use case overload, people fear failure so the concept of “fail fast” is often not adopted. As a result, programs, workstreams and experiments become monolithic. You can’t scale everything, and not every idea can be adopted. Organizations that can accept that not all ideas and work packages are beneficial in the long run—and can re-channel resources and energies without creating emotional debt amongst contributors as a result—will run a much leaner and value-based transformation culture.

Pameljit Kalra: Digital is not about technology per se. It’s about new ways of working across an organization’s value chain. Value can only be realized if it’s designed and implemented for scale, and scale can only be achieved if we look at it as a fundamentally different way of working that transcends functional boundaries. That said, this is not about making it so big that it buckles under its own weight. It’s about an opportunistic mindset to execution with a long-term strategic view.

To make it real, let’s take the example of patient centricity in R&D. Pharma companies make many informed bets about what will strengthen a patient’s experience in a trial. So, they try things like simplifying the informed consent process, or taking steps to make clinical research a part of clinical care so that doctors can easily determine which trial to offer to their patients. Companies try to make sure patients’ voices are included in the protocol synopsis, or even in the design of the drug modality. The heart of making these bets is a strong innovation model—a model where fail-fast approaches help prove or disprove an innovation and where a balanced innovation portfolio allows you to invest in moonshots and the mundane. Once some of these bets are ready to graduate into the real messy world, the operating model and culture are already primed for change. It takes a village to scale, and where most companies fall short is activating this village.

ZS: How should organizations start to think differently, in terms of adopting a value mindset that involves scale as a starting concept?

PK: Digital transformation is not a one-and-done thing. It’s a continuous journey, with some waves of transformation running deeper than the others. Historically, specific business and IT transformation drivers shaped these waves of transformation, but now several of these drivers are converging to shape deeper and faster waves of transformation. Earlier in my career, I helped CIOs shape cloud-first transformations in R&D. Back then, it was helping R&D leaders with a new wave of data- and analytics-driven transformation to drive a step change in clinical development. Now, AI and machine learning are creating new opportunities in clinical development. Digital transformation must be embedded into business and IT as a new way of working with an operating model that can adapt to the ebbs and flows of transformation, allowing talent to collaborate across boundaries. This elevates the impact of digital and allows a culture of continuous innovation to thrive.

BQ: Yes, the operating model is different now, and clinical development is a unique space for digital health enablement. And while the European market is primed for innovation, digital can be truly global in how it delivers on the promise of a development program in a particular disease space. Digital can enable a focus on the cure itself rather than red tape around internal and external buy-in.

We see two big opportunities for digital in clinical development—unlocking the power of data upfront in trial design and tapping into digital modalities to optimize outcomes on three fronts:

• Patient engagement
• Clinical measurements—such as generating evidence through digital biomarkers and digital endpoints
• Health outcomes—via the use of digital therapeutics or software as a medical device

Pharma should invest and find partners to help scale here.

When it comes to this new era of AI, organizations should favor a “fast AI” approach that involves experimentation and “insighting” and moving on to the next research question quickly and in a lean way. If you’re planning on using AI centers of excellence (COEs), take care that you don’t spend more effort bringing teams together than learning from experiments that can be taken to scale. Adopting the concept “design room” or “design studio” like those used in the launch space can be helpful in the design phase. Your data scientists should be sitting side by side with your clinical development and disease area leaders.

As for digital health, organizations must bring healthcare to the patient, rather than patients to healthcare systems. This is the future. Patients should be screened for trials virtually, and data collection and patient monitoring should be done through digital channels. This is happening now, but on a small, regional scale.

ZS: What critical actions can organizations take today? What have you seen that’s working today?

BQ: Organizations should embed digital transformation in organizational culture so employees can adopt it as the way of the future, so there’s continuous development, adoption and learning. What’s working well today is that healthcare and digital have almost become synonymous. Companies have added this as part of their branding, and then vision and setup teams and groups are running the digital remit. However, a lot of work is still needed to move beyond one pilot project. Leaders should consider:

• Having digital COEs and teams that are embedded across functions and closely linked to countries and affiliates
• Assessing the digital readiness and adoption of nearly all business processes and creating a roadmap for acceleration if they’re determined to be behind
• Keeping the patient and consumer in mind and developing a digital customer and patient data strategy and path
• Embedding a governance operating model and privacy considerations in the design of digital programs

PK: Digital is not a question of “if” and it’s not even a question of “how.” It’s a question of making transformation continuous and effective through an operating model that is set up for success. Successful organizations are investing in changing their core to adapt and respond to new transformation drivers—emerging technologies, new ways of working or new operating and business models. They are creating a runway for digital innovation by investing in digitally savvy talent, strong and fluid cross-functional collaboration, an innovative mindset, multimodal ways of operating and a strong ecosystem of partnerships.