Embedding the Patient’s Voice in Drug Development
By: Mohammad Ali, PhD
Interviewees: Laura A. Williams, MD, MPH, Chief Patient Officer, Ardelyx
Embedding the Patient’s Voice in Drug Development
By: Mohammad Ali, PhD
Interviewee: Laura A. Williams, MD, MPH, Chief Patient Officer, Ardelyx
In drug development — where the urgency to deliver safe and effective treatments must be matched by a commitment to inclusivity (including the patients most impacted by the disease in clinical trials) — integrating the patient voice is no longer optional. Yet many clinical trials still fall short of reflecting the communities they aim to serve.
Black and Hispanic Americans account for only 8% and 11% of clinical trial participants, respectively, despite representing 14% and 18% of the US population. Rural residents, who face disproportionately high rates of chronic illness, are also underrepresented, often due to structural barriers such as limited proximity to trial sites and a lack of provider awareness.
Digital inequity adds another layer of complexity. As decentralised and tech-enabled research models become more common, nearly 27% of rural Americans still lack reliable broadband access, creating substantial hurdles for virtual engagement, patient portals and digital enrolment platforms.
These disparities — whether geographic, racial or socioeconomic — are not simply logistical issues. They reflect deeper inequities in how patients are seen, heard and supported throughout the therapeutic journey.
Dr. Laura Williams, Chief Patient Officer at Ardelyx, is leading a cultural and operational shift in how the life sciences industry addresses these gaps. With nearly 30 years of experience in drug development, including leadership roles in clinical research, medical affairs and patient advocacy, she offers a structured approach to one of the industry’s most vital mandates: creating research and access programs that are inclusive, equitable and deeply informed by lived patient experience.
In this conversation, Dr. Williams discusses how her team integrates patient input into every stage of development, expands access through digital-friendly support programs and builds trust with underrepresented communities through empathy-based partnerships and inclusive trial design.
Embedding Patient Input from Discovery to Delivery
Many life science organizations recognize the value of patient input, but few integrate it meaningfully across every stage of development. According to Dr. Williams, this integration must begin at the earliest phases and be sustained.
“The most impactful thing that any company can do is to continuously engage the patient,” she said. One key strategy is the creation of patient advisory councils — diverse groups of individuals who share insights into their health journeys, challenges, expectations and unmet needs. These stories help contextualize disease burden in ways that data alone cannot, providing directional input on what interventions matter most.
Surveys, focus groups and real-world experience collection complement these councils, offering both qualitative and quantitative insight into the patient journey.
“When you know what their values and expectations are, you can decide where to intervene — what would be most beneficial in terms of the innovation you’re working on,” Dr. Williams explained.
But capturing patient feedback isn’t enough. True impact comes from turning insight into action. At Ardelyx, patient-centricity is institutionalized through governance. It’s built into performance goals, measured with defined metrics and rewarded when it drives outcomes. “You highlight the value and the success of these processes,” she said, “and by doing so, you amplify the voice of the patient.”
Crucially, this voice is represented at the highest levels of the organization. Dr. Williams reports directly to the CEO, a structure that ensures patient insights shape — not follow — strategic decisions. “You have the right people at the table,” she said. “And decisions are made through the lens of the patient.”
“Trust is everything. And you build trust through open, transparent communication that’s based in empathy.”
— Laura Williams, Chief Patient Officer, Ardelyx
“Trust is everything. And you build trust through open, transparent communication that’s based in empathy.”
— Laura Williams, Chief Patient Officer, Ardelyx
Digital Support Programs: Meeting Patients Where They Are
In addition to human-centred design, Ardelyx is expanding its use of digital-forward patient support tools to improve access, equity and experience. From streamlining enrollment to improving disease literacy, these platforms reduce friction and provide real-time engagement opportunities tailored to individual needs.
“Our patient assistance program uses a digital platform that simplifies enrollment,” Dr. Williams shared. “It ultimately improves access to our medications — and it does so in a fair and equitable manner.”
But support extends far beyond access logistics. Patient portals offer medication reminders, trial participation updates, educational videos and interactive infographics. These features empower patients to understand their disease better, navigate care decisions and remain adherent to complex treatment regimens.
As patient populations become more digitally diverse, inclusive design is paramount.
“Mobile-first tools, low-bandwidth options — those are crucial for usability, especially for patients who may not have broadband or smartphones,” she explained. These tools ensure that geography or socioeconomic status doesn’t preclude engagement, particularly for individuals in rural communities or medically underserved areas.
In addition, Ardelyx is investing in personalized communications, language and health literacy optimization and omnichannel touchpoints that connect with patients on their terms.
“We use a number of these tools today,” Dr. Williams said, “but I envision increased utilization going forward because I think it only helps the patients we're trying to serve.”
