"The cures and the treatments that are really going to improve people's lives — if it wasn't for clinical trials, we wouldn't have that hope on the radar."
Victoria DiBiaso has been integrating the patient perspective into Sanofi's development programs since 2010. She is a nurse by training, a former research nurse and study coordinator, and a personal advocate in the Parkinson's community. She has participated in three clinical research studies herself — including a lumbar puncture for biomarker collection that contributed to the landmark PPMI study — and brings that lived experience to her work leading patient-informed development at scale.
This conversation covers what patient-informed development actually means in practice, why the industry still struggles with consistency, how Sanofi measures the ROI of patient centricity, and what it took to build Paladin — a cross-industry consortium of nearly 30 organizations working to standardize how pharma and advocacy groups collaborate.
From Bedside to Global Strategy
DiBiaso's path into patient-informed development was, by her own description, almost accidental. Early in her nursing career she landed in clinical trials as a research nurse and study coordinator. "I think that was probably the most rewarding and almost accidental part of my career that's ever happened," she said. "It gave the gift of understanding the hope that a clinical trial can bring to individuals and their families."
That grounding in the clinic — and in the Parkinson's community through personal and family experience — shapes her conviction that accelerating clinical trials isn't just a business imperative. It's a human one. In Parkinson's, there has been no meaningful therapeutic advancement in over 60 years. "The cures and the treatments that are really going to improve people's lives — it's the truth. And if it wasn't for clinical trials, we wouldn't have that hope on the radar."
What Patient-Informed Development Actually Means
At Sanofi, the function is called Patient Informed Development and Health Value Translation. The name is intentional. It isn't just about incorporating patient feedback into clinical operations — it's about pulling the patient experience upstream, into preclinical decision-making, and then translating that experience into health value outcomes that matter to regulators, payers, and patients alike.
"We are integrating the patient experience — their needs, their preferences, the comprehensive patient experience — into the decision-making and how we move programs from preclinical and make the decisions to come into development," DiBiaso explained. "And then shaping that entire development strategy to include the patient considerations."
Sanofi integrates this into 100% of its programs across 100% of its indications — a claim DiBiaso makes with specificity. "I think we're one of the few biopharma companies, and I think the only large pharma, that actually integrates patient perspective in 100% of our programs, 100% of our indications, in every single clinical trial that we do."
Defining Patient Centricity — And Why It Matters
When Sanofi restructured its patient team a few years ago, the group sat down and wrote a common definition of patient centricity — because without one, different people were doing different things under the same label. "What we found is that everybody defined what patient centricity was a little bit differently, and that really could impact how they address their jobs."
The definition they landed on: "The commitment to listen and translate patient insights into actions that develop new healthcare solutions with meaningful outcomes that address unmet medical needs and improve health-related quality of life."
The emphasis on health value translation is the piece DiBiaso says often gets overlooked. It's the difference between capturing patient insights and actually acting on them in ways that shape endpoints, label language, and benefit-risk assessments — so that when a product reaches market, a patient and their physician can make a genuinely informed decision about whether it's right for them.
Introducing Paladin: A Cross-Industry Consortium
One of the structural problems DiBiaso identified is that the industry has a consistency problem. Different companies engage patient communities in different ways. Advocacy organizations don't always know what to expect. There's variation in contracting, in communication, in what gets measured. That variation slows everything down.
In January 2023, she helped launch Paladin — a cross-industry, cross-advocacy, disease-agnostic consortium focused on creating common standards for how pharma and advocacy organizations work together. They started by bringing the concept to over 100 advocates and asking whether there was appetite for consolidation. "It was a resounding yes."
By the time of this conversation, Paladin had grown to nearly 30 organizations. "We'll have our first outcomes reported in October," DiBiaso said.
The Four Work Streams
Paladin organized its work into four areas:
Common standards and foundations — templates for how to start a collaboration, including contracting frameworks that can be publicly downloaded and adapted. Non-promotional, practical, and designed to reduce the startup friction that wastes time and resources on both sides.
Training and education — for organizations beginning to build patient-informed development capabilities, and for the clinical trial participation space — including common materials explaining what clinical trials are, why participation matters, and why diversity in research matters.
Diversity and inclusion frameworks — not one-off initiatives, but sustainable, measurable approaches to improving the representativeness of research participation. "We want to see an improvement in inclusion in the diversity of research participation."
Solutions at scale — a shared body of knowledge built from what's working and what isn't. DiBiaso was direct about this: "I would advocate that we need to do more sharing around what hasn't been working. If we all begin to share that body of knowledge, then collectively what one company is doing — if it benefits another company by bringing a medicine that could benefit an individual faster — we've done right by society."
Measuring the Impact of Patient Centricity
The question of how to quantify the value of patient-informed development is one DiBiaso hears often. She acknowledged the industry hasn't historically had a strong shared framework for it, and that developing one has been a focus.
The metrics she described fall into a few buckets. Timeline acceleration — for individuals waiting for a treatment that may not exist yet, faster development has real human value. From the company perspective, moving programs through faster frees resources to deploy on other studies, which compounds.
Patient-relevant endpoints — understanding what actually matters to patients allows teams to design clinical outcome assessments that capture meaningful change. "There are a lot of health scales that physicians will use to measure progress of a disease. Do those scales mean anything to anybody? Or is what matters to an individual — I still have pain in my hands and I still have a hard time carrying out daily activities of living?" If pain is what matters, then the endpoint should measure pain. If that's built into the strategy early enough, the label can reflect it — and that has direct implications for market access.
Protocol efficiency — "We see on average three procedures per protocol that are reduced every time our patient advisors help us design a study from draft to final." Eligibility becomes more inclusive. Diversity becomes more representative. These aren't soft outcomes.
Starting Early Is Non-Negotiable
The single most consistent thing DiBiaso returned to was timing. If you want patient insights to actually shape a development program, you have to engage before the decisions are locked in.
"If we are listening prior to even starting a development program, we're able to do really in-depth work around what those meaningful endpoints and outcomes are." In some cases, the tools to measure what patients care most about don't yet exist. Developing a novel patient-reported outcome measure, validating it with regulators, and having it ready for a pivotal trial takes years. That work can only happen if patient engagement begins in the research phase.
At Sanofi, this early engagement gets codified into what they call a patient disease strategy — a comprehensive, end-to-end framework for each indication that's continuously updated as the program evolves and new insights come in.
The Future: AI, Holistic Recruitment, and Clinical Trials as a First Option
When asked about the future of patient-centric clinical trials, DiBiaso pointed in two directions. First, she wants to see every pharma company commit to integrating patient perspective into 100% of programs — and share enough of their learnings that the industry doesn't keep duplicating effort.
Second, she sees AI as potentially transformative, particularly in one area: "If we can begin to use artificial intelligence more to help identify patients that would be eligible for a clinical study, I think that would be hugely helpful."
But her biggest wish was more fundamental. Clinical trials, she argued, are still treated as a last resort — an afterthought — when they should be the first consideration for anyone who needs something better from their healthcare. "The first person who's going to be cured or receive a better, more holistic treatment for what they're looking for is somebody who's been in a clinical trial."
When asked what's stopping that from being reality, she pointed to two gaps: awareness, and the difficulty of finding trials. ClinicalTrials.gov was designed to fill that function, she noted, but "we've missed the mark on it being really accessible."
What You'll Learn
- How Sanofi defines patient centricity — and why a shared definition matters more than most organizations realize
- What "patient-informed development" means from preclinical through label, and why the health value translation component is the most underappreciated piece
- How to measure the ROI of patient engagement: timelines, endpoints, protocol burden reduction
- Why starting early is the single most important lever — and what happens when teams start late
- What Paladin is, why it was built, and what its four work streams are targeting
- How social determinants of health shape trust-building with historically underrepresented patient communities
- Why DiBiaso believes clinical trials should be the first consideration — not the last resort — for patients who need better treatment options
Episode Highlights
- [00:34] Victoria's Background: From Research Nurse to Global Patient Strategy Lead
- [02:34] What Is Patient-Informed Development and Health Value Translation?
- [04:04] Defining Patient Centricity at Sanofi
- [06:38] Where the Industry Goes Wrong: The Consistency Problem
- [09:13] Introducing Paladin: A Cross-Industry Consortium
- [10:44] Paladin's Four Work Streams
- [13:12] Diversity and Inclusion: Bringing Underrepresented Voices Forward
- [14:57] Measuring the Value and ROI of Patient Centricity
- [20:29] Designing Clinical Trials That Reflect What Patients Actually Need
- [22:07] Why Starting Early Is Non-Negotiable
- [25:51] What the Industry Should Publish More Of: Failures and Shared Learnings
- [26:52] The Future of Patient-Centric Clinical Trials and the Role of AI
- [28:17] What Modern Patient Recruitment Means
- [29:49] The Magic Wand: Clinical Trials as a First Consideration
- [33:52] Closing
