On the Way to Creating an ‘Innovation Structure’: Personalised Approach, Cross-Functionality and Expertise

Digital therapeutics is ought to bring various opportunities, but also great challenges. What is the right way to overcome them?


Jacqueline Lutz

Medical Science Lead for Mental Health

The following responses are my personal opinion and may not represent Biogen’s view.

What are the digital therapeutics opportunities, threats and challenges for pharmaceutical companies?

In general, there are various opportunities in the field of digital therapeutics. These range from empowering patients, delivering holistic treatments and addressing unmet needs to creating innovative digital-drug combinations for precision medicine. Additionally, data acquired through digital therapeutics – from active user reports and behavior to passive sensor-based information – can inform pharmaceutical companies about patient journeys and how their products perform in the real world.
However, there are challenges in this relatively young and rapidly evolving field. The regulatory and reimbursement pathways for digital therapeutics are still evolving. Navigating this complexity requires the right ‘innovation structure’ inside a pharmaceutical company, the right external partnerships but also internal expertise in the form of employees with diverse backgrounds. Lastly, digital health products demand a different development approach due to their fast development cycles and need for early user-acceptance evaluation. Therefore, it is important to bring all cross-functional partners within Pharma along the digital therapeutics journey.

How to build patient and physician understanding and drive personalised support and educational interventions?

Digital therapeutics have the potential to deliver tailored interventions to patients when they need them, adjusting content to match their individual needs and health literacy levels. Despite this intuitive appeal, getting physicians to embrace these innovative solutions will involve educating them about the existing evidence and providing them with tools and features to seamlessly integrate digital therapeutics into their clinical workflows. Furthermore, improvements in billing and reimbursement for these tools will further advance physician adoption and recommendation.

How can the tools for capturing information on patient behaviour be more effective but still provide the best patient journey?

Indeed, there may be a trade-off between patient burden to assess multiple patient reported outcomes and behavior across domains of interest. Several approaches may address this challenge:
1) personalisation: allow users to tailor the level of data track for example by offering simple global rating visual analog items while offering opt-in opportunities to track additional contextual information.

2) validation: developing and validating of shorter more frequent ePRO assessments against ‘gold standard’ assessments’.

3) adaptive data capture: collecting data more frequently when changes in data and behavior are detected, and spread out assessments otherwise.

4) data sharing: sharing back data with users can can serve as a significant motivator, particularly when presented in user-friendly formats, making the process more engaging and rewarding for patients.

Dive into the world of limitless opportunities and brainstorming with Jacqueline Lutz during our 3rd Annual Digital Therapeutics and Pharma Summit on 18 – 19 October 2023 in Vienna.

Where she will be presenting the case study ‘Conducting Clinical Trials and Collecting Evidence for Dtx – How Do Good Trial Designs and Control Group Choices Look Like’.

Short Speaker BIO:

Jacqueline Lutz is a behavioral neuroscientist and digital health expert, with a Ph.D. in Neuropsychology from the University of Zurich and postdoctoral training at Harvard Medical School. Her academic research focused on how mindfulness benefits patients with depression, anxiety, and chronic pain, utilizing brain imaging and digital assessments.

Currently, Jacqueline serves as the Medical Science Lead for Mental Health at Biogen Digital Health where she shapes scientific strategy and evidence for digital mental health solutions. She also contributes her expertise in Psychiatry and digital mental health as Assistant Professor at Boston University School of Medicine.

Before Biogen, Jacqueline was the lead scientist for EndeavorRx, a digital therapeutic for pediatric ADHD that achieved FDA-clearance. She also led the platform discovery team at Click Therapeutics, developing innovative digital treatments evaluated in remote pilot trials across patients with chronic pain, multiple sclerosis, and cancer.

Jacqueline’s work is published in top clinical neuroscience and digital health journals. She’s deeply passionate about the potential of digital therapeutics to provide scalable, patient-focused, and highly personalized solutions.