Whether it’s a chatbot that answers medication questions in real time or a culturally relevant infographic explaining trial participation, these resources extend the reach and relevance of engagement strategies.
Community-based collaboration remains a critical complement to digital solutions. Partnerships with nonprofit organizations, local clinics and advocacy groups are essential for building trust and tailoring outreach.
Designing Trials That Reflect the Real World
One of the industry’s most persistent challenges is ensuring that clinical trial populations reflect the patients who will ultimately use the therapy. Underrepresentation of key groups can lead to therapies that are less effective — or even unsafe — for segments of the population.
Dr. Williams outlined a clear, structured approach. “You have to understand the epidemiology of the disease,” she said. “What are the pertinent demographics — age, gender, race, ethnicity? Where are those patients located?”
Once identified, the next step is outreach. Ardelyx collaborates with patient advocacy organizations, community leaders and healthcare providers who already serve underrepresented populations. These partnerships help extend trial awareness and build trust.
“Trust is everything,” she said. “And you build trust through open, transparent communication that’s based in empathy.” Equally important is ensuring that trial staff and site personnel reflect the diversity of the patients they serve. Cultural competency and representation help reduce barriers to participation and foster more meaningful engagement.
The results speak for themselves. In Ardelyx’s chronic kidney disease (CKD) clinical trials, African Americans made up 45% of participants, and Hispanics 28% — a representation that closely aligns with the disease’s disproportionate impact on those groups. “That was intentional,” Dr. Williams said, “because those groups bear a disproportionate burden of the disease.”
“Empathy builds trust, and trust enables access. That’s how we create better outcomes — not just for individuals, but for the healthcare system as a whole.”
— Laura Williams, Chief Patient Officer, Ardelyx
“Empathy builds trust, and trust enables access. That’s how we create better outcomes — not just for individuals, but for the healthcare system as a whole.”
— Laura Williams, Chief Patient Officer, Ardelyx
Building Trust with Underrepresented Communities
For many patients, particularly in marginalized or historically excluded communities, clinical trial participation is fraught with skepticism, often for good reason. Addressing that legacy requires more than recruitment incentives; it requires a genuine, long-term partnership.
“We have to lead with empathy,” Dr. Williams emphasized. “We must listen to understand, not just to respond. You can’t camouflage sincerity — people know when you’re not being genuine.”
Building that trust starts with presence. While financial investment is valuable, visibility and ongoing support often matter more. Ardelyx partners with faith-based leaders, cultural organizations, local elected officials and community health workers — individuals already trusted in the communities they serve.
These efforts are reinforced by collaborations with national organizations like the National Kidney Foundation and the American Kidney Fund, which help amplify outreach and connect patients with trials relevant to them.
Engaging academic institutions and regional health systems also plays a role, particularly in areas where infrastructure may be limited. Through these partnerships, Ardelyx is able to bring trials to the patient — not the other way around.
As Dr. Williams noted, “Empathy builds trust, and trust enables access. That’s how we create better outcomes — not just for individuals, but for the healthcare system as a whole. The patients are waiting...”
ABOUT Laura Williams
Laura has served as Ardelyx’s Chief Patient Officer since 2025, having joined the company in November 2020 as Senior Vice President, Global Therapeutic Strategies and Patient Advocacy. Laura was later promoted to Chief Medical Officer in 2021.
Laura is a life science enterprise leader with extensive experience as a pharmaceutical drug developer, healthcare policy advisor, patient advocate and portfolio strategist. She is an accomplished, results-oriented, physician scientist and board member who is committed to discovering, developing and commercializing innovative therapies that address unmet medical need. With nearly 30 years of pharmaceutical experience, across all clinical development phases and multiple therapeutic areas, in both large pharma and smaller biotech, Laura has a proven track-record in drug development, as indicated by her leadership and major contributions toward eight drug approvals.
Prior to Ardelyx, Laura served as Senior Vice President and Head of Clinical Development and Biostatistics at AMAG Pharmaceuticals, where she was responsible for four investigational-staged assets and two on-market compounds. Prior to AMAG, she served as Vice President of Clinical Development at Myovant Sciences, where she was responsible for an investigational infertility compound and co-led business development activities to expand the women’s health pipeline. Previously, in her 18-year career at Abbott/AbbVie, she held roles of increasing responsibility, leading multiple global clinical development programs and managing the general medicine therapeutic area.
Laura earned her Bachelor of Science degree from Mississippi State University, a Doctor of Medicine degree from University of Iowa, and a Master of Public Health degree in Epidemiology from University of Washington, where she also completed a clinical fellowship in infectious diseases. She completed her Internal Medicine residency at University of Michigan, where she also served as Chief Resident and Junior Faculty.