Novartis Brings on Digital in Patient Centricity Trials

In continuing our series on patient centricity, we are adding the digital perspective from inside of a biopharmaceutical enterprise. In this interview with Jeremy Sohn, VP, Global Head of Digital Business Development & Licensing at Novartis, we will delve into how biopharmaceutical enterprises are incorporating digital strategy into patient centric study execution, and elaborate on some of the cultural challenges of adopting novel study methods.

Moe Alsumidaie: What does patient centricity mean to you?

Jeremy Sohn

Jeremy Sohn: Patient centricity is a critical component to Novartis’ values and beliefs; it underlies and informs everything that we do from clinical trial design and implementation to medical education and direct to consumer advertising. But, let me start by saying what patient-centricity is NOT. Patient centricity is not about clinical trial recruitment. Unfortunately, for the last few years, there were many groups within pharma, including Novartis, that unintentionally equated the two. Thankfully, that is largely no longer the case.

So, what is patient-centricity? Patient centricity is about understanding the patient and the impact that we have and that we want to have on their lives. As such, in our R&D programs, patient centricity means understanding more deeply how different diseases affect people’s lives and where our therapeutic interventions can make a real difference – both directly and indirectly. This is encouraging our research teams to explore less invasive ways to track existing clinical endpoints (for example at home instead of at the doctor’s office) as well as new novel clinical endpoints that may be more valued by patients (for example, sleep or mobility). It is also leading to improvements in both how we dose and deliver drugs.

In our clinical trial programs, patient centricity is about trying to reduce the burden of participation (eliminating unnecessary clinic visits or bringing the trial entirely to the patient’s home), while also reinforcing the desire to engage, inform, empower, and, dare I say, thank our patients for volunteering their bodies and time to support our studies.

In our commercial strategy, patient centricity means Novartis’ “industry-first” commitment to shifting our business and pricing model to align with the outcomes we deliver for our patients. Outcomes based contracting models ensure that we are paid commensurate with the value our drugs create for patients, providers, and payors.

MA: How is Novartis incorporating digital health strategy to achieve patient centric outcomes?JS: We are actively investing in many different applications of digital technologies. You can simplify or characterize these efforts in two categories: “around the pill” and “beyond the pill” applications. Around the pill applications are technologies that support or enable the efficacy of our drugs. These might include: adherence tools and applications, intelligent drug delivery systems, monitoring tools, precision diagnostic tools, and behavior change applications. Beyond the pill technologies might include digital therapeutics – that is, digital applications or devices that are specifically designed and clinically tested as interventions, either as standalone solutions or in combination with a drug or disease management program.

We are also using technology in many innovative ways to optimize how we run our clinical trial programs. We want to run our trials better, faster, and cheaper, so we can deliver on our promise to expeditiously bring the best drugs to market and to make them accessible to all patients. You can categorize these efforts as: engagement and compliance apps, clinical endpoint and data capture tools, and telehealth and remote trial delivery systems. For example, we are using mobile patient engagement apps in our clinical trials to better inform and empower patients. These apps improve patient awareness and, in turn, increase patient adherence and compliance. We are using a wide range of wearable and connected sensors to passively collect data, reduce patient burden, and explore new insights that might inform patient outcomes. And we are using a wide range of telemedicine techniques to bring clinical trials closer to where patients are, reducing patient burden and narrowing the gap between clinical research and clinical practice.

MA: Incorporating digital health in clinical trials requires a lot of piloting in order to evaluate technology effectiveness. However, every study is different, and many pilots get swept under the rug and are not scaled across the organization. How is Novartis assessing new technology scalability with novel digital health initiatives?

JS: In many cases, the challenge for pharma companies is not technology, but our own internal processes. Novartis isn’t perfect, but we are trying very hard to avoid the 5 common mistakes that pharma companies typically make when driving innovation: One mistake many pharma companies make is to test new technologies in studies that are not generally representative of the vast majority of trials that we run, e.g., a Phase I or IIa study, in the US only, at 1 site, and without integration into the core data management processes. As such, the learnings from the pilot or proof of concept study are not transferable. The team running the pilot trial should also be representative of the operating team that would run your next pivotal study – otherwise, it is extremely challenging to get buy-in from that next study team. A second mistake pharma companies make is creating a culture where taking risks, including the possibility for mistakes and/or unknown challenges, is tantamount to professional suicide. Historically, we have been willing to take scientific risk, but not operating risk. This needs to change. A third common mistake is we let Legal, Regulatory, and Quality, play traffic cop instead of traffic enabler. We need to challenge these critical leaders within our companies to lead, enable, and accelerate innovation. Fourth, we cannot fall into the trap where we believe it is safer and wiser to be a fast follower than a first mover. There are numerous cases within pharma today, where 7+ years have passed and no one has stepped up to lead. What do we do then? We need to accept that in the technology world, and in life in general, there is only one “first”. After all, who knows the name of the second person to walk on the moon? Lastly, we need to move away from the mantra that we need to “crawl, walk, and then run”. While we cannot and should not jump into a new technology recklessly, success is not only measured by getting to the finish line, but how quickly you get there. Especially with technology cycles that are shorter than most pharma product lifecycles, we need to find ways to scale quickly and effectively, all the while laying the foundation for the next change in technology.   

MA: How are digital strategies transforming the way departments interact with one another in the drug development process?JS: Digital technologies are the lifeblood of how clinical trials are run today; they are the heart and circulating system of everything we do. Our clinical scientists are using real-time, federated databases to inform protocol design and to validate feasibility. This same system is then used by clinical operations teams to inform site selection and patient recruitment. Our clinical sites are using highly integrated platforms that connect patient randomization (IVRS), with electronic informed consent (eICF), with drug delivery and dispensing, with direct source data capture, and with patient engagement and reporting tools (ePRO). Our clinical trial monitoring and data management teams are seamlessly coordinating the operations and flow of data between a world-wide network of sites and our internal data aggregation and analytics systems. As we add more technologies to capture data (for example, wearable sensors), AND, as we shift our sites from the physician’s office to the patient’s home, this tightly orchestrated system becomes even more important and dependent on technology.

MA: What will a clinical trial of the future look like to you?JS: The future of clinical trials will be studies that are designed from start to finish to minimize patient burden and to optimize passive data capture. This will likely mean conducting clinical trials locally – within a patient’s community or at his/her home; we will shift away from traditional sites and move towards virtual sites, leveraging telehealth platforms, visiting nurses, and local provider networks to deliver the care and capture the data required for the study. That convergence is already happening today; eICF, direct source data capture, ePRO, patient engagement, connected sensors, and meta or virtual site-based studies are already underway. So, candidly, the future is already sitting in front of us. The real question is area we ready to embrace it!

Moe Alsumidaie, MBA, MSF is Chief Data Scientist at Annex Clinical, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.