From the Archive: How Sanofi’s Integration of the Patient Voice Impacted Recruitment, Protocols and Time to Market
In this article from the Patients as Partners archive, we highlight Sanofi’s integration of the patient voice, with 2024 Patients as Partners EU co-chair Victoria DiBiaso, MPH, VP, Head of Patient Informed Development & Health Value Translation, Sanofi.
What work do you lead as Sanofi’s Global Head of Patient-Informed Development and Health Value Translation?
The department is fully dedicated to facilitating the patient voice and the patient priorities across our preclinical research programs, and 100% of our development-stage programs. The health value translation is focused on making sure that the health value is recognized by patients. I can say that our work is intentional. It's systematic, it's early, and it's across the entire lifecycle of the pre-approval pipeline. It also connects to the functions that help ensure access to clinical trials and also later staged support programs for individuals once a product becomes approved.
How does your department relate to the rest of the business?
We're the front end of the connectivity with patients that helps ensure that, by the time a product makes it into the real world as medicine, we’ve developed it by understanding how it addresses what individuals need in a healthcare solution and that the data generated support access and help facilitate discussions with their physician around treatment options. A large component of this is connecting patients to clinical trial opportunities and we work closely with colleagues in the countries to help facilitate study participation.
One thing that I would accentuate is that while the function is responsible for ensuring that the patient voice is reflected, this attitude is part of the company culture. Every team member within Sanofi R&D carries this culture – this intentional, proactive curiosity and desire – to make sure that we do actually make our decisions from an informed position.
"It was about listening and translating those insights into actions that lead to the development of meaningful healthcare solutions for individuals."
Sanofi created a definition of “patient centricity.” Why did it feel necessary to do so?
I think most people would recognize that if you ask someone, “What does patient centricity mean to you?”, everybody has their own way of articulating it. We felt it was important to have a single North Star of what it was that we recognized as a definition. It was about listening and translating those insights into actions that lead to the development of meaningful healthcare solutions for individuals. And that way, if we're able to walk through that definition and check the box, then we know that we are all working in the same manner.
How are you deploying patient insights?
Starting in the basic discovery research in the labs, understanding that we know what the unmet needs are of individuals living with specific diseases. And so when our research teams are thinking about bringing something over into development, they're able to think about things such as “If this does go into real life, theoretically could this mechanism of action also address other comorbidities or challenges that a patient has?” “Is it easy to take?”
How are you gathering patient insights?
It’s direct interactions with individuals, early and often. We have patient advisors, patient advocates, and patient advocacy groups, starting in the research stages to help us understand what it's like to live with a disease or an illness and these insights build throughout development to inform evidence generation plans, patient preferences, study design, diversity & inclusion, and clinical innovations that help integrate clinical trials into daily life.
"We want to understand some of the dynamics that we can help bridge very early on, so that everybody has an opportunity for health outcomes to be at their optimal."
We also augment that with real world data, patient-generated health data, because we want to make sure that we're looking at the various elements that determine health outcomes. We know that some individuals have health outcomes that may be less optimal than others, such as those from traditionally underrepresented groups. We want to understand some of the dynamics that we can help bridge very early on, so that everybody has an opportunity for health outcomes to be at their optimal.
Can you share an example of your work?
Systematically our teams focus on early understanding patient experiences, preferences, unmet needs plus social determinants of health that address disparities across diverse communities and geographies. This work includes understanding the factors that influence an individual’s treatment decision making, including the decision to join a clinical trial. An example of how early understanding has shaped our research is in our rare disease pipeline. The team’s early focus on understanding unmet need identified a gap in the ability to measure the true burden of disease linked to symptoms not treated by current therapies. As a result, the team worked with the patient community to develop a new and novel patient reported outcome measure.
What is the impact of developing this outcome measure?
Being able to measure health outcomes that matter most to patients is front line to being able to address their needs. We hear from patient advisors that clinical trials which measure meaningful outcomes are more relevant for participation and if a program is eventually approved, those data will help patients make a more informed decision about treatment options. In this example, the patient reported outcome is the primary endpoint therefore it reflects a clinical trial that has been derived from the very start to focus on what matters to this patient community.
What would you say to people who worry that all of this early patient research would impede timeliness to trial?
We participate in a lot of the industry benchmarks. Year over year, Sanofi has gotten faster in the ability to develop our medicines and while there are many reasons for the acceleration, working in collaboration with patients has contributed to it. And that's been one of the hallmarks of why we have embedded the patient upfront. They are the decision-makers in whether or not they're going to join a clinical trial.
The number one way that you can help reduce your development timeline is to accelerate recruitment. That drives your data generation; that drives your filing; that drives your time to access. And so making sure that we co-create an ecosystem with individuals that represent them, we’ve made it easier for them to participate. I see a lot of companies that wait until they have a clinical trial, and then they do a reactive review. Ours is proactive. It actually reduces the timeline for decision-making, it reduces the time to develop a study, because we've known for a while what we need to do to make it better.
What are the KPIs you’re using, and how do you check on them?
The patient is a priority. We have KPIs that allow us to measure our commitment towards that. One of them this year is that 100% of our clinical trials will have diversity goals. Other ones make sure that we have endpoints and outcomes that are reflective of patient priorities. We have to meet a certain percentage of studies with a patient informed outcomes strategy before we even start proof-of-concept; that's incredibly early.
We also measure our commitment to making sure that 100% of our development programs are informed by patients. We have innovation KPIs that reflect remote. We are all in on making sure that patients have opportunities for remote and distributed participation in 100% of our Phase II/III programs.
Being able to measure what we do demonstrates a commitment, but it also helps us become better. So within my department, we also have additional metrics that we maintain. We monitor them because if we don't understand how we’re operating and the impact that it has, we will not be able to go further on behalf of patients.
What do you attribute to the changing attitude of embarking on end-to-end patient insights integration?
I think the way individuals approach engaging in health care has evolved. There's more of a recognition that healthcare is more consumerism. With the questions that people are asking, we need to have the answers there for them. I also believe that – as a nurse, as a researcher and as somebody with family members managing chronic illnesses – it's just the right thing to do.
The entire ecosystem has changed. I see healthcare like the FDA, the EMA, PMDA, the UK’s MHRA, and China now are starting to put together guidelines around how they incorporate the patient voice. It's nice to see that the industry is listening and taking it to heart and intentionally listening to patients.
