From Patient Involvement to Patient Leadership - Donna Cryer, JD and Chief Patient Officer

From Patient Involvement to Patient Leadership: A Conversation with Donna Cryer, JD

Real Pharma, hosted by Na-Ri Oh and Ian Wendt

As AI moves deeper into drug development, from trial design to evidence generation, the more pressing question isn't what the technology can do. It's who has the authority to decide how it's used. In this episode, Na-Ri and Ian sit down with Donna Cryer, JD, founder of the Global Liver Institute, longtime FDA patient representative, and the person credited with creating the Chief Patient Officer role in Pharma. Donna draws a hard line between patient involvement and patient leadership and makes the case that one changes outcomes while the other is often just theater.

Donna Cryer is a lawyer, patient advocate, and two-time (arguably four-time, counting interim roles) CEO who has spent decades pushing patients from the margins of drug development into governance roles with real authority. She was diagnosed with inflammatory bowel disease at 13, which led to a rare autoimmune liver disease and a liver transplant in her twenties. She founded and led the Global Liver Institute for a decade, serves as an FDA patient representative on advisory committees, sits on the board of PathAI, and built the framework that became the pharmaceutical industry's Chief Patient Officer role.

[00:00] Intro — Framing the episode: patient leadership in a moment when pharma is becoming more data-driven and AI-enabled, and why the real question is one of authority, not just capability.

[02:19] What shaped Donna's philosophy — How a decade building the Global Liver Institute, and a career of being one of the only people in the room who knows where the liver actually is, shaped her approach to patient leadership.

[05:33] Liver disease and stigma — Why most of what people think they know about liver disease is wrong, how stigma shows up differently across hepatitis B, hepatitis C, and cirrhosis, and how Donna worked to change CPT coding so mash patients weren't buried under cardiovascular or diabetes diagnoses.

[07:34] Donna's own story — Diagnosed with IBD at 13, an autoimmune liver disease in her twenties, and a transplant that gave her a kind of authority no amount of professional training can substitute for.

[11:22] Defining patient centricity — Donna's litmus test: did something actually change because a patient was in the room? If nothing changed, it wasn't patient engagement, no matter what the meeting deck says.

[17:47] From involvement to leadership — Why one patient out of twenty on a P&T committee isn't leadership, and what it actually takes for patient input to carry weight in a decision rather than just being collected.

[23:14] Building the Chief Patient Officer role — The origin story, why nearly every CPO hire ended up being a physician despite Donna's original intent, and the trust gap she thinks still needs to close: can a patient leader be trusted with fiduciary and business responsibility, not just advocacy.

[30:09] FDA patient representative: voice vs. vote — What it's actually like sitting on an FDA advisory committee with a vote, not just a comment period, and how that changed the outcome of specific drug approval decisions.

[36:50] Culture and acceptance — The uneven reception patient reps still get in rooms full of physicians and biostatisticians, and Donna's approach to turning skepticism into buy-in, plus her case for clinician training on working with patients as peers rather than problems.

[44:24] AI in pharma — Donna's board role at PathAI, and a guiding principle she credits to a colleague: if a task doesn't require your judgment, your license, or your network, AI can probably do it. Where that leaves the parts of the job that still require a human.

[50:06] Where AI helps, and where it doesn't yet — The problem of patient data missing from the sources most models are trained on, and why patient registries, patient communities, and even patient co-authorship on publications matter for closing that gap.

[51:51] Patient skepticism about AI and health data — Why concerns about data governance and security are real, but patients in genuine medical need are often more willing to adopt AI tools than the industry assumes.

[55:05] Closing advice for pharma CEOs — Donna's ask: don't just bring a patient in to solve "a patient problem." Bring a patient in to help solve the biggest problem facing the company.

On what patient centricity actually requires: "My favorite definition of patient centeredness, and certainly patient engagement, is: did something change because a patient was there? If nothing changed, then it wasn't patient... it certainly wasn't patient engagement."

On the difference a vote makes: "The difference between a voice and a vote. A vote is so much better."

On AI and professional judgment: "If it doesn't need my judgment, my license, or my network, I shouldn't be doing it. AI can probably do it."

• Global Liver Institute
• PathAI
• Advanced Advocacy Academy
• Cutting for Stone by Abraham Verghese
• PatientsLikeMe