By Deborah Borfitz

July 6, 2021 | At Almirall, a novel Digital Garden accelerator program for startups with digital health technologies is measuring success not by traditional operational metrics but on having high achievers from across the organization mentor the startups and help embed an “entrepreneurial way of working,” according to Francesca Wuttke, Ph.D., chief digital officer for the global biopharmaceutical company. The focus is on solutions for medical dermatology or improving pharma processes and commercial models.

Change management, she stresses, is the key to long-term change.

“We’re the engine for innovation and we transfer that to the business owners,” Wuttke says. The in-house mentors “help startups get to their next stage of growth.”

Companies up to now have been taking a somewhat siloed approach by focusing on one vertical rather than launching scalable experiments that can transform the enterprise from end to end. Stories from the trenches on ways to pick up the breadth and speed of innovation will be shared during a fireside chat Wuttke will be moderating at SCOPE’s Clinical Research Leadership Forum, being presented virtually July 13-14 by the producers of the Summit for Clinical Ops Executives.

Pharma can be its “own worst enemy” when it comes to accelerating digital transformation, says Wuttke. Although the industry is highly regulated and legal and patient privacy concerns loom large, there is still much that can safely be accomplished.

The process at Almirall begins with identifying the problem statement, Wuttke shares. Teams in various areas are asked what keeps them up at night and a gap analysis helps directs the search for digital solutions to those problems.

It is important to be honest about the timescale for digital health innovation in an industry where medicines can take a decade or more to usher to market, she says. Speed expectations can be “a little bit incongruous” with pharma norms, even for digital therapeutics (software as a medical device or SaMD) which follow a similar development and regulatory path as more traditional therapeutics.

How innovation gets scaled across geographies, therapeutic areas, and brands—including who owns the budget and the organizational structure of the effort—will impact a company’s digital transformation journey, as will be discussed at the conference session, says Wuttke. Panelists are Jacob LaPorte, Ph.D., co-founder and global head of BIOME - The Digital Innovation Lab at Novartis, and Shwen Gwee, head of global digital strategy at Bristol-Myers Squibb (BMS). Gwee will also be speaking at a separate session on digital therapeutics trials and how they differ from traditional clinical trials.

Wuttke will be bringing a wealth of experience, and perspectives, to the conversation. She has worked on both the commercial and strategic side of drug development over the past 25 years as well as led venture capital investments in biotech and digital health.  

Scaling Innovation

A few big-pharma companies are already actively working on transcending the silos. Roche, for example, is making strides in diagnostics as well as data with the acquisition of Flatiron Health and Foundation Medicine. And Novartis, initially focused on clinical trials, three years ago introduced its BIOME franchise model of innovation for bringing early-stage technology to the company across geographies and areas of focus.

In his previous role heading up open innovation at Novartis, Gwee co-developed BIOME with LaPorte. Gwee says he is now working to embed digital innovation into the business strategy at BMS.

First steps on the journey are to identify challenges across the enterprise with a potential role for external solution providers, says Gwee. He will also be exploring partnership options from both a contracting and business development standpoint and ways of engaging innovative startups in a “culture of learning and experimentation.”  

Digital modalities are “starting to become integral to every part of our business, including the therapeutic area that has long been [dominated by] more traditional chemical compounds,” Gwee says. Digital therapeutics, which can be primary interventions as well as adjunctive treatments, represent a growing area of focus industry wide.

The timelines, regulations, and required skillset for SaMD are distinct from that of traditional prescribed compounds, says Gwee. The discovery and development process for digital therapeutics tends to be much more accelerated, and “not everything needs to go through a full randomized controlled trial.”

Since the regulatory body for SaMD is the Center for Devices and Radiological Health rather than the Center for Drug Evaluation and Research, the marketing approvals needed are also slightly different, he adds.