Calvin N. Ho, PhD, is a Patient Reported Outcomes Scientist at AstraZeneca, where he ensures that patients’ experiences are captured and analyzed in clinical trials. Previously, as Science Project Coordinator at the Tuberous Sclerosis Alliance, Dr. Ho organized an Externally-Led Patient-Focused Drug Development (ELPFDD) meeting with the US Food and Drug Administration (FDA). He also conducted the patient experience research behind the international drug development survey and Voice of the Patient report that accompanied the meeting. The ELPFDD meeting, one of the first such meetings ever held, empowered patient advocates to tell FDA representatives about their experiences living with the disease. These data can inform regulators’ reviews of new treatments as well as drug and device companies’ development plans.