What is Johnson & Johnson Innovative Medicine’s patient-centric operating model?
At J&J, the values that guide our decision-making are spelled out in our Credo, which begins: “We believe our first responsibility is to the patients.” Our vision for patient advocacy in R&D is to support J&J’s commitment to reflecting the patient voice, and to become the partner of choice for the patient community.
This led to the creation of our Patient Engagement Strategy Roadmap and the subsequent development of the Patient Advocacy Strategic Framework (PASF), with a deeper focus on patient advocacy within the early stages of clinical trial design and product development. Both strategies are based on the EUPATI roadmap for patient involvement in medicines development.
At its core, the PASF serves three main purposes: first, it identifies key touchpoints for patient input throughout the drug development lifecycle; second, it ensures that patient input and insights are reflected in our clinical trial strategy and execution; and third, it enables patient involvement to live and breathe across all functions within J&J.
"We needed to build a model at a scale that reflects the voice of patients in a more strategic way and is consistent throughout the development lifecycle, so that we can make a bigger impact for patients."
What changes have already occurred since this process began?
First, we have seen our internal stakeholders come to us, versus our team going out to them, which indicates that there is an appetite at J&J to transform the way we do patient engagement and patient advocacy.
Second, we have already seen the early impact of some projects. At this year’s Patients as Partners 2025 event, I highlighted our toolkit for managing relationships with patient organizations when we start or finish a trial. This toolkit can save roughly 125 hours (resulting in 3,000 operational savings of hours per year) in efficiency and day-to-day work, which is a significant improvement for a company with hundreds of trials. There has also been a marked improvement in the perceptions of J&J from advocacy groups, which are more appreciative of the ways that we are engaging with them.
However, we’re not done yet. We’re committed to continuous improvement, so that, ultimately, patients choose to participate in our clinical trials because they value the experience we offer and recognize that we involve them from the very beginning.
Why build a new operating model?
We have built a model to incorporate the patient perspective throughout the lifecycle because we realized that the patient voice can be incorporated in a more consistent way throughout our hundreds of trials. We needed to build a model at a scale that reflects the voice of patients in a more strategic way and is consistent throughout the development lifecycle, so that we can make a bigger impact for patients.
The main focus is to incorporate the patient perspective in a more systematic way at different touchpoints. We have developed this model in collaboration with patients and with a cross-functional team, identifying the most valuable opportunities to integrate the patient perspective – from phase I through to the end of phase III – ensuring it is embedded throughout our deliverables.
Can you expand on what you mean by “different touchpoints” and “a more systematic way?”
By ‘touchpoint’, we refer to any point in early discovery to in-market where we have the opportunity to seek and involve patients and patient organizations in drug development. This can include insights generation, such as conducting early disease landscape assessments, gaining insights on Target Patient Product Profile (TPPP), through to making our clinical trials more patient-centric by seeking input into clinical trial strategies.
For such a model to be effective, it is important it is structured, ongoing and embedded in the way we work. Importantly, we have an approach of “systematizing, not standardizing,” which allows us to adapt to the needs of the particular function, country and, most importantly, the patient community.
What has been the timeline from inception to today?
I joined J&J a year ago and in my first 100 days, I did an analysis of our engagement with patients and advocacy leaders. From there, we assessed the potential opportunities and built a model over a three- to six-month period, which we then socialized externally with patients and patient leaders, and internally with our stakeholders. We have now moved into the execution mode and we anticipate it to take between three-to-five years to achieve our patient advocacy vision.
How are you implementing this new operating model without adding excess burden to teams?
The first thing you have to do is socialize the model and be very open to what other colleagues are doing in advocacy and engagement. You have to respect that there is a foundation set and great work being done already in terms of engaging with patients and patient leaders. The model is an opportunity to progress the way we do R&D by engaging with the patient community in a more systematic way.
While we allocate resources to priority areas, patient advocacy activities are not the responsibility of just one function. All functions should ensure the patient voice is reflected across the product life cycle.
What metrics are you putting into place to help gauge success?
One of the key metrics we track is the strength of our engagement with patient organizations and how they perceive us as partners. This includes not only our pipeline priorities, but also whether J&J is meaningfully incorporating the patient perspective into protocol design and the overall trial experience.
We’re looking at R&D in a very holistic way and measuring the perception from patient leaders and patient communities as to how J&J is delivering on our promise of being the partner of choice for patient communities.
The other way of measuring success is about perceptions from internal stakeholders. That’s not just about how we partner with patients and bridge the gap between patients and the industry, but also about the measurements of the engagement. For example, how many times did we engage patients regarding protocol design? How many amendments were we able to reduce by partnering with patients? In my presentation at Patients as Partners 2025, I mentioned that we were able to reduce about 125 hours per clinical trial by delivering one specific toolkit.
Ultimately, we aim to accelerate our R&D programs to bring medicines to patients faster. We can achieve this by co-creating our programs not only for patients, but also with them.
"I see patient advocacy and engagement as a new way of doing business, incorporating the patient voice on the same level as other key stakeholders."
Can you share an example of how processes have changed/are changing as a result of this new model?
A great example of the new model in action is how we recently collaborated with the Prostate Health Education Network (PHEN) to develop new patient educational materials that would improve representation in our prostate cancer trials. We sought their input after having identified a need to increase awareness, education and recruitment in an under-represented, skeptical subpopulation of prostate cancer patients.
As a result, our visibility within the community has increased and we are continually reflecting the patient voice into our prostate cancer clinical trials. By collaborating with PHEN, moving forward, we have created a strong model from project initiation to enable more efficient and compliant discussions when flagging upcoming trials to patient groups.
What are your key learnings from this process?
You have to spend time and effort in understanding both your external environment and internal stakeholders, specifically what they want to see and how to establish what success looks like. I have spent a lot of time being very clear on how we’re going to measure impact and aligning with business partners to make sure it’s cohesive.
I see patient advocacy and engagement as a new way of doing business, incorporating the patient voice on the same level as other key stakeholders. Given that, you also have to focus on change management by investing time and effort to transform the culture of an organization. It’s not about ‘educating’ stakeholders; it’s about understanding their perspective and finding common ground in order to show where patient advocacy and engagement can bring the highest value.
What would you want to see from industry?
As an industry, we need to focus on creating a common language and elevating our metrics, so that we can speak to our colleagues in business in the same way.
By committing to continuous improvements and learning from one another, we can strengthen how we validate and communicate the value of our work.
