On the second day of the virtual PODD 2021 Conference (Partnering Opportunities in Drug Delivery), I had the pleasure of participating on a panel discussion in the Devices and Connected Digital Health track of the meeting entitled, “Digital Health’s Role in Making Personalized Medicine a Reality”.
Joining me on the panel were digital, device and innovation leaders from leading biopharma companies with experience building and commercializing digital health solutions—in fact, our moderator pointed out that we collectively have over 150 years of experience in biopharma and digital health. Moderated by Sujit Basu, Ph.D. SVP & Head, Global Manufacturing & Technical Operations, Fore Bio, the other panelists were Jim Collins, Vice President, Device Development Unit, Sanofi, Paul Upham, Head, Smart Devices, Genentech/Roche, and Quentin Le Masne, Ph.D. Head of Business Development & Innovation, Merck Group.
Let me share key points from our discussion that highlight the enormous potential of digital health to improve outcomes and enhance patients’ care experience by enabling more efficient disease management, diagnosis, dosing, patient identification and adverse event monitoring.
As Jim noted, technology and software is not biopharma’s core competency. Technology is pretty much ubiquitous as we all have access to the same type of connectivity and the basic software is the same. So when you embark on building digital solutions, the first question is not a technology question. The first question should be, ‘what value will this data and information bring to the patient, the provider and the payer’ and then work backwards from there.
If you build it, will they come? It’s not enough to build a regulated digital health solution. It’s important to consider how your digital solution will fit in to the HCP’s workflow so that they make the time and have the interest in recommending or prescribing your solution. Adoption is key to proving value and impact on outcomes, which is what payers are going to want to see.
Also, think about it from the patient’s perspective and how your digital product fits into that patient’s care. If every drug has a digital companion, and someone is on several different medications, using five different apps can be challenging. You want to think about ecosystem integrations for your digital solution so that a patient can use their anchor app of choice but get the full benefit of different tools and services.
If you had asked me when we launched BrightInsight what the biggest use case would be, I would have said connected drug delivery. Fast forward, and the biggest demand we see among our biopharma clients is regulated algorithms. Leveraging data to gain insights and build algorithms is key to personalizing clinical care and improving outcomes, which can also reduce costs and influence reimbursement. As Paul points out, clinical trials are a huge data source. To power AI/ML predictive models, biopharma companies are building regulated digital solutions to predict adverse events and improve patient matching. We recently worked with a company to build their first regulated algorithm to predict a specific patient’s risk of having a major adverse event on their drug, which gives prescribing physicians more confidence to prescribe the treatment.
Pharma can learn a lesson from the automotive industry. Detroit car makers dismissed Silicon Valley tech companies, instead attempting to build technology accessories for navigation, music and more. That didn’t go so well, and now Apple Carplay and Google Auto for instance are ubiquitous. Pharma should acknowledge that companies like Google, Apple, Amazon have deep understanding of technology and end users and see healthcare as a huge market opportunity. Pharma’s expertise is in developing life-changing therapies. Acknowledge what you’re good at and start from the perspective that as pharma you know how to build regulated products. Jim pointed out that SaMD is harder to do than drug delivery devices, in some ways, because biopharma is culturally and clock speed-wise different from tech. “We need to be agile. To be a learning organization, and an organization with persistence” to effectively build regulated digital products.