This year, global pharmaceutical company launched its Patient-Informed Development and Health Value translation team, an effort to ensure patient centricity is a top priority at every level of the drug development process. Victoria DiBiaso, global head of the team, discussed the patient-centric culture at the company and the importance of integrating the patient perspective throughout the pipeline.
OSP: What does it mean for pharma companies and their research partners to be truly ‘patient centric’ in their studies?
VD: I can speak about the views within Sanofi and our culture, and how we’re defining it. It needs to be pervasive, first and foremost. At Sanofi, a patient-centric culture means everything begins and ends with patients.
Companies can be centric, but not informed. Sanofi distinguishes between the two—we need to be fully committed to listening, then translating patient insights into clear actions, so that there are meaningful outcomes according to the patient need. Within R&D, we are focused on developing those solutions in line with the patient.
A patient is a whole person and a consumer of healthcare. In order to do right by them, we have to work from their perspective.
OSP: What are some of the ways that patient-centricity has evolved in clinical trials and drug development in recent years?
VD: There has been a significant evolution over the years, and at Sanofi, we have more than a decade of experience working in this model—we’re one of the first companies to have patients work as advisors. This advisory focuses on optimizing procedures, and logistics to reduce the burden on patients. Along with that, we turn to our patient advisors to help advance the engagement effort—how do we support study participants so that they can be retained?
Working with patient advisors and advocates helps add to patient-generated data; it allows us to evolve. We talk about unmet needs, their experiences, and priorities. We determine value according to the patient. That helps us determine how the data is valued and relevant. Does it touch upon the parts of the disease that impact a patient’s quality of life the most?
Working with patients and advocates, we look at how we do remote trials, leverage telehealth, and bring the clinical trials closer to the participant's home. We have broad experience in remote trials; it’s something we've focused on for quite some time. Patient advisors really deliver insights to help us identify early on what are the relevant outcomes and measures.
These relationships help us design research and collect the data that is most important to patients. It helps us understand patient preference, tolerability, and adherence solutions. Just because you manufacture a medicine, it doesn’t mean the patients can stay on it. We want to make sure they can tolerate it.
There is a risk of unconscious bias in a design. If you increase the diversity, you can increase the health equity solutions. It is important to understand all the elements of a person—their whole life, not just the disease.
We use a lot of real-world evidence (RWE) as well as insight data provided by the patient; the insight can help us model novel clinical trial designs, reduce the sample size, and recruit for studies faster. With trial designs, this can quickly point out where the challenges are
100% of our studies are reviewed with patient insights and perspectives; this isn’t just something we dabble in. There is a pervasive commitment to listen, in every study and program.
The time commitment to study participation is beyond the time they allow for study activity and plan into their lives. They have to, say, get the kids to school. If they can’t go to a clinic once a week, what we can do is follow up via telehealth, then maybe go to the clinic down the road.
If you really want to be able to include a broad patient population, you can’t put in barriers that prevent them from participating. A study running at a major hospital in the middle of the city might not work for someone that doesn’t have a car.
OSP: Could you please talk about the Patient Informed Development and Health Value translation team?
VD: The team in its current structure came together recently, but the individuals and what they do dates back 10 years. We basically consolidated the patient-centric functions of the various parts into one organization.
The individuals within the teams are all quite tenured, with a great deal of experience, and what we’re able to do is coordinate efforts in a much more standardized and inclusive atmosphere. It’s a global team, with members located across Europe, the Asia-Pacific region, and beyond.
We work to make sure our perspectives are diverse because our medicines serve a global patient community. Our work is also closely tied to the local level; we work with clin-ops teams in all the various countries. You cannot fundamentally couple a relationship between the patient and the healthcare system unless you are deeply embedded at the local levels.
We felt if we had a single line of sight, we could be more coordinated and fully positioned around the patient. With this model, the way that it’s structured, any function that supports getting a product through R&D to approval is part of that patient experience conversation.
One of our goals this year centers around reducing patient burden and increasing their ability to access clinical trials. Historically, it can be difficult to even find them; it also can be difficult to understand where people get information about clinical trials, including clinical trials as a healthcare option. If we want to include as many people as possible, it is important that we engage people, share the information where they’re looking, and address any questions that they have. As we’re shaping our outreach, making sure that placement of that in.
OSP: Do you have anything to add that we didn’t touch upon above?
VD: I just want to share how much we appreciate how the patient communities have been collaborating with us; this has made a tremendous difference in Sanofi’s ability to do better by them. I want to make sure to say thank you every chance we get. It makes us better at what we do for them, and we couldn’t do it without them.
