When Worlds Converge: Digital Therapeutics Meets Biopharma Alliance Management

Even a year or two ago, the idea of digital therapeutics didn’t stir up a great amount of interest among most participants at ASAP’s BioPharma Conference, according to Mike Leonetti, president and CEO of ASAP. That sort of ambivalence no longer applies, as was evident at the September 23 Leadership Forum that kicked off ASAP’s BioPharma 2019, held Sept. 23–25 in Boston.

The invitation-only gathering of 20-some biopharma alliance leaders was treated to a glimpse into the future—and a privileged look at a rapidly changing present—by senior executives from two companies that have been fast-tracking prescription digital therapeutics in their own alliance. Alex Waldron, chief strategy officer at Pear Therapeutics, and Joris van Dam, head of digital therapeutics for the Novartis Institutes for BioMedical Research, were introduced by Leonetti and by Brooke Paige, vice president of alliance management at Pear Therapeutics and ASAP’s board chair.

Waldron and van Dam described digital therapeutics as “software as a therapeutic,” or customer-facing software that helps clinically treat disease. It’s still relatively new, but already has become one of the five modalities of modern medical treatment (small molecule, large molecule, gene, cell, and digital). Whereas traditional biopharma alliances are asset-based partnerships formed on the basis of a molecule, in a partnership around digital therapeutics, the technology product is the asset.

While we often think of wearable devices when we think about digital therapeutics, perhaps the most common such device is your smartphone. So far Pear and Novartis are experiencing some success around products used to treat depression that occurs with patients who have multiple sclerosis (MS) or schizophrenia, for example.

Patients’ usage of and familiarity with their own cell phones is a big plus in such treatment, both in terms of access—a phone app is available 24/7, when patients need it, unlike a doctor or psychiatrist—and also adherence to the treatment plan, since the app can remind patients to stick to the program they’re on and help them get going with it again. Other uses being explored include the treatment of addiction and other types of depression.

Managing an alliance between a smaller, tech-oriented company and a large pharma company can be challenging, of course—as can any partnership between more traditional biopharma and tech. In this case, Novartis brought its commercial infrastructure, clinical trials expertise, and scientific strengths to the table; Pear brought technology, manufacturing, and ownership of the pharmacovigilance aspect, i.e., safety and data reporting.

As part of the forum, the 20-plus alliance leaders were asked several questions and polled on their responses. Among the highlights:

• More than 50 percent said their company had at least one or two digital/nontraditional alliances that were being operated as managed partnerships.
• More than 50 percent said someone other than alliance management or business development managed these partnerships at their companies.
• More than 80 percent said they expected their companies to increase the number of these digital/nontraditional partnerships in the next two years.
• Nearly 70 percent reported the biggest challenges of such partnerships included finding a common language, the lack of alliance management skills, and cultural differences.
• Fifty percent of respondents felt that these partnerships should be managed by the alliance management group in their organization—but nearly as many acknowledged that they don’t currently have the bandwidth to do so.

In the roundtable discussion portion of the forum, participants came up with a number of elements or processes in traditional biopharma alliance management that would need to be revised, modified, leveraged, or speeded up to meet the needs of digital and nontraditional partnerships and to take advantage of the potential for innovation. These included:

• Increasing the frequency of governance meetings and check-ins
• Speeding up decision-making processes and structures and including more senior people in them
• Educating senior management and managing stakeholders to ensure senior-level support and alignment
• Hiring more tech-savvy alliance managers
• Having more people on board who are well versed in IP issues and the regulatory environment
• Needing to trust the partner in ways beyond what has been common in the past—including continuous data sharing
• Hiring more disruptors and fewer people who are invested in protecting “the way we do things here”
• Establishing clear roles and responsibilities from the outset of the alliance, as early as the kickoff (if not before)
• Understanding each other better, given the different cultures of tech and biopharma companies

A window into the future indeed, and certainly there will be much more to come on this subject as the numbers of digital and nontraditional partnerships in biopharma continue to increase. And as ASAP BioPharma Conference 2019 continues, stay tuned for more of the latest coverage